Ex Parte Ward et alDownload PDFPatent Trial and Appeal BoardMay 18, 201611838468 (P.T.A.B. May. 18, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111838,468 08/14/2007 38473 7590 05/20/2016 ELMORE PATENT LAW GROUP, PC 484 Groton Road Westford, MA 01886 FIRST NAMED INVENTOR Kevin L. Ward UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 2685.3020 USl 6770 EXAMINER ALSTRUM ACEVEDO, JAMES HENRY ART UNIT PAPER NUMBER 1675 NOTIFICATION DATE DELIVERY MODE 05/20/2016 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): docketing@elmorepatents.com pair_elmore@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KEVIN L. WARD, THEAN Y. YEOH, REBECCA MARTIN, and CHARLES D. BLIZZARD 1 Appeal2014-000170 Application 11/83 8,468 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and JACQUELINE T. HARLOW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants state the real party-in-interest is Civitas Therapeutics, Inc. App. Br. 1. Appeal2014-000170 Application 11/83 8,468 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner's Final Rejection of claims 1-15, 23, 26, and 37. Specifically, claims 1-12, 23, 26, and 37 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Basu et al. (US 2004/0042970 Al, March 4, 2004) ("Basu"), McCullers (US 2004/0248825 Al, December 9, 2004) ("McCullers"), Leonard et al. (US 2004/0092470 Al, May 13, 2004) ("Leonard"), and Brito et al. (US 2011/0077284 Al, March 31, 2011) ("Brito") Claims 1-15, 23, 26, and 37 also stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of McCullers, Weers et al. (US 6,638,495 B2, October 28, 2003) ("Weers"), and Adjei et al. (US 6,458,338 Bl, October 1, 2002) ("Adjei"). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is related to pharmaceutical formulations and methods of treating a subject afflicted with the influenza virus. The method includes administering to the respiratory tract of the patient particles that include approximately five to fifty weight percent of a neuraminidase inhibitor. The particles are delivered to a patient's pulmonary system, including the upper airways, central airways and deep lung. Abstract. 2 Appeal2014-000170 Application 11/83 8,468 REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal, and recites: 1. A mass of biocompatible particles comprising, by weight, about 5% to about 50% of a neuraminidase inhibitor, a salt, and a material selected from the group consisting of a buffer, an amino acid, and any combination thereof, wherein the particles are delivered to the pulmonary system. App. Br. 13. ISSUES AND ANALYSES We agree with, and adopt, the Examiner's findings and conclusion that the appealed claims are prima facie obvious over the cited prior art references. We address the arguments raised by Appellants below. A. Claims 1-12, 23, 26, and 37 over Basu, McCullers, Leonard, and Brito2 Issue Appellants argue the Examiner erred in concluding that it would have been obvious to a person of ordinary skill to use a neuraminidase inhibitor, as taught by McCullers, in the formulations described by Basu and to determine the amounts of each component. App. Br. 4. Analysis Appellants argue the Examiner has found only that the various elements of the claims exist separately in multiple prior art publications, 2 Claims 13-15 are not rejected over the combination of Basu, McCullers, Leonard, and Brito and we do not address them here. See Final Act. 4. 3 Appeal2014-000170 Application 11/83 8,468 which Appellants assert is insutlicient to establish obviousness. App. Br. 5. Appellants argue Basu teaches generic antiviral agents amongst a long list of possible active agents, but that Basu neither teaches nor suggests either a neuraminidase inhibitor or the amounts of the neuraminidase inhibitor recited in the claims. Id. According to Appellants, a broad generic disclosure, such as that provided by Basu, is generally insufficient to establish that a claim is obvious. Id. (citing In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994)). Appellants contend further that, although McCullers discloses neuraminidase inhibitors for use in treating viral and bacterial infections, McCullers neither teaches nor suggests the use of biocompatible particles comprising the claimed amounts of neuraminidase inhibitor for pulmonary delivery. Id. Appellants argue Leonard and Brito disclose only suitable excipients in pharmaceutical powders. Id. Appellants dispute the Examiner's reasoning that it would be obvious to combine the references because influenza is a common problem and thus the skilled person would have been motivated to modify Basu to include