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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
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`KVK-TECH, INC. and
`FLAT LINE CAPITAL, LLC,
`Petitioners,
`
`v.
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`SILVERGATE PHARMACEUTICALS, INC.,
`Patent Owner.
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`————————————————
`Case PGR2017-00039
`Patent 9,463,183
`————————————————
`
`SILVERGATE’S REHEARING REQUEST
`37 CFR §42.71(d)(1)
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`
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`I.
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`II.
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`III.
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`IV.
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`
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`TABLE OF CONTENTS
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`Page
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`PRECISE RELIEF REQUESTED ............................................................... 1
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`REASONS FOR RELIEF ............................................................................ 1
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`A.
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`B.
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`C.
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`D.
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`E.
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`Introduction ....................................................................................... 1
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`Insufficient showing of pH between about 4 and about 5 ................... 1
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`Nerurkar is not Analogous Art ........................................................... 4
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`No Basis for Asserted “Routine Optimization” .................................. 7
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`Hindsight ........................................................................................... 8
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`CONCLUSION ........................................................................................... 9
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`SERVICE CERTIFICATION .................................................................... 11
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`I.
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`PRECISE RELIEF REQUESTED
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`The patent owner (“Silvergate”) respectfully requests rehearing of the
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`institution decision (Paper 8) on points the Board misapprehended or overlooked.
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`Silvergate further requests modification of the institution decision, to deny
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`institution on Ground 3. 37 CFR §42.71(d)(1).
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`II. REASONS FOR RELIEF
`A. Introduction
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`In three instances, the decision overlooks argument supported with evidence
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`and authority contrary to the decision’s preliminary holdings. In each case, the
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`overlooked argument identifies unsupported positions in the petition that are
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`nevertheless adopted in the decision to Silvergate’s prejudice. Neither the patent
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`owner nor the Board should have to bear the cost of a trial over a facially deficient
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`petition.
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`B. Insufficient showing of pH between about 4 and about 5
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`Page 17 of the decision states that the petition sufficiently shows that an
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`ordinary artisan would have been prompted to buffer the formulation to within the
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`claimed pH range of about 4 to 5. The decision discusses argument on pages 46-48
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`of the preliminary response (Paper 7), but overlooks relevant discussion at pages
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`35-36 of the preliminary response. Specifically, the preliminary response explained
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`(at 35-36, original emphasis):
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`According to the results of Beidel, for the varied pH formulations stored
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`at 45°C, the formulation at pH 5.8 exhibited the highest % lisinopril
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`remaining at 210 days (i.e., 88%), compared to the other samples stored
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`at 45°C (i.e., pH 4.2 (80%); pH 5.2 (67%); 4.8 (85%)). Ex. 1005,
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`Results. Consistent with this reading, Beidel concludes “[a] lisinopril
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`solution will show acceptable stability (at least 2 years) if buffered to pH
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`5.75 and stored in the refrigerator at 5°C.” Ex. 1005, Conclusion.
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`The preliminary response further explained (at 36):
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`Dr. Kibbe asserts in his Declaration “[a] person of ordinary skill in the art
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`would recognize that Beidel’s reference to ‘pH 5.75’ in this conclusion
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`was a typographical error since the results do not support this
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`conclusion.” Kibbe Decl. at n. 4 (Ex. 1002 at 36). Yet, Dr. Kibbe does
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`not state how this can be true when only one pH was tested at 25°C, and
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`the formulation at pH 5.8 was the most stable of the samples having
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`different pH values stored at 45°C. Further, the Declaration of Benjamin
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`Beidel, the first author of the Beidel reference, does not corroborate this
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`alleged typographical error; indeed Mr. Beidel is silent as to any errors in
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`the reference. Ex. 1021.
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`Overlooking this material is prejudicial to Silvergate because it directly
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`undermines the petition’s premise for the pH selection, which the decision found
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`sufficient. As the preliminary response explained, “the premise that a POSA would
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`select a buffer having a pKa of 4.8 is not supported by the references, because the
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`references do not establish that lisinopril is most stable at a pH of 4.8.” Paper 7
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`at 36. While the decision broadly dismisses argument on these pages as “bare
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`attorney argument assigning contrary views and understandings to the ordinary
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`artisan.” (Paper 8 at 19), Silvergate’s arguments about what Beidel actually shows
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`are not directly addressed or refuted.
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`The petitioner’s expert is unreliable: his expert testimony is not only
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`baseless but actually contrary to the express teaching of the reference, and his fact
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`testimony (about the typographical error) is uncorroborated and facially
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`inconsistent. Precedent has long counseled that unsupported testimony about what
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`was known in the prior art “must be regarded with suspicion and subjected to close
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`scrutiny.” Carella v. Starlight Archery and Pro Line Co., 804 F.2d 135, 138 (Fed.
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`Cir. 1986). Attorney argument, while not evidence in itself, is an appropriate
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`method for highlighting the facial flaws in the petitioner’s evidence, particularly
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`when the argument is well-grounded in petitioner’s own exhibits.
