Conceptus, Inc. v. Hologic, Inc.

Filing 475

FINAL CHARGE TO THE JURY. Signed by Judge Alsup on October 14, 2011. (whalc1, COURT STAFF) (Filed on 10/14/2011)

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IN THE UNITED STATES DISTRICT COURT

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FOR THE NORTHERN DISTRICT OF CALIFORNIA
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CONCEPTUS, INC.,

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For the Northern District of California

United States District Court

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No. C 09-02280 WHA

Plaintiff,
v.
HOLOGIC, INC.,
Defendant.
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FINAL CHARGE TO THE JURY

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Members of the jury, it is my duty to instruct you on the law that applies to this case.

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A copy of these instructions will be available in the jury room for you to consult as necessary.
It is your duty to find the facts from all the evidence presented in the case. To those facts

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you will apply the law as I give it to you. You must follow the law as I give it to you whether you

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agree with it or not. You must not be influenced by any personal likes or dislikes, opinions,

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prejudices, or sympathy. That means that you must decide the case solely on the evidence before

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you. You will recall that you took an oath promising to do so at the beginning of the case. In

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following my instructions, you must follow all of them and not single out some and ignore others;
they are all equally important. You must not read into these instructions or into anything the

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Court may have said or done as suggesting what verdict you should return — that is a matter

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entirely up to you.

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2.
The evidence from which you are to decide what the facts are consists of:
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The sworn testimony of witnesses, on both direct and

cross-examination, regardless of who called the witness;

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2.

The exhibits which have been received into evidence;

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3.

The sworn testimony of witnesses in depositions read into

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evidence or played by video; and
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Any facts to which all the lawyers have stipulated here in the

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courtroom before you. You must treat any stipulated facts as having been

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conclusively proven.

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3.
In reaching your verdict, you may consider only the testimony and exhibits and other

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items received into evidence. Certain things are not evidence and you may not consider them in

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deciding what the facts are. I will list them for you:

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1.

Arguments and statements by lawyers are not evidence.

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The lawyers are not witnesses. What they have said in their opening statements,

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closing arguments, and at other times is intended to help you interpret the

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evidence, but it is not evidence. If the facts as you remember them differ from the

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way the lawyers have stated them, your memory controls.

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2.

A suggestion in a question by counsel or the Court is not evidence

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unless it is adopted by the answer. A question by itself is not evidence. Consider

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it only to the extent it is adopted by the answer.

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3.

Objections by lawyers are not evidence. Lawyers have a duty to

their clients to consider objecting when they believe a question is improper under

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the rules of evidence. You should not be influenced by any question, objection,

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or the Court’s ruling on it.

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4.

Testimony or exhibits that have been excluded or stricken, or that

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you have been instructed to disregard, are not evidence and must not be

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considered. In addition, some testimony and exhibits have been received only for

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a limited purpose; where I have given a limiting instruction, you must follow it.

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5.

Anything you may have seen or heard when the Court was not in

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session is not evidence. You are to decide the case solely on the evidence

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received at the trial.

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4.

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Certain charts, animations, and summaries have been shown to you in order to help

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explain the facts disclosed by the books, records, and other documents which are in evidence in

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the case. They are not themselves evidence or proof of any facts. If they do not correctly reflect

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the facts or figures shown by the evidence in the case, you should disregard these charts and

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summaries and determine the facts from the underlying evidence.

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5.
Evidence may be direct or circumstantial. Direct evidence is direct proof of a fact, such as
testimony by a witness about what that witness personally saw or heard or did. Circumstantial
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evidence is proof of one or more facts from which you could find another fact. By way of

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example, if you wake up in the morning and see that the sidewalk is wet, you may find from that

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fact that it rained during the night. However, other evidence, such as a turned-on garden hose,

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may explain the presence of water on the sidewalk. Therefore, before you decide that a fact has

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been proven by circumstantial evidence, you must consider all the evidence in light of reason,

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experience, and common sense. You should consider both kinds of evidence. The law makes no

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distinction between the weight to be given to either direct or circumstantial evidence. It is for you

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to decide how much weight to give to any evidence. You should base your decision on all of the

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evidence, regardless of which party presented it.
6.

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In deciding the facts in this case, you may have to decide which testimony to believe and

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which testimony not to believe. You may believe everything a witness says or part of it or none

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of it. In considering the testimony of any witness, you may take into account:

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The opportunity and ability of the witness to see or hear or know

the things testified to;

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2.

The witness’ memory;

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3.

The witness’ manner while testifying;

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4.

The witness’ interest in the outcome of the case and any bias

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or prejudice;

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Whether other evidence contradicted the witness’ testimony;

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The reasonableness of the witness’ testimony in light of all the

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evidence; and
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Any other factors that bear on believability.

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7.

