- Shenzhen Tuozhu Technology Co., Ltd. v. Stratasys, Inc.No claims unpatentablePTAB · Jun 9, 2026 · IPR2025-00321 · APJ Christopher M Kaiser · IPR · Final written decision
The Board held claims 1, 2, 5–7, 9, 16, and 17 not unpatentable because the asserted combinations did not establish the required purge-tower teachings or prior-art status.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art “would have had (1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶¶ 14–16). Petitioner also argues that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 24. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. We adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’324 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“According to the ’713 patent, “[p]urge tower 24 itself may be . . . recycled or otherwise discarded as desired.” Ex. 1001, 8:27–28. This description provides some support for Patent Owner’s view, because a purge tower too intimately integrated with the part would be difficult or impossible to recycle or discard. This is further supported by the ’713 patent’s statement that “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Id. at 8:30–34. It also is supported by Dr. Hickner’s testimony that the ’713 patent “clearly shows . . . the 24 purge tower separated from the part” and that “the purge tower is a separate physical object.” Ex. 2016, 28:8–10, 64:1–9. On the other hand, there is evidence supporting Petitioner’s view that, as long as the purge tower is generally separate from the part and the support structure, it may still make contact with those portions of the print. As noted above, “purge tower 24 may be printed at any suitable location on build substrate 44 (i.e., at any location in the x-y build plane not occupied by 3D part 20 or support structure 22).” Ex. 1001, 8:30–34. This language does not exclude locations adjacent to or in contact with the part or the support structure. Thus, determine that a “purge tower,” as that term is used in the context of the ’713 patent, may not be an integrated portion of a printed part or support structure but need not be free of all contact with the printed part or support structure.” slip op. at 9
- BurdenNot shown unpatentable
“There is evidence of record to support both Petitioner’s view and Patent Owner’s view. On the record developed at trial, however, we cannot say that the preponderance of the evidence favors Petitioner, who bears the burden of proof. See 35 U.S.C. § 316(e). Accordingly, Petitioner has not shown by a preponderance of the evidence that KISSlicer teaches printing a layer of a purge tower each time the printer switches one extruder to the operating mode. Because proving the obviousness of claims 1 and 16 requires such a showing, Petitioner has not shown by a preponderance of the evidence that claims 1 and 16 would have been obvious over the combination of Priedeman and KISSlicer. 5. Analysis of Remaining Claims Claims 2, 6, 7, 9, and 17 all depend, directly or indirectly, from claim 1 or claim 16. Accordingly, they all include the limitations of either claim 1 or claim 16. Because, as discussed above, Petitioner has not shown that the combination of Priedeman and KISSlicer teaches or suggests all the limitations of claims 1 and 16, Petitioner also has not proven by a preponderance of the evidence that claims 2, 6, 7, 9, and 17 would have been obvious over that combination of references.” slip op. at 21
- Obviousness (§103) › Analogous artAnalogous artOther
“On the record developed at trial, we agree with Petitioner. According to several industry forum posts, people interested in three-dimensional printing located the website where KISSlicer was posted between February 2012 and April 2012. Ex. 1028, 1 (post discussing and directing others to KISSlicer on April 11, 2012); Ex. 1031, 1 (two posts discussing KISSlicer on March 16, 2012, and March 21, 2012); Ex. 1032, 1 (two posts discussing KISSlicer on February 11, 2012, and February 14, 2012). Thus, not only was it possible for people of ordinary skill in the art to locate KISSlicer; people of ordinary skill in the art actually did locate it. Accordingly, Petitioner has shown by a preponderance of the evidence that KISSlicer was publicly accessible.” slip op. at 19
Patent outcomesUS 9,421,713 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,421,713 - Adobe Inc. v. Jonathan E. JaffeNo claims unpatentablePTAB · Mar 4, 2026 · IPR2024-01352 · APJ Bach V Hoang · IPR · Final written decision
