- Salvacion USA, Inc. v. Trutek Corp.InstitutedPTAB · Dec 6, 2024 · IPR2024-00711 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1–3 and 8 on all asserted grounds, finding a reasonable likelihood that Chen anticipates or renders obvious each challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Accordingly, we determine that Petitioner has shown a reasonable likelihood of prevailing in its challenge of claims 1–3, and 8 as anticipated by, or obvious over Chen.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not specifically address or dispute Petitioner’s proposed definition or a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding, we adopt Petitioner’s proposed level of ordinary skill in the art as we find it consistent with the cited prior art and it is undisputed on this record. 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” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“of independent claims 1, 2, and 8 are limiting. Prelim. Resp. 7. According to Patent Owner, for these claims, the preamble “recites specific steps in the process that are not recited in the body of the claim or are recited in a way particulate matter; infecting an individual through nasal inhalation; formulation is applied to the skin or tissue of nasal passages; and a thin film.” Id. Petitioner does not allege any contention regarding whether the preamble is limiting. See Pet. 14–16. Based on our review, we agree with Patent Owner that the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body have been used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.” Id.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“one “biocidic agent.” Petitioner asserts that this term means “an agent which has the capacity to neutralize, inactivate, render harmless or kill airborne particles, which include microorganisms, for example viruses and/or bacteria.” Pet. 14. Patent Owner asserts that the term refers to “a chemical substance that destroys or inhibits the growth or activity of living organisms.” Prelim. Resp. 12 (citing Merriam-Webster Dictionary). Independent claim 2 recites a formulation comprising at least one “cationic agent.” Dependent claim 3 recites that the “cationic agent is a polymeric quaternary ammonium compound.” Patent Owner asserts that a “cationic agent” is “a chemical substance that creates a positive electrostatic term. Based on our review, we determine that an explicit construction is not necessary for purposes of our determination whether to institute an inter partes trial, as there is no dispute as to whether the prior art discloses formulations comprising a biocidic agent and a cationic agent.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - PTAB · Aug 22, 2024 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1, 3–6, and 8 on all asserted grounds, finding a reasonable likelihood that at least claim 1 would be shown obvious over the ’772 Publication and Snowdy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claim 1, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown a reasonable likelihood of succeeding in establishing that the combination of the ’772 Publication and Snowdy renders at least claim 1 obvious.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not dispute this definition for purposes of the Preliminary Response. Prelim. Resp. 16. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’462 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 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)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“We agree with Patent Owner on the record before us that Petitioner does not appear to offer sufficient evidence and reasoning as to why a POSA would have modified AAVrh.10 at position 665 as described as opposed to other modifications based solely on the disclosure of the ’772 Publication. We do agree with Petitioner, however, that on the record before us, Snowdy provides such sufficient evidence and reasoning. See Pet. 47–52.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - PTAB · May 6, 2024 · IPR2023-00565 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted review of claims 1–20 on all asserted grounds, finding a reasonable likelihood that ResMed would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Petitioner’s stipulation disposes of the Fintiv issue. The Director’s Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation2 (“Interim Procedure”) directs that 2 Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation, available at 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. Patent Owner’s reliance on NXP is misplaced. Paper 21 at 4. According to Patent Owner, “[t]he plain language of the Director’s holding in NXP requires that any stipulation should be filed before the Board’s initial Institution Decision.” Id. With the Director’s vacatur of our earlier Decision Denying Institution, i.e., setting aside our prior decision, that is the posture now before us. Paper 15 at 6 (“Decision Denying Institution (Paper 13) is vacated.”). We accordingly follow the Interim Procedure’s directive and decline to deny the Petition under Fintiv.” slip op. at 11
