- Motorola Mobility LLC / Google LLC v. Multifold International Incorporated Pte. Ltd.All claims unpatentablePTAB · May 15, 2026 · IPR2025-00038 · APJ Kristen L Droesch · IPR · Final written decision
Claims 1–7, 10–13, 16, 17, 19, and 20 are unpatentable as obvious over Chin; the Board did not find them anticipated by Chin or Whitehorn.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts that [a] person of ordinary skill in the art . . . (‘POSITA’) would have had at least a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field plus at least two years of work or post-graduate experience in image capture, image processing, image display, user interfaces, or a related field. Additional education could offset a lesser amount of experience and vice versa. Pet. 16. Patent Owner accepts Petitioner’s definition. See PO Resp. 25. We adopt Petitioner’s undisputed definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’842 Patent Specification and the asserted prior art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We agree with Petitioner that claim construction is unnecessary. As demonstrated in the analysis provided below addressing this claim limitation in view of the prior art, we need not explicitly construe “wherein in each image capture mode a display on the first or second screen is different.” 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))). Similarly, we need not construe any other claim terms or phrases to resolve the controversy between the parties.” slip op. at 9
- Strike new argumentNew argument disregardedDecided for patent owner
“We agree with Patent Owner that Petitioner’s arguments relying on Kennametal are belated. A “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019)6 at II.I. Thus, we need not consider Petitioner’s belated argument raised for the first time in the Reply. In any event, we agree that Kenneametal is inapplicable for the purpose of supplying a claim limitation missing from Chin’s disclosure. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274 (Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would ‘at once envisage’ the missing limitation.”). Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not 6 Available at www.uspto.gov/patents/ptab/trial-practice-guide. displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See generally Ex. 1004.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that the theory of inherency was not raised in the Petition and is therefore waived. Compare Pet. 29–33, with Pet. Reply 11–15. In any event, we also agree that Petitioner’s speculation regarding the disclosure of Chin is insufficient to support a theory of inherency. See Pet. Reply 11–15. As explained above, Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See Ex. 1004. Speculation regarding the possibilities and probabilities of what is displayed on first display 51 in self-photographing mode, and what is displayed on second display 52 in outward-facing mode are insufficient to establish inherency. See In re Robertson, 169 F.3d at 745. For the forgoing reasons and based on the entire record developed during trial, the preponderance of the evidence does not support Petitioner’s showing that Chin discloses “wherein in each image capture mode a display on the first or second screen is different.” Accordingly, based on the entire record developed during trial the preponderance of the evidence does not support Petitioner’s showing that Chin anticipates claim 1.” slip op. at 20
Patent outcomesUS 8,836,842 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,836,842 - PTAB · Nov 7, 2025 · IPR2025-00913 · APJ Brian P Murphy · IPR · Institution
The Board instituted review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claims 1–25, 27–28, and 30 are obvious over Menon, Trefethen, RS6000, and POEref.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an inter partes review, the burden of persuasion is on the petitioner to prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never shifts to the patentee.” In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (quoting Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)); see also Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1306 (Fed. Cir. 2017 (en banc (quoting Magnum Oil)). A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious to a person of ordinary skill in the art at the time the invention was made. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). A party who petitions the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). We assess Petitioner’s evidence and argument according to the above- referenced obviousness standard. We determine that the Petition satisfies the reasonable likelihood of prevailing standard under 35 U.S.C. § 314(a). We begin our analysis with a discussion of the Menon, Trefethen, RS6000, and POEref references. slip op. at 15
- Skill levelSkill level petitioner adoptedOther
