Printed Matter Cannot Be a Patentable Limitation Unless it is Functionally Related to the Claim Elements

In Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., [2016-2616, 2016-2656](May 16, 2018), the Federal Circuit affirmed the PTAB decision that claims 1–8 and 10–11 of U.S. Patent 8,846,112 directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications were unpatentable as obvious, and reversed the decision that claim 9 was not unpatentable.

In construing the claims, the Board applied the printed matter doctrine. The Board interpreted the providing information, evaluating, and recommendation claim limitations to be either printed matter or purely
mental steps not entitled to patentable weight, as those limitations lacked a functional relationship to the other claim limitations except in claim 9.  With respect to claim 9, however, the Board interpreted “in accordance with” to mean “based on, or as a result of” the recommendation to discontinue nitric oxide treatment from claim 7,
thereby establishing a functional relationship to the recommendation limitation.  The Board found that the cited prior art collectively taught each limitation of claims 1–8 and 10–19 that did have patentable weight, and held they were obvious.

The Federal Circuit began with the printed matter doctrine, applied by the PTAB.  The Federal Circuit explained that claim limitations directed to printed matter are not entitled to patentable weight unless the printed matter is functionally related to the substrate on which the printed
matter is applied.  However the printed matter doctrine is not limited to printed materials, and applies if the claims are directed to the content of information.

If a claim limitation is directed to printed matter, then the next step is to ascertain whether the printed matter is functionally related to its “substrate.” Printed matter that is functionally related to its substrate is given patentable weight, while where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the
invention from the prior art in terms of patentability.  In in Ngai, there was no functional relationship between claimed instructions and a diagnostic kit, as the instructions “in no way depended on the kit, and the kit did not dependon the” instructions. However, Ngai distinguished Gulack, where
there was a functional relationship between printed digits on a circular band because “the printed matter and the circularity of the band were interrelated, so as to produce a new product useful for educational and recreational mathematical purposes.”

The Federal Circuit agreed that the Board properly addressed the printed matter doctrine during claim construction.  The Federal Circuit rejected Mallinckrodt’s argument that the printed matter/mental steps doctrines only apply to patent eligibility, noted that the printed matter doctrine raises an issue where the § 101 patent-eligibility inquiry and the
§ 102 and § 103 novelty and nonobviousness inquiries overlap.  The Federal Circuit explained because claim limitations directed to mental steps may attempt to capture informational content, they may be considered printed matter lacking patentable weight in an obviousness
analysis. Accordingly, a limitation that merely claims information by incorporating that information into a mental step will receive patentable weight only if the limitation is functionally related to the substrate.

The Federal Circuit noted that claim 3’s requirement that the medical provider weigh “the potential benefit of treating the [neonatal patient]
with 20 ppm inhaled nitric oxide vs. the potential risk that inhaled nitric oxide could cause an increase in PCWP” merely requires a medical provider to think about the information claimed in the providing information limitation of claim 1.  The Federal Circuit said that adding an ineligible mental process to ineligible information still leaves the claim limitation directed to printed matter. To hold otherwise would make
the printed matter doctrine a dead letter, requiring no more than a “think about it” step to give patentable weight to a claim limitation directed to information content.

The Federal Circuit found that the reference to “pharmaceutically acceptable” referred to the nature of the nitric acid gas, not the prescribing information that may accompany it, and thus there was no functional relationship between the information and methods of providing and potentially administering the drug.  Since no other functional relationship was asserted, the Federal Circuit held that the printed matter in claims 1–8 and 10 lacks a functional relationship to its substrate, and thus cannot be the basis of patentability.

The Federal Circuit then turned to claim 9, which survived the IPR, summarizing it as: (1) determining that a neonatal patient has preexisting LVD; (2) treating that neonate with nitric oxide, whereupon
the neonate experiences pulmonary edema; (3) providing information and a recommendation to the medical provider to discontinue nitric oxide treatment for a patient with preexisting LVD who experiences a pulmonary edema; and (4) “based on” the  recommendation,  discontinuing nitric oxide treatment due to the pulmonary edema. The Federal Circuit noted that claim 9 requires a medical provider to take a specific action, discontinuing treatment, as a result of the  recommendation limitation, and agreed that this creates the required functional relationship with the rest of the claim.  However the Federal Circuit disagreed with the Board that claim 9 as a whole would not have been obvious.

