- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Runergy Alabama Inc. / Runergy USA Inc. et al. v. Trina Solar Co., Ltd.All claims unpatentablePTAB · Apr 15, 2026 · IPR2025-00187 · APJ Debra L Dennett · IPR · Final written decision
Claims 1–17 are unpatentable under § 103, principally because Chang in view of Jin renders them obvious; the Jin/Feldmann grounds were not shown.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art would have been someone with an advanced degree involving the disciplines of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field. Alternatively, that person would have had a bachelor’s degree in electrical engineering, applied physics, or materials science, and at least three years of experience designing, developing, or researching in the field. Pet. 4 (citing Ex. 1003 ¶ 49).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 24. Patent Owner does not address claim construction. See generally Resp.; Sur-reply. For purposes of this Decision, we need not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11
- Expert testimonyPatent owner expert creditedDecided for patent owner
“gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 116 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide. Ex. 2001 ¶ 152 (referring to Ex. 2001 ¶¶ 149–151). Moreover, Dr. Peckerar testifies that “Dr. Banerjee also appears to be arguing that incorporation of impurities into the oxide will produce a MOSFET-like structure, with the contaminated oxide acting as a MOS gate leading to enhanced leakage,” but, for that to occur, “the source and drain areas would need to be of the same type.” Ex. 2001 ¶ 159. Here however, “the tunnel oxide layer is located between an n-type polysilicon layer and p-type frontside emitter layer” so “[n]o MOSFET-like structure can form because the source and drain are of different types.” Ex. 2001 ¶ 159. Neither Petitioner nor Dr. Banerjee address or dispute this testimony. See generally Reply; Ex. 1037. We credit Dr. Peckerar’s testimony in this regard. Without an apparent reason to modify the teachings of Jin and Feldmann to” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“On this complete trial record, we agree with Patent Owner. It is improper to base a conclusion of obviousness upon facts gleaned only through hindsight. “The invention must be viewed not after the blueprint has been drawn by the inventor, but as it would have been perceived in the state of the art that existed at the time the invention was made.” Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)). Therefore, “to establish a prima facie case of obviousness based on a combination of elements disclosed in the prior art, the [Petitioner] must articulate the basis on which it concludes that it would have been obvious to make the claimed invention.” Id. Impermissible hindsight is inferred when the specific understanding or principle within the knowledge of one of ordinary skill in the art that would motivate one (with no knowledge of the claimed invention) to make the proposed combination has not been explained. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998).” slip op. at 17
Patent outcomesUS 10,230,009 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,230,009 - Runergy Alabama Inc. / Runergy USA Inc. et al. v. Trina Solar Co., Ltd.All claims unpatentablePTAB · Apr 15, 2026 · IPR2025-00006 · APJ Debra L Dennett · IPR · Final written decision
Claims 1–17 are unpatentable under § 103, principally over Chang and Jin; the Board rejected the Jin and Feldmann combinations for lack of a reason to combine.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’009 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’009 patent and the prior art.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 24. Patent Owner does not address claim construction. See generally Resp.; Sur-reply. For purposes of this Decision, we need not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“However, Petitioner proposes to remove the tunnel oxide layer from the edge and offers little explanation of why the skilled artisan would apply Jin’s gap- T isolation region to both of Feldmann’s polysilicon and tunnel oxide layers. As noted above, Petitioner states that the skilled artisan would have included Jin’s gap-T isolation region in order to prevent shorting. Pet. 26. Petitioner’s reasoning is questionable—supported only by the conclusory testimony of Dr. Banerjee. Dr. Banerjee’s testimony offers no more evidentiary support than provided in the Petition. Compare Ex. 1003 ¶ 116 with Pet. 26). Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” See Magnum, 829 F.3d at 1380. We acknowledge Dr. Banerjee’s testimony that the combination of Jin’s gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 116 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide. Ex. 2001 ¶ 152 (referring to Ex. 2001 ¶¶ 149–151). Moreover, Dr. Peckerar testifies that “Dr. Banerjee also appears to be arguing that incorporation of impurities into the oxide will produce a MOSFET-like structure, with the contaminated oxide acting as a MOS gate leading to enhanced leakage,” but, for that to occur, “the source and drain areas would need to be of the same type.” Ex. 2001 ¶ 159. Here however, “the tunnel oxide layer is located between an n-type polysilicon layer and p-type frontside emitter layer” so “[n]o MOSFET-like structure can form because the source and drain are of different types.” Ex. 2001 ¶ 159. Neither Petitioner nor Dr. Banerjee address or dispute this testimony. See generally Reply; Ex. 1037. We credit Dr. Peckerar’s testimony in this regard.