Ameritox, Ltd. v. Millennium Health, LLC
Filing
215
ORDER granting in part and denying in part #126 Motion for Summary Judgment by Defendant Millennium Laboratories, Inc.; Granting #192 Motion for Leave to File Sur-Reply by Plaintiff Ameritox, Ltd. Defendant may have until 3/2/2015, to serve and file its response as to why summary judgment should not be entered against it on the question of infringement of the '680 patent. Signed by District Judge William M. Conley on 2/18/2015. (voc)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF WISCONSIN
AMERITOX, LTD., and
MARSHFIELD CLINIC, INC.,
Plaintiffs,
OPINION AND ORDER
v.
MILLENNIUM HEALTH, LLC.
13-cv-832-wmc
Defendant.
This patent dispute presents a question of first impression with respect to the
subject matter eligibility of a urine or other biological sample for drug screening and
compliance protocols under 35 U.S.C. § 101, as well as related issues of enablement
under § 112. The analysis is made more challenging by the state of flux in the treatment
of competing goals inherent in § 101 challenges in recent years, and even in recent
months. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289
(2012); In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755
(Fed. Cir. 2014); DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014);
Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014). Of course, this debate
reflects a broader tension in patent law between what is legitimate invention in need of
the incentives of patent law and what is merely description of the natural world for which
no further incentive is required than our desire to understand it better -- a tension
recognized virtually from the outset of the American patent system. See Le Roy v. Tatham,
55 U.S. 156, 159 (1852). Justice Breyer’s relatively recent opinion in Mayo attempts to
reconcile the goal of ensuring that patents do not “impede innovation more than it would
tend to promote it,” and the axiomatic notion that “all inventions, at some level embody,
use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Id.
at 1293.
Thus, Justice Breyer cautions that “too broad an interpretation of the
exclusionary principle could eviscerate patent law.” Id.
Here, plaintiffs Ameritox, Ltd., and Marshfield Clinic, LLC allege that defendant
Millennium Health, LLC infringes two of their patents: U.S. Patents No. 7,585,680 (“the
’680 patent”), purporting to describe a method for drug screening and compliance
protocols for one sample of urine from a patient on a prescribed medication regimen; and
7,785,895 (“the ’895 patent”), purporting to describe a similar method for one biological
sample generally.
(See Am. Compl., Exs. A, B (dkt. ##106-1, 106-2).)
Defendant
Millennium seeks summary judgment of non-infringement and invalidity as to both
patents. (Dkt. #126.) The parties also ask the court to construe various terms common
to both patents, including most notably “known normative data” and “quantifying the
concentration.”
(Def.’s Opening Br. (dkt #130); Pl.’s Opp’n (dkt. #172).)
For the
reasons that follow, the court will deny Millennium’s motion for summary judgment of
non-infringement and invalidity with respect to the ’680 patent and grant the motion
with respect to the ’895 patent, finding the patent invalid for lack of enablement under §
112. For many of the same reasons, the court finds the ’895 patent is vulnerable to the
application of the exclusionary principle under § 101, while the ’680 patent is
substantially less so.
2
UNDISPUTED FACTS
I. The Licensing Agreement
Plaintiff Marshfield Clinic is a health care and research organization. Marshfield
is also the assignee of the patents-in-suit from the inventors, Dr. Michael Larson and Dr.
Thomas Richards.
Plaintiff Ameritox Ltd. is in the field of pain medication monitoring, including a
provider of urine drug testing (“UDT”) services. Ameritox is the exclusive licensee of the
patents-in-suit pursuant to an exclusive license agreement between Ameritox and
Marshfield dated March 15, 2010. In exchange for an exclusive license, Ameritox agreed
to make certain royalty payments to Marshfield and to use good faith commercial efforts
to develop, market, and sell a drug testing service based on the asserted patents.
II. The Testing Protocols
Ameritox tests urine samples on behalf of doctors, nurses, and other health-care
providers who prescribe pain medications to treat chronic pain.
(Am. Compl. (dkt.
#106) ¶ 7.) Ameritox describes its UDT service as being able to “help clinicians assess
whether patients are correctly taking medications and whether the prescription should be
adjusted.”
(Dr. Paul J. Orsulak Infringement Report (“Orsulak Infringement Rept.”)
(dkt. #117) ¶ 27.)
Healthcare professionals periodically use Ameritox’s services to
monitor drug levels in their patients in order to help assess their patients’ therapeutic
response to medications and adherence to the treatment plan, as well as to detect
3
aberrant behaviors (e.g., illegal drug use) that may complicate treatment. (’680 patent at
2:17-20.)1
On May 16, 2011, Ameritox launched its current Rx Guardian CD service, which
Ameritox asserts is based on the patents-in-suit.2 The testing protocol for Rx Guardian
CD has three phases. (Dr. Paul J. Orsulak Rebuttal Report (“Orsulak Rebuttal Rept.”)
(dkt. #118) ¶¶ 246-56.) First, Ameritox performs a series of laboratory tests to detect
and measure the amount of drug and drug metabolites in a patient’s urine sample (the
“detection” steps, which are reflected in steps (a)-(d) of the ’680 patent).
Second,
Ameritox “normalizes” or “adjusts” urine drug levels for a patient’s hydration status by
determining the metabolite/creatinine ratio of the patient (the “normalization” step, as
reflected in step (e) of the ’680 patent).3 Third, the Rx Guardian CD protocol compares
a patient’s normalized test results to a range of “normative data” collected from other
clinical patients on the same medication, who Marshfield carefully monitored to insure
When citing to the patent, the number before the colon refers to the column number, and the
number or numbers after the colon refer to the line number or line range.
1
The court outlines Ameritox’s patented services here purely for illustrative purposes. Ameritox’s
services have no bearing on claims construction or the court’s infringement analysis. See Zenith
Labs. v. Bristol–Myers Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994) (“As we have repeatedly
said, it is error for a court to compare in its infringement analysis the accused product or process
with the patentee’s commercial embodiment or other version of the product or process; the only
proper comparison is with the claims of the patent.”).
2
3
Creatinine is a by-product of muscle metabolism excreted in urine in relatively constant
amounts throughout the day. (’680 patent at 1:63-2:1.) The patents-in-suit teach calculating a
“drug metabolite/creatinine ratio” to adjust for patient hydration; in other words, measuring the
value of the drug metabolite and the creatinine in the urine sample and then dividing the former
by the latter to obtain a normalized value. (Id. at 5:34-39.) According to Ameritox, urine
creatinine had never been used successfully to develop a urine drug screen that allowed for
comparison and identification of proper and improper use of prescribed medications. (See id. at
2:55-3:3.)
4
adherence to their prescribed opioid regimen (the “determining” step, as reflected in step
(f) of the ’680 patent).
By comparing the patient’s normalized value to a range of values for other clinical
patients believed to be prescribed and taking the same medication properly, the health
care provider can better assess whether a patient is likely to be taking the prescribed drug
in a manner consistent with the prescribed regimen.
The three steps outlined above
largely truncate the steps outlined in claim 1 of the ’680 patent, which states:
1. A method for quantifying at least one metabolite in a biological sample
comprising the steps of:
(a) providing one biological sample obtained from a patient on a prescribed
medication regimen, wherein the sample comprises at least one test
metabolite, wherein in the sample is urine;
(b) providing one set of known normative data specific to a reference
metabolite, wherein the set of data is collected from a population that is on
a prescribed medication regimen;
(c) contacting the biological sample with an analytical device;
(d) detecting the presence of at least one test metabolite in the biological
sample with the device, wherein the device is capable of measuring the
concentration of the test metabolite in the sample;
(e) normalizing the biological sample to adjust for changes in the patient's
hydration status by determining the metabolite/creatinine ratio of the
patient; and
(f) quantifying the concentration of at least one test metabolite in the
biological sample by comparing a ratio between the concentration of the
test metabolite from the patient to the set of known normative data specific
to the reference metabolite concentration.
(’680 patent at 21:9-32.)
5
III. The Specification, Prosecution History and Reexamination Certificates
The patents-in-suit have a priority date of August 28, 2003, and cover a method
to monitor medication usage and to detect aberrant drug usage patterns, including overuse and under-use of prescribed medications. (’680 patent at ABSTRACT.) The patents
share the same specification, which states that adherence to a prescribed medication
regimen is important to the success of most treatments, “particularly in patients in drug
abuse or chronic pain programs.” (Id. at 1:21-24.) The specification further describes a
number of sources used by health care professionals to monitor medication usage,
including interviews with patients, medical records, pill counts, prescription monitoring
programs, and testing of biological samples, such as urine. (Id. at 1:42-48, 15:11-15.)
The specification also states that urine drug screens available in 2003 were limited to
reporting a positive or negative result because of “the large amount of variability in urine
drug concentrations, mostly due to variations in hydration and urinary output volume.”
(Id. at 1:50-53.)
Both patents highlight problems with purely “up or down” test results.
In
particular, so long as patients took some amount of medication, their test results were
positive and patients who overused or underused their medications continued to receive
the same prescription:
To date, a test is purely negative or positive as to the presence or absence of a drug
metabolite in the urine. Accordingly, it would be useful to develop a method
to assess with confidence patient adherence to prescribed drug treatment
regimens.
(Id. at 2:61-3:3 (emphasis added).)
In light of the problems in the prior art, the
specification goes on to state that:
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[t]he method of the present invention enables improved clinical accuracy of
protocols used in testing biological samples, such as, urine testing [and] the
present invention can substantially improve the ability of a clinician to monitor
and confirm whether a patient has been using the medication in a manner which is
consistent with the prescription.
(Id. at 3:17-19, 4:50-54) (emphasis added).) The specification thus describes a method
to “improve” or “enhance” medication monitoring and seeks to identify aberrant drug
use. (Id. at 3:17-19.)
The description of the invention is also reflected in the prosecution history,
including the inventors’ statement that:
Applicants developed a normative database for the drug metabolite
hydration corrected ratio that allows statistical analysis of drug metabolite
level in urine to determine if the medication is utilized in a manner
consistent with the prescription or what the potential dose may have been.
(Declaration of Rebecca C. Mandel (“Mandel Decl.”), Ex. 24 (dkt. #129-24) pp.14-15);
see also id., Ex. 17 (dkt. #129-17) p.9.)
By contrasting the invention with prior art
references, the invention is better elucidated. For example, the inventors submitted to
the Patent Office that the “Kell [reference] focuses on adulteration of the urine sample,
whereas applicants’ method [a] focuses on identification of the urine, [b] correction of
hydration in order to reduce variability and then [c] comparison of that corrected drug
metabolite to a normative database to identify appropriate or inappropriate” drug use.
(Id., Ex. 24 (dkt. #129-24) p.15.) The inventors further represents that “none of the
patent publications from the Kell portfolio anticipate or render the claims obvious.” (Id.)
The Patent Office agreed with the inventors’ submission leading to issuance of
both patents. The patents also survived two more recent reexaminations, with the Patent
Office issuing: the first reexamination certificates for the patents-in-suit in May and June
7
2013, leaving each of the challenged claims intact and issuing additional claims, and a
second set of reexamination certificates on May and July 2014 -- again leaving each of
the challenged claims intact. (See id., Ex. 1 (dkt. #129-1) pp.27-30; id., Ex. 2 (dkt. #1292) pp.26-29.)
IV. Prior Art4
There are several references cited in the prosecution history (and by the parties
themselves) that constitute prior art so well known by the “scientific community” at the
time of the invention that it assists in determining whether the combination of elements
in ’680 patent constitute inventive concept. See Mayo, 132 S. Ct. at 1298 (patent is
invalid if any additional steps consist of well-understood, routine, conventional activity
already engaged in by the scientific community). In reviewing these references, the court
is mindful that when prior art is put into evidence -- either existing as part of the
prosecution history or cited in expert reports -- the reference must be considered in its
entirety, i.e., as a whole, including portions that would teach or steer away from the
claimed invention. W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed.
Cir. 1983).
One of the most relevant prior art references in this case is the George Article. S.
George & R.A. Braithwaite, A Pilot Study to Determine the Usefulness of the Urinary Excretion
4
Relevant prior art references are outlined at this juncture not only to provide the lens through
which a person skilled in the art would construe the claims, but because Millennium makes the
representation at the beginning of its brief that “[t]he patents-in-suit attempt to employ [a] prior
art creatinine-normalization method to detect whether a patient is abusing or diverting his/her
drug by predicting the dosage of medication taken by the patient.” (Def.’s Opening Br. (dkt.
#130) 21.) This argument is central to Millennium’s theory that the claims are invalid under 35
U.S.C. § 101.
8
of Methadone and its Primary Metabolite (EDDP) as Potential Markers of Compliance in
Methadone Detoxification Programs, J. ANALYTICAL TOXICOL., Mar./Apr. 1999, at 81-85. (See
Mandel Decl., Ex. 43 (dkt. #129-43).) The authors of the George Article investigate
urinary excretion to determine whether “methadone or EDDP could be a simple and
noninvasive marker of methadone compliance.” (Id. at 83.) Testing was specifically
performed “to try to resolve the issue of whether urinary excretion could be used in place of
plasma concentration as a mechanism to monitor compliance during methadone
replacement therapy for opiate addiction.” (Id. (emphasis added).)
The George Article was cited before the Patent Office, and it is also cited at length
in Dr. Wu’s expert report, opining that the patents were invalid on §§ 101, 102 and 103
grounds.5
Millennium further cites the George Article in support of the factual
proposition that “normalizing urinary samples via metabolite/creatinine ratios [was] a
routine and conventional practice” at the time of the invention. (Def.’s PFOFs (dkt.
#127) ¶ 259.) The crux of the article, however, is best summarized by Ameritox’s expert
Dr. Orsulak who explains:
One aim of the George article was to determine if quantitative urinary
excretion data of methadone and EDDP may be used to distinguish
between compliant and noncompliant subjects undergoing methadone
detoxification. (George article at 83.) The George article discloses two
datasets from different patient populations. One patient population
consisted of 14 control subjects. A second patient population consisted of
56 drug abusers, including those suspected of missing dosages or topping
up from other sources of methadone. (George article at 83.) The George
article concludes, “there is too large of an interindividual variation to use
While Millennium does not move for summary judgment on novelty and obviousness grounds,
as evidenced by the George Article, “in evaluating the significance of additional steps, the § 101
patent-eligibility inquiry and the § 102 novelty inquiry might sometimes overlap.” Mayo, 132 S.
Ct. at 1304.
5
9
urinary excretion concentrations of methadone or EDDP as markers of
compliance.” (George article at 83.)
(Orsulak Rebuttal Rept. (dkt. #118) ¶ 59.)
As Dr. Orsulak points out, the George Article “never compares the results from
any of the 56 drug abusers to the 14 control subjects.
Rather, to the extent any
comparison is made, the George article only discloses comparing a patient’s test result to
earlier results from that same patient.” (Id. at ¶ 86 (emphasis added).) “In other words,
the George article discloses a straight historical results analysis, without any 95%
inclusion range being involved, nor is any comparison to a known normative database
disclosed.” (Id.) Thus, the “only comparison disclosed in the George article is a single
patient’s test result to his/her own earlier test results.”
