- Amerigen Pharmaceuticals Limited v. Shire LLCRehearing deniedPTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Amerigen’s rehearing request, leaving claims 1–3, 5, 8, 9, and 11 uninstituted because Mehta did not disclose the claimed release limitation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Amerigen’s arguments with these principles in mind.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“These arguments are not persuasive. First, Petitioner cites no authority for the proposition that a generic disclosure, such as that discussed above, is an express disclosure of every possible permutation of that generic disclosure. Second, even if we were to accept, for the sake of argument, that Mehta’s combined disclosures constitute an express disclosure of a composition capable of delayed release of “essentially all [of the drug] . . . within about 60 minutes,” non-instituted claims 1–3, 5, 8, 9, and 11 further require that the delayed release is enteric (i.e., the composition releases the second dose of the drug in the intestines, not the stomach). As we noted in the Decision, however, Mehta does not use the word “enteric,” nor does Mehta discuss delivery of the delayed dose to the intestines. Dec. 28. Nevertheless, we considered the possibility that Mehta might inherently disclose a composition that releases into the intestine not less than 80% of the second dose of the drug within about 60 minutes of the delayed release. Accordingly, we turned to Mehta’s Examples 1–5, but determined that not one of the exemplified delayed release compositions achieved a release of “essentially all” of the drug from a delayed release coating within about 60 minutes—regardless of whether the delay was long enough to be considered enteric.3 Id. at 24. As we noted in the Decision,” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“This argument is not persuasive. We considered, for example, Dr. Elder’s testimony that one of ordinary skill in the art would expect “that the number of variables and number of experimental runs to optimize the coating for the amphetamine would present no unusual problems of technology or expense” because one “can use statistical experimental design to optimize a formulation within the 21 trials that Mehta discloses to design one for amphetamine salts” (Ex. 1005 ¶ 471), as well as Dr. Elder’s testimony that one would expect “that routine optimization of the coating using the parameters identified by Mehta would provide enough guidance for controlling the release timing” (id. ¶ 512). Nevertheless, we found the actual results reported by Mehta to be more compelling. As we stated in the Decision: [N]one of Mehta’s delayed release formulations that could be considered to be enteric by virtue of their delay periods (i.e., those with delays of 4 or 5 hours) had release rates of “essentially all” of the drug anywhere near the required time period. Even if Mehta could be read to suggest that a delay of 4 or 5 hours followed by a release of essentially all of the delayed dose within 60 minutes would be desirable, we are not persuaded that Mehta’s disclosure that “the amount of drug released is influenced by: amount of coating, ratio of the two 4 Amerigen supported its challenges with the Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph., executed September 30, 2015 (“Elder Declaration”) (Ex. 1005). polymers, amount of talc, and curing time” is adequate guidance for one of ordinary skill in the art to achieve such a dosage form. In general, Mehta demonstrates that longer delays are accompanied by longer release times, with formulations that could be considered to provide enteric release (i.e., a release after a 4 or 5 hour [delay]) having 85% release times of 8 or more hours. Dec. 33–34 (citing Ex. 1003, Table 1).” slip op. at 8
§ 102 anticipation§ 103 obviousness - 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 - Adlens USA, Inc. / Adlens, Ltd. v. Superfocus Holdings LLC, Superfocus, LLC, Insolvency Services Group, Inc., And Dr. Stephen KurtinAll claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01824 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1–5 are unpatentable as obvious under § 103 over Kurtin ’532 and Kurtin ’629 in view of Gordon and/or Cronin.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “manually adjustable” (claim 1) Patent Owner contends that this term should be construed to mean “capable of being manually adjusted by a wearer of the spectacles.” PO Resp. 7. Petitioner contends that Patent Owner’s proposed construction improperly incorporates an extraneous limitation—by a wearer—into the claims. Pet. Reply 6. We agree with Petitioner. Claim 1 of the ’797 Patent expressly recites “by a wearer” (Ex. 1002, 4:46), but there is no such limitation in either of claims 1 or 4 of the ’487 Patent. Patent Owner identifies various specification passages discussing adjustment by a wearer or user. PO Resp. 7–8. None of these passages amounts to an express definition or disclaimer requiring that “by a wearer” be read into the claims not reciting that phrase. Bigio, 381 F.3d at 1325 (“[T]his court counsels the PTO to avoid the temptation to limit broad claim terms solely on the basis of specification passages.”).” slip op. at 8
