Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Claims 1-101, 106-112, 114, 117, 119 and 132-137 have been canceled. Claims 102, 113, 115, 116, 118 and 120-131 are pending and under examination.
Claim Rejections - Withdrawn
The rejection of claim(s) 102, 113, 115, 116, 118 and 120-131 under 35 U.S.C. 103 as being unpatentable over Malley et al. WO 2012/155053 11-15-2012 (cited in IDS) in view of Baker et al. WO 2004/080490 9/23/2004 and Foster et al. US 2007/0036814 2/15/2007 and Patti et al. US 2005/0026170 2/3/2005 and Anderson et al. US 20120107327 5/3/2012 is withdrawn. The declaration of Dr. Taylor Stevenson under 37 CFR 1.132 filed 3/4/2026 is sufficient to overcome the instant rejection.
Double Patenting Maintained
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 102, 113, 115-116, 118, 120, 121, 122, 123, 124, 126 and 127-131 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11305001 (‘001), further in view of Baker et al. WO 2004/080490 9/23/2004 and Foster et al. US 2007/0036814 2/15/2007 and Anderson et al. US 20120107327 5/3/2012.
Although the claims at issue are not identical, they are not patentably distinct from each other as set forth above but the ‘001 claims is set forth above but does not disclose:
The ‘001 claims do not disclose the immunogenic composition comprises clumping factor A (ClfA), clumping factor B (ClfB).
The ‘001 claims do not disclose the ClfA peptide or polypeptide antigen comprises amino acids 182-520 of SEQ ID NO: 2.
The ‘001 claims do not disclose the ClfB peptide or polypeptide antigen comprises the amino acid sequence of SEQ ID NO: 5.
Baker et al disclose S. aureus immunogenic polysaccharide-surface adhesin carrier protein conjugate comprising at least one polysaccharide antigen conjugated to at least one staphylococcal surface adhesins. See claims 1 lines 1-10, p. 4 under summary of the invention, p. 5 lines 1-5.
Baker et al disclose that the S. aureus capsular polysaccharide is from serotype 5 (CP5) and serotype 8 (CP8). See p. 2 under capsular polysaccharide.
Baker et al disclose the S. aureus surface adhesins disclose that they include ClfA, ClfB and SdrD, (see p. 12-14, lines 1-19). Baker et al disclose that these proteins together with the capsular polysaccharide can be used in multicomponent vaccines to impart broad spectrum immunity to bacterial infection and also can be used to produce monoclonal or polyclonal antibodies that impart broad spectrum passive immunity. See p, 14 lines 11-16 and p. 18 lines 12-28.
Foster et al disclose a ClfA polypeptide comprising amino acids 182-520 of SEQ ID NO: 2. See sequence alignment with Appendix A.
Anderson et al disclose a ClfB polypeptide comprising the amino acid sequence of SEQ ID NO: 5. See sequence alignment with Appendix B.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the invention to have modified the ‘001 claims by associating the second affinity molecule associated with hemolysin and SdrD with other S. aureus proteins such as ClfA comprising amino acids 182-520 of SEQ ID NO: 2 as disclosed by Foster et al and ClfB comprising the amino acid sequence of SEQ ID NO: 5 as disclosed by Anderson et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Baker et al disclose that S. aureus immunogenic polysaccharide can be conjugated to surface adhesin carrier proteins ClfA, ClfB and SdrD and that these proteins together with the capsular polysaccharide can be used in multicomponent vaccines to impart broad spectrum immunity to bacterial infection and also can be used to produce monoclonal or polyclonal antibodies that impart broad spectrum passive immunity.
Claim 125 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11305001 (‘001) and Baker et al. WO 2004/080490 9/23/2004 and Foster et al. US 2007/0036814 2/15/2007 and Anderson et al. US 20120107327 5/3/2012 as applied to claims 102, 113, 115-116, 118, 120, 121, 122, 123, 124, 126 and 127-131 above, further in view of Malley et al. WO 2012/155053 11/15/2012 cited in IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other as set forth above but the combination of the ‘001 claims and Baker et al and Foster et al and Anderson et al is set forth above but does not disclose:
Claim 121: the immunogenic composition wherein the first affinity is a biotin derivative.
Claim 125: the immunogenic composition wherein the first affinity molecule is cross-linked or covalently bonded to the immunogenic polysaccharide.
Malley et al disclose a multiple antigen presenting system (MAPS) comprising a polymer, at least one protein or peptide antigen, and at least one complementary affinity- molecule pair, where the complementary affinity-molecule pair comprises a first affinity molecule that associates with the polymer and a complementary affinity molecule that associates with the protein or peptide antigen, so that when the first affinity molecule associates with the complementary affinity molecule, it indirectly links the antigen to the polymer. See paragraph 107.
Malley et al disclose a second affinity complementary molecule i.e. the biotin binding protein rhizavidin associated with at least one of the S. aureus polypeptide antigens such as hemolysin wherein the second affinity molecule is fused to the hemolysin (see abstract); and a first affinity molecule associated with a polysaccharide, and wherein the first affinity molecule and second complementary affinity molecule serve as an indirect link between the polysaccharide and the hemolysin to form a multiple antigen presenting system (MAPS). See paragraph 102.
Malley et al disclose that the polysaccharide polymer can attach at least 2 or a plurality of the same protein or peptide antigen (see paragraph 102, 127) or at least 5 or at least 10 or at least 15 or at least 20 or at least 50 or at least 100 or at least more 100 antigens, wherein the antigens can be the same antigen.
Regarding claim 121: Malley et al disclose that the first affinity molecule associated with a polysaccharide is biotin or a biotin derivative such as an amine -PEG3 -biotin ((+)- biotinylation-3-6,9-trixaundecanediamine). See paragraph 109.
Regarding claim 125: Malley et al disclose the first affinity molecule (biotin or derivative thereof) is cross-linked or covalently bonded to the immunogenic polysaccharide. See paragraph 108.
Regarding claim 121: It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date that the first affinity molecule in the combination of the ‘001 claims and Baker et al and Foster et al and Anderson et al could be substituted with a biotin derivative. This is because Malley et al discloses in the MAPS the first affinity molecule could be biotin derivatives such as an amine -PEG3 -biotin ((+)- biotinylation-3-6,9-trixaundecanediamine) and the second affinity molecule is a biotin binding protein such as rhizavidin as disclosed the combination of the ‘001 claims and Baker et al and Foster et al and Anderson et al.
Regarding claim 125: it would have been prima facie obvious to a person of ordinary skilled in the art as of the effective filing date to have modified the combination of the ‘001 claims and Baker et al and Foster et al and Anderson et al claims such that the first affinity molecule is cross-linked or covalently bonded to the immunogenic polysaccharide as taught by Malley et al thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Malley et al disclose in the MAPS the first affinity molecule e.g. biotin or derivative thereof is cross-linked or covalently bonded to the immunogenic polymer e.g. polysaccharide.
Applicant’s Response:
Applicants request the rejection be held in abeyance until allowable subject matter is identified.
Applicants request is considered but will not overcome the instant rejection until the claims are patentably distinct or a terminal disclaimer is filed or other action that is sufficient to overcome the rejection.
Status of Claims
Claims 102, 113, 115, 116, 118 and 120-131 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645