Claims 1–6 were not shown unpatentable under any asserted §103 ground because the references did not teach monitoring the physical coupling between the sensor and memory.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The Institution Decision adopted and applied Petitioner’s proposed level of ordinary skill because Petitioner’s “definition generally comports with the level of skill necessary to understand and implement the teachings” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“The parties present various claim construction arguments, disputing the meaning of three limitations recited in claim 1: “a sensor, which is tightly coupled to said memory”; “monitoring the integrity of the tight coupling between said memory and said sensor”; and “based on.” See Pet. 9–14; PO Resp. 5–12; Pet. Reply 4–9; PO Sur-reply 4–11. For purposes of this Decision, we do not need to discuss the construction of “based on.” 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)). As explained below, this Decision turns on whether Glass or Rieger discloses limitation [1c] reciting “monitoring the integrity of the tight coupling between said memory and said sensor.” Ex. 1001, 20:65–66; see infra §§ II.C.2, II.E.1, II.F. That limitation recites an element which overlaps with the earlier-recited limitation “a sensor, which is tightly coupled to said memory.” To reach our decision, we need only provide a limited discussion of two of the parties’ claim construction arguments. Our analysis follows.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“said integrity is compromised, then also providing an indication of said compromised integrity.” Ex. 1001, 20:65–21:2. Although Petitioner points out that the limitation does not expressly recite “‘specifically’ monitoring the tight coupling” (Pet. Reply 8), the structure of the clause suggests that the tight coupling is specifically monitored. At a high level, the limitation is straightforward in its recitation that the integrity being monitored is “of the tight coupling” (Ex. 1001, 20:65–66 (emphasis added)), plainly suggesting that the tight coupling is specifically monitored. More granularly, breaking the relevant clause down to its grammatical parts, the clause recites a gerund (“monitoring”) acting on a direct object (“the integrity”) which is modified by a prepositional phrase (“of the tight coupling”). Notably, the object of the preposition (“of”) is “the tight coupling.” Altogether, this reads that the integrity being monitored is specifically of the tight coupling. Also, the claim recites that “if said integrity is compromised, then also providing an indication of said compromised integrity.” Therefore, from the claim language we know that the “integrity” of the tight coupling is something that may be “compromised,” which is consistent with Patent Owner’s proposed construction of determining whether the physical coupling has been “accessed or disturbed.” Petitioner’s interpretation effectively inserts additional language into the limitation such that the limitation includes monitoring the integrity of a device containing or surrounding the tight coupling, such as a camera (or camera housing), e.g., “monitoring the integrity of a camera that includes the tight coupling.” But, because the plain reading and the structure of the limitation reads that it is specifically the tight coupling’s integrity—not another physical structure, like a camera—which is being monitored, a monitored is not consistent with the language of the claim. See PO Resp. 9 (arguing that “Petitioner’s construction is improper because the claim language explicitly requires monitoring the physical coupling between the memory and the sensor as opposed to some third structure” (emphasis omitted)).” slip op. at 17
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“package 50 does not specifically monitor the integrity of the coupling between Glass’s sensor and the memory and, instead, argues that Glass detects tampering of all “the components and interconnections contained in that packaging,” e.g., control logic 44, cropper 46, compressor 47, MUX 45, code generator 48, and the various interconnections between those components. See Pet. Reply 16; Ex. 1005, 5:13–41. As explained above, we construe “monitoring the integrity of the tight coupling between said memory and said sensor” to mean determining whether the physical 7 Petitioner does not assert that a person of ordinary skill in the art would have been motivated to modify Glass’s device in any way; Petitioner solely argues that Glass teaches limitation [1c], based on Petitioner’s proposed claim construction. See Pet. 30–32 (“Glass discloses this limitation.”); Pet. Reply 16–17 (“Glass and Rieger disclose the ‘monitoring’ step.”). disturbed, which specifically requires monitoring the physical coupling between the sensor and the memory. See supra § II.C.2. As we agree with Patent Owner that this limitation requires monitoring the physical coupling between the sensor and the memory, monitoring Glass’s tamper resistant package 50 does not teach or disclose “monitoring the integrity of the tight coupling between said memory and said sensor.” Accordingly, we determine that Petitioner fails to show that Glass teaches or suggests [1c] monitoring the integrity of the tight coupling between said memory and said sensor when said at least one internal and unique parameter is generated, and, if said integrity is compromised, then also providing an indication of said compromised integrity, as required by claim 1. Consequently, we determine that Petitioner has not shown, by a preponderance of the evidence, that the subject matter of claim 1 would have been obvious over Glass.8” slip op. at 30
