- Symrise AG / Symrise Inc. v. Inolex Investment CorporationAll claims unpatentablePTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision
The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “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 took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“2. Analysis A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said claimed invention pertains. See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23
Patent outcomesUS 10,995,048 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,995,048 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Aug 20, 2024 · IPR2024-00463 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 2–6, 8, 9, 13–16, and 18, finding a reasonable likelihood that at least claims 2, 8, and 13 are anticipated by Mehta.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Videndum, at 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint submissions of Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 8–10), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus,” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We agree with Jeisys. Mehta is not substantially the same as Mehta ’705. What Mehta ’705 omits, but Mehta includes, is an embodiment comprising “graphical user interface 320” and “tissue characteristic indicator 350” that allows a user to monitor the needle’s “location” in the tissue so as to decide when the needle is placed at a “desired depth.” Ex. 1006, 32:46– 13 US 8,540,705 B2, issued Sep. 24, 2013 (Ex. 1011). 14 Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). 33:29, Figs 10A–10F. Nowhere do we discern a similar embodiment in Mehta ’705. At best, Mehta ’705 discloses a “display screen” for displaying a “variety of information to the physician . . . such as treatment delivery settings, electrode impedance, electrode temperature, tissue temperature, treatment duration, power delivered, energy delivered, etc.” Ex. 1011 (Mehta ’705), 29:44–58, Figs. 10A, 10B. But, notably lacking from Mehta ’705 is any disclosure of determining the “depth” and “location” of the needle’s placement in the tissue, let alone means for doing so, which Mehta discusses at length and upon which Jeisys relies to meet the “desired distance” limitation. See Ex. 1006, 32:46–33:61; Pet. 27–28. Because Mehta includes disclosure relevant to the disputed “desired distance” limitation that is absent from Mehta ’705, Serendia fails to satisfy the first part of the Advanced Bionics framework. See Wolfspeed, Inc. v. The Tr. of Purdue Univ., IPR2022-00761, Paper 13, at 7–8 (PTAB Mar. 30, 2023) (Vidal, K.) (reference not “substantially the same prior art” when it includes disclosure relevant to unpatentability grounds not present in references previously before the Office). And to the extent Serendia makes a similar argument with respect to the asserted secondary references of Na, Lee, and Livneh, it is of no consequence given Serendia’s failed showing with respect to the primary reference of Mehta.15 Thus, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 11
- Skill levelSkill level petitioner adoptedOther
“Jeisys proposes, and Serendia agrees, that we should adopt the level of ordinary skill in the art as defined in the parallel ITC proceeding, that is, (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 11 (citing Ex. 1005, at 14); Prelim. Resp. 33 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we see no reason to depart from that definition, as it appears consistent with the level reflected in the asserted prior art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the plain language of the claims limits their scope to extendable needles (as opposed to fixed needles), and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,869,812 - PTAB · Jul 26, 2024 · IPR2024-00459 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 over all six asserted obviousness grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 325(d) and 314(a).
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). Upon considering the arguments 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 and we decline to exercise our discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d). Accordingly, we institute an inter partes review of the challenged claims of the ’781 Patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Owner, a POSA would have had “a doctoral degree in medicine, chemistry, biochemistry, biology, or a related field and 1–2 years of experience in the processing and analysis of biological samples, including fecal samples.” Id. at 47 (citing Ex. 2001 ¶ 43). Patent Owner also indicates that such a person could have been an individual or a member of a team of scientists addressing fecal sample processing and analysis. Id. Patent Owner notes that Petitioner’s proposal in the Petition is significantly different from the proposal in its ex parte reexamination request, which merely required a bachelor’s degree and several years of experience processing biological samples. Id. at 46; Ex. 1021, 7.8 Patent Owner also contends that the level of skill set forth in the Petition requires an extraordinary level of skill within an overly narrow focus. Prelim. Resp. 47. Regardless, Patent Owner states that its expert, Dr. Backman, is a person of at least ordinary skill and the claims of the ’781 Patent would not have been obvious under any of the parties’ proposed definitions of the level of ordinary skill in the art.