Ex Parte ODownload PDFPatent Trial and Appeal BoardOct 25, 201613041042 (P.T.A.B. Oct. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/041,042 03/04/2011 27476 7590 10/27/2016 NOV ARTIS VACCINES atGSK 709 Swedeland Road UW2220 KING OF PRUSSIA, PA 19406-0939 FIRST NAMED INVENTOR Derek O'Hagan 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. P ATOS 1223-US-CNT 4163 EXAMINER TONGUE, LAKIA J ART UNIT PAPER NUMBER 1645 NOTIFICATION DATE DELIVERY MODE 10/27/2016 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): us_cipkop@gsk.com arlene.e.cannon@gsk.com laura.m.mccullen@gsk.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DEREK O'HAGAN Appeal2014-002707 Application 13/041,042 Technology Center 1600 Before DEMETRA J. MILLS, JOHN G. NEW, and RYAN H. FLAX, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF CASE The following claim is representative. 1. A composition for mucosal delivery, comprising a mucosal adjuvant and two or more of the following: (a) an antigen which induces an immune response against Haemophilus injluenzae; (b) an antigen which induces an immune response against Neisseria meningitidis; and ( c) an antigen which induces an immune response against Streptococcus 1 Appeal2014-002707 Application 13/041,042 pneumonia, wherein the mucosal adjuvant comprises a detoxified cholera or E. coli heat labile toxin. Examiner Cited References Lian et al. US 2011/0045017 Al Capiau et al. WO 00/56359 Rappuoli et al. WO 01/22993 A2 Appellant Cited References (see Br. 9--10) Feb. 24, 2011 ("Lian") Sept. 28, 2000 ("Capiau") Apr. 5, 2001 ("Rappuoli") Aucouturier et al., Adjuvants designed for veterinary and human vaccines, 19 VACCINE 2666-2672 (2001) ("Aucouturier"). Robert Edelman, The Development and Use of Vaccine Adjuvants, 21 MOLECULAR BIOTECHNOLOGY 129--148 (2002). Wuorimaa et al., Avidity and Subclasses of IgG after Immunization of Infants with an I I-Valent Pneumococcal Conjugate Vaccine with or without Aluminum Adjuvant, 184 I.INFECTIOUS DISEASES 1211-1215 (2001) ("Wuorimaa"). Grounds of Rejection 1. Claims 1-15 and 17 are rejected under 35 U.S.C. § 102(e) as being anticipated by Lian. Claims 1-15 and 17 are rejected under 35 U.S.C. § 103(a) as beingobvious over Capiau and further in view of Rappuoli. 2 Appeal2014-002707 Application 13/041,042 PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). ,,_T?_ej ection 1 We vacate the Examiner's anticipation in favor of a new ground of rejection for obviousness in view of Lian alone or in combination with Capiau. NEW GROUNDS OF REJECTION Claims 1-15 and 17 are newly rejected under 35 U.S.C. § 103(e) as obvious in view of Lian. FINDINGS OF FACT 1. Lian disclosed HIV vaccine compositions for mucosal delivery comprising antigens which may advantageously include saccharide 3 Appeal2014-002707 Application 13/041,042 antigens from N. meningitidis serogroup A, C, W135 and/or Y, such as the oligosaccharide; a saccharide antigen from Streptococcus pneumonia; and a saccharide antigen from Haemophilus influenzae (see paragraphs 49--53 and 60). 2. Lian disclosed that its vaccine composition can be administered by an intranasal route; the vaccine of the invention may be in the form of a nasal spray, nasal drops, gel, or powder (see paragraph 80). 3. Lian disclosed mucosal adjuvants suitable for use in the invention include, but are not limited to, heat-labile enterotoxins or detoxified mutants thereof, such as the L TK63 or L TR 72 mutants (see paragraphs 13 and 82). 4. Lian disclosed where a saccharide or carbohydrate antigen is included; it is conjugated to a carrier protein, which is bacterial toxins or toxoids, such as diphtheria (CRM197), cholera or tetanus toxoids (see paragraph 74). 5. In Lian, preferred carrier proteins are bacterial toxins or toxoids, such as diphtheria, cholera, E. coli heat labile or tetanus toxoids. The CRM197 diphtheria toxoid is particularly preferred. (See paragraph 74). 6. Capiau disclosed that it was well known in the art to prepare combination vaccines which provide protection against a range of different pathogens. P. 7, 1. 29-p. 8, 1. 4; p. 25, 11. 5-6. ANALYSIS 4 Appeal2014-002707 Application 13/041,042 The composition of claim 1 includes the transitional phrase "comprising," which opens the claim up to additional elements or ingredients. Therefore, it is of no consequence that the composition of Lian is primarily directed to an HIV vaccine for mucosal delivery [i-f 13], but which also includes additional antigens. Lian's vaccine can include additional [i-f 49] (any or all) antigens including: (a) Haemophilus influenza [i-f 60]; (b) an antigen which induces an immune response against Neisseria meningitidis [i-f 52]; and (c) an antigen which induces an immune response against Streptococcus pneumonia [i-f 53]; wherein the mucosal adjuvant comprises a detoxified cholera or E. coli heat labile toxin [i-f 14]; [i-f 74]. With respect to the anticipation rejection, Appellant argued that there was a substantial amount of picking and choosing from a laundry list of 24 disclosed additional antigens in Lian. Reply Br. 6. As explained in Arkley, picking and choosing may be entirely proper in the making of a 103, obviousness rejection, where the applicant must be afforded an opportunity to rebut with objective evidence any inference of obviousness which may arise from the similarity of the subject matter which he claims to the prior art, but it has no place in the making of a 102, anticipation rejection. In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972). Furthermore, picking one of a finite number of known solutions to a known problem is obvious. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), states: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under§ 103. 5 Appeal2014-002707 Application 13/041,042 Finally, "[ d]isclos[ ure of] a multitude of effective combinations does not render any particular formulation less obvious." Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989). Here, Lian would reasonably appear to disclose multiple effective vaccine combinations, in that Lian discloses that additional antigens (plural) may be present in the disclosed HIV mucosal vaccine. [i-f49 and i-f 50-7 4.] Moreover, this list of optional antigen components is not excessively long, but is limited to just over twenty. [Id.] Conceivably, while unlikely, nothing would prevent the skilled artisan from including several or all of them in a single composition. In addition, Capiau discloses that it is well known in the art to prepare combination vaccines which provide protection against a range of different pathogens. P. 7, 1. 29- p. 8, 1. 4; p. 25, 11. 5-6. It would have been obvious to one of ordinary skill in the art at the time of the invention to prepare a vaccine composition comprising a mucosal adjuvant and any or all of the following: (a) an antigen which induces an immune response against Haemophilus injluenzae; (b) an antigen which induces an immune response against Neisseria meningitidis; and ( c) an antigen which induces an immune response against Streptococcus pneumonia, wherein the mucosal adjuvant comprises a detoxified cholera or E. coli heat labile toxin, in view of Lian. Lian discloses a vaccine having a mucosal adjuvant, an antigen which induces an immune response against Haemophilus influenzae; and an antigen which induces an immune response against Neisseria meningitides, in conjunction with a detoxified cholera or 6 Appeal2014-002707 Application 13/041,042 E. coli heat labile toxin. Alternatively, Capiau motivates one of ordinary skill in the art to include multiple antigens in combination vaccines. Rejection 2 Claims 1-15 and 17 are rejected under 35 U.S.C. § 103(a) as being obvious over Capiau and further in view of Rappuoli. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 2-14. The following facts are highlighted. 7. Capiau disclosed vaccine compositions comprising at least one Streptococcus pneumoniae polysaccharide antigen (preferably conjugated) and a Streptococcus pneumoniae protein antigen or immunologically functional equivalent thereof, optionally with an adjuvant (see page 8, lines 15-20). 8. The polysaccharides of Capiau may be conjugated to protein carriers, such as; diphtheria and tetanus toxoids (DT, CRM197 and TT) (see page 14, lines 13-18). 9. Capiau disclosed that polysaccharides to be conjugated and contemplated by this invention, include, but are not limited to meningococcal polysaccharides (including type A, C, W135 and Y) and the capsular polysaccharide from Haemophilus injluenzae (see page 23, lines 5- 15). 10. In one Capiau embodiment, the combination includes a vaccine that affords protection against Neisseria meningitidis C and Y infection 7 Appeal2014-002707 Application 13/041,042 wherein the polysaccharide antigen from one or more serotypes Y and Care linked to a protein. 11. Additionally, Haemophilus injluenzae polysaccharide based vaccine conjugated with TT, OT, or CRM197, may be formulated with the above combination vaccine. Page 23. Capiau disclosed that many vaccines are now given as a combination vaccine so as to reduce the number of injections a subject has to receive. Thus, for Capiau's vaccines, other antigens may be formulated with the vaccines of the current invention (see page 25, lines 17-29; page 26, lines 21-30; and page 27, lines 1-2). 12. Capiau disclosed that the vaccine composition preparation is administered via a mucosal route and include intranasal administration (see page 18, lines 1-8), which necessarily encompasses the form of a nasal spray, nasal drops, a gel or a powder. 13. Lastly, Capiau disclosed that suitable adjuvant systems include, but are not limited to, monophosphoP;l lipid i\., saponin and CPG (see page 15, line 27 and page 16, lines 8-14). Since Capiau used the entire capsular polysaccharide and in light of Appellant's definition of oligosaccharide (a fragment of capsular polysaccharide ), the capsular saccharide antigen of the prior art necessarily encompasses an oligosaccharide. 14. Capiau disclosed vaccine polysaccharides may be conjugated to protein carriers, which provide bystander T-cell help. It is preferred, therefore, that the polysaccharides utilised in the invention are linked to such a protein carrier. Examples of such carriers which are currently commonly used for the production of polysaccharide immunogens include the Diphtheria and Tetanus toxoids (DT, DT CRMl 97 and TT respectively), Keyhole Limpet 8 Appeal2014-002707 Application 13/041,042 Haemocyanin (KLH), OMPC from N. meningitidis, and the purified protein derivative of Tuberculin (PPD). Page 14. 