- 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 - Coalition For Affordable Drugs Vi LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01092 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1–10 are unpatentable as obvious under § 103 over Powell, Mitchell, and Dishman.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner
“qualifications of an ordinary artisan, over the somewhat different qualifications proposed by Petitioner, would materially alter the obviousness inquiry. The prior art references asserted in the Petition are representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (absence of specific findings on “level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent that a more specific definition of the ordinary artisan is required, we hold that the definition encompasses pharmacists and other persons having experience restricting the distribution of teratogenic drugs. Specifically, we find that the prior art references, like the ’501 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”); Ex. 1005, 901 (Powell, disclosing guidelines for restricting the distribution of thalidomide); Ex. 1006, 101 (Mitchell, describing a method for restricting the distribution of the teratogenic drug Accutane); Ex. 1007, 899 (Dishman, describing a national registry for restricting distribution of the psychoactive drug Clozaril). Consistent with the prior art, Dr. Fudin testifies that the types of problems encountered by a person of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1002 ¶¶ 33–55. The prior art demonstrates that a person of ordinary skill in the art would have experience in controlling the distribution of a drug. We credit Dr. Fudin’s testimony that a person of ordinary skill in the art would encompass a pharmacist. Ex. 1002 ¶ 15. We also credit Dr. Frau’s testimony that an ordinary artisan would not be limited to pharmacists but also would encompass persons having at least two years of experience in risk management relating to pharmaceutical products, as pharmacists are not the only persons having restricted drug distribution experience and knowledge. Ex. 2059 ¶ 60. Accordingly, we find that a person of ordinary skill in the art would include pharmacists and persons having at least two years of experience in risk management relating to pharmaceutical products as pharmacists. Additionally, we determine that, even if we were to adopt verbatim Dr. Frau’s definition of ordinary skill in the art, Patent Owner has failed to present sufficient and credible evidence to persuade us that Patent Owner’s defined person of ordinary skill in the art would be led to a different outcome regarding the obviousness of the challenged claims. Specifically, Dr. DiPiro, testifying for Patent Owner, acknowledged that many” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“No claim term requires express construction for the purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). One issue of claim construction, however, requires some discussion. Patent Owner argues that the term “computer readable storage medium” in claim 1 should be read to require a “centralized” computer readable storage medium—namely “a centralized database that includes all registration information regarding the claimed prescribers, pharmacies, and patients.” Resp. 22, 35. We are not persuaded that the wording of the claim, or the disclosure of the ’501 patent specification, supports Patent Owner’s view.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“distribution of Accutane and Dishman’s method for controlling distribution of Clozaril—and apply those features to controlling the distribution of another potentially hazardous drug (thalidomide, which Powell discusses as requiring controlled distribution). Patent Owner’s contention that a person of ordinary skill in the art would not have recognized or applied the teachings of Mitchell or Dishman to the problem identified in Powell lacks merit. Resp. 49–53. On that point, Patent Owner itself identifies in the Response an article, which explains that Patent Owner’s “plan [for thalidomide] is built on experience with restrictions on such other drugs with severe side effects as Accutane . . . and Clorazil.” Ex. 2063, 1136; see Resp. 6 (quoting Ex. 2063, 1135). Furthermore, both of Patent Owner’s witnesses acknowledged the relevance of the programs disclosed in Mitchell and Dishman to the problem at hand, namely, controlling distribution of thalidomide. Specifically, Dr. DiPiro testified that, “in some of the literature where isotretinoin [Accutane] and clozapine [Clorazil] systems were discussed,” even researchers employed by Patent Owner recognized “that the results from these systems could guide an individual in either direction, as a way to do it or as a way not to do it. So in that sense they are