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“At this stage of the proceeding, we agree with the parties that no construction of any claim term is necessary for purposes of our Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). C.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“shown sufficiently that a POSA would have had a reason to modify the assay of Lenhard to combine Vilkin’s iFOBT and Itzkowitz’s collection process and DNA stabilization buffer with a reasonable expectation of success. Lenhard expressly states that “[t]he combination of [HIC1 methylation analysis with gFOBT] resulted in increased detection rates for CRCs” and includes data that supports this statement. See Ex. 1004, 147, 146 (Table 4); see also id. at 143 (“The combination of HIC1 methylation analysis with FOBT allowed for the detection of two thirds of CRCs.”). We find these positive statements and supporting data in Lenhard are sufficient to provide a “rational underpinning” to combine the gFOBT and DNA test at this stage of the proceeding. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, we are persuaded on this record that Vilkin’s explanation of the benefits of iFOBT over gFOBT provide a reason to replace Lenhard’s gFOBT with Vilkin’s iFOBT assay. See Ex. 1005, 2519. And we agree at improve Lenhard’s assay by requiring a patient to directly defecate into a sealable container and add a stabilization buffer to the sample so it could be shipped to a laboratory without freezing, as described in Itzkowitz. See Ex. 1002 ¶¶ 148–158.” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,634,781 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Jul 23, 2024 · IPR2024-00384 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 1–8 and 11–18 after finding a reasonable likelihood that claim 11 is anticipated by Mehta.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Videndum, at 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint submissions by Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 10– 11), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus,” slip op. at 8
- Skill levelSkill level board ownOther
“Jeisys proposes, and Serendia agrees, that one of ordinary skill in the relevant art would have had (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 14–15 (citing Ex. 1003 ¶ 50); see also Prelim. Resp. 32 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the plain language of the claims limits their scope to “extendable” needles, and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We disagree with Serendia’s analysis of Mehta. As Jeisys correctly explains, Mehta discloses the “desired distance” limitation even assuming Serendia’s construction of that limitation, i.e., that the needles are extendable to a depth selected by the user. See Pet. 33. Indeed, although Mehta may not use the term “desired distance” expressly, it comes about as close as one would expect from an anticipatory disclosure. For example, as Jeisys notes, Mehta discloses an embodiment that includes “depth markings” on the needles (i.e., probes) that allow the user to determine a desired depth of the needles— The electrodes of the probe array can also include any number of visually distinguishing features (e.g., depth markings, colors, shades, etc.) that enable a physician to observe proper placement. . . . This ensures that the probe is not driven too far into tissue. Alternatively, the probe can be marked with one or more features that allow the physician to determine the depth of insertion of the probe. Id. (citing Ex. 1004, 13:37–45 (emphases added)). Notably, as Jeisys also explains, Mehta discloses another embodiment, depicted in Figures 10A–F, having a graphical user interface 320 (“GUI”) that displays the actual and target depths of needles so as to avoid placement of the needles in an undesired region. See id. at 32–34 (citing Ex. 1004, 10:38–39, 12:5–8, 32:63–33:43; Ex. 1003 ¶¶ 101–104). The GUI, as described, “can provide information for a physician (or other medical staff) to monitor various treatment parameters as well as other information regarding the placement of the array 108 or probes 104 when inserted in the tissue” and “maintain visual contact with the treatment device and tissue being treated.” Ex. 1004, 11:1–13. To do so, the GUI incorporates a “tissue characteristic indicator (whether visual, virtual, audible, or other feedback)” that allows the user to monitor the needle’s actual location in the tissue and advance the needle a desired distance for providing treatment— FIG. 10B illustrates a tissue characteristic indicator showing a virtual depiction 350 of the depth or location of the probe array. . . . [T]he virtual depth/location depiction 350 can illustrate an actual placement of the probe array 340. . . . [T]he system can be configured to show (or the system can have an option to show) additional probe array information. For example, the virtual depth/location depiction 350 can also show a desired probe location (e.g., array 342 can represent the desired depth of placement for providing a treatment). . . . As shown by FIG. 10B, providing the virtual depth/location depiction 350 allows the physician to not only identify whether the array is located within the desired tissue layer but also allows the physician to observe the angle of the electrode array in tissue. . . . Therefore, the physician would be informed that further advancement of the probes is necessary to place the probes within the second layer 326 (which corresponds to the dermal layer). Id. at 32:46–33:29 (emphases added); see also id. at 33:57–66 (further describing “virtual depth/location depiction 350”).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,320,536 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Jul 22, 2024 · IPR2024-00383 · APJ Carl M Defranco · IPR · Institution
