Ex Parte Richardson et alDownload PDFPatent Trial and Appeal BoardNov 30, 201813737823 (P.T.A.B. Nov. 30, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/737,823 01/09/2013 Peter Richardson 45200 7590 12/04/2018 K&L Gates LLP-Orange County 1 Park Plaza Twelfth Floor IRVINE, CA 92614 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. 1951300.00254CON(090) 1069 EXAMINER LIU, SAMUEL W ART UNIT PAPER NUMBER 1656 NOTIFICATION DATE DELIVERY MODE 12/04/2018 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): uspatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER RICHARDSON, ROBERT A. BAUGHMAN, ANDREA LEONE-BAY, and DONALD COSTELL0 1 Appeal2017-000785 Application 13/737,823 Technology Center 1600 Before RICHARD M. LEBOVITZ, JOHN G. NEW, and RICHARD J. SMITH, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants state that the real party-in-interest MannKind Corporation. App. Br. 3. Appeal2017-000785 Application 13/737,823 SUMMARY Appellants file this appeal under 35 U.S.C. § I34(a) from the Examiner's Non-Final Rejection of claims 1-10 and 12-21. Specifically, claims 1-9, 13-19, and 21 stand rejected as unpatentable under 35 U.S.C. § 103 (a) as being obvious over the combination of Steiner et al. (US 6,428,771, August 6, 2002) ("Steiner '771"), Roy et al. (WO 2007/100535 A2, September 7, 2007) ("Roy"), and Steiner et al. (US 6,652,885 B 1, November 25, 2003) ("Steiner '885"). Claims 12 and 20 stand rejected as unpatentable under 35 U.S.C. § I03(a) as being obvious over the combination of Steiner '771, Roy, Steiner '885, and DeFelippis et al. (US 2005/0043228 Al, February 24, 2005) ("DeF elippis"). Claim 10 stands rejected as unpatentable under 35 U.S.C. § I03(a) as being obvious over the combination of Steiner '771, Roy, Steiner '885, and Schuckmann (US 2007/0240708 Al, October 18, 2007) ("Schuckmann"). Claims 1-9, 12, and 14--20 stand rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting as being obvious over claims 1-7 of Richardson et al. (US 8,377,869 B2, February 19, 2013) (the "' 869 patent"). Claims 1-10 and 13-19 stand rejected under the nonstatutory doctrine of obviousness-type double patenting as being obvious over claims 1-8, 13, and 20 of Richardson et al. (US 8,372,804 B2, February 12, 2013) (the "'804 patent"). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART and enter a NEW GROUND OF REJECTION. 2 Appeal2017-000785 Application 13/737,823 NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to a method of introducing a physiologically-active labile agent into the circulatory system of a mammal. Abstr. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A method of administering a labile active agent to a patient in need thereof comprising: administering to said patient by inhalation a pharmaceutical composition comprising the labile active agent associated with a diketopiperazine microparticle wherein about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5. 8 µm, wherein the active agent is subject to degradation in a patient as a result of exposure to peripheral tissue, vascular venous tissue, or liver metabolism, and wherein the effectiveness of said active agent is reduced by said degradation prior to reaching the agent's site of action, and further wherein insulin is not a labile active agent. App. Br. 24. ISSUES AND ANALYSES We are persuaded by, and expressly adopt, the Examiner's findings, reasoning, and conclusion that Appellants' claims are prima facie obvious over the combined cited prior art, with the exception of claim 10, which we reverse. We also enter a new ground of rejection for claim 10. We address the arguments raised by Appellants below. 3 Appeal2017-000785 Application 13/737,823 A. Rejection of claims 1-9, 13-19, and 21 under 35 U.S.C. § 103(a) Issue 1 Appellants argue the Examiner erred because there would have been no reason for a skilled artisan to combine the prior art elements in the manner claimed. App. Br. 10. Analysis The Examiner finds that Steiner '885 teaches administering a composition of an active agent ( active peptide) in the form of microparticles in a dry powder form for pulmonary (inhalation) administration. Final Act. 2 (citing Steiner '885 col. 3, 11. 7-13, 42--46; col. 10, 11. 37--42). The Examiner finds that Steiner '885 teaches that the active agent is formulated into microparticles with diketopiperazine ("DKP"), the most preferred embodiment of which includes fumaryl diketopiperazine ("FDKP"), and is suitable for pulmonary administration. Id. (citing Steiner '885 Abst.; col. 3, 11. 12-13, 29-33; col. 7, 11. 