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 .
Priority
This application, discloses and claims only subject matter disclosed in PCT/US21/53503. In the Provisional Application 63/087427, the composition comprising
a ganglioside having the structure:
(A)x-[ (P)y-(L)z ]-(M)b;
wherein A is a ganglioside, or any portion thereof; x is an integer from 1 to 32; P is a
heteroaryl; y is 1; L is a linker; z is an integer from 0 to 8; M is a core; and b is 0 or 1
is not claimed or disclosed per se. Accordingly, the priority of the instant Application is recognized to the filing date of the PCT Application: 10/05/2021.
Election/Restrictions
Applicant’s election without traverse of (Group I -claims 1, 7 and 112-124) in the reply filed on 01/20/2026 is acknowledged. Claims 1, 7, 11-14 and 111-124 are pending; claims 11-14 and 111 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1, 7 and 112-124 are examined.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 04/05/2023, 10/23/2024, 10/03/2025 were considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 1, 117 and 118 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, the structure (A)x-[(P)y-(L)z]-(M)b of claim 1 and the definition of its
constituents are vague and unclear for several reasons:
The minuses "-" appear to require that (i) each "A" is directly linked to a "P" (a heteroaryl), and (ii) each "P" is directly linked to "L" (if z is not 0) or directly linked to "M" (if b is not 0). However, it is not conceivable how up to 32 gangliosides can be linked to a single "P" (y is 1 and x can be up to 32).
In the same line of reasoning, it is not clear how up to 8 linkers "L" can be linked to a single "P" (a heteroaryl) (y is 1 and z can be up to 8).
It is not clear why a linker "L" should be present, if "M" is absent, because there is nothing to link (z is independent of b).
If "A" can be "any portion" of a ganglioside, the definition of "A" is unclear, since this includes any kind of fragment as small as an individual atom.
It is unclear what the “core” is; a "core" can be an "amine" according to claim 116, the term can refer to anything and everything such as a carbon atom of a methylene moiety or an oxygen atom of an ether moiety.
The subject-matter of claim 8 is unclear, because GloboH, PSA, do not represent "gangliosides".
As such, the metes and bounds of the claims could not be determined.
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, 112-115, 117-119 and 124 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al. (WO 2017048823- cited by Applicant).
Chang et al. discloses a composition based on 1 to 4 GloboH antigens or
ganglioside antigens such as GD2, GD3, GM2, or fucosyl GM1 that are conjugated via 1 to 4 1,2,3-triazole moieties (comprising one hydrogen substituent) to 1 to 4 consecutive lysine residues at the C-terminal end of a peptide epitope representing a core. (formula II, Scheme 2, [0020], [0030], [0058], [0059], [0098]; claims 1, 2, 10-14; example 4 ).
Thus, in the broadest reasonable interpretation, claims 1, 112-115, 117-119 and 124 are anticipated by the reference cited.
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, 7, 112-119 and 124 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11, 786, 586. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant Application is already claimed in the U.S. Patent claims.
Claims 120-121 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11, 786, 586.
The claims add the limitations that the ganglioside anticipated by the U.S. Patent is ganglioside is detectably labeled with an enzyme, a prosthetic group, streptavidin, biotin, a fluorophore, a luminescent tag, a bioluminescent tag, and/or a radioisotope.
The labeling of compound was widely used in the art at the time that the invention was filed so a that a person of ordinary skill in the art would have applied well-known and widely used reagents and techniques in order to successfully label the compound claimed in the U.S. Patent, that anticipates the instantly claimed compound.
Allowable Subject Matter
Claims 122 and 123 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647