Hold the Mayo: Specific Method of Treatment for Specific Patients using a Specific Compound at Specific Doses to Achieve a Specific Outcome Is Patent-Eligible Subject matter

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In Vanda Pharmaceuticals Inc. v. West-ward Pharmaceuticals International Limited, [2016-2707, 2016-2708] (April 16. 2018), the Federal Circuit affirmed the district court;s determination that claims 1–9, 11–13, and 16 of U.S. Patent 8,586,610 (infringed and not invalid.

The Federal Circuit noted that inducement can be found where there is evidence of active steps taken to encourage direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.  Thus ican be found where there is evidence of active steps taken to encourage
direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.  The Federal Circuit rejected West-ward’s argument that the proposed label was insufficient to find inducement, without an underlying direct infringer, because in an ANDA case infringement is statutorily defined as filing or amending the application, not by selling a product.

The Federal Circuit also found that the district court did not clearly err in finding that the proposed label recommends performance of all the claimed steps, finding that potential noninfringing uses do not preclude a finding of specific intent to induce infringement.

Regarding subject matter eligibility, the Federal Circuit rejected West-ward’s argument that the claims were similar to the the claims found patent ineligible in Mayo.  First, the claims in Mayo were not directed to a novel method of treating a disease. Instead, the claims were directed to a diagnostic method based on the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.  This relation was a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.  in contrast, the Federal Circuit found the instant claims were directed to “a new way of using an existing drug” that is safer for patients.

Second, the Federal Circuit found that unlike the claim in Mayo, the present claims do not tie up the doctor’s subsequent treatment decision.  The claim in Mayo did not go beyond recognizing  a need to increase or decrease a dose — it could be infringed even if the doctor did not actually change the treatment.  In other words, the claim in Mayo did not involve using the natural relationship. In contrast, the claims in suit recite the steps of carrying out a dosage regimen based on the results of genetic testing.  Thus the claims do not broadly tie up the doctor’s subsequent treatment decisions.

The Federal Circuit analogized the case to CellzDirect, where the claims were not directed to an observation or detection, but to a method of preserving cells. There, the natural ability of the subject matter to undergo the process did not make the claim “directed to” that natural ability. The Federal Circuit also distinguished Myriad, where the court noted that method claims and patents on new applications of knowledge about particular  genes were not implicated by its decision, noting the claims fall squarely  within categories of claims not implicated by its decision.

The Federal Circuit concluded that the claims were directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo because they recite more than the
a natural relationship; instead, they recite a method of treating patients based on this relationship.

The Federal Circuit affirmed that the district court clearly erred in finding that the  patent sufficiently discloses the claimed invention.

Finally, the Federal Circuit agreed that 35 U.S.C. § 271(e)(4) supports the injunctive relief granted by the district court.

 

 

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PTAB is not Bound by prior Litigation-Based Claim Constructions Provided They are Appropriately Considered

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In Knowles Electronics. v. Iancu, [2016-1954] (April 6, 2018), the Federal Circuit affirmed the PTAB’s affirmance of the Examiner’s determination that claims 1–2, 5–6, 9, 11–12, 15–16, and 19 of U.S. Patent No. 8,018,049 were anticipated, and claims 21–23 and 25–26 would have been obvious.

The claims were directed to a silicon condenser microphone and manufacturing method.  Knowles argued that the PTAB erred by improperly construing “package,” including by failing to consider the Federal Circuit construction of package in a related patent, and by improperly relying on a new ground of rejection to sustain the Examiner’s obviousness findings.

The Federal Circuit noted that it has held that, in some circumstances, previous
judicial interpretations of a disputed claim term may be relevant to the PTAB’s later construction of that same disputed term. While the PTAB is not generally bound by a previous judicial interpretation of a disputed claim term does not mean that it has no obligation to acknowledge that interpretation or to assess whether it is consistent with the BRI.  The Federal Circuit found that the PTAB considered a previous interpretation of the term and properly determined its claim construction was consistent with the term’s BRI, and the PTAB adequately explained its adoption a claim construction
relative to the prior construction.