16-17). The Examiner finds that Steiner '885's preferred active agent is glucagon, which, though unstable, can be stabilized when formulated with (DKP) to form microparticles. Id. (citing Steiner '885 col. 5, 11. 20-21; col. 11, 11. 16-19). The Examiner finds that Steiner '885 further teaches that DKP serves to stabilize and enhance delivery of the active agent, and defines the term "enhance" as meaning "to enhance transport of the active agent across biological membrane, thereby rapid increase in the concentration of active agent in the blood circulation after administration of the FDKP/DKP formulated active agent." Final Act. 3 ( emphasis omitted) ( citing Steiner col. 4, 1. 12-22). The Examiner finds that these teachings suggest that 4 Appeal2017-000785 Application 13/737,823 FDKP-fornmlated, stabilized glucagon microparticles are suitable for pulmonary delivery. Id. The Examiner further finds that Steiner '885 teaches that it is desirable to apply the DKP-based delivery composition to other biologically active agents, including glucagon (but not insulin). Final Act. 3 (citing Steiner '885 col. 3, 11. 4---6; col. 6, 11. 9-10; col. 5, 11. 20-21). The Examiner finds that Steiner '885 teaches that pulmonary administration of the FDKP- formulated active peptides enhances delivery efficiency via rapid adsorption of said active peptides into blood circulation ( col. 4, 11. 43--48). The Examiner finds that Roy teaches the peptide hormone oxyntomodulin ("OXM," also known as "glucagon-37"), a preproglucagon. Final Act. 5 ( citing Roy 1 ). The Examiner finds that OXM has a very short half-life and is rapidly inactivated (degraded) by cellular peptidases. Id. The Examiner finds that Roy also teaches that OXM is useful in treating both obesity and diabetes. Id. ( citing Roy 18). The Examiner concludes that it would have been obvious to a skilled artisan to combine the teachings of the references and substitute OXM, as taught by Roy, for the similar peptidergic active agents, including glucagon, taught by Steiner '885. Final Act. 5. The Examiner concludes that a person of ordinary skill would have been motivated to combine the references in this way so as to increase the efficiency of OXM administration in the treatment of obesity and diabetes. Id. Appellants argue that the Examiner has provided no reasoning as to why a person of ordinary skill in the art would have selected the various elements from the prior art and combine them in the claimed manner. App. Br. 11. 5 Appeal2017-000785 Application 13/737,823 We disagree. The Examiner concludes that a person of ordinary skill in the art would have been motivated to combine the teachings of the cited prior art references and substitute OXM, as taught by Roy, for the similar peptidergic active agents, including glucagon, taught by Steiner '885 so as to increase the efficiency of OXM administration in the treatment of obesity and diabetes. Final Act. 5. Appellants adduce no evidence or argument to rebut the Examiner's conclusion in this respect beyond an unsupported conclusory statement that the Examiner has articulated no reasoning as to why a person of ordinary skill in the art would combine the teachings of the references. We accord such attorney argument little probative value and are not persuaded by Appellants in this regard. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (holding that attorney arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value). We are consequently not persuaded by Appellants' contention. Issue 2 Appellants argue that the references relied upon by the Examiner do not teach or suggest each claim element. App. Br. 11. Analysis Appellants contend that, whereas Steiner '885 discloses some advantages associated with pulmonary administration for certain active agents, the reference is focused on storage or shelf stability prior to administration. Id. at 12 ( citing Steiner '885 col. 2, 11. 42-54; Ex. 2). According to Appellants, Steiner '885 mentions "degradation" twice, in the 6 Appeal2017-000785 Application 13/737,823 context of a storage stability test, and teaches overcoming this shelf stability problem by complexing the active agent with a diketopiperazine. Id. In contrast, Appellants argue, the instant claims address the problem of in vivo degradation by using diketopiperazine microparticles for administration specifically by the pulmonary route, thus minimizing degradation of the active agent in venous blood circulation, in a peripheral tissue, or in the liver, associated with administration of active agent. App. Br. 12. Appellants therefore assert that, because the reference does not address these disadvantages associated with certain modes of active agent administration as compared to other modes, Steiner '885 would not have suggested to a skilled artisan that active agents can be administered to better effect using specific modes of administration. Id. at 12-13. Appellants also argue that, with respect to dependent claims 12 and 20, Steiner '885 does not teach the claimed glucagon-like protein ("GLP- 1"), but, rather, teaches glucagon. 