(Id.)
These facts were not
squarely controverted in Dr. Wu’s opinion, nor is there anything else in the record that
puts them into dispute.
The George Article offers further insights into what was well known at the time of
the claimed invention:
“there is too large of an interindividual variation to use urinary excretion
concentrations of methadone or EDDP as markers of compliance”;
urinary excretion testing “would point to a lack of suitability of using urine
concentrations of EDDP or methadone as markers of compliance”; and
“the only reliable method available to monitor methadone compliance is the use of
plasma methadone drug testing.”
(Mandel Decl., Ex. 43 (dkt # 129-43) 84-85.)
In each respect, the George Article
supports a conclusion that at the time of the invention, blood testing was the only
10
reliable method to determine whether a patient was complying with a prescribed drug
regimen.
Another article that reflects the state of the art is the Haddow Article. Haddow,
J., et al., Replacing Creatinine Measurements with Specific Gravity Values to Adjust Urine
Cotinine Concentrations, CLINICAL CHEM. 562 (1994).
(See Expert Report of Roger L.
Bertholf, Ph.D. (“Bertholf Rept.”), Ex. H (dkt. #209-8).) The Haddow Article evaluates
the use of creatinine and specific gravity values in a study of environmental tobacco
smoke exposure in non-smoking children with asthma. (Id. at 562.) Haddow uses a
regression analysis of the logarithm of urinary cotinine and creatinine in a population of
116 children who were not exposed to environmental tobacco smoke. (Id.)
“[A]lthough measuring creatinine measurements to reflect hydration” was known,
Haddow teaches that it adds “complexity and cost when such measurements are applied
in routine and clinical practice.” (Id.) This is why “specific gravity (relative density)
measurements in urine samples from children with asthma” were used to “provide
information equivalent to that from creatinine measurements.” (Id.) Moreover, Haddow
does not involve drug treatment or compliance with a prescribed drug regimen and no
known normative database is developed. (Id. at 562-64.)
V. The Skilled Addressee6
For the purposes of identifying a person of ordinary skill in the art, the court
agrees with Dr. Orsulak that the “relevant art of the subject matter claimed by the
For the purposes of this opinion the terms “skilled addressee” or “skilled artesian” mean persons
having ordinary skill in the art (often abbreviated POSITA or PHOSITA).
6
11
patents-in-suit is medication or therapeutic drug monitoring.” (Orsulak Rebuttal Rept.
(dkt. #118) ¶ 3.) Orsulak further opines that such a person would have a degree in a
field “such as medicine, biochemistry, biology, clinical health psychology, clinical
laboratory sciences, clinical toxicology, or pharmacology and several years of work
experience related to medication or therapeutic drug monitoring, including drugs-ofabuse testing or substance abuse testing.”
(Id.)
This characterization of the skilled
addressee seems sensible; nothing in Millennium’s materials alters this viewpoint; and the
characterization is consistent with the field of the art applicable to the invention.7
VI. The Claims of the ’680 and the ’895 patent
The disputed claims in suit -- specifically claims 1, 2, 4-7, 10 and 16-18 of the
’680 patent and claims 1, 4-5, 10-12 and 14 of the ’895 patent -- generally disclose a
series of six steps that culminate in a final comparison step between the drug collected
from a patient’s urine sample to “known normative data” collected from a patient
population. Neither party disagrees with this characterization. As such, the asserted
independent claims of the ’680 patent (claims 1 and 4) and the ’895 patent are
represented below.
Claim 1 of the ’680 patent states:
1. A method for quantifying at least one metabolite in a biological sample
comprising the steps of:
Millennium acknowledges in its briefing that the parties dispute the level of ordinary skill
required in the art. Millennium further argues, however, that its assertions throughout its brief
apply equally to both parties’ proposed characterizations of the level of ordinary skill in the art.
This strongly suggests, whether or not Millennium would still technically dispute it, that there is
no material difference between the parties’ characterizations of the level of knowledge of the
skilled addressee.
7
12
(a) providing one biological sample obtained from a patient on a prescribed
medication regimen, wherein the sample comprises at least one test
metabolite, wherein in the sample is urine;
(b) providing one set of known normative data specific to a reference
metabolite, wherein the set of data is collected from a population that is on
a prescribed medication regimen;
(c) contacting the biological sample with an analytical device;
(d) detecting the presence of at least one test metabolite in the biological
sample with the device, wherein the device is capable of measuring the
concentration of the test metabolite in the sample;
(e) normalizing the biological sample to adjust for changes in the patient's
hydration status by determining the metabolite/creatinine ratio of the
patient; and
(f) quantifying the concentration of at least one test metabolite in the
biological sample by comparing a ratio between the concentration of
the test metabolite from the patient to the set of known normative
data specific to the reference metabolite concentration.
(’680 patent at 21:9-32 (terms in dispute have been bolded).)
Claim 1 of the ’895 patent states:
A method for quantifying at least one metabolite in at least one biological
sample comprising the steps of:
(a) providing at least one biological sample obtained from a patient on a
prescribed medication regimen, wherein the biological sample comprises at
least one test metabolite;
(b) providing one set of known normative data specific to a reference
metabolite, wherein the set of data is collected from a population that is on
a prescribed medication regimen;
(c) contacting the biological sample with an analytical device;
(d) detecting the presence of at least one test metabolite in the biological
sample with the device, wherein the device is capable of measuring the
concentration of the test metabolite in the at least one biological sample;
(e) normalizing the biological sample to adjust for changes in the patient’s
13
hydration status by determining the metabolite/creatinine ratio of the
patient; and
(f) quantifying the concentration of at least one test metabolite in the
biological sample by comparing a ratio between the concentration of the
test metabolite from the patient to the set of known normative data specific
to the reference metabolite concentration.
(’895 patent at 20:56-21:12.)
With regard to the disputed terms, the parties’ preferred constructions are
summarized in the following table:
Disputed Terms
Plaintiff
Ameritox’s
Preferred
Construction
Defendant Millennium’s
Preferred
Construction
“known normative data”
(all asserted claims)
Plain and Ordinary
Meaning
Known dose-specific data that is
related to the population it is
intended to predict
“quantifying the
concentration of at least one test
metabolite in the biological
sample by comparing a ratio
between the concentration of the
test metabolite from the patient to
the set of known normative data
specific to the reference
metabolite concentration”
(all asserted claims)
Plain and Ordinary
Meaning
To the extent that this term can be
construed, it means: predicting the
dosage taken by a
patient from at least one test
metabolite in the biological sample
by comparing the ratio based on
the concentration of the test
metabolite from the patient to the
set of known normative data
specific to the reference metabolite
concentration
Millennium contends that the purpose of the patents is to quantify a specific dose.
It argues that this purpose provides the proper context and is dispositive of what is meant
by “known normative data.” Similarly, with respect to the second disputed phrase -“quantifying the concentration” -- Millennium argues in favor of a definition that
14
specifically predicts the dosage of the test metabolite. Ameritox contends that neither of
these disputed terms should be so confined.
More specifically, Ameritox argues that
Millennium’s construction seeks to import limitations from the specification to deviate
from the plain and ordinary meaning of the claim terms.
OPINION
Analysis of patent infringement is a two-step process: “first, the scope of the
claims are determined as a matter of law, and second, the properly construed claims are
compared to the allegedly infringing device to determine, as a matter of fact, whether all
of the limitations of at least one claim are present, either literally or by a substantial
equivalent, in the accused device.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313,
1323 (Fed. Cir. 2002); Split Pivot, Inc. v. Trek Bicycle Corp., 12-CV-639-WMC, 2013 WL
6564640, at *2-3 (W.D. Wis. Dec. 13, 2013).
I. Claim Construction
Claim terms “are examined through the viewing glass of a person skilled in the
art.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). This provides an
“objective baseline” from which to begin the claim analysis. Innova, Inc. v. Safari Water
Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004). The inquiry is assessed at the
time of the invention, where the words of a claim “are generally given their ordinary and
customary meaning.” Phillips, 415 F.3d at 1313.
Because an “ordinary and customary” meaning may not be readily apparent, and
because “patentees frequently use terms idiosyncratically,” courts look to the patent
15
specification, the prosecution history, and pertinent extrinsic evidence to construe
disputed claim terms. Id. at 1314. The specification is typically considered the “best
source for discerning the proper context of the claims.” Phillips, 415 F.3d at 1315; United
States v. Adams, 383 U.S. 39, 49 (1966) (describing as “fundamental that claims are to be
construed in the light of the specification”). But when using the specification for the
purposes of context, the skilled addressee must not improperly import a limitation from
the specification into the claims themselves. See Innova, 381 F.3d at 1117 (district court
improperly read limitations from the specification into the claims); White v. Dunbar, 119
U.S. 47, 51, (1886).8
Claim construction, therefore, requires a scalpel, not a sledgehammer because
there is a thin line between interpreting the claims in view of the specification and
improperly reading limitations from the specification into the claims. See Innova, 381 F.3d
at 1117 (considering the contrasting nature of these axioms to be a “longstanding
difficulty”); see also Componex Corp. v. Electronics for Imaging, Inc., No. 13-CV-384-WMC,
2014 WL 3556064, at *7 (W.D. Wis. July 18, 2014).
A. “Known Normative Data”
The term “known normative” data is referenced in element (b) and element (f) of
claim 1. (See, e.g., ’680 patent at 21:28-32.) The claim language expressly states that
known normative data is “collected from a population that is on a prescribed medication
Given the minor differences among the asserted claims, the court’s construction for “known
normative data” and “quantifying the concentration” applies equally to all of the asserted claims.
This approach, noted in the parties’ briefs, also seems sensible given that both patents share the
same specification which informs claim meaning.
8
16
regimen.” (Id. at 21:16-17.) In the abstract, known normative data is collected from a
population and used as the invention’s baseline so it may be compared to a patient’s
normalized urine sample to determine whether there is compliance with a prescribed
medication regimen.
Millennium contends that the term known normative data is known “dose-specific
data that is related to the population it is intended to predict.” (Def.’s Opening Br. (dkt.
#130) 20.)
Millennium contends that its proposed construction is the only one that
reflects the express function of the invention. That function, Millennium contends, is to
determine the exact dosage taken by a patient (and thereby determining whether a
patient is complying with the prescribed dosage). Much of Millennium’s construction is
based on passages and examples in the specification, with particular emphasis placed on
the following passages:
“This example describes how a drug metabolite/urine creatinine ratio . . . could be
used to improve the ability of clinicians to predict appropriate use of prescribed
medication, as well as detect and quantify inappropriate use.” (’680 patent at 6:
58-62.)
“The goal of the model was to be able to predict whether a patient had adhered
to a prescribed dosage regimen.” (’680 patent at 9:65-66.)
Arguing that these passages reflect the purpose of the patents -- “to predict the
dosage taken by a patient” -- Millennium contends that the claim language should be
construed in accordance with that purpose. (Def.’s Opening Br. (dkt. #130) 24.) In
addition, Millennium points to Example 1 for support. That example “describes how a
17
drug metabolite/urine creatinine ratio in patients . . . could be used to improve the ability
of clinicians to predict appropriate use of prescribed medication, as well as detect and
quantify inappropriate use.” (’680 patent at 6:58:62.) Specifically, Example 1 describes
the collection of UDT data from a population of seven patients on “a specified
methadone dosing regimen.” (Id. at 7:7-8.) Such data is reflected in Table III in each of
the patents. Example 1 thus teaches a “regression model for the prediction of methadone
intake,” namely statistical analysis of “known normative data” to predict the dosage of
methadone taken by a patient. (Id. at 9:31-33.) From this, Millennium concludes that
because the example is the “only detailed disclosure of the claimed invention in the
patents-in-suit,” it is instructive and should dictate claim meaning. (Def.’s Opening Br.
(dkt. #130) 30.)
The court, however, rejects Millennium’s construction for several
reasons.
To succeed, Millennium ignores a “‘bedrock principle’ of patent law that ‘the
claims of a patent define the invention.’” Phillips, 415 F.3d at 1312; see also Thorner v.
Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). Millennium also
faces an uphill battle in negating the general rule that claims are given their customary
and ordinary meaning.
See Teleflex, Inc. v., 299 F.3d at 1325 (“We indulge a ‘heavy
presumption’ that a claim term carries its ordinary and customary meaning.”).
Specifically, courts should “only interpret a claim term more narrowly than its ordinary
meaning under two circumstances: (1) when a patentee sets out a definition and acts as
[its] own lexicographer, or (2) when the patentee disavows the full scope of a claim term
either in the specification or during prosecution history.” Aventis Pharma SA v. Hospira,
18
Inc., 675 F.3d 1324, 1330 (Fed. Cir. 2012) (internal quotation omitted). “The standards
for finding lexicography and disavowal are exacting.” Hill-Rom Servs., Inc. v. Stryker Corp.,
755 F.3d 1367, 1371 (Fed. Cir. 2014) (emphasis added). Neither of these circumstances
applies here; nor is there any other canon of construction that allows Millennium to
prevail.
First, Millennium points to no definitive definition of “known normative data” in
the specification that supports its construction. When the skilled addressee turns to the
specification the only definition that even comes close to the disputed phrase is the
phrase: “normative database.” (’680 patent at 5:60-65.) Notwithstanding the fact that
“normative database” is worded differently to “known normative data” (the disputed
term), Millennium’s reliance on the former falls flat because the definition of “normative
database” simply states “a collected set of data that is related to a specific population it is
intended to predict.” (Id. at 5:58-60.) Contrary to Millennium’s position, there is no
mention of dose specific data or dose specific regimen. Because none of the definitions in
the specification supply claim meaning, Millennium’s proposed construction must be
rejected. See Hospira, Inc., 675 F.3d at 1330; Aria Diagnostics, Inc. v. Sequenom, Inc., 726
F.3d 1296, 1301 (Fed. Cir. 2013) (“Taken in context, this evidence does not support the
trial court’s interpretation, and certainly is not clear lexicography or disavowal.”).
Second, there is no claim disavowal in the prosecution history.
The best that
Millennium can muster is the following passage:
Applicants developed a normative database for the drug metabolite
hydration corrected ratio . . . to determine if the medication is utilized in a
manner consistent with prescription or what the [patient’s] potential dose
may have been.
19
(Def.’s Opening Br. (dkt. #130) 29 (emphasis altered).) Millennium’s reliance on this
passage is deficient for much the same reason as the first: the term normative database is
used instead of the actual disputed term that is subject to the litigation (i.e., known
normative data). But even if the proper disputed phrase had been referenced above, the
passage still supplies little to support Millennium’s position. Indeed, the passage creates
more questions than answers due to the permissive language used. Said another way, the
word “may” preceded by the phrase “manner consistent with the prescription” is hardly
verbiage that disavows the full scope of a claim term.
Neither phrase is “exacting.”
Stryker Corp., 755 F.3d at 1371. While Millennium argues that a person skilled in the art
would equate the phrase “manner consistent with prescription” as meaning dose specific
data, the court is not so convinced.
