- Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Rehearing deniedPTAB · Oct 1, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied rehearing and maintained its denial of PGR because Petitioner did not show that Perkins and RCSB PDB made claims 1–30 more likely than not unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. LEGAL STANDARD Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Owner’s argument persuasive because Perkins discloses embodiments with “mutations at I182 among a group of 20 other possible locations for modifications,” 13 of which are mutations of specific amino acids that “can be changed to any of the 19 other natural amino acids.” Id. Perkins discloses further that modifications at each of those 20 possible sites can be combined such that “one, two, or more” of the mutations can be made together in other embodiments (Ex. 1006, 17–18), or in other words, “each species [is] combinable to create a vast number of species.” Dec. 35. In addition to the locations of modifications expressly listed in Perkins, Perkins adds yet another option in which “the mutated VSV-G envelope protein is as described in Nikolic et al.” (Ex. 1006, 18), which “describes the crystal structures of VSV G bound to its native LDL-R receptor” that RCSB PDB depicts in entries 5OY9 and 5OYL (Dec. 18). We also considered Dr. Rose’s testimony about the crystal structures depicted in RCSB PDB, namely that a person of ordinary skill in the art would have been motivated to modify Perkins based on the VSV-G crystal structures in the RCSB PDB. Perkins taught that mutations to VSV-G “inhibit binding of VSV-G to the low-density lipoprotein receptor (‘LDL-R’), while preserving the VSV-G protein’s fusogenic function,” and expressly disclosed making a mutation at I182. (See, e.g., Ex. 1005 at 19:29-20:2, 20:29-21:14, 21:16-27; Ex. 1006 at 16.) The VSV-G crystal structures in the RCSB PDB taught that I182 is nearby negatively charged amino acids on the LDL-R. Thus, a person of ordinary skill in the art would have been motivated to incorporate a mutation which negated an interaction with the negatively charged residues in the LDL-R. (Ex. 1005 at 19:29–20:2; Ex. 1006 at 16.) Dec. 37. discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 7
§ 103 obviousnessPatents in suitUS 11,767,366 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 17, 2020 · IPR2019-00338 · APJ Ken B Barrett · IPR · Rehearing
The Board denied Cooler Master’s rehearing request, leaving intact the determination that claim 8 was not shown obvious over Morikawa and Takahashi because the petition did not establish the claimed top shoulder.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“that “Petitioner has not demonstrated that Morikawa discloses the recited [top shoulder limitation].” Final Dec. 45. In other words, our determination was that Petitioner had not met its burden of proving that a limitation was taught by the prior art, and therefore had not met its burden of proving that the challenged claim is unpatentable.” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the Final Decision, we stated: Petitioner’s implied construction is that the claimed “shoulder” is the top end of a column. This is inconsistent with the claim language which recites that the “hollow column . . . has a top shoulder disposed near a top end” thus indicating that the top shoulder is not merely the top end of the column but a structure “near” and discernable from the top end of the hollow column.” slip op. at 8
- Strike new argumentNew argument disregardedDecided for patent owner
“based on a misapprehension of the arguments associated with a figure . . . [from page 57] in the Petition,” and that “the Board incorrectly inferred Petitioner’s ‘implied construction’ for the term, ‘[a top] shoulder,’ in claim 8 of the ’680 patent as ‘the top end of a column.’” Req. Reh’g 1 (citing Final Dec. 45). Petitioner further argues that it “has always and consistently pointed to the corner portions located around the top outer rim of the hollow column as meeting the limitation of ‘a top shoulder,’ as shown [in the two figures from pages 56 and 57 of Petition and reproduced above].” Id. at 5–6.” slip op. at 8
Claim construction§ 103 obviousnessPatents in suitUS 7,100,680 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 16, 2020 · IPR2019-00334 · APJ Linda E Horner · IPR · Rehearing
The Board denied Petitioner’s rehearing request, leaving in place its determination that claim 1 was not shown unpatentable over Morikawa, Takahashi, and Nakamura.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- Expert testimonyPatent owner expert creditedDecided for patent owner
