What’s Zup? Water Board Patent Obvious; Secondary Considerations Too Weak to Show Otherwise

In Zup, LLC v. Nash Manufacturing, Inc., [2017-1601] (July 25, 2018), the Federal Circuit affirmed the district court’s judgment that claims 1 and 9 of U.S. Patent No. 8,292,681 on a water recreational board and a method of riding such a board were invalid for obviousness.

Zup and Nash had discussions about a potential joint manufacturing venture for the ZUP Board, and when they fell through, and Nash
brought the accused product to market.  Zup sued Nash, and the district court granted Nash’s motion for summary judgment of invalidity.  The parties agreed on the content of the prior art, and level of skill, but disagreed on whether a person of ordinary skill in the art would have been motivated to combine the prior art references in the way claimed in the patent, and whether the district court properly evaluated Zup’s
evidence of secondary considerations.

The Federal Circuit said that a “motivation to combine may be found explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem
known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill.”  The district court explained that the ’681 patent identified known elements in the prior art that aided in rider stability while engaging a water recreational device and simply combined them in one apparatus and method.  The district court said that one of ordinary skill in the art would have been motivated to combine the various elements from the prior art references, noting that such motivation would have stemmed from a desire to aid in rider stability, to allow a wide variety of users to enjoy the device, and to aid users in maneuvering between positions on a water board — all
motivations that were “a driving force throughout the prior art and have been shared by many inventors in the water recreational device industry.

The Federal Circuit found that the record supported the district court’s analysis.  The Federal Circuit observed that helping riders switch between riding positions had long been a goal of the prior art, citing various portions of the references of record.  The Federal Circuit pointed out that Zup admitted that achieving rider stability is an “age-old motivation in this field,” and found that such stability was enhanced in the prior art through the same components employed in the ’681 patent: tow hooks, handles, foot bindings, and other similar features.

In the face of significant evidence regarding the consistent desire for riders to change positions while riding water recreational boards (and the need to maintain stability while doing so), and given that the elements of the ’681 patent were used in the prior art for this very purpose, the Federal Circuit said there was no genuine dispute as to the existence of a motivation to combine the references.

The Federal Circuit further found that Zup’s minimal evidence of secondary considerations does not create a genuine dispute of fact
sufficient to withstand summary judgment on the question of obviousness.  The Federal Circuit rejected ZUP’s contention that the district court improperly shifted the burden to prove non-obviousness to Zup because Nash introduced no evidence as to secondary
considerations, yet Zup still lost, noting that “any concerns regarding improper burden allocation can be quickly dismissed. The Federal Circuit said that the burden of persuasion remains with the challenger during litigation because every issued patent is entitled to a  presumption of validity. However, while the burden of persuasion remains with the challenger, a patentee bears the burden of production with respect to evidence of secondary considerations of nonobviousness.  The Federal Circuit said that it is clear that the district
court kept the ultimate burden of persuasion on the patent challenger throughout the obviousness analysis. Any argument that the district court improperly shifted the burden is therefore without merit.

On the issue of secondary considerations the Federal Circuit said that where the differences between the prior art and the claimed invention are minimal, it cannot be said that any long-felt need was unsolved.  The Federal Circuit further found that the record evidence indicates that the claimed invention was not the first to achieve the goal of helping users maneuver between positions on a water recreational board.

The Federal Circuit rejected the arguments of copying, noting that Nash’s instructions suggest a configuration that is different from Zup’s product, dispelling any inference of copying.

The Federal Circuit concluded that the weak evidence of secondary
considerations presented here simply cannot overcome the strong showing of obviousness, quoting “a claimed invention represents no more than the predictable use of prior art elements according to
established functions, as here, evidence of secondary indicia are frequently deemed inadequate to establish non-obviousness.”

Federal Circuit Finds No Error in District Court Determination the Claimed Invention was not Obvious

In Endo Pharmaceutical Solutions, Inc. v. Custopharm Inc., [2017-1719] (July 13, 2018), the Federal Circuit affirmed the determination that the claims of U.S. Patent Nos. 7,718,640 and 8,338,395 on a long-acting injectable testosterone replacement therapy were not invalid for obviousness.

the district court found that the prior art did not disclose the 750 mg TU injection dosage, and that Custopharm had not shown, by clear and convincing evidence, that a skilled artisan would have been motivated to lower the dosage of TU from 1000 mg to 750 mg.  The district court
found that articles about studies do not inherently disclose the particular co-solvent or the particular ratio of solvent to co-solvent claimed by the patents-in-suit simply because this formulation was what had been used in the studies forming the basis of the articles.