relevant.” Ex. 1066, 326:23–327:5. Dr. Frau similarly acknowledged that the clozapine program was a restricted distribution program (Ex. 1067, 112:7–15; 113:3–8) and, thus, addressed the very same problem that would have been focused upon by a person of ordinary skill in the art. We find unpersuasive Patent Owner’s assertions that a person of ordinary skill in the art would not have been led to consider the combined disclosures of Mitchell, Dishman and Powell—all of which pertain to controlling the distribution of a drug to a subpopulation of patients likely to suffer serious side effects. Resp. 31–32, 38–41 (arguing that various features of known methods for controlling distribution of Accutane and Clozaril, as disclosed or suggested by the combined prior art, would not have been applied to controlling distribution of thalidomide in the manner claimed). Patent Owner, in essence, argues that an ordinary artisan would understand each applied reference only for its express teachings and would not have applied those teachings beyond the specific uses disclosed in the particular prior art reference. However, “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. In that regard, we are persuaded that the invention of claim 1 represents the “predictable use of prior art elements according to their established functions.” KSR Int’l, 550 U.S. at 417. Claim 1 is directed to a combination of known steps (registering patients, prescribers, and pharmacies in a computer readable storage medium; identifying and counseling a subpopulation of patients whose access to a teratogenic drug should be restricted; and authorizing drug therapy only for non-pregnant patients) to accomplish a known purpose (prescribing drug only to non-pregnant patients) and achieve a predictable result (preventing fetal exposure to the drug). Pet. 36–41 (claim chart). We agree with Petitioner that Patent Owner approaches this dispute as if the ground set for trial was based on anticipation. Reply 14 (pointing out that Patent Owner’s Response “reads as if [the ground set for trial] was based on an anticipation”). For example, Patent Owner focuses on specific features not present in one applied reference, without meeting head on the question whether all the features would have been suggested by the combined disclosures of the prior art. See Resp. 25–29, 31–32, 36–37 (attacking disclosures of each applied reference in isolation). Patent Owner’s attack on the individual disclosures of Powell, Mitchell, and Dishman is ineffective to counter Petitioner’s evidence that the subject matter of claim 1 would have been obvious over the combined disclosures of those prior” slip op. at 22
- Expert testimonyPetitioner expert creditedDecided for petitioner
“As an initial matter, we determine that Petitioner complies with our rules, and precedent of our reviewing court, by presenting Mann as objective support for Dr. Fudin’s opinion testimony. See 37 C.F.R. § 42.65(a) (opinion testimony that does not disclose underlying facts “is entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (lack of objective support for expert opinion “may render the testimony of little probative value in a validity determination”). We have considered, but find unpersuasive, Patent Owner’s counterview that the Board should disregard Mann because, according to Patent Owner, the reference is directed “to teratologists or reproductive toxicologists, not pharmacists or [] those focusing on risk management.” Resp. 44. Patent Owner’s position on that point is not persuasive in view of Patent Owner’s own prior reliance on information supplied by teratologists in connection with the controlled distribution of thalidomide. Reply 16–17 (citing Ex. 2094, 7, 130, 137). Taking account of the full record developed during trial, we credit Dr. Fudin’s testimony that a person of ordinary skill in the art would have recognized the desirability of identifying a subpopulation of male patients in view of Mann. Ex. 1002 ¶¶ 95–98. We are persuaded that Mann reveals the state of the art at the time of the invention, and supports Dr. Fudin’s testimony that an ordinary artisan would have 7 Passage of Chemicals into Human and Animal Semen: Mechanisms and Significance, Thaddeus Mann and Cecelia Lutwak-Mann, CRC Critical Reviews in Toxicology (1982) 11:1, 1–14 (Ex. 1018, “Mann”). understood the necessity of counseling males, capable of impregnating females, about the risks that attend fetal exposure to a teratogenic drug. Pet. 23 (quoting Ex. 1002 ¶¶ 95–98 (citing Ex. 1018, 7–8) (Mann, suggesting that thalidomide was known to become “strongly adsorbed by spermatozoa” and adversely affect the pregnancy in female rabbits mated to males that were administered thalidomide prior to conception)). We have considered, but are not persuaded by, Patent Owner’s counterview that one would not have considered Mann’s discussion of rabbit sperm to apply to human sperm. Resp. 44–45. As Petitioner points out, Patent Owner previously admitted that studies relating to rabbit sperm were relevant to evaluating the effects of thalidomide on human sperm. Reply 17 (citing Ex. 2064, 951). Dr. Fudin’s opinion—that it would have been “apparent that the sperm of male patients could be damaged by teratogenic drugs and consequently result in birth defects, if the male was to impregnate a female”—is supported by objective factual evidence, namely, Mann. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Ex. 1018, 7–8)). We recognize that Powell’s Patient Information Sheet, under a heading relating to “side effects,” contains this statement: “No effects on male sperm are recognized.” Ex. 1005, 903; Resp. 45. That isolated statement in Powell, standing alone, does not defeat the sufficiency of Petitioner’s evidence that one of ordinary skill in the art would have recognized that the sperm of male patients, treated with teratogenic drugs, could result in birth defects. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Mann (Ex. 1018, 7–8)). Significantly, the statement in Powell is preceded by a discussion of the necessity of using “adequate contraception throughout the duration of thalidomide therapy.” Ex. 1005, 903. When read in the context of the surrounding disclosure, Powell suggests that no contraceptive “effects on male sperm are recognized” as a side effect of thalidomide therapy. Id.” slip op. at 16
Patent outcomesUS 6,045,501 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 6,045,501 - PTAB · Oct 20, 2016 · IPR2015-01047 · APJ Stephen C Siu · IPR · Rehearing
The Board denied VirnetX’s rehearing request, rejecting its real-party-in-interest arguments and finding the challenged claims remained unpatentable based on the Petition and Kiuchi.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“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 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.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“Paper 82, 8. We are not persuaded by Patent Owner’s argument. Even assuming that Petitioner, in fact, “admitted that the US Feeder and the Cayman Feeder are ‘controlling shareholders’ of the Mangrove Petitioner,” as Patent Owner asserts, Patent Owner does not demonstrate persuasively that Petitioner also “admitted” that the “US Feeder and the Cayman Feeder” exerted control over the filing or preparation of the Petition. Nor does Patent Owner provide sufficient evidence demonstrating such control.” slip op. at 2
- Expert testimonyDecided for petitioner
“1003 is entitled to no weight and reverse its findings of unpatentability that improperly rely on Exhibit 1003.” Paper 82, 14. Reference to Exhibit 1003 in the Decision was made in conjunction with the Petition in describing the Kiuchi disclosure with respect to claim features. Decision 5. We note that Exhibit 1003 merely confirms what is already apparent in the Petition and/or the Kiuchi reference itself (both of which are also relied upon in consideration of the Kiuchi reference with respect to claim features). Hence, to the extent that any modifications might have been made to the relevant portions of Exhibit 1003, we conclude that such alleged potential modifications (if any) are of insubstantial relevance in view of the fact that analysis of the Petition and the Kiuchi reference itself (without reliance on Exhibit 1003 in this regard) indicate that Petitioner has met its burden by a preponderance of the evidence that claims 1, 2, 6–8, and 12–14 of the ’151 patent are unpatentable, as indicated in the Decision. See, e.g., Decision 1-4, 6-24, and 26-38. Reference to Exhibit 1003 in the Decision was also made in the Petition as corroboration that RFC documents are “publications [that] are prepared and distributed,” “published and widely distributed” for “a period for others to provide comments on the document,” “can be obtained from a number of Internet hosts using . . . document-retrieval systems,” and contain a date “in the top right corner of the first page of the document.” Decision 25. Such testimony merely corroborates what is already clear on its face. For example, the fact that RFC documents are prepared and distributed, are for others to provide comments, are published on a specific date, and that the top right corner of such documents specify a date is clear on simple inspection of the RFC document itself. Therefore, we determine that the importance of any alleged modifications to Dr. Guerin’s testimony confirming what is already apparent on its face is of insubstantial importance. Also, Patent Owner does not demonstrate sufficiently that any modifications were, in fact, made to Dr. Guerin’s testimony that RFC documents are published on a specific date and that the top right corner of such documents specify a date.” slip op. at 6