The Federal Circuit found the Board improperly construed claim 9 as requiring the exclusion of persons from the treatment, rather than discontinuing persons from treatment if edema occurs, and thus the prior art teaching of treatment with monitoring  made the claimed invention obvious.

Wash Your Hands Before Meals and Before Going to Court; Unclean Hands Wipe out Recover for Valid and Infringed Patents

In Gilead Sciences, Inc. v. Merck & Co., [2016-2302, 2016-2615] (April 25, 2018), the Federal Circuit affirmed the district court’s determination that the claims the jury found to be valid and infringed were unenforceable because of pre-litigation business misconduct and litigation misconduct attributable to Merck.

The Federal Circuit looked the the Supreme Court’s decision in Keystone Driller Co. v. General Excavator Co., for an explanation of unclean hands — there the Court held that a determination of unclean hands may be reached when “misconduct” of a party seeking relief “has immediate and necessary relation to the equity that he seeks in respect of the matter in litigation,” i.e., “for such violations of conscience as in some measure affect the equitable relations between the parties in respect of something brought before the court.”  The Federal Circuit noted that Merck argued that the connection between the misconduct and the litigation must be “material,” but failed to make clear to the Federal Circuit had that requirement affected the case.  The Federal Circuit noted that in the present case which involves clear misconduct in breaching commitments to a third party and clear misconduct in litigation, the “immediate and necessary relation” standard, in its natural meaning, is met if the conduct normally would enhance the claimant’s position regarding legal rights that are important to the litigation if the impropriety is not discovered and corrected.  The Federal Circuit found that considering the conduct as a whole the district court’s determination of unclean hands was adequately supported.

Specifically, the district court found that Merck violated the “firewall” understanding between Merck and Pharmasset, when at least one person involved in a conference call with Pharmasset was involved, and continued to be involved in Merck related patent prosecution, which the Federal Circuit characterized as “serious misconduct,
violating clear standards of probity in the circumstances.”  The improperly acquired knowledge influenced Merck’s filing of narrowed claims, a filing that held the potential for expediting patent issuance and for lowering certain invalidity risks.

The district court also found litigation misconduct, first in giving knowing false deposition testimony (presumably to hide the business misconduct) and false trial testimony. The Federal Circuit agreed with the district court that Merck’s litigation misconduct infects
the entire lawsuit, including the enforceability of the other patents in the suit.

Because the district court did not abuse its discretion in applying the doctrine of unclean hands, the Federal Circuit affirmed.

Lack of Corroboration Caused Claim of Prior Invention to Fail

In Apto Miitors APS v. Kamstrup, [2017-1681] (April 17, 2018) the Federal Circuit affirmed the Board’s determination that U.S. Patent No. 8,893,559 was anticipated by Nielsen, U.S. Patent App. Pub. No. 2012/0006127, finding substantial evidence supported the Board’s finding that Apator failed to sufficiently corroborate the
inventor testimony of earlier conception.

An inventor can swear behind a reference by proving he conceived his invention before the effective filing date of the reference and was diligent in reducing his invention to practice after that date.  However, that when a party seeks to prove conception
through an inventor’s testimony the party must proffer evidence corroborating the inventor’s testimony.  The sufficiency of the proffered corroboration is determined
by a “rule of reason” analysis in which all pertinent evidence is examined, but even under the rule of reason analysis, the evidence of corroboration must not depend solely on the inventor himself.

The evidence of prior conception included emails sent by the inventor transmitting drawings and presentations, but the only identification of the attachments was by the inventor.  The Federal Circuit noted the catch-22 of corroboration: Apator attempts to corroborate the inventor’s testimony with the emails and the drawings, but the emails and drawings can only provide that corroboration with help from the inventor’s
testimony.

The Federal Circuit concluded that a reasonable mind could conclude that Apator
failed to proffer evidence corroborating the inventor’s testimony regarding conception, and accordingly held that substantial evidence supports the Board’s finding
that Apator has not established prior conception.