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The weight of the evidence as to a fact does not necessarily depend on the number of

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witnesses who testify. Nor does it depend on which side called the witnesses or produced

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evidence. You should base your decision on all of the evidence, regardless of which party

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presented it. You are not required to decide any issue according to the testimony of a number of
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witnesses, which does not convince you, as against the testimony of a smaller number of

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witnesses or other evidence, which is more convincing to you. The testimony of one witness

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worthy of belief is sufficient to prove any fact. This does not mean that you are free to disregard

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the testimony of any witness merely from caprice or prejudice, or from a desire to favor either

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side. It does mean that you must not decide anything by simply counting the number of witnesses

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who have testified on the opposing sides. The test is not the number of witnesses but the

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convincing force of the evidence.

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A witness may be discredited or impeached by contradictory evidence or by evidence that
at some other time the witness has said or done something, or has failed to say or to do

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something, that is inconsistent with the witness’ present testimony. If you believe any witness

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has been impeached and thus discredited, you may give the testimony of that witness such

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credibility, if any, you think it deserves.

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Discrepancies in a witness’ testimony or between a witness’ testimony and that of other

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witnesses do not necessarily mean that such witness should be discredited. Inability to recall is

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common. Innocent misrecollection is not uncommon. Two persons witnessing an incident or a

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transaction sometimes will see or hear it differently. Whether a discrepancy pertains to an

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important matter or only to something trivial should be considered by you.

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However, a witness who was willfully false in one part of his or her testimony is to be

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distrusted in others. You may reject the entire testimony of a witness who willfully has testified

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falsely on a material point, unless, from all the evidence, you believe that the probability of truth

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favors his or her testimony in other particulars.

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10.
In determining what inferences to draw from the evidence, you may consider, among other
things, a party’s failure to explain or deny such evidence.

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You have heard testimony from witnesses referred to as “expert witnesses.” These are

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persons who, because of education or experience, are permitted to state opinions and the reasons

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for their opinions. Opinion testimony should be judged just like any other testimony. You may

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accept it or reject it, and give it as much weight as you think it deserves, considering the witness’

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education and experience, the reasons given for the opinion, and all the other evidence in the case.

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If an expert witness was not present at the events in question, his or her opinion is necessarily

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based on an assumed set of circumstances. In evaluating the opinion during the trial, you should

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take into account the extent to which you do agree or do not agree with the circumstances
assumed by the expert witness.

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In these instructions, I will often refer to a party’s burden of proof. I will be discussing

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two different burdens of proof. The first is known as a burden of proof by a preponderance of the

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evidence. When a party has the burden of proof on any issue by a preponderance of the evidence,

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it means you must be persuaded by the evidence that the issue is more probably true than not true.

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To put it differently, if you were to put the evidence favoring plaintiff and the evidence favoring

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defendant on opposite sides of a scale, the party with the burden of proof on the issue would have

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to make the scale tip somewhat toward its side. If the party fails to meet this burden, then the

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party with the burden of proof loses on that issue. Preponderance of the evidence basically means

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“more likely than not.”

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The second burden of proof involved in this case is known as a burden of proof by clear

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and convincing evidence. When a party has the burden of proving any issue by clear and

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convincing evidence, it means you must be persuaded by the evidence that the contention is

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highly probable. This burden requires a higher standard of proof than proof by a preponderance

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of the evidence.

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If you find that plaintiff carried its burden of proof as to an issue, your verdict should be

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for plaintiff on that specific issue. If you find that plaintiff did not carry its burden of proof, you
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must find against plaintiff on that issue. This same principle also applies to defendant on issues

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on which it has the burden of proof.

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14.

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I now will turn to the law that applies to this case. As you know, in this lawsuit

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Conceptus seeks money damages from defendant Hologic for allegedly inducing or contributing

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to the infringement of claims 37 and/or 38 of United States Patent Number 6,634,361. I will refer

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to claims 37 and 38 as the “asserted claims.” The method that Conceptus contends infringes the

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asserted claims is Hologic’s Adiana procedure. I will refer to the Adiana procedure as the

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“accused method.” Hologic denies infringement and contends that the asserted claims are invalid.
Your job is to decide the issues of infringement and validity. If you decide that either

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claim has been infringed and is valid, you will then need to decide on any monetary damages.

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As you know, the patent claims are the numbered paragraphs at the end of the patent. The

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claims are important because they specifically define the exclusive rights granted by the patent

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office. The figures and the specification in the rest of the patent provide a description and/or

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examples of the invention and provide a context for the claims but the claims define how broad or

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narrow the patent holder’s rights are. It is often the case that a patent specification and its figures

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disclose more than the specific matter claimed as inventions, so it is important to keep straight

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what the specification says versus what the claims say.

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In a patent, an independent claim is one that is a stand-alone claim and does not

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incorporate any other claim. A dependent claim is one that depends on an earlier claim by

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incorporating it by reference and then adding one or more additional elements. Such

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incorporation imports the entirety of the incorporated claim, including all of its elements, into the

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dependent claims. You will note that both of the asserted claims are dependent claims. Claim 37

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incorporates claim 36. Claim 38 incorporates claim 37 and thereby also incorporates claim 36.

