- Swiss Pharma International AG v. Biogen IdecRehearing deniedPTAB · Feb 3, 2017 · IPR2016-00915 · APJ Lora M Green · IPR · Rehearing
The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–4 because the petition did not show a reasonable likelihood of obviousness.
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 Patent Owner’s arguments with these principles in mind.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As noted in our Decision, however, Petitioner failed to demonstrate that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 10‒12 (quoting Pet. 27). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 10. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 12‒13.” slip op. at 7
- Obviousness (§103) › KSR rationalesMotivation not foundDecided for patent owner
“The court held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Id. at 456. The court noted, however, that “changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” Id. In concluding that the patentability of the claims was not demonstrated, the court noted that “[a]ny chemist reading the article could logically assume that higher yields might be obtainable, and by experimentally varying the conditions of temperature and acidity could find the most productive conditions.” Id. at 458. In In re Antonie, 559 F.2d 618 (CCPA 1977), the court noted, however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 7
- BurdenDecided for patent owner
“37 C.F.R. § 42.108 relates to institution of inter partes review. 37 C.F.R. § 42.108(c) states: Sufficient grounds. Inter partes review shall not be instituted for a ground of unpatentability unless the Board decides that the petition supporting the ground would demonstrate that there is a reasonable likelihood that at least one of the claims challenged in the petition is unpatentable. The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. A petitioner may seek leave to file a reply to the preliminary response in accordance with §§ 42.23 and 42.24(c). Any such request must make a showing of good cause. 37 C.F.R. § 42.108(c), therefore, applies to those situations in which patent owner submits testimonial evidence to support its preliminary response. In those situations where that testimonial evidence creates an issue of material fact, the evidence will be considered in the light most favorable to the petitioner. Patent Owner did not submit any such testimonial evidence in support of its Preliminary Response in the instant proceeding. Moreover, the rule does not relieve Petitioner of its burden of demonstrating in its Petition a reasonable likelihood that at least one of the challenged claims is unpatentable, such that inter partes review may be instituted. In the instant proceeding, for the reasons discussed in the Decision, we determined that the Petition failed to make such a showing.” slip op. at 11
§ 103 obviousnessPatents in suitUS 8,349,321 - Swiss Pharma International AG v. Biogen IdecRehearing deniedPTAB · Feb 3, 2017 · IPR2016-00916 · APJ Lora M Green · IPR · Rehearing
The Board denied rehearing of its denial of institution because Petitioner did not show an abuse of discretion in finding the obviousness showing insufficient.
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 Patent Owner’s arguments with these principles in mind.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As noted in our Decision, however, Petitioner failed to demonstrate that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 11‒12 (quoting Pet. 27‒28). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 11. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 13.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 11‒12 (quoting Pet. 27‒28). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 11. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 13.” slip op. at 7
§ 103 obviousnessPatents in suitUS 8,900,577 - Advanced Micro Devices, Inc. v. LG Electronics Inc.Rehearing deniedPTAB · Feb 2, 2017 · IPR2015-01409 · APJ Garth D Baer · IPR · Rehearing
The Board denied AMD’s rehearing request, leaving unchanged its determination that AMD had not shown claim 30 unpatentable over Orenstien, Nicol, and ACPI.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“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.” 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
- Strike new argumentNew argument disregardedDecided for patent owner
“We find Petitioner’s predictable-variation argument is not persuasive because Petitioner did not raise it in the Petition. Instead, when mapping Orenstien to the disputed element, Petitioner merely quoted Orenstien’s separate processor-monitoring and core-shutdown teachings and, without further discussion, concluded “a POSA would have understood Orenstien to teach or suggest that a core of a multi-core processor could be turned off if the total use amount of the processor fell below a prescribed value.” Pet. 41–42; see Ex. 1011 ¶¶ 49, 169, 170; Paper 20, 15–17. That mapping did not address “predictable variations” of Orenstein’s teachings, or suggest that leakage current or power consumption would have motivated one skilled in the art to combine Orenstein’s separate teachings. Id. Accordingly, we did not misapprehend or overlook this argument because Petitioner did not raise it in the Petition.” slip op. at 4
- BurdenNot shown unpatentable