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

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.

 

 

Anda Your Patent is Not Infringed

In Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, [2017-1560] (February 9, 2018), the Federal Circuit affirmed the district court, finding that it did not abuse its discretion in denying Merck’s request for additional samples and a new trial, that it did not err in finding that Merck failed to demonstrate that Amneal’s ANDA product, which formed the basis for the district court’s noninfringement finding, was not representative of Amneal’s final commercial product, and that district court did not clearly err in finding that three Raman peaks were required to prove infringement.

On the denial of additional discovery issue, the Federal Circuit reviews a district court’s denial of additional discovery under regional circuit law, and the Third Circuit will not disturb a denial of additional discovery
absent an abuse of discretion and “a showing of actual and substantial prejudice.  The Federal Circuit found the question “a close one.” The Federal Circuit noted that Amneal’s failure to abide by the standing discovery order resulted in a trial situation that was “less than ideal.”  However the Federal Circuit concluded that the district court did not abuse its discretion in denying the additional discovery, noting that the district court took adequate steps to ensure that proceeding with trial would not prejudice Merck.

The Federal Circuit said that the ultimate determination of infringement is a question of fact, which is reviewed for  clear error. The Federal Circuit rejected Merck’s argument that the district court improperly determined infringement of an intermediate product, rather than the final product, as imposing a heightened evidentiary standard in ANDA cases not supported by case law.  The Federal Circuit said that regardless of the type of sample (e.g., commercial or batch), the critical inquiry is
whether it is representative of what is likely to be approved and marketed.

Finally, the Federal Circuit discerne no clear error in the district court’s
fact-finding of noninfringement.  The district court found Amneal’s expert
evidence “at least as consistent and credible” as Merck’s expert and concluded that Merck failed to prove infringement by preponderant evidence.  Amneal’s expert testified that although a single peak can be used at times, three Raman peaks are typically used to absolutely confirm the presence of molecules in complex mixtures like MFM. Because the noninfringement finding was supported by this evidence in the record, the Federal Circuit concluded that the district court did not clearly err in its noninfringement finding.

The Ultimate Reasonable Royalty Award Must be Based on the Incremental Value that the Patented Invention Adds

In Exmark Manufacturing Company Inc. v. Briggs & Stratton Power Products Group, LLC., [2016-2197](January 12, 2018) the Federal Circuit vacated summary judgment that claim 1 of U.S. Patent No. 5,987,863 is not anticipated or obvious, affirmed summary judgment that claim 1 was not indefinite, reversed the denial of a new trial on damages and several evidentiary rulings related to damages, vacated the finding of willfulness; and affirmed the denial of Briggs’ laches defense.

Regarding the denial of summary judgment of invalidity, the Federal Circuit found that the district court denied the motion because “examined four times by the PTO, and each time the PTO held the claims of the ’863 patent to be patentable.”  While facially logical, this is not legally correct, the Federal Circuit held that

a reexamination confirming patentability of a patent claim alone is not determinative of whether a genuine issue of fact precludes summary judgment of no invalidity.  Surviving a reexamination does not warrant ipso facto summary judgment that a patent is not invalid. Holding otherwise would improperly give complete deference  and preclusive effect to the PTO’s patentability determination, foreclosing challenges to patent validity in district court based on the same prior art.

This holding is supported by Federal Circuit precedent that that a district court is never bound by an examiner’s finding in an ex parte patent application proceeding.  To the extent that an ex parte reexamination is entitled to deference, it comes from the presumption of validity of an issued patent.

The Federal Circuit found that the district court’s denial of summary judgment went beyond giving substantial weight to the reexamination proceedings.  The Federal Circuit found that the district court’s summary judgment was based solely on the fact that the patentability of claim 1
was confirmed following multiple reexaminations — the district court made no other findings regarding the elements of anticipation or obviousness to determine whether a genuine issue of material fact precluded summary judgment.