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Thus, claim 36 is incorporated into both of the asserted claims, even though claim 36 by itself is

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not asserted. I now want to explain how this affects the logic of the issues before you.
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If claim 37 is not infringed, then by default claim 38 cannot be infringed. In other words,

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if a claim 37 element is missing from the accused method, then it also is missing, by definition, as

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to claim 38. If claim 37 is infringed, however, claim 38 may or may not also be infringed. This is

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because claim 38 adds an extra limitation. For invalidity purposes, I will address these logical

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relationships later on in these instructions.

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I am now going to instruct you on the meaning of some of the words and phrases in the
patent claims at issue. You must accept and use these meanings in your deliberations.
A pre-formed resilient structure: The phrase “a pre-formed resilient structure” appears in
claim 36, which is incorporated into the asserted claims. The phrase means a pre-formed resilient

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intrafallopian device.

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Lumen-traversing region of the resilient structure: The phrase “lumen-traversing region of

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the resilient structure” appears in claim 36, which is incorporated into the asserted claims. The

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phrase means a region of the resilient structure that interacts with the wall of the fallopian tube

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lumen to permanently affix the resilient structure within the fallopian tube lumen. A person

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having ordinary skill in the relevant art at the time the patent application was filed would not

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understand the “lumen-traversing region” as being required to traverse a “substantial portion” of

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the length of the tube.

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Permanently affixing the resilient structure within the fallopian tube with a lumen-

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traversing region of the resilient structure: The phrase “permanently affixing the resilient

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structure within the fallopian tube with a lumen-traversing region of the resilient structure”

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appears in claim 36, which is incorporated into the asserted claims. For purposes of claim 37, the

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phrase means permanently affixing the resilient structure within the fallopian tube with a

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lumen-traversing region of the resilient structure by (at least) promoting tissue ingrowth of the

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tubal wall surrounding the resilient structure.

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So that at least a portion of the fallopian tube is open: The phrase “so that at least a

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portion of the fallopian tube is open” appears in claim 36, which is incorporated into the asserted

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claims. The phrase means so that at least a portion of the fallopian tube is not

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completely occluded at the time when permanent affixation occurs.

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You must accept these definitions as established for purposes of your deliberations and

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verdict. You may, however, consider all of the evidence in the case as to whether or not the

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accused method meets these definitions. If a witness has based his view on meanings of the terms

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contrary to my stated definitions, you should discount that part of his testimony accordingly.

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Conceptus has the burden of proof on infringement. Conceptus must persuade you that it
is more likely than not that Hologic has induced or contributed to the infringement of claims 37
and/or 38 of the ’361 patent.

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18.

Induced infringement and contributory infringement are two different types of indirect

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infringement. A patented method is directly infringed by a party who practices the method. A

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patented method is indirectly infringed by a party who either induces another party to practice the

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method or contributes to the practicing of the method by another party. Only if one party directly

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infringes can another party be found to indirectly infringe. That is, indirect infringement by one

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party must be based on direct infringement by another party.

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In this case, defendant Hologic is accused of indirect infringement based on alleged direct

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infringement by doctors who perform the Adiana procedure. There is no claim for direct

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infringement in this case, and there are no doctors named as defendants in this case. Yet, you

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must decide whether the Adiana procedure performed by doctors directly infringes the asserted

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claims. This question of direct infringement is a prerequisite to the question whether defendant

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Hologic indirectly infringes the asserted claims.

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For Conceptus to carry its burden of proof on direct infringement, it must show that each
and every step of either claimed method is found in the accused method.
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In deciding whether the accused method infringes the asserted claims, you must compare

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the Adiana procedure to the specific elements of each asserted claim. You must not compare the
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Adiana procedure to the Essure procedure. The Essure procedure is not relevant to the

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infringement analysis. Only the specific claims of a patent can be the basis for infringement. A

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product made by a patent owner may or may not practice the claims and therefore cannot be the

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basis for infringement.

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If all steps of an asserted claim have been proven, it is not a defense to infringement that

accused method carries out a step in the asserted claim in a way not described in the examples in

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the patent specification. For infringement to be proven, the step must be carried out as per the

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claim language. For example, if a patented method claim calls out three steps to paint a wall, it

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the accused method includes an additional step not called out in the patent claim or that the

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would be infringed by a method including the same three steps in the claim and it would be no

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defense that a fourth step is also done or that one step is carried out in a way different from the

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examples in the patent specification. For infringement to be proven, the step must be carried out

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as per the claim language.

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22.
To prove infringement by the doctors, it is not necessary to prove that any infringement
was intentional or willful. Innocent infringement by doctors would still be infringement.

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23.

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The fact, if true, that the accused method was independently developed without any

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copying of the patent owner’s method is not a defense. All that matters for purposes of

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infringement is whether all limitations of the claim reside in the accused method. Independent

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development in the same approximate time frame as the claimed invention, however, may be

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considered by you on the issue of obviousness, an invalidity question.

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To assist you on the infringement issue, counsel gave you a handout that identified the

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limitations in dispute and underlined in red the elements disputed. Conceptus contends that the

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accused procedure satisfies all the limitations of the asserted claims.