Id. at 1372 (“Disavowal requires that the
specification or prosecution history make clear that the invention does not include a
particular feature.”).
Third, Millennium provides no meaningful discussion for how references in the
specification and the prosecution history narrowed claims scope to circumvent prior art.
More specifically, nothing in the specification indicates that “dose specific data” is an
essential feature of the claimed invention over the prior art. See Liebel–Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 906-09 (Fed. Cir. 2004) (distinguishing cases where the court
narrowly construed an otherwise broad claim term).
To be fair, Millennium does argue that:
[d]uring prosecution of the ’680 patent, the patentees specifically used the
known dose-specific element of “known normative data” to distinguish the
claimed invention from the prior art. Specifically, the patentees asserted
that “[a]pplicants are able to not only accurately analyze the level of drug
20
metabolite, within a specific patient, but more importantly, across
individuals on the same drug and drug dose.”
(Def.’s Opening Br. (dkt. #130) 29 (emphasis omitted).) But, in the next sentence, and
without supplying any further analysis, Millennium concludes that its construction
“makes sense.” (Id.) The problem with Millennium’s argument is simple: it lacks depth.
While an argument based on prosecution estoppel would tend to have traction in most
cases, Millennium’s argument here is only limited to the above mentioned passage -perhaps because it had little to work with in the first place.
This limited analysis
contrasts starkly with a recent case in this court, finding that a functional definition was
deliberately used by the patentees to avoid prior art.
See Componex Corp., 2014 WL
3556064, at *7 (holding that during the litigation, the definition could not be abandoned
in order to expand the scope of its “patent beyond what was previously claimed”).
Here, no effort is made by Millennium to show that the inventors deliberately
abandoned claim scope to traverse prior art, let alone refer to the specific prior art
references that inventors were seeking to distinguish in the prosecution history to provide
a basis for estoppel.
Without such analysis, Millennium’s construction is far less
persuasive. It is rejected accordingly. Cf. Spectrum Int’l, Inc. v. Sterilite Corp., 164 F.3d
1372, 1379-80 (Fed. Cir. 1998) (“By distinguishing the claimed invention over the prior
art, an applicant is indicating what the claims do not cover.”).
Fourth, Millennium’s argument fares no better when it points to examples in the
specification to construe the claims.
Specifically, Millennium argues that known
normative data must mean “dose specific” data because Example 1 expressly supplies
such meaning when read in the context of both patents. To succeed in this argument,
21
Millennium must again overcome the presumption that favors plain and ordinary
meanings of claim terms. In Teleflex, the Federal Circuit held that the district court erred
when it imported a limitation from the specification, thereby straying from the ordinary
meaning of the claim term “clip” by requiring a “clip” to have a “single pair of legs,” even
though the only embodiment in the specification disclosed a clip having a single pair of
legs. 299 F.3d at 1327-28 (emphasis added). Thus, in Teleflex, the only embodiment in
the specification supported the alleged infringer’s position -- and the Federal Circuit still
reversed.
Unlike Teleflex, multiple embodiments are provided in the ’680 and ’895 patents.
Although Example 1 does provide a dose specific embodiment, other embodiments are
not so confined.
Ameritox directed the court to the following passage from the
specification that is illustrative:
The method [of the invention] is carried out by contacting the biological
sample with a device capable of distinguishing between the test metabolite
and a reference metabolite; detecting the presence of at least one test
metabolite in a biological sample; and quantifying the concentration of at
least one test metabolite in a biological sample by comparing a ratio
between a set of unknown data from the test metabolite versus a set of
known normative data specific to the reference metabolite. The method of
the present invention enables improved clinical accuracy of protocols used
in testing biological samples, such as urine testing.
(’680 patent at 3:6-18 (emphasis added).)
Even if all the embodiments described known normative data as including dosespecific data (and they do not), Millennium’s construction would still stray impermissibly
from the plain and ordinary meaning of the claim term. Teleflex states as much. 299 F.3d
at 1325; see also Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1301 (Fed. Cir.
22
2013) (“[E]ven if a specification has only one embodiment, its claims will not be
confined to that example ‘unless the patentee has demonstrated a clear intention to limit
the claim scope using words or expression of manifest exclusion or restriction.”’ (quoting
Liebel-Flarsheim, 358 F.3d at 906)); MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d
1323, 1334 (Fed. Cir. 2007) (“[A] fundamental principle of patent claims construction is
that the court should not read limitations from the specification into the claim language;
the specification can only be used to limit a claim if there has been ‘a clear disclosure that
the patentee intended the claims to be limited.’” (internal citation omitted)).
As the passage explains, the use of the phrase known normative data is
deliberately juxtaposed with unknown data from the test metabolite. The juxtaposition
is used to demonstrate that while the invention does require known normative data to
provide a baseline from which to improve clinical urine testing, that data need not be a
specific dosage. Indeed, had the patentee sought to limit the claim language in this way,
it would have elected to do so. The lack of a limitation in the claims reinforces the case
against a restrictive reading of the disputed term. See ACTV Inc. v. Walt Disney Co., 346
F.3d 1082, 1088 (Fed. Cir. 2003) (“[T]he analytical focus of claim construction must
begin, and remain centered, on the language of the claims themselves.”).
More specifically, element (b) of claim one expressly states: “providing one set of
known normative data specific to a reference metabolite, wherein the set of data is collected
from a population that is on a prescribed medication regimen.” (‘680 patent at 21:16-17
(emphasis added).) Language in the embodiment above tracks key language in claim 1 of
the ’680 patent as demonstrated here, only strengthening Ameritox’s construction -- i.e.,
23
data that is not unknown, and certainly not limited to data that is dose specific. The
view is fortified by the fact that when inventors knew how to specify dose in one of the
patents’ embodiments (Example 1), they did so.
And by not doing the same in the
claims, this tends to end the debate over the disputed term. (Compare ’680 patent at
9:65-66 (specification using the term “prescribed dosage regimen”), with id. at 21:16-1
(claim 1 using the phrase “prescribed medication regimen”).)
Accordingly, because of the claim language conforms with embodiments cited in
the specification and because there is no clear scope disavowal, the court rejects
Millennium’s proposed construction.
B. “Quantifying” (step (f))
Millennium argues that interpretation of step (f) is guided by the “intended
purpose of the patents,” which is “to predict or determine drug dosage taken by a
patient.” (Def.’s Opening Br. (dkt. #130) 44.) It follows, Millennium contends, “that
any construction of the claim -- specifically step (f)’s comparison between the patient’s
ratio to the known normative data from a population -- must reflect the stated goal.” (Id.
at 45.) The court disagrees.
As an initial matter, the purpose of the patents is far broader than what
Millennium maintains. Millennium’s entire construction is predicated on the flawed
assumption that that the patents’ sole objective is to identify the specific dose of a
patient.9
This purpose is too narrowly drawn because the patents’ specification and
In the context of construing element (f), the focus is on the theory that the element is seeking to
quantify a specific dose of the patient; whereas, the focus of the term in element (b), “known
9
24
prosecution history directs one skilled in the art to an invention that allows “analysis of
drug metabolite level in urine to determine if the medication is utilized in a manner
consistent with the prescription or what the potential dose may have been” -- a broader
goal. (Mandel Decl., Ex. 24 (dkt. #129-24) pp.14-15; see also id., Ex. 17 (dkt. #129-17)
p.9.)
Instead of being dose specific, the method of the “invention enables improved
clinical accuracy of protocols used in testing biological samples, such as, urine testing.”
(’680 patent at 3:17-19.)
This, as the inventors say, “can substantially improve the
ability of a clinician to monitor and confirm whether a patient has been using the
medication in a manner which is consistent with the prescription.” (Id. at 4:50-54.)
When compared with pre-existing testing protocols, the state of the art sought to
determine “a positive or negative result as to the presence or absence” of a drug. (Id. at
2:66-67.) In contrast, the ’680 patent provides a method to “improve” and “enhance”
medication monitoring and identify aberrant drug use.
(Id. at 3:17-19.)
While
Millennium is correct in saying that courts look to the object or purpose of the invention,
such analysis must be examined in the totality so to guard against the claims being pulled
in different ways by the different embodiments in the specification. See White, 119 U.S.
at 51-52 (patents are not “nose[s] of wax which may be turned and twisted in any
direction by merely referring to the specification”).
Millennium further contends that each of the examples indicate specific
embodiments of the invention that seek to predict dosage based on the comparison
applied in step (f). For reasons similar to that stated above, this argument must also be
normative data,” was that such data was based on a subject of specific known population where
each subject’s prescribed regimen was specifically known.
25
rejected. Two aspects of the claimed invention include: (1) “determine if the medication
is utilized in a manner consistent with the prescription” and (2) “determine … what the
[patient’s] potential dose may have been.” (Mandel Decl., Ex. 24 (dkt. #129-24) pp.1415; see also ‘680 patent at 3:20-27.) The first aspect can be accomplished with or without
definitive prediction of dosage.
While the second aspect uses dose-specific data, the
patent stops short of claiming that the invention definitively predict ingested dose,
simply stating that the invention may be used to approximate what the “potential” dose
“may have been.”
The multiple aspects of the patent demonstrate that the asserted
claims do not require dose-specific data.
As such, the asserted patents are prime
examples for why the Federal Circuit “repeatedly warn[s] against confining the claims to
[the] embodiments” of the specification. Phillips, 415 F.3d at 1323; see also Teleflex, 299
F.3d at 1325.
Claim language that is narrow would only limit the patents to determining
potential or approximate doses, not whether medication is being used in a manner
consistent with the prescription. The claim encompasses both these embodiments. A
broader purpose afforded to the patented invention reflected in the actual claim language
ensures a plurality of embodiments that fall within the claims. This broad reading of the
claims is further fortified by the fact that the word “dose” and “dose-prediction” appear
nowhere in the asserted claims. Like the previous disputed term, the lack of a limitation
in the claims reinforces the case against a restrictive reading of the disputed term here.
See ACTV, 346 F.3d at 1088 (“[T]he analytical focus of claim construction must begin,
and remain centered, on the language of the claims themselves.”).
26
Accordingly, Millennium’s request that the court read a definitive dose-prediction
limitation into the asserted claims finds no support in the actual claim language. Because
of this, the court will decline Millennium’s invitation to insert a limitation when canons
of construction suggest otherwise. See Phillips, 415 F.3d at 1323; MBO Labs., Inc., 474
F.3d at 1334.
II. Motion for Summary Judgment on Invalidity and Infringement
Summary judgment is warranted under Federal Rule of Civil Procedure 56 “if the
movant shows that there is no genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). The moving party bears
the burden of showing that the facts material to the motion are not in dispute. Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986).
The nonmoving party may not avoid
summary judgment merely by showing that some facts are in dispute; rather, it must
establish that there are factual issues that might affect the outcome of the suit under
governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). Although
the court must “take all facts and reasonable inferences in the light most favorable to”
the nonmoving party, Helman v. Duhaime, 742 F.3d 760, 761 (7th Cir. 2014), the
nonmoving party must still come forth with enough evidence to support a reasonable jury
verdict in its favor, Delta Consulting Grp., Inc. v. R. Randle Constr., Inc., 554 F.3d 1133,
1137 (7th Cir. 2009). Summary judgment is “not a dress rehearsal or practice run,” but
the “put up or shut up moment” in which a party must show what evidence it has to
convince a trier of fact to accept its version of events. Nichols v. Nat’l Union Fire Ins. Co.
of Pittsburgh, PA, 509 F. Supp. 2d 752, 760 (W.D. Wis. 2007) (quoting Schacht v. Wis.
27
Dep’t of Corr., 175 F.3d 497, 504 (7th Cir. 1999)).
Because a patent is presumed valid, Millennium must prove invalidity by clear and
convincing evidence. See Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238, 2242 (2011).
Thus, for Millennium to succeed in the instant motion for summary judgment, it must
present clear and convincing evidence from which a reasonable jury could find that the
patent is invalid. See Nystrom v. TREX Co., 424 F.3d 1136, 1149 (Fed. Cir. 2005); see also
CertusView Techs., LLC v. S & N Locating Servs., LLC, No. 2:13cv346, 2015 WL 269427,
at *14 (E.D. Va. Jan. 21, 2015).10
A. Section 101
Section 101 of the Patent Act defines patentable subject matter:
“Whoever
invents or discovers any new and useful process, machine, manufacture, or composition
of matter, or any new and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.” 35 U.S.C. § 101. The section
defines four categories of patentable inventions: processes, machines, manufactures, and
compositions of matter. Despite these broad categories, § 101 does not encompass all
products of human effort and discovery.
For example, “laws of nature, physical
phenomena, and abstract ideas” constitute ineligible subject matter and are not
patentable. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). All of these exceptions
Other courts, along with some judges on the Federal Circuit, have suggested that it is
inappropriate to require a party challenging validity on § 101 grounds to prove invalidity by clear
and convincing evidence. E.g., Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 720 (Fed. Cir. 2014)
(Mayer, J., concurring) (“Although the Supreme Court has taken up several section 101 cases in
recent years, it has never mentioned -- much less applied -- any presumption of eligibility. The
reasonable inference, therefore, is that while a presumption of validity attaches in many contexts .
. . no equivalent presumption of eligibility applies in the section 101 calculus.”). Although
certainly a closer question, the conclusions reached here would not change under either standard.
10
28
are well established. See, e.g., Diamond v. Diehr, 450 U.S. 175, 185 (1981); Parker v. Flook,
437 U.S. 584, 599 (1978) (Stewart, J., dissenting); Gottschalk v. Benson, 409 U.S. 63, 67
(1972); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948); Mackay Radio &
Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939); Le Roy v. Tatham, 55 U.S. 156
(1853).
1. Recent Legal Developments
The validity of many business and software patents has been called into question
following the Supreme Court’s decision in Alice Corporation v. CLS Bank International, 134
S. Ct. 2347 (2014).11 Patents in the biotechnology and diagnostic fields have also come
under scrutiny since the Alice decision was handed down in June of 2014, with some
having already been found invalid. See, e.g., In re BRCA1- & BRCA2-Based Hereditary
Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014).
As a result, courts and
commentators are understandably seeking more concrete contours in the application of §
101, which instead of acting like the coarse “filter” it once was, now arguably imposes a
“higher bar,” invalidating numerous patents in district courts and inter partes proceedings
before the Patent Office.
Cal. Inst. of Tech., 2014 WL 5661290, at *2; see also
Ultramercial, 772 F.3d at 720. Accordingly, this court will follow the Supreme Court’s
A recent decision by Judge Mariana R. Pfaelzer surveys the many patents that have been
invalidated since June 2014. See Cal. Inst. of Tech. v. Hughes Commc’n, No. 2:13-cv-07245-MRPHEM, 2014 WL 5661290, at *8-11 (C.D. Cal. Nov. 3, 2014); see also Robert R. Sachs, A Survey of
Patent Invalidation Since Alice, LAW360, Jan. 13, 2015, http://www.law360.com/articles/604235/asurvey-of-patent-invalidations-since-alice (noting that only 26% of all patents considered in
district courts since the Alice decision have survived).