The Federal Circuit said that is must be furnished with sufficient findings and reasoning to permit meaningful appellate scrutiny.  These were lacking so the Federal Circuit vacated the district court’s summary
judgment of no invalidity and remanded with instruction for the district court to consider the entire record and reach its own independent conclusion on validity.

On the issue of definiteness, Briggs complained that Briggs contends that the patent does not explain how to objectively determine whether a
baffle portion is straight enough or long enough to be “elongated and substantially straight” as required by the claim.  The Federal Circuit disagreed, holding no numerical precision is required when using such terms of degree.  All that is required is some standard for measuring the term of degree.

The Federal Circuit also found that the function of the elongated and substantially straight baffle portions provided further guidance regarding
the scope of the claim language. The Federal Circuit noted that functional language can promote definiteness because it helps bound the scope of the claims by specifying the operations that the claimed invention must undertake.

With respect to damages, Briggs complained first that Exmark improperly determined a royalty rate without properly identifying a royalty base to apportion the value of the patentee’s invention in comparison to the value of the whole, and second that at Exmark’s expert did not adequately explain how she arrived at her proposed 5% royalty rate.  The Federal disagreed that the Exmark needed to apportion the value of the baffle from the other features of the mower through the royalty base rather than the royalty rate, noting that apportionment can be achieved, by careful selection of the royalty base to reflect the value added by the patented feature; by adjustment of the royalty rate so as to discount the value of a product’s non-patented features; or by a combination thereof.  The essential requirement is that the ultimate reasonable royalty award must be based on the incremental value that the patented invention adds to the end product.

While the Federal Circuit agreed with Exmark on the apportionment question, and agreed with Briggs that Exmark’s damages expert’s opinion was inadmissible as it failed to adequately tie the expert’s proposed reasonable royalty rate to the facts of this case. Exmark’s expert concluded with little explanation the parties would have agreed to a 5% reasonable royalty rate; nowhere in her report, however, did she tie the relevant Georgia-Pacific factors to the 5% royalty rate or explain
how she calculated a 5% royalty rate using these factors.  The Federal Circuit vacated the damages award and remand for a new trial on
damages.

The Federal Circuit held that the district court abused its discretion by holding that prior art is relevant to damages only to the extent that the prior art was commercialized, stating that the fact that some prior art mowers were not commercialized does not make them immaterial to determining the extent to which the claimed subject matter provides utility and advantages over the prior art.  but affirmed the district court’s exclusion of other types of mower, and of Exmark’s delay in bringing suit.

On the award of damages for willful infringement,  the Federal Circuit found that the District Court’s precluding Briggs from presenting any evidence regarding the validity of the claim or how closely the prior art tracked the claim was error.  The Federal Circuit said that to the extent that decision excluded evidence relevant to Briggs’ state of mind at the time of the accused infringement,  however, it does not comport with the standard articulated in Halo, which mandates that willfulness is an issue for the jury, not the district court.  The Federal Circuit vacated the jury’s finding of willful infringement, vacated the district court’s enhanced damages award, and remanded for the district court to determine whether a new trial on willfulness is necessary.

Finally, on this issue of laches, the Federal Circuit agreed with the district court that in light of SCA Hygiene Products Briggs cannot assert laches as a defense.

 

Vocabulary: Infundibuliform

Today’s A.Word.A.Day from wordsmith is infundibuliform, a neat word for funnel-shaped.  The word has been used in at least two dozen patents and in the claims of five: 6,276,549, 4,747,343, 4,416,404, 4,288,982,  4,054,970.  In U.S. Patent No. 4,747,343, claim 6 is directed to the  infundibuliform shape of the end of an auger, which is described in the specification:

One can imagine circumstances where a fancy word like infundibuliform might enhance the prestige of an invention, but for most applications good old “funnel-shaped” is probably the best choice

Anticipation Analysis Indisputably Allows for Some Flexibility; Substantial Evidence Still Supports Finding of No Anticipation

In Microsoft Corp v. Biscotti, Inc., [2016-2080, 2016-2082, 2016-2083] (December 28, 2017), the Federal Circuit affirmed the Board’s determination in the IPR’s that Microsoft failed to show by a  preponderance of the evidence that the challenged claims of U.S. Patent No. 8,144,182 were anticipated or obvious.