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Now, who is a person of ordinary skill in the art? It is up to you to decide the level of

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ordinary skill in the field. You should consider all the evidence introduced at trial in making this

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decision, including:

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the field;

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The types of problems encountered in the field; and

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The sophistication of the technology.

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The levels of education and experience of persons working in

Sometimes I may refer to such a person as a “skilled artisan.”
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For Conceptus to carry its burden of proof on induced infringement, it must show that

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Hologic actively induced doctors to directly infringe the asserted claims. Specifically, Conceptus

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must show the following three elements: (1) that Hologic intentionally took action that actually

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induced direct infringement by doctors; (2) that Hologic knew of the ’361 patent; and (3) that

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Hologic knew its action would cause direct infringement by the doctors.

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If you find that there has been no direct infringement by doctors performing the Adiana

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procedure, of course, then there was no infringement in the first place and no need for you to

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address the question of induced or contributory infringement.

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For Conceptus to carry its burden of proof on contributory infringement, it must show the

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following four elements: (1) that the asserted claims were directly infringed by doctors

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performing the Adiana procedure; (2) that Hologic supplied an important component of the

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infringing part of the procedure; (3) that the component had no substantial non-infringing use;

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and (4) that Hologic supplied the component with knowledge of the ’361 patent and knowledge

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that the component was especially made or adapted for use in an infringing manner.

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If you find that there has been no direct infringement by doctors performing the Adiana

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procedure, of course, then there was no infringement in the first place and no need for you to

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address the question of induced or contributory infringement.
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Now, let’s turn to the affirmative defenses raised by defendant. We will first address the

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invalidity defenses. A patent issued by the Patent Office is presumed to be valid. The burden is

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on defendant Hologic to prove to the contrary. Hologic must do so by clear and convincing

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evidence. When a party has the burden of proving any issue by clear and convincing evidence, it

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means you must be persuaded by the evidence that the issue is highly probable. In deciding how

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much deference to give the examiner’s judgment on a particular point, you may take into account

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the extent to which the specific point was considered by the examiner; the more a point was

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considered by the examiner, the more deference it deserves; conversely, the less a point was
considered by the examiner, the less deference it deserves.

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29.

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The first invalidity defense is called anticipation. Hologic contends that the asserted

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claims were anticipated by various prior-art references.
Patents are supposed to be limited to new revelations, among other requirements. A

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patent claim is invalid if the claimed invention was not new at the time of the patent application,

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which was September 24, 1997, for purposes of anticipation and obviousness. For a claim to be

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invalid because it is not new, all of its elements must have already existed in a single procedure

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before the claimed invention or must have been described in a previous publication or patent

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before the claimed invention. In patent law, previous publications or patents are called “prior art”

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or “prior-art references.” All of the “claimed” elements must be contained within a single

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reference for anticipation to apply.

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For anticipation to apply, it is not enough that all of the elements could have been found

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among two or more references. If, at the time of the patent application, a single prior-art

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reference already described all of the elements of the claimed invention and would have informed

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those skilled in the art that those elements could have been arranged as in the claimed invention,

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then the prior-art reference is deemed to “anticipate” the claimed invention and thereby render it

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unpatentable and thus invalid. It would not be enough, however, that all of the elements were in

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random passages in the reference. By the same token, for anticipation to apply, it is not necessary
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that the prior-art reference expressly lay out the elements in the exact way laid out in the claim.

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Rather, for anticipation, it is sufficient if the single reference would have informed those skilled

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in the art that all of the claimed elements could have been arranged as in the claimed invention.

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Also, the reference must have enabled one of ordinary skill in the art to make the invention

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without undue experimentation. Where one of ordinary skill in the art would have known that an

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element was necessarily present in the reference, it may be said to be inherent; that is, it is as

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though the element was expressly disclosed in the reference.

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in the prior art and highlighted in blue or green for you the elements disputed. This was only as

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To assist you, counsel gave you a handout that identified the elements concededly found

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to two of the prior-art references. You must keep in mind that defendant Hologic advances more

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than two items of prior art as anticipatory.

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31.
Now, we turn to the issue of obviousness. Even when a claimed invention is new and is

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not anticipated in the prior art, it may still be found unpatentable and invalid by reason of

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obviousness. This is the next ground for invalidity asserted by defendant. I will now explain the

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ground rules for obviousness.

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32.
No one is entitled to obtain a patent on a claimed invention that would have been obvious

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to those of ordinary skill in the field at the time of the invention. Put differently, if a skilled

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artisan, knowing all the prior art, would have known that all of the claimed elements already

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existed in the prior art, that those elements could have been arranged in the manner of the claimed

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invention, and would have seen the benefit of doing so, then the claimed invention should not

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receive a patent. This means that even if all of the requirements of the claim cannot be found in a

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single prior-art reference, the claimed invention was obvious if a person of ordinary skill in the

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relevant field who knew about all the prior art would have come up with the claimed invention by

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combining the prior art references, or by combining a single prior art reference with the

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knowledge and creativity of one of ordinary skill in the art. In deciding what would have been
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obvious to a skilled artisan, remember that a person of ordinary skill is also a person of ordinary

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creativity, not an automaton.