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“Our reviewing court instructs that “merely because an element does not include the word ‘means’ does not automatically prevent that element from being construed as a means-plus-function element.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc) (quoting Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed.Cir.1996)). “Generic terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other nonce words that reflect nothing more than verbal constructs may be used in a claim in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’ and therefore may invoke § 112, para. 6.” Id. at 1350. We agree with Patent Owner that the term, “adjustable connector” (claims 1 and 4), should be construed as a means-plus-function term. The word “connector” is “tantamount to using the word ‘means’” because it is a generic description that does not connote a definite structure. Williamson, 792 F.3d at 1350. Dr. Savidis agrees that the term, “adjustable connector,” is a generic term that does not define a particular structure. Ex. 2003, 82:15–84:8. Accordingly, we construe this term in accordance with 35 U.S.C. § 112 ¶ 6.” slip op. at 9
- Skill levelSkill level board ownDecided for petitioner
“B. Person of Ordinary Skill in the Art We determine that a person of ordinary skill in the art would have an undergraduate degree in mechanical engineering or equivalent education and one to two years of experience with optics. Our determination is supported 3 The parties dispute whether the corresponding structure disclosed in the ’487 Patent Specification includes a flexure. PO Resp. 11 (citing Ex. 1001, 4:34–37); Pet. Reply 7 n.2. It is not necessary for us to resolve this dispute because a flexure is not relevant to any ground of unpatentability raised in the Petition. by the testimony of Dr. Plummer (Ex. 2002 ¶ 49), as well as the testimony of Dr. Savidis (Ex. 2003, 66:24–67:7, 67:16–20, 69:14–20). We also rely on Petitioner’s asserted references as establishing the level of skill in the art at the relevant time. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Based upon their stated qualifications, we consider both Dr. Savidis and Dr. Plummer qualified to opine from the viewpoint of a person of ordinary skill in the art regarding the subject matter of the ’487 Patent. Ex. 1002 ¶¶ 5–11, Appendix A (Savidis CV); Ex. 2002 ¶¶ 9–22, Attachment A (Plummer CV).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that a person of ordinary skill in the art would have had a reason or motivation to modify the spectacles of Kurtin ’532 to provide independent adjustability of each lens. Our finding is supported by the undisputed testimony of Dr. Savidis that “the desirability of having independently and manually adjustable, liquid filled, variable focus lenses was known in the art well prior to 2010.” Ex. 1003 ¶ 77. Our finding is further supported by Dr. Savidis’ testimony that both Gordon (Ex. 1007) and Cronin (Ex. 1006) describe adjustable, liquid filled, variable focus eyeglasses in which each eye’s lens can be manually adjustable independently of the other eye’s lens. Id. Dr. Savidis’ testimony (and our finding) is further supported by Gordon, which discloses that the focus of each lens can be independently adjusted by turning a screw. Ex. 1007, Figs. I–IV, 1:67–80, 1:87–100, 2:5– 22; see also Ex. 1011, 75:9–13 (Plummer agrees that Gordon’s screws are independently adjustable.). Dr. Savidis’ testimony (and our finding) is also supported by Cronin, which discloses left and right calibration screws for allowing independent adjustment of the focal length of the left and right lenses, respectively. Ex. 1006, 4:27–32, 5:16–22, 5:66–6:2, Figs. 2 and 4. We also rely on Cronin’s disclosure of the purpose and advantage of the independent adjustment feature: According to Cronin, it allows the focal lengths of the left and right lens assemblies to be matched or related to each other in a pre-determined manner to compensate for unusual visual disorders, thereby avoiding visual discomfort by focusing each of the user’s eyes at sensibly the same object distance. Id. at 5:9–16. The preponderance of the evidence establishes that one way suggested by the prior art to provide independent adjustability of each eye’s lens would have been to replace the non-adjustable connector (leaf hinge 23) of Kurtin ’532 with an adjustable connector, such as the nut, screw, and tab arrangement of Kurtin ’629. See PO Resp. 15 (describing Petitioner’s first proposed modification); Tr. 14:16–20 (Petitioner is relying on modifications 1 and 3.). Our finding is supported by Dr. Savidis’ testimony that, in order to have independent adjustability of each lens unit, a person of ordinary skill in the art would have been motivated to seek a suitable adjuster structure to replace the non-adjustable connector of Kurtin ’532. Ex. 1003 ¶ 77. Our finding is also supported by Dr. Savidis’ testimony that a person of ordinary skill in the art “would have exercised no more than routine skill in the art to implement this substitution by utilizing existing seal 21 of Kurtin ’532 shown in Figure 3 and by attaching tabs to or creating tabs for Kurtin’s ’532 front and rear rings to accommodate Kurtin’s ’629 screw and nut.” Id. ¶ 81. Our finding is further supported by Kurtin ’532 Figure 5, which shows leaf hinge 23 connecting the front and rear rings, and Kurtin ’532 Figure 3, which shows elastomeric bellows 21 allowing the rear ring to move with respect to the front ring. Ex. 1004 ¶¶ 32, 33, Figs. 3, 5. Our finding is further supported by Kurtin ’629, which discloses adjustable spectacles including nut 20, screw 21, and actuating tabs 19, where nut 20 can be turned by the wearer to adjust the optical power of the lenses. Ex. 1009, Abstract, Figs. 1–3, 3:50–4:9.” slip op. at 15