The Board instituted IPR on claims 13 and 14, finding a reasonable likelihood that Mehta anticipates them.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“At the outset, we note that the Director’s decisions in Ford and Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” See Videndum, Paper 12, 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint invalidity defense of Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 9–10), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus, does not alone create the type of “significant relationship” contemplated by Valve. See Pet. Reply 2–3 (citing Ford, at 3; Exs. 1028, 1029); see also Prime Time Toys LLC v. Spin Master, Inc., IPR 2023-01339, Paper 12, at 19–20 (Vidal July 9, 2024) (“Prime Time Toys”) (“The parties’ collaboration as co-respondents in the ITC investigation does not by itself support a finding of a “significant relationship.”). As such, Jeisys’s knowledge of the prior art asserted in the ITC proceeding and its collaboration with Cartessa on a joint invalidity defense does not create a significant relationship where such knowledge and collaboration arises from the rules of the ITC proceeding itself.” slip op. at 8
- Skill levelSkill level board ownOther
“Jeisys proposes, and Serendia agrees, that one of ordinary skill in the relevant art would have had (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 14–15 (citing Ex. 1003 ¶ 48); see also Prelim. Resp. 33 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the language of the claims limits the scope of claims 13 and 14 to “extendable” needles, and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We disagree with Serendia’s analysis of Mehta. As Jeisys correctly explains, Mehta discloses the “desired distance” limitation even assuming Serendia’s construction of that limitation, i.e., that the needles are extendable to a depth selected by the user. See Pet. 26–27. Indeed, although Mehta may not use the term “desired distance” expressly, it comes about as close as one would expect from an anticipatory disclosure. For example, as Jeisys notes, Mehta discloses an embodiment that includes “depth markings” on the needles (i.e., probes) that allow the user to determine a desired depth of the needles— The electrodes of the probe array can also include any number of visually distinguishing features (e.g., depth markings, colors, shades, etc.) that enable a physician to observe proper placement. . . . This ensures that the probe is not driven too far into tissue. Alternatively, the probe can be marked with one or more features that allow the physician to determine the depth of insertion of the probe.” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,775,774 - PTAB · Jun 24, 2024 · IPR2024-00313 · APJ Tawen Chang · IPR · Institution
The Board instituted review of claims 1–54 on all three obviousness grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot reached
“Under our precedent, where there is no time bar or estoppel implication with respect to alleged unnamed real parties-in-interest, the Board need not address, for the purposes of institution, whether such parties should be so named. SharkNinja Operating LLC v. iRobot Corp., IPR2020- 00734, Paper 11, 18–20 (PTAB Oct. 6, 2020) (precedential) (“SharkNinja”). In this case, Patent Owner has not alleged that either Lin BioScience or Belite Bio is barred or estopped from this proceeding. Patent Owner suggests that “Belite Bio’s status as a publicly traded company with a vested interest in the outcome of this Petition, and the Petition’s failure to disclose Belite Bio as a [real party-in-interest,] raise concerns about its motivations.” Prelim. Resp. 75. However, Patent Owner has not pointed to any evidence tending to show beyond speculation that Petitioner purposefully omitted these parties to gain an unfair advantage. SharkNinja at 19. Accordingly, on this record, we will not consider whether Lin BioScience and Belite Bio must be named as real parties-in-interest and” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had an advanced degree (e.g., Ph.D., M.D., M.S., or equivalent), in chemistry, biochemistry, pharmaceutical science, medicine, or a related field. This individual may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration. Moreover, skilled artisans would have had practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect, including the patents and publications discussed herein.” slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“First, the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a compound for a specific purpose (i.e., treating a macular degeneration), and the method comprises a single step of administering that compound in an 30 effective amount, the Federal Circuit “[has] generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. Moreover, “[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003); see also Eli Lilly & Co., 8 F.4th at 1341. In this case, claim 28 recites “[a] method of treating a macular degeneration, comprising administering an effective amount of a substituted C20-D1-3-retionoid to a patient in need thereof.” The preamble of “treating a macular degeneration” is necessary to understand the patients to whom the substituted C20-D1-3-retionoid should be administered; thus, it limits the claim. See Eli Lilly & Co., 8 F.4th at 1341–42 (citing Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1332–33 (Fed. Cir. 2003)); Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (holding the preamble to be limiting in a claim directed to “[a] method for treatment of sleep apneas comprising administration of a therapeutically effective amount of a [recited] compound . . . to a patient in need of such treatment,” because otherwise “the phrase ‘to a patient in need of such treatment’ would not have a proper antecedent basis”). Thus, we construe the preamble of claim 28 as limiting and give patentable weight to the phrase “method of treating a macular degeneration.” To the extent either party disagrees with our construction, the parties are welcome to further address this issue at trial.