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“configuration in which the emitter area and back surface field area are not adjacent to each other, thus eliminating “the necessity of performing an isolation process when the emitter area [] and the back surface field are [] are formed to be adjacent to each other.” Resp. 42 (citing Ex. 1013 ¶ 76). In so doing, Patent Owner side steps Chang’s unambiguous definition that “‘entirely formed’ means that an element such as a layer is formed over an entire surface without an empty area or a non-coverage area, or is formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Ex. 1013 ¶¶ 45, 51, 56, 62 (emphasis added). Chang discloses that a first tunneling layer, a first portion of an emitter area, a second tunneling layer, and a back surface field area may each be “formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Id. Chang’s definition of “entirely formed” (“excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like”) implies use of a mask. See Chang ¶ 62; Tr. 15:20–17:11. Dr. Banerjee testifies that the need to electrically isolate the emitter region from the back surface field was well known in the field, and both Chang and Jin teach backside isolation regions. Ex. 1003 ¶¶ 73, 217 (citing Ex. 1023 § 1). Chang also discloses that the emitter area may be formed by thermal diffusion, ion implantation or the like. Ex. 1013 ¶ 98. Petitioner persuasively argues that Chang’s disclosure of thermal diffusion of the emitter layer would result in dopants diffused into not only the top surface of the substrate, but also the exposed lateral surfaces, a problem also noted in Jin. See Pet. 11–12; Reply 6–7; Ex. 1003 ¶ 71; Ex. 1009 ¶¶ 57–58. Jin discloses avoiding shorting of the emitter layer and back surface field layer by edge isolation on the back surface field layer using a mask to create a “gap-T.” Ex. 1009 ¶¶ 57–58, 83. Chang discloses excluding a tunneling layer and a base surface field area from periphery region and isolation region. Ex. 1013 ¶¶ 56, 62. Using a mask, as implied in Chang and explicitly disclosed in Jin, would “pre-designate” and/or “inevitably form” the regions where the tunneling layer and back surface field area are excluded. We credit Dr. Banerjee’s testimony that one of ordinary skill in the art reviewing Chang would therefore understand the importance of implementing the isolation region in Chang’s device, and would therefore be motivated to look to other references, such as Jin (which was assigned to the same original assignee as Chang, LG Electronics, EX1009-Jin, face; EX1013-Chang, face) to understand details regarding Chang’s isolation region.” slip op. at 32
Patent outcomesUS 10,230,009 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,230,009 - Runergy Alabama Inc. / Runergy USA Inc. et al. v. Trina Solar Co., Ltd.All claims unpatentablePTAB · Apr 15, 2026 · IPR2025-00918 · APJ Avelyn M Ross · IPR · Final written decision
Claims 1–11 are unpatentable under § 103 over Chang and Jin; the Board rejected the Jin and Feldmann based grounds for lack of a reason to combine without hindsight.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art would have been someone with an advanced degree involving the disciplines of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field. Alternatively, that person would have had a bachelor’s degree in electrical engineering, applied physics, or materials science, and at least three years of experience designing, developing, or researching in the field.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 23. And, Patent Owner does not address claim construction. See generally PO Resp. As neither party proposes an express construction for our consideration and because we determine that an express claim construction is not necessary for us to render a decision in this matter, we do not construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“base a conclusion of obviousness upon facts gleaned only through hindsight. “The invention must be viewed not after the blueprint has been drawn by the inventor, but as it would have been perceived in the state of the art that existed at the time the invention was made.” Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)). Therefore, “to establish a prima facie case of obviousness based on a combination of elements disclosed in the prior art, the [Petitioner] must articulate the basis on which it concludes that it would have been obvious to make the claimed invention.” Id. Impermissible hindsight is inferred when the specific understanding or principle within the knowledge of one of ordinary skill in the art that would motivate one (with no knowledge of the claimed invention) to make the proposed combination has not been explained. