DETAILED ACTION
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 .
Claims 1-26 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 1/30/2026 has been considered. A signed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-13 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 is indefinite because it is not clear how the dosage fits with the parent claim. The claim is drawn to a complex, not a composition. A “dose” is a measured quantity of an agent to be taken at one time. Thus, there needs to be an amount of the complex to be a dose. Since the claim is drawn to the complex itself, not an amount of said complex, it is not clear how the complex can have 4 micrograms in a dose when there is no actual dose.
Claim 13 is indefinite because it is not clear how the dosage fits with the parent claim. The claim is drawn to a complex, not a composition. A “dose” is a measured quantity of an agent to be taken at one time. Thus, there needs to be an amount of the complex to be a dose. Since the claim is drawn to the complex itself, not an amount of said complex, it is not clear how the complex can have .5% to .7% of polysaccharide in a dose when there is no actual dose.
Claim 23 is indefinite because it is not clear how a complex can “comprise a therapeutically effective amount” of itself.
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 1-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapre et al (US Patent Applicant Publication 2021/0220461; IDS filed 1/30/2026).
The instant claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG.
Kapre et al disclose immunogenic compositions comprising complexes with S. pneumoniae capsular polysaccharides conjugated to carrier proteins through PEG linkers (see paragraph 002 and 0049, and claims 1-30). More than 25 different polysaccharides, including those recited in claim 5 are disclosed (see paragraph 0045). The polysaccharides have a molecular weight from 100 kDa to 300kDa and the PEG is from 1-3.5 kDA (see paragraph 0055-056). The complexes include covalent linkage to a carrier protein including those recited in claim 11 (see paragraphs 0048-0049). The dose comprises 4 micrograms or less of total polysaccharide and the complex contains .5-.7% polysaccharide and carrier protein per dose (see paragraph 0052). There is an equal amount of polysaccharide to total carrier molecule or a greater amount of polysaccharide to total carrier molecule (see claims 13-14). Adjuvants, including those recited in claim 17-18 are disclosed (see claims 16-17). The complex generates a lower immune response than a monovalent conjugate (see claim 19). Since the same structural components as what is claimed are disclosed, these complexes would necessarily have the same functional characteristics. Therefore, they would necessarily provide treatment or prevention of infection by Gram positive and negative bacteria. The complex also includes a pharmacologically acceptable carrier (see claim 21). The methods for manufacturing the complexes are also disclosed by Kapre et al including the steps recited in claims 24-26 (see claims 22-24 and 28-30 and paragraph 0055-0056).
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12251438. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG.
The patented claims are drawn to methods of protecting against S. pneumonaie infection by administering multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG. The compositions administered in the patented claims include each of the limitations recited in the instant claims. Therefore, the instant claims are anticipated.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10729763. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG.
The patented claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG. The compositions claimed in the patented claims include each of the limitations recited in the instant claims. Therefore, the instant claims are anticipated.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 19070661 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG.
The patented claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG. The compositions claimed in the patented claims include each of the limitations recited in the instant claims. Therefore, the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 11-17, and 20-30 of copending Application No. 17151445 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG.
The patented claims are drawn to multivalent immunogenic complexes comprising bacterial capsular polysaccharides conjugated to PEG. The compositions claimed in the patented claims include each of the limitations recited in the instant claims. Therefore, the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
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