Patent outcomesUS 6,757,828 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,757,828 - Champion Laboratories, Inc. / First Brands Group, LLC v. Hengst SENo claims unpatentablePTAB · Sep 8, 2025 · IPR2024-00603 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1, 3, 5, 8–11, 15–17, 19, 23–25, and 28–30 were not shown unpatentable over Yokoyama, Yokoyama and Cline, or Honermann and Cline.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the 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, 163–64 (Fed. Cir. 1985))). Because the level of ordinary skill in the art is not in dispute, and because the parties’ definition is consistent with the disclosures in the ʼ203 patent, the prior art, and the declaration testimony of Mr. Nranian and Dr. Basirat, we view the prior art and arguments through this lens when determining whether the claims are unpatentable as obvious over the prior art.5 See Graham, 383 U.S. at 17 (identifying “the level of ordinary skill in the pertinent art” as an underlying factual inquiry to be resolved in deciding obviousness, which is a question of law).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Although the parties spend significant portions of their briefing discussing the term “eccentric” and how it applies to certain figures from the ʼ203 patent and the relied-upon prior art, we determine that it is not necessary to expressly construe the term “eccentric” beyond the parties’ agreed-upon definition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Expert testimonyPetitioner expert discountedDecided for patent owner
“(opining that “Patent Owner’s construction of ‘having an axis no located in a geometric center’ is too narrow”). Mr. Nranian’s Declaration testimony in this respect is not persuasive for several reasons. First, it is internally inconsistent. Compare Ex. 1016 ¶ 3 (criticizing the “axis” language in Patent Owner’s definition), with id. ¶¶ 9, 11 (relying on that very language to support an argument). Also, Mr. Nranian’s proposed definition of “eccentric” to merely mean “not located at the center” begs the question of what, precisely, is “the center”? Mr. Nranian does not persuasively explain how far a person of ordinary skill in the art would understand she could travel from the exact center point of an object and still be in “the center” of that object. See Tr. 10:13–19 (Judge McGee asking whether the center is “a miniscule point in the middle of [the] disc”); see also id. at 10:25–12:26 (Judge Weatherly highlighting the significant ambiguity in referring to something as in “the center”). Also, Mr. Nranian’s opinion is inconsistent with how the ʼ203 patent compares something that is “central,” i.e., “at the center,” and something that is “eccentrically” located. Ex. 1001, 7:13–14 (describing pipe nozzle 15 as “central”); id. at 8:53–56 (describing a “through hole” as “located in the center of the front panel 22” depicted in Figures 7 and 8); id. at 10:23–31 (describing return 12 as “in the center” and outlet 13 as “eccentrically thereto” in Figure 17). Patent Owner’s colorized and annotated Figure 7 is reproduced below: Patent Owner’s colorized and annotated version of Figure 7 of the ʼ203 patent illustrates “central pipe nozzle 15” in yellow passing through the “through hole” located in “the center” of front panel 22. PO Resp. 20. Significantly, pipe nozzle 15 and the through hole in panel 22 are both described as “central” and in “the center” but must have different diameters; otherwise, “central pipe nozzle 15” would not be capable of traveling through “through hole 22.” Ex. 1001, Fig. 7. Thus, the ʼ203 patent intrinsically bases whether an element is “central” or “in the center” on whether its axis is located at the geometric center. This is also illustrated in Figure 17 of the ʼ203 patent, reproduced below: Figure 17 of the ʼ203 patent illustrates filter housing 10 with return 12 “in the center . . . and, eccentrically thereto, the outlet 13 with the seat 14 for the blocking element 24.” Ex. 1001, 10:23–30. Finally, Mr. Nranian’s narrow interpretation of “eccentric”––which excludes the “having the axis or support so located” in the geometric center language––is at odds with the arguments it was proffered to support. Cf. Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”).” slip op. at 29