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Patent Owner focuses on Chang’s description in paragraph 76 of a single configuration in which the emitter area and back surface field area are not adjacent to each other, thus eliminating “the necessity of performing an isolation process when the emitter area [] and the back surface field are [] are formed to be adjacent to each other.” PO Resp. 42–43 (citing Ex. 1013 ¶ 76). But, in so doing, Patent Owner side steps Chang’s unambiguous definition that “‘entirely formed’ means that an element such as a layer is formed over an entire surface without an empty area or a non-coverage area, or is formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Ex. 1013 ¶¶ 45, 51, 56, 62 (emphasis added). Chang discloses that a first tunneling layer, a first portion of an emitter area, a second tunneling layer, and a back surface field area may each be “formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Ex. 1013 ¶¶ 45, 51, 56, 62. Chang’s definition of “entirely formed” (“excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like”) implies use of a mask. See Ex. 1013 ¶ 62; Tr. 15:20– 17:11. Dr. Banerjee testifies that the need to electrically isolate the emitter region from the back surface field was well known in the field, and both Chang and Jin teach backside isolation regions. Ex. 1003 ¶¶ 70–81, 91–96, 200 (citing Ex. 1026 § 1 and stating that “[b]oth Chang and Jin likewise teach backside isolation regions”). Chang also discloses that the emitter area may be formed by “thermal diffusion, ion implantation or the like.” Ex. 1013 ¶ 98. Petitioner persuasively argues that Chang’s disclosure of thermal diffusion of the emitter layer would result in dopants diffused into not only the top surface of the substrate, but also the exposed lateral surfaces, a problem also noted in Jin. See Pet. 11–12; Pet. Reply 6–7; Ex. 1003 ¶ 71; Ex. 1009 ¶¶ 57–58. Jin discloses avoiding shorting of the emitter layer and back surface field layer by edge isolation on the back surface field layer using a mask to create a “gap-T.” Ex. 1009 ¶¶ 57–58, 83. Chang discloses excluding the second tunneling layer and a base surface field area from periphery region and isolation portion. Ex. 1013 ¶¶ 56, 62. Using a mask, as implied in Chang and explicitly disclosed in Jin, would “pre-designate” and/or “inevitably form” the regions where the tunneling layer and back surface field area are excluded. We credit Dr. Banerjee’s testimony that one of ordinary skill in the art “reviewing Chang would therefore understand the importance of implementing the isolation region in Chang’s device, and would therefore be motivated to look to other references, such as Jin (which was assigned to the same original assignee as Chang, LG Electronics, EX1009-Jin, face; EX1013-Chang, face) to understand details regarding Chang’s isolation region.” Ex. 1003 ¶ 201.” slip op. at 33
Patent outcomesUS 9,722,104 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,722,104 - Runergy Alabama Inc. / Runergy USA Inc. et al. v. Trina Solar Co., Ltd.All claims unpatentablePTAB · Apr 15, 2026 · IPR2025-00007 · APJ Avelyn M Ross · IPR · Final written decision
Claims 1–11 are unpatentable under §103 over Chang and Jin because the combination teaches the claimed isolation portion and the claimed tapering.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“Petitioner contends that a person of ordinary skill in the art would have been someone with an advanced degree involving the disciplines of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field. Alternatively, that person would have had a bachelor’s degree in electrical engineering, applied physics, or materials science, and at least three years of experience designing, developing, or researching in the field. Pet. 4 (citing Ex. 1003 ¶ 49). Patent Owner does not address the level of ordinary skill in the art. See generally PO Resp; Sur-reply. In light of the complete trial record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’104 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’104 patent and the prior art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 23. And, Patent Owner does not address claim construction. See generally PO Resp. As neither party proposes an express construction for our consideration and because we determine that an express claim construction is not necessary for us to render a decision in this matter, we do not construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightTeaching away not foundNot shown unpatentable
“On this complete trial record, we agree with Patent Owner. It is improper to base a conclusion of obviousness upon facts gleaned only through hindsight. “The invention must be viewed not after the blueprint has been drawn by the inventor, but as it would have been perceived in the state of the art that existed at the time the invention was made.” Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)). Therefore, “to establish a prima facie case of obviousness based on a combination of elements disclosed in the prior art, the [Petitioner] must articulate the basis on which it concludes that it would have been obvious to make the claimed invention.” Id. Impermissible hindsight is inferred when the specific understanding or principle within the knowledge of one of ordinary skill in the art that would motivate one (with no knowledge of the claimed invention) to make the proposed combination has not been explained. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998).” slip op. at 16