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Nevertheless, based on its showing with the combination of the ’029 Stahmann and Edgar as applied to claim 8, we determine that Petitioner has sufficiently demonstrated a material error during the examination. Other Board panels have instituted an inter partes review after inferring material error based on the strength of the petitioner’s grounds. See, e.g., STMicroelecs., Inc. v. Trustees of Purdue Univ., IPR2022-00309, Paper 14 at 12–13 (PTAB July 6, 2022) (finding that petitioner demonstrated examiner erred by not appreciating that reference on IDS disclosed features recited in the challenged claims, as demonstrated by petitioner’s unpatentability grounds); Apple Inc. v. Telefonaktiebolaget LM Ericsson, IPR2022-00457, Paper 7 at 8 (PTAB Sept. 21, 2022) (same); Sci. Design Co. v. Shell Oil Co., IPR2021-01537, Paper 7 at 24–25 (PTAB Mar. 18, 2022) (same). Furthermore, Advanced Bionics specifically provides that we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims,” not whether Petitioner has expressly stated that the Office erred in a manner material to patentability. Advanced Bionics, IPR2019-01469, Paper 6 at 8 (emphasis added). Consistent with these cases, here we find that Petitioner sufficiently shows material error by pointing to material teachings in the ’029 Stahmann reference that were not raised during prosecution. Claim 8 and its dependent claims were allowed after Patent Owner amended the claim to recite “the positive airway pressure apparatus comprising a controller adapted to adjust the pharmaceutical agent.” Ex. 1002, 29. This suggests the Examiner determined that the art did not agent. The Examiner, therefore, did not appreciate that the controller as taught in the ’029 Stahmann reference could be used to administer both CPAP treatment and a pharmaceutical agent. See Ex. 1010, 237–238 (“Positive airway pressure devices, e.g., continuous positive airway pressure (CPAP) devices are among the most frequently used mechanical respiration therapy devices employed for treating sleep disordered breathing. . . . Drugs may [also] be delivered to the patient through one or more automatically controllable drug delivery devices. . . [such as a] nebulizer.”), see also 322 (“The therapy control unit 7930 may also include respiration therapy control unit 7934 that provides control signals to a respiratory therapy device 7954 and a drug control unit 7936 that provides control signals to a drug delivery device 7956.”). Moreover, the Petition presents additional evidence regarding element 8.b (see Ex. 1004 ¶¶ 120–124) that warrants reconsideration of the ’029 Stahmann reference in this proceeding. For these reasons, we find that Petitioner has demonstrated a material error, and therefore, will not exercise discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 19
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’269 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See CTPG 64; (interpreting the relevant statutory provisions, in light of SAS, to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. IV. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–20 of the ’269 patent based on the unpatentability challenges presented in the Petition;” slip op. at 49
- BurdenInstituted
“We are not persuaded by Patent Owner’s argument that element 1.b.3 is missing from the combination of Genger, Schmidt, Westbrook, and the ’737 Farrell. See Prelim Resp. 30–32. With respect to the location of the respiratory sensor in claim element 1.b.3, Petitioner’s articulated sensor. Instead, Petitioner is relying on the teaching in the ’737 Farrell that suggests the sensors can be included in the mask, which is part of the CPAP machine. See Pet. 34–36; Ex. 1004 ¶¶ 85–88. The ’737 Farrell teaches that “a flow sensor 4f and/or pressure sensor 4p may also be utilized in which case mask flow may be measured using a pneumotachograph and differential pressure transducer or similar device to derive a flow signal F(t), and mask pressure is measured at a pressure tap using a pressure transducer to derive a pressure signal Pmask(t).” Ex. 1008, 5:5–9. The ’737 Farrell also teaches that “[t]here is a sense tube 14 connected to the main housing of the blower to the mask that allows the apparatus to sense oxygen concentration and pressure levels in the mask 6.” Id. at 5:36–6:2. Based on these teachings, Petitioner shows a reasonable likelihood that this disclosure in the ’737 Farrell suggests incorporating sensors into the mask. Genger explains that generally ventilators and respirators have “[a] spirometer [that] is built into the expiration segment of these devices, which measures the patient’s respiratory volume.” Ex. 1005, 1:15–17. Genger explains that “wireless sensor units may be provided for recording the respiration volume, the air pressure with which the patient is ventilated, or the patient’s blood oxygen content.” Ex. 1005, 10: 28–30, Figure 1. According to Petitioner, “[m]otivation for modifying Genger’s CPAP would also have come from the fact that Genger wants the CPAP device 4/5/6/7/8 to have the airflow data.” Pet. 36. “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing United States v. Patent Owner’s arguments but find the arguments unavailing. We find that Petitioner has directed us to sufficient evidence in the record to demonstrate a reasonable likelihood that Genger includes a sensor for measuring respiratory airflow in the device and that Farrell reasonably teaches that a sensor can be included in the mask of the CPAP device.” slip op. at 29