a neuraminidase inhibitor. App. Br. 5. Appellants argue to the contrary that, given that Basu teaches hundreds of potential compounds that are used to treat influenza, the cited references provide no motivation as to why a skilled artisan would select a neuraminidase inhibitor or combine a neuraminidase inhibitor with the excipients of the claim, i.e., a salt and a buffer and/or an amino acid, and reasonably expect to produce a biocompatible particle formulation suitable for pulmonary delivery. Id. The Examiner finds the cited prior art provides motivation to select neuraminidase inhibitors because: (1) McCullers teaches neuraminidase is essential for the replication of influenza A and B virus; (2) McCullers also 4 Appeal2014-000170 Application 11/83 8,468 teaches second-generation neuraminidase inhibitors zanamivir and oseltamivir are suitable for the treatment of influenza; (3) influenza is a viral-borne disease; and ( 4) Basu explicitly teaches the incorporation of anti- viral agents into its composition. Ans. 13. The Examiner also finds the class I formulations in Table II of Basu include a combination of an active agent with a buffer salt (i.e., sodium citrate), a salt (i.e., calcium chloride) and an amino acid (i.e., leucine ). Id. (citing Basu i-fi-1256-257). Therefore, the Examiner finds, a person of ordinary skill in the art, searching for a suitable vehicle for the administration of second generation anti-viral agents, would be motivated to combine the anti-viral agent with the class I compositions taught by Basu, which Basu explicitly teaches are suitable vehicles for antiviral agents. Ans. 13. We agree with the Examiner. McCullers teaches: Neuraminidase inhibitors are analogues of sialic acid, that represent a new class of second-generation antiviral agents that sho\'l/ efficacy against both influenza ii~ and B virt1ses. These agents interact with a common region of the active site located in a central cleft that is conserved among all Type A and Type B influenza viruses studied to date despite wide variation in other regions of the enzyme. McCullers ,-r 25. Basu is directed to "the unexpected discovery that particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that comprise a phospholipid and a sufficient amount of leucine [an amino acid] can produce sustained effect of the agent." Basu Abstr. Appellants are correct that Basu teaches a wide variety of possible active agents may be incorporated into their compositions including: "vasoactive agents, neuroactive agents, hormones, anticoagulants, immunomodulating agents, cytotoxic agents, prophylactic agents, antibiotics, antivirals, antisense, 5 Appeal2014-000170 Application 11/83 8,468 antigens, antineoplastic agents and antibodies." Basu if 69 (emphasis added). But the essence ofBasu's invention is the carrier, which includes, from Table II, Class I compounds comprising the ethanol-soluble lipids DPPC and DSPC, sodium citrate, calcium chloride, and leucine. Basu iii! 256-257. We consequently agree with the Examiner that the combination of Basu and McCullers teaches "a neuraminidase inhibitor, a salt (e.g., calcium chloride), and a material selected from the group consisting of a buffer (e.g., sodium citrate), an amino acid (e.g., leucine), and any combination thereof," as required by claim 1. The gravamen of Appellants' argument is that, given the wide variety of possible active agents taught by Basu as being suitable for incorporation into its composition, there would be no obvious motivation for a person of ordinary skill to select the second-generation antiviral neuraminidase inhibitors taught by McCullers for combination with Basu. See App. Br. 5. We think Appellants' reasoning has the analysis backward. We agree, rather, with the Examiner that a person of ordinary skill, seeking a vehicle for the effective antiviral neuraminidase inhibitors taught by McCullers, would be motivated to combine the neuraminidase inhibitors as the active agent into the vehicle taught by Basu, because Basu teaches its composition is compatible with antiviral agents and because of the vehicle's unexpected effectiveness at producing a "sustained effect of the agent." See Basu if 69, 17. We consequently affirm the Examiner's rejection of the claims. 