NonePatents in suitUS 7,490,151 - PTAB · Oct 19, 2016 · IPR2016-00379 · APJ Tina E Hulse · IPR · Rehearing
The Board denied rehearing and declined to institute review of claims 1–6 under § 325(d), finding substantially the same art and arguments had been presented previously.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Petitioner relies primarily on the same prior art that the examiner relied on during examination. See Dec. 9 (noting Petitioner and examiner both relied on Van Lommen1). Because, under 35 U.S.C. § 325(d), we have discretion to reject a Petition if “the same or substantially the same prior art or arguments previously were presented to the Office,” Petitioner has not established that we abused our discretion in denying the Petition because substantially the same prior art was previously before the Office. See § 325(d) (emphasis added).” slip op. at 3
Discretionary denialPatents in suitUS 6,545,040 - Nestlé USA, Inc. v. Steuben Foods, Inc.Rehearing deniedPTAB · Sep 26, 2016 · IPR2015-00195 · APJ Christopher G Paulraj · IPR · Rehearing
The Board denied Steuben Foods’ rehearing request, leaving claims unpatentable over the Biewendt-based combination because the evidence supported the Board’s obviousness conclusion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The requirements for rehearing are set forth in 37 C.F.R. § 42.71(d), which provides, in relevant part, that “[t]he burden of showing a decision should be modified lies with the party challenging the decision,” and that “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” We determine that we did not misapprehend the evidence and arguments of record supporting our conclusion of obviousness based on Biewendt, and for the reasons that follow, Patent Owner’s request for rehearing is denied. .” slip op. at 2
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Second, Patent Owner has failed to demonstrate error in our consideration of Dr. Heldman’s unequivocal testimony—based on his studying of clean room technology for 40 years—that he expected that Biewendt’s sterilization machine would be kept above atmospheric pressure based on its description as a “clean room.” FWD, 29; see generally Ex. 2055, 146:3–157:19. Indeed we accorded the testimony of both Dr. Heldman and Dr. Sharon the weight that was appropriate in view of the arguments and evidence of record in the trial.1 As to Patent Owner’s argument that this was a “new position” not presented in the Petition or the accompanying declaration, we note that Dr. Heldman was merely responding to questions posed by Patent Owner’s counsel during his deposition, rather than injecting a new theory of his own accord. See, e.g., Ex. 2055, 147:13–14 (“Q. Are all clean rooms overpressured? A. That's the only design that I know.”). Dr. Heldman’s testimony is consistent with the statement in the Petition “that the entire sterilization machine of Biewendt is maintained under positive pressure to prevent contamination from the” slip op. at 3
- Strike new argumentNew argument disregardedDecided for petitioner
“argument that we “overlooked the fact that the cited passage in ZFL says that the “fully enclosed system, which is ventilated by sterile air at a slight overpressure, is free of unsterile transport media that may get into the system and works with packages and lids which are sterile on all sides.” Req. Reh’g 4 (citing Ex. 1010, 298). Specifically, that “ZFL and Buchner are consistent with Biewendt in explaining that that those portions of the machine downstream of the sterilization chamber are kept at a pressure above atmospheric in order to ensure sterility during the filling and sealing process.” Id. at 5. Patent Owner, however, did not previously present this interpretation of ZFL and Buchner, and a request for rehearing is not an opportunity to present such new arguments. Moreover, contrary to Patent Owner’s new argument, these references plainly indicate that the “fully enclosed system” and the “entire plant” of the Bosch system is subject to a “slight overpressure.” Ex. 1010, 298; Ex. 1011, 27. As such, we find no basis in the record to conclude that we overlooked any persuasive evidence suggesting that only those portions of the Bosch system downstream of the sterilization machine are subject to overpressure.” slip op. at 4