The claims required a 750 mg dosage, which the parties agreed was not disclosed by the prior art.  However, Custompharm argued the district court erred in finding no motivation for a skilled artisan to lower the dose of TU from the 1000 mg disclosed in the prior art to 750 mg.   After discussing the evidence, the Federal Circuit said the district court
reasonably rejected Custopharm’s argument that a skilled artisan would consider 1000 mg of TU to be an overdose and would have been motivated to lower the dosage to the patented 750 mg.

Custopharm also argued that the district court erred in finding that the
claimed formulation was not inherently described by prior art articles Articles.  Although the formulation was not disclosed is the articles,  Custopharm argues that the vehicle formulation was “necessarily present” in the articles because it was later revealed to be the actual formulation the authors of the Articles used in their reported clinical studies, but the Federal Circuit disagreed.  The Federal Circuit noted that Custopharm has not demonstrated that a skilled artisan could extrapolate the vehicle formulation used in the Articles from pharmacokinetic performance data.  It was Custopharm’s burden to present clear and convincing evidence that the Articles necessarily disclosed the vehicle formulation to one of skill in the art, and  Custopharm’s expert’s testimony and briefing fall short of meeting this burden.  The Federal Circuit said that under the circumstances
of this case, the incomplete description of the injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the articles.

Regarding the motivation to combine, the Federal Circuit said that the district court thus did not err in considering the obviousness inquiry from the perspective of a skilled artisan “confronted with the same problems as the inventor,” which in the present case is developing a commercially
viable long-acting testosterone therapy.  Doing so, the district court properly found that Custopharm failed to meet its burden of showing that a skilled artisan would combine the lowered dose with the injection schedule in the manner claimed.

Federal Circuit Affirms Non-obvious Holding in “Close” Case, Declining to Disturb Factual Findings on Motiviation

In Impax Laboratories Inc. v. Lannett Holdings Inc., [2017-2020] (June 28, 2018), the Federal Circuit affirmed the district court decision that claims 4, 11, 12, and 14 of U.S. Patent 6,760,237 and claims 6 and 14–
16 of U.S. Patent 7,220,767 were not shown to be invalid and entering an injunction.

The claims at issue are directed to pharmaceutical formulations, intranasal administration devices, or aqueous solutions, of zolmitriptan.  The Federal Circuit noted that all of the claims at issue rise and fall together with the issue of whether it would have been obvious to make zolmitriptan into a nasal spray.

In considering the asserted obviousness of the claimed invention, the Federal Circuit noted that while the reference mentioned the possible nasal administration of zolmitriptan (just once, and not in a claim or an example), the reference was not about administering zolmitriptan, but about the nasal administration of active ingredients generally.  The Federal Circuit also noted evidence in the record that a skilled artisan would have expected delayed or lower therapeutic effectiveness from
zolmitriptan if administered nasally because it would have been “absolutely counterintuitive to make a nasal spray when you have an active metabolite which is more potent . . . than the drug itself.”

The Federal Circuit said that:

In view of the totality of the record evidence of the state of the prior art, we cannot find that the district court clearly erred in its findings. Far from disregarding the prior art’s discussion of zolmitriptan, the court specifically considered and acknowledged that zolmitriptan was mentioned in connection with nasal formulations and
sprays. However, the court also properly considered additional record evidence to make findings on the state of the prior art as a whole.

The Federal Circuit noted that the presence or absence of a motivation to combine references in an obviousness determination is a pure  question of fact, as is what a reference teaches and whether it teaches toward or away from the claimed invention.  Based on the record before it, the Federal Circuit could not find that the court clearly erred in concluding that at the time, zolmitriptan’s known significant reliance on its active metabolite would have, on balance, dissuaded a person of
skill in the art from making nasal formulations of zolmitriptan.  The Federal Circuit said that it does not and should not reweigh evidence or make factual findings anew on appeal.

Board Failed to Properly Consider Circumstances of Disclosure When It Determined They Were Not Printed Publications

In Medtronic, Inc. v. Barry, [2017-1169, 2017-1170] (June 11, 2018) the Federal Circuit affirmed-in-part and vacated-in-part two PTAB Decisions finding that the Board erroneously concluded that asserted videos and slides were were not prior art because
the Board did not fully consider all the factors for determining whether the video and slides were publicly accessible.