3 3 Appellants also make a generalized argument that their claimed composition: [P]rovides unexpected improvements in stability and dispersability . . . and also provides improved reduction of 6 Appeal2014-000170 Application 11/83 8,468 B. Claims 23 and 374 Issue Appellants argue these claims separately. App. Br. 7. Claim 37 is representative, and recites: A method of treating a subject with influenza, comprising: administering to the respiratory tract of the subject an effective amount of particles consisting essentially of by weight, about 5% to about 30% of a neuraminidase inhibitor, about 5% to about 20% sodium chloride, about 20% to about 85% leucine and about 5% to about 20% sodium phosphate, wherein the particles are delivered to the pulmonary system. Id. at 15. Appellants contend the Examiner erred because the combined cited prior art references change the principle of operation of the primary prior art reference and/or teach away from Appellants' invention. Id. at 8. Analysis 1A .. ppellants contend Basu relies on the presence of a phospholipid, 1, 2-dipalmitoyl-sn-glycero-3-phosphocholine ("DPPC") to provide sustained release of the active agent. App. Br. 8. Therefore, argue Appellants, any modification to Basu that eliminates phospholipid from the powder agglomeration and optimized FPF [fine particle fraction] of the emitted dose allowing for a larger mass of particles to be packed into a single receptacle ... and further provides for highly efficient delivery of the particles to the pulmonary system. App. Br. 6. However, Appellants only make particularized arguments on this ground with respect to the claims argued subsequently, and we address those arguments, as raised, infra. 4 See fn.2, supra. 7 Appeal2014-000170 Application 11/83 8,468 particles changes the basic principle of operation of the Basu reference and is therefore insufficient to establish obviousness. Id. Appellants argue Basu teaches the importance of DPPC on the release properties of the formulation. App. Br. 7-8. According to Appellants, the data presented in their Specification establishes that the presence of DPPC has a substantial adverse impact on the physical characteristics of the powder, including flowability and dispersability. Id. at 8-9. Appellants argue, therefore, that the Examiner was unreasonable in concluding that such an excipient would be embraced by the claims given the transitional phrase. Id. (citing Spec. Table 2). The Examiner finds claims 23 and 37 do not require any specific threshold static sensitivity or lack thereof. Ans. 18. Therefore, the Examiner finds, it is unclear that Appellants' characterization of the performance of the formulation of Lot 12 from Table 2 of the Specification (which falls within the scope of the claims, but lacks DPPC) is required by the claims in dispute. Id. Furthermore, the Examiner finds that Appellants adduce no evidence establishing the static sensitivity of the formulations of Basu' s class I and V formulations, which include the combination of a phospholipid (i.e., DPPC), a salt, an amino acid, and/or a buffer. Id. Therefore, the Examiner finds, one cannot reasonably compare the static sensitivity of Lots 11 and 7 (which contain DPPC) of Appellants' Table 2 to the formulations taught by Basu and conclude that Appellants' recitation of "consisting essentially of' necessarily excludes phospholipids. Id. We are not persuaded by Appellants' arguments. As an initial matter, we are not persuaded by Appellants' assertion that it is the phospholipid alone, which increases the duration of Basu's composition's effect. Basu 8 Appeal2014-000170 Application 11/83 8,468 teaches: "The present invention is based, in part, on the unexpected discovery that particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that comprise a phospholipid and a sufficient amount of leucine can produce sustained effect of the agent." Basu i-f 17 (emphasis added). Basu thus teaches it is the combination of phospholipid and leucine which produces the unexpectedly sustained duration of the active agent's effect. More materially, we find Appellants are not conducting the proper inquiry. Our reviewing court has held: "Consisting essentially of' is a transition phrase commonly used to signal a partially open claim in a patent. Typically, "consisting essentially of' precedes a list of ingredients in a composition claim or a series of steps in a process claim. By using the term "consisting essentially of," the drafter signals that the invention necessarily includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention. ii:\. "consisting essentially of' claim occupies a middle ground between closed claims that are written in a "consisting of' format and fully open claims that are drafted in a "comprising" format. PPG Industries v. Guardian Industries Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). Appellants argue the claims preclude the inclusion of phospholipids because excluding phospholipids would impermissibly alter the principle of operation of Basu by depriving it of that which gives it longer-lasting effectiveness. See App. Br. 8. However, as the Federal Circuit has stated, the proper inquiry is whether the inclusion of a phospholipid with the ingredients listed in the claims would affect the basic and novel properties of Appellants' claimed invention. 