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“However, Petitioner proposes to remove the tunnel oxide layer from the edge and offers little explanation of why the skilled artisan would apply Jin’s gap- T isolation region to both of Feldmann’s polysilicon and tunnel oxide layers. As noted above, Petitioner states that the skilled artisan would have included Jin’s gap-T isolation region in order to prevent shorting. Pet. 25. Petitioner’s reasoning is questionable—supported only by the conclusory testimony of Dr. Banerjee. Dr. Banerjee’s testimony offers no more evidentiary support than provided in the Petition. Compare Ex. 1003 ¶ 113, with Pet. 25. Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” Magnum Oil, 829 F.3d at 1380. We acknowledge Dr. Banerjee’s testimony that the combination of Jin’s gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 113 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide.” slip op. at 18
Patent outcomesUS 9,722,104 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,722,104 - Deltran USA LLC v. The Noco CompanyAll claims unpatentablePTAB · Mar 13, 2026 · IPR2025-00885 · APJ Avelyn M Ross · IPR · Final written decision
Claims 1–11 are unpatentable under Richardson-based obviousness grounds; the Yu and Paparrizos grounds do not establish unpatentability.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art, “[a]s of the claimed priority date of July 3, 2014, . . . would have been a person with a bachelor’s degree in electrical engineering or its equivalent and two years of experience in the field of electrical engineering including some experience in design of battery charging systems.” Pet. 21 (citing Ex. 1003 ¶¶ 19–30). Patent Owner “does not propose a different level of skill in the art[.]” PO Resp. 16. In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art, because it is supported by the testimony of C. Arthur MacCarley and not disputed by Patent Owner.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“As neither party proposes an express construction for our consideration and because we determine that claim construction is not necessary, we do not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11
- PTAB / AIA Trials › §315(e) estoppelNot reached
“arguments relating to whether the prior findings are “necessary to the determination” or whether estoppel applies to arguments relating to Richardson being inoperative. See Pet. Reply 27. Nor does Petitioner respond to our inquiry about whether collateral estoppel maybe applied on a limitation by limitation basis. See Pet. Reply 27. At the hearing, however, Petitioner confirmed that resolution of the issue is not necessary to our final determination. JUDGE ROSS: Do we even need to decide the collateral estoppel issue? I mean, it seems to me that if your petition clearly made out your case for the combination of Richardson and Zhao, then we don't even need to reach that. MR. CHANDRA: That’s exactly right, Your Honor. That is our position, as well. We believe collateral estoppel applies, but you don't need to decide that issue in order to find these claims unpatentable. As I mentioned before, these are the same references. We have fairly sought out all of the portions of Richardson, we cited to specific portions. Not just relying on collateral estoppel, but the teachings of the reference itself. So, while this is an issue, we believe that collateral estoppel should apply. It does not have to apply in order to find the challenged claims unpatentable. Tr. 19:9–20. We are persuaded, as discussed in Section II.G., that Petitioner has shown where Richardson in combination with Zhao meets each limitation of the claims of the ’203 patent. Accordingly, we need not address whether Petitioner has demonstrated sufficiently that collateral estoppel applies here.” slip op. at 14
- Strike new argumentNew argument consideredOther
“Our Practice Guide states, that “[o]nce a trial is instituted, the Board may decline to consider arguments set forth in a preliminary response unless they are raised in the patent owner response.” Consolidated Trial Practice Guide (“Practice Guide”), 52 (Nov. 2019) (citing In re Nuvasive, Inc., 842 F.3d 1376, 1381 (Fed. Cir. 2016) (explaining that a patent owner waives an issue presented in its preliminary response if it fails to renew the issue in its response after trial is instituted)).12 In addition, in our Scheduling Order, we stated that “Patent Owner is cautioned that any arguments not raised in the response may be deemed waived.” Paper 9 at 10; see also Practice Guide, 94 (same). Patent Owner confirmed at the Oral Hearing its understanding that arguments raised in its Preliminary Response and not reasserted in its Patent Owner Response were not appropriate for consideration during trial. Tr. 4:10–6:17. Petitioner does not identify any particular argument raised in the Patent Owner Preliminary Response that is not present in the Patent Owner Response. But, in this Final Written Decision, we do not consider arguments made in the Patent Owner Preliminary Response and instead assess only those fairly presented in the Patent Owner Response.” slip op. at 15