“criticism of Morikawa’s heat pipe in its Reply, Petitioner failed to provide any expert testimony to support its argument as to how a person of ordinary skill in the art would understand Nakamura. Instead, Petitioner argued that “Nakamura describes some of its advantages over Morikawa’s ‘metal pipe 6’ only” and that “Nakamura is not describing any disadvantages at all associated with Morikawa’s ‘conventional spacer’ by ‘welding and fixing a metal column to upper and lower inner surfaces of the panel.” Pet. Reply 31–32 (citing Nakamura at 4; Morikawa, 4:31‒33). Patent Owner, however, provided expert testimony as to how a person having ordinary skill spacers. PO Resp. 57 (citing Ex. 2002 ¶ 160). We credited this testimony in our Final Decision. Final Dec. 47 (citing PO Resp. 58); id. at 47–48 (agreeing with Patent Owner’s argument).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“improvement to Morikawa’s heat pipe, and, in fact, found that Nakamura’s teaching of an improvement and criticism of Morikawa’s configuration would have led one having ordinary skill in the art to replace all of Morikawa’s spacers with Nakamura’s concavities. See Final Dec. 47–48 (agreeing with Patent Owner’s arguments as to the manner in which Morikawa would have been modified in light of Nakamura’s disclosure); id. at 69–70 (finding, in the context of independent claim 3, that Petitioner provided adequate reasoning, premised on Nakamura’s criticism, to substitute Nakamura’s concavity for the pipe of Morikawa). Petitioner’s citation to pages 58–59 is misplaced to the extent Petitioner relies on this portion of the Petition for a reason to modify Morikawa to replace only some of Morikawa’s spacers with Nakamura’s concavities. Pages 58–59 of the Petition address Petitioner’s proposed modification of Morikawa to substitute Nakamura’s concavities for Morikawa’s pipes to meet the “depression” limitation found earlier in claim 1. See Pet. 55, 62–63 (Petitioner explaining that the proposed combination is the modification of Morikawa’s pipes “to solve these problems.”). The “spacer” limitation appears later in claim 1 and, similarly, Petitioner’s purported reasoning associated with that spacer limitation appears later in the Petition. See Pet. 71–75. The Petition’s discussion of the earlier “depression” limitation does not include a reason to replace only some of Morikawa’s spacers with Nakamura’s concavities.” slip op. at 5
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,100,680 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 16, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Rehearing
The Board denied the petitioner’s rehearing request, leaving claim 11 not shown unpatentable because the petition did not adequately explain why only some Morikawa spacers would be replaced with Nakamura depressions.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“As explained in the Final Decision, upon review and consideration of the arguments and evidence submitted by the parties, Petitioner failed to show that the combined teachings of Morikawa and Nakamura would have led one having ordinary skill in the art to the combination of conventional spacers, as discussed in Morikawa, and depressions formed by Nakamura’s concavities, as recited in claim 11. Petitioner’s arguments in the Request for Rehearing do not persuade us that we erred in our application of the facts as presented by Petitioner to the standard for determining obviousness, as set forth in KSR, in finding that Petitioner failed to show unpatentability of claim 11. C. Conclusion For the foregoing reasons, Petitioner has not shown that we misapprehended or overlooked Petitioner’s arguments or evidence in determining that Petitioner did not show by a preponderance of evidence that challenged claim 11 of the ’240 patent is unpatentable.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“not in accordance with the law.” Request 2; see also id. at 6 (arguing that “Petitioner need only provide ‘a reason’ as to why a [person having ordinary skill in the art] would substitute Nakamura’s depressions for some, but not all, of Morikawa’s columns in Morikawa’s device.”). Petitioner discusses the proposed replacement of Morikawa’s “through path” spacers with Nakamura’s concavities, but Petitioner does not discuss why Morikawa’s remaining spacers would also not be similarly replaced. In other words, as explained above, Petitioner provided no reason in its Petition to explain why one would have modified Morikawa by substituting only some spacers with Nakamura’s concavities, when Nakamura teaches making all of its spacers using abutting concavities. Pet. 88‒89 (citing Pokharna ¶ 93, which cross-references itself); Final Dec. 57 (describing Nakamura). As explained in the Final Decision, upon review and consideration of the arguments and evidence submitted by the parties, Petitioner failed to show that the combined teachings of Morikawa and Nakamura would have led one having ordinary skill in the art to the combination of conventional spacers, as discussed in Morikawa, and depressions formed by Nakamura’s concavities, as recited in claim 11. Petitioner’s arguments in the Request for Rehearing do not persuade us that we erred in our application of the facts as presented by Petitioner to the standard for determining obviousness, as set forth in KSR, in finding that Petitioner failed to show unpatentability of claim 11.” slip op. at 11
- BurdenNot shown unpatentable
“2. Petitioner’s Burden As also explained in the Final Decision, “Petitioner bears the burden of proving unpatentability of the claims challenged in the Petition, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish by a preponderance of the evidence that the challenged claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R. § 42.1(d) (2018).” Final Dec. 9.” slip op. at 5