9 Appeal2014-000170 Application 11/83 8,468 Appellants, pointing to their Table 2, argue that inclusion of the phospholipid DPPC in the claimed formulation increases undesirable static sensitivity and handling characteristics of their claimed formulation. However, we agree with the Examiner's findings that neither of the claims at issue make any mention of static sensitivity or any other handling characteristics. It is the claims and the Specification that prescribe the scope of an invention, and an applicant can "define[] the scope of the phrase 'consisting essentially of' for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention." PPG Indus. v. Guardian Indus. Corp, 156 F.3d 1351, 1354 (Fed. Cir. 1998). Appellants may not attempt to import limitations into the claims from their Specification in an attempt to further limit the scope of the invention, including attempting to set restrictions on the static sensitivity or other properties of their composition. See CollegeNet, Inc. v. Apply Yourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005) ("In examining the specification for proper context" it is improper to "import limitations from the specification into the claims"). Furthermore, Appellants' Specification elsewhere discloses preferred embodiments that explicitly include phospholipids, including DPPC. Specifically, the Specification discloses: In further embodiments, the particles of the invention can optionally include one or more additional component(s), e.g., phospholipids, also referred to herein as phosphoglyceride or a non-reducing sugar in combination with or without the excipients as described above. In a preferred embodiment, the phospholipid, is endogenous to the lung. Such a phospholipid is particularly advantageous in preparing spray-dried particles suitable for 10 Appeal2014-000170 Application 11/83 8,468 delivery to the respiratory system of a patient. In another preferred embodiment the phospholipid includes, among others, phosphatidylcholines, phosphatidylethanolamines, phosphatidylglycerols, phosphatidylserines, phosphatidyl- inositols and combinations thereof. Specific examples of phospholipids include but are not limited to phosphatidylcholines dipalmitoyl phosphatidylcholine (DPPC), dipalmitoyl phosphatidylethanolamine (DPPE), distearoyl phosphatidylcholine (DSPC), dipalmitoyl phosphatidyl glycerol (DPPG) or any combination thereof. Spec. 12-13, 11. 23--4 (emphasis added). Appellants' Specification thus explicitly contemplates the inclusion of phospholipids, including DPPC, in preferred embodiments of their invention. We therefore agree with the Examiner that the claim language reciting "consisting essentially of' does not preclude the inclusion of DPPC, or other phospholipids, because including DPPC does not materially affect the basic and/or novel properties of Appellants' claimed invention. We arrive at this conclusion because: (1) the static sensitivity of 1A .. ppellants' claimed compositions is not defined in the claims; and (2) Appellants' Specification explicitly discloses the inclusion of phospholipids, including DPPC, in preferred embodiments of the invention and therefore, by Appellants' admission, the claims do not preclude the inclusion of phospholipids in their composition. We consequently affirm the Examiner's rejection of the claims. Appellants also argue, almost in passing, that claim 23 recites that release of the active agent is rapid and that, therefore, Basu teaches away from this embodiment as Basu is specifically directed to a particle formulation for sustained release. App. Br. 9. 