- Sun Pharmaceutical Industries Ltd. / Sun Pharmaceutical Industries, Inc. v. Novo Nordisk A/SInstitutedPTAB · May 28, 2024 · IPR2024-00107 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Sun’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“The Director set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation or any alleged “behind the scenes” participation by Petitioner such as paying for experts, participating in expert reports or deposition preparation “in connection with any of the stipulated grounds.” See Paper 14, 1. Petitioner has filed such a stipulation. See Ex. 1099. Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the original statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Mylan IPR, Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.9” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - PTAB · May 24, 2024 · IPR2023-00861 · APJ Christopher M Kaiser · IPR · Remand
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under any asserted ground.
RulingsRemand decision- RemandOther
“Accordingly, the Director instructed us to “determine whether Petitioner has demonstrated that Figure 1 of Godefroy ‘is clear on its face’ or would have reasonably suggested the placement of Godefroy’s sacrificial anode ‘within 10 inches’ of the hot liquid inlet.” Id. at 9. “In making this determination,” the Director instructed us to “consider whether the expert testimony provides sufficient ‘technical detail, explanation, or statements supporting why the expert determines that the feature in question was required or would have been obvious based on the prior art disclosure.’” Id. In addition, although the Director’s decision “is limited to [our] application of Hockerson to the grounds in the Petition involving Godefroy,” the Director instructed us also to “consider what effect, if any, this decision has on the other asserted grounds.” Id. Finally, the Director instructed us to “set forth [our] interpretation” of “the limitation ‘within 10 inches of a hot liquid inlet to the radiator.’” Id. at 8 n.4.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“original decision, the Director’s decision, and the evidence currently of record, we determine that Petitioner has not shown a reasonable likelihood that it will prevail in showing that at least one of the challenged claims is unpatentable. Accordingly, we do not institute an inter partes review of any challenged claim based on any ground asserted in the Petition. IV. ORDER For the reasons given, it is: ORDERED that, pursuant to 35 U.S.C. § 314, the Petition is denied, and no inter partes review is instituted.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“evidence. The challenged claims require that a sacrificial anode be placed within a certain distance—10 inches—of the hot liquid inlet, and, because the inlet has some non-zero size, it might be possible for an anode to be within that distance from some parts, but not from all parts, of the inlet. Accordingly, specifying the center axis of the inlet as the point from which to measure the distance to the anode improves on the plain words of the claim in terms of achieving the claim’s objective of placing the anode within a specified distance of the inlet. Moreover, when discussing the distance from the inlet to the anode, the specification of the ’494 patent uses the language “within 10 inches in any direction of the center axis of the inlet connection.” Ex. 1001, 7:61–64. Thus, the intrinsic evidence supports adopting Petitioner’s claim construction. Petitioner’s declarant, Dr. Medlin, relies on Petitioner’s proposed construction. See, e.g., Ex. 1004 ¶¶ 20 (noting that the construction “within 10 inches of the center axis of [a] hot liquid inlet” “ha[s] been adopted by Petitioner”), 96 (“the sacrificial anodes contained in each of the turbulators 2 would be placed within 10 inches of a center axis of a hot liquid inlet to the radiator of Tomosada”), 144 (“A POSITA would understand from Figure 1 that the sacrificial anode 14 is within 10 inches of a center axis of a hot liquid inlet”), 267 (“These teachings would further motivate a POSITA to located the sacrificial anode 12 within 10 inches of a center axis of the hot liquid inlet.”). This support for Petitioner’s proposed construction provides further reason for us to adopt it. Because it is supported by the intrinsic evidence of record, because Patent Owner proposes no alternative construction, and because Petitioner’s expert supports it, we adopt the construction of “within 10 inches of a hot liquid inlet to the radiator” that Petitioner proposes. Thus, we construe this term as “within 10 inches of the center axis of a hot liquid inlet to the radiator.” In other words, when discussing the distance between a hot liquid inlet and a sacrificial anode, we interpret “hot liquid inlet” as “center axis of the hot liquid inlet.”” slip op. at 5
- BurdenNot shown unpatentable