Patent outcomesUS 9,023,203 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 9,023,203 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., 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 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - Bj’S Wholesale Club Holdings, Inc. v. Walmart Apollo, LLCNo claims unpatentablePTAB · Apr 3, 2024 · IPR2022-01509 · APJ Arthur M Peslak · IPR · Final written decision
Claims 1–19 were not shown unpatentable over Poole and Hammad because the combination did not teach the claimed machine-readable element, and Poole did not teach the claimed scanning and decoding.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“priority date would have had a ‘bachelor’s degree in electrical engineering (or equivalent subject) together with one to two years of experience in research, design, development, and/or testing of location-based systems including mobile device applications,’” also noting that “[m]ore education can supplement practical experience and vice versa.” Pet. 7 (citing Ex. 1003 ¶ 20). Patent Owner adds that a person of ordinary skill in the art “could also have a bachelor’s degree in computer science, but otherwise agrees with Petitioner’s definition.” PO Resp. 15 (citing Ex. 2004 ¶¶ 54–58). We apply Petitioner’s proposed level of skill in the art, but, add that the person of ordinary skill in the art could also have a bachelor’s degree in computer science because that is consistent with the problems addressed in the ’188 patent and the prior art. Our Decision, however, would not be affected if we adopted Petitioner’s level of skill in the art.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes a specific construction for any claim term. Pet. 8–9; PO Resp. 17. Based on our review of the record, we determine it is not necessary to construe expressly any claim term for the 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 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Based on the disclosure of Poole and Hammad, we find that Petitioner’s argument that an ordinarily skilled artisan “would have understood that the QR code generated and displayed by Hammad would perform the same function as the barcode taught by Poole” (Pet. 16) is not supported by the evidence of record. Poole does not teach that a user can initiate a purchase transaction by scanning Poole’s barcode. Poole discloses that a bar code on sensor 214 can be scanned to identify the sensor and that a 5 Petitioner states: “[t]o the extent that Poole does not expressly disclose a ‘machine readable element generator . . .’, Hammad does.” Pet. 13. To the extent that this statement can be construed as an argument that Poole alone satisfies limitation 1[d], Petitioner does not direct us to any disclosure that Poole teaches “a machine-readable element generator.” See Pet. 11–13. Petitioner relies on Poole’s disclosure in paragraph 94 of “scanning a bar code.” Id. at 12. Poole’s paragraph 94 does not address how the barcode is generated. Ex. 1006 ¶ 94. Consequently, we determine that Petitioner has not met its burden to show that Poole alone teaches “a machine-readable element generator” as recited in limitation 1[d]. bar code on a merchandise item is scanned to identify the merchandise item as part of the store inventory management process. Ex. 1006 ¶¶ 94, 97. Petitioner, thus, does not persuade us that Hammad’s use of a QR code to initiate a purchase transaction is functionally equivalent to the use of Poole’s barcode.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Mr. Williams provides testimony that cites to the same evidence as the Petition and similarly concludes that Hammad’s QR code performs the same function as the barcode taught by Poole. Ex. 1003 ¶¶ 103–105. Because we find that Poole and Hammad themselves fail to support this conclusion, his testimony is unsupported and thus entitled to little, if any, weight. Additionally, he testifies that Poole’s mobile application scans the bar code. Id. ¶ 118. His testimony that Poole’s mobile application scans the barcode, like the Petition, relies on paragraphs 32 and 94 of Poole. Although Poole describes its customer device 220 wirelessly receiving “a coordinate position” of sensor 214, Poole does not describe its customer device 220 receiving location information by scanning a barcode. Ex. 1006 ¶ 32. When Poole does describe using a barcode to convey sensor identifiers including location information for the sensor, it does so in the context of its description of inventory management, but not in connection with the customer’s use of customer device 220. Id. ¶¶ 94, 95. Consequently, Mr. Williams’s testimony on this point is entitled to little, if any, weight because it is not supported by paragraphs 32 and 94 of Poole.” slip op. at 27
Patent outcomesUS 10,368,188 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,368,188 - Apple Inc. v. Logantree, LPNo claims unpatentablePTAB · Aug 30, 2023 · IPR2022-00037 · APJ Patrick R Scanlon · IPR · Final written decision