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33.
A patent claim combining several elements, all of which were already known in the prior

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art, is not necessarily invalid. To the contrary, many valid patent claims are new combinations of

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features already known. To be obvious, the particular combination and arrangement must have

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been obvious to those skilled in the art at the time of the invention.

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You must be careful not to use hindsight; many valid inventions might seem obvious after
the fact. You should put yourself in the position of a person of ordinary skill in the field at the
time the claimed invention was made and you should not consider what is known today or what is

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learned from the teaching of the patent.

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34.
In evaluating the obviousness issue, you should consider whether the trial evidence has

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identified a persuasive reason that would have prompted a person of ordinary skill in the field to

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combine the elements or concepts from the prior art in the same way as in the claimed invention.

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For example, market forces or other design or manufacturing incentives might have naturally

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led to new combinations of prior-art elements. Such circumstances may indicate obviousness.

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You should also consider whether there was some teaching or suggestion in the prior art to

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combine the elements claimed in the patent. If, however, the teachings of the prior art directed a

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person skilled in the art away from combining certain known elements, the discovery of a

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successful way to combine those elements was more likely to be nonobvious. Also, you should

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consider whether the claimed invention applied a known technique that had already been used to

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improve a similar device in a similar way. You should also consider whether the claimed

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invention would have been obvious to try, meaning that the claimed innovation was one of a

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relatively small number of possible approaches to a problem with a reasonable expectation of

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success by those skilled in the art. You should also consider whether there was a design need or

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market pressure to solve a problem with a finite number of identified, predictable solutions, such

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that persons of ordinary skill in the art would have had good reason to pursue the known possible
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solutions within his or her technical grasp. Such circumstances would be indicative, not of

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innovation, but of straightforward application of ordinary skill and common sense, meaning that it

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was obvious.

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35.

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The ultimate conclusion of whether a claim is obvious should be based upon your

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determination of several points. First, you must decide the level of ordinary skill in the field that

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someone would have had at the time the claimed invention was made. Second, you must decide

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the scope and content of the prior art. Third, you must decide what difference, if any, existed

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between the claimed invention and the prior art. The ultimate question is whether the differences
between the prior art and the claimed invention were so insubstantial that the claimed invention

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would have been obvious to those of ordinary skill in the art. In this you must presume that those

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of ordinary skill in the art would have known and understood all of the relevant prior art,

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including all relevant patents and articles.

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36.

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In addition, you should consider any of the following factors that you find have been

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shown by the evidence. These are sometimes called “secondary considerations”:
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commercial success of a product due to the merits of the

claimed invention;

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a long-felt need for the solution provided by the claimed invention;

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3.

unsuccessful attempts by others to find the solution provided by

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the claimed invention;

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4.

copying of the claimed invention by others;

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5.

unexpected and superior results from the claimed invention;

24

6.

acceptance by others of the claimed invention as shown by praise

25

from others in the field or from the licensing of the claimed invention;

26

7.

other evidence tending to show non-obviousness;

27

8.

independent invention of the claimed invention by others before or

28

at about the same time as the named inventor thought of it; and
15

1

9.

other evidence tending to show obviousness.

2

The presence of factors 1–7 may be considered by you as an indication that the claimed invention

3

would not have been obvious at the time the claimed invention was made. The presence of

4

factors 8–9 may be considered by you as an indication that the claimed invention would have

5

been obvious at such time. Although you should consider any evidence of these factors, the

6

relevance and importance of any of them to your decision on whether the claimed invention

7

would have been obvious is up to you.

8

37.

in a relevant market, and that the successful product is the invention disclosed and claimed in the

11
For the Northern District of California

When a patentee can demonstrate commercial success, usually shown by significant sales

10

United States District Court

9

patent, it is presumed that the commercial success is due to the patented invention. If a patentee

12

makes the requisite showing of nexus between commercial success and the patented invention,

13

the burden shifts to the challenger to prove that the commercial success is instead due to other

14

factors extraneous to the patented invention, such as advertising or superior workmanship.

15

If the successful product embodies the claimed features but is not coextensive with them,

16

however, there is no presumption that the commercial success is due to the patented invention.

17

For example, a single product may embody multiple different inventions. In such an instance, the

18

burden remains with the patentee to prove a nexus between the success of the product and the

19

claimed invention.

20

You must consider all the evidence that was presented to you by both sides in your

21

consideration of all the secondary considerations. Although you must consider such evidence, the

22

importance of any of them to your decision on the issue of obviousness is up to you.

23
24

38.
In deciding whether Hologic has carried its burden of proof as to anticipation or

25

obviousness, you may consider the extent to which any claimed prior-art reference was before the

26

examiner. A given prior-art reference may have been cited to the patent examiner or may not

27

have been cited to the examiner. A cited reference may or may not have been explained to the

28

examiner, and the examiner may or may not have addressed the reference in a written opinion.
16

1

You are not bound by the action of the Patent Office and must make your own decision as to

2

validity. You may take into account whether you heard evidence that the Patent Office had no

3

opportunity to evaluate before granting the patent.