“Inherency may be relied upon in arguing either anticipation or obviousness. Schering, 339 F.3d at 1377 (applying inherency in an anticipation context); Par Pharma. Inc. v. TWI Pharma., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014) (applying inherency in an obviousness context). In both cases, however, “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Instead, “the limitation at issue necessarily must be present, or the natural result of the combination of elements expressly disclosed by the prior art.” Par Pharma., 773 F.3d at 1195–96. Here, Petitioner has not shown sufficiently that, in Godefroy, the sacrificial anode necessarily is placed within 10 inches of the center axis of the hot liquid inlet. Dr. Medlin testifies that Figure 1 of Godefroy shows that “an entirety . . . or at least a significant portion of the sacrificial anode 14, is within 10 inches of a center axis of the inlet.” Ex. 1004 ¶ 144. But we cannot say that Figure 1 of Godefroy is clear on its face, or reasonably suggests, that this is necessarily the case. There are no dimensions shown on Figure 1, so it is unclear from the figure what the diameter of pipe 12 is. If that diameter is larger than 20 inches, then it simply is untrue that “sacrificial anode 14 is . . . necessarily placed within 10 inches of a center axis of a hot liquid inlet to the radiator,” as Dr. Medlin testifies. Id. ¶ 361. As noted above, neither Petitioner nor Dr. Medlin relies on the hot liquid inlet of Godefroy having any particular diameter, and Godefroy is silent as to the diameter of its inlet. Pet. 69–70; Ex. 1004 ¶¶ 144, 359–361, 381–382, 406–408; Ex. 1008, 1–15. Moreover, as Patent Owner notes, there is a wide range of sizes of radiators, including automobile radiators, available. Prelim. Resp. 3–5; Exs. 2001–2003. In the absence of any testimony or other evidence that tends to show that radiator inlet pipes necessarily have diameters less than 20 inches, Petitioner has not shown sufficiently that the diameter of Godefroy’s inlet pipe is small enough to ensure that any portion of the anode necessarily is within 10 inches of the center axis of the inlet.” slip op. at 11
Claim constructioncites Phillips - Canon U.S.A., Inc. / Canon Inc. v. Slingshot Printing LLCAll claims unpatentablePTAB · May 20, 2024 · IPR2022-01541 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1–7, 9, 10, 20–22, and 24 are unpatentable as obvious over Hamafuku, Whitman, and Imanaka, with Cleland added for claim 5.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Upon review of the prior art of record, we determine that no claim terms require construction for purposes of this Final Written Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Upon review of the prior art of record, we adopt Petitioner’s definition of a person of ordinary skill in the art as it is consistent with the prior art of record, but note that neither party contends the outcome of this case depends on whether a person of ordinary skill could include an individual with a degree in Materials Science.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In this case, there was a known desire to increase nozzle pitch in inkjet printheads, Imanaka’s heater and nozzle configuration had been used in the art to achieve this goal, and there is no suggestion that combining the teachings of Hamafuku, Whitman, and Imanaka was beyond the skill of an ordinarily skilled artisan. See Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1381 (Fed. Cir. 2023). Thus, we credit the testimony of Mr. Curley that one of ordinary skill in the art would have sought to use Imanaka’s heater and nozzle pitch in Hamafuku in order to provide a more compact and higher density printhead. Ex. 1002 ¶¶ 404–05. A conclusion of obviousness requires a reasonable expectation of success. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1365 (Fed. Cir. 2016). This inquiry asks whether one of ordinary skill in the art would have had a reasonable expectation of combining the references to achieve what is claimed in the patent-at-issue. Id. at 1367. The inquiry does not look to whether unclaimed elements or functions would or would not also be achieved, or whether “one would reasonably expect the prior art reference to operate as those references intended once combined.” Id.” slip op. at 42
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“As noted by Patent Owner, the components of Imanaka are made of silicon-based materials, manufactured using thin film technology. PO Resp. 53–54 (citing Ex. 1008, 6:50–61). We are not persuaded, however, that Imanaka’s preference for silicon-based materials would teach away from, or otherwise discourage, one of ordinary skill in the art from combining Hamafuku, Whitman, and Imanaka. Imanaka does not suggest that failure to use silicon-based materials would result in an inoperable device. Rather, Imanaka states that use of silicon-based materials may “improve the mechanical characteristics” and “reliability” of “the liquid discharge head.” Ex. 1008, 6:50–61. Given the considerable increase in printhead nozzle pitch and print resolution provided by Imanaka’s heater and nozzle pitch configuration, we are not persuaded that a failure to capture the same improvement in mechanical characteristics and reliability from the use of silicon-based materials would prevent one of ordinary skill in the art from implementing Imanaka’s nozzle pitch in Hamafuku and Whitman or counsel against this modification.” slip op. at 41