On the question of whether the Board relied upon a new ground of rejection, the Federal Circuit said that the PTAB is not limited to reciting and agreeing with the examiner’s rejection in haec verba, and can further explain the examiner’s rejection and thoroughly respond to an applicant’s argument. Knowles argued that the the PTAB’s finding regarding the motivation to combine, based upon the principles of operation of the references, does not appear anywhere in the Examiner’s decision.  However, after examining the decisions of the Examiner and the Board, the Federal Circuit found taht the PTAB’s rejection relied on the same reasons provided by the Examiner, albeit using slightly different verbiage.  The Federal Circuit noted that Knowles was given, and actually used its opportunity to respond to the theory of unpatentability before the Board.

 

 

“Ordinary Creativity” is no Different Than “Common Sense” and Requires Explanation

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In DSS Technology Management, Inc. v. Apple Inc., [2016-2523, 2016-2524] (March 23, 2018), the Federal Circuit reversed the decision of the PTAB finding claims 1–4 and 9–10 of U.S. Patent No. 6,128,290 obvious, because the Board failed to provide a sufficient explanation for its conclusions.

The patent is directed to a wireless communication network for a single host device and multiple peripheral devices.  The sole issue on the appeal was whether it was obvious to modify the single asserted reference.  The Federal Circuit noted that common sense and common knowledge have their proper place in the obviousness inquiry, if it is explained with sufficient reasoning.  However there are at least three caveats to the application of “common sense”: First, common sense is typically invoked to provide a known motivation to combine, not to supply a missing claim limitation.  Second, common sense is invoked to fill in a missing limitation only when “the limitation in question was unusually simple and the technology particularly straightforward.  Third, reference to “common sense” —whether to supply a motivation to combine or a missing limitation—cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation
missing from the prior art references specified.

The Federal Circuit found that the Board’s invocation of “ordinary creativity” was no different from “common sense,” and requires a “searching” inquiry.  The Federal Circuit noted that the full extent of the Board’s analysis was contained in a single paragraph.  In finding the claimed invention obvious, the Board made no citation to the record, and instead referred to the “ordinary creativity” of the skilled artisan.

The Federal Circuit said that to the extent the Board’s obviousness findings were based on expert testimony — which was questionable, since it was not cited. Dr. Hu’s testimony—which is questionable, because the Board never cited her testimony directly— the “conclusory statements and unspecific expert testimony” were insufficient to support the Board’s findings.

The Federal Circuit said that without “a reasoned explanation that avoids conclusory generalizations,” the Board’s reasoning was not sufficient.

 

“BRI.” You Keep Using That Word. We Do Not Think it Means What You Think it Means.

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In In re: Power Integrations, Inc., [2017-1304] (March 19, 2018), the Federal Circuit reversed the decision on remand that claims 1, 17, 18, and 19 of U.S. Patent No. 6,249,876 were anticipated, because the Board relied upon an unreasonably broad claim construction.  The patent describes a technique for reducing electromagnetic interference (“EMI”) noise “by jittering the switching frequency of a switched mode power supply.”

The Board affirmed the examiner’s rejection of the claims as anticipated in light of its construction of the term “coupled” that was broad enough to encompass an EPROM between the counter and the digital to analog
converter.  The Federal Circuit noted that the patent had been previously litigated, and the claims were found to be not obvious or anticipated.  When the case was previously before it, the Federal Circuit remanded, finding that the Board had an obligation to evaluate the construction from the litigation to determine whether it was consistent
with the broadest reasonable construction of the term.

The Federal Circuit noted that on remand the Board acknowledged that the Federal Circuit’s “concern” that its original decision had failed to assess whether the district court’s interpretation of the term “coupled” was consistent with the broadest reasonable construction, but the Board concluded that such a comparison was “unwarranted.”  The Federal Circuit said that the Board adhered to a generalist dictionary definition of the term“coupled,” and could glean no substantial guidance from either the context of the claim itself or the specification.