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. For purposes of this Decision, we adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the description in the ’034 patent, the prior art of record, and the testimony of both experts.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard. Pet. 12–13 (citing 37 C.F.R. § 42.100(b)). The Petition addresses the construction of “peer-to-peer architecture” recited in independent claims 1 and 30 of the ’034 patent, a limitation we need not construe to decide the institution question. Id. at 13; 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)). Patent Owner contends that “no claim construction is required” to address the Petition’s asserted deficiencies. Prelim. Resp. 6. Patent Owner also contends, however, that the Petition relies on a “novel claim construction” of limitations [1.4.1] and [1.5.1]—“second [third] hardware processor with a plurality of processing cores”—to support Petitioner’s obviousness argument. Id. at 11–12.8 Patent Owner challenges the Petition’s reliance on “single core processors on different chips,” such as the Power3 single-core processors of the Symmetric Multi- Processor (“SMP”) configuration disclosed in the RS6000 reference, as a disclosure of limitations [1.4.1] and [1.5.1]. Id. Patent Owner contends that such single-core processors on different chips do not satisfy limitations [1.4.1] and [1.5.1] because the ’034 patent “claims only multicore processors.” Prelim. Resp. 5 (citing Ex. 1001, 7:15–27). Petitioner responds in part as follows: To the extent PO is implicitly arguing that RS6000’s “four, eight, twelve, or sixteen 375 MHz 630FP 64-bit processors” do not teach the recited “cores,” Patent Owner’s argument excludes embodiments described in the ’034 patent’s specification. The ’034 patent describes “[p]rocessor cores [as] generally independent microprocessors.” Ex.1001, 5:14–15. Patent Owner’s attempt to exclude RS6000 from the scope of the claims 8 Pursuant to the Board’s Order on Related Matter Updates (Paper 14), the parties filed the September 26, 2025 Claim Construction Order entered in the co-pending District Court litigation in this proceeding. Ex. 1085. The District Court Claim Construction Order did not construe the claim phrase “hardware processor with a plurality of processing cores.” Id. patent where the processor has independent microprocessors. Patent Owner’s attempt to distinguish RS6000’s Symmetric MultiProcessor as a “configuration” (Paper 8, 24) also fails because a “Symmetric MultiProcessor configuration” is no different than the ’034 patent’s description of a configuration of independent microprocessors. Id. Paper 9, 30.9 It is apparent there is a dispute over the plain meaning of Limitations [1.4.1] and [1.5.1], “a second [third] hardware processor with a plurality of processing cores,” recited in the independent claims.10 The parties are ordered to propose and support a particularized plain meaning or other construction of Limitations [1.4.1], [1.5.1], and [30.1.2] in their briefs. The parties are ordered to analyze the relevant claim language and cite to the specification and prosecution history in support of their claim construction, where applicable, with particular attention to the description of a hardware processor with a plurality of processing cores in the ’034 patent. See, e.g., Ex. 1001, 5:11–37, 7:14–36, 9:50–10:3.” slip op. at 12
- Obviousness (§103) › Analogous artAnalogous artInstituted
“Motivation to Combine and Analogous Art The Petition offers several motivations to combine Menon, Trefethen, RS6000, and POEref in the manner claimed in the ’034 patent with a reasonable expectation of success, which we find sufficient on the present record. The Petition first asserts that Menon and Trefethen are analogous prior art because they pertain to the same “field of cluster computing” as the ’034 patent and “are reasonably pertinent to the problem of the ’034 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex.1001, 1:14–15; Ex.1003, ¶¶ 65–69; Ex. 1005, 2; Ex. 1006, Abstract). The Petition points out that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1003 ¶ 71; Ex. 1005, 1–2). The Petition also contends that: Accordingly, Menon and Trefethen together represent a combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Id. at 22–23 (citing Ex. 1003 ¶ 70; Ex.1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,570,034 - PTAB · May 21, 2025 · IPR2025-00040 · APJ Brian P Murphy · IPR · Institution