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The Petition points to Mata’s express suggestion of “‘[p]harmacologic inhibition of one or more steps in the A2E synthetic pathway’ as ‘an effective treatment strategy for other macular degenerations associated with lipofuscin accumulation.’” Pet. 31 (quoting Ex. 1010, 7159) (alteration in original). The Petition, again relying on Dr. Guengerich’s testimony, further explains Mata taught that deprotonation at C-20 of retinal — involving cleavage of a carbon-hydrogen bond — was “a pre-requisite for undesirable A2E formation,” and that a skilled artisan “would have recognized that this deprotonation likely was a rate-limiting step in A2E formation” such that slowing the deprotonation “would slow A2E formation,” i.e., lower the production of a toxic reaction product. Id. at 41 (citing Ex. 1002 ¶¶ 259– 260). Moreover, although the evidence of record may suggest that, at least as of 1999, “there are no drugs on the market that contain deuterium in the molecule,” Ex. 1046, 85, left col., Petitioner has also provided evidence, for instance in the form of Dr. Calman’s testimony, that “there was significant interest in making deuterated versions of known therapeutics in order to slow rates of undesirable reactions.” Ex. 1004 ¶ 96; see also Pet. 15 (stating that “it was known before 2007 to . . . use deuterium to slow undesirable reaction”) (citing Ex. 1002 ¶ 123; Ex. 1004 ¶¶ 96–102). 18 Kushner et al., Pharmacological Uses and Perspectives of Heavy Water and Deuterated Compounds, 77 CANADIAN J. PHYSIOLOGY & PHARMACOLOGY 79 (1999) (Ex. 1046, “Kushner”). 37 Finally, we note that claim 1, at least, is not directed to a method of treating any particular disease, but only a method of retarding the accumulation of particular compounds (i.e., lipofuscin pigments). We are persuaded, at least at this stage of the proceeding and based on the present record, that Petitioner has shown sufficiently that a skilled artisan would have had a reason to use C20-deuterated vitamin-A in the manner suggested in the Petition, with a reasonable expectation of success, based on alleged similarities between the use of deuterated compounds in the claimed method and use of such compounds to, e.g., lower production of toxic metabolites.” slip op. at 37
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham - Symrise AG / Symrise Inc. v. Inolex Investment CorporationAdverse judgmentPTAB · Jun 24, 2024 · IPR2023-01439 · APJ Tina E Hulse · IPR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after it disclaimed all challenged claims: 1–7, 9–11, 24–26, 28, 29, 35, and 36.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 37 C.F.R. § 42.73(b), a party may request adverse judgment against itself at any time during a proceeding. The Board construes a “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial” as a request for adverse judgment. See 37 C.F.R. § 42.73(b)(2). Here, we instituted inter partes review of claims 1–7, 9–11, 24–26, 28, 29, 35, and 36 of the ’803 Patent, and Patent Owner has statutorily disclaimed each of those claims. See Ex. 3002. Accordingly, we consider Patent Owner’s disclaimer of the challenged claims as a request for adverse judgment, and we grant that request.” slip op. at 2
NonePatents in suitUS 10,882,803 - PTAB · Jun 24, 2024 · IPR2024-00312 · APJ Tina E Hulse · IPR · Institution
The Board instituted review of claims 1–28 on all 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
“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 ’432 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSA”) would have had “an advanced degree (e.g., Ph.D., M.D., M.S., or equivalent), in chemistry, biochemistry, pharmaceutical science, medicine, or a related field.” Pet. 7. Petitioner further contends that that POSA “may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration” and would have had “practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect.” Id. (citing Ex. 1002 ¶¶ 47–50; Ex. 1004 ¶¶ 38–40). 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” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“construction standard that would be used to construe claims in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that no construction is necessary for purposes of this decision. Petitioner also notes that the Specification confirms that the claim term “pharmaceutically acceptable carrier” “encompasses a wide variety of conventional carriers, including water, saline solution, corn oil, and starch.” Pet. 22 (citing Ex. 1001, 15:9–27; Ex. 1002 ¶¶ 26–30; Ex. 1004 ¶ 27). At this stage of the proceeding, we agree with Petitioner that no construction of any claim terms is necessary for purposes of our Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 foundInstituted