Patent outcomesUS 11,667,203 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,667,203 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 10, 2026 · IPR2024-01209 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–27 are unpatentable as obvious over the asserted combinations, principally Racz, Fitz, and Lee; both parties’ motions to exclude are dismissed as moot.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“PO Resp. 30 (citing Ex. 2006 ¶ 58). Patent Owner’s proposal is too narrow in two respects. First, it mandates certain education and experience in RF neurotomy specifically. This is too narrow as the description of the scope of the invention set forth in the ’782 patent as described above is not limited to RF neurotomy. Second, it requires the POSA to be both a physician who performs thermal ablation (RF neurotomy specifically) and an engineer with training and experience “in the design and development of devices and methods” for performing the same. Id. This is too narrow because it excludes physicians and other advanced degree holders who research and design devices and methods for performing thermal ablation but do not actually operate on patients. We adopt the Petitioner’s definition of a POSA, quoted above, as it is reflective of the level of skill in the art when viewed in light of the disclosure of the ’782 patent. Supra (quoting Pet. 11).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 12 (citing Ex. 1031 ¶106 (Dr. Robert D. Tucker’s11 testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 12. We likewise find no need to do so now, as neither party has proposed a construction for any claim term and none of the parties’ arguments turns on a disputed meaning of any claim language.” slip op. at 11
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“(Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Clay, 966 F.2d at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 34. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 18.” slip op. at 24
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 148 of his declaration. Ex. 1031 ¶148. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶110–117 (Racz), ¶¶118–123 (Fitz), ¶¶124–131 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶132–147). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he has “been a Professor at the University of Iowa where [he] direct[s] an active research program in radiofrequency electrosurgical procedures and instrumentation.” Ex. 1031 ¶3. He has a Ph.D. in biophysics, and he is also a medical doctor (albeit he is not Board certified as pointed out by Patent Owner19). Id. ¶2. He also has additional training and experience that is relevant, but which is not necessary, but further establishes that he is well qualified to offer the opinions set forth in his declaration. Id. ¶¶2–11. Patent Owner argues that Dr. Tucker is not qualified to testify here because “he is not Board certified” and he is “not a pain-specialist physician and has never performed a neurotomy.” PO Resp. 30. Dr. Tucker explained, however, that he is not Board certified nor does he operate on 19 See PO Resp. 30 (citing Ex. 2020, 10:19–12:20). patients because his work focuses on the development of instrumentation, not the use of it, explaining on cross-examination:” slip op. at 39
Patent outcomesUS 10,966,782 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,966,782 - R.J. Reynolds Vapor Company v. Healthier Choices Management Corp.All claims unpatentablePTAB · Mar 9, 2026 · IPR2024-01458 · APJ Kristina M Kalan · IPR · Final written decision
Claims 1, 7, 8, and 11 are unpatentable as obvious over Lee-based combinations; the Gilbert-based grounds did not establish unpatentability.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 15 (citing Ex. 1003 ¶ 18). Petitioner further argues a “POSA would have been familiar with electrically powered cigarettes and their components and underlying technologies or similar components and technologies.” Id. “For the purposes of this Response,” Patent Owner “does not dispute Petitioner’s proposed level of skill in the art.” Resp. 17. On this complete record, we adopt Petitioner’s unopposed definition because it appears consistent with the’788 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner states that “Petitioner and [Petitioner’s declarant] Mr. Kodama interpret the meaning of the claims based on [Patent Owner’s] construction of the claims by its allegations of infringement in the ongoing litigation.” Resp. 18. Patent Owner further states that for “the purposes of this response,” it “agrees on how the claims are to be construed.” Id. Upon review of the record, we determine that no claim terms require express construction. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“the combination of proposed references would operate. As shown in Petitioner’s proposed modification, the Gilbert bulb would have been modified to fit the Lee device. Pet. 57 (annotated Figure); Ex. 1003 ¶ 123 (stating that the combination would work “by merely replacing [Lee’s] heating element (133) with this bulb heater inside of the vaporization unit (14)” and the “bulb heater could be connected to [Lee’s] electric circuit board (111) and battery assembly (11) in a very similar fashion to the nichrome wire heater represented in Lee”); Reply 29–30 (explaining Petitioner’s annotated figure wherein “the fiber rod is not encapsulated inside the bulb”); Ex. 1026 ¶¶ 29–30 (clarifying how the fiber in Petitioner’s proposed combination from its annotated Figure in the Petition extends to, and makes contact with, the outside of the bulb, putting the fluid into direct contact with the bulb; explaining various simple ways a POSA would understand to accomplish this). We credit Petitioner’s proposal and Mr. Kodama’s testimony in this regard. Therefore, we agree that Lee would not have to be “significantly modified or reimagined” as alleged by Patent Owner, nor would the inclusion of a bulb in the Lee device “render Lee inoperable” in view of the modifications to the Gilbert bulb included in Lee, as proposed by Petitioner. Resp. 30–31.