4

39.

5

The next defense is called lack of an adequate written description. This relates to whether

6

the specification, figures, and/or claims as originally filed adequately described the

7

asserted claims.

8

Defendant Hologic can meet its burden of proving that the asserted claims are invalid by

9

showing that the patent specification, figures, and/or claims as originally filed did not contain an
adequate written description for those claims. The purpose of this written-description

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For the Northern District of California

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10

requirement is to make sure that a patent specification, figures, and/or claims as originally filed

12

described the claimed invention so as to demonstrate that the named inventor or inventors were in

13

possession of the invention at the time the application for the patent was originally filed, which,

14

as stated, is the presumed date of invention.

15

Sometimes, new claims are requested while the prosecution is underway, and the new

16

claims may or may not have been discussed in the original application. So, it is important that it

17

be demonstrated that the inventor or inventors were in possession of the claimed invention as

18

eventually allowed. Here, no evidence has been presented indicating that the 1997 provisional

19

application (TX 341) was substantially different from the patent that ultimately issued so you may

20

use the patent that issued to determine whether the written description requirement has

21

been satisfied.

22

A claim will not be invalidated on written description grounds simply because the

23

embodiments of the specification do not contain examples explicitly covering the full scope of the

24

claim language. That is because the patent specification is written for a person of skill in the art,

25

and such person comes to the patent with the knowledge of what has come before. Put

26

differently, the specification does not need to describe every possible embodiment covered by a

27

claim. Placed in that context, it is unnecessary to spell out every detail of the invention in the

28
17

1

specification; only enough must be included to convince a person of skill in the art that the

2

inventor possessed the invention at the time the application for the patent was filed.

3
4

40.
The next defense is called lack of enablement. This relates to whether the patent

5

specification and figures, as originally filed, disclosed the claimed inventions in a way that

6

enabled those skilled in the art to make and use them.

7
8
9

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41.
With respect to the question of enablement, the Patent Act provides:
The specification shall contain a written description of the
invention, and of the manner and process of making and using it,
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 same.

12
42.
13
To prove invalidity by reason of non-enablement, defendant Hologic must prove that the
14
asserted claims are invalid by showing that the patent specification and figures, as originally filed,
15
failed to contain a description of the claimed invention sufficiently full and clear to enable a
16
person of ordinary skill in the field to make and use the full scope of the asserted claims without
17
undue experimentation. The purpose of the enablement requirement is to make sure that a patent
18
specification and figures, as originally filed, disclosed how to practice the full invention in return
19
for the limited monopoly granted by the government to the inventor. The question of whether a
20
patent is enabling is judged as of the date the original application for the patent was first filed.
21
It is presumed that all relevant prior art was already known to those practicing in the field.
22
43.
23
Even disclosure of a single example in a specification can sometimes support the full
24
scope of a claim. On the other hand, disclosure of one example for carrying out a claimed method
25
does not necessarily entitle an inventor to a broad generic claim covering any and all means for
26
achieving its objective. Whether or not claims 37 and 38 were enabled is a question for you the
27
jury to decide based on the trial evidence, the critical question being whether the specification and
28
drawings, when combined with all prior art known to those skilled in the art, disclosed how to
18

1

practice the full scope of the asserted inventions as claimed without having to undertake

2

excessive experimentation.

3
4
5

44.
In determining whether excessive experimentation would have been required, you may
consider the following factors:
the scope of the claimed invention;

2.

the amount of guidance presented in the patent;

8

3.

the amount of experimentation necessary;

9

4.

the time and cost of any necessary experimentation;

10

5.

how routine any necessary experimentation was in the field;

11
For the Northern District of California

1.

7

United States District Court

6

6.

whether the patent disclosed specific working examples of the

12
13
14
15

claimed invention;
7.

the nature and predictability of experimentation and variations of

the field; and
8.

the level of ordinary skill in the field.

16
17

45.
I will now elaborate on some of these factors. With respect to the first factor, the scope of

18

the claimed invention, a patentee who chooses broad claim language must make sure the broad

19

claims are fully enabled. The scope of the claims must be less than or equal to the scope of the

20

enablement to ensure that public knowledge is enriched by the patent specification to a degree at

21

least commensurate with the scope of the claims. Put differently, the narrower the claims, the

22

easier it is to sustain enablement.

23

As stated, you may consider the predictability of experiments and variations in the field.

24

You may consider whether the invention pertains to an art where the results of variations and/or

25

experiments were predictable, such that variations on the embodiments disclosed in the

26

specification would have been predictable.

27
28
19

1

46.