Claim constructionDiscretionary denialcites KSRPatents in suitUS 10,076,269 - PTAB · Apr 1, 2024 · IPR2023-01431 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR on claims 1–28 and all asserted grounds, finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1359–60 (Fed. Cir. 2018) (interpreting the relevant statutory provisions to require “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
“Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the “type of problems encountered in the art, [the] prior art solutions to those problems, [the] rapidity with which innovations are made, [the] sophistication of the technology, and [the] educational level of active workers in the field.” Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had “(1) a degree in Mechanical Engineering or equivalent technical background and (2) at least two years experience designing or implanting spinal implants with threaded connections. More education could substitute for less experience, and vice versa.” Pet. 6–7 (citing Ex. 1003 ¶¶ 36–42). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally Prelim. Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“We disagree with Patent Owner’s allegation because Petitioner sufficiently explains the plain meaning of the terms. See Pet. 8–16. On this record, and for purposes of this Decision, we adopt Petitioner’s proposed constructions of these terms and apply them to our analysis below. 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 address the construction of any other claim term.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“concave and convex surface. The leading surface in claim 1 only needs to have a curvate surface. Based on the current record, Petitioner has provided a sufficient rationale why one of ordinary skill in the art would have arrived at a structure containing a leading face that has a curvate surface based on the combination of the ’477 Publication and Boschert. Specifically, Petitioner contends that because the closure is intended to be used in a surgical environment the ordinary artisan would have been motivated to eliminate any sharp edges that could pierce a surgeon’s glove. Pet. 23 (citing Ex. 1003 ¶¶ 202–204); see also Ex. 1003 ¶ 64 (“By truncating a thread start a POSA was able to avoid very thin portions of the tapered thread, which are sharp and could cut a surgeon’s glove, could be easily damaged, and could lead to cross threading.”). Petitioner’s declarant, Dr. McMillin, asserts that “a POSA would have had an expectation of success with this combination, at least because multi-start threads and curvate[10] leading faces, and techniques for manufacturing them, were well known in the art.” Pet. 22; see Ex. 1003 ¶ 232 (citing ¶¶ 48–79 of the McMillin declaration). In addition, Petitioner asserts that “a 10 The ’641 patent recites that “[e]ach of the start structures . . . includes a leading face having at least one radius of curvature. In one embodiment, the at least on one curvate surface is both concave and convex.” Ex. 1001, 7:51–55. We interpret “curvate” leading face to be either a concave or convex structure unless the language of the claim specifies that the structure contains both, such as for example recited in claims 9–13 and 26. Id. at 13:24–42, 16:1–3. combination of familiar elements using known methods would yield predictable and successful results.” Pet. 23 (citing Ex. 1003 ¶ 204). Specifically, Petitioner contends that the “benefits of double-lead threads, including balancing insertion forces and increasing insertion speed” were known. Pet. 22–23 (citing Ex. 1003 ¶¶ 202–204). The use of truncated thread starts was also known for further easing thread insertion, reducing thread deformation, and reducing sharp edges. Pet. 23 (citing Ex. 1003 ¶¶ 202–204).” slip op. at 42
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,548,641 - PTAB · Mar 29, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 on all asserted §103 grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). Upon considering the argument and evidence presented in the Petition, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’803 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 17 (citing Ex. 1002 ¶¶ 15–16). 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 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 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Claim Construction › Intrinsic evidence (Phillips canons) › Conventional terms ('about', 'substantially', 'a'/'an', 'configured to')Term construed petitioner constructionDecided for petitioner