The Board instituted IPR of claims 1–9 on all grounds, finding a reasonable likelihood that Yook anticipates at least claims 1 and 7 and Purcell anticipates at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Anticipation under 35 U.S.C. § 102 requires “the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). To anticipate a patent claim under 35 U.S.C. § 102, “a reference must describe, either expressly or inherently, each and every claim limitation and enable one of skill in the art to practice an embodiment of the claimed invention without undue experimentation.” American Calcar, Inc. v. Am. Honda Motor Co., 651 F.3d 1318, 1341 (Fed. Cir. 2011) (citing In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009)). “[E]xtrinsic evidence may be considered when it is used to explain, but not expand, the meaning of a reference.” In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (citing Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1576–77 (Fed. Cir. 1991).” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Anticipation under 35 U.S.C. § 102 requires “the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). To anticipate a patent claim under 35 U.S.C. § 102, “a reference must describe, either expressly or inherently, each and every claim limitation and enable one of skill in the art to practice an embodiment of the claimed invention without undue experimentation.” American Calcar, Inc. v. Am. Honda Motor Co., 651 F.3d 1318, 1341 (Fed. Cir. 2011) (citing In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009)). “[E]xtrinsic evidence may be considered when it is used to explain, but not expand, the meaning of a reference.” In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (citing Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1576–77 (Fed. Cir. 1991).” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). We apply a two-part test when evaluating whether to exercise discretion under § 325(d). See Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Specifically, we consider: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Id. In doing so, we consider the factors discussed in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.; informative) (“Becton, Dickinson”). Id. at 9– 11.” slip op. at 29
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. Based on the preliminary record, we adopt Petitioner’s as yet undisputed level of ordinary skill to determine whether there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition.” slip op. at 10
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 9,134,756 - PTAB · May 21, 2025 · IPR2025-00060 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1 and 12 are anticipated by Ogawa.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review under 35 U.S.C. § 314(a). See 37 C.F.R § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner notes that it “applies [Petitioner’s] definition of a POSITA for the purposes of th[e] preliminary response but expressly reserves the right to urge a different definition of a POSITA and support such definition with evidence including expert testimony.” Prelim. Resp. 6. For the purposes of this Decision, we apply Petitioner’s currently uncontested definition because it appears consistent with the problems addressed in the ’080 patent and the prior art.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner submits that “the Board need not construe any terms of the challenged claims to resolve the underlying controversy.” Pet. 9. Petitioner however notes the multiple “displays” recited in, e.g., independent claim 12 and dependent claims 2 and 4, and submits that Patent Owner’s infringement contentions “suggest that the ‘first display’ and ‘second display’ in claim 12 read on a single physical display divided into two or more logical displays.” Pet. 9–10 (citing Ex. 1015, 33–34). Petitioner submits that (i) the presented grounds 1 and 2 cover the respective claims under Patent Owner’s interpretation of “display” which Petitioner alleges to encompass the claimed “first display” and “second display” being logically divided displays of a single physical display, (ii) grounds 3 and 4 cover the respective claims under a narrower interpretation of “display” under which the claimed “first display” and “second display” are physically distinct from each other,7 and (iii) ground 3 also covers the respective claims under Patent Owner’s interpretation of “display.” In response, Patent Owner submits that for the purposes of the Preliminary Response, its arguments “do not turn on any specific construction of ‘display’ and the Board need not address the construction of this term for institution.” Prelim. Resp. 5. Based on the record at this stage of the proceeding, we need not construe “display” or any other claim term to resolve the controversy before us. 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 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Patent Owner begins its argument with the premise that “Ogawa’s teaching of an active screen indicator cannot suggest the claimed open application state indicator.” Prelim. Resp. 8. We note that Patent Owner does not direct us to any portion of the Specification or prosecution history of the ’080 patent describing the recited “open application state” nor does Patent Owner propose a construction of this term. See generally Prelim. Resp. Our review of the Specification and prosecution history does not reveal any explicit description of “open application state.” Consequently, we give this term its plain and ordinary meaning that an application screen is open in the display.” slip op. at 18