Patent outcomesUS 7,152,951 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,152,951 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Institution deniedPTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,767,366 - PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,672,803 - PTAB · Apr 25, 2024 · IPR2024-00009 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petition grounds, declined discretionary denial, and granted joinder with IPR2023-00724.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Director Vidal set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation. Petitioner has filed such a stipulation. Reply 2 (“Petitioners stipulate that, if instituted, they will not pursue in the parallel district court proceeding the same grounds as in the Petition or any grounds that could have reasonably been raised therein”). Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the current statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.10” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter parties review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - Mara Renewables Corporation v. DSM IP Assets, B.V.Institution deniedPTAB · Apr 18, 2024 · IPR2024-00070 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–15 were anticipated by Radianingtyas or obvious over either asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim term “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (holding that the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application”). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not provide a definition of the level of ordinary skill in the art. See Prelim. Resp. 19. Patent Owner also states that any differences between the parties’ proposed definition of the skill level would not impact its arguments. Id. For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the level of ordinary skill at the relevant time. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“triglyceride, DHA, and heptadecanoic acid content recited therein. In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements arranged as in the claim.” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quotation marks omitted). A reference, however, can anticipate a claim “even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017) (quotation marks and brackets omitted). As explained below, here, Petitioner has not shown Radianingtyas discloses a microbial oil comprising the required triglyceride, DHA and heptadecanoic acid content. Specifically, although the exemplified strain ONC-T18 produces oil that meets the claimed triglyceride fraction and heptadecanoic acid level, Petitioner has not shown the same oil contains the recited DHA level.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,207,363 - PTAB · Mar 26, 2024 · IPR2023-01382 · APJ Kimberly Mcgraw · IPR · Institution
The Board instituted IPR of claims 1–3 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim would be unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we determine the information presented in the Petition establishes a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we institute an inter partes review of all challenged claims of the ’347 patent on all grounds asserted in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that a decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had a “at least a four-year degree in electrical engineering, chemical engineering, physics, or material science or a closely related field, and at least two years of experience in semiconductor device design and/or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies.” Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Petitioner also contends that “[a]dditional education could substitute for professional experience and vice versa.” Pet. 19. Patent Owner does not challenge Petitioner’s definition or offer its own. See generally Prelim. Resp. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’347 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’347 patent and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”)” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“type gate material of independent claim 1 requires that the “bottom of the ptype gate material is more than 10% wider than the top of the material.” Pet. 19. We begin our analysis with the language of the claims themselves. See Phillips, 415 F.3d at 1312. Here, the claims do not recite any numerical degree of horizontal extension, let alone a requirement that the bottom of the p-type gate material must be more than 10% wider than the top of the material. Thus, the plain language of the claims themselves do not support Petitioner’s proposed construction. Of course, the claims do not stand alone, but rather, must be read in view of the specification, of which they are part. Phillips, 415 F.3d at 1313. Petitioner relies on a numerical value for horizontal extension disclosed in Lidow, which is incorporated by reference in the ’347 patent. Pet. 20 (citing Ex. 1011 ¶¶ 41–42, Fig. 8; Ex. 1003 ¶¶ 70–74). But Lidow’s disclosure of a numerical value (10%) is made in the context of discussing a single embodiment. Ex. 1011 ¶ 41. Lidow does not include a numerical value in its disclosure of other embodiments. See, e.g., Ex. 1011 ¶¶ 43–51.