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“art would not have combined Lee and Gilbert or Levin, particularly with respect to element [1d], we are persuaded by Petitioner’s arguments that one of ordinary skill in the art would have been motivated to make the combination with a reasonable expectation of success. Petitioner states that the motivation to make the combination would have come from issues “with e-cigarettes at the time, such as metallic taste issues or inhalation risks associated with the use of a metal wire heating element,” and would have explored “heat conducting materials that could vaporize the nicotine liquid without making direct contact with the heating wire.” Pet. 57 (citing Ex. 1003 ¶ 117 (discussing the metallic flavor “dry hit” problem)); see also Reply 18–19. Additionally, Petitioner argues that one of ordinary skill in the art would have implemented “a heating element within a glass bulb to increase the life of the heating element and prevent failure of a device.” Id. at 57–58 (citing Ex. 1009 ¶ 4; Ex. 1003 ¶ 119), 59 (a “POSA would have been motivated to implement a heating element within a glass bulb like that described in Levin for all of the reasons described above” in connection with Gilbert). Petitioner depicts one example of how its proposed combination would incorporate the Gilbert bulb into the Lee device. Pet. 57 (citing Ex. 1003 ¶ 118)). Petitioner additionally relies on Levin’s disclosure that using a bulb will “allow for a consistent and reliable heat source” and “achieve a desired operating temperature when compared to conventional devices.” Id. at 59 (citing Ex. 1009 ¶¶ 56, 49). Mr. Kodama also notes the age and ubiquity of bulb heaters, credibly testifying that “a POSA would have been motivated to implement a bulb heater in the Lee device, and, due at least to the ubiquitous nature of such heaters, the implementation of such a heater would have been well within the knowledge and skill of a POSA.” Pet. 59; Reply 20; Ex. 1003 ¶¶ 39–48, 123. Petitioner also provides sufficient explanation as to “how” and “why” the combination of proposed references would operate. As shown in Petitioner’s proposed modification, the Gilbert bulb would have been modified to fit the Lee device. Pet. 57 (annotated Figure); Ex. 1003 ¶ 123 (stating that the combination would work “by merely replacing [Lee’s] heating element (133) with this bulb heater inside of the vaporization unit (14)” and the “bulb heater could be connected to [Lee’s] electric circuit board (111) and battery assembly (11) in a very similar fashion to the nichrome wire heater represented in Lee”); Reply 29–30 (explaining Petitioner’s annotated figure wherein “the fiber rod is not encapsulated inside the bulb”); Ex. 1026 ¶¶ 29–30 (clarifying how the fiber in Petitioner’s proposed combination from its annotated Figure in the Petition extends to, and makes contact with, the outside of the bulb, putting the fluid into direct contact with the bulb; explaining various simple ways a POSA would understand to accomplish this). We credit Petitioner’s proposal and Mr. Kodama’s testimony in this regard. Therefore, we agree that Lee would not have to be “significantly modified or reimagined” as alleged by Patent Owner, nor would the inclusion of a bulb in the Lee device “render Lee inoperable” in view of the modifications to the Gilbert bulb included in Lee, as proposed by Petitioner. Resp. 30–31.” slip op. at 24
Patent outcomesUS 9,538,788 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,538,788 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 6, 2026 · IPR2024-01211 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 18–47 and 53–74 are unpatentable as obvious over the asserted combinations of Racz, Fitz, Lee, and the additional references in Grounds 2–8.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 17
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 162 of his declaration. Ex. 1033 ¶162. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶124–131 (Racz), ¶¶132–137 (Fitz), ¶¶138–145 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶146–161). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he” slip op. at 39
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“35. “Although § 103 does not, by its terms, define the ‘art to which [the] subject matter [sought to be patented] pertains,’ this determination is frequently couched in terms of whether the art is analogous or not, i.e., whether the art is ‘too remote to be treated as prior art.’” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 33. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 17.” slip op. at 25
- BurdenDecided for petitioner
“Patent Owner does not identify any legal requirement for petitions to illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 28
Patent outcomesUS 10,736,688 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,736,688
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.