11
29
admonition in Alice to “tread[] carefully” in applying this reinvigorated exclusionary
principle to the patents at issue here. 134 S. Ct. at 2354.
In Alice, the Supreme Court articulated a “framework” for determining whether 35
U.S.C. § 101 is met. 134 S. Ct. at 2355 (citing Mayo, 132 S. Ct. at 1296-97). First, a
court determines “whether the claims at issue are directed to one of those patentineligible concepts” -- i.e., whether the claims are directed to laws of nature, natural
phenomena, and abstract ideas. Id. Second, if the claims are directed to patent-ineligible
concepts, the process sought to be patented must include an additional element or a
combination of additional elements that constitute “inventive concept’” -- i.e., “an
element or combination of elements that is ‘sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the [ineligible concept] itself.’”
Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 129); see also Funk Bros., 333 U.S.
at 130 (“If there is to be invention from [a discovery of a law of nature], it must come
from the application of the law of nature to a new and useful end.”).
Before applying the Alice framework to the patents-in-suit, a review of the
Supreme Court’s recent decisions in Mayo, which similarly dealt with drug level testing
and diagnostic patents, as well as some of the post-Alice Federal Circuit decisions may be
helpful.
In Mayo, the patents-in-suit concerned the use of thiopurine drugs in the
treatment of autoimmune diseases. In particular, doctors knew that such drugs could be
helpful in treating Crohn’s disease and that the drugs’ toxicity or effectiveness could be
measured relative to how thiopurine metabolized in the body. Before the filing date of
the invention, however, it had been difficult for doctors “to determine whether for a
30
particular patient a given thiopurine dose was too high, risking harmful side effects, or
too low, and so likely ineffective.” Mayo, 132 S. Ct. at 1295.
Said another way, the
scientific community did not know the precise correlations between metabolite levels and
likely harm or ineffectiveness.
The Supreme Court found that this is where the patent addressed a need, with
claims directed to “processes embodying researchers' findings that identified these
correlations with some precision.”12 Id. While the Court had not yet adopted the twostep framework later set out in Alice, the Mayo analysis certainly reflected the first step of
the Alice framework while suggesting the second.
Specifically, upon coming to the
conclusion that the patent was directed to ineligible subject matter, the Court asked
rhetorically: “What else is there in the claims before us?” Id. at 1297. This provided the
segue to what is now the second part of the Alice framework: the search for inventive
12
The representative claim provided:
A method of optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immunemediated gastrointesti-nal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immunemediated gastrointesti-nal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8x10 red blood
cells indicates a need to increase the amount of said drug subsequently
administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 red
blood cells indicates a need to decrease the amount of said drug subsequently
administered to said subject.
Id. at 1295.
31
concept. At that juncture, the representative claim was divided into an “administering”
step, a “determining” step, and a “wherein” step. Id.
To begin, the Supreme Court held that the “administering” step” did not supply
inventive concept because the “step simply refers to the relevant audience, namely
doctors who treat patients with certain diseases with thiopurine drugs.”
Id.
The
“determining” step was treated with equal disdain because it simply “tells the doctor to
determine the level of relevant metabolites in the blood, through whatever process the
doctor . . . wishes to use.” Id. Justice Breyer found that step “nothing more [than] wellunderstood, routine, conventional activity previously engaged in by scientists who work
in the field.” Id.
To support this conclusion, Justice Breyer cited admissions in the
patent itself that the processes for determining the level of metabolites in a patient’s
blood were “well known in the art.” Id. at 1298.13 As to the “wherein” step in Mayo, the
Supreme Court found those clauses simply “tell the relevant audience about the laws
while trusting them to use those laws appropriately where they are relevant to their
decision-making (rather like Einstein telling linear accelerator operators about his basic
law and then trusting them to use it where relevant).” Mayo, 132 S. Ct. at 1298.
Next, the Court addressed the patentability of the combination of these steps. The
Court found that “to consider the three steps as an ordered combination adds nothing to
While no specific prior art reference outside the four corners of the specification was cited in
support, Justice Breyer presumably relied on undisputed facts in the prosecution history (the
intrinsic administrative record) to determine whether these steps in the process were inventive in
the context of section 101. Cf. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015)
(“[W]hen the district court reviews only evidence intrinsic to the patent (the patent claims and
specifications, along with the patent’s prosecution history), the judge’s determination will amount
solely to a determination of law.”).
13
32
the laws of nature that is not already present when the steps are considered separately.”
Id. Justice Breyer’s opinion distinguished the decision from the Court’s previous holding
in Diamond v. Diehr, 450 U.S. 175 (1981). To Justice Breyer, nothing in Diehr suggests
that the steps of the claimed process or their combination “were in context obvious,
already in use, or purely conventional,” as had been found to be true with respect to the
claimed process in Parker v. Flook, 437 U.S. 584 (1978).14 Mayo, 132 S. Ct. at 1299 (“[I]t
was nowhere suggested that all the steps [in Diehr’s invention], or at least the
combination of those steps were . . . conventional.”). Because of this, Justice Breyer
concluded that “the patentees [in Diehr] did not seek to pre-empt the use of [the]
equation, but sought only to foreclose from others the use of that equation in
conjunction with all of the other steps in their claimed process.” Id. (internal quotations
omitted). In Justice Breyer’s view, these other steps apparently added to the formula in
Diehr something that had significance in terms of patent law's objectives – “they
transformed the process into an inventive application of the formula.”
Id. at 1299
(emphasis added.).
Finally, Justice Breyer expressly addressed the risk of preemption, stating that “the
Court has repeatedly emphasized the concern that patent law [must] not inhibit further
discovery by improperly tying up the future use of laws of nature.” Mayo, 132 S. Ct. at
1301. For this reason, Justice Breyer cautioned against patents that would “foreclose[]
See John M. Golden, Flook Says One Thing, Diehr Says Another: A Need for Housecleaning in the Law
of Patentable Subject Matter, 82 GEO. WASH. L. REV. 1765, 1790-91 (2014) (providing an-in depth
analysis of the Mayo Court’s explanation of its holding).
14
33
more future invention than the underlying discovery could reasonably justify.”
Id.15
Justice Breyer concluded that, as in Benson, where the claimed mathematical formula had
“no substantial practical application except in connection with a digital computer,” the
claims in Mayo were overly broad because they “did not differ significantly from a claim
that just said apply the algorithm.” Id. (citing Benson, 409 U.S. at 71).
Since Mayo and Alice, the Federal Circuit has continued to develop the standard
for what constitutes patentable subject matter.
In particular, two recent decisions
provide insights into what constitutes an “inventive concept” under Alice’s second step.
In DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014), for example,
the Federal Circuit reviewed patents “directed to systems and methods of generating a
composite web page that combines certain visual elements of a host website with content
of a third-party merchant.” 773 F.3d at 1248. Judge Chen found that the patents were
directed toward more than an abstract idea or fundamental business practice; they solved
a problem particular to the internet. Id. at 1257. “Instead of the computer network
operating in its normal, expected manner . . . the claimed system generate[d] and direct[ed]
the visitor to [a] hybrid web page that presents product information from the third-party
and visual ‘look and feel’ elements from the host website.” Id. at 1258-59 (emphasis
Cf. Mark A. Lemley, Point of Novelty, 105 NW. U. L. REV. 1253 1279 n.12 (2011) (“[T]here is
good reason to worry about overbroad patent claims that lock up a wide swath of potential future
applications. But the enablement and written description doctrines largely address that
concern.”); see also Michael Risch, Everything is Patentable, 75 TENN. L. REV. 591, 598–606 (2008)
(offering examples of patentable subject matter cases that could be reframed through the lens of
other patentability doctrines, such as novelty, utility, and adequate disclosure); Anna B.
Laakmann, An Explicit Policy Lever for Patent Scope, 19 MICH. TELECOMM. & TECH. L. REV. 43, 5354 (2012) (“Although they are treated as distinct patentability criteria, the disclosure
requirements are conceptually linked both to each other and to the PSM doctrine.”).
15
34
added). Because the patents were directed toward solving a new problem, particular to
the internet, and solved the problem beyond “routine or conventional use of the
internet,” Judge Chen found that the patents were significantly more than just an
abstract idea. Id. at 1259.16
More recently, the Federal Circuit examined whether gene sequences known as
BRCA1 and BRCA2 could overcome a § 101 challenge. In re BRCA1- & BRCA2-Based
Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014). The case involved
Myriad Genetics, Inc. suing Ambry Genetics Corporation for infringement of U.S. Patent
No. 5,753,441 and U.S. Patent No. 5,747,282. In the 1990s, Myriad had discovered the
precise locations and sequences of the BRCA1 and BRCA2 genes, mutations linked to
hereditary breast and ovarian cancers. Myriad was then able to determine the typical
sequences of the genes most often found in humans (i.e., the “wild-type” sequence for
each), as well as mutations that depart from these two sequences. Some mutations were
harmless, while other mutations correlated with an increased likelihood of developing
particular cancers.
By testing for the presence of these mutations, doctors could
determine whether a patient is particularly prone to developing breast or ovarian cancer.
As in the present case, the method claims involved comparison steps. Ambry,
however, argued that Mayo was directly on point because these claims “simply
identif[ied] a law of nature (the precise sequence of the BRCA genes, and comparisons of
wild-type BRCA sequences with certain mutations of those gene sequences found in the
test subject) and appl[ied] conventional techniques.” Id. at 762. In a slight twist, the
16
Among other things, this case is of note for being the first Federal Circuit case using the Alice
framework that upheld eligibility of a patent under 35 U.S.C. § 101.
35
Federal Circuit declined to decide whether Mayo applied to the process patents “because
the method claims suffer[ed] from a separate infirmity: they recite[d] abstract ideas.” Id.
In analyzing claims 7 and 8, the court noted that both were similar and dependent from
claim 1. In applying the two-step framework of Alice, the court dissected the claims to a
first set of paragraphs, “which describe the comparison of wild type genetic sequences
with the subject's genetic sequence and correspond to the first step of Alice” and the
second set of paragraphs, “which describe the techniques to be used in making the
comparisons and correspond to the second step of Alice.” Id. at 763.
Holding that the first paragraphs -- the comparison step -- amounted to an
abstract idea, the court turned to the second paragraphs in claim 7 and claim 8,
respectively. Id. The court found that the second paragraph of claim 7 described the way
in which the “sequences are compared: they are compared by 1) hybridizing a BRCA
gene probe and 2) detecting the presence of a hybridization product.”
Id. at 764.
Similarly, the court said that “claim 8 requires 1) amplification of the BRCA1 gene and
2) sequencing of the amplified nucleic acids.” Id. The court found that “claims 7 and 8
do not add ‘enough’ to make the claims as a whole patent-eligible.” Id. This holding was
predicated on the unchallenged finding by the district court that the elements of the
second paragraphs of claims 7 and 8 “set forth well-understood, routine and conventional
activity engaged in by scientists at the time of Myriad's patent applications.”
(quotations omitted). The court concluded:
The second paragraphs of claims 7 and 8 do nothing more than spell out
what practitioners already knew -- how to compare gene sequences using
routine, ordinary techniques. Nothing is added by identifying the techniques
to be used in making the comparison because those comparison techniques
36
Id.
were the well-understood, routine, and conventional techniques that a
scientist would have thought of when instructed to compare two gene
sequences.
Id. (emphasis added).
Just as Justice Breyer tethered the notion of well-understood, conventional steps to
“activity already engaged in by the scientific community” in Mayo, 132 S. Ct. at 1298,
the Federal Circuit in BRCA1 tethered the notion of well-understood, conventional steps
to “techniques that a scientist would have thought” to use when deciding to engage in
experiments that were directed to the invention, 774 F.3d at 764 (emphasis added).
Both of these articulations amount to the same concept:
whether the scientific
community would have thought to do something at the time of invention is very much
dependent on what activities scientists had already been engaged in at the time.
Of course, the inverse concept also is true: if inventors engage in activities that
run counter to scientific thought, those activities can hardly be considered conventional
under § 101.
This latter concept would similarly apply when a patent involves a
combination of elements that the scientific community would not have thought to use or
implement to deliver a new, improved and useful result. 35 U.S.C. § 100 (“The term
‘process’ means process, art or method, and includes a new use of a known process.”).
Indeed, the new and useful result of a combination patent resides precisely in a
combination that neither existed in the prior art, nor was the possibility of such a
combination well known in the art at the time of the invention.
When invention is based on the combination of elements that cuts against the
37
grain of scientific thought, this heightens the novelty of invention itself.17 This is not to
say that all inventions must cut against the grain to supply inventiveness. Far from it.
This was not taught in DDR, nor was it in the California Institute of Technology case. The
common thread in both those cases was that both inventions were directed towards a
specific problem in the art and improved functionality.
By doing so, both patents
contributed to the art. See, e.g., Cal. Inst. of Tech., 2014 WL 5661290, at *20 (“Caltech’s
patents improve a computer’s functionality by applying concepts unique to computing
(like using a linear transform operation to encode data) to solve a problem unique to
computing (data corruption due to noise).”). Solving those problems was not said to
preempt because the elements in each invention were combination patents and created
new and useful results that did not foreclose the use of other means to arrive at that same
result: “it at least must be true that § 101 protects a unique computing solution that
addresses a unique computing problem.” Caltech, 2014 WL 5661290, at *20.
The Supreme Court recognized the potential for overlap between § 101 and § 102 in Mayo,
132 S. Ct. at 1304 (“the § 101 patent-eligibility inquiry and, the § 102 novelty inquiry might
sometimes overlap”). This is also borne out by the legislative history that states expressly that §
102 is an amplification and definition of “new” in § 101. Specifically, the Senate Report
associated with the 1952 Patent Statute stated:
17
Section 101 sets forth the subject matter that can be patented, ‘subject to the conditions
and requirements of this title.’ The conditions under which a patent may be obtained
follow, and section 102 covers the conditions relating to novelty.
S. Rep. No. 82-1979, 1952 U.S.C.C.A.N. 2349, 2399. Later, the same Report observes:
Section 102, in general, may be said to describe the statutory novelty required for
patentability, and includes, in effect, an amplification and definition of ‘new’ in section 101.
Id. (emphasis added). Of course, this amplification of § 101 does not mean that 101 and 102 are
the same. Perhaps a better analogy is that the sections “overlap,” much like two circles in a Venn
diagram. Mayo, 132 S. Ct. at 1304.
38
While not expressly referenced in the Alice framework, an underlying concern is
general preemption. That concern was underscored in Mayo. As previously discussed,
what lies at the core of preemption is the question of whether the patent “forecloses more
future invention than the underlying discovery could reasonably justify.”18 Id. at 1301.
For example, a well-tailored invention seeking to solve a specific problem with specific
claim limitations should not typically trigger preemption concerns, at least where the
invention is new and useful.19
To satisfy the framework laid out in Alice, therefore, the invention must “supply a
“‘new and useful’” application of the idea in order to be patent eligible.” Alice, 134 S. Ct.
at 2357; see also Le Roy v. Tatham, 55 U.S. 156, 159 (1852) (“There can be no doubt that,
if this combination is new, and produces a new and useful result, it is the proper subject
of a patent. The result is a new manufacture. And even if the mere combination of
machinery in the abstract is not new, still, if used and applied in connection with the
practical development of a principle, newly discovered, producing a new and useful result,
the subject is patentable.”).