2 App. Br. 13. Appellants further point out that Steiner '885 explicitly states that its glucagon compositions are intended for subcutaneous administration, rather than by inhalation. Id. at 14 (citing Steiner '885 col. 15, 11. 8-18). Appellants contend that Roy does not remedy the alleged deficiencies of Steiner '885. App. Br. 14. According to Appellants, Roy relates to oxyntomodulin derivatives and discloses "pulmonary" a single time amidst an alleged laundry list of prospective administration methods. Id. ( citing Roy 19). Appellants assert these teachings of Roy would not provide a 2 Appellants also point out that dependent claim 13 expressly excludes GLP- 1. App. Br. 13. Steiner '885 teaches the use of other peptides, including glucagon. See Steiner '885 col. 3, 11. 4---6; col. 6, 11. 9-1 O; col. 5, 11. 20-21. 7 Appeal2017-000785 Application 13/737,823 person of skill in the art any reason to select pulmonary administration from the disclosed options. Id. Furthermore, Appellants argue, even if one of ordinary skill were motivated to combine Steiner '885 with Roy, the combination would not suggest the claimed methods, because, Appellants contend, Steiner '885 does not teach or suggest the claimed administration of a labile active agent by inhalation. Id. at 14--15. Furthermore, Appellants argue, Roy teaches that pulmonary administration can more efficiently deliver certain active agents to particular target organs when compared to other routes, thereby requiring lower doses of active agent and preventing or reducing these unwanted side effects. Id. at 15. We are not persuaded. As an initial matter, we observe that: "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references." In re Keller, 642 F.2d 413,426 (C.C.P.A. 1981). We thus look to the combined teachings of the references. We also note that the claimed advantages of Appellants' invention, i.e., that administration via inhalation of an active agent: "minimiz[ es] degradation of the active agent in venous blood circulation, in a peripheral tissue, or in the liver" (App. Br. 15), although recited in the claims, is an inherent property of inhaling the claimed active agents. Administering the active agent combined with DKP as described in Steiner '885 would have reasonably been expected to achieve the same results recited in the claims because the same agents are administered through the same route, thus presumptively having the same properties and results. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical 8 Appeal2017-000785 Application 13/737,823 or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product"). The burden therefore shifts to Appellants to show that, following the explicit guidance in the cited prior art, the results recited in the limitation (i.e., avoiding degradation of the activation via inhalation) would not have been achieved. In response to the rejection, Appellants did not provide adequate evidence to show that the result would not been routinely achieved by following the guidance in the prior art. Steiner '885 teaches that: Encapsulation or entrapment of large polymers, such as proteins and peptides, in diketopiperazines can be used to remove impurities or contaminants such as metal ions or other small molecules. The diketopiperazines also serve both to stabilize and enhance delivery of the entrapped materials. Formulations also have been developed for the enhanced transport of active agents across biological membranes. These formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the membrane. The formulations can provide rapid increases in the concentration of active agent in the blood following administration of the formulations. Steiner '885 col. 4, 11. 8-22. Steiner '885 teaches that preferred active agents include: "[H]ormones, cytokines and other immunomodulatory peptides, and antigens/vaccines .... In another preferred embodiment, the active agent is glucagon." Id. at col. 5, 11. 16-21. Steiner '885 also teaches that other peptides can be delivered with fumaryl diketopiperazine to achieve rapid absorption. Id. at col. 4, 11. 