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 .
Detailed Action
This application is a continuation of US application 17/025947, now US patent 11925680, filed September 18, 2020, which claims benefit of provisional application 63/060452, filed August 3, 2020, which claims benefit of provisional application 62/904312, filed September 23, 2019. Claims 1-20 are pending in this application and examined on the merits herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 13, 15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipates by Yoshihiko Okaichi et al. (Foreign patent document H08-51998, Reference included with PTO-1449 submitted June 12, 2024, English machine translation included with PTO-892)
Independent claim 1 is directed to a composition of a carbohydrate-protein conjugate and an adjuvant, having a structure wherein the carbohydrate and the carrier protein are linked by a linking group having a specific structure. Okaichi discloses conjugates of a sugar with the protein bovine serum albumin having the structure R’-O-A-X-B-CO-BSA, wherein R’ is a carbohydrate and BSA is bovine serum albumin. (p. 9 paragraphs 68-71) Furthermore A and B are defined as including alkylenes that can be ethylene or trimethylene, and X can be sulfur atom. (p. 3 paragraphs 13-18) Specific examples are described wherein the group corresponding to “B” is ethylene, the group corresponding to “A” is propylene, and X is sulfur. (e.g. p. 17 paragraph 145) This specific compound (22) is described as being conjugated to BSA. (p. 34 paragraphs 275-276) These conjugates were formulates as a composition with an adjuvant, (p. 34 paragraphs 277-278) and injected into mice to produce antibodies. An injectable composition would at the very least include water as an excipient. This composition would therefore anticipate present claims 1 and 15, and administering it to mice to produce antibodies would anticipate present claim 17.
Regarding claim 5, the sugar moieties used by Okaichi (p. 9 paragraph 71) include LacNAc, which according to Wu et al. (Reference included with PTO-892) is a tumor antigen. Therefore LacNAc containing conjugates would inherently anticipate present claim 5. Regarding claim, 13, the conjugates are drawn in such a way that only a single carbohydrate is attached to each BSA carrier, thereby indicating that p is 1. (p. 9 paragraph 69)
For these reasons Okaichi anticipates the present claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Okaichi as applied to claims 1, 5, 13, 15, 17, and 18 above, and further in view of Song et al. (NPL reference 38 included with 6/12/2024 PTO-1449)
The disclosure of Okaichi is discussed above. Okaichi does not specifically disclose a conjugate wherein the protein carrier is CRM197. However, Song discloses the synthesis of immunogenic carbohydrate-protein conjugates. (p. 915 right column first and second paragraphs) In these conjugates the carrier protein can be either CRM197 or BSA. (p. 916 scheme 2) It would have been obvious to one of ordinary skill in the art at the time of the invention to use CRM197 in place of BSA as the protein carrier in the conjugates described by Okaichi et al. One of ordinary skill in the art would have seen the disclosure of Song as suggesting that these two protein carriers are equivalents usable for the same purpose as protein carriers in immunogenic carbohydrate conjugates.
Therefore the invention taken as a whole is prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Okaichi as applied to claims 1, 5, 13, 15, 17, and 18 above, and further in view of Roy et al. (NPL reference 32 included with 6/12/2024 PTO-1449)
The disclosure of Okaichi is discussed above. Okaichi does not specifically disclose a conjugate wherein the protein carrier is tetanus toxoid. However, Roy discloses the synthesis of immunogenic carbohydrate-protein conjugates. (p. 293 figure 3) In these conjugates the carrier protein can be either BSA or tetanus toxoid. It would have been obvious to one of ordinary skill in the art at the time of the invention to use tetanus toxoid in place of BSA as the protein carrier in the conjugates described by Okaichi et al. One of ordinary skill in the art would have seen the disclosure of Roy as suggesting that these two protein carriers are equivalents usable for the same purpose as protein carriers in immunogenic carbohydrate conjugates.
Therefore the invention taken as a whole is prima facie obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Okaichi as applied to claims 1, 5, 13, 15, 17, and 18 above, and further in view of Dahmen et al. (NPL reference 6 included with 6/12/2024 PTO-1449)
The disclosure of Okaichi is discussed above. Okaichi does not specifically disclose a conjugate wherein the protein carrier is Keyhole limpet hemocyanin. (KLH) However, Dahmen discloses the synthesis of carbohydrate-protein conjugates. (p. 16 compounds 21 and 22) In these conjugates the carrier protein can be either KLH or BSA. (p. 916 scheme 2) It would have been obvious to one of ordinary skill in the art at the time of the invention to use KLH in place of BSA as the protein carrier in the conjugates described by Okaichi et al. One of ordinary skill in the art would have seen the disclosure of Dahmen as suggesting that these two protein carriers are equivalents usable for the same purpose as protein carriers in immunogenic carbohydrate conjugates.
Therefore the invention taken as a whole is prima facie obvious.
Double Patenting
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 1-3, 5-8, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-7 of U.S. Patent No. 11925680. (Cited in PTO-892, herein referred to as ‘680) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘680 anticipate the present claims.
Specifically, claim 1 of ‘680 claims a composition comprising a synthetic neoglycoconjugate having the same structure as that recited in present claim 1, and an adjuvant, thereby anticipating present claim 1. Claim 1 further specifies that the carbohydrate antigen and carrier protein are selected from specific options anticipating present claims 2, 3, and 5-8. Claim 2 of ‘680 further claims a composition comprising an excipient, anticipating present claims 15 and 16. Claim 3 of ‘680 further describes the vaccine as an anti-cancer vaccine. Claims 5 and 6 of ‘680 claim methods of immunizing a subject which anticipate present claims 17 and 18. Claim 7 of ‘680 specifies that p is between 1-50, anticipating claims 13-14.
Claims 1-8 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 10, 11, 15-18 of U.S. Patent No. 10973910. (Cited in PTO-1449, herein referred to as ‘910) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘910 anticipate the present claims.
Specifically, claim 1 of ‘910 claims a process for immunizing against SARS-CoV2, comprising administering to a subject a conjugate of a Tf or Tn antigen to a carrier protein. Dependent claims 4-7 further define the structure of the conjugate in a manner that anticipates the structure recited in present claim 1. Dependent claims 15-18 further specify the presence of an excipient and an adjuvant. Therefore the claims of ‘910 are seen to anticipate present claims 1, 5-8, and 15-18.
Regarding claims 2-4, claims 10 and 11 of ‘910 recite the same carrier proteins as these claims.
Conclusion
Claims 1-8 and 13-18 are rejected. Claims 9-12, 19, and 20 are objected to for depending from a rejected claim but would be allowable if rewritten in independent form incorporating all the limitations of the rejected base claim and any intervening claims.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 4/28/2026
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