2

By analogy, suppose that an inventor created a particular method for fuel efficiency and

3

described the method in such detail in the specification that a person of ordinary skill in the art

4

would be able to achieve fuel efficiency. Although the specification would meet the requirements

5

of enablement with respect to a claim directed to that particular method, it would not necessarily

6

support a broad claim to every possible type of method to achieve fuel efficiency no matter how

7

different in operation from the claimed invention. A single embodiment would support such a

8

generic claim only if the specification would enable a person skilled in the art to use the full

9

scope of the claimed invention at the time of application without undue experimentation.
In our case, a question for you is whether defendant Hologic has proven that the

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For the Northern District of California

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10

specification and figures failed to enable the full scope of claims 37 and 38 asserted by

12

plaintiff Conceptus.

13
14

47.
I will now instruct you on the issue of damages. By instructing you on damages, I am not

15

suggesting which party should win on any issue. I am instructing you on damages only so that

16

you will have guidance on how to consider the evidence on damages if you reach this issue. If

17

you find that Hologic has induced or contributed to infringement of either asserted claim, and that

18

the infringed claim(s) is/are valid, then you must determine the amount of money damages to be

19

awarded from Hologic to Conceptus to compensate it for the infringement.

20

48.

21

Under the law, a patent holder is entitled to receive damages starting from the date of first

22

infringement. If you determine that there has been infringement, then the appropriate date for the

23

commencement of damages would be July 6, 2009, the date of FDA approval.

24
25

49.
Under the law, the amount of damages must be adequate to compensate the patent holder

26

for the infringement. A damages award should put the patent holder in approximately the

27

financial position it would have been in had the infringement not occurred. You should keep in

28

mind that the damages you award are meant to compensate the patent holder and not to punish
20

1

an infringer. There are two different ways to calculate damages: the “lost profits” method and the

2

“reasonable royalty” method.

3
4

50.
The first possible way to calculate damages is by the “lost profits” method. To recover

5

lost profits for infringing sales, Conceptus must show that but for the infringement there is a

6

reasonable probability that it would have made sales that Hologic made of the infringing method.

7

Conceptus must show what share, if any, of Hologic’s sales that it would have made if the

8

infringing method had not been on the market.

9

You must allocate the lost profits based upon the customer demand for the patented
features of the infringing method. That is, you must determine which profits derive from the

11
For the Northern District of California

United States District Court

10

patented invention, and not from other features of the Adiana system.

12
13

51.
Conceptus is entitled to lost profits if it proves all of the following:

14

1.

that there was a demand for the patented feature(s);

15

2.

that no acceptable non-infringing substitutes were available;

16

3.

that Conceptus had the manufacturing and marketing capacity to

17

make any infringing sales actually made by Hologic for which Conceptus seeks

18

lost profits; and

19

4.

20
21

the amount Conceptus would have made if Hologic had

not infringed.
You do not need to determine the second element because it already has been decided in

22

this case. You must assume that there were no acceptable non-infringing substitutes available.

23

This does not necessarily mean that each Adiana sale would have been an Essure sale if Adiana

24

had not been on the market. Conceptus must meet its burden of proving what additional profits it

25

would have made but for any infringement by Hologic.

26
27
28

52.
The second possible way to calculate lost damages is by the “reasonable royalty” method.
If Conceptus has not proved its claim for lost profits, or has proved its claim for lost profits for
21

1

only a portion of the infringing sales, then Conceptus should be awarded a reasonable royalty for

2

all infringing sales for which it has not been awarded lost-profits damages.

3

Let me define for you what I mean by the terms “royalty” and “reasonable royalty.” A

4

royalty is a payment made to a patent holder by a non-owner in exchange for getting a license,

5

which gives a person the right to make, use, or sell the claimed invention. A reasonable royalty is

6

the payment that would have resulted from a hypothetical negotiation between a reasonable patent

7

holder and a reasonable party needing a license as of the time when infringement first began. If

8

you find that infringement has occurred, then that date would be July 6, 2009, the date of

9

FDA approval.
In considering the nature of this negotiation, your focus should be on what the reasonable

11
For the Northern District of California

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10

expectations of Conceptus and Hologic would have been had they entered into a royalty

12

agreement in lieu of this litigation and acted reasonably in their negotiations. The law does not

13

require actual negotiations of a reasonable royalty between the parties. Instead, the law requires a

14

jury in a case like this to estimate what royalty would have been agreed to had reasonable parties

15

in like circumstances conducted negotiations when infringement first began. However, you must

16

assume that both parties believed the patent was valid and infringed. This is because you only

17

decide damages in the event you decide in favor of infringement and validity. In addition, you

18

must assume the parties were willing to enter into an agreement. Your job is to determine what

19

that agreement would have been.

20
21

53.
In determining the reasonable royalty, you may consider real-world facts including the

22

fifteen factors that both sides presented to you via their damages expert witnesses. It is up to you

23

to decide how much weight to give to any of these factors.

24

54.

25

As the party seeking damages, Conceptus has the burden of proving the amount of

26

damages by a preponderance of the evidence. While Conceptus is not required to prove damages

27

with mathematical precision, it must prove its damages with reasonable certainty. If Conceptus

28
22

1

has met its burden, your damages award should put Conceptus in approximately the financial

2

position it would have been in had the infringement not occurred.

