- Amerigen Pharmaceuticals Limited v. Shire LLCRehearing deniedPTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Shire’s rehearing request and confirmed claim 25 is in the trial only through its dependency from claims 18–20, not claims 2 or 13.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We are not persuaded and decline to alter the Order concluding the Decision of April 19, 2016 in any way. Claim 25 would fall should Petitioner prevail in its obviousness challenge—so long as claim 25’s dependency from claims 18–20 remains. However, we take this opportunity to confirm that claim 25 is part of the trial only to the extent it depends from claims 18–20, and not to the extent it depends from non-instituted claims 2 and 13.” slip op. at 4
None - PTAB · Dec 22, 2016 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable as obvious over the Advisory Committee Art under § 103(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
- Claim Construction › Extrinsic evidence (dictionaries, experts)Decided for petitioner
“Id. at 20–22 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48, 4:13–6:4, 8:4–7, 40–44, 9:56–60, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45– 49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).” slip op. at 6
Claim constructioncites PhillipsPatents in suitUS 7,765,106 - Monosol RX, LLC v. Arius Two, Inc.Rehearing deniedPTAB · Dec 19, 2016 · IPR2014-00376 · APJ Christopher L Crumbley · IPR · Rehearing
The Board denied Monosol’s rehearing request, leaving claims 1–7 not shown unpatentable because the request showed no prejudicial APA error in the Board’s multilayer construction of “bioerodable device.”
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that the premise of Monosol’s argument—that we changed theories in our Final Written Decision—is incorrect. Our Decision on Institution did not articulate a construction for “bioerodable device,” or even state that we were not providing an express construction because the plain and ordinary meaning of the term controlled. Rather, we noted that an explicit construction was not necessary at that stage of the proceeding, because it was not material to resolving the question before us at the time: whether Monosol had established the reasonable likelihood of success required by 35 U.S.C. § 314 to institute trial. Dec. on Inst. 10–11. In this sense, our determination in the Decision on Institution was similar to a trial court’s ruling on a motion for preliminary injunction, and the” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“In instituting trial, we construed various terms in the challenged claims, but determined that other terms, such as “bioerodable device,” did” slip op. at 3
- PTAB / AIA Trials › Discretionary denialDecided for patent owner
“Our denial of institution on particular grounds was based on the fact that we had determined to institute trial on other grounds, and Monosol had not explained why the grounds (such as anticipation by Heiber, or obviousness over Keith combined with Heiber or Schiraldi) were sufficiently distinctive from the instituted grounds. Dec. on Inst. 16, 20 n.2. We, therefore, exercised our discretion to deny these grounds as redundant of the instituted grounds. Id.” slip op. at 3
- BurdenDecided for patent owner
“construction of “bioerodable device” earlier—it would have presented evidence that the Heiber and Schiraldi references met that limitation. But Monosol could not have done so post-institution, because neither Heiber nor Schiraldi were part of any ground on which trial was instituted, and could not form any basis for our patentability determination. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,765 (Aug. 14, 2012) (“Any claim or issue not included in the authorization for review is not part of the trial.”). Relying on non-instituted prior art in the Final Written Decision— and thereby introducing factual assertions into the proceeding at the end of trial—would trade Monosol’s alleged APA violation for an actual one. See Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016).” slip op. at 10
Claim constructionDiscretionary denialPatents in suitUS 7,579,019 - Amazon.Com, Inc. / Amazon Web Services, LLC v. Personalized Media Communications, LLCRehearing deniedPTAB · Dec 9, 2016 · IPR2014-01530 · APJ Trenton A Ward · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving its final written decision on claim 6 unchanged.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A request for rehearing “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). The party challenging a decision bears the burden of showing the decision should be modified. Id.” slip op. at 2
- BurdenDecided for petitioner