The Federal Circuit said that even under the broadest reasonable
construction rubric the Board must always consider the claims in light of the specification and teachings in the underlying patent, and that there was no reason why this construction could not coincide with that
of a court in litigation.  The Federal Circuit added that while the broadest reasonable interpretation standard is broad, it does not give the Board an unfettered license to interpret the words in a claim without regard for the full claim language and the written description.  The Federal Circuit found that the board’s claim construction here was unreasonably broad and improperly omitted any consideration of the disclosure in the specification.

The Federal Circuit explained under the board’s overly expansive view of the term “coupled,” every element anywhere in the same circuit is
potentially “coupled” to every other element in that circuit, no matter how far apart they are, how many intervening components are between them, or whether they are connected in series or in parallel.  The Federal Circuit pointed out that the correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is not whether the specification proscribes or precludes some broad reading of the claim term adopted by the examiner.

The Federal Circuit noted that the board has had two opportunities to come up with a sustainable interpretation that differs from the one that
survived litigation and has failed, and concluded there was not one.  The Federal Circuit thus reversed the Board without remand.

 

Presenting IPR Arguments Too Late is . . . Well Too Late

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In Dell Inc. v. Acceleron, LLC, [2017-1101](March 19, 2018), the Federal Circuit affirmed the Board’s decision on remand not to consider Dell’s late-presented arguments, rather than giving Acceleron the opportunity to address them.

In the previous appearance of this IPR before the Federal Circuit, Acceleron persuaded the Federal Circuit that the Board had improperly relied upon late-presented arguments by Dell made for the first time during the oral argument to which Acceleron did not have the opportunity to respond.  The Federal Circuit remanded the case, and on remand the the Board decided the proper course was to ignore the arguments made by Dell because they were no and not responsive to Acceleron’s arguments.

The Federal Circuit said that the Board was obligated to dismiss Dell’s
untimely argument given that the untimely argument in this case was raised for the first time during oral argument.  Dell argued that ignoring evidence of unpatentability was against public policy because it will not improve patent quality, but the Federal Circuit found that due process and preserving the Board’s discretion outweigh any negative effects of not invalidating a patent claim, especially since other parties remained free to challenge the validity of the claims.

 

Written Description is Met by What the Disclosure Reasonably Conveys to Those Skilled in the Art

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In Hologic, Inc. v. Smith & Nephew, Inc., [2017-1389] (March 14, 2018), the Federal Circuit affirmed the Board’s determination that S&N’s earlier-filed PCT application has sufficient written description to make it a priority document instead of an invalidating obviousness reference to U.S. Patent No. 8,061,359.

The claim in disputed is directed to an endoscope “having a light guide
permanently affixed therein.”  The PCT application from which the patent derived described a “fibre optics bundle.”  The Examiner found it did not, and rejected the claims as obvious over the prior PCT application.  However, the Board reversed, finding that the disclosure in the PCT provides sufficient written description support for the claimed “light guide,” entitling the patent to the priority date of the PCT.

The Federal Circuit said that to be entitled to the priority date of the earlier-filed PCT, S&N must show that the PCT discloses what the patent claims, according to the written description requirement of 35 U.S.C. §112.  Specifically, based on an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention
claimed.  The Federal Circuit found that it did.

The Federal Circuit noted that substantial evidence showed that the PCT
discloses a “light guide,” including the fact that the parties did not dispute that a “fibre optic bundle” is a type of light guide, and that various types of light guides were well-known in the art.  The Federal Circuit also rejected the argument that a light guide was not shown in the Figures, pointing out that “written description does not require that every claimed element be illustrated in the figures, particularly in predictable arts and where the element not depicted is conventional and not “necessary for the understanding of the subject matter sought to be patented.”