“At this stage of the proceeding—and without a substantive response from Patent Owner—we determine Petitioner’s construction is consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the bio-alkene is “about 5 to about 20 carbons atoms.” Ex. 1001, claim 1 (emphasis added). We agree with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ is used as part of a numeric range, the use of the word ‘about,’ avoids a strict numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20 carbon atoms” does not require precisely 5 to 20 carbon atoms. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses a carbon chain length of 4 carbon atoms, and “about 20” at the upper end of the range encompasses a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the related ’902 Application—which also claims the benefit of the ’985 Provisional and shares a virtually identical specification as the ’803 Patent— supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8 to about 20” to “carbon chain length of 7 to 20.” See Ex. 1006, 335 see also id. at 16, 23–63. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 7
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,882,803 - PTAB · Jan 16, 2024 · IPR2023-01064 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR on claims 1–50 under all petition grounds, finding a reasonable likelihood of unpatentability, including anticipation by COLCOT protocol for claims 27, 29–36, and 39.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). Upon considering the arguments and evidence presented in the parties’ briefs, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–50 of the ’063 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“For these reasons, we determine that all the references that Petitioner asserts in the Petition (i.e., Bouabdallaoui, COLCOT protocol, Nidorf, ESC guidelines, and COLCRYS) are the same or substantially the same art that were previously presented to the Office. Accordingly, we determine that the first part of the Advanced Bionics framework is satisfied. Part 2: Whether the Petitioner Demonstrates Material Error Next, we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, 8. Patent Owner argues that “[t]he Examiner also did not make any material error in evaluating the prior art, or even determining the closest prior art.” Prelim. Resp. 9. Patent Owner contends that “Examiner did not err in evaluating the COLCOT Protocol as neither version of the protocol discloses key limitations of the claims that eventually issued, including the claim limitation that early intervention with colchicine reduces the risk of stroke.” Id. at 11–12. During prosecution, Examiner identified Hennessy as being the closest prior art. See Ex. 1002, 348–349, 399. Hennessy describes treating a patient population that has had a recent myocardial infarction (MI). The patient population described in Hennessy received 0.5 mg of colchicine once a day and describes the population as adults 18 years or older that have had a MI event within the prior 7 days. See Ex. 1028, 2 (“[a]dult (>18 years old) patients were eligible for enrolment if they had sustained a type 1 acute MI (by the 3rd universal definition[]) within the prior 7 days.”). Hennessy teaches that the “[r]eadmission rates [for their patient population] were significantly lower in the colchicine treated patients but [recognizes that] the numbers are small.” Ex. 1028, 6. This comports with the “Low Dose Colchicine (LoDoCo) study, treatment with 0.5 mg colchicine per day in addition to standard treatment in patients with stable [coronary heart disease] CHD significantly reduced the risk of developing an acute coronary syndrome, an out of hospital cardiac arrest or non-cardioembolic stroke.” Ex. 1028, 7. In the notice of allowability, Examiner asserts that the closest prior art also appears to be [Hennessy (Ex. 1028)] American Heart Journal (September 2019), Vol. 215, pp. 62-69, outlined above. The reference does not teach, show, suggest or make obvious the instant method of reducing the risk of a stroke in a patient having had a myocardial infarction by the administration of daily low dose colchicine within about 30 days of the myocardial infarction.” slip op. at 23
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“If the body of the claim sets out the complete invention, and the preamble is not necessary to give “life, meaning and vitality” to the claim, “then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation.” Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999). Here, the body of claim 27 recites “initiating the administration of colchicine at a daily low dose to the patient within about 30 days of an MI.” Ex. 1001, 42:34–36. The claim body, therefore, identifies the patient population that is to be treated with the low dose colchicine and the time frame in which to initiate treatment. The preamble, therefore, does not narrow the patient population nor change the way colchicine is administered – all that is required by the claim is that colchicine is administered to patients that have suffered a MI within a particular time period after the MI event. The step of the method is preformed the same way whether or not the patient experiences a reduction in the risk of stroke. See, e.g., In re Hirao, 535 F.2d 67, 70 (CCPA 1976) (“the preamble merely recites the purpose of the process; the remainder of the claim . . . does not depend on the preamble for completeness, and the process steps are able to stand alone.”); see Pet. 23 (“‘reducing the risk of a stroke’ does ‘not result in a manipulative difference in the steps of the claim’ and is [therefore] non-limiting.” (citing