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,066,240 - PTAB · Jun 30, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood that claims 21–28 and 31 were obvious over Voyksner, Watson, and Rainbow.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The party challenging a decision in a request for rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. Upon a request for rehearing, the decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). III. ANALYSIS” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“precursor of 25-hydroxvitamin D2 having a molecule weight of 412.7 g/mol.” Id. (citing Pet. 27; Ex. 1002 ¶ 57). Petitioner’s arguments explain what a skilled artisan could have done, i.e., select an appropriate precursor ion. However, as discussed in the Decision, the Petition, even when considered along with Dr. Fitzgerald’s testimony, “does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion” (Dec. 19), when as discussed above, multiple precursors are possible.5 See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“prior art teaches determining the presence or amount of 25-hydroxyvitamin D2 in a sample. However, as discussed in the Decision, claim 21 “requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample.” Id. at 18. Petitioner does not argue that our interpretation of the plain meaning of claim 21 is incorrect or that we should disregard the step of generating “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” See id. Accordingly, we are not persuaded that we overlooked Petitioner’s arguments. Further, we agree with Patent Owner that the Petition lacks sufficient explanation of why a person of ordinary skill in the art “would have chosen to [specifically] investigate 25-hydroxyvitamin D2 using Voyksner’s methods in the first place, particularly since Voyksner only discusses ‘dihydroxyvitamin D3’ for the purposes of evaluating the orientation of certain mass spectrometry equipment.” Opp. 5 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362–63 (Fed. Cir. 2016) (noting that it is error to accept general knowledge in the art without evidence on the record for limitations that are “not evidently and indisputably within the common knowledge of those skilled in the art”) (emphasis in original)).” slip op. at 9
§ 103 obviousnessPatents in suitUS 7,972,867 - Hologic, Inc. v. Biomérieux, Inc.Rehearing deniedPTAB · Jan 31, 2019 · IPR2018-00568 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Hologic’s rehearing request, leaving in place the § 325(d) denial of institution for claims 1–6 because Hologic did not show the Board abused its discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“The Board determined that these factors weighed in favor of denying institution because, inter alia: the Examiner considered the same prior art or prior art cumulative to Petitioner’s prior art during prosecution, id. at 12–13; the Examiner thoroughly considered the patentability of the ’352 patent’s claims over the lengthy period of prosecution, id. at 13–15; Petitioner’s arguments were substantially the same as the findings the Examiner made with respect to prior-art reference Montagnier, which is a strong (if not stronger) reference than the prior art Petitioner asserted in these Petitions for inter partes review, id. at 15–18; Petitioner failed to address §325(d) in the Petition, id. at 18; and Petitioner failed to persuade the Board that the Examiner erred in relying on the unexpected results shown in the Laayoun Declaration, id. at 18–21; see also id. at 21–22 (weighing the factors). As to the final finding, the Board considered Petitioner’s argument that the Laayoun Declaration is not persuasive evidence of non-obviousness because the Declaration compares the claimed invention to Bell’s prior-art primers, rather than Backus’s “closest prior art” primers. Id. at 20–21. The Board explained that Petitioner bears the burden to prove unpatentability in an inter partes review, and had failed, in this case, to provide “some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers.” Id. at 21. The Board noted that the Examiner was aware of Backus, but nevertheless “accepted Bell as the closest prior art.” Id. The Board “decline[d] to revisit that decision,” because “Petitioner d[id] not persuade us that the Examiner erred in accepting that evidence as showing unexpected results.” Id. at 21–22.” slip op. at 4
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for patent owner
“Here, Petitioner attempted to show that Bell is not the closest prior art by presenting schematics comparing the nucleotide sequences of Backus’s primers to Bell’s primers and repeating Dr. Linnen’s statements that he considered the Backus primer set “closer” to the claimed primer set than the Bell primer set. Pet. 52–54 (citing Ex. 1020 ¶¶ 317–327). But neither Petitioner nor Dr. Linnen attempted to explain—or present any evidence— that Backus’s primers would have achieved the same results as the claimed primers. See Instit. Dec. 21. Put differently, Petitioner’s bare assertions failed to establish a reasonable likelihood that Patentee’s unexpected results would have been any different when compared to Backus. See Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006) (calling patent challenger Unilever’s argument that patentee Kao’s unexpected results were not compared to the closest prior art “not sustainable”: “Even if we were to conclude that Gangadharan was clearly the closest prior art, Unilever has not demonstrated, or even alleged, that Gangadharan achieved [the unexpected results] reported by Kao. . . . In the absence of such an allegation, any error made by the trial