“Decision that “[t]o prevail in its challenges to the patentability of the claims, a petitioner must establish facts supporting its challenges by a preponderance of the evidence.” Dec. 12 (citing 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d)) (emphasis added).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“189:4–9)), require that these data modules must be part of a larger computer program. Even considering the disclosures in the specification cited by Patent Owner, we are not persuaded that the examples cited require that all data modules must be a discrete unit of a larger computer program. For example, disclosure in the specification that a data module containing the “particular cost-of-a-trimmed-pork-belly-unit” might be executed by a linked computer program to deliver personalized advertisements does not require that it must be a discrete unit of a larger computer program in all circumstances. See Req. 6–7. Yet, as we determined in the Final Written Decision, the specification does disclose that each type of module, including program modules, object modules, and data modules, is executed by a computer to perform a specific function. See Dec. 9 (citing Ex. 1003, 186:10–17, 188:35–37, 188:59–61). Accordingly, we modified our initial construction of “module” in the Decision on Institution as “a discrete unit of digital data” (Paper 8, 8) to incorporate “being executed by a computer to perform a specific function” (see Dec. 9–10). Patent Owner fails to establish persuasively how the examples of data modules in the specification are not met by a construction of “module” as “a discrete unit of digital data that is executed and/or processed to perform a specific function.”” slip op. at 5
Claim constructionPatents in suitUS 7,864,956 - Polygroup Limited v. Willis Electric Co., Ltd.Rehearing deniedPTAB · Dec 6, 2016 · IPR2016-00802 · APJ William V Saindon · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting inter partes review.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The standard of review for rehearing requests is set forth in 37 C.F.R. § 42.71(d), which states: 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. Specifically for rehearing requests of decisions on institution, “a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Patent Owner’s second argument for rehearing involves the discretion we have under 35 U.S.C. § 325(d) not to institute review if “the same or substantially the same prior art or arguments previously were presented to the Office.” In our Decision, we declined to exercise our discretion to deny. Dec. on Inst. 14. One factor behind our decision that we highlighted was that the grounds asserted against the ’186 patent were going forward already in a related proceeding (namely, the grounds in IPR2016-00802) against a very similar patent. Id. As such, we saw little substantive burden in proceeding on the merits. Id. Further, denying institution here causes additional inefficiencies, as it leaves to the district court issues that we are going to resolve on a closely related patent. Id. Patent Owner points to other cases having different facts in which petitions were denied. See Req. Reh’g 9–11. Different facts will give different results, especially in a multi-factor test such as that involved in § 325(d). Patent Owner does not address any facts that would make us reconsider our Decision. Patent Owner then points out that more cases were filed against it after this particular proceeding was filed (Req. 11–14); this is immaterial as to our decision regarding this proceeding. See 35 U.S.C. § 325(d) (referring to “prior art or arguments [that] previously were presented to the Office”) (emphasis added).” slip op. at 3
- Strike new argumentDecided for petitioner
“Patent Owner’s first argument for rehearing is directed to whether the Petition provided sufficient notice to Patent Owner regarding the basis of the unpatentability challenge. Req. 2–7. Patent Owner argues that Petitioner’s ground was to modify one reference with another as a “wholesale” slip op. at 2
Discretionary denialPatents in suitUS 9,044,056 - Polygroup Limited v. Willis Electric Co., Ltd.Rehearing deniedPTAB · Dec 6, 2016 · IPR2016-00801 · APJ William V Saindon · IPR · Rehearing
The Board denied Willis Electric’s rehearing request, leaving institution in place because it found no abuse of discretion in its notice analysis or decision not to deny under § 325(d).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“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. Specifically for rehearing requests of decisions on institution, “a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“we have under 35 U.S.C. § 325(d) not to institute review if “the same or substantially the same prior art or arguments previously were presented to the Office.” In our Decision, we declined to exercise our discretion to deny. Dec. on Inst. 14. One factor behind our decision that we highlighted was that the grounds asserted against the ’186 patent were going forward already in a related proceeding (namely, the grounds in IPR2016-00802) against a very similar patent. Id. As such, we saw little substantive burden in proceeding on the merits. Id. Further, denying institution here causes additional inefficiencies, as it leaves to the district court issues that we are going to resolve on a closely related patent. Id. Patent Owner points to other cases having different facts in which petitions were denied. See Req. Reh’g 9–11. Different facts will give different results, especially in a multi-factor test such as that involved in § 325(d). Patent Owner does not address any facts that would make us reconsider our Decision. Patent Owner then points out that more cases were filed against it after this particular proceeding was filed (Req. 11–14); this is immaterial as to our decision regarding this proceeding. See 35 U.S.C. § 325(d) (referring to “prior art or arguments [that] previously were presented to the Office”) (emphasis added).” slip op. at 3