Claim construction§ 102 anticipationcites Phillips · KSR · GrahamPatents in suitUS 8,842,080 - ROKU, Inc. v. Videolabs, Inc.InstitutedPTAB · Dec 9, 2024 · IPR2024-01025 · APJ Karl D Easthom · IPR · Institution
The Board instituted IPR on claims 100–109 and 111 on all petitioned grounds, finding a reasonable likelihood of success on anticipation by Russ and obviousness over Russ with Robert or Eskicioglu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Under § 314, the Board may not institute review on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). If the Board institutes a review, it will institute “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Upon consideration of the Petition, the Preliminary Response, Reply, Sur-Reply, and the evidence of record, for the reasons set forth below, we conclude Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim in the ’236 patent. Accordingly, we institute an inter partes review of claims 100–109 and 111 on all grounds set forth in the Petition. See 37 C.F.R. § 42.108(a).1” slip op. at 2
- Parallel petitionsDecided for petitioner
“1 Petitioner filed a Notice Ranking Petitions and Explaining Material Differences. Paper 3. Petitioner states that it filed three parallel IPR petitions challenging three different claim sets of the ’236 patent “solely for word count purposes that preclude all claims from being challenged in [a] single petition,” “there is no duplicative overlap of the same claims across petitions,” and there is a “need to set” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“someone having “a bachelor’s degree in computer science, electrical engineering, or a related field, and approximately two or more years of experience in multi-media content distribution and management. Additional education could substitute for professional experience, and vice versa.” Pet. 13. Patent Owner applies Petitioner’s proposed definition for purposes of its Preliminary Response. Prelim. Resp. 5 (citing Malek Dec. Ex. 2001 ¶ 38).7” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“on claim construction and disregard everything else.8 The parties direct our attention in particular to the proper construction of an “independent” second root of trust in context of the recited claim limitation: “a second authentication process which is independent of the first authentication process and wherein the second authentication process uses a second root of trust which is independent of and different than the first root of trust.” We refer to this disputed claim limitation hereafter as the “independent authentication” limitation.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,291,236 - 3shape Medical A/S v. Sirona Dental Systems GmbHNo claims unpatentablePTAB · Jun 21, 2017 · IPR2016-00481 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–10 were not shown unpatentable: Mushabac did not anticipate claims 1–5 and 9–10, and the asserted combinations did not render claims 1–8 obvious.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“We determine that only the following claim phrase requires explicit construction for purposes of this Decision. 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.’” (internal citation omitted)).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Petitioner provides evidence that a person of ordinary skill in the art (“POSA”) is someone with a D.M.D. (Doctor of Medicine in Dentistry or Doctor of Dental Medicine) or D.D.S. (Doctor of Dental Surgery) and at least several years of experience with 3-D technology used in dental implant treatment, planning, and surgery. Pet. 9–10 (citing Ex. 1004 ¶¶ 63–66). Alternatively, such a person may have a computer engineering degree or be a trained dental laboratory technician having substantial experience with 3-D technology and software applications used in dental implant treatment, planning, and surgery. Id. Patent Owner has accepted Petitioner’s definition of a POSA for purposes of this IPR. We adopt and apply Petitioner’s definition of a POSA in this Decision.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“2. Analysis of “optical measuring of the visible surfaces of the jaw” Anticipation under 35 U.S.C. § 102 requires “the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008).” slip op. at 11