15. Rappuoli discloses Rappuoli et al. disclose that mucosal vaccine compositions where cholera toxin and E. coli heat labile toxin (L T-K63 or LT-R72) act as a mucosal adjuvant, both of which have been found to enhance antigen specific serum lgG, sigA and local and systemic T cell responses. L T-K63 is preferred, as it has been found reliable in animal models to result in a high level of protection. Lastly, both are homologous and are interchangeable (see page 1, lines 56-27 and page 2, lines 1-7) Ans. 4. 16. The vaccines of Rappuoli include Bordetella pertussis, diphtheria antigen (D), a tetanus antigen, and are for mucosal delivery. Page 1. 17. Rappuoli discloses that the detoxified form of cholera toxin (CT) or E.coli heat labile toxin (LT) acts as a mucosal adjuvant. CT and LT are homologous and are typically interchangeable. Page 1. ANALYSIS We agree with the Examiner's fact finding, statement of the rejection and responses to Appellant's arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comment to the Examiner's argument set forth in the Final Rejection and Answer. We agree with the Examiner that 9 Appeal2014-002707 Application 13/041,042 It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the invention of Capiau et al. with the cholera toxin and E.coli heat labile toxin (LT-K63 or LT-R72) ofRappuoli et al. because they act as a mucosal adjuvants that are homologous and are interchangeable. Both have enhanced antigen specific serum lgG, slgA and local and systemic T cell responses, and result in a high level of protection. One would have had a reasonable expectation, barring evidence to the contrary, that the composition, which is intended for mucosal delivery would be effective for inducing an immune response against the claimed bacterial antigens. Ans. 4. Appellant argues that, Capiau "never suggest[ ed] that they be used together in a single composition." App. Br. 8. Appellant argues that the art of selecting adjuvants in order to enhance immune responses to specific antigens is unpredictable as noted in the three adjuvant review articles of i~ .. ucouturier, Edelman, and \Vuorimaa. i~ .. pp. Br. 9. We are not persuaded. As articulated in KSR, "[ t ]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR, 550 U.S. at 416. We agree with the Examiner that, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the invention of Capiau with the cholera toxin and E. coli heat labile toxin (LT- K63 or LT-R72) ofRappuoli because they act as a mucosal adjuvants that are homologous and are interchangeable. Although Appellant argues that there is lack of predictability with respect to adjuvant selection, Appellant's lack of predictabile data from Aucouturier, Edelman, and Wuorimaa primarily relate to the unpredictability 10 Appeal2014-002707 Application 13/041,042 associated with the use of alum adjuvant. Br. 10. The cholera toxin or E.coli heat labile toxin mucosal adjuvants of Rappuoli are appropriate for use with Bordetella pertussis, diphtheria antigen (D), a tetanus antigen. FF15. Similarly, the polysaccharide vaccines of Capiau include the Diphtheria and Tetanus toxoids. FF13. Therefore, Rappuoli establishes the appropriateness of the use of cholera toxin or E.coli heat labile toxin mucosal adjuvants with vaccines such as that of Capiau which may also include similar antigens. Appellant has provided no contrary evidence or further evidence of unexpected results. Capiau disclosed that it is well known in the art to prepare combination vaccines which provide protection against a range of different pathogens. P. 7, 1. 29-p. 8, 1. 4; p. 25, 11. 5-6. Capiau disclosed vaccine compositions comprising at least one Streptococcus pneumoniae polysaccharide antigen (preferably conjugated) and a Streptococcus pneitmoniae protein antigen or immunologically fi1nctional equivalent thereof, optionally with an adjuvant (see page 8, lines 3-20). It would have been obvious to one of ordinary skill in the art aware of Capiau and Rappuoli to include multiple antigens in a vaccine to form a combination vaccine with an expectation of success. Appellant has provided no evidence that one of ordinary skill in the art would be unsuccessful in combining the specific antigens disclosed in Capiau. Rejection 2 is affirmed for the reasons of record. CONCLUSION OF LAW The anticipation rejection 1 is vacated in favor of a new ground of rejection for obviousness in view of Lian. The cited references support the 11 Appeal2014-002707 Application 13/041,042 Examiner's obviousness rejection 2, which is affirmed. All pending, rejected claims fall. This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b), which provides that a "new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. § 41.50(b) also provides that the appellant, 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 .... Should the Appellant elect to prosecute further before the Examiner pursuant to 37 C.F.R. § 41.50(b)(l), to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection(s), the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If the Appellant elects prosecution before the Examiner and this does not result in allowance of the application, abandonment, or a second appeal, 12 Appeal2014-002707 Application 13/041,042 this case should be returned to the Patent Trial and Appeal Board for final action on the affirmed rejection, including any timely request for rehearing thereof. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED; NEW GROUND UNDER 37 C.F.R. § 41.50(b) 13 Copy with citationCopy as parenthetical citation