“In our Decision, we concluded Petitioner had not met its burden of showing claim 30 would have been obvious over Orenstien,1 Nicol,2 and ACPI.3 Dec. 21–23. Specifically, we determined Petitioner did not show sufficiently that Orenstien discloses “the computer to turn off at least one core . . . when the determined processor use amount is less than a second prescribed value,” as claim 30 requires. Id.” slip op. at 2
NonePatents in suitUS 7,636,863 - 10x Genomics, Inc. v. Raindance Technologies, Inc.All claims unpatentablePTAB · Jan 18, 2017 · IPR2015-01558 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1–17 are unpatentable: claims 1–7 and 10–17 as obvious over Link, and claims 8–9 as obvious over Link and Nguyen.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We accept Petitioner’s assertions regarding the level of ordinary skill in the art, as set forth in the paragraph bridging pages 3 and 4 of the Petition. Our finding is supported by Dr. Huck’s testimony (Ex. 1002 ¶ 12), as well as the prior art references cited by Petitioner, which reflect the level of skill in the art asserted by Petitioner. See, e.g., Ex. 1004 ¶¶ 160, 316 (discussing use of aqueous droplets in microfluidic devices as “nanoreactors” for chemical and biochemical reactions and assays); Ex. 1006, 2 (discussing principles of fluid dynamics relevant to droplet formation in microfluidic devices); Ex. 1009,1 2032 (review article addressing fluid dynamics of microfluidic droplets, including for “lab on a chip” applications in which chemical or biochemical reactions are performed in droplets). See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the level of skill in the art).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“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). 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)). Construction of claims 1–3 is discussed below in connection with patentability of those claims over Link. Except for the terms of claims 1–3 discussed below, we determine that it is not necessary to provide an explicit construction of any other claim term for purposes of this decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Under a broadest reasonable construction, the phrase, “a reservoir,” in claim 2 means one or more reservoirs. See Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008) (“[A]n indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of ‘one or more’ in open-ended claims containing the transitional phrase ‘comprising.’”). Applying this construction in context, claim 2 requires that each carrier fluid channel be in fluid communication with one or more reservoirs, all of which apply a same constant pressure to the carrier fluid. Based on that construction, we do not accept Patent Owner’s position that claim 2 requires a common syringe for all of the oil channels in the system. PO Resp. 40.” slip op. at 34
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“droplet formation disclosed in Link relates to the step of “applying a same constant pressure to the carrier fluid in each of the immiscible carrier fluid channels.” Ex. 1001, 16:17–28. More specifically, we find that, although Link teaches controlling pressures applied to the carrier fluid and aqueous fluid channels to regulate droplet size and periodicity (Ex. 1004 ¶ 166), Link does not expressly disclose applying a “same constant pressure” to the carrier fluid in each of the immiscible carrier fluid channels, as recited in the penultimate step of claim 1. For the reasons discussed below, we find that the preponderance of the evidence supports that a person of ordinary skill in the art would have found it obvious to implement Link’s disclosures by applying a same constant pressure to the carrier fluid in each of the immiscible carrier fluid channels. This step of claim 1 includes two aspects: (1) applying a same pressure, and (2) applying a constant pressure. We discuss each aspect below.” slip op. at 16
Patent outcomesUS 8,658,430 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,658,430 - Advanced Micro Devices, Inc. v. LG Electronics Inc.All claims unpatentablePTAB · Jan 4, 2017 · IPR2015-01411 · APJ Kalyan K Deshpande · IPR · Final written decision
Claims 1, 9–13, 15, 19, and 20 are unpatentable as obvious over Zhang and Altmejd and over Orenstien and Filippo.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“We interpreted “power conversion unit,” under the broadest reasonable interpretation, to mean “a system or device that changes power from one form or level to another” in our Decision to Institute. Dec. 5‒6. Patent Owner has not presented any further arguments that would require us to disturb that construction. Accordingly, on this record, we interpret “power conversion unit” to mean “a system or device that changes power from one form or level to another.” See id. 2. “power management unit” Claim 1 recites a “power management unit.” In our Decision to Institute, we interpreted “power management unit” to mean “hardware or software that manages or assists in managing of power.” Id. at 6‒8. Patent Owner does not present any arguments that would require us to disturb that construction. Accordingly, on this record, we interpret “power management unit” to mean “hardware or software that manages or assists in managing of power.” See id..” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“blocks and processor cores, including the vast differences in sizes and structure, communication patterns, timing issues, and redesign of circuitry are not persuasive because they assume a bodily incorporation of Altmejd’s functional units in to Zhang’s processor core system, whereas Petitioner’s rationale to combine is limited to power-management of processor cores of Zhang with the power-management policy taught by Altmejd. “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference. . . . Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, the issue is what the combination of Zhang and Altmejd would have suggested to a person with ordinary skill in the art. Altmejd discloses the adjustment of power to functional units based on usage amounts, and a person with ordinary skill in the art would have been motivated to combine the specifics of Altmejd’s power management policies in to Zhang. Pet. 16‒17 (citing Ex. 1002 ¶ 47). Specifically, a person with ordinary skill in the art would have been motivated to combine Altmejd’s power management policy to Zhang in order to provide a more granular and efficient power management policy, and, as explained by Mr. Gafford, Altmejd’s power management policy would lead to more cost savings. Id. at 17‒18 (citing Ex. 1002 ¶ 48). Petitioner identifies that this motivation is explicitly disclosed in the Zhang and Altmejd, where Zhang discloses the individual turning off of processor cores “may result in a reduction of the overall power consumed by the processor” (Ex. 1006 ¶ 30), and Altmejd discloses that “it is advantageous from a power savings perspective to reduce the voltage when possible because the power saved is proportional to the square of the voltage reduction, whereas the power savings is linear with respect to frequency reductions” (Ex. 1007, 7:9–13). Pet. 18‒19 (citing Ex. 1002 ¶ 49). Petitioner’s analysis demonstrates that the claimed combination is merely a combination of known elements, for their known use to achieve a predictable result. Accordingly, we are not persuaded by Patent Owner’s argument that a person with ordinary skill in the art would not have been led to combine the teachings of Zhang and Altmejd because of the difference between functional units and processor cores only. Rather, Petitioner has demonstrated by a preponderance of the evidence that a person with ordinary skill in the art would have been motivated to combine the power management policy described by Altmejd in to Zhang’s multi-core processor management system.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We disagree with Patent Owner. “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” Ricoh Co., Ltd. v. Quanta Computer, Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008) (citations and quotation marks omitted). We are unpersuaded by Patent Owner’s citations to Orenstien as criticizing an on/off scheme as teaching away from such a scheme. Orenstien’s disclosure of such a scheme’s impact on performance and latency is, at best, a general preference to minimize the use of an on/off scheme. A reference does not teach away if it merely expresses a general preference for an alternative invention from amongst options available to the ordinarily skilled artisan, but does not discredit or discourage investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Orenstien’s characterization is more fully understood as a preference, rather than discouragement or discrediting, because, as argued by Petitioner, Orenstien discloses an embodiment that turns a processor core off. Pet. Reply 15 (citing Ex. 1008, 6:6‒46, Fig. 4; Pet. 43; Ex. 1002 ¶ 103).” slip op. at 25
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We disagree with Patent Owner. Claim 1 recites “a first power conversion unit configured to independently supply a first supply voltage to the first core” and “a second power conversion unit configured to independently supply a second supply voltage to the second core.” Claim 1 further recites “the first supply voltage being controlled based on the information relating to the usage amount of the first core and being controlled independent of the information relating to the usage amount of the second core” and “the second supply voltage being controlled based on the information relating to the usage amount of the second core and being controlled independent of the information relating to the usage amount of the first core.” As such, although we agree with Patent Owner that claim 1 explicitly requires that the voltages supplied to the first and second core are based on usage information of that core, and independent of the usage information of the other core, we agree with Petitioner that claim 1 does not recite the “based only on” language as alleged by Patent Owner. Regardless, we determine that the combination of Zhang and Altmejd discloses the claimed limitations under either construction. See id. As discussed above, Zhang discloses supplying voltages to each core” slip op. at 16
Patent outcomesUS 7,664,971 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,664,971 - 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 - 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 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01096 · APJ Michael P Tierney · IPR · Final written decision
Claims 1–32 are unpatentable as obvious over Thalomid PI in view of Cunningham, Keravich, Zeldis, and Mundt.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedOther
“representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003, 1006, 1009, 1012, 1018. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1021 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“for close constant monitoring to identify noncompliance or other problems, but concluded by stating that Celgene was committed to making the program succeed and would be willing to make any modifications to the program necessary to ensure its effectiveness. Ex. 1012 at 329. This willingness to make any modifications is consistent with the understanding that the underlying drug remains a safety concern because controlling the distribution of the drug does not negate the actual side effects of the underlying drug. In dealing with such drugs, such as those capable of causing severe birth defects, the highest level of safety is desired. Under such circumstances, consistent with the teachings of Zeldis and the art of record one skilled in the art would understand that where significant safety risks exist with a drug, one would continuously search for safer ways to control the distribution of the drug. Put simply, where significant safety concerns exists, one of ordinary skill in the art would not wait until an accident occurred to seek out improvements.” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“limitations recited in independent claims 1 and 28, with the exception of the generation of a prescription approval code to be retrieved by a pharmacy before the prescription is filled. Pet. 52. Petitioner states that one skilled in the art, following the teachings of Thalomid PI and seeking to avoid treating pregnant women with thalidomide, would have implemented the methods disclosed in Cunningham to limit dispensation of a drug associated with adverse effects to certain risk groups. Id. at 54. We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 20
Patent outcomesUS 6,315,720 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,315,720 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01103 · APJ Michael P Tierney · IPR · Final written decision
Claims 1–32 are unpatentable as obvious over Mitchell and Dishman in view of Cunningham and the additional cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2067. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 43–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b). Generally, Petitioner states that the claim terms are presumed to take on the ordinary and customary meaning that they would have to one of ordinary skill in the art. Pet. at 10. Petitioner proposes constructions for several claim terms including “consulted,” “teratogenic effect,” and “adverse side effect.” Id. at 10–11. Patent Owner does not propose distinct constructions of the identified terms. We determine that the identified claim terms should be given their ordinary and customary meaning, as would be understood by one with ordinary skill in the art, and need not be construed explicitly at this time for purposes of this Decision.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 14
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
Patent outcomesUS 6,315,720 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,315,720 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01102 · APJ Michael P Tierney · IPR · Final written decision
Claims 1–32 are unpatentable as obvious over Powell and Dishman in view of Cunningham and the additional cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Based on the record presented, we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2066. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“The specification defines prescription approval code such that the prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Patent Owner states that Cunningham’s pharmacy approval code is part of a method of tracking and managing the dispensing of pharmaceutical trial products and has no connection to patient information at all. Id. at 38. Patent Owner also states that Cunningham’s pharmacy approval code is merely a number or identifier associated with samples of pharmaceutical products. Id. at 39. Patent Owner contends that a person of ordinary skill in the art would have therefore understood that Cunningham’s pharmacy approval code is not the same as the claimed prescription approval code. Id. at 39–40. Cunningham describes a method of dispensing, tracking, and managing pharmaceutical products whereby prescribers and pharmacies are linked to a central computing station. Ex. 1008, 1:6–11. Certain pharmaceutical drugs, such as thalidomide, were known in the art to require a prescription in order for a patient to be provided the drug whereby a prescriber would authorize a patient to receive a drug from a pharmacy. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421. Dr. Fudin testified that the use of an approval code of Cunningham could be like that of a consumer credit card approval code, and is used to track things and the technology should allow you to combine it with other materials that you could track. Ex. 2061 at 412:17–25, 429:18–430:10. Based on the record presented, we hold that a person of ordinary skill in the art would understand that an approval code used by prescribers and pharmacies to track and manage pharmaceutical products could likewise be used by prescribers and pharmacies to track and manage prescription pharmaceutical products. We further hold that the claimed improvement recited in the challenged claims represents a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects).” slip op. at 25
Patent outcomesUS 6,315,720 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,315,720
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.