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Dr. Ganz agreed under cross-examination that “Mushabac optically measures the teeth [a]nd then it uses … bone sounding to measure the surfaces of the jawbone.” Ex. 2026, 252:11–20. When directly asked where a three-dimensional optical measuring of visible surfaces of the jaw was “stipulated” in Mushabac, Dr. Ganz could not identify any passage to support that assertion made in paragraph 100 of his Declaration. Id. at 248:16–252:20. We find Dr. Ganz’s cross-examination testimony to be highly persuasive and consistent with the disclosures in Mushabac and the testimony of Dr. Erickson. For the reasons given above, we determine that Mushabac does not expressly disclose an “optical” (light-based) measurement of the “visible surfaces of the jaw” in three dimensions, as recited in claim 1 of the ’006 patent.” slip op. at 16
Patent outcomesUS 6,319,006 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,319,006 - Institut Straumann AG / Dental Wings Inc. v. Sirona Dental Systems GmbHSome claims unpatentablePTAB · Nov 15, 2016 · IPR2015-01190 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–8 were held unpatentable as obvious over Bannuscher and Truppe; claims 9–10 were not shown unpatentable; the motion to amend was denied.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“interpretation of the language used in claim 1 and the additional limitations of dependent claims 9 and 10. Patent Owner’s proposed construction also impermissibly reads limitations from the preferred embodiment of Figure 5 into claim 1. Patent Owner would limit the pilot hole location exclusively to a position directly over the implant position and require the drill bit to pass through the pilot hole while drilling a bore hole into the patient’s jaw. The language recited in claim 1, in the context of the ’006 specification, does not so-limit the “determinating a pilot hole” step. First, Patent Owner fails to consider the present participle form “determinating”5 at the beginning of the recited method step at issue. As a result, Patent Owner conflates the recited device production step with a specific process for drilling a bore hole into a patient’s jaw during tooth implant surgery. PO Resp. 14–15. For example, Patent Owner relies on Dr. Erickson’s Declaration testimony (and Dr. Benjamin’s deposition testimony) for the proposition that “pilot hole” is a term of art referring to “an initial hole through which a pilot drill passes during an operation.” Ex. 2002 ¶ 37 (cited at PO Resp. 16–17); see also PO Resp. 16–17 (citing Ex. 2023, 24:3– 22, 25:18–27:2, 52:2–9). The ’006 patent does not describe or reference any such “pilot drill” or “initial hole” being made during a tooth implant operation. Regardless, the claim limitation at issue is a step in a method of producing a drill template. It recites defining a pilot hole in a drill template with reference to the surfaces of neighboring teeth, nothing more. The function of actually passing a drill through a pilot hole in a drill template” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner argues that the term “pseudo-x-ray picture” is not a term that has a commonly understood meaning to a POSA. Pet. 19 (citing Ex. 1002 ¶ 45 [47]). Patent Owner does not comment on the construction of “pseudo-x-ray picture.” PO Resp. 15–19. Having reviewed the complete record, we adopt Petitioner’s argument and evidence in support of Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture.” Therefore, we adopt Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture” as “any representation of measured data records of the three-dimensional optical measuring that can be superimposed on an x-ray image.” Pet. 19 (citing Ex. 1002 ¶ 49).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInherency not foundNot shown unpatentable
“stylus is used to penetrate the surface of the gum repeatedly to measure the structure of the jaw bone displayed in Figure 25. PO Resp. 30–31 (citing Ex. 1007, 24:53–65 (“[S]tylus member 52 is provided with a sharp stylus 574 (FIG. 1) having a length sufficient[ly] long to penetrate gum tissue and contact the bone surface. . . . [P]ractitioner repeats the procedure of piercing the gum tissue in a region about the desired implantation site and taking point data until enough data has been collected . . . to map . . . the entire surface of bone 558 [Fig. 25] about the implantation site.”)). We agree with Patent Owner and find that the use of a sharp stylus to pierce the gum and take multiple data points via contact digitization of the jaw bone beneath the skin surface is not a 3-D optical measuring of the visible surfaces of a patient’s jaw.