Discretionary denialPatents in suitUS 8,454,187 - Polygroup Limited v. Willis Electric Co., Ltd.Rehearing deniedPTAB · Dec 6, 2016 · IPR2016-00800 · APJ William V Saindon · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review after rejecting its notice and § 325(d) arguments.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The standard of review for rehearing requests is set forth in 37 C.F.R. § 42.71(d), which states: 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. Specifically for rehearing requests of decisions on institution, “a panel will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“we have under 35 U.S.C. § 325(d) not to institute review if “the same or substantially the same prior art or arguments previously were presented to the Office.” In our Decision, we declined to exercise our discretion to deny. Dec. on Inst. 14. One factor behind our decision that we highlighted was that the grounds asserted against the ’186 patent were going forward already in a related proceeding (namely, the grounds in IPR2016-00802) against a very similar patent. Id. As such, we saw little substantive burden in proceeding on the merits. Id. Further, denying institution here causes additional inefficiencies, as it leaves to the district court issues that we are going to resolve on a closely related patent. Id. Patent Owner points to other cases having different facts in which petitions were denied. See Req. Reh’g 9–11. Different facts will give different results, especially in a multi-factor test such as that involved in § 325(d). Patent Owner does not address any facts that would make us reconsider our Decision. Patent Owner then points out that more cases were filed against it after this particular proceeding was filed (Req. 11–14); this is immaterial as to our decision regarding this proceeding. See 35 U.S.C. § 325(d) (referring to “prior art or arguments [that] previously were presented to the Office”) (emphasis added).” slip op. at 3
Discretionary denialPatents in suitUS 8,454,186 - Atlanta Gas Light Company v. Bennett Regulator Guards, Inc.Rehearing deniedPTAB · Dec 6, 2016 · IPR2015-00826 · APJ Patrick M Boucher · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable, and granted sanctions for Petitioner’s failure to timely update real-party-in-interest notices.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“IV. REQUEST FOR REHEARING On rehearing, the burden of showing that the Decision should be modified lies with Patent Owner, the party challenging the Decision. 37 C.F.R. § 42.71(d). “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.” Id.” slip op. at 10
- PTAB / AIA Trials › Real party in interest / privityDecided for patent owner
“With respect to Southern Company Gas, Petitioner’s assertion ignores the fact that Southern Company Gas did not result merely from a name change, but rather also from a merger with AMS Corp. that occurred before the name change. See Paper 34, 3. In the related IPR, the Board specifically found that AGLR is a real party in interest, and it follows that the merged entity is also a real party in interest. Atlanta Gas, slip op. at 13 (PTAB Jan. 6, 2015) (Paper 88). The merger with AMS Corp. has meaningful effects that impose an obligation on Petitioner to apprise the Board that Southern Gas Company is a real party in interest. Petitioner’s failure to file timely the updated mandatory notice is especially significant in light of the central nature that the issue of AGLR’s status as a real party in interest played in the related IPR. See Atlanta Gas, Paper 87, 46:6–9 (“The problem that we have, and you will remember, we had to fight like tooth and nail to get these documents. At every turn there was an objection to producing documents related to the real party in interest issue or the privity issue.” (statement by Patent Owner at oral hearing in the related IPR)). With respect to The Southern Company, we do not credit Petitioner’s argument that The Southern Company is not a real party in interest in light of Petitioner’s explicit notification to the contrary. Petitioner cannot have it both ways, identifying The Southern Company as a real party in interest (even “out of an abundance of caution”) to ensure compliance with 35 U.S.C. § 312(b), while simultaneously maintaining that it is not a real party in interest to evade the obligations of 37 C.F.R. § 42.8(a)(3). In light of these various considerations, we conclude that Petitioner has performed conduct that warrants a sanction.” slip op. at 5