3
4

55.
You may only award Conceptus damages that are adequate to compensate for

5

infringement. You may not award any more or less damages. Although Conceptus may recover

6

future damages (after the cut-off date) that it can prove with reasonable certainty, Conceptus is

7

not entitled to speculative damages, which means compensation for future loss or harm which,

8

although possible, is conjectural or not reasonably certain. Your award must be based upon

9

evidence and not upon speculation, guesswork, or conjecture.

11
For the Northern District of California

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10

Nor may you include any amount for the purpose of punishing Hologic or setting
an example.

12

56.

13

When you begin your deliberations, you should elect one member of the jury as your

14

foreperson. That person will preside over the deliberations and speak for you here in court.

15

I recommend that you select a foreperson who will be good at leading a fair and balanced

16

discussion of the evidence and the issues.

17

57.

18

In your deliberations, it is usually a mistake to take a straw vote early on. This is due to

19

the risk of jury members expressing a premature opinion and then, out of pride, digging in their

20

heels. Rather, it is usually better to discuss the evidence, pro and con, on the various issues

21

before proceeding to take even a straw vote. In this way, all the viewpoints will be on the table

22

before anyone expresses a vote. These are merely recommendations, however, and it is up to you

23

to decide on how you wish to deliberate.

24

58.

25

Your verdict as to each issue and as to damages, if any, must be unanimous. Each of you

26

must decide the case for yourself, but you should do so only after you have considered all of the

27

evidence, discussed it fully with the other jurors, and listened to the views of your fellow jurors.

28
23

1
2

59.
Do not be afraid to change your opinion if the discussion persuades you that you should.

3

Do not come to a decision simply because other jurors think it is right. It is important that you

4

attempt to reach a unanimous verdict but, of course, only if each of you can do so after having

5

made your own conscientious decision. Do not change an honest belief about the weight and

6

effect of the evidence simply to reach a verdict.

7
8
9

Some of you have taken notes during the trial. Whether or not you took notes, you should
rely on your own memory of what was said. Notes are only to assist your memory. You should
not be overly influenced by the notes.

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For the Northern District of California

United States District Court

10

60.

12

61.
When you retire to the jury room to deliberate, the Clerk will bring you the following:

13

1.

All of the exhibits received into evidence;

14

2.

An index of the exhibits;

15

3.

A work copy of these jury instructions for each of you;

16

4.

A work copy of the verdict form for each of you; and

17

5.

An official verdict form.

18

You do not have to discuss the questions in the strict sequence indicated in the special

19

verdict form, but you must, by the end, answer them unanimously as indicated in the form.

20

When you recess at the end of a day, please place your work materials in the brown

21

envelope provided and cover up any easels containing your work notes so that if my staff needs to

22

go into the jury room, they will not even inadvertently see any of your work in progress.

23
24

62.
A United States Marshal will be outside the jury-room door during your deliberations.

25

If it becomes necessary during your deliberations to communicate with me, you may send a

26

note through the Marshal, signed by your foreperson or by one or more members of the jury.

27

No member of the jury should ever attempt to communicate with me except by a signed writing,

28

and I will respond to the jury concerning the case only in writing or here in open court. If you
24

1

send out a question, I will consult with the lawyers before answering it, which may take some

2

time. You may continue your deliberations while waiting for the answer to any question.

3

Remember that you are not to tell anyone — including me — how the jury stands, numerically or

4

otherwise, until after you have reached a unanimous verdict or have been discharged. Do not

5

disclose any vote count in any note to the Court.

6
7

63.
I have told you that you will be required to be here each day from 7:45 a.m. to 1:00 p.m.

8

Now that you are going to begin your deliberations, however, you are free to modify this schedule

9

within reason. For example, if you wish to continue deliberating in the afternoons after a
reasonable lunch break, that is fine. The Court does, however, recommend that you start your

11
For the Northern District of California

United States District Court

10

deliberations by 8:00 a.m.

12

It is very important that you let the Clerk know in advance what hours you will be

13

deliberating so that the lawyers may be present in the courthouse at all times when the jury

14

is deliberating.

15

64.

16

You may only deliberate when all of you are together. This means, for instance, that in

17

the mornings before everyone has arrived, or when someone steps out of the jury room to go to

18

the restroom, you may not discuss the case. As well, the admonition that you are not to speak to

19

anyone outside the jury room about this case still applies during your deliberations.

20
21

65.
After you have reached a unanimous agreement on a verdict, your foreperson will fill

22

in, date, and sign the verdict form and advise the Court through the Marshal that you have

23

reached a verdict. The foreperson should hold on to the filled-in verdict form and bring it into the

24

courtroom when the jury returns the verdict. Thank you for your careful attention. The case is

25

now in your hands. You may now retire to the jury room and begin your deliberations.

26
27

Dated: October 14, 2011.

WILLIAM ALSUP
UNITED STATES DISTRICT JUDGE

28
25