11 Appeal2014-000170 Application 11/83 8,468 We are not persuaded. Claim 23 recites, in relevant part: "A method of treating a human subject in need of a neuraminidase inhibitor comprising administering pulmonarily to the respiratory tract of a subject in need of treatment an effective amount of particles consisting essentially of by weight .... " App. Br. 14. Claim 23 thus requires that the human subject be in need of treatment with a neuraminidase inhibitor, but does not necessarily require that the release of the active agent is rapid. Claims under examination before the PTO are given their broadest reasonable interpretation consistent with the specification. See In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007). We find that the claim language reciting "treating a human subject in need of a neuraminidase inhibitor," means what it means on its face: that the subject is in need of treatment, but it does not necessarily require that the onset of the active agent be rapid. Furthermore, Basu teaches its compositions produce a sustained effect of the active agent, but also explicitly teaches that preferred embodiments of its invention can be formulated to provide rapid release of the active agent. See Basu i-f 79 ("On the other hand, rapid release [of the active agent] can be obtained by including in the particles phospholipids having lower transition temperatures"). A reference teaches 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." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994 ). Appellants point to no passage of Basu in which a person of ordinary skill would be discouraged or diverted from treating a human subject in need of treatment with a neuraminidase inhibitor, as required by claim 23. 12 Appeal2014-000170 Application 11/83 8,468 Moreover, contrary to Appellants' contention, Basu explicitly teaches that the active agent can be released rapidly by including in the particles of its compositions phospholipids having lower transition temperatures. We therefore find Appellants' arguments are without merit and we affirm the Examiner's rejection of claims 23 and 37. C. Claims 14 and 15 Appellants also argue these claims separately, contending the Examiner erred because the combined cited prior art references do not teach or suggest the concentrations prescribed by the claims. App. Br. 9. The Examiner responds that claims 14 and 15 are not rejected over the teachings of Basu, McCullers, Leonard, and Brito, and therefore Appellants' arguments are unresponsive. Ans. 19 (citing Final Act. 4). The Examiner is correct. Only claims 1-12, 23, 26, and 37 are rejected over the teachings of Basu, McCullers, Leonard, and Brito. Final Act. 4. Claims 14 and 15, inter alia, are rejected over the combination of Weers, McCullers and Adjei. Id. at 14. Consequently, we do not reach Appellants' arguments. 13 Appeal2014-000170 Application 11/83 8,468 D. Claims 1-15, 23, 26, and 37 over Weers, McCullers, and Adjei Issue Appellants repeat their arguments supra with respect to claims 1-12, 23, 26, and 37 that the Examiner has erred by failing to establish a prima facie case of obviousness. Analysis Appellants contend that, as with Basu, Weers teaches antivirals suitable as bioactive agents that may be incorporated into the microstructures taught by Weers. App. Br. 9. Appellants contend Weers does not name a single antiviral out of the hundreds known in the art. Id. According to Appellants, the fact that influenza is a common problem in the human population is insufficient reason for a person of ordinary skill to combine a neuraminidase inhibitor, as taught by McCullers, with the microstructures described in Weers. Id. We have related our reasons supra as to why we are not persuaded by Appellants' arguments with respect to claims 1-12, 23, 26, and 37, and we incorporate them by reference here with respect to claims 1-15, 23, 26, and 37. Like Basu, Weers is directed to formulations and methods for the administration of bioactive agents to a patient via the respiratory tract, and is suitable for delivering, inter alia, antiviral agents. Weers col. 1, 11. 19-21; col. 19, 11. 32--46. Appellants do not dispute the combined cited prior art teaches or suggests all of the limitations of the claims, but argue rather that a person of ordinary skill in the art would have neither reason nor motivation to combine the references. See App. Br. 9-10. However, 14 Appeal2014-000170 Application 11/83 8,468 we agree with the Examiner, for the reasons we have related supra, that a person of ordinary skill would be motivated to combine the teachings of McCullers' second-generation antiviral neuraminidase inhibitors with an effective delivery vehicle to obtain an effective antiviral treatment delivered via the pulmonary system. We therefore affirm the Examiner's rejection of claims 1-15, 23, 26, and 37. E. Claims 13, 14, 15, 23, and 37 Issue Appellants argue these claims separately. App. Br. 11. Appellants argue the Examiner erred because the formulations recited in the claims are particularly advantageous with regard to their ability to resist agglomeration under storage conditions and the ease of handling of the powder. Id. Analysis Appellants argue Weers teaches that incorporation of high levels of phospholipids increases stability and reduces agglomeration. App. Br. 11 (citing Weers col. 17, 11. 