A non-conventional application of an abstract idea will tend not to preempt. This is how
Justice Breyer attempted to reconcile Diehr with Flook -- explaining that in Diehr, “the patentees
did not seek to pre-empt the use of [the] equation, but sought only to foreclose from others the
use of that equation in conjunction with all of the other steps in their claimed process.” Mayo, 132 S. Ct
at 1299 (quoting Diehr 450 U.S. at 187) (emphasis added); see also Cal. Inst. of Tech., 2014 WL
5661290, at *15 (“Although many of these limitations are mathematical algorithms, these
algorithms are narrowly defined, and they are tied to a specific error correction process. These
limitations are not necessary or obvious tools for achieving error correction, and they ensure that
the claims do not preempt the field of error correction. The continuing eligibility of this patent
will not preclude the use of other effective error correction techniques. Therefore, all of the
asserted claims are patentable.”).
18
Of course, all valid patents foreclose use and preempt. That’s their purpose. See Bernard Chao,
Finding the Point of Novelty in Software Patents, 28 BERKELEY TECH. L.J. 1217, 1235-36 (2013)
(“Almost any claim can be characterized as too broad if the concept is defined narrowly.”).
19
39
2. Analysis of the ’680 patent
In what amounts to a conspiracy of silence, while Millennium challenges both the
’680 patent and the ’895 patent under § 101, both parties focus their § 101 analysis
narrowly on the more tailored ’680 patent, likely because Millennium must prevail in its
challenge with respect to both and plaintiffs are happy to argue § 101 using the stronger
of its two patents. Because the ’895 patent is invalid for lack of enablement, the analysis
here will also focus on the ’680 patent, although the likely implications for a similar
analysis with respect to the ‘895 patent may at times be obvious.20 For the reasons set
While the ’680 patent is valid under both §§ 101 and 112, the ’895 patent claims too much
under either section. Not restricted to urine screening, the claims in the ’895 patent extend to
blood, saliva, etc., while at the same time failing to enable one skilled in the art to properly
understand the invention. Indeed, there is not only overlap between §§ 101 and 102/103, as
Justice Breyer suggests in Mayo, the preemption concern bridges the divide between §§ 101 and
112. 132 S. Ct. at 1301. See Mark A. Lemley, et al., Life After Bilski, 63 STAN. L. REV. 1315,
1329-30 (2011) (noting similarities and some of the nuanced differences between enablement
and patentable subject matter regarding issues relevant to the time of filing). Even so, the court
will follow the Supreme Court’s lead in Mayo and decline an invitation to forego any analysis of
the ‘895 patent, 132 S. Ct. 1304, while acknowledging that a dispute exists in the Federal Circuit
and lower courts as to whether this is necessary. Compare Ultramercial, Inc. v. Hulu, LLC, 772
F.,3d 709, 718 (Fed. Cir. 2014) (Mayer, J., concurring) (“Just as a court must assure itself of its
own jurisdiction before resolving the merits of a dispute, it must likewise first assess whether
claimed subject matter is even eligible for patent protection before addressing questions of
invalidity or infringement.”) (internal citation omitted), I/P Engine, Inc. v. AOL Inc., 576 F. App’x
982, 995-96 (Fed. Cir. 2014) (Mayer, J., concurring) (“Until it is determined that claimed subject
matter is even eligible for patent protection, a court has no warrant to consider subordinate
validity issues such as non-obviousness under 35 U.S.C. § 103 or adequate written description
under 35 U.S.C. § 112.”), and SmartGene, Inc. v. Advance Bio. Labs., SA, 852 F. Supp. 2d 42, 51-52
(D.D.C. 2012) (treating the § 101 inquiry as the “threshold inquiry for patent validity”), with
MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250, 1260 (Fed. Cir. 2012) (noting that “courts could
avoid the swamp of verbiage that is § 101 . . . and insist that litigants initially address patent
invalidity issues in terms of the conditions of patentability defenses as the statute provides,
specifically §§ 102, 103, and 112), and Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1335 (Fed. Cir.
2012) (Plager, J., concurring in part and dissenting in part) (“[T]his court should exercise its
inherent power to control the processes of litigation and insist that litigants, and trial courts,
initially address patent invalidity issues in infringement suits in terms of the defenses provided in
the statute: ‘conditions of patentability,’ specifically §§ 102 and 103, and in addition §§ 112 and
251, and not foray into the jurisprudential morass of § 101 unless absolutely necessary.”).
20
40
forth below, the court ultimately concludes that the claims in the ’680 patent are patent
eligible, while finding the broader claims in the ‘895 patent foreclose more future
inventions than the inventors narrow discovery could reasonably justify.
a. Step One of the Alice Framework
At step one, the court determines “whether the claims at issue are directed to
ineligible subject matter.” Alice, 134 S. Ct. at 2355. Millennium argues that the claims
as a whole are directed to an abstract idea, but places particular emphasis on element (b)
and element (f) of claim 1 and the related claims. The latter recites a comparison “of a
person’s metabolite/creatinine ratio to ‘known normative data’ (a population of
metabolite/creatinine ratios).”
(Def.’s Opening Br. (dkt. #130) 63-64.)
Ameritox
counters by pitching the invention at a more specific level, arguing that the claims are
directed “to quantifying a metabolite concentration by adjusting the concentration for
the patient’s hydration status and then statistically comparing the adjusted concentration
to a set of known normative data.”21 (Id. at 87.) This, Ameritox argues, reflects the
purpose of the invention -- providing a method to improve medication monitoring and
identifying aberrant drug use.
The court finds Millennium’s position more persuasive.
While the skilled
addressee would view comparative analysis of the invention as one that seeks to achieve a
new and useful result over prior urine screening protocols, this new and useful result still
Millennium criticizes Ameritox’s characterization, stating that it merely parrots claim 1 itself,
but in more generalized form. Since the court adopted the plain and ordinary meaning of the
claims here, Ameritox can hardly be criticized for adopting at step one of Alice precisely what the
plain and ordinary meaning of the claims provides.
21
41
rests upon an abstract idea, at least at some level. This finding is consistent with the
recent BRAC1 decision, which also involved method claims.
Specifically, the claims
identified “a law of nature ([i.e.] the precise sequence of BRCA genes and comparisons of
wild-type BRCA sequences with certain mutations of those genes found in the test
subject) and applied conventional techniques” to determine a patient’s propensity to
cancer. See BRCA1, 774 F.3d at 761. In finding in favor of the defendant, the BRAC1
court held that the comparative analysis of the invention “recite[d] abstract ideas.” Id. at
762.
Because the present case involves a comparative analysis like that found in
BRCA1, Millennium satisfies step one of the Alice framework. Id.; see also Bilski, 561 U.S.
at 611-12 (characterizing abstract idea as “the concept of hedging” where claim
limitations described initiating transactions and identifying market participants); Alice,
134 S. Ct. at 2356 (characterizing abstract concept as “intermediated settlement” despite
claim elements reciting use of shadow credit records and debit records); buySAFE Inc. v.
Google, Inc., 765 F.3d 1350, 1354-55 (Fed. Cir. 2014) (holding that “[t]he claims are
squarely about creating a contractual relationship” despite presence of more specific
claim limitations); Ultramercial, 772 F.3d at 715 (holding that “the concept embodied by
the majority of the limitations describes only the abstract idea of showing an
advertisement before delivering free content” despite presence of other limitations).22
Millennium also argues that element (e) of the claimed process in particular -- “normalizing the
biological sample to adjust for changes in the patient’s hydration status by determining the
metabolite/creatinine ratio of the patient” -- is a natural law that satisfies step one of the Alice
analysis. (Pl.’s Opp’n (dkt. #172) 87.) Whether Millennium intends to advance this theory in
the alternative to the abstract nature of the claims as a whole is unclear, but the issue is moot
22
42
But as Millennium must readily acknowledge and as previously discussed, it would
be a rare case where a patent is not directed to ineligible subject matter under § 101. See
Mayo, 132 S. Ct. at 1293 (“[A]ll inventions, at some level . . . apply laws of nature,
natural phenomena or abstract ideas.”); cf. AutoForm Eng’g GMBH v. Eng’g Tech. Assocs.,
Inc., No. 10-14141, 2014 WL 4385855, at *3-4 (E.D. Mich. Sept. 5, 2014); Ameranth,
Inc. v. Genesis Gaming Solutions, Inc., No. 11-00189, 2014 WL 7012391, at *6 (C.D. Cal.
Nov. 12, 2014) (explaining that the cotton gin could sound abstract if one uses broad
enough terms); see also Michael V. Risch, Everything is Patentable, 75 TENN. L. REV. 591
(2008).
No doubt, this is precisely why § 101 has traditionally been considered a
“threshold test” under the statute. See, e.g., Diehr, 450 U.S. at 188 (“that process is at
the very least not barred at the threshold by 101”); Alexsam, Inc. v. IDT Corp., 715 F.3d
1336, 1348 (Fed. Cir. 2013) (Mayer, J., dissenting) (“Whether claims are directed to
statutory subject matter is a “threshold” question.”).
b. Step Two of the Alice Framework
Holding that the claims are directed to an abstract idea, however, does not win the
day for Millennium.
As noted at the outset, an invention is not rendered ineligible
since Millennium succeeds at step one regardless. Moreover, the process of normalizing a urine
sample by determining the metabolite/creatinine ratio is not necessarily a natural law, at least on
this record. (Orsulak Rebuttal Rept. (dkt. #118) ¶¶ 237-238 (finding a ratio is not a law of
nature).) Creatinine normalization is a process that the inventors considered and then
implemented. The ratio is simply the end result. This ratio can hardly be considered a natural
law in isolation. The ratio more closely resembles an abstract idea (if at all). Perhaps realizing
that its natural law theory was unsound, and inappropriately dissects the claims at step one of the
Alice analysis, Millennium makes this very argument in its reply brief. (Def.’s Reply (dkt. #183)
47.) Moreover, because it was not raised in its opening brief, Millennium has waived this
argument, at least for purposes of summary judgment. Gold v. Wolpert, 876 F.2d 1327, 1331 n.6
(7th Cir. 1989); Shlay v. Montgomery, 802 F.2d 918, 922 n.2 (7th Cir. 1986).
43
simply because it involves an abstract idea.
Applications of concepts ‘‘to a new and
useful end’’ remain eligible for patent protection. Alice, 134 S. Ct. at 2354 (quoting
Benson, 409 U.S. at 67). To meet this second step under Alice, claims directed to an
abstract idea must contain an “inventive concept,” that is “an element or combination of
elements that is sufficient to ensure that the patent in practice amounts to significantly
more than a patent upon the [ineligible concept] itself.” Id. at 2355 (emphasis added).
Claim 1 of the ’680 patent states:
1. A method for quantifying at least one metabolite in a biological sample
comprising the steps of:
(a) providing one biological sample obtained from a patient on a prescribed
medication regimen, wherein the sample comprises at least one test
metabolite, urine;
(b) providing one set of known normative data specific to a reference
metabolite, wherein the set of data is collected from a population that is on
a prescribed medication regimen;
(c) contacting the biological sample with an analytical device;
(d) detecting the presence of at least one test metabolite in the biological
sample with the device, wherein the device is capable of measuring the
concentration of the test metabolite in the sample;
(e) normalizing the biological sample to adjust for changes in the patient's
hydration status by determining the metabolite/creatinine ratio of the
patient; and
(f) quantifying the concentration of at least one test metabolite in the
biological sample by comparing a ratio between the concentration of the
test metabolite from the patient to the set of known normative data specific
to the reference metabolite concentration.
(’680 patent at 21:9-32.) For ease of reference, elements (a)-(d) will be described as the
“detection” steps. Element (e) will be described as the “normalization” step. Element (f)
will be described as the “comparative” step.
44
Millennium argues that the claims are conventional because they “direct medical
professionals to measure the level of a drug metabolite, to normalize data via a creatinine
ratio, and then to compare that value against the creatinine ratios of a population of
individuals.”
(Def.’s Opening Br. (dkt. #130) 78.)
Millennium further argues that
because these elements are conventional, the invention lacks an “inventive concept”
beyond the abstract idea itself.
Ameritox’s position is more nuanced. Ameritox argues that the claim elements are
unconventional because the asserted claims are drawn to specific methods of monitoring
medication through normalization and quantification of metabolites in a urine sample.
Ameritox contends that these steps contain an inventive concept because the process
described seeks to implement a novel solution to a pre-existing problem in the field.
(Pl.’s Opp’n (dkt. #172) 99.) Indeed, much of Ameritox’s argument centers on the fact
that: (1) the invention produces an improved result over existing technology; and (2) the
necessary inventive concept is combining the normalization step with the detection and
comparative steps. As to the ‘680 patent, the court agrees.
First, when the invention is examined as an ordered combination, the combination
of steps produces a new and useful result. 35 U.S.C. § 101 (the patent statute provides
protection for “any new and useful process”). The instant case shares similarities with
Diehr in this respect. In both cases, the subject patents are directed to abstract ideas that
improve pre-existing technology.
Specifically, like the rubber curing improvements
taught in the Diehr patent, new improvements are similarly taught in the ’680 patent
(albeit with respect to drug compliance monitoring). Indeed, each additional step taught
45
directs the skilled addressee to an invention that allows quantifiable analysis of urine
samples to determine a patient’s compliance with a prescribed drug regimen. This type
of improvement in existing technology is the type of invention that the statute seeks to
encourage, not dismiss. 450 U.S. at 183; see also Alice, 134 S. Ct. at 2359 (looking at
improvements in the “functioning” of a computer and the “technical field”); Bilski, 561
U.S. at 601 (“Congress took this permissive approach to patent eligibility to ensure that
ingenuity should receive a liberal encouragement.”) (internal quotation marks omitted).
In DDR, Judge Chen similarly upheld under § 101 scrutiny, an invention that
addressed the challenge of retaining website visitors that was specific to the internet, as
opposed to the “performance of a business practice known prior to the ‘pre-internet
world.’” DDR, 773 F.3d at 1257. Although the patent claimed a solution “rooted in
computer technology,” Judge Chen found the hybrid functionality of the invention
constituted inventive concept.
Id.
This holding was reinforced by the fact that the
claims addressed the problem of retaining website visitors otherwise instantly transported
away from a website after “clicking” on an advertisement. Id. While the invention at
issue in DDR was in the software field, that decision establishes that inventive concept
can be established by something more than “conventional functioning” that targets and
improves existing technological processes for a specific problem in field of the invention.
Id.; see also Wavetronix LLC v. Iteris, Inc., No. A-14-CA-970-SS, 2015 WL 300726, at *6
(W.D. Tex. Jan. 22, 2015) (citing Alice, 134 S. Ct. at 2358).