43--48. Steiner '885 further teaches that: 9 Appeal2017-000785 Application 13/737,823 The compositions of active agent described herein can be administered to patients in need of the active agent. The compositions preferably are administered in the form of microparticles, which can be in a dry powder form for pulmonary administration or suspended in an appropriate pharmaceutical carrier, such as saline. The microparticles preferably are stored in dry or lyophilized form until immediately before administration. The microparticles then can be administered directly as a dry powder, such as by inhalation using, for example, dry powder inhalers known in the art. Alternatively, the microparticles can be suspended in a sufficient volume of pharmaceutical carrier, for example, as an aqueous solution for administration as an aerosol. Id. at col. 10, 11. 38-51. We acknowledge that Steiner '885 additionally teaches that its disclosed formulations are useful in preventing degradation of the active agent during storage. See Steiner '885, col. 2, 11. 42-54. Nevertheless, as the passages quoted supra liberally illustrate, Steiner '885 also expressly teaches: "administering ... by inhalation a pharmaceutical composition comprising the labile active agent associated with a diketopiperazine microparticle," as recited in claim 1. With respect to claims 12 and 20, which recite that the active agent is GLP-1, we note that the Examiner has rejected these claims as obvious over the combination of Steiner '885, Roy, Steiner '771, and DeFelippis. See Final Act. 8. The Examiner finds that DeFelippis teaches that GLP-1 can be formulated into particles in dry powder form for inhalation or pulmonary administration. Id. (citing DeFelippis ,r,r 9, 57, 178). The Examiner finds that GLP-1, which is useful for treating Type 2 diabetes, is a labile peptide with an extremely short in vivo half-life. Id. (citing DeFelippis ,r,r 1, 5). 10 Appeal2017-000785 Application 13/737,823 The Examiner further finds that DeFelippis teaches an "enhancer," i.e., diketopiperazine (DKP), that can be added to the formulation to increase bioavailability after pulmonary administration. Final Act. 8 ( citing DeFelippis ,r 201). The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to formulate GLP-1 with DKP for pulmonary administration, because the Steiner '885 teaches the usefulness of formulating a peptide active agent with DKP for administration by inhalation to increase the active agent concentration in blood stream. Final Act. 8. The Examiner concludes that a person of ordinary skill would have understood from the teachings of the references that the peptidergic active agent of Steiner '885 could include GLP-1, as taught by DeFelippis, using DKP to enhance the bioavailability of the active agent when administered via pulmonary administration, for the treatment of Type 2 diabetes. We agree with the Examiner. DeFelippis expressly teaches: Doses of the compositions of the present invention depend on the potency and bioavailability of the GLP-1 compound in the particular composition. Generally, when delivered by the pulmonary route, the compositions of the present invention will have a bioavailability that is approximately 10% to 50% that of the compound delivered subcutaneously. However, an enhancer such as diketopiperazine [i.e., DKP] may be added to further increase bioavailability after pulmonary administration. DeFelippis ,r 201. We agree that the teachings ofDeFelippis, combined with the teachings of Steiner '885, Steiner '771, and Roy, as explained supra, teach the limitation of claims 12 and 20 reciting: "The method of claim 10 wherein said composition comprises GLP-1." Furthermore, with respect to claim 13, which recites: "The method of claim 1 wherein the labile active agent is not GLP-1," Steiner '885 teaches the use of other peptidergic active 11 Appeal2017-000785 Application 13/737,823 agents, particularly glucagon, which, as Appellants point out, is not GLP-1. See, e.g., Steiner '885 col. 11, 11. 