The patents in suit, U.S. Patent Nos. 7,670,358 and 7,776,072 are directed to methods and systems for ameliorating aberrant spinal column deviation conditions.  After being sued for infringement, Medtronic instituted two IPRs relying in part on a video demonstration and a related slide presentation to spinal surgeons at various industry meetings and conferences in 2003.  The Board found that the video and slides, although presented at three different meetings in 2003, were not publicly accessible and therefore were not “printed publications,” in accordance with 35 U.S.C. § 102.

The determination of whether a document is a “printed publication” under 35 U.S.C. § 102(b) “involves a case-by-case inquiry into the facts and circumstances surrounding
the reference’s disclosure to members of the public. There are many ways in which a reference may be disseminated to the interested public, so public accessibility is the touchstone in determining whether a reference constitutes a ‘printed publication’
bar under 35 U.S.C. § 102(b).  A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence could locate it.

The Federal Circuit noted that the distribution of certain materials to groups of people at one or more meetings presents a slightly different question than references stored in libraries, and that in the former, the publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.  The Federal Circuit identified several relevant factors from the case law, including (1) whether the copies were freely distributed to interested members of the public; (2) any expectations of confidentiality; (3) the length of time the display was exhibited, (4) the expertise of the target audience (to determine how easily those who viewed the material could
retain the information), (5) the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied,” and (6) “the simplicity or ease with
which the material displayed could have been copied.”

The Federal Circuit said the record does not show that the Board fully considered
all of the relevant factors, including effect of the differences in the various disclosures.  The Federal Circuit said that the nature of those meetings, as well as any restrictions on
public disclosures, expectations of confidentiality, or, alternatively, expectations of sharing the information gained, can bear important weight in the overall inquiry.  For these reasons, the Federal Circuit vacated the Board’s finding that the video and slides are not printed publications and remand for further proceedings.

One of Ordinary Skill Would not Blindly Incorporate One Reference’s Exact Methodology into the Other

In PGS Geophysical AS v. Iancu, [2016-2470, 2016-2472, 2016-2474] (June 7, 2018), the Federal Circuit affirmed the Board’s decisions finding certain claims of U.S. Patent No. 6,906,981 invalid.  After the Board issued its final written decisions, PGS settled with the Petitioner, leaving the Director to defend the final Written decision on appeal.

The Federal Circuit first considered its jurisdiction, concluding the Board’s decisions were final (and thus appealable) even though the decision not to institute as to some grounds is known after SAS to be erroneous, it was nonetheless final.

As to obviousness, the Federal Circuit noted that the obviousness inquiry entails
consideration of whether a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art references to achieve the claimed invention,
and would have had a reasonable expectation of success in doing so.  Such a motivation and reasonable expectation may be present where the claimed invention
is the combination of familiar elements according to known methods that does no more than yield predictable results.

On appeal PGS could not dispute that the references disclosed all of the elements of the claims, but argued that the Board erred regarding the needed motivation.  The Federal Circuit noted that w it may not supply a reasoned basis for the agency’s action that the agency itself has not given, it will uphold a decision of less than ideal clarity if the agency’s path may reasonably be discerned.

PGS argued,with the support of expert testimony, that the combination of the references would result in an eight-fold loss of spatial resolution.  However the Federal Circuit noted that this argument relies on the presumption that one of ordinary skill would blindly incorporate one reference’s exact methodology into the other.  The Federal Circuit found that the Board properly did not view the proposed combination to be so limited.

 

 

The Novelty of an Optical Isomer is not Negated by the Prior Art Disclosure of its Racemate

In UCB, Inc. v. Accord Healthcare, Inc., [2016-2610, 2016-2683, 2016-2685, 2016-2698, 2016-2710, 2017-1001] (May 23 2018), the Federal Circuit affirmed the district court’s determination that UCB’s patents on lacosamide, an anti-epileptic drug, were not invalid for obviousness-type double patenting, obviousness, and anticipation.