46-67). Therefore, contend Appellants, a person of ordinary skill in the art would not expect the formulations of claims 13, 14, 15, 23, and 37 that do not contain phospholipids to possess the desired characteristics of decreased agglomeration under storage conditions as well as enhanced powder handling. Id. Appellants maintain that these unexpected and desirable properties render their claimed invention nonobvious over the prior art. Id. 15 Appeal2014-000170 Application 11/83 8,468 We are not persuaded. As we have related supra, the basic premise upon which Appellants' argument is based, that the "consisting essentially of' language of the claims precludes the addition of phospholipids, is not persuasive and, indeed, the Specification explicitly discloses the addition of phospholipids in a preferred embodiment. Furthermore, we agree with the Examiner's finding that the Appellants make no comparison of their claimed invention with the compositions of the prior art to show that Appellants' compositions show unexpected properties. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion. Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). We agree with the Examiner that even if, arguendo, Appellants' reported superior properties are real, as reported they are insufficient to overcome the Examiner's conclusion of prima facie obviousness because the lack of direct or indirect comparison with the prior art does not permit us to determine whether they are an unexpected improvement. F. Claims 14 and 15 Issue Appellants argue the Examiner erred in finding the combined cited prior art teaches or suggests the concentrations of active agent, sodium chloride, leucine, and sodium phosphate recited in the claims. App. Br. 11. 16 Appeal2014-000170 Application 11/83 8,468 Analysis Appellants argue there is no guidance in any of the cited prior art references for selecting a specific active agent, the specific excipients and the specific concentrations of agent and excipients. App. Br. 11. According to Appellants, the picking and choosing from long lists of each species and then combining them in a specific way, without more definitive guidance to making these selections, is nonobvious. Id. Appellants further argue the formulations of claims 14 and 15, as demonstrated by Tables 3-7 of the Appellants' Specification, had superior storage stability as well as flowability. Id. The Examiner finds the combined prior art explicitly teaches overlapping ranges of the active agent and the excipients with those of the claims. Final Act. 17. The Examiner concludes a prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. Id. (citing MPEP § 2144.05). Furthermore, the Examiner responds that the data in Tables 3-7 of Appellants' Specification provide no comparison of the performance of compositions of Lots 14 and 15 (which correspond to the formulations of claims 14 and 15, respectively) to any compositions disclosed in the prior art. Ans. 24. Consequently, the Examiner finds there is no basis to determine if the storage and flow properties of Appellants' formulations of Lots 14 and 15 are unexpectedly improved in comparison to compositions obtained from the teachings of the combined prior art. Id. 17 Appeal2014-000170 Application 11/83 8,468 We agree with the Examiner. As an initial matter, Appellants adduce no evidence to rebut the Examiner's findings that the prior art references teach ranges of active ingredients and excipients that overlap those recited in Appellants' claims. Rather, Appellants merely assert that the combined cited prior art fails to teach the language recited in the claims. As such, Appellants' argument is unsupported by evidence and we accord it little probative weight. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011): ("[W]e hold that the Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art"). Furthermore, and as we have related supra, Appellants fail to produce evidence of unexpected results sufficient to overcome the Examiner's prima facie conclusion of obviousness, with which we agree. See Harris, 409 F.3d at 1344. We therefore affirm the Examiner's rejection of claims 14 and 15. DECISION The Examiner's rejection of claims 1-15, 23, 26, and 37 as unpatentable under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R. § 1.136(a)(l )(iv). 18 Appeal2014-000170 Application 11/83 8,468 AFFIRMED 19 Copy with citationCopy as parenthetical citation