court in using Gueret for its comparison would be harmless.”). Third, we note that Petitioner’s case appears to rely on an overly mechanical application of the “closest prior art.” See Reh’g Req. 6–12. Although unexpected results must be shown to be unexpected compared to the closest prior art, the Federal Circuit has warned against applying that requirement “so rigidly as to require [patentee] to identify and focus on just one prior art product when multiple, similar” products “existed or were described in the prior art.” Tris Pharma, Inc. v. Actavis Labs. FL, Inc., 2019 WL 254418, at *7 (Fed. Cir. Jan. 16, 2019). Thus, as we stated in the Institution Decision, we decline to revisit the Examiner’s decision to accept the Laayoun Declaration absent some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers. Instit. Dec. 21.” slip op. at 8
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,697,352 - PTAB · Nov 28, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–3, 5, and 6 unpatentable under Ground IV based on Akinaga and the cited supporting references.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“UCN-01 alone, and in combination with the DNA damaging agent mitomycin C. See Dec. 27–28; Ex. 1004. Noting that the two compounds had 1) complementary effects in delaying cell cycle progression; and 2) synergistic cytotoxic and antitumor effects, Akinaga expressly suggests the combination of UCN-01 and DNA-damaging agents for cancer chemotherapy. Id. Seynaeve establishes that UCN-01 inhibits multiple tyrosine kinases in human breast cancer cells coincident with promoting cell cycle arrest. Dec. 28–29, 34–35; Ex. 1014. Accordingly, “Seynaeve proposes a link between UCN-01’s inhibitory effects on tyrosine kinases and its inhibitory effects on the cell cycle.” Dec. 29.8 Akinaga further suggests combining a chemotherapeutic DNA damaging agent with UCN-01 because the two compounds cause delays in different stages of the cell cycle and result in synergistic cytotoxic and antitumor effects, whereas Seynaeve examines the effects of UCN-01 on the cell cycle of human carcinoma cells and shows that UCN-01 is a tyrosine kinase inhibitor. See Dec. 37–38. Because both references 8 Considering Seynaeve teachings with respect to UCN-01, we reject Patent Owner’s contention that “there is no evidence from which one can reasonably find that Petitioner carried its burden of proving that people of ordinary skill in the art considered either staurosporine or UCN-01 to be tyrosine kinase inhibitors.” See Reh’g. Req. 6. one of ordinary skill in the art would have found reason to combine their teachings. See id.” slip op. at 4
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Akinaga teaches that UCN-01 inhibits v-src (as does Seynaeve), one of ordinary skill in the art would have no reason to believe that UCN-01 would inhibit its cellular homolog c-src because v-src is “found only in chickens” and “is more difficult to inhibit.” Dec. 28, 32. We instead credited the testimony of Petitioner’s expert, Dr. Eastman that “[b]ecause v-Src and c-Src have similar structures, compounds that inhibit the tyrosine kinase activity of v-Src generally inhibit c-Src as well. Thus, a person of ordinary skill would have understood that an inhibitor of v-Src would also inhibit the c-Src protein present in A431 cells and other human tumors.” Id. at 33 (quoting Ex. 1002 ¶ 202). Dr. Eastman testified that Robinson, for example, showed “that staurosporine, a molecule very similar to UCN-01, inhibited both v-Src and c-Src. . . . Thus, a person of ordinary skill in the art would have recognized that UCN-01 would inhibit tyrosine kinases in both animals and humans.” Id.” slip op. at 5
§ 103 obviousnessPatents in suitUS 7,838,512 - Guardant Health, Inc. v. Foundation Medicine, Inc.Rehearing deniedPTAB · Nov 8, 2017 · IPR2017-01170 · APJ Richard J Smith · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving instituted review of claims 65, 66, 72, 73, 75–77, and 80–85 based on its reasonable-likelihood determination.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“DISCUSSION When rehearing a decision on petition, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“According to the ’830 patent, the term “bait” is defined as including “a nucleic acid molecule . . . which can hybridize to (e.g., be complementary to), and thereby allow capture of a target nucleic acid.” Ex. 1001, 28:47–50. Patent Owner acknowledges that “both primers and baits hybridize to a complementary portion of the target nucleic acid.” Req. Reh’g. 3 (citing Prelim. Resp. 30). However, Patent Owner does not explain or otherwise persuasively address why the subject nucleic acids in Shah are not included within that definition of “bait.” We did not overlook Patent Owner’s explanation of why, in its view, “primers” are not “baits.” Rather, at this stage of the proceeding, we found such explanation unpersuasive as we stated in the Decision. Dec. 13. (stating “we are not persuaded that the definition of the term ‘bait,’ as set forth in the ’830 patent, does not include primers”). Moreover, because we did not overlook Patent Owner’s explanation, we find no basis to reconsider the disclosures of Shah.