Here, the ’680 specification states that previous urine protocols were restricted in
their application because they could only test for positive or negative results as to the
46
“presence or absence of a drug metabolite in urine.” (’680 patent at 2:64-67.) This
problem was described as a “major difficulty” in the art because of the “large amount of
variance in urine drug concentrations, mostly due to variations in hydration and urinary
output volume.” (’680 patent at 1:51-52.) In addressing the problem, the inventors
coupled the normalization step with the comparative step, allowing for more accurate
assessment of aberrant drug use. Nothing in Millennium’s summary judgment materials
rebuts what was plainly identified on the face of the specification as a problem in the
field, nor directly rebuts the solution that the patent provided. This is telling.23 Just as
the patent in DDR was deemed eligible because it solved a “problem specifically arising
in the realm of computer networks,” so, too, does the ’680 patent solve a unique problem
with respect to drug testing technology. See DDR, 773 F.3d at 1257; Cal. Inst. of Tech.,
2014 WL 5661290, at *20 (Ҥ 101 protects a unique computing solution that addresses
a unique computing problem”); cf. Alice, 134 S. Ct. at 2359 (“The method claims do not
. . . purport to improve the functioning of the computer itself.”).
In this case, what is referred to in the specification actually helps the patentee for 35 U.S.C. §
101 purposes because the prior art in the “background of the invention” demonstrates the
problems faced by those in the field, since those problems appear to have been significant and
solved by solutions specifically tailored in the applicant’s invention. See generally DDR, 773 F.3d
at 1257 (explaining that the patent claimed a specific solution addressing a specific problem that
was “rooted in computer technology”). Indeed, it is the admissions on the face of the
specification that assist the patentee in more clearly elucidating the specific problem that is then
solved by the patented invention so to meet § 101 requirements. This is in contrast to other
recent district court decisions that have noted how the admissions in the specification tend to
hurt the patentee in the § 101 context. See McRO, Inc. v. Namco Bandai Games Am., Inc., No. CV
12-10327-GW (FFMx), 2014 WL 4749601, at *11 (C.D. Cal. Sept. 22, 2014) (“And the patent’s
casual—and honest—description of the prior art was made at a time when, under the thenprevalent interpretation of the law, such admissions were unlikely to be harmful. One unintended
consequence of Alice, and perhaps of this and other decisions to come, is an incentive for patent
applicants to say as little as possible about the prior art in their applications.”).
23
47
Second, Millennium’s analysis of the second Alice step to the ’680 patent is flawed.
As an initial matter, Millennium argues that the comparative step must be filtered out of
the analysis when looking at a combination patent, because it is either a “known
method” or “an unpatentable . . . process.” (Def.’s Opening Br. (dkt. #130) 78.) But
there is nothing in Alice suggesting that any steps are “filtered out” when considering a
combination patent. To the contrary, the invention in Alice was considered as “a whole”
when assessing the second step of the framework. 134 S. Ct. at 2359 (“Considered as an
ordered combination [and] . . . [v]iewed as a whole, petitioner’s method claims simply
recite the concept of intermediated settlement as performed by a generic computer.”
(internal quotations omitted, emphasis added)).
Alternatively, Millennium argues that instead of ignoring the comparative step,
the detection and normalization steps must be discounted because they exist in the prior
art, leaving only an abstract idea at the comparative step. (Def.’s Opening Br. (dkt.
#130) 78.) Essentially, Millennium appears to assert that any additional steps beyond
the abstract idea do not elevate the claim to “inventive concept,” because each step was
either “established” or “conventional.” (Id.) Not so under Alice.
Specifically, looking at the normalization step, Millennium merely relies on its
proposed finding that: “Normalizing urine samples [had] been routine and conventional
practice for over 40 years.” (Dr. Alan H. Wu Invalidity Report (“Wu Invalidity Rept.”)
(dkt. #115) ¶ 112.) To support this proposed finding, Millennium infers that because
creatinine normalization was mentioned in the George article, someone skilled in the art
would know to simply combine the normalization step with the detection and
48
comparative steps. Millennium argues that this finding is also supported by Dr. Wu,
who opined that for § 101 purposes, “neither the individual claim steps of the patented
methods nor the series of claim steps in the patented methods are novel.” (Id.)
In reviewing the experts’ reports, however, there is nothing that supports a finding
that the combination of the steps is routine and conventional.24 For example, Dr. Wu
merely isolates the prior art in disparate references, but provides no meaningful rationale
for why they would be combined. Even more telling, Wu cherry-picks aspects of the
George article while wholly ignoring those sections that steer away from the combination
claimed in the ‘680 patent.
When looking at a combination patent, what courts most want to know is: who
would have thought to combine the known elements in the first place and why?25
Providing such evidence is even more important for a moving party in the summary
judgment context, where all “reasonable inferences” are made in the light most favorable
to “the nonmoving party.”
Helman v. Duhaime, 742 F.3d 760, 761 (7th Cir. 2014).
When, as here, Millennium is asking the court to infer that the combination of elements
is conventional, it must supply some evidence to convince the trier of fact to accept its
In contrast, Dr. Larson testified that aspects of the invention were novel concepts “within the
urine screen testing world” in combination with the other steps of the invention. (Deposition of
Michael Larson (“Larson Dep.”) (dkt. #114) 60).
24
At step two, Alice expressly requires that the elements be viewed in “combination.” 134 S. Ct.
at 2359 (“Considered as an ordered combination [and] . . . [v]iewed as a whole.”). See generally
Parks v. Booth, 102 U.S. 96, 102 (1880) (“Modern inventions very often consist merely of a new
combination of old elements or devices, where nothing is or can be claimed except the new
combination.”). This echoes what was said in Mayo, 132 S. Ct. at 1298 (“to consider the three
steps as an ordered combination”). In contrast to Mayo, Millennium has offered nothing in the
prior art that indicates that the scientific community would have combined the steps of the ’680
patent.
25
49
version of events. Since those facts are lacking here, Millennium’s position is necessarily
rejected. See Schacht, 175 F.3d at 504 (explaining that summary judgment is “not a dress
rehearsal or practice run,” but the “put up or shut up moment” in which a party must
show what evidence it has to convince a trier of fact to accept its version of events). In
the end, Millennium does not approach its burden of producing “clear and convincing”
evidence that the combination taught in the ‘680 patent was known.
Third, and a close corollary of the second, evidence of combination helps to guard
against hindsight bias. To ignore this concern would provide a ‘blank check’ to all those
who challenge patents without sufficient legal or evidentiary basis. Given that Alice now
expressly requires that courts look at patented elements in combination when assessing
inventive concept (as did Mayo), the concern of hindsight bias has as much relevance to a
§ 101 challenge as it does a § 103 challenge. See generally Mayo, 132 S. Ct. at 1299 (“at
least the combination of those steps, were in context obvious, already in use, or purely
conventional”).
Where, as here, § 101 is effectively being used as a de facto § 103
challenge, some rational basis for combination must be proffered, particularly in a case like
this where the patent has survived prosecution and two further rounds of re-examination,
as plaintiffs point out (repeatedly) in briefing. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 417-18 (2007) (noting the need to “be cautious of arguments reliant upon ex post
reasoning”); Scientific Plastic Prods., Inc. v. Biotage AB, 766 F.3d 1355, 1362-63 (Fed. Cir.
2014) (Moore, J., dissenting); W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540,
1553 (Fed. Cir. 1983) (“To imbue one of ordinary skill in the art with knowledge of the
invention in suit, when no prior art reference or references of record convey or suggest
50
that knowledge, is to fall victim to the insidious effect of a hindsight syndrome wherein
that which only the inventor taught is used against its teacher.”).
Finally, having had the benefit of claims construction and viewing the claims
through the lens of the skilled addressee, the court is well versed in the state of the art at
the time of the invention. In many ways, claim construction has confirmed the basic
subject matter of the invention. There would seem no reason why the state of the art
should not also be used to analyze claims in the § 101 context when evaluating the
“significance of the additional steps” for the purposes of assessing inventive concept.
Mayo, 132 S. Ct. at 1304. Like other provisions of the statute, it is the state of the art
that provides the objective baseline for the analysis. Section 101 should be no exception.
Id.; Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014) (“[A] patent’s
claims, viewed in light of the specification and prosecution history, [need only] inform
those skilled in the art about the scope of the invention with reasonable certainty.”);
Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 (1966) (skilled addressee in the
obviousness context); Innova, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116
(Fed. Cir. 2004) (using prior art as an “objective baseline” from which in claims
construction); Lemley, supra note 20, at 1330.
Here, Millennium can point to no reference demonstrating the existence of or even
suggesting the combination of the comparative step with the additional steps of the
invention.
And there is certainly nothing in the art that demonstrates that such a
combination was well-known. This provides indicia that the ’680 patent is inventive for
§ 101 purposes.
See Mayo, 132 S. Ct. at 1297-99.
51
Indeed, in Mayo, Justice Breyer
explained that the invention in Diehr was patentable because the “ordered combination”
of the steps of the claimed invention were “nowhere suggested” to be “in context obvious,
already in use, or purely conventional.” Id. at 1299; see also Oleksy v. Gen. Elec. Co., No.
06-C-01245, 2013 WL 3233259, at *5 (N.D. Ill. June 26, 2013) (“Oleksy’s process is
patentable despite its reliance on mathematical equation because of the way the equation
is integrated into a process that also uses steps that are not obvious, already in use or
purely conventional”); France Telecom S.A. v. Marvel Semiconductor Inc., No. 12-cv-04967WHO, 2014 WL 1478850, at *8-9 (N.D. Cal. Apr. 14, 2014) (finding the claims are
“narrow and they confine and tie down the otherwise abstract processes cited” and
provide “‘inventive concepts’ that exceed the prior art, namely coding in parallel and a
novel method of iterative coding”).
Moreover, Millennium has failed to offer any evidence that someone in the
scientific community would have even “thought” to combine the claimed elements.
BRCA1, 774 F.3d at 764. For § 101 purposes, this makes the claims new and useful over
the prior art. Id.; see also Diehr, 450 U.S. at 188 (“[A] new combination of steps in a
process may be patentable even though all the constituents of the combination were well
known and in common use before the combination was made.”); Ultramercial, 772 F.3d at
715 (“[A]ny novelty in implementation of the idea is a factor to be considered only in the
second step of the Alice analysis.” (emphasis added)); Parks v. Booth, 102 U.S. 96, 102
(1880).
As stated previously, the George Article is indicative of routine and well-known
techniques at the time of the invention in the urine testing world.
52
Not only was it
frequently cited in the prosecution history, but both parties’ experts rely upon the article
for purposes of §§ 101, 102 and 103, and Millennium expressly put the article into
evidence to support its position on § 101. The article also predated the invention by four
years, making it indisputably well known before the patent’s filing date. The purpose of
the study as described in the George Article was to find a noninvasive way of testing for
drug compliance.
At the end of the study, the article expressly concluded that creatinine
normalization was problematic and “[f]or practical purposes . . . the only reliable method
available to monitor methadone compliance is the use of plasma methadone drug
testing.” (Mandel Decl., Ex. 43 (dkt. #129-43) 85.) Indeed, the George Article not only
indicates that use of creatinine normalization was anything but routine and
commonplace in the urine drug testing protocols, but suggests that it was viewed as
unreliable. Cf. Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir.
2007) (“Applying modern electronics to older mechanical devices has been commonplace
in recent years.”). Instead, blood testing at the time of the invention was considered the
only reliable method to determine whether a patient was complying with a prescribed
drug regimen.26
26
Similarly, the Haddow Article, which was cited in the specification and formed part of the
prosecution history, teaches that although the use of “creatinine measurements to reflect
hydration” was known, it adds “complexity and cost when such measurements are applied in
routine and clinical practice.” (Bertholf Rept., Ex. H (dkt. #209-8) 562.) This is why “specific
gravity (relative density) measurements in urine samples from children with asthma” were used to
“provide information equivalent to that from creatinine measurements.” (Id. at 562-63.)
Moreover, Haddow neither involves drug treatment nor compliance with a prescribed drug
regimen, nor any known normative database.
53
If the seminal reference in the art at the time stated that blood sampling was by
far preferable to urine normalization, because of the latter’s unreliability, why would
anyone in the industry have thought to use a normalization step for urine in drug
protocols?
Cf. BRCA1, 774 F.3d at 764 (addressing what a “scientist would have
thought of” with respect to gene sequences). Regardless, a normalization step that others
skilled in the art had rejected as unreliable can hardly be considered conventional in the
§ 101 context.27 Moreover, it is this normalization step that distinguishes the present
patent’s claims from the Mayo patent claims. The fact that the claims in the ’680 patent
are even more specific -- limiting their reach to creatinine normalization -- further narrows
their scope, especially since there were other means to adjust for changes in a patient’s
hydration status.28
Because the inventors cut against scientific thought at the time of the invention,
and because the invention targeted a specific problem in the field of urine testing, the
court finds that there is sufficient inventive concept in the ’680 patent for the purposes
of meeting the threshold test of section 101. BRAC1, 774 F.3d at 764; Ultramercial, 772
F.3d at 715.
While each of the reasons above address Millennium’s section 101 challenge in
isolation, Millennium also fails to proffer any meaningful evidence to support a finding of
Further compounding Millennium’s position is that it supplies no meaningful evidence that a
scientist would have thought to use creatinine normalization in combination to achieve the new
and useful results produced by the invention over the prior art.
27
Articles noting these other means are cited in the patent specification itself, and there are even
more specific limitations in the dependent claims of the ’680 patent. See, e.g., ’680 patent at
22:19-48 (claim 4).
28
54
preemption for the ’680 patent. See Helios Software, LLC v. SpectorSoft Corp., No. 12-081LPS, 2014 WL 4796111, at *17 (D. Del. Sept. 18, 2014) (finding that because
defendant “provided no support” the court could not find “that the patents-in-suit were
drawn to [eligible subject matter]”). This further suggests that the limitations in the ’680
patent do not have preemptive effect, something reinforced by Dr. Orsulak, who noted
several other methods besides blood sampling that the patent also did not preempt.
These examples were not controverted by Millennium’s expert witnesses or in its briefing.
(Def.’s Reply (dkt. #183) 56-58.)
None of this can be said with respect to the ’895 patent. On the contrary, the
sweeping claim to “a method for quantifying at least one metabolite in at least one
biological sample” refers to nothing more than the claimed discovery of a method for
“quantifying the concentration of at least one test metabolite in the biological sample”
against an unspecified and undisclosed “known normative data specific to the reference
metabolic concentration.” Unlike element (e) of the claims in the ’680 patent, there is
no teaching against the art well-known at the time with respect to the use of creatinine
concentration in urine, no specification of a similar test metabolite in other biological
samples, or unique relationships between at least one biological sample obtained from a
patient and a set of known normative data specific to the referenced metabolite
concentration. In short, the ’895 patent merely deletes the limitation of the biological
sample of urine leaving a sweeping claim to biological samples consisting of “blood,
salvia, sweat, spinal and brain fluids.” (’895 patent at 4:58-60.) Not only does the patent
not provide enablement for biological samples other than urine under § 112 for reasons
55
discussed below, but it amounts to nothing more than speculative claims that purport to
preempt similar discoveries with respect to other biological samples. This would appear
exactly the kind of preemption strongly disfavored by the United States Supreme Court
because it “forecloses more future invention than the underlying discovery could
reasonably justify.” Mayo, 132 S. Ct. at 1301; see also Lemley, supra note 20, at 1329-30
(“The abstract ideas exception should disallow those claims to ideas unmoored to realworld applications, taking into account the extent to which the claim forecloses afterarising embodiment of the idea, the nature and extent of the prior art, and the level of
disclosure by the inventor.”).