Bristol-Myers, 246 F.3d at 1375–76; Ex. 1049 ¶¶ 104–108)). We agree with Petitioner that Examiner’s claim interpretation is in error. Here, the body of claim 27 defines a structurally complete invention by identifying the target population as any patient that has had a myocardial infarction (MI) and the onset of treatment using 0.5 mg colchicine within a 30-day time window. See Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (“[W]here a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.”); IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000) (“If the preamble adds no limitations to those in the body of the claim, the preamble is not itself a claim limitation and is irrelevant to proper construction of the claim.”). The recitation of “reducing the risk of a stroke” in the preamble, therefore, does not result in a difference in the way colchicine is administered to the identified patient population. See Pet. 23. We have reviewed the parties’ contentions, and determine at this stage of the proceedings that Petitioner has provided a requisite showing that the body of claim 27 describes a structurally complete invention. The preamble of claim 27, therefore, is not limiting because it simply expresses the intended result of the positively recited method step within the body of the claim. See Pet. 23.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The dispute between the parties is directed to the third wherein clause “wherein the patient is at a lower risk of a cardiovascular event, relative to a patient not being administered colchicine.” This third wherein clause simply asks for a comparison between patients receiving colchicine with a similar situated patient population not receiving the colchicine treatment. “An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Although “[s]uch statements often . . . appear in the claim’s preamble,” a statement of intended use or purpose can appear elsewhere in a claim. In re Stencel, 828 F.2d 751, 754 (Fed. Cir. 1987). We have reviewed the parties’ contentions, and determine at this stage of the proceedings that Petitioner has provided a requisite showing that this third clause merely describes the benefit of the administration of colchicine to the identified patient population. We are not persuaded by Patent Owner’s contention that this clause is material to how the method is performed. This “wherein clause,” therefore, merely defines the result of the positively recited method steps. See Pet. 23; see, e.g., Minton, 336 F.3d at 1381 (a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,400,063 - PTAB · Nov 16, 2023 · IPR2023-01035 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–6, 8–10, and 22–28, finding a reasonable likelihood that Petitioner would prevail on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’048 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner takes no position on” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this stage of the proceeding, we determine Petitioner’s construction is most consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the resulting bio-alkene is “about 5 to about 20.” Ex. 1001, claim 1 (emphasis added). We agree with Petitioner that use of the term “about” indicates a lack of specificity with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20” does not require precisely 5 to 20 carbons. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses at least a carbon chain length of 4, and “about 20” at the upper end of the range encompasses at least a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the parent application supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8” to “carbon chain length of 7.” See Ex. 1006, 335. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“institution under 35 U.S.C. § 325(d) for only these grounds (i.e., Grounds 5 and 6). Prelim. Resp. 19–25. Specifically, Patent Owner argues that Wright was considered by the Office and Petitioner has failed to demonstrate that the Office erred in any material way. Id. Even if we found Patent Owner’s arguments persuasive, after the Supreme Court’s decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), we are compelled to proceed with this inter partes review on all grounds raised in the Petition because we find above. See Guidance on the impact of SAS on AIA trial proceedings, available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sasaia-trial (“If the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”). Thus, we find Patent Owner’s § 325(d) arguments to be moot.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,995,048 - PTAB · Sep 1, 2023 · IPR2023-00712 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 6–8, 14, and 16–18 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Fintiv Order 5–6. In evaluating these factors, “the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Additionally, the Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation issued by the Director of the United States Patent and Trademark Office (the “Memorandum”)10 provides that the Board will not discretionarily deny institution of inter partes review “where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Memorandum, 3.” slip op. at 9