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“would have been motivated to combine their teachings with respect to correlating X-ray imaging data of the jaw and 3-D surface data of the jaw and teeth. Reply 22–23 (citing Ex. 1002 ¶¶ 89, 92; Ex. 1008, 1:10–11 (“precise planning of the surgical operation is necessary”); Ex. 1010, 5:19– 25 (“it is possible to carry out the entire implantological, treatment and operation planning on a scientific basis . . . to implement holistic planning results in a precisely clinical manner”)). More particularly, Bannuscher discloses the desire to obtain “all the necessary [clinical] parameters” relevant to pre-surgical implant planning, which can be “combined together” (“correlated” in the language of claim 1) using planning simulation software, for transfer to a drill template. Ex. 1010, 5:44–6:13, 6:24–40, 7:38–8:4. As Dr. Erickson testified, it would have been desirable for a POSA to have as much diagnostic information as possible when planning for dental implant surgery. Ex. 1029, 31:12–21. Truppe discloses the advantage of correlating three-dimensional X-ray imaging data of the jaw and optical imaging data of the jaw and teeth, using simulation software, to obtain a “vivid” representation. Ex. 1008, 2:7–16, 3:19–28, 3:56–58; 4:1–5. Truppe, therefore, discloses a similar process to that disclosed in Bannuscher with respect to correlating 3-D X-ray imaging data and 3-D optical data representing the surfaces of the jaw and teeth, to generate the best possible representation of the patient’s jaw and teeth. Ex. 1002 ¶¶ 89–92. A POSA would have been motivated to use Truppe’s optical measurement system to generate 3-D surface data of the jaw and teeth for use in Bannuscher’s planning simulation software, in order to produce an enhanced image for determining the optimal bore hole and pilot hole in the drill template. Id.; Ex. 2023, 186:8–187:13 (“the optical imaging [of Truppe] would basically just enhance the diagnostic data [of Bannuscher]”). For example, a POSA would have optically measured the plaster model of the jaw and teeth referenced in Bannuscher and the patient’s actual jaw and teeth, as in Truppe, to produce a “vivid” image for correlation with the X-ray imaging data. Ex. 1002 ¶¶ 89, 92.20 Bannuscher’s determination of the optimized bore hole and corresponding pilot hole in the drill template would be based on the enhanced imagery generated from the correlated 3-D data sets. In short, we are persuaded that a POSA would have had reason to incorporate the teaching of Truppe’s enhanced 3-D optical measurement technique into Bannuscher’s method for correlating 3–D X-ray image and model geometry data sets, to determine an optimal bore hole and corresponding pilot hole in the drill template. For the reasons given above, we are persuaded that Petitioner has established a sufficient motivation for a POSA to combine the relevant teachings of Bannuscher and Truppe, with a reasonable expectation of success, by a preponderance of the evidence.” slip op. at 40
Patent outcomesUS 6,319,006 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,319,006 - Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentablePTAB · Jul 27, 2016 · IPR2015-01818 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable as obvious over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over that …
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In view of the claims at issue here, we are not persuaded that the level of ordinary skill in the art is limited to the level of skill or interest of a pharmacist that dispenses FDA-approved drugs, such as one that “sits behind the counter at Walgreens.” Id. at 31:1–5. We adopt the level of ordinary skill in the art as described by Petitioner and its witness, Dr. Valuck, because it is consistent with the subject matter before us, the ’730 patent, and with prior art of record, such as Talk About Sleep (Ex.1033), Honigfeld (Ex. 1034), Elsayed (Ex. 1035), and Lilly (Ex. 1036). See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionTerm construed board ownMixed
“Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 18
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“For the reasons given above, we find Petitioner’s evidence sufficient to prove by a preponderance that Exhibits 1004–1006 were publicly accessible on the FDA’s website not later than July 1, 2001.” slip op. at 35
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“of the ’730 patent (and claims 1, 4–9, and 12–15 of the ’988 patent) would have been obvious over the ACA (Exhibits 1003–1006), because the ACA is a public disclosure of the proposed risk management system for Xyrem—the same system covered by the ’730 and ’988 patents. Pet. 18–38; Reply 1. Petitioner relies on the Declaration testimony of Dr. Valuck in support of its argument that a POSA would have had “ample” reason to combine the ACA documents because the documents were prepared for the Advisory Committee Meeting and “relate to the same restricted distribution program, which the meeting was convened to discuss.” Pet. 19 (citing Ex. 1007 ¶ 51). Petitioner asserts, in particular, the Preliminary Clinical Safety Review (Ex. 1004), Briefing Booklet (Ex. 1005), and Xyrem Video and Transcript (Ex. 1006) were “all distributed together for a single meeting before the FDA seeking approval for prescription Xyrem®,” and the FDA Advisory Committee Transcript and Slides (Ex. 1003) was “a public transcript of and presentation given at the meeting itself.” Id. at 19 (citing Ex. 1007 ¶ 