Claims 1–5, 8–11, 20, 25, 30–32, 36, 39–42, 45–51, 61–65, 144, and 147 were not shown unpatentable under the asserted obviousness grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Decision on Institution, we adopted Petitioner’s proposed level of ordinary skill in the art, stating it was “consistent with the evidence of record, including the asserted prior art.” Dec. Inst. 8. In proposing a different level of ordinary skill in the art, Patent Owner does not explain why its proposed skill level is more appropriate.12 PO Resp. 16. In addition, the parties’ proposed definitions are materially similar. 12 Petitioner does not address the level of ordinary skill in the art in its Reply. definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that we need not expressly construe “movement sensor” to resolve the parties’ disputes because doing so would have no effect on the analysis below. 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, 200 F.3d at 803 (Fed. Cir. 1999)). To the extent the parties raise claim construction issues in addressing the asserted grounds, we address such issues below.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Also, the Petition merely states that “Ono supports instances where the user stops the step-counting mode operation using switch S2 after the processor detects that” the target distance or the target number of steps has been reached and notifies the user by generating an alarm sound. Pet. 53 (emphasis added). In this case, supporting the notion of the user stopping the step-counting mode operation in response to the alarm is not the same as teaching or suggesting the notion to one of ordinary skill in the art. The possibility that a user could stop the step-counting operation in response the alarm is insufficient to render claims 1 and 20 obvious to one of ordinary skill in the art. See In re Facebook, Inc., 743 F. App’x. 998, 1001–02 (Fed Cir. 2018) (deciding that an example in a prior art reference showing that it is possible for image elements to be contiguous is not sufficient to teach a LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”). Petitioner’s reliance on the Hewlett-Packard and Unwired Planet cases (Pet. 56) is unavailing, as the facts in those cases are distinguishable from the facts of the present proceeding. Namely, both of those cases involved prior art references that disclosed operations that satisfied a claimed feature some, but not all, of the time. Hewlett-Packard, 340 F.3d at 1326; Unwired Planet, 841 F.3d at 1002. Here, Ono does not disclose the user stopping the step-counting mode operation in response to the alarm even some of the time. In view of the above, we determine, based on the full record, that the combination of Ono and Hutchings does not disclose limitations [1f] or [20f]. Accordingly, we are not persuaded that Petitioner has met its burden of showing, by a preponderance of the evidence, that independent claims 1 and 20 are unpatentable over the combination of Ono and Hutchings.” slip op. at 28
- BurdenNot shown unpatentable
“We have determined incorporated Grounds 1, 2, 3A, 3B, and 4, as well as Ground 5A, deficient for the reasons discussed above. Furthermore, to the extent Petitioner contends that any of these combinations somehow adds something to supplement or strengthen the patentability analysis of the incorporated grounds, we note that neither the Petition nor Dr. Kenny provides sufficient particularity to support such a position. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” (citing 35 U.S.C. § 312(a)(3)); see 1359, 1369 (Fed. Cir. 2016) (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” (quoting 35 U.S.C. § 312(a)(3))). Accordingly, we are not persuaded on the complete record before us that Petitioner has demonstrated, by a preponderance of the evidence, that: (1) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Amano, Conlan, Kaufman, and Hickman (Ground 5B); (2) claims 1–5, 8–11, 20, 25, 30, 31, 36, 39–42, 45–47, 49, and 61–65 are unpatentable over the combination of Ono, Hutchings, Amano, and Conlan (Ground 6A); (3) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Amano, Conlan, and Hickman (Ground 6B); (4) claims 1, 3–5, 8–11, 20, 25, 30, 36, 39–42, 61–65, 144, and 147 are unpatentable over the combination of Ono, Hutchings, Amano, and Kaufman (Ground 7); (5) claims 1–5, 8, 10, 20, 25, 30, 31, 39, 41, 42, 45–47, 49, 61–65, 144, and 147 are unpatentable over the combination of Ono, Hutchings, Conlan, and Kaufman (Ground 8A); and (6) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Conlan, Kaufman, and Hickman (Ground 8B).” slip op. at 36
Patent outcomesUS 6,059,576 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,059,576 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When 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.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentablePTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision
The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedOther
“It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16
Patent outcomesUS 10,561,659 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,561,659 - SHDS, Inc. / Galderma Laboratories, L.P. v. Truinject Corp.No claims unpatentablePTAB · Nov 15, 2021 · IPR2020-00937 · APJ Josiah C Cocks · IPR · Final written decision
Claims 1, 3, 4, 6–16, and 20–26 were not shown unpatentable because the petition did not account for required simulated therapeutic-agent delivery and real-time digital-plunger limitations.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“In light of the parties’ mutually acknowledged agreement of the meaning of the noted-term, and given that we do not see reason on the record before us to deviate from that meaning, we apply the same meaning of “a simulated flow of therapeutic agent delivered from the digital model of the syringe to the digital model of the training apparatus” to the noted claim phrase and consider no further construction to be necessary. 3. Remaining Claim Terms We discern that no other term needs an express construction to resolve the parties’ dispute. See Nidec, 868 F.3d at 1017.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Thus, Patent Owner proposes a construction of the above-noted phrase as “a simulated flow of therapeutic agent delivered from the digital model of the syringe to the digital model of the training apparatus.” Petitioner acknowledges that “the parties agreed to the construction of this term in the Delaware Action. No further construction of the term is required.” Pet. Reply 5. In light of the parties’ mutually acknowledged agreement of the meaning of the noted-term, and given that we do not see reason on the record before us to deviate from that meaning, we apply the same meaning of “a simulated flow of therapeutic agent delivered from the digital model of the syringe to the digital model of the training apparatus” to the noted claim phrase and consider no further construction to be necessary.” slip op. at 9
- Strike new argumentNew argument disregardedDecided for patent owner
“on Lampotang’s paragraph 89, Petitioner attempts to expand its proposed ground, and uses the Petitioner Reply to do so. To that end, Petitioner turns to specific disclosure of Samosky at paragraph 67 as providing an evidentiary basis to conclude that depiction of a simulated delivery of a therapeutic agent “would have been obvious.” Pet. Reply 14. A reply provides an opportunity for a party to respond to arguments made, for instance, in a patent owner response. 37 C.F.R. § 42.23(b). A reply, however, is not an appropriate vehicle to reconfigure a proposed ground based on new or additional evidence that is not reasonably tied to a ground advanced in the Petition, which is what Petitioner seeks to do here. The Petition does not set forth an adequate basis to conclude that Petitioner relied on Samosky’s teachings to account for features of claim 1 of the ’232 patent. As Patent Owner points out (PO Sur-reply 13–14), it is impermissible and untimely for Petitioner to now attempt to do so as a part of the Reply. See, e.g., Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1330–31 (Fed. Cir. 2019) (“[A]n [inter partes review] petitioner may not raise in reply ‘an entirely new rationale’ for why a claim would have been obvious.”) (citing Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1370 (Fed. Cir. 2016)).” slip op. at 21
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Lampotang’s disclosure with reference to Figure 2 focuses on the CVL technique, which involves withdrawing blood from a blood vessel rather than injecting medication into the patient’s body. Ex. 1008 ¶¶ 89-90. The CVL technique is not concerned with visualizing a simulated flow of therapeutic agent delivered from a digital model of the syringe to the digital model of the training apparatus. Ex. 2005 ¶ 102; see PO Resp. 41. We credit Dr. Pugh’s testimony on this matter, as we find it consistent with Lampotang’s disclosure as to the content of its Figure 2 and Lampotang’s description of the CVL technique. See, e.g., Ex. 1008 ¶¶ 78, 89–90.” slip op. at 20
Patent outcomesUS 10,290,232 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 10,290,232 - Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentablePTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision
Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20
- Strike new argumentNew argument disregardedDecided for patent owner
“Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18
Patent outcomesUS 10,195,214 not shown unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,195,214
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.