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`Although, Dr. Kibbe’s testimony calls into question whether any of the
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`values in the Beidel reference can be trusted, his “litigation-driven testimony”
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`about an uncorroborated typographical error on the very point that the petitioner
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`must prove is not entitled to weight. Velander v. Garner, 348 F.3d 1359, 1371
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`(Fed. Cir. 2003) (author’s post-litem testimony inconsistent with reference is
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`entitled to little weight). His testimony does not establish that an error necessarily
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`exists, much less that it must be corrected in the manner he asserts. Certainly Dr.
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`Kibbe’s unsupported testimony is not entitled to more weight than the reference on
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`which he relies. Silvergate respectfully suggests that if the evidence on the pH
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`limitation is weighed in its entirety for all that it fairly shows, the proper finding
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`would be that Dr. Kibbe’s testimony and supporting exhibits are not sufficient to
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`provide motivation to select the claimed pH range, and hence the petitioner failed
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`to demonstrate a reasonable likelihood of unpatentability.
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`C. Nerurkar is not Analogous Art
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`On page 17, the decision acknowledges that Nerurkar (Ex. 1009) is directed
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`formulations of a different drug: “Nerurkar relates to liquid formulations, not of
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`lisinopril, but of a different drug—namely, alendronic acid. Id. at 48 (citing 1009,
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`1:12).” The decision then concludes without explanation “that the ’183 patent and
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`Nerurkar are within the same general field (liquid drug formulations).” This
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`conclusion overlooks argument and evidence to the contrary.
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`The preliminary response explained that the fields of use are very different
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`(at 48):
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`The field of endeavor of Nerurkar is liquid formulations of alendronic
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`acid or a pharmaceutically acceptable salt thereof. Nerurkar, Abstract
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`(Ex. 1009 at 1). More specifically, alendronic acid is a bisphosphonate
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`that is used as an oral osteoporosis treatment in post-menopausal women.
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`Id. at 1 (Ex. 1009 at 3). Accordingly, alendronic acid’s clinical use is
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`unrelated to lisinopril, which is an angiotensin-converting enzyme (ACE)
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`inhibitor for treating hypertension.
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`The preliminary response relied on evidence to show that the drugs present very
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`different problems (at 49):
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`alendronic acid, or the salt form thereof (alendronate), is known to be
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`poorly absorbed when administered orally (e.g., bioavailability of less
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`than 1% in one clinical study of normal healthy volunteers. Ex. 2010 at
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`5), and at the pH of the small intestine (i.e., pH 6-8) is completely ionized
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`and possesses negative charges. Id. at 4. In contrast, lisinopril has a net
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`charge of zero, existing as a double zwitterion under the pH conditions of
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`the small intestine, and has an oral bioavailability of 25-30%. Ex. 2009
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`at 2 and 10. Based on the chemical structures, physico-chemical
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`properties and uses for alendronic acid, Nerurkar is therefore in a
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`completely different field of endeavor than that of the ’183 patent.
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`At 50:
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`Nerurkar is directed to solving the problem of developing a formulation
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`of alendronic acid that can be taken orally to relieve heartburn symptoms.
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`Nerurkar at 1 (Ex. 1009 at 3)….In contrast, lisinopril is not known for
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`causing esophageal reflux or heartburn, which are not listed among the
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`adverse effects in the prescribing information for Zestril® lisinopril
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`tablets. Ex. 2005.
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`Overlooking (or misapprehending) these points is prejudicial to Silvergate.
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`The decision’s field determination—“liquid drug formulations”—oversimplifies
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`the field and overlooks the different problems that these drugs would present to a
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`drug formulator. The Federal Circuit addressed a similar situation in which a
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`reference (“Sydansk”) directed to filling holes in underground petroleum reservoirs
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`was used to reject claims to a solution filing dead space in above-ground storage
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`tanks. In re Clay, 966 F.2d 656 (Fed. Cir. 1992). The court explained at 659-60:
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`[The reference] Sydansk is faced with the problem of recovering oil from
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`rock, i.e., from a matrix which is porous, permeable sedimentary rock of
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`a subterranean formation where water has channeled through formation
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`anomalies and bypassed oil present in the matrix. Such a problem is not
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`reasonably pertinent to the particular problem with which Clay was
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`involved — preventing loss of stored product to tank dead volume while
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`preventing contamination of such product. Moreover, the subterranean
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`formation of Sydansk is not structurally similar to, does not operate under
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`the same temperature and pressure as, and does not function like Clay's
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`storage tanks.
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`In Clay, the examiner had oversimplified the problem to be filing structural voids
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`in an oil-industry context, while ignoring the significant differences that were
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`readily apparent from the record. Similarly, reducing the problem here to simply
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`making liquid formulations for drugs prejudicially oversimplifies the differences
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`those in the art would have recognized based on the exhibits Silvergate cited in the
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`preliminary response.