13-24. We consequently do not find Appellants' arguments persuasive with respect to this issue. Issue 3 Appellants argue that the Examiner erred because a person of ordinary skill in the art would have had no reasonable expectation of success in combining the teachings of the cited prior art to arrive at Appellants' claimed invention. App. Br. 16. Analysis Appellants argue that, as with Steiner '885, neither Roy nor Steiner '771 recognizes that pulmonary administration can more efficiently deliver certain active agents to particular target organs (such as the brain and the liver) as compared to other routes, thereby requiring lower doses of active agent and preventing or reducing these unwanted side effects. App. Br. 16. Therefore, Appellants argue, the references fail to provide any reasonable expectation that the claimed methods would provide any benefit over the prior art. Id. Appellants further argue that Steiner '771 provides no teaching or suggestion that the claimed inhaled administration provides any benefit over subcutaneous administration. App. Br. 15. Appellants point to Steiner '771 's teaching that, with respect to administration of salmon calcitonin ("SCt"): "The bioavailability of the pulmonary route in this preliminary analysis was 17% versus the subcutaneous administration." Id. ( quoting Steiner '771 col. 12, 11. 21-28; also citing Steiner '771, Fig. 2A). 12 Appeal2017-000785 Application 13/737,823 We are not persuaded by Appellants' arguments. As we have explained supra, both Steiner '885 and Steiner '771 expressly teach administration of a peptidergic active agent and DKP microparticles via inhalation, as recited in the claims. Steiner '885 col. 10, 11. 38-51; Steiner '771 Abstr., ,r 3. Roy similarly teaches that its OXM peptide prohormone can be administered via pulmonary methods (i.e., inhalation). Roy 19. Similarly, DeFelippis teaches administration of GLP-1 and DKP microparticles via inhalation (i.e., pulmonary administration). DeFelippis ,r 201. We agree with the Examiner that the combined teachings of the prior art would have revealed to a person of ordinary skill that pulmonary administration was routine in this field of endeavor, and that there would therefore have been a reasonable expectation of success in administering the claimed composition via this method. We consequently affirm the Examiner's rejection of the claims. B. Rejection of claims 12 and 20 under 35 U.S.C. § 103(a) Appellants argue these claims separately. App. Br. 17-20. However, Appellants raised these same issues supra, viz., that neither Steiner '885. Steiner '771, nor Roy teach the use of GLP-1. We have already explained our reasoning as to why we affirm the Examiner's rejection of these claims, viz., that the Examiner relies upon DeFelippis as teaching this limitation. See App. Br. 13. Appellants additionally argue that DeFelippis teaches GLP-1 complexed with a basic polypeptide, in contrast to the claimed labile active agent associated with a diketopiperazine microparticle. App. Br. 20. Appellants further note that DeFelippis mentions diketopiperazine a single 13 Appeal2017-000785 Application 13/737,823 time as an optional component, and not in the context of administering a diketopiperazine-containing microparticle. Id. We disagree. As we have pointed out supra, DeFelippis expressly teaches combining GLP-1 and DKP and administering them via inhalation. DeFelippis ,r 201. We agree with the Examiner that a person of ordinary skill in the art would understand this teaching of DeFelippis, especially when combined with the teachings of the other cited references, would understand that GLP-1 could be administered in this manner with a reasonable expectation of success. The fact, as Appellants argue, that DeFelippis teaches this but a single time is of little moment, particularly given the express manner of DeFelippis' teaching. See supra; see also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that all disclosures of the prior art, including unpreferred embodiments, must be considered). We consequently affirm the Examiner's rejection of the claims. C. Rejection of claim 10 under 35 U.S.C. § 103(a) Claim 10 depends ultimately from claim 1, and recites: "[W]herein the step of administering said composition to said patient comprises administration of said composition using a breath-powered dry powder inhaler comprising a cartridge." App. Br. 25. Appellants essentially repeat their arguments presented supra, contending that Schuckmann does not cure the alleged deficiencies of Steiner '885 and '771 and Roy. App. Br. 22. As we have explained supra, we do not find Appellants' arguments persuasive. 14 Appeal2017-000785 Application 13/737,823 Furthermore, Appellants argue that Schuckmann relates to inhalers comprising a pressurized cartridge. App. Br. 22 ( citing Schuckmann ,r 3). Appellants contend that because claim 10 recites "a breath-powered ... inhaler," Schuckmann neither teaches nor suggests the limitation of claim 10. The Examiner responds that Steiner '885 that the: "dry powder inhaler has been known in the art," and that Schuckmann teaches that a hand-held inhaler that comprises a cartridge for delivery of inhaler medicaments. Ans. 19 (citing Steiner col. 10, 11. 