- Apple Inc. v. Voip-Pal.Com, Inc.Rehearing deniedPTAB · May 24, 2019 · IPR2016-01201 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that the challenged claims were not shown obvious over the asserted Chu and Chen combinations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“evidence that, in Chu ’684, users would dial according to the dialing conventions of their geographic area. Reh’g Opp’n 8 (citing Ex. 2016 ¶ 66). Patent Owner’s expert witness, Dr. Mangione-Smith, testified that “in Chu ’684, the users would dial PSTN ‘public numbers’ based on the location of the customer premises.” Ex. 2016 ¶ 66 (citing Ex. 1006, Fig. 2). Figure 2 of Chu ’684 supports Dr. Mangione-Smith’s testimony, in that Figure 2 of Chu ’684 illustrates customer premises 105 (which includes IP phones) as connected to a service provider central office 205. See Ex. 1006, Fig. 2; Reh’g Opp’n 9 (contrasting Petitioner’s assertion” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,542,815 - Apple Inc. v. Voip-Pal.Com, Inc.Rehearing deniedPTAB · May 24, 2019 · IPR2016-01198 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that challenged claims of the ’005 and ’815 patents were not shown obvious over the asserted combinations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- Expert testimonyPatent owner expert creditedDecided for patent owner
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“testimony by Dr. Mangione-Smith—when rejecting Petitioner’s view of the prior art and reason for the combination. See FWD 19 (citing Ex. 2016 ¶¶ 65–67); Reh’g Opp’n 6. Thus, when the panel concluded that Petitioner had not shown that Chu ’684’s method would apply to a number reformatted by the secondary references (see FWD 22–23), it relied on record evidence supporting its conclusion. We determine that the panel did not misapprehend the nature of the proposed combination; rather, based on the record, it resolved a factual dispute and concluded that Petitioner failed to show the proposed combination would operate as asserted.” slip op. at 5
§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,179,005 - Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentablePTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing 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))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34
Patent outcomesUS 8,007,826 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,007,826 - Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentablePTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached
“For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43
Patent outcomesUS 8,663,685 not shown unpatentable§ 102 anticipation§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,663,685 - Mexichem Amanco Holdings S.A De C.V. v. Honeywell International, Inc.Some claims unpatentablePTAB · Dec 9, 2016 · IPR2015-01309 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1, 3, 5, 6, 10–13, 16, and 19 are unpatentable as obvious; claims 7–9, 14, and 15 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner and Patent Owner propose constructions for all, or a portion of, the term “Formula I, XCF3(I), where X is a C2 unsaturated, substituted, alkyl radical.” Pet. 17–19 (proposing a construction for the term “C2 unsaturated, substituted, alkyl radical”); PO Resp. 12–15. Neither party contends, however, that express construction of this claim term, or any other term in the ’808 patent, would impact any of Petitioner’s or Patent Owner’s arguments in this proceeding. Accordingly, we determine that no claim terms require construction for purposes of this Final Written Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 7
- Skill levelSkill level patent owner adoptedDecided for patent owner
“art. Patent Owner, relying upon the testimony of Dr. Bivens, asserts that one of ordinary skill in the art would have had either: “(1) a bachelor of science degree in a specialty area (such as chemical engineering or chemistry) and five years of work experience in developing/testing refrigerants, blowing agents, and propellants, or (2) a Ph.D. or masters of science degree and 2-3 years of work experience.” PO Resp. 12 (citing Ex. 2034 ¶¶ 21–24). Patent Owner’s identification of a person of ordinary skill in the art is uncontroverted and is consistent with the prior art of record. Accordingly, we adopt Patent Owner’s identification for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect the level of ordinary skill in the art).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundMixed
“Accordingly, we are persuaded that: (1) Petitioner has identified where every limitation of claim 1 is disclosed or suggested in the combination of Kruse, Inagaki, and Butler; (2) Petitioner has set forth reasoned explanations supported by factual underpinnings to explain why one of ordinary skill in the art, prior to the earliest filing date of the ’808 patent, would have sought to combine Kruse, Inagaki, and Butler to achieve the invention set forth in claim 1 of the ’808 patent; and (3) Petitioner has set forth reasoned arguments, supported by record evidence, to show why a person of ordinary skill in the art would have had a reasonable expectation of success in combining Kruse, Inagaki, and Butler to achieve the composition of claim 1.” slip op. at 17
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“patent met a long-felt but unresolved need or were commercially successful, we have been directed to no persuasive evidence to demonstrate these propositions. See Graham, 383 U.S. at 17–18 (noting that “long felt but unsolved needs” and commercial success may be utilized as indicia of nonobviousness). Indeed, we have been directed to no persuasive evidence that a mixture of CO2 and a fluoroalkene of claim 1 has ever been used commercially, or that such a mixture was considered by those of ordinary skill in the art to have met a long felt but previously unresolved need.9, 10 See Tr. 51:24–52:7; Pet. Reply 9 (asserting that Patent Owner “has provided no evidence, post- or pre- issuance of the ’808 patent, of the commercial advantages or uses of the claimed compositions”). With respect to Petitioner’s prior patent applications, although Patent Owner initially characterizes these applications as relating to CO2 and partially fluorinated hydrocarbons, Patent Owner later notes that these patents are directed to blends of HFO-1234yf, CO2, and R-134a. PO Resp. 44; Ex. 2024, 12 (arguing in support of patentability that “[t]he specific 9 To be relevant, Patent Owner must show that the asserted secondary considerations are attributable to “the merits of the claimed invention beyond what was readily available in the prior art.” Asyst Techs. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008). Here, Inagaki discloses using compounds within the scope of claim 1 of the ’808 patent as refrigerants. Patent Owner presents no persuasive evidence that the addition of CO2 to the compounds of Inagaki, or the particular ranges recited in claim 1, resulted in a product that met a long felt but unresolved need or resulted in a commercially successful product beyond what was provided in Inagaki. Thus, we are also not persuaded that there is any nexus between the asserted secondary considerations and the features of claim 1 that are not disclosed in Inagaki. 