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“be to expunge the Decision and the request for rehearing, dismiss the Petition with prejudice, and order [Petitioner] to pay compensatory expenses and attorney fees to [Patent Owner].” Mot. 5. We disagree that this proposed sanction is proportionate to the harm suffered by Patent Owner. In particular, as Petitioner contends, the harm suffered by Patent Owner is limited because “the estoppel provisions apply to the petitioner and ‘the real party in interest or privy of the petitioner.’” Opp. 6 (citing 35 U.S.C. § 325(e)(1)) (emphasis by Petitioner). There is no requirement that a petitioner identify all of its privies in a petition, and Patent Owner’s ability to address whether The Southern Company was a privy that would give rise to estoppel was not impacted by Petitioner’s original failure to file an updated mandatory notice. Furthermore, “[a] sanction imposed under this rule must be limited to what suffices to deter repetition of the conduct or comparable conduct by others similarly situated.” 37 C.F.R. § 42.11(d)(4) (emphasis added). We have considered, but are not persuaded by, Patent Owner’s argument that “[a]ny remedy short of termination with prejudice would encourage future petitioners to try to suppress the identification of real parties-in-interest.” Mot. 6. A more limited sanction will have sufficient deterrent effect. We determine that an appropriate sanction, proportionate to the harm suffered by Patent Owner, is to award costs and fees incurred in association with this proceeding from the time after issuance of the Final Written Decision until the date of this Decision. 37 C.F.R. § 42.12(b)(6).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“Although we agree with Patent Owner in the abstract that the “ordinary and customary meaning” standard applied to expired patents requires that evidence be viewed through the eyes of one of ordinary skill in the art, Patent Owner stretches that principle too far. See id. at 9–10. “[A] claim construction analysis must begin and remain centered on the claim language itself.” Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 382 F.3d 1111, 1116 (Fed. Cir. 2004). Patent Owner asks us to deviate far from this cardinal principle by incorporating features of the Fisher S254 regulator that are not recited in the claims themselves, under circumstances in which the Fisher S254 regulator is not explicitly identified as such anywhere in the specification of the ’029 patent. “Reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim, to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” In re Prater, 415 F.2d 1393, 1404–05 (CCPA 1969). This is particularly the case when the standard we are obliged to apply does not afford Patent Owner a presumption of validity of the patent’s claims. For these reasons, we are not persuaded that we misapprehended or overlooked any aspect of Patent Owner’s claim-construction arguments. Nor are we persuaded that Patent Owner’s evidence in support of those arguments was inadequately considered.” slip op. at 16
Claim constructioncites PhillipsPatents in suitUS 5,810,029 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter motivation issue, denied rehearing on the remaining issues, vacated the prior Final Written Decision, and entered a modified decision concurrently.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“§ 42.71 (d), which requires the party requesting rehearing to “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.”” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed
“Patent Owner first asserts that we “misconstrued data in Flechter illustrating that alternate day dosing was as effective as daily dosing and found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 32). Upon review of the Decision, we agree. See Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.F of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable
“regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient” slip op. at 8
- Expert testimonyPatent owner expert discountedDecided for patent owner
“Dr. Ziemssen, however, qualifies this comparison and explains that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,232,250 - Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Rehearing
The Board granted rehearing on the Pinchasi–Flechter combination, retracting reliance on Flechter’s efficacy data, and denied rehearing on the remaining issues.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with Flechter’s alternateday dosing schedule would conclude that such a regimen would likely exacerbate the frequency of injection site reactions, as Patent Owner asserts. See PO Resp. 36.” slip op. at 4
- Expert testimonyPatent owner expert discountedDecided for petitioner
“Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data, Patent Owner and its declarant, Dr. Tjalf Ziemssen, M.D., Ph.D., compare Flechter’s data reporting adverse events in its patients with Meiner’s data reporting adverse events in a different cohort of patients. PO Resp. 35–36; Ex. 2135 ¶ 89. From that comparison, Patent Owner argues that Flechter’s data allegedly teaches that alternate-day administration is less tolerable than daily administration. Reh’g Req. 8.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner
“Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7
§ 103 obviousnessPatents in suitUS 8,969,302
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.