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 .
It is noted that the present application has been transferred to a new Examiner, Terra C. Gibbs of Art Unit 1635.
DETAILED ACTION
This Office Action is a response to Applicant’s Amendment and Remarks filed February 23, 2026.
Claims 53-59, 61-64, 67-70, and 72 have been amended.
Claims 53-72 are pending in the present application.
This application contains claims 61-71 drawn to an invention nonelected without traverse in the reply filed December 17, 2024. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Accordingly, claims 53-60 and 72 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Official Action considers Applicant’s Amendment to the Claims and Remarks filed February 23, 2026. The Amendment to the Claims and Remarks are sufficient to overcome the previous rejections of record under 35 U.S.C. 112 for indefiniteness and 102(a)(2) as being anticipated by Benson et al. (US20190284529).
Applicant’s Amendment filed February 23, 2026 necessitated a new ground of rejection as detailed below:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 53-60 and 72 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the disclosure must provide written support for the entire scope of the genus. Support for a genus is generally found where the Applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed and that applicant was in possession of the claimed genus.
The instant claims are drawn to a combination comprising (i) at least one compound that specifically inhibits expression, activity, and/or stability of Src homology region 2 domain-containing Phosphatase-1 (SHP-1) (ii) at least one compound that specifically inhibits expression, activity, and/or stability of Casitas B-lineage Lymphoma-b (Cbl-b); and (iii) at least one compound that specifically inhibits expression, activity, and/or stability of c-Casitas B-lineage Lymphoma (c-Cbl); or any nano- or micro-particle, micellar formulation, vehicle, matrix, composition or kit comprising said combination. As discussed below, there is insufficient written description for the compounds that specifically inhibit expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl encompassed by the claims.
The Specification discloses:
A “Compound” is used herein to refer to any substance, agent (e.g., molecule), supramolecular complex, material, or combination or mixture thereof. A compound may be any agent that can be represented by a chemical formula, chemical structure, or sequence. Example of compounds applicable for the present invention, include, e.g., nucleic acid molecules (e.g., RNAi agents, antisense oligonucleotide, gRNAs, aptamers), small molecules, amino acid based molecules, for example, polypeptides, peptides, antibodies specific for SHP, and Cbl, that inhibit or disturb the activity thereof, lipids, polysaccharides, etc. It should be understood that any compound described in connection to the present aspect is also applicable in all aspects of the invention.
The instant Specification provides an example of the synergistic effect of combined silencing SHP-1 and Cbls (e.g. Cbl-b; and c-Cbl) in enhancement of natural killer (NK) cell function using a siRNA triple-target composition (e.g. SHP-1, Cbl-b; and c-Cbl). The Specification also explicitly discloses at Example 1:
In order to suppress the key inhibitors of NK cell cytotoxicity, siRNA oligos were designed for SHP-1, Cbl-b and c-Cbl. More specifically, the following siRNAs were used: SHP-1 siRNA sense CCCUGACCCUGUGGAAGCAdTdT, as denoted by SEQ ID NO: 9, said siRNA targets the sequence as denoted by SEQ ID NO: 10, SHP-1 siRNA anti-sense UGCUUCCACAGGGUCAGGGdTdT, as denoted by SEQ ID NO: 11, said siRNA targets the sequence as denoted by SEQ ID NO: 12; Cbl-b siRNA sense CCCUUAUUUCAAGCCCUGAdTdT, as denoted by SEQ ID NO: 1, said siRNA targets the sequence as denoted by SEQ ID NO: 2, Cbl-b siRNA anti-sense UCAGGGCUUGAAAUAAGGGdTdT, as denoted by SEQ ID NO: 3, said siRNA targets the sequence as denoted by SEQ ID NO: 4; c-Cbl siRNA sense CUGUUGACAGACAGACUAAdTdT, as denoted by SEQ ID NO: 5, said siRNA targets the sequence as denoted by SEQ ID NO: 6, c-Cbl siRNA anti-sense UUAGUCUGUCUGUCAACAGdTdT, as denoted by SEQ ID NO: 7, said siRNA targets the sequence as denoted by SEQ ID NO: 8.
The art teaches nano‐carriers encapsulate siRNAs targeting three genes critical for suppression of NK cell activity, namely, SHP‐1, Cbl‐b, and c‐Cbl. See Biber et al. (EMBO Mol Med. 2021 Nov 2;14(1), pages 1-18, plus Supplemental Information). NOTE: Biber et al. teach siRNAs specific for human c-Cbl or Cbl-b, SHP-1 which comprise the same sequences of Applicant’s Disclosure supra. See Biber et al., RNA interference at page 13, for example.
Other than the siRNA molecule specific for SHP-1 comprising the nucleic acid sequences as denoted by SEQ ID NO: 9 and SEQ ID NO: 11; the siRNA molecule specific for Cbl-b comprising the nucleic acid sequences as denoted by SEQ ID NO: 1 and SEQ ID NO: 3; and the siRNA molecule specific for c-Cbl comprising the nucleic acid sequences as denoted by SEQ ID NO: 5 and SEQ ID NO: 7, no other compounds, variants, homologs or derivatives thereof have been disclosed in the present invention or the art that function as claimed to inhibit expression, activity, and/or gene stability.
There is insufficient written description of the compounds that specifically inhibits expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl encompassed by the claims because there is a substantial variation within the genus of compounds and the single nucleic acid siRNA species which carry out the functionality of the instant claims does not adequately describe or represent the entire genus of compounds. Only the specific siRNA nucleic acid compounds (e.g. SEQ ID NOs.) described above have been reduced to practice.
The written description requirement for claims that require compounds that specifically inhibits expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl is not met because the claims encompass a genus of compounds which are not adequately described.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
To satisfy the written description requirement an applicant must describe the invention is such a way as to convey to one skilled in the art that applicant had the invention in his possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In cases such as the instant application where a genus is claimed, the specification must contain “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. However, written description requirement for claims that recite compounds that specifically inhibits expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl is not met.
The entire genus of compounds that specifically inhibits expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl that function as claimed does not exist