- 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 - PTAB · Mar 4, 2021 · CBM2018-00040 · APJ Christopher G Paulraj · CBM · Rehearing
The Board denied Petitioner’s second rehearing request and left in place its denial of institution because the patent’s CBM review eligibility was not subject to judicial review.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“rehearing of our denial of institution in this proceeding in light of the Federal Circuit’s decision in SIPCO, LLC v. Emerson Elec. Co., 939 F.3d 1301, 1313 (Fed. Cir. 2019). Paper 19. We also authorized Patent Owner to file an opposition to Petitioner’s second request for rehearing. Paper 20. Subsequently, the Supreme Court granted a petition for certiorari, vacated the Federal Circuit’s first opinion in the SIPCO case, and remanded the case “for further consideration in light of Thryv, Inc. v. Click-to-Call Technologies, LP,” 140 S. Ct. 1367 (2020). On remand, the Federal Circuit determined that the issue of whether a patent qualifies for CBM review is not subject to judicial review. SIPCO, LLC v. Emerson Elec. Co., 980 F.3d 865, 870 (Fed. Cir. 2020). Accordingly, because the circumstances that warranted further reconsideration of our denial of institution no longer hold true, we hereby decline to consider the second request for rehearing. For the foregoing reasons, Petitioner’s second request for rehearing is denied. Our original decision to deny institution based on lack of CBM review eligibility therefore stands.” slip op. at 2
NonePatents in suitUS 6,758,370 - Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing deniedPTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing
The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing 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 arise 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. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship 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
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7
Claim construction§ 112 disclosurePatents in suitUS 10,155,039 - 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 - Boragen, Inc. v. Syngenta Participations AGRehearing deniedPTAB · Aug 10, 2020 · IPR2020-00124 · APJ Timothy G Majors · IPR · Rehearing
The Board denied Boragen’s rehearing request and left in place the denial of institution under § 325(d), finding no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if there was an erroneous interpretation of law, a factual finding not supported by substantial evidence, or an unreasonable judgment in weighing relevant factors. 37 C.F.R. § 42.71(c); Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); The Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). The rehearing request “must specifically identify all matters the [requesting] 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
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for patent owner
“Petitioner contends the Board “failed to exercise its discretion under 325(d)” (Req. 2), but this is plainly inconsistent with the Decision, because we did exercise discretion under § 325(d) and denied the Petition because it was based on substantially the same prior art as already considered by the Office. See Dec. 6–35 (analyzing, inter alia, the asserted prior art, the prosecution history, declarant testimony, and the precedential Becton, Dickinson factors under a framework explained further in Advanced Bionics, in route to denial under § 325(d)).1 Petitioner continues, arguing the Board “improperly” slip op. at 3
- Expert testimonyPetitioner expert discountedDecided for patent owner
“expert” may opine on the unpatentability of the challenged claims generally represents one factor that we account for in exercising our discretion under § 325(d) (e.g., insofar as it may comprise “additional evidence” addressing prior art that the Office may have already considered). Becton, Dickinson at 17–18. It is not, however, a super-factor that overrides others in the manner urged by Petitioner that would, in effect, require we institute inter partes review so long as the challenge is accompanied by “new” testimony slip op. at 4
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“precedential after the Petition was filed, and requests “additional briefing to directly address the Advanced Bionics factors” if this Request is denied. Req. 1 n.1. Petitioner’s request for additional briefing is denied. Additional briefing is unnecessary because the arguments and evidence already submitted by the parties is sufficient for us to make a determination based on the two-part framework in Advanced Bionics. Furthermore, we have reviewed the arguments based on Advanced Bionics submitted by Petitioner on rehearing and do not find them persuasive. Req. 8–10 (“Petitioner highlights such errors herewith separately under the guidelines set forth in Advanced Bionics”). Moreover, Advanced Bionics became precedential six weeks before we denied institution in this case, where discretionary denial” slip op. at 10
Discretionary denialPatents in suitUS 10,130,096 - 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 - Genome & Company v. The University Of ChicagoRehearing deniedPTAB · Jan 9, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Rehearing
The Board denied the Patent Owner’s rehearing request, leaving institution in place for claims 1–29 because the Board found no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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 rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Owner’s argument. As we noted in our Decision, the issue of whether undue experimentation is required to practice the claimed invention is evaluated using the factors outlined in In re Wands, a fact based inquiry. Dec. 8. Our conclusion for purposes of institution that undue experimentation would be required to practice the claimed invention was based, not only on Dr. Braun’s statement to that effect, but on the detailed analysis presented by Petitioner and Dr. Braun of all of the Wands factors as supported by the evidence of record. Dec. 14–15. show that the experimentation required was other than routine and found it unpersuasive at the institution stage of the proceeding. Id. Patent Owner’s argument was based on the premise that Dr. Braun’s opinion regarding nonenablement was based on the number of experiments and not whether the experiments were routine. Prelim. Resp. 2–4. This argument ignores the fact that our consideration of Dr. Braun’s opinion was based on an analysis of all of the Wands factors, a fact based inquiry that includes analyzing the minimal guidance presented in the Specification and the unpredictability of cancer treatments and unpredictable nature of CPIS, and not merely the number of experiments required. Id. at 15; Ex. 1002 ¶ 166; In re Morsa, 713 F.3d 104, 109 (Fed. Cir. 2013) (“Enablement is a question of law based on underlying factual findings.”). Although we acknowledge Patent Owner’s argument in support of its position that the claimed subject matter is enabled, we remind Patent Owner that, for purposes of deciding whether to institute a post-grant review, we view a genuine issue of material fact in the light most favorable to the petitioner. 37 C.F.R. § 42.208(c). As Patent Owner offered attorney argument concerning enablement based on the current record, we resolved the parties’ dispute regarding enablement for which Petitioner offered Dr. Braun’s opinion as supported by evidence of record in favor of Petitioner.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for petitioner
“Patent Owner contends that we should reconsider our decision to institute to avoid having Patent Owner address Petitioner’s legally insufficient enablement challenge. Reh’g. Req. 6–9. Patent Owner further contends that we should exercise our discretion and deny the Petition to help maintain the integrity of the patent system and promote fairness. Id. We have considered Patent Owner’s new arguments and are not persuaded. Those arguments were not previously raised in the Preliminary Response, and a request for rehearing is not the proper vehicle to set forth new argument.” slip op. at 5
NonePatents in suitUS 9,855,302 - Hologic, Inc. v. Biomérieux, Inc.Rehearing deniedPTAB · Jan 31, 2019 · IPR2018-00569 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Hologic’s rehearing request, leaving in place the denial of institution under § 325(d) for claims 1–6.
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
Discretionary denialPatents in suitUS 8,697,352
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