“Petitioner asserts that a POSA would have had a reason to combine Bergen and Furr with a reasonable expectation of success. Pet. 31–32. Specifically, Petitioner argues that a POSA would have understood by September 2007 that making use of Bergen’s deuterated compounds for biological studies would have involved formulation in a pharmaceutically acceptable carrier, as corroborated by Furr’s success in doing so. Id. (citing Ex. 1002 ¶¶ 225–226). Moreover, Petitioner asserts that a POSA would have had a reasonable expectation of success in making a pharmaceutical composition comprising the claimed C20-D3-retinol acetate and a pharmaceutically acceptable carrier because Bergen had already synthesized the retinoid and Furr had already formulated deuterated vitamin A retinoids in a pharmaceutical composition comprising a pharmaceutically acceptable carrier. Pet. 36–37 (citing Ex. 1002 ¶ 235). Accordingly, at this stage of the proceeding, having considered the arguments and evidence set forth in the Petition, we find Petitioner has shown a reasonable likelihood of prevailing on its assertion that Claims 1–4 would have been obvious in light of the combination of Bergen and Furr. See Pet. 24–26, 30–38; Ex. 1006, Abstract, 15–19; Ex. 1007, Abstract, 714; Ex. 1002 ¶¶ 191–216, 223–238; Ex. 1004 ¶¶ 127–144.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,486,432 - Candela Corporation v. Nikolai TankovichNo claims unpatentablePTAB · Jun 5, 2024 · IPR2023-00234 · APJ Sheridan K Snedden · IPR · Final written decision
The Board held claims 1–28 not shown unpatentable because the asserted combinations did not establish simultaneous delivery of overlapping and non-overlapping laser beams.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 19; Ex. 1002 ¶ 77. Patent Owner does not dispute this proposed level of skill, but offers that a “POSA may have alternatively held a degree in electrical engineering.” PO Resp. 10; Ex. 4–10, 13, 15–17. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record, and also consider Patent Owner’s additional proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed patent owner constructionDecided for patent owner
“In this case, the Specification is devoted to the teaching simultaneous delivery of multiple laser beams. The Specification begins by stating that “[t]here are no lasers or laser handpieces on the market today that can simultaneously deliver two or more wavelengths of laser energy in spacial, fractional form.” Ex. 1001, 1:12–14. The Specification explains that “laser treatment usually requires different modalities of energy in order [to] successfully treat the pathologies to which they are applied,” but that “the sequential application of multiple wavelengths of laser energy compromises the treatment.” Id. at 1:16–25. The Specification then continues to explain various problems associated with the sequential application of multiple wavelengths. Id. at 1:25–52. The Specification concludes its introduction as follows: What is needed in the art therefore is an effective laser therapy system that can simultaneously deliver multiple wavelengths of laser energy through the use of a single laser unit without producing interference between the wavelengths within the treated tissue.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“summarized above, we find Patent Owner to have the better position. In particular, we agree with Patent Owner that the combination of Hsia and Black fail to teach or suggest simultaneously delivering non-overlapping beams. The combination also fails to teach or suggest producing beam patterns that include both overlapping and non-overlapping beams. PO Resp. 34. To begin, while we recognize that Hsia discloses overlapping and non-overlapping treatment patterns, those patterns are achieved by the sequential delivery of laser beams as a user physically moves a single handpiece that delivers a single beam across the skin of a patient. Ex. 1004 ¶ 68, Figs. 8 and 9; Ex. 2001 ¶¶ 73–74. Black does not cure that deficiency as Black does not disclose treatment with non-overlapping beams. Ex. 2001 ¶ 99. Black discloses using a “refractive optics, mirror-based optical delivery device” for the simultaneous delivery of multiple overlapping laser beams. Ex. 1006 ¶¶ 12– 13. The beams align on an optical path and, using different laser beam parameters, deliver treatment at various depths within a combined beam path. Id. ¶¶ 54, 58–59. Thus, while Black may be characterized as creating overlapping beams, we do not find sufficient support for a finding that Black teaches or suggests creating non-overlapping beams for simultaneous delivery, and the claims require both. We also do not find sufficient support for Petitioner’s claim that a POSA would have found it obvious to combine Black and Hsia to simultaneously produce both overlapping beams and nonoverlapping beams, based on the disclosures in these references. See, e.g.,” slip op. at 31
- BurdenFwd all claims patentableNot shown unpatentable
“Claims Claims Not 35 U.S.C. § Reference(s)/ Claims Shown Shown Basis Unpatentable Unpatentable 1–28 103 Hsia, Black 1–28 Hsia, Black, 23 103 23 Negus Hsia, Black, 27, 28 103 27, 28 Altshuler Altshuler, 1–28 103 1–28 Black Altshuler, 23 103 23 Black, Negus Overall Outcome 1–28 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–28 of the ’481 patent are unpatentable; and” slip op. at 41
Patent outcomesUS 10,675,481 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,675,481 - 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
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.