The Federal Circuit was satisfied that the Board applied the correct law and that substantial evidence supports the Board’s finding that the PCT provides sufficient written description disclosure of the claimed
“first channel having a light guide permanently affixed therein.”

 

Collateral Estoppel Applies in IPRs Where the Issues are the Same

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In Nestle USA, Inc. v. Steuben Foods, Inc., [2017-1193] (March 13, 2018), the Federal Circuit vacated the Board’s construction of “aseptic” in U.S. Patent No. 6,481,468 because of collateral estoppel considerations, and remanded for further proceedings.

The Federal Circuit noted that Nestle had previously appealed the construction of “aseptic” in another IPR involving a related patent (U.S. Patent No. 6,945,013), and in that case, the Federal Circuit vacated the
Board’s construction, relying on binding lexicography in the specification for “aseptic” to construe the term to mean the “FDA level of aseptic.”

The Federal Circuit explained that collateral estoppel protects a party from having to litigate issues that have been fully and fairly tried in a previous action and adversely resolved against a party opponent, and that it is well established that collateral estoppel applies in the administrative
context.  The Federal Circuit said that it was undisputed that the claims at issue in the two appeals use the term “aseptic” (or its related variation
“aseptically disinfecting”) in a similar fashion.  More critically, the Federal Circuit said, the two patents also provide identical lexicography
for the term “aseptic” in their specifications.

The Federal Circuit concluded that collateral estoppel protects Nestlé and obviates the need to revisit an issue that was already resolved against Steuben Foods. The Federal Circuit said that collateral estoppel is not
limited “to patent claims that are identical; it is the identity of the issues that were litigated that determines whether collateral estoppel should apply.

Terminal Disclaimer is a Strong Clue, But Not Conclusive Proof That Continuation Claims Are Not Patentably Distinct

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In Simpleair, Inc. v. Google LLC, [2016-2738] (March 12, 2018), the Federal Circuit vacated the district court’s dismissal under FRCP 12(b)(6) because the district court erred by presuming that terminally disclaimed
continuation patents are patentably indistinct variations of their parent patents without analyzing the scope of the patent claims.

This case is SimpleAir’s fourth complaint asserting infringement by Google Cloud Messaging services, this one involving U.S. Patent Nos. 8,639,838 and 8,656,048.  The district court dismissed both complaints under Rule 12(b)(6) as barred by claim preclusion and the Kessler doctrine, reasoning that patents shared the same title and specification with previously adjudicated continuation patents, and the filing of a terminal disclaimer
to overcome the PTO’s obviousness-type double patenting rejections indicated that the PTO believed the content of the patents in suit to be patentably indistinct from the earlier patents.

The Federal Circuit agree that agreed that claim preclusion was not foreclosed because SimpleAir asserted patents in this case that were not before the district court in the prior actions.  However, the Federal Circuit found that the record before it record before us wis not sufficient to sustain
the district court’s holding of claim preclusion.

The Federal Circuit said that it is the claims of the patent which define the invention, and that the district court concluded that the underlying inventions were the same without ever analyzing the claims of any patent in making that conclusion.  The Federal Circuit distinguished the situation of reexamined patents, where the claims in the reissued patent cannot be broader than the claims in the original patent.  In a continuation, even a continuation with a terminal disclaimer, the claims can be broader.

The Federal Circuit held that where different patents are asserted in a first
and second suit, a judgment in the first suit will trigger claim preclusion only if the scope of the asserted patent claims in the two suits is essentially the same.  However Federal Circuit case law forecloses the
inference that filing a terminal disclaimer functions as an admission regarding the patentability of the resulting claims.

The Federal Circuit said that the filing of a terminal disclaimer is a strong indicator that the claims are not patentably distinct, but something more is still required:

Thus, a terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent. But as our precedent indicates, that strong clue does not give rise to a presumption that a patent subject to a terminal disclaimer is patentably
indistinct from its parent patents. It follows that a court may not presume that assertions of a parent patent and a terminally-disclaimed continuation patent against the
same product constitute the same cause of action. Rather, the claim preclusion analysis requires comparing the patents’ claims along with other relevant transactional facts.