NonePatents in suitUS 6,475,435 - Avx Corporation v. Greatbatch, Ltd.All claims unpatentablePTAB · Sep 20, 2016 · IPR2015-00908 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1–9, 11–22, 24–34, and 36–38 are unpatentable, and the motion to amend is denied, because Stevenson anticipates the claims.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner contends that the relevant field is more specific and narrower than filter capacitors and requires knowledge of electromagnetic interference (EMI) filtering and implantable medical devices (IMDs) and that Petitioner’s declarant lacks such knowledge. Prelim. Resp. 27–30. On the present record, we determine a person of ordinary skill in the art would have had a Bachelor’s degree in electrical engineering, chemistry, and/or physics, along with several years of relevant applied research or industry work experience in the field of filter capacitors, including electromagnetic interference (EMI) filtering and implantable medical devices (IMDs). Our conclusion is supported by Petitioner’s asserted prior art references, which disclose filter capacitors for electromagnetic interference (EMI) filtering and implantable medical devices (IMDs). Ex. 1002, 1:17–24; Ex. 1003, 1:9–14; Ex. 1004, 1:12–21. 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). On the present record and based upon the stated qualifications of Petitioner’s declarant, Ex. 1007 ¶¶ 2–5; Ex. 1008, we consider Petitioner’s declarant qualified to opine from the viewpoint of a person of ordinary skill in the art regarding Petitioner’s asserted grounds of unpatentability.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Wolf’s ground plates 132, 134, and 136 were known alternatives for providing conductive coupling between the interior and peripheral edge of a component in a capacitor assembly. Ex. 1007 ¶ 47; Ex. 1003, 9:17–21, 5:62–6:11, 12:40–61, Figs. 20 and 21; Ex. 1004, 3:64–4:3, 6:66–7:10, 8:38– 42, Fig. 5. We credit the unrebutted testimony of Mr. Galvagni that substituting Wolf’s ground plates for the ground plane of Brendel provides the predictable result of creating a path to ground for the filtering of unwanted signals from the terminal pin of a feedthrough assembly. Ex. 1007 ¶ 48; Ex. 1004, 4:48–56, 7:11–16, 8:28–32; KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007) (“[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976))). A person of ordinary skill in the art would have been motivated to substitute Wolf’s ground plates for Brendel’s ground plane to avoid manufacturing complexity. Ex. 1007 ¶ 46. More particularly, the unrebutted testimony of Mr. Galvagni establishes that ground plates having a flat profile, as disclosed in Wolf, are more readily manufactured than a ground plane that needs to be sputtered or plated into a small hole for receiving a ground pin, as disclosed in Brendel. Ex. 1007 ¶ 49; compare Ex. 1003, 7:22–32, 12:40–61, Fig. 21 (showing ground plane 430 that has been sputtered into counter-bored hole for receiving ground pin), with Ex. 1004, 9:53–65, 10:19–24, 10:35–40 (describing steps S104 and S114 for forming flat conductive layers). Thus, the evidence establishes that a person of ordinary skill in the art “would have seen a benefit” to making the substitution proposed by Petitioner. KSR, 550 U.S. at 424.” slip op. at 24
- BurdenDecided for petitioner
“Based on the foregoing, we find that Petitioner has shown by a preponderance of the evidence that Stevenson discloses every element of the challenged claims, arranged as set forth in the claims. See Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (“Anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.”). Patent Owner does not present any persuasive argument or objective evidence to refute Petitioner’s showing that claims 1–9, 11–22, 24–34, and 36–38 of the ’076 patent are anticipated by Stevenson. See Paper 13. 3 The identification of this layer by the identifier 282 in Figure 71 appears to be a typographical error. Accordingly, we determine that Petitioner has shown by a preponderance of the evidence that claims 1–9, 11–22, 24–34, and 36–38 of the ’076 patent are anticipated by Stevenson.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Based on the foregoing, we find that Petitioner has shown by a preponderance of the evidence that Stevenson discloses every element of the challenged claims, arranged as set forth in the claims. See Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (“Anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.”). Patent Owner does not present any persuasive argument or objective evidence to refute Petitioner’s showing that claims 1–9, 11–22, 24–34, and 36–38 of the ’076 patent are anticipated by Stevenson. See Paper 13. 3 The identification of this layer by the identifier 282 in Figure 71 appears to be a typographical error. Accordingly, we determine that Petitioner has shown by a preponderance of the evidence that claims 1–9, 11–22, 24–34, and 36–38 of the ’076 patent are anticipated by Stevenson.” slip op. at 16
Patent outcomesUS 7,035,076 unpatentable§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,035,076
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.