The challenged patent related to “tools and techniques for providing video calling solutions” and relates to real-time video conferencing where two or more users communicate, over a network, in a conference that includes video and audio of each participant.

Microsoft appeared to challenge the standard of review of anticipation, so the Federal Circuit began by reiterating that anticipation is a question of fact subject to substantial evidence review.  Noting that the Board correctly articulated the anticipation standard, the Federal Cricuit considered whether the Board properly applied that standard. ,   anticipate the claimed invention, a prior art reference must disclose all elements of the claim within the four corners of the document, and it
must disclose those elements arranged as in the claim, the Federal Circuit.  Noting that the Board may have used wording such as  “identically” more liberally than it should have because an anticipation analysis indisputably allows for some flexibility, the Federal Circuit found that the Board’s analysis did not suffer from a misapplication of the anticipation standard.  The Federal Circuit found that the Board therefore did not require word-for-word similarity or perfection, and explicitly considered whether a POSA would “at once envisage” the combination of the claimed invention given the disconnected teachings of the reference.

However even though the Board articulated the correct standard, and applied the correct standard, this did not mean that the Board’s analysis was correct.  Microsoft argued that the Board read the prior art too narrowly, limiting certain disclosures to particular embodiments, and not applying them to all disclosed embodiments.  The Federal Circuit said although Microsoft’s arguments were not unreasonable, it does not review this question de novo; anticipation is a question of fact, reviewed for substantial evidence.  In light of this deference, the Federal Circuit affirmed the Board’s decision.

The Federal Circuit found that Microsoft’s brief on appeal with respect to one claim was more detailed and contained substantial new arguments regarding anticipation, and rejected them because they were not presented in the Petition.

 

Dear Santa . . .

Dear Santa:

I’ve been a good patent lawyer this year, and always comply with Rule 56.  For all of the inventors we represent, I was hoping that this Christmas you would bring:

  1. A new 35 USC §101.  The Supreme Court broke the one we had.  We need a law that protects all inventions, and doesn’t exclude a whole class of inventions merely because they can be reduced to a simple-sounding concept.  A method that includes at least one non-mental step is not abstract.  It may not be novel, it may not be non-obvious, but it is not abstract.  Likewise, a product or machine is never abstract.
  2. A new  35 USC §102.  Although  the one we have is just a few years old, it never worked right.  The most fundamental concept of any patent system is prior art, yet we don’t have clarity about what is or what is not prior art.  Does a sale or use have to be disclosing or is the fact that the sale or use is known enough?  Does “secret” prior art apply to obviousness?  These are things we need to know.
  3. A new 35 USC §311 that is more fair to patent owners.  Inter Partes Review may be here to stay, but the process can be unfair to patent owners.  There is no standing requirement — a petition can be filed even if the patent owner has not asserted or even threatened to assert the patent.  A patent owner can be subjected to multiple proceeding, sometimes simultaneously, and even if the patent owner wins there is essentially no estoppel against relitigating validity in the courts.  Even after litigation is started, an accused infringer can use Inter Partes Review to change the claim construction (BRI) and the burden of proof (preponderance).  What happened to the presumption of validity.  You and your elves have a lot of work to fix this.
  4. If it fits in your bag, how about a presumption in favor of an injunction? The Constitution promised exclusive rights, but the Supreme Court seems to think otherwise.  How about limiting claims to what is disclosed and enabled in their accompanying specification, instead of invalidating claims to important inventions under §112?

Thanks, Santa, and Merry Christmas!

No Need to be your Own Lexicographer

The word of the day for December 14 from  Wordsmith.org is ensiform, meaning sword-shaped, which is a potentially useful work for patent prosecutors, and in fact has been useful to at least a few:

U.S. Patent No. 9,061,129:Col. 15: 21-25.  U.S. Patent No. 5,489,406:

Col. 3, lns. 36-47.  Lastly, U.S. Patent No. 5,460,842:

Col. 8, lns. 7-18 is a virtual thesaurus for words describing stabby things.  The English language is so rich in descriptive words that patent drafters don’t always have to make up their own.