- Parallel petitionsNot reached
“9 Petitioner filed an Explanation of Parallel Petitions in both this proceeding and in IPR2023-00713 stating that it requests that the Board consider the Petition in this proceeding first, followed by the petition filed in IPR2023- 00713. Paper 4, 1. Accordingly, we do not reach the issue of whether institution of inter partes review based on a second petition is warranted in this proceeding.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2022). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that 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). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham, 383 U.S. at 17–18; Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree and/or master’s degree in mechanical engineering or industrial design, along with at least 4 to 6 years of experience designing consumer or medical device products to optimize human factors such as handleability or ergonomics.” Pet. 7. Patent Owner asserts that a person of ordinary skill in the art would have “completed college-level coursework, and/or obtained a bachelor’s degree, in engineering, such as mechanical engineering or biomechanical engineering, or another similar discipline, and (2) have had at least one year of experience researching, developing, and/or designing mechanical medical devices.” Prelim. Resp. 5. Patent Owner further states that its Preliminary Response “does not turn on the definition of a [person of ordinary skill in the art].” Id. Although Patent Owner notes that Petitioner proposes “a higher level of skill,” at this stage of the proceeding neither Party has shown a material difference between the levels of skill each has proposed and either Party may further address the issue, if necessary, during the trial. For purposes of this Decision, we apply Petitioner’s proposed level of skill because, on the current record, it is consistent with the level of skill at the time of the claimed invention reflected by the ’635 patent and the cited prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,840,635 - PTAB · Aug 15, 2023 · IPR2023-00551 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR of claims 1, 2, and 4–13 on all petitioned grounds, finding a reasonable likelihood that the claims would be unpatentable as obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics at 8.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends: A POSA [person of ordinary skill in the art] as of December 2016 would have been a scientist or clinician, having a Ph.D. or M.D., or a team of such individuals, who alone or in combination had experience with (i) the concept of radioimmunoconjugation, (ii) the chemical behavior of radiometals from the d- and f-blocks of the Periodic Table such as 111In, 177Lu, and 225Ac, (iii) the design, synthesis, and use of chelators that form kinetically and thermodynamically stable complexes with the radiometals, and (iv) the clinical use of radiotherapeutic agents.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “asserts that the claim terms should be given their plain and ordinary meaning” but does not argue any constructions for any claim terms. Pet. 17–18. Patent Owner contends that “it is not necessary to construe any claim term at this stage.” Prelim. Resp. 6. For purposes of this decision on institution, at this stage of the proceeding, we need not construe any claim terms. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 15
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“chelated with a targeting compound of Formula (A), (B), (C), (D) or (E) Petitioner contends that Weineisen 2015 teaches Formula C complexed with the beta emitter 177Lu. Pet. 41–42 (citing Ex. 1028, 2; Ex. 1002 ¶¶ 95–98). Petitioner reasons that “[i]t would also have been obvious to a POSA to complex the alpha emitter 225Ac with PSMA I&T.” Id. at 42 (citing Ex. 1002 ¶ 98). According to Petitioner, a POSA would have known that 177Lu and 225Ac can be used interchangeably in a chelator targeting molecule. Id. Petitioner finds support for this position in Miederer that “shows that 177Lu and 225Ac can be used interchangeably in an chelator targeting molecule. . . . When used in the same targeting compound, 225Ac and 177Lu showed similar stability profiles, but 225Ac exhibited increased efficacy compared to the 177Lu analog.” Id. (citing Ex. 1015, 5–6; Ex. 1002 ¶ 98). Formula C of the ’901 patent is reproduced below: The above figure shows Formula C of the ’901 patent. Ex. 1001, 19:20–39. Weineisen 2015’s structural formula for PSMA I&T, as annotated by Petitioner’s declarant, is reproduced below: The PSMA I&T formula shows the targeting moiety, the linker, and the chelating moiety DOTAGA. Ex. 1002 ¶¶ 59–60, see also id. ¶ 26 (“dodecane tetraacetic acid (‘DOTA’) . . . , is a well-known chelator, capable of forming complexes with many different types of radionuclides, such as 177Lu, 90Y, and 225Ac, upon deprotonation” (citing Ex. 1014, 1–2; Ex. 1027, 11; Ex. 1035, 4, 14, 16)). Weineisen 2015 describes the above formula PSMA I&T as a third-generation tracer. Ex. 1028, 6, see also id. at 2 (Figure 1 (lower formula)).” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,980,901
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.