51) (emphasis added). In addition, according to Petitioner, all four ACA documents “clearly relate to the same restricted distribution program, which the meeting was convened to discuss,” and are “all linked from a single [web] page.” Id. Patent Owner does not address directly the cited evidence in the context of motivation to combine the ACA. Patent Owner challenges the motivation of a POSA to confirm that a patient has read the Xyrem educational material prior to shipping the drug product to the patient (step 1.4), an issue we address below. PO Resp. 37, 49–59. We agree with Petitioner’s analysis and determine that a POSA would have had ample motivation to combine the ACA documents, which were prepared at the same time, relate to the same drug product and the same restricted drug distribution system, were discussed together at the same Xyrem Advisory Committee Meeting, and were made available via file links from a single FDA web page.” slip op. at 39
Patent outcomesUS 7,668,730 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,668,730 - Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentablePTAB · Jul 27, 2016 · IPR2015-01820 · APJ Jacqueline Wright Bonilla · IPR · Final written decision
Claims 1–6 are unpatentable as obvious over the Advisory Committee Art under § 103(a), based on the Board’s finding that the references were publicly accessible and disclose or suggest the claimed limitations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’107 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’107 patent priority date. Pet. 3–6; see also Ex. 1001, Related Application, 1:6–9 (indicating earliest priority date for the ’107 patent).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“In our Decision on Institution, we construed the phrase “determining with the computer processor . . . patterns of potential prescription abuse . . . from periodic reports generated only by the central database” to mean “using the central database via the computer processor to generate periodic reports containing prescriber, patient, and/or prescription related information, which permits evaluation of potential abuse of a prescription drug.” Dec. on Inst. 22. Patent Owner indicates that it generally agrees with that construction, but proposes that the construction is incomplete in relation to the term “periodic reports.” PO Resp. 25. Patent Owner contends that “periodic reports” should be construed to mean “at regular frequencies or intervals, as opposed to intermittently or upon request.” Id. at 25–26 (citing Ex. 2046 ¶¶ 30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the specification of the ’107 patent, such as Figures 13A–C, and where the specification states “[e]ach report has an associated frequency or frequencies.” Id. at 26–27; Ex. 1001, 8:22–28. The cited portions of the specification, however, describe Figures 13A–C as “descriptions of sample reports obtained by querying a central database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis added); see also id. at 2:55–57 (also describing Figs. 13A–C as describing “sample reports”); Reply 13. Thus, we do not agree that the specification indicates that “periodic reports” as recited in the claims refers only to reports obtained at regular frequencies or intervals, even if the term includes such reports.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’107 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 27 (quoting Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’107 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 26–28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act. We are not persuaded by Patent Owner’s argument that Petitioner’s Internet Archive evidence is insufficient, given the totality of evidence presented in this case. PO Resp. 5–9. For example, Patent Owner submits the Second Affidavit of Christopher Butler and asserts that, if one clicks on the links shown in Exhibits 1019, the earliest archive dates for the URLs corresponding to Exhibits 1004–1006 are dated after the ’107 priority date: 16 The 3754 code is consistent with the code used for other Xyrem Advisory Committee documents, as discussed above in subsection II.C.1.b. August 30, 2003, for Exhibit 1006; September 13, 2011 for Exhibit 1005; and November 21, 2011 for Exhibit 1004. Id. at 8–9 (citing Ex. 2052, 6, 129, 483, 495, 498, and 501). As Petitioner explains, however, quoting from a Third Affidavit of Christopher Butler, the first available archive or “captured” date of a URL “does not represent the first time that the pdf was posted online at that address and it is possible that the pdf was available at this URL on an earlier date.” Reply 6–7 (citing Ex. 1058 ¶¶ 6–8). The pdf “may have been available days, weeks, months, or years prior to the date it was first captured.” Ex. 1058 ¶ 6; see also Rackspace US, Inc. v. Personalweb Techs., LLC, Case IPR2014-00059, slip op. at 35 (PTAB April 15, 