On the issue of double patenting, the Federal Circuit noted that in chemical cases, the double patenting inquiry is not whether a person of ordinary skill in the art would select the earlier compound as a lead compound, but rather whether the later compound would have been
an obvious or anticipated modification of the earlier compound — the underlying patent in the double patenting analysis need not be prior art to the later claim.  The Federal Circuit found that the district court did not err by focusing its double patenting analysis on the claims’ differences, as well as the claims as a whole.  The Federal Circuit said that proving that a claim is invalid for obviousness-type double patenting “requires identifying some reason that would have led a chemist to modify the earlier compound to make the later compound with a reasonable expectation of success.  Acknowledging that it was a close case, because it discerned no clear error in the district court’s underlying fact finding that there would have been no reasonable expectation of success in making the modifications needed to make the claimed combination, the Federal Circuit agreed with the district court that the asserted claims of the ‘551 patent were patentably distinct from the ’301 patent.

With respect to obviousness, the Federal Circuit applied a lead compound analysis, rejecting the proposition that the test does not apply in purification cases.  The lead compound analysis first determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts, and then determines “whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.  The Federal Circuit found substantial evidence supported the district court’s conclusion that a person of ordinary skill in the art would not have selected either of the proferred lead compounds.

On anticipation, appellants argued that because the prior art disclosed the chemical structure, it it necessarily disclosed the R-enantiomer (lacosamide) recited in claim 9 of the ’551 patent.  The district court concluded that the prior art disclosed neither the R-enantiomer, nor any of its characteristics.  The Federal Circuit noted that the novelty of an optical isomer is not negated by the prior art disclosure of its racemate, and that the references specifically stated that it prepared the racemic amino acid derivatives rather than the individual enantiomers.  Thus, the Federal Circuit found no clear error in the finding of no anticipation.

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.

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

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.

 

Even Under a Narrower Construction Because of Disclaimer; The Board was Correct that the Claims were Obvious

In Arendi S.A.R.L. v. Google LLC, [2016-1249] (February 20, 2018), affirmed the PTAB’s determination that all of the claims of U.S. Patent No. 6,323,853 were obvious.  The PTAB presented two alternative claim construction, one rejecting prosecution disclaimer and one adopting prosecution history disclaimer.

The Federal Circuit held that the construction rejecting prosecution disclaimer was incorrect, but found the alternative construction based upon prosecution disclaimer correct. The Federal Circuit noted that applicant amended the claims and explained what was changed and why, and the examiner confirmed the reasons why the amended claims were deemed allowable.  However, even under this narrow construction, the Federal Circuit agreed with the PTAB that the claims were unpatentable for obviousness.

 

Board’s Construction of the Claims was Unreasonably Broad and Inconsistent with the Specification

In In re Hodges, [2017-1434] (February 12, 2018), the Federal Circuit reversed the Board’s anticipation determinations, vacate
its obviousness determinations, and remand for further
proceedings.  The application is directed to a valve assembly
for draining contaminants, condensation, and other fluids that adversely affect the efficiency and function of a pressurized system.

The Federal Circuit found that the Board’s Finding that the claims were anticipated was unsupported by substantial evidence.  A prior art reference anticipates a patent’s claim when the four corners of the document “describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.  At issue was the positioning of a valve in the prior art relative to the claimed invention.  The Board found the positioning “similar,” but the Federal Circuit found that the Board neither supported its assertion of
similarity, nor explained how the positioning of the valve in the prior art would enable a skilled artisan to “practice the invention without
undue experimentation.”

As to anticipation by another reference, the Board affirmed a rejection that a piston stem and piston head collectively constitute the claimed “sensor” because they sense pressure insofar as they move in response to the pressure applied thereto.  The Federal Circuit noted that the Patent Office did not attempt to defend this finding on appeal “for good reason” as the Board’s anticipation finding was predicated on an erroneous construction of “signal,” and the reference did not disclose a sensor.  The Federal Circuit found the Board construction of the claims to be unreasonably broad and inconsistent with the specification.  The Federal Circuit said that under any reasonable construction of “signal,”
the prior art’s piston stem and head combination cannot fairly
be characterized as a sensor that generates a signal.  The Federal Circuit reversed the rejection, not wanting to give the Patent Office “a second chance to reject the claims on grounds that it is unwilling or unable to defend on appeal.”

On the obviousness rejections, the Board concluded in a “single paragraph” that the claims would have been obvious, but did not explain how the reference could be modified.  The Federal Circuit also noted that the Board made no findings on any of the Graham factors.  The Federal Circuit said that the Board must “explicate its factual conclusions, enabling us to verify readily whether those conclusions are indeed supported by ‘substantial evidence’ contained within the record,” but that the Board failed to do so, so the Federal Circuit remanded the case.