10 As Patent Owner has not demonstrated any commercial use of the claim 1 compounds for any purpose, or provided evidence that those of skill in the art considered the claimed compounds to have met an unresolved need in the art, this analysis applies equally to the dependent claims of the ’808 patent, which each depend, directly or indirectly, from claim 1. combination of trans-R1234ze and R134a and CO2 simply is not suggested in Singh, let alone in the amounts defined in claim 1”). Patent Owner does not explain sufficiently why Petitioner’s arguments directed to the patentability of a blend of three compounds, utilized in specific proportions, are necessarily applicable to the combination of Kruse, Inagaki, and Butler proposed by Petitioner, or why these arguments are otherwise strong evidence of the nonobviousness of claim 1 of the ’808 patent. Based on the foregoing, and upon review of Patent Owner’s arguments as a whole, we are not persuaded that Patent Owner’s proffered objective evidence of nonobviousness is strong or tends to refute Petitioner’s arguments and evidence with respect to the obviousness of claim 1 of the ’808 patent.” slip op. at 25
Patent outcomesUS 8,623,808 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,623,808 - Biodelivery Sciences International, Inc. v. Monosol RX, LLCRehearing deniedPTAB · Sep 26, 2016 · IPR2015-00165 · APJ Francisco C Prats · IPR · Rehearing
The Board denied the petitioner’s rehearing request, leaving in place the final decision that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 were not shown unpatentable over Chen.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW The party requesting rehearing has the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). III. ANALYSIS” slip op. at 3
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“As we noted in our Final Decision, under the doctrine of collateral estoppel, also known as issue preclusion, a judgment on the merits in a first proceeding precludes relitigation in a second proceeding “of issues actually litigated and determined in the first [proceeding].” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994). In Freeman, the court explained that the rationale underlying issue preclusion is that “a party who has litigated an issue and lost should be bound by that decision and cannot demand that the issue be decided over again.” Id. The court set out the requirements of the doctrine as follows: Issue preclusion is appropriate only if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom issue preclusion is asserted] had a full and fair opportunity to litigate the issue in the first action. Id. (citations omitted). As to element (3), when determining whether the issue in question in the second action was essential to the final judgment in the first action, the court advised that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” Id. at 1466.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for patent owner
“Accordingly, Petitioner does not persuade us that we misapprehended or overlooked any point of fact or law, or any arguments Petitioner presented during trial, on the issue of whether the ’337 decision should be given preclusive effect. To the extent that Petitioner attempts, in its Request for Rehearing, to present for the first time a specific explanation as to why the ’337 decision meets the requirements of collateral estoppel, Petitioner does not explain why that discussion could not have been presented earlier in the proceeding, at the very least in its Reply. We, therefore, decline to consider those new contentions. In any event, Petitioner does not explain with any particularity why the ’337 decision meets the four elements of collateral estoppel. See, e.g., Req. Reh’g 12–13.” slip op. at 8
- Expert testimonyNot reached
“Lastly, Petitioner presents arguments explaining why the testimony of Drs. Reitman and Goldberg demonstrate that the ultimate conclusion in our Final Decision was erroneous. Req. Reh’g 8–10. Petitioner, however, does not identify specifically the place in the record where it presented these particular arguments, such that we may have misapprehended or overlooked them. We, therefore, decline to consider these new arguments. IV.” slip op. at 13
Nonecites PhillipsPatents in suitUS 8,765,167 - 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 - Amneal Pharmaceuticals, LLC / Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.All claims unpatentablePTAB · Jul 27, 2016 · IPR2015-01813 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–26 are unpatentable as obvious over the Advisory Committee Art under § 103.
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 ’182 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 (54), 1:15–31. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“First, we agree with Petitioner that the preamble language “[a] method of treatment of a narcoleptic patient” in the independent claims is not “necessary to give life, meaning, and vitality” to the claims of the ’182 patent. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). The claims recite method steps for controlling distribution of a prescription drug prone to abuse, misuse, or diversion; the claims do not recite treating a patient, administering a compound or drug product for therapeutic effect, or other treatment-related method steps. See, Ex. 1007 ¶ 37. Therefore, we determine the preamble language “[a] method of treatment of a narcoleptic patient” to be non-limiting.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“Second, the wherein clause at issue does not recite a method step. Independent claims 1, 8, and 19 consistently recite method steps using the present participle verb form, “receiving,” “entering,” “checking,” and “authorizing.” The wherein clause, however, recites the GHB drug product “treats” cataplexy, rather than reciting a method step of “treating” cataplexy. The absence of the present participle verb form and the use of a wherein clause indicate an intended use or inherent property of the GHB drug product to treat cataplexy, not a method step. See Credle v. Bond, 25 F.3d 1566, 1572 (Fed. Cir. 1994) (“[B]efore each clause containing an undisputed present participle designating the method steps—‘providing an insert;’ ‘joining two opposed webs’ . . . there is a comma, indicating the beginning of a new, distinct step . . . . There is no such comma preceding ‘flexibly securing.’ This suggests that ‘securing’ is not a present participle signifying a distinct method step.”).” slip op. at 15
- 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 1018.15 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 28
Patent outcomesUS 8,589,182 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,589,182
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.