2014) (Paper 9) (“[T]he mere fact that a ‘downloaded’ copy of [the prior art reference] has a date subsequent to the critical date is not sufficient to rebut Rackspace’s supporting evidence that [the reference] was posted originally on publicly accessible sites well known to those interested in the art before the critical date.”). We further note that Patent Owner’s Internet Archive evidence corroborates the fact that pdf files for each of Exhibits 1004–1006 were linked to the FDA’s website with the code “briefing/3754b1.” Ex. 2052, 5 (Ex. 1004 “Preliminary Clinical Safety Review” - “briefing/3754b1_02_section %203.pdf”), 128 (Ex. 1005 “Briefing Booklet” - “briefing/3754b1_01_1-orphan-medical.pdf ”), 482 (Ex. 1006 “Video Script 2/2/01” - “briefing/3754b1_01_2-orphan-medical%20video%20tape%20Revised%20Script.pdf”). “Briefing/3754b1” is the same code linking the “Briefing Information” to the FDA’s website as of June 17, 2001 (Ex. 1018, 5) and July 1, 2001 (Ex. 1019). As in” slip op. at 33
Patent outcomesUS 7,765,107 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,765,107 - Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentablePTAB · Jul 27, 2016 · IPR2015-01815 · APJ Jacqueline Wright Bonilla · IPR · Final written decision
Claims 1–8 are unpatentable as obvious over the Advisory Committee Art because it disclosed or suggested the claimed distribution controls and a skilled artisan would have combined the references.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’106 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’106 patent priority date. Pet. 3–6; see also Ex. 1001, Related U.S. Application Data, 1:6–9 (indicating earliest priority date for the ’106 patent).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“1. “exclusive central computer system” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central computer system” to mean “single or sole computer system,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20–21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 9; PO Resp. 25 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from these interpretations.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’106 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner’s circumstantial evidence. As discussed above, it is undisputed that Exhibit 1003 was available as a file link on the FDA’s website no later than October 4, 2001. It is also undisputed that Exhibits 1004–1006 were prepared and submitted to the Xyrem Advisory Committee just over one month prior to the June 6, 2001 meeting. The Safety Review (Ex. 1004) has a few redactions that tend to indicate the document was prepared for public dissemination, and the Briefing Booklet (Ex. 1005) contains the statutory legend indicating it is available for public disclosure without redaction. Reply 2–3 (citing Ex. 1057, 415). Thus, the evidence indicates Exhibits 1004–1006 were prepared, distributed to the Xyrem Advisory Committee, and available for posting to the FDA’s website 24 hours prior to the meeting, as stated in the Federal Register Notice (Ex. 1015). The Federal Register Notice even provided instructions on how to locate materials from the FDA’s website—“Click on the year 2001 and scroll down to the Peripheral and Central Nervous Systems Drugs meetings.” Reply 5 (citing Ex. 1015). As Petitioner points out, Patent Owner has not adduced evidence to indicate the FDA failed to follow the public inspection requirements of the Federal Advisory Committee Act and FDA’s own guidance document in effect at the time. Reply 2–4 (citing Ex. 1057, 2, 4, 6, 8). FDA’s guidance document states that seven business days prior to an advisory committee meeting “the sponsor package and CDER’s [Center for Drug Evaluation and Research] redacted package will be submitted . . . for posting on the FDA website.” Ex. 1057, 8 ¶ 9. The guidance document further states that 24 hours prior to the meeting “FDA will post on its website the sponsor 15 Our citations are to the internal numbering of the document, consistent with Petitioner’s citations. package and CDER’s redacted package.” Id. at ¶ 10. If for some reason the FDA is unable to post the documentation prior to a meeting, “the two packages will be made publicly available at the location of the advisory committee meeting, and the two packages will be posted on the Agency website after the meeting.” Id. The transcript of the Xyrem Advisory Committee Meeting contains internal references to the briefing material made available to the committee members and discussed at the meeting, thus tending to corroborate the availability of Exhibits 1004–1006 as of the June 6, 2001 meeting date. Reply 4 (citing Ex. 1003, 12, 179, 284, 330, 342). Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act.” slip op. at 32
Patent outcomesUS 7,765,106 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,765,106
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.