Patent outcomesUS 8,708,487 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,708,487 - Adlens USA, Inc. / Adlens, Ltd. v. Superfocus Holdings LLC, Superfocus, LLC, Insolvency Services Group, Inc., And Dr. Stephen KurtinAll claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01821 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1–12 and 14–17 are unpatentable as obvious over Kurtin ’532 and Kurtin ’629 in view of Gordon and/or Cronin; anticipation by Cronin was not shown for claims 3–12 and 14–17.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, we generally give claim terms their ordinary and customary meaning, as understood by a person of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification . . . when [it] expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “Although an inventor is indeed free to define the specific terms used to describe his or her invention, this must be done with reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We construe claim terms only to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“Our reviewing court instructs that “merely because an element does not include the word ‘means’ does not automatically prevent that element from being construed as a means-plus-function element.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc) (quoting Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed.Cir.1996)). “Generic terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other nonce words that reflect nothing more than verbal constructs may be used in a claim in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’ and therefore may invoke § 112, para. 6.” Id. at 1350. We agree with Patent Owner that the terms, “adjustable element” (claim 3) and “controllable spacing member” (claim 15), should be construed as means-plus-function terms. The words “element” and “member” are the same as or similar to the words the Federal Circuit indicated are “tantamount to using the word ‘means.’” Williamson, 792 F.3d at 1350. Dr. Savidis agrees that the terms, “adjustable element” and “controllable spacing member,” do not define a particular structure. Ex. 2003, 76:4–21, 77:1–7, 80:8–17. Accordingly, we construe these terms in accordance with 35 U.S.C. § 112 ¶ 6. Construing a means-plus-function claim term is a two-step process. We first identify the claimed function, and then we determine what structure disclosed in the specification corresponds to the claimed function. Williamson, 792 F.3d at 1351; In re Donaldson Co., 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc).” slip op. at 9
- Skill levelSkill level board ownDecided for patent owner
“B. Person of Ordinary Skill in the Art We determine that a person of ordinary skill in the art would have an undergraduate degree in mechanical engineering or equivalent education and one to two years of experience with optics. Our determination is supported by the testimony of Dr. Plummer (Ex. 2002 ¶ 49), as well as the testimony of Dr. Savidis (Ex. 2003, 66:24–67:7, 67:16–20, 69:14–20). We also rely on Petitioner’s asserted references as establishing the level of skill in the art at the relevant time. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“Dr. Plummer testifies that “assembly of Gordon’s spectacles would have to be performed by a skilled technician.” Ex. 2002 ¶ 165 (emphasis added). That testimony does not persuasively support Patent Owner’s argument, PO Resp. 45, that Gordon’s adjustment can only be performed by a skilled technician. To the extent that Dr. Plummer’s testimony could be read to support Patent Owner’s argument, we give greater weight to Dr. Savidis’ testimony, which is consistent with Gordon’s disclosure of an adjustment that can be performed “quickly and readily.” Ex. 1013, 1:14, 1:18.” slip op. at 21
Patent outcomesUS 8,967,797 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,967,797 - Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- BurdenMixed
“Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed
“Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19
Patent outcomesUS 8,252,316 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,252,316 - Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- Skill levelSkill level board ownOther
“The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Expert testimonyPetitioner expert creditedDecided for petitioner
“not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
Patent outcomesUS 8,679,524 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,679,524 - Advanced Micro Devices, Inc. v. LG Electronics Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01409 · APJ Garth D Baer · IPR · Final written decision
Claims 4, 8, and 9 are unpatentable under § 103; claim 30 was not shown unpatentable because the prior art did not teach shutdown based on total processor use below a threshold.