Claim preclusion implicates both the weighty policies
of judicial economy and fairness to parties.   It “encourages reliance on judicial decisions, bars vexatious litigation, and frees the courts to resolve other disputes.  However, because claim preclusion shields the fraud and the cheat as well as the honest person, it is to be invoked only
after careful inquiry.

The Federal Circuit also found that the Kessler Doctrine does not unless (and until) the claims have been found to be patentably distinct.

Stare Decisis: Previous Claim Constriction Prevented Finding of Infringement

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In Ottah v. Fiat Chrysler, [2017-1842] (March 7, 20180, the Federal Circuit affirmed the district court’s grant of summary judgment of non-infringement of U.S. Patent No. 7,152,840 on a book holder.

The Federal Circuit noted that it had previously reviewed claim construction of the ’840 Patent, and ruled that several claim limitations
require that the claimed book holder has a “removable mounting.”  This ruling on claim scope is a matter of “claim construction,” which is ultimately a question of law, and not subject to collateral review.  The Federal Circuit said that no error has been shown in this claim construction, and no reason for departing from the rules of collateral
estoppel or stare decisis as to this claim term.

The Federal Circuit discerned no error in the district court’s grant of
summary judgment of non-infringement, for no reasonable fact finder could find that the accused cameras meet the “removably attached” limitation of claim 1.  The Federal Circuit added that it had liberally
construed the pleadings, but have concluded that the Second Amended Complaint’s accusation of infringement lacks plausibility. The district court correctly dismissed Ottah’s complaint with prejudice.

Written Description Must Do More Than Make Claimed Subject Matter Obvious

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In Knowles Electronics, LLC v. Cirrus Logic, Inc., [2016-2010] (March 1, 2018), the Federal Circuit affirmed the PTAB affirmance of the Examiner that claims 1−4 of U.S. Patent No. 6,781,231 were anticipated, and that new claims 23−27 for lack of an adequate written description.

Knowles argued that the term “package” should be construed to
mean an assembly that “requires a second-level connection
with a mounting mechanism.”  However, as the Federal Circuit noted, neither the claims nor the specification specify the type of connection required.  Because intrinsic evidence is not definitive, the Federal Circuit turned to extrinsic evidence, and found support in the definitions that the PTAB selected.  Although Knowles complained that the Board impermissibly selected the broadest definition, but the Federal Circuit rejected this, finding the Board reviewed all extrinsic evidence, including evidence proffered by Knowles.

Regarding the support for the new claims, the Federal Circuit said that the written description must clearly allow a PHOSITA to recognize that the inventor invented what is claimed.  A description which renders obvious a
claimed invention is not sufficient to satisfy the written description requirement of that invention.  The amended claims require solder pads “configured to mechanically attach and electrically connect the package to a surface of an external printed circuit board using a solder reflow process,” however the specification merely discloses a genus―solder pads that are capable of being connected to a board, and fails completely to disclose the newly claimed species of such pads―pads that are connectable to a board specifically by using a reflow process.

The Federal Circuit rejected the Knowles argument that the PTAB disregarded “the state of the art at the time of filing” and “prior art knowledge” that would have demonstrated that a PHOSITA knew
solder pads were “intended to be capable of reflow attachment
to a user’s board.”  Given uncertainties in the art, and at best a passing
reference to solder pads in the specification, the PTAB reasonably found that a PHOSITA would not have recognized that the inventor possessed solder pads “configured to” connect to a printed circuit board through a reflow process.  The Federal Circuit further noted that the consideration
for adequate written description asks what the applicant conveyed with reasonable clarity, and the ’231 patent “failed to even mention, much less spell out any detail of, the claimed reflow process”).

Judge Newman dissented because the claim construction adopted by the PTAB, and affirmed by the Federal Circuit was at odds with the construction of the same claims in a prior Federal Circuit case, which she believed should be binding.