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Again, Patent Owner’s arguments raise issues that are best resolved on a full record. While we do have some concern’s regarding Petitioner’s asserted reasons to combine all of the prior art references, Petitioner has provided sufficient argument and evidence for purposes of institution that a POSITA would have had reason to manufacture the modified Figure 1A of Saxler by using Beach’s self-aligned technique with Shenoy’s isotropic etching process, and would have had a reasonable expectation of success. Pet. 32 (citing Ex. 1003 ¶¶ 60–62, 93; Ex. 1014 (Xu); Ex. 1021 (Sheppard); Ex. 1015 (Smith); Ex. 1018 (Hu); Ex. 1009 (Shenoy); Widmann (Ex. 1023); Ahn (Ex. 1010); see also Pet. 31–35. For example, Dr. Shealy testifies that a POSITA would have recognized that using Beach’s self-aligned techniques and Shenoy’s isotropic etching process to arrive at Saxler’s non-recessed gate structure would have been a simple and predictable combination in view of Smith’s use of self-alignment techniques to create its stacked gate structure and would have done so to reduce steps and costs while improving reproducibility. Ex. 1003 ¶ 93. We also note that we understand Petitioner’s proposed combination uses a single photomask when etching both the gate metal and the p-type gate material layer, including when etching the gate metal to form a pair of ledges on the p-type gate material below the gate metal. See, e.g., Pet. 48 (stating that it would have been obvious to use one mask to etch the gate metal and cap layer and further stating that using Shenoy’s method of isotropically etching the gate metal would form symmetric undercuts of the photomask). To the extent, the Board’s understanding of Petitioner’s argument is not correct, the parties are urged to address this issue. Finally, Patent Owner asserts that Shenoy is non-analogous art and may not be combined with Saxler or Beach because Shenoy involves electrochemical etching, a highly specialized etching method with little relevance to the process described in the ’347 patent or Saxler. Prelim. Resp. 27.” slip op. at 32
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,748,347 - PTAB · Mar 26, 2024 · IPR2023-01384 · APJ Jeffrey W Abraham · IPR · Institution
The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claims 1, 3, and 4 are unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION Because Petitioner has demonstrated a reasonable likelihood that at least one challenged claim of the ’335 patent is unpatentable over the prior art of record, we institute an inter partes review of all challenged claims. And because we find some grounds sufficient for institution, we institute on all grounds in the petition. See SAS, 138 S. Ct. at 1353 (2018); PGS Geophysical, 891 F.3d at 1360. determination with respect to the patentability of any challenged claim or any underlying factual or legal issue, including claim construction. IV. ORDER For the reasons given, it is: ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes review of claims 1–7 of the ’335 patent is instituted with respect to all grounds of unpatentability asserted in the Petition, commencing on the entry date of this Decision; and FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of trial.” slip op. at 54
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art would have had “at least a four-year degree in electrical engineering, chemical engineering, physics, or material science or a closely related field, and at least two years of experience in semiconductor device design and/or 1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, took effect on March 16, 2013. Because the ’335 patent has an effective filing date prior to the effective date of the applicable AIA amendments, the pre-AIA version of § 103 applies. 2 US 2006/0108606 A1, published May 25, 2006 (Ex. 1007). 3 JP H11-261053, published Sept. 24, 1999 (Ex. 1005 (original language); Ex. 1006 (certified English translation)). 4 US 2007/0007547 A1, published Jan. 11, 2007 (Ex. 1008). 5 R.V. Shenoy, et. al, Effect of Mask Wall Angle on Shape Evolution during Through-Mask Electrochemical Micromachining, J. ELECTROCHEM. SOC., Vol. 143, No. 2, 544, Feb. 1996 (Ex. 1013). device operation, or the development of new device topologies.” Pet. 18 (citing Ex. 1003 ¶¶ 52–53). Petitioner also contends that “[a]dditional education could substitute for professional experience and vice versa.” Pet. 18. Patent Owner does not challenge Petitioner’s definition or offer its own. See generally Prelim. Resp. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’335 patent and the prior art of record, at this stage of the proceeding we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’335 patent and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“type gate material of independent claims 1 and 5 requires that the “bottom of the p-type gate material is more than 10% wider than the top of the material.” Pet. 19. We begin our analysis with the language of the claims themselves. See Phillips, 415 F.3d at 1312. Here, the claims do not recite 7 Patent Owner cites to the Lidow-508 patent itself, instead of the published application included in the record as Ex. 1011, which Petitioner cites to. The parties have not identified any difference between the two references. the bottom of the p-type gate material must be more than 10% wider than the top of the material. Ex. 1001, 5:5–6:30. Thus, the plain language of the claims themselves does not support Petitioner’s proposed construction.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“As discussed above, however, we are persuaded, at this stage, by Petitioner’s argument that that Saxler teaches or suggests an operable enhancement-mode device. See § II.D.1.a.i, supra. Additionally, Patent Owner’s argument regarding modifications that “could be detrimental” to certain devices is not only speculation, but also comprised entirely of attorney argument. Finally, Patent Owner does not directly address Petitioner’s arguments and accompanying evidence that a person of ordinary skill in the art would have had reason to combine the teachings of Saxler and Yoshida to take advantage of simplified manufacturing steps and reduced costs. Based on the present record, Petitioner has sufficiently shown that Saxler and Yoshida disclose or suggest all of the limitations in claims 1, 3, and 4, and that a person of ordinary skill in the art would have had a reason to combine the teachings of Saxler and Yoshida with a reasonable expectation of success. Accordingly, we determine Petitioner has established a reasonable likelihood of prevailing on its challenge that claims 1, 3, and 4 are unpatentable as obvious in view of Saxler and Yoshida. For the same reasons as noted above, we decline to address Petitioner’s challenge of claims 2 and 5–7 based on Saxler and Yoshida alone at this stage. See § II.D.1.c, supra.” slip op. at 44
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,312,335 - Kinderfarms LLC v. Genexa Inc.InstitutedPTAB · Mar 25, 2024 · PGR2023-00051 · APJ Deborah Katz · PGR · Institution
Instituted PGR of claims 1–24 on all asserted grounds; the Board found the §103 challenges more likely than not to render claim 1 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” See 35 U.S.C. § 324(a).” slip op. at 6
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Level of Skill Each party puts forth a characterization of the ordinarily skilled artisan in the field of the claims of the ’795 patent. (See Pet. 13 (citing Crowley Decl., Ex. 1003, ¶¶ 90–91); see Prelim. Resp. 3–4.) The parties’ proposed characterizations of the ordinarily skilled artisan are sufficiently similar that adoption of either would lead to the same result, institution. Thus, for the purposes of this Decision only, we adopt Patent Owner’s characterization of the ordinarily skilled artisan as having a bachelor of science degree in a relevant life sciences field, such as, chemistry, biochemistry, or pharmacy, with at least two years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals, or, in the alternative, at least three to four years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals. (See Prelim. Resp. 3–4.) We also note that the level of skill of an ordinarily skilled artisan is revealed by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (holding that the absence of specific findings on the level of skill in the art does not give rise to reversible error “the prior art itself reflects an appropriate level and a need for testimony is not shown.” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163, 225 USPQ 34, 38 (Fed.Cir.1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Petitioner puts forth constructions of certain terms used in the claims of the ’795 patent. (See Pet. 14–19.) Patent Owner does not dispute any of these constructions specifically, but at this point, argues that we need not construe any terms “to resolve the present controversy.” (Prelim. Resp. 2.) We agree that an express construction is not required at this point in the proceeding. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Thus, at this point in the proceeding, Patent Owner’s argument is not persuasive because it does not address the teachings in the prior art that Petitioner asserts would render the formulations claimed in the ’795 patent obvious.” slip op. at 20
Claim construction§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 11,617,795
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.