47--48; Schuckmann (claims 10 and 17)). The Examiner thus relies upon Schuckmann as teaching the structural limitation "cartridge" and concludes that the breath-powered dry-powder inhaler taught in the prior art is an obvious variation of the claimed breath-powered dry power inhaler. Id. We are not persuaded by the Examiner's reasoning. In addition to the teachings of Steiner '885, Appellants' Specification discloses that dry- powder inhalers are known in the prior art: In one embodiment, the formulation comprising the active ingredient can be administered to the patient in a dry powder formulation by inhalation using a dry powder inhaler such as the inhaler disclosed, for example, in U.S. Patent No. 7,305,986 and U.S. Patent Application Serial No. 10/655,153 (US 2004/01823 87), which disclosures are incorporated herein by reference. Spec. 22. Appellants' Specification is otherwise silent with respect to "breath-powered inhalers." Steiner '885 similarly teaches that dry-powder inhalers are known in the art. Steiner '771 also teaches a "breath-activated" inhaler. Steiner '771, col 2, 11. 22-25. However, we are not persuaded, nor can we discern, based 15 Appeal2017-000785 Application 13/737,823 upon the evidence of record, that any of these references teaching the use of a "breath-activated inhaler" can be unambiguously said to teach or suggest a "breath-powered" inhaler. We consequently reverse the Examiner's rejection of claim 10. NEW GROUND OF REJECTION We hereby enter a new ground of rejection. Claim 10 is rejected as unpatentable under 35 U.S.C. § I03(a) as being obvious over the combination of Steiner '885, Steiner '771, Roy, Schuckmann, and Volgyesi (US 6,325,063 Bl, December 4, 2001) ("Volgyesi"). Volgyesi teaches a "breath-powered inhalation device" that "provides advantages over conventional inhalation devices using compressed gases as propellants since it is more compact, simpler and does not require synchronization of activation of the device and inhalation by the user. Volgyesi Abstr. We conclude that it would have been obvious for a person of ordinary skill in the art to substitute the breath-powered inhaler of Volgyesi for the pressurized cartridge inhaler of Schuckmann. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (holding that, here a skilled artisan merely pursues "known options" from a "finite number of identified, predictable solutions," obviousness under § 103 arises); see also id. at 416 ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results"). We conclude that a person of ordinary skill in the art would have been motivated to substitute the breath-powered inhaler of Volgyesi to obtain the advantages expressly taught by the Volgyesi Abstract, as quoted supra. 16 Appeal2017-000785 Application 13/737,823 For the same reason, we agree with the Examiner that a person of ordinary skill in the art would have had a reasonable expectation of success in substituting a breath-powered inhaler for a pressurized dry-powder inhaler, not least because Appellants adduce no evidence, beyond mere attorney argument, that a person of ordinary skill in the art, making such a substitution, would have had no reasonable expectation of success. See App. Br. 23. We consequently affirm the Examiner's rejection of the claim. D. Rejection of claims 1-10 and 13-20 under the nonstatutory doctrine of obviousness type double patenting Appellants make no argument in their Brief addressing the Examiner's rejections upon this ground. We consequently summarily affirm the Examiner's rejections of the claims upon this ground. DECISION The Examiner's rejection of claims 1-9 and 12-21 under 35 U.S.C. § 103(a) is affirmed. The Examiner's rejection of claims 10 under 35 U.S.C. § 103(a) is reversed. The Examiner's rejection of claims 1-10 and 13-20 under the nonstatutory doctrine of obviousness-type double patenting is affirmed. We also enter a new ground of rejection under 37 C.F.R. § 4I.50(b) for claim 10. This decision contains a new ground of rejection pursuant to 37 C.F.R. § 4I.50(b). 37 C.F.R. § 4I.50(b) provides that "[a] new ground of rejection ... shall not be considered final for judicial review." 17 Appeal2017-000785 Application 13/737,823 37 C.F.R. § 4I.50(b) also provides that the Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner .... (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record .... 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) (2010). AFFIRMED-IN-PART 37 C.F.R. § 4I.50(b) 18 Copy with citationCopy as parenthetical citation