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successDecided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument. We expressly addressed that argument with respect to bait sets (i) and (ii) by stating that “we find that choosing bait sets that select somatic mutations that appear at a frequency of about 5% or less and at a frequency of about 10% or higher is taught or suggested by the combined teachings of Levin and Shah.” Dec. 17 (emphasis added); see also Dec. 20 (“Having considered the arguments and evidence, we are persuaded at this stage of the proceeding that Petitioner has sufficiently shown that the limitations of claim 65 are taught or suggested by, or would have been obvious in view of, the combined teachings of Levin and Shah.”). Moreover, contrary to Patent Owner’s argument, the fact that the Decision may not recite the words “used together” does not indicate that we overlooked and/or misapprehended Patent Owner’s argument. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (stating “this court has said on multiple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it”) (citing cases).” slip op. at 5
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Decided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument; rather, we considered it and found it unpersuasive. See Dec. 13 (stating “on this record, we find that Levin’s disclosure of multiple baits would include multiple bait sets”). In particular, we found that Levin teaches the use of multiple bait sets, not one bait set as argued by Patent Owner. See id. Furthermore, Patent Owner’s argument that all of the baits in Levin were “designed in precisely the same way” was based on Levin’s statement that “[b]aits were designed in a tiling fashion with minimal overlap to span the entire protein-coding region of each transcript.” See Prelim. Resp. 28 (citing Ex. 1010, 2). However, that statement suggests the design of multiple different baits that would include multiple different bait sets.” slip op. at 6
Claim construction§ 103 obviousnessPatents in suitUS 9,340,830 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Rehearing deniedPTAB · Aug 3, 2017 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Rehearing
The Board denied Merial’s rehearing request, leaving institution denied for claims 1–22 because the evidence did not show that the prior art suggested the claimed cyphenothrin concentration.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3 For the foregoing reasons, Petitioner has not demonstrated that we abused our discretion in denying institution of an inter partes proceeding in this case. Consequently, Petitioner’s Request for Rehearing is denied.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We considered this evidence of Dr. Clark’s testimony concerning the teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
§ 103 obviousnessPatents in suitUS 8,614,244 - Roxane Laboratories, Inc. v. Vanda Pharmaceuticals Inc.Rehearing deniedPTAB · Nov 4, 2016 · IPR2016-00690 · APJ Robert A Pollock · IPR · Rehearing
The Board denied rehearing, finding no abuse of discretion in its determination that Petitioner failed to show claim 1 unpatentable because the claimed dose reduction was unpredictable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We concluded that the record as a whole, including FDA Guidance 1999, supported a mere invitation to experiment as rejected in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1073 (Fed. Cir. 2012). Dec. at 19, 22–23; see id. at 22 (“Such invitations to experiment do not, in light of the present record, predict the dosage reduction of the subject claim.”). The Decision, including our citation to Cylobenzaprine, makes clear our implicit rejection of Petitioner’s argument that, “to arrive at the claimed dosages, a POSA need only have followed FDA Guidance 1999’s comprehensive guidelines for the performance of drug interaction and dose regimen studies” using only “routine experimentation” and with “predictable results.” Pet. 54–55, 58; Reh’g Req. 4–5. Petitioner’s reliance on Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989) and Genzyme” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Unlike in Merck and Genzyme, the present case does not involve predictable results that may be confirmed or fine-tuned by routine experimentation. Rather, upon careful consideration of the asserted prior art as a whole, we determined that, “it could not be predicted whether a change in iloperidone metabolism would have increased, decreased, or had no effect on the risk of QT prolongation” and, thus, the amount of dose reduction (if any) was unpredictable and would need to be determined empirically. Dec. at 22–23 (quoting Prelim. Resp. 15–16); see also id. at 22 (stating that, “the art as a whole taught a careful evaluation of [drugs such as iloperidone] for evidence of clinically-relevant drug-drug interactions, which may or may not be addressed with dose reductions”).1 Thus, our determination rejects Petitioner’s contention that one of ordinary skill in the art would have arrived at the claimed dosage reduction by routine experimentation. See Coherus Biosciences, Inc., v. Abbvie Biotechnology LTD., Case IPR2016- 00189, slip op. at 2 (PTAB July 14, 2016) (Paper 27) (“The Board is not obligated to respond in writing to every unpersuasive argument made before it.”). Accordingly, we are not persuaded we misapprehended or overlooked any of Petitioner’s arguments.” slip op. at 4
§ 103 obviousnessPatents in suitUS 9,138,432
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.