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`
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`Analogousness is part of the scope-and-content analysis of the prior art and
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`must be addressed in the petition. Parrot SA v. Drone Techs., Inc., IPR2014-00730,
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`Paper 31 at 2-3 (2016). Assuming analogousness improperly shifts the burden to
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`Silvergate to disprove what the petition failed to address. 35 U.S.C. 316(e) (burden
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`always on petitioner). Overlooking evidence to the contrary properly presented in
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`the response only compounds the prejudice to Silvergate. The preponderance of the
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`evidence supports a finding that Nerurkar is not analogous art.
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`D. No Basis for Asserted “Routine Optimization”
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`Although the claims require very specific amounts of each ingredient in
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`claim 1, the decision states (at 16-17) that “the Petition is supported by the
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`testimony of Dr. Kibbe, who explains … how, through routine optimization, one
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`would have been led to add them in the amounts specified in claim 1.” The
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`decision overlooks specific argument (Paper 7 at 37-39) regarding the small
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`concentrations of citric acid and sodium citrate in the claims, particularly
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`distinguishing the non-analogous disclosures in Nerurkar (Ex. 1009).
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`The preliminary response explained (at 38):
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`KVK argues that “the purported invention is non-obvious [sic] because it
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`is nothing more than the result routine optimization.” Pet. at 59. Yet,
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`KVK provides no reasoning as to why it would have been routine for a
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`POSA to arrive at the small concentrations of citric acid and sodium
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`citrate required by the claims, particularly in view of the large amounts of
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`buffer that were key to Nerurkar’s disclosure.
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`Overlooking this argument is prejudicial to Silvergate. As urged in the
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`preliminary response (at 38), unsupported assertion is insufficient to support
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`obviousness. In re Stepan Co., 868 F.3d 1342, 1346 (Fed. Cir. 2017) (“Absent
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`some additional reasoning, the Board's finding that a skilled artisan would have
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`arrived at the claimed invention through routine optimization is insufficient to
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`support a conclusion of obviousness.”). Because the ’183 patent and the
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`Nerurkar reference are in different fields addressing different problems, it
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`makes sense that Nerurkar would provide no direction for the asserted “routine
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`optimization” on which the petition must rely in the absence of any actual
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`teaching. Cf. Honeywell Int’l Inc. v. Mexichem Amanco Holding S.A., 865 F.3d
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`1348, 1355 (Fed. Cir. 2017) (reversing obviousness holding based on “routine
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`testing” without guidance leading to the claimed choices). An expert’s bare
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`assertion of routine optimization cannot create an issue of material fact.
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`Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1329 (Fed. Cir.
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`2001) (“Broad conclusory statements offered by Telemac's experts are not
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`evidence and are not sufficient to establish a genuine issue of material fact.”).
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`Dr. Kibbe’s unsupported assertion about routine optimization is not sufficient to
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`create a triable issue.
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`E. Hindsight
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`Silvergate’s preliminary response closed with a discussion of impermissible
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`hindsight that pointed to these same issues. Paper 7 at 53-55. The decision
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`overlooked this section of the preliminary response and does not address the points
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`made in this section. The preliminary response explains that Beidel does not
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`actually support selection of pH 4.8 as an acceptable value. Id. at 53-54. Dr. Kibbe
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`provided no indication that he thought Beidel (his own work) needed correction
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`until he was paid for his testimony in this case. Without this amendment to the
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`reference, the petition provides no reason why a person skilled in the art would
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`have picked the claimed pH range rather than the pH value (5.75) that Beidel
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`actually teaches is acceptable. Similarly, Silvergate’s preliminary response
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`explained that the petition gives no reason to have looked at the Nerurkar reference
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`in the first place, much less have reached conclusions inconsistent with what
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`Nerurkar expressly teaches, except to recreate the claimed values with hindsight.
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`Id. at 55. Selecting (or correcting post hoc) values with no rationale other than it
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`could have been done1 is not optimization, it is hindsight. The expense and burden
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`of a trial based on impermissible hindsight is also prejudicial to Silvergate.
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`III. CONCLUSION
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`For the reasons stated above, Silvergate respectfully requests the Board to
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`reconsider its institution decision and to deny institution on Ground 3.
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`1 Of course it could be done: Silvergate’s specification is fully enabled.
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`Dated: 20 February 2018
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`Respectfully submitted,
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` / Richard Torczon/
`Richard Torczon, Counsel for Silvergate
`Reg. No. 34,448
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`IV. SERVICE CERTIFICATION
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`By consent (Paper 1 at 3), SILVERGATE’S REHEARING REQUEST is
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`served via electronic mail to:
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`Zachary D. Silbersher
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`zsilbersher@kskiplaw.com
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`Gaston Kroub
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`gkroub@kskiplaw.com
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`
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`info@kskiplaw.com
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`Dated: 20 February 2018
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`Respectfully submitted,
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` / Richard Torczon /
`Richard Torczon, Counsel for Silvergate
`Reg. No. 34,448
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`PGR2017-00039
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