Indeed, as detailed already, it is the very combination of integers in the ’680
patent that supplies the inventive concept to that invention. By stark contrast, the ’895
patent makes one of those elements redundant -- namely element (e) -- effectively seeking
to broaden that patent because there is one less limitation that must be met when
seeking infringement with respect to, for e.g., blood. Said another way, and to draw an
analogy with a mechanical patent, element (e) provides a pivot point between the
detection steps ((a) - (d)) and the comparative step (f) that is essential to invention
described in the ’680 patent. Rendering that pivot point irrelevant to the combination of
the ’895 patent -- for example, because blood does not require creatinine-normalization -cuts away from the novelty and inventiveness of the patent itself, which in turn, cuts
away from any justification for allowing the broad claim scope of the ’895 patent. Mayo,
132 S. Ct. at 1301. Accordingly, without restriction to urine screening, the claims in the
56
’895 patent are invalid under § 101, and for reasons that are foreshadowed here, invalid
under § 112 (a).
B. Section 112 and Other Invalidity Challenges
Regardless of the court’s conclusions on claim construction and § 101, Millennium
argues that the patents-in-suit are invalid under § 112. Specifically, Millennium argues
that the claims of both patents are invalid under the doctrines of indefiniteness and
enablement. Since both patents share the same specification, the court addressed the
patents together, just as Millennium did in briefing.
1. Indefiniteness
Because the court has earlier found that the claims can be construed by a person
having ordinary skill in the art, much of Millennium’s indefiniteness argument falls flat,
but the court will briefly address why, beginning with § 112 itself. Paragraph 2 of § 112
provides that a patent’s specification must “conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter [that] the applicant regards as
[the] invention.” 35 U.S.C. § 112, ¶ 2. In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.
Ct. 2120 (2014), the Supreme Court recently explained that under § 112, ¶ 2, “a
patent’s claims, viewed in light of the specification and prosecution history, [need only]
inform those skilled in the art about the scope of the invention with reasonable certainty.”
Id. at 2129 (emphasis added). The Supreme Court further explained in Nautilus that
indefiniteness requires a “delicate” balance:
On the one hand, the definiteness requirement must take into account the
inherent limitations of language. Some modicum of uncertainty . . . is the
57
price of ensuring the appropriate incentives for innovation. . . . At the
same time, a patent must be precise enough to afford clear notice of what is
claimed.
Id. at 2128-29 (internal citations and quotation marks omitted).
Accordingly, the
definiteness requirement “mandates clarity,” while recognizing that absolute precision is
“unattainable.” Id. at 2129.
Here, Millennium primarily challenges the validity of Ameritox’s construction of a
term in element (f) of each of the independent claims in the patents-in-suit -“quantifying the concentration.”
Millennium argues that under this now adopted
construction, the independent claims are all rendered indefinite.
Under § 112 ¶ 2,
however, Millennium must provide clear and convincing evidence that the claims fail to
provide reasonable certainty as to the scope of the patent.
P’ship, 131 S. Ct. 2238, 2242 (2011).
Microsoft Corp. v. i4i Ltd.
That threshold has not been satisfied here,
particularly in light of what is stated in the specification and the prosecution history.
With respect to the former, Example 1 provides a detailed summary of the
invention, which is cross-referenced to Figure 4. The example explains how the claimed
invention will “improve the ability of clinicians to predict appropriate use of prescribed
medication” and “detect and quantify inappropriate use.” (’680 patent at 6:58-62.) The
inventors further teach how this is achieved with respect to element (f) via statistical
analysis of normative data establishing “95% prediction intervals” to identify aberrant
medication.
(Id. at 6:30-35.)
That data, as the specification suggests, can then be
translated into prediction limits, which are depicted in Figure 4 of the patent:
58
(’680 patent at FIG. 4.) The circles represent normative data. The black squares reflect
“known outliers” or “aberrant results.” The graph demonstrates that quantifying a urine
sample quickly identifies instances of nonadherence. (Id. at 4:6-10; see also id. at 11:1112 (“The data used in this study was sufficient to yield a highly significant regression
analysis that allowed the demonstration of known outliers.”).)
Examples 2, 5, 6, 7, 8, 12, and the “Summary of the Invention,” likewise describe
ranges, confidence intervals, and regression equations, established from normative data to
compare patient information and to “identify aberrant drug use patterns.” (Id. at 3:2028, 45-54; id. at Exs. 2, 5, 6, 7, 8, 12.) These examples provide objective data that the
skilled addressee could rely upon to determine the scope of the patented claims. Compare
DDR, 773 F.3d at 1259-60 (finding that the term “look and feel” satisfied § 112 because
it “had an established, sufficiently objective meaning in the art”), and Augme Techs., Inc. v.
Yahoo! Inc., 755 F. 3d 1326, 1340 (Fed. Cir. 2014) (finding that the term “receiving, by
59
an ingest server, the unique identifier to the digital content” satisfied § 112 because it
was “clear on its face”), with Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370-71
(Fed. Cir. 2014) (finding that the term “unobtrusive manner” was indefinite under § 112
because it was “highly subjective,” “provide[d] little guidance to one of skill in the art,”
and “offer[ed] no objective indication of the manner in which content images are to be
displayed to the user”).
Moreover, when the skilled addressee views the prosecution history, she would
readily appreciate the inventors’ explanation that element (f) “allows statistical analysis
of the drug metabolite level in the urine to determine if the medication is utilized in a
manner consistent with the prescription or that the potential dose may have been.”
(Mandel Decl., Ex. 24 (dkt. #129-24) pp.14-15; id., Ex. 17 (dkt. #129-17) p.9.) The use
of well-known statistical models in the prosecution history is consistent with the
teachings in the specification itself -- and, when read together, this would confirm to the
skilled addressee with reasonable certainty both how the patented invention works and
the “scope of the invention” itself. Nautilus, 134 S. Ct. at 2129.
Millennium raises two more arguments that at least deserve mention.
First,
Millennium emphasizes the term “quantifying the concentration” is not “expressly
defined anywhere in the specification or prosecution history of the patents-in-suit.”
(Def.’s Opening Br. (dkt. #130) 30.)
However, whether the inventors “expressly
defined” a claim term is not the test for indefiniteness.
See Bancorp Serv., L.L.C. v.
Hartford Life Ins. Co., 359 F.3d 1367, 1373 (Fed. Cir. 2004) (“The failure to define the
term is, of course, not fatal, for if the meaning of the term is fairly inferable from the
60
patent, an express definition is not necessary.”). At some level, ambiguity resides in the
claims of most (if not all) patented inventions, but as the Supreme Court explained in
Nautilus, “[s]ome modicum of uncertainty is the price of ensuring the appropriate
incentives for innovation.” 134 S. Ct. at 2128-29.
Second, Millennium argues that the claims are indefinite because one of the
inventors, Dr. Larson, misunderstood what was meant by the “quantifying” step at his
deposition. While Millennium placed heavy emphasis on this point, the Federal Circuit
has long recognized that an inventor, represented by counsel during the application
process, may not understand the meaning of a precise claim in a patent as issued.
[C]ommonly the claims are drafted by the inventor’s patent solicitor and
they may even be drafted by the patent examiner in an examiner’s
amendment (subject to the approval of the inventor’s solicitor). While
presumably the inventor has approved any changes to the claim scope that
have occurred via amendment during the prosecution process, it is not
unusual for there to be a significant difference between what an inventor thinks his
patented invention is and what the ultimate scope of the claims is after allowance
by the PTO.
Markman v. Westview Instruments, Inc., 52 F.3d 967, 985-86 (Fed. Cir. 1995) (emphasis
added); see also Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1380 (Fed. Cir. 2000);
Componex Corp., 2014 WL 5361946, at *8.
In light of the above, both the specification and the prosecution history supply
enough notice so that the skilled addressee would understand the scope of the claims
with reasonable certainty.29
As such, the court finds that the claims meet the
Millennium, through its technical expert, Dr. Alan Wu, also maintains that the term “ratio” as
used in the asserted claims is indefinite. Ameritox correctly points out that this new invalidity
theory was not included in Dr. Wu’s invalidity report, which was due and served on August 11,
2014. Rather, it was first raised in Dr. Wu’s rebuttal infringement report, to which plaintiffs’
29
61
requirements of 35 U.S.C. § 112, ¶ 2.
2. Enablement
The enablement requirement provides that:
The specification shall [describe] the manner and process of making and
using [the invention], in such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the [invention].
35 U.S.C. § 112(a) (emphasis added).
To be enabling, “the specification of a patent must teach those skilled in the art
how to make and use the full scope of the claimed invention without ‘undue
experimentation.’”
MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377,
1380-81 (Fed. Cir. 2012) (citations omitted). “The enablement determination proceeds
as of the effective filing date of the patent.” Id. (citation omitted). “Enablement serves
the dual function in the patent system of ensuring adequate disclosure of the claimed
invention and of preventing claims broader than the disclosed invention.” Id. (citation omitted,
emphasis added).
A court may consider the following factors when determining if a
disclosure requires undue experimentation: (1) the quantity of experimentation
necessary, (2) the amount of direction or guidance presented, (3) the presence or absence
of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of the art, and
expert never had a chance to respond. The court rejects Millennium’s attempt to inject a new
invalidity theory through a rebuttal expert report. See Ruppert v. Alliant Energy Cash Balance
Pension Plan, No. 08-cv-127, 2010 WL 2518853, at *2 (W.D. Wis. June 18, 2010) (excluding
expert’s new theory offered in deposition for the first time because “to allow testimony on a
matter beyond the scope of the expert report would be improper”). Regardless, the court has
reviewed this new invalidity theory, as well as plaintiff’s sur-reply, and finds that it does not
change the analysis under § 112, ¶ 2.
62
(8) the breadth of the claims. ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940
(Fed. Cir. 2010).
Millennium addresses enablement at two levels. On one level, Millennium argues
that had the court adopted its proposed construction of element (f), then the claims in
both patents are invalid for lack of enablement. Even accepting the court’s construction,
on another level, Millennium argues that the ’895 patent is still invalid due to its failure
to teach the claimed methods directed to non-urine biological samples. Since the court
did not adopt Millennium’s construction, the first argument obviously falls away, but the
second of these arguments is persuasive.
As discussed earlier, one skilled in the art would readily appreciate that the claims
in the ’895 patent are not limited to urine samples, which contrasts starkly with similar
claims in the ’680 patent. Unlike that patent, the ’895 patent claims expressly extend to
other biological samples, including “blood, saliva, sweat, and spinal and brain fluids, or a
combination thereof.” (’895 patent at 4:58-60.) Tellingly, Ameritox neither disputes
this contrast, nor explains how the ’895 patent teaches the practice of the claimed
invention as to any of these non-urine samples except in the broadest possible terms.
The court finds this terminal to Ameritox’s chances of succeeding with respect to the
’895 patent. See, e.g., Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1378-79 (Fed.
Cir. 2007) (holding that the patentee must provide a “reasonable enablement of the
scope of the range” of the patented embodiments (emphasis added)); Gen. Elec. Co. v.
SonoSite, Inc., 641 F. Supp. 2d 793, 817 (W.D. Wis. 2009) (explaining that although a
patentee need not describe “how to make and use every possible variant of the claimed
63
invention,” where claims are “open-ended,” the patent would need to be supported by
“reasonable enablement of the scope of the range”).
In basic patent parlance, the teaching of how to practice the claimed invention
supplies the “quid pro quo of the patent bargain.” Liebel-Flarsheim, 481 F.3d at 1380; see
also Promega Corp. v. Life Technologies Corp., 773 F.3d 1338, 1347 (Fed. Cir. 2014) (stating
that the “scope of the claims” must be “commensurate” with the specification). In this
respect, the ’895 patent does not live up to its promise. The only biological sample in the
specification is the same urine samples already disclosed and claimed in the ’680 patent.
Indeed, the bulk of the ’895 patent is primarily directed to explaining how creatinine
normalization plays a critical role in accounting for hydration when testing urine
samples, not unlike the ’680 patent. This lack of disclosure as to the other biological
samples is enough to defeat the ’895 patent on enablement grounds given that undue
experimentation would obviously be required to determine how non-urine samples work
in conjunction with creatinine normalization so to provide a new and useful result. Id.;
see also MagSil, 687 F.3d at 1380-81 (“To be enabling, the specification of a patent must
teach . . . without [the need] for undue experimentation.”).
Reinforcing the strength of Millennium’s argument is the fact that applying
creatinine normalization to other biological samples (e.g., blood) makes no sense. As
Millennium’s unrebutted expert report explained, hydration does not need to be
accounted for in non-urine, biological samples, since fluids, like blood, do not reflect
variations in hydration like urine. (Wu Invalidity Rept. (dkt. #115) ¶ 100) (noting that,
with respect to non-urine biological samples, “[t]he body already has a defense
64
mechanism in place to prevent wide variation in hydration and dehydration”).
While the enablement inquiry also allows assessment of the state of the art and
the relative skill of those scientists involved in the industry, the patent fares no better
when considering these sources at the time of the ’895 patent filing. On the contrary,
the lack of teachings in the specification is not saved by what was known outside the
specification -- i.e. what was common general knowledge or commonplace. When turning
to these sources, the skilled addressee would find references such as the George Article
that make no reference to how blood applies creatinine normalization to achieve more
accurate results. Most likely, this is because, as Dr. Wu opines, it makes no difference
since blood has built-in mechanisms to prevent wide variations in hydration. (Id.)
Not only is this not controverted in the parties’ summary judgment materials,
Ameritox goes so far as to say that the case is not about blood, it’s about urine samples.
Specifically, Ameritox concludes that because non-urine samples are not relevant to the
other issues of this case -- in particular, infringement -- the court should ignore
Millennium’s contention that the ’895 patent is invalid for lack of enablement. (Pl.’s
Opp’n (dkt. #172) 63-64.) At the same time, Ameritox seems to be conceding that the
’895 patent is irrelevant to the current lawsuit, it neither offers to withdraw the patent
from these proceedings nor cite law as to how the much broader claims of the ‘895 patent
satisfy an enablement inquiry.
Instead, Ameritox relies principally (really exclusively) on Takeda Pharm. Co. Ltd. v.
Zydus Pharm. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014), for the proposition “that the
enablement requirement is met if the description enables any mode of making and using
65
the invention.” Id. at 1369-70 (internal quotation omitted). More specifically, Ameritox
contends that because Millennium does not dispute the “claims are . . . enabled and
operable with regards to urine . . . [, t]hat is enough.” (Pl.’s Opp’n (dkt. #172) 105.