RulingsFinal written decision- BurdenOther
“III. ANALYSIS A. PRINCIPLES OF LAW Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Public accessibility” is the touchstone in determining whether a reference is a “printed publication.” In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986). A reference is publicly accessible upon a satisfactory showing that such document has been made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it. Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (quoting SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)). slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). We presume a claim term carries its “ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only those claim terms necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for patent owner
“We decline to disregard all of Mr. Gafford’s testimony. In light of Mr. Gafford’s education and experience (a Bachelor of Science Degree in Electrical Engineering and over 43 years working for corporations in the design, manufacturing, and support for computer systems and microprocessors, see Ex. 1011 ¶¶ 14–20), we see no reason why Mr. Gafford’s frequent participation in other cases—even to ultimately mixed results—makes his testimony here unhelpful in understanding the evidence in this case. See Fed. R. Evid. 702(a). In assessing the merits of this case, we have considered the proffered testimony from Mr. Gafford, as well as Patent Owner’s Declarant Dr. Friedman, and accorded weight based on the testimony’s substantive persuasiveness.” slip op. at 29
Patent outcomesUS 7,636,863 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,636,863 - Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution deniedPTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[U]nless a reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14
§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 6,667,061 - Hamilton Beach Brands, Inc. v. F’Real Foods, LLCInstitution deniedPTAB · Nov 30, 2016 · IPR2016-01105 · APJ Brian P Murphy · IPR · Institution
Institution was denied because Petitioner did not show a reasonable likelihood of proving claims 1 and 6–11 anticipated by Neilson or claims 1 and 5–11 obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“October 6, 2014—the date the 2014 Complaint alleging infringement of the ’658 patent was served on Petitioner. Prelim. Resp. 5, 11. It is undisputed, however, that Patent Owner did not own the ’658 patent at the time the 2014 Complaint was filed and served. Pet. 4; Prelim. Resp. 7; Ex. 1030 ¶¶ 5–7. Title to the ’658 patent was transferred to Patent Owner by an assignment executed January 25, 2016. Pet. 4; Prelim. Resp. 9; Ex. 1030 ¶ 7, Ex. C (patent assignment). Accordingly, Patent Owner lacked standing to sue for infringement of the ’658 patent at the time the 2014 Complaint was filed and served. Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309 (Fed. Cir. 2003) (“[I]n order to assert standing for patent infringement, the plaintiff must demonstrate that it held enforceable title to the patent at the inception of the lawsuit.”). The patent counts of the 2014 Complaint were jurisdictionally defective, and the defect could not be cured after the filing date of the complaint, e.g., by a subsequent assignment or by joining the patent title holder to the lawsuit. Alps S., LLC v. Ohio Willow Wood Co., 787 F.3d 1379, 1385 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 897 (2016) (“The party asserting patent infringement is ‘required to have legal title to the patents on the day it filed the complaint and that requirement can not be met retroactively.’”) (quoting Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1366 (Fed. Cir. 2010)). The Delaware district court was required to—and actually did— dismiss the patent infringement counts of the 2014 Complaint for lack of Article III standing. Ex. 1031 n.1 (Delaware district court order granting motion for voluntary dismissal: “the court lacks jurisdiction to make a judgment on the merits”); see also, Abraxis, 625 F.3d at 1367 (“[T]he action must be dismissed because [plaintiff] lacked standing on the day it filed the action.”); Schreiber Foods, Inc. v. Beatrice Cheese, Inc., 402 F.3d 1198, 1203 (Fed. Cir. 2005) (“[I]f the original plaintiff lacked Article III initial standing, the suit must be dismissed, and the jurisdictional defect cannot be cured by the addition of a party with standing, . . . nor by the subsequent purchase of an interest in the patent in suit.”) (citing Paradise, 315 F.3d at 1309). Thus, the allegation of infringement of the ’658 patent in the 2014 Complaint was not a proper federal pleading and did not trigger the one-year time period under 35 U.S.C. § 315(b). Petitioner was not served with a complaint properly alleging infringement of the ’658 patent until January 2016. The instant petition was filed in May 2016. Accordingly, the Petition is not time-barred under § 315(b).” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“unpatentable under 35 U.S.C. § 102(b) and claims 1 and 5–11 as unpatentable under § 103. Pet. 9. Based on the arguments and evidence presented in the Petition and Preliminary Response, we determine Petitioner has not established a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Therefore, institution of an inter partes review is denied.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Petitioner and Patent Owner offer competing constructions for several claim terms. Pet. 18–20; Prelim. Resp. 26–35. We determine that only the following claim terms require express 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.’”) (citation omitted).” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“position.” During a mixing operation, the ’658 patent describes how the cup holder is reciprocated to move axially upward so the mixing element is in a position within the liquid-filled cup, i.e. the recited “first position,” then reciprocated downward so the mixing element is moved upward to the recited “second position” closer to the opening at the top of the cup, “to allow the blade to pass through the full contents of the cup more than one time.” Ex. 1001, 3:58–64. When the mixing element is moved upward within the cup to the second position, the weight of the splash shield must be sufficient to keep the liquid-filled cup in the cup holder. Id. at 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The force generated by upward movement of the mixing element is not further described in the ’658 patent, although the ’658 patent provides a preferred embodiment where a splash shield weighing 5 pounds (dependent claim 5) provides sufficient downward force to perform the recited function. Id. at 4:20–23. Petitioner argues that “sufficient mass” in claim 1 should be construed in accordance with the interpretation allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to retain the cup in the cupholder during mixing.” Pet. 19 (no citation). Petitioner further argues that “the mass of the splash shield” limitation in claim 6 should be construed in accordance with the construction allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to prevent separation of the cup from the cupholder during mixing.” Id. (no citation). Patent Owner responds with a slightly different interpretation of a splash shield having a “sufficient mass”: “heavy enough to retain the vessel within the holder during relative movement of the mixing element and vessel.” Prelim. Resp. 31 (citing Ex. 1001, 4:3–24; Ex. 2025 (definition of “sufficient”)). Both parties appear to agree that the ’658 patent describes the “sufficient mass” of the splash shield in functional terms as enough weight to retain the vessel or cup within the holder during mixing. Ex. 1001, 3:65– 4:23. Based on the description provided in the ’658 patent, the claim language at issue in claim 1 – “the splash shield having sufficient mass to retain the vessel within the holder during relative movement of the mixing element and vessel from the first position to the second position when liquid is present in the vessel” – is entitled to its plain and ordinary meaning: “the splash shield is heavy enough to create sufficient downward force on the vessel so as to retain the vessel within the holder when the mixing element moves upwardly in the vessel from the first position to the second position when liquid is present.” See Ex. 1001, 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The claim language in claim 6 “the mass of the splash shield preventing separation of the holder and the vessel during translation” is similarly construed to mean “the splash shield is heavy enough to create sufficient downward force on the vessel so as to prevent separation of the holder and the vessel during translation of the mixing element or holder.”” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,520,658 - Vista Outdoor Operations LLC v. Liberty Ammunition, LLCRehearing deniedPTAB · Oct 31, 2016 · IPR2016-00539 · APJ Michael L Woods · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution for claims 1–42 on all six grounds, finding no overlooked or misapprehended matter.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. 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, opposition, or a reply. Furthermore, when rehearing a decision on a motion, the Board will review the decision for an abuse of discretion. Id. at § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,748,325
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.