Just as Millennium’s application lacked depth with respect to construction,
Ameritox suffers from the same vice with respect to enablement on the ’895 patent.
First, Ameritox makes no effort to square what is said in Takeda -- regarding use of the
word “mode” -- with the well-established rule that the patent must teach how to practice
the full scope of an invention. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380,
1384 (Fed. Cir. 2013) (citing MagSil Corp., 687 F.3d at 1380-81) (“not enabled when . . .
one of ordinarily skill in the art could not practice their full scope without undue
experimentation”); see also Edwards Lifesciences AG v. CoreValve, Inc., 699 F.3d 1305, 1309
(Fed. Cir. 2012) (“The enablement defense does not require an intent to withhold; all
that is required is a failure to teach how to practice the full scope of the claimed
invention.” (emphasis added)).
To use the language of Takeda, if the putative mode does not provide means on
how to make and use other embodiments of the invention, then it can hardly be
considered a mode that allows the skilled addressee to “practice the full scope of the
claimed invention.” Edwards Lifesciences, 699 F.3d at 1309. This is precisely the case
here: there is nothing in the evidence to show how the urine embodiment -- Ameritox’s
putative mode -- supplies enough information to the skilled addressee to make and use
the invention with respect to samples of blood, saliva, sweat, spinal and brain fluid.
Accordingly, the ’895 patent is invalid for lack of enablement.
66
Second, Ameritox’s two sentence “analysis” ignores that, as Millennium points out,
the Takeda case is factually inapposite to the present. In Takeda, the defendant argued
that because the specification only disclosed one method of measuring the drug particles’
diameter to determine whether the invention was infringed, the patent did not enable the
claims for other methods of measuring drug particles. 743 F.3d at 1369. “[B]ecause the
patent identifie[d] laser diffraction as a viable measurement technique, and there [was]
no dispute that a skilled artisan would know how to use laser diffraction to measure
particle diameter,” the Federal Circuit found that the patent “sufficiently enabled the full
scope of the claims.” Id. (emphasis added). Thus, to satisfy the enablement requirement,
the patentee was only required to show that there was at least one mode to determine
how differing embodiments (i.e., different sizes of a drug particle) of the invention could
infringe.
The present patent claims differ in kind from the patent claims in Takeda in
several respects. For instance, while the ’895 patent extends to the use of blood samples
to quantify drug metabolites, it cannot be said that blood (or any of the other biological
samples) are being used as a universal measuring device, as laser diffraction was in the
Takeda case.
In particular, laser diffraction was a mode for measuring whether an
infringing embodiment fell within the full scope of the claims. In contrast, here, each
biological source represents an alternative embodiment of how the ’895 patent can be
implemented. Urine is one embodiment, while blood is another entirely. Because blood
is not taught in the specification, blood stretches the scope of the ’895 patent beyond its
description in the patent. Saliva, sweat, spinal and brain fluids are further embodiments
67
that each expand the scope further.
Moreover, each of these biological samples are
embodiments of the invention unto themselves, expanding the scope of the ’895 patent
far beyond what is disclosed in the ’680 patent.
In expanding its scope dramatically, Ameritox was required to ensure that the
disclosure was “commensurate” with the specification.
Its failure to provide the
necessary quid pro quo results in the ’895 patent being held invalid. See Promega Corp. v.
Life Techs. Corp., 773 F.3d 1338, 1347 (Fed. Cir. 2014); Nat’l Recovery Techs., Inc. v.
Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195-96 (Fed. Cir. 1999) (“[T]he public
knowledge is enriched by the patent specification to a degree at least commensurate with
the scope of the claims . . . [being] less than or equal to the scope of enablement.”).
Similarly, there is nothing in the specification that teaches how creatininenormalization can be combined with blood (much less other biological samples) to
determine the scope of the ’895 patent.
MagSil Corp., 687 F.3d at 1381 (“The
specification must contain sufficient disclosure to enable an ordinarily skilled artisan to
make and use the entire scope of the claimed invention at the time of filing.”).
As
addressed earlier, the skilled addressee would also be of no assistance. Id. at 1381. Nor
does Ameritox’s briefing or affidavits even attempt to reconcile these obvious differences
between Takeda and the present case.
A more apt case than Takeda is Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371,
(Fed. Cir. 2007). On appeal in that case, the patentee unsuccessfully argued as Ameritox
does here that the teaching of one embodiment was enough for enablement purposes:
Liebel contends that the court erroneously considered whether an injector
without a pressure jacket was enabled . . .Because it is undisputed that
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Liebel provided an enabling disclosure of what it calls its preferred
embodiment, viz., an injector with a pressure jacket, Liebel asserts that the
court should have held that the disclosure was enabling for the full scope of
the claims.
Id. at 1378. In construing the claims, however, the Federal Circuit concluded the claims
in Liebel-Flarsheim were “not limited to an injector with a pressure jacket.” Id. at 1379.
And, therefore, “the full scope of the claimed inventions include[d] injectors with and
without a pressure jacket.” Id. (emphasis added).
As for the enablement question, and turning to the specification, the Federal
Circuit then held that “nowhere does the specification describe an injector with a
disposable syringe without a pressure jacket.” Id. at 1379. In fact, the Federal Circuit
noted, “the specification teaches away from such an invention.” Id. When turning to the
skilled addressee, the Federal Circuit found that “undue experimentation” would be
required “to make and use the injector without a pressure jacket.” Id. at 1380. Because
the specification did not teach how to make an embodiment of the invention -- an
injector without a pressure jacket -- and because the skilled artesian could not “fill the
gaps,” the Federal Circuit held the “claims were invalid for lack of enablement.” Id.
Strong parallels exist between the present claims in the ’895 patent and the claims
in the Liebel-Flarsheim patent.30 Just as nowhere in the specification of the Liebel-Flarsheim
patent did the patentee describe an injector without a pressure jacket, nowhere in the
For example, the Federal Circuit noted, as is true here, “[t]he irony of this situation is that
Liebel successfully pressed to have its claims include a jacketless system, but, having won that
battle, it then had to show that such a claim was fully enabled, a challenge it could not meet. The
motto, ‘beware of what one asks for,’ might be applicable here.” Liebel-Flarsheim, 481 F.3d at
1380.
30
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’895 specification did the patentee describe embodiments of the invention based on
blood, saliva, brain fluid or the other claimed biological samples.
Moreover, and
consistent with Liebel-Flarsheim the skilled addressee in this case would be unable to “fill
the gaps” in the specification so that invention could meet the enablement requirement.
Id. Because of the similarities between instant case and Liebel-Flarsheim, among others,
the court has little hesitation in finding the ’895 patent invalid. See 35 U.S.C. § 112, ¶ 1
(providing in pertinent part that the specification shall describe “the manner and process
of making and using [the invention], in such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it pertains, or with which it is most nearly
connected, to make and use the [invention]”); see also Stirick v. Dreamworks LLC , 516
F.3d 993, 999-1000 (Fed. Cir. 2008) (affirming summary judgment that claims were
invalid for lack of enablement when the claims encompassed both video games and
movies, but the specification did not enable the invention for use in movies); Auto. Techs.
Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1285 (Fed. Cir. 2007) (affirming
summary judgment that the claims were invalid for lack of enablement when the
specification did not enable one of the embodiments).
In sum, because of this fairly blatant overreach and because Millennium has
demonstrated through clear and convincing evidence that the ’895 patent captures far
more than what is taught in the specification, the court grants Millennium’s motion for
invalidity as to the ’895 patent pursuant to § 112(a) of the statute.
Lifesciences AG v. CoreValve, Inc., 699 F.3d 1305, 1309 (Fed. Cir. 2012).
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See Edwards
3. Utility
Finally, Millennium argues that each of the patents lack utility. Given that the
’895 patent does not constitute eligible subject matter and is invalid for lack of
enablement, this analysis will be strictly limited to the ’680 patent. The threshold of
utility “is not high:
An invention is ‘useful’ . . . if it is capable of providing some
identifiable benefit.” Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1365 (Fed. Cir.
1999).
To fail the utility requirement, the claims must be totally inoperable.
See
Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1571 (Fed. Cir. 1992) (“To
violate § 101 the claimed device must be totally incapable of achieving a useful result.”).
As previously discussed, Millennium fails to prove this is so here.
Millennium repeats its argument that the asserted claims are not useful because
they require definitive dose prediction.
Specifically, Millennium asserts that “it is
scientifically impossible to predict or determine the dosage of medication taken by a
patient from a metabolite/creatinine ratio”, the patent lacks utility. (Def.’s Opening Br.
(dkt. #130) 59.) At the outset, Millennium’s argument only succeeds if the court adopts
its construction of element (f): “quantifying the concentration.” That construction, as
addressed earlier, was rejected, since it was founded on the flawed premise that the
purpose of the patents was to provide a definitive dosage prediction. In order to provide
such a result, the invention would have been required to teach the skilled addressee how
to correct or adjust for all sources of variability in urine drug concentrations -- not just
through creatinine normalization.
Nowhere in the ’680 patent is this promise made.
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In fact, the specification
expressly acknowledges that the claimed method does not attempt to account for all
sources of variability. (’680 patent at 11:11-19.) Because Millennium’s utility argument
is wedded to the erroneous premise that the invention seeks to predict dosage
definitively, when it does not, its argument is rejected.
Contrary to Millennium’s understanding of the’ 680 patent, the claimed invention
is directed to providing a method that allows for improvement in a doctor’s ability to
determine whether a patient has been taking medication as prescribed. As addressed
earlier, and prior to the claimed invention, the only information gained from urine drug
testing was the presence or absence of a drug (i.e., the urine samples could only provide
for positive or negative testing result).
The invention here does more than this; it
provides doctors with information that allows assessment of whether a patient “has been
using the medication in a manner which is consistent with the prescription.” (Id. at 3:1719; see also id. at 4:50-54 (emphasis added).) The examples in the specification further
demonstrate this.
On review of Millennium’s briefing, there is nothing by way of evidence that
establishes that the invention could not deliver on the new and useful improvements that
are stated in the ’680 specification.
See Juicy Whip, 185 F.3d at 1365.
This is
Millennium’s burden, even more so in the context of summary judgment.31 While there
is certainly room for argument that the invention could not predict or determine the
dosage of medication, evidence proffered to support this point is only applicable had the
court adopted Millennium’s claim construction (which it did not). Because Millennium’s
31
Schacht v. Wis. Dep’t of Corr., 175 F.3d 497, 504 (7th Cir. 1999) (describing summary
judgment as the “put up or shut up moment”).
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claim construction was not adopted -- and since there is no evidence to suggest that the
invention does not deliver the claimed improvements over the prior art -- the ’680 patent
meets at least one objective in the specification and satisfies the utility requirement. See
Raytheon Co. v. Roper Corp., 724 F.2d 951, 958 (Fed. Cir. 1983) (“When a properly
claimed invention meets at least one stated objective, utility under § 101 is clearly
shown.”).
C. Infringement
Based on the undisputed positions of the parties on summary judgment and the
rulings by the court above, there would appear to be just one arguable issue left for trial
as to infringement:
whether Millennium’s RADAR Report infringes (f) of the ‘680
patent claims? Even more refined, there would appear to be a single factual dispute:
whether the RADAR Report compares “a ratio between the concentration of the test
metabolite from the patient to the set of known normative data specific to the reference
metabolite concentration.”
Even as to this narrow issue, Ameritox and Millennium both maintain that there is
no material factual dispute, although they would draw opposite legal conclusions from
those facts. Contrary to Millennium’s position, however, the undisputed facts would
seem to compel the conclusion that it infringes step (f) by use of the RADAR software:
1. Millennium is a clinical laboratory that competes in the medicationmonitoring industry. (Pl.’s PFOFs (dkt. #163) ¶ 1.)
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2. Millennium tests urine samples on behalf of doctors, nurses, and other
health care providers who prescribe pain medications to treat chronic pain.
(Pl.’s PFOFs (dkt. #163) ¶ 2.)
3. Healthcare professionals use Millennium’s services to test specimens and
monitor drug levels periodically in their patients to whom medications are
prescribed. (Def.’s Resp. to Pl.’s PFOFs (dkt. #185) ¶ 3.)
4. The test results are provided to the requesting doctor via a detailed
written report which Millennium calls “Rapid Assessment Drug Adherence
Report” or “RADAR Report.” (Pl.’s PFOFs (dkt. #163) ¶¶ 4, 5.)
Despite these undisputed facts, Millennium still argues in reply that there are two
factual distinctions relieving it of any finding of infringement:
(1) the health care
provider, not Millennium, makes the comparison; and (2) an individual patient’s doctor
ultimately decides whether the comparison provided in the RADAR Report has any
bearing on assessing a patient’s over or under dosing based on a variety of other
independent factors. (Def.’s Reply (dkt. #183) 62-65.)
The first distinction would appear contradicted by the undisputed facts, since
Millennium contracts and produces the RADAR Report that provides a comparison of
the ratio between the concentration of a test metabolite from a patient to a set of
normative data, as laid out by the reasoning and facts outlined in Ameritox’s opposition
brief.
(Pl.’s Opp’n (dkt. #172) 79-81.)
Indeed, Millennium has provided RADAR
Reports providing this comparative data for oxycodone. The court finds it difficult not to
conclude that the skilled addressee (a trained toxicologist, who is familiar with clinical
laboratory science) would view this comparative data as falling within the plain and
ordinary meaning of element (f).
The second distinction morphs with the first and strikes the court as equally
74
meaningless, since the possibility that a doctor may ultimately decide to disregard
whether an individual falls inside or outside the 95% confidence range established by the
RADAR Report does not mean the report does not infringe, any more than a
manufacturer of a thermometer could claim its product does not infringe because a
doctor may discount the results of a low or high thermometer reading. Similarly, the fact
that the “RADAR Report includes an explicit disclaimer, warning physicians that
Millennium makes no interpretations regarding the patient through the RADAR Report”
(Def.’s Reply (dkt. #183) 72), does not mean the Report did not convey the comparison
contemplated by (f) of the ‘680 claims.
Even so, only Millennium actually moved for summary judgment on infringement.
Pursuant to Federal Rule of Civil Procedure 56(f), therefore, the court will give
Millennium ten days to advise in a supplemental brief why summary judgment should
not be entered against it on the question of infringement of the ‘680 patent. No further
briefing or oral argument will be allowed except by express order of the court.
ORDER
IT IS ORDERED that:
1) defendant Millennium Health, LLC’s motion for summary judgment (dkt.
#126) is GRANTED as to the ‘895 patent and DENIED as to the ‘680 patent
as set forth above;
2) plaintiff Ameritox, Ltd.’s motion to file sur-reply (dkt. #192) is GRANTED;
and
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3) Millennium may have until March 2, 2015, to serve and file its response as to
why summary judgment should not be entered against it on the question of
infringement of the ‘680 patent.
Entered this 18th day of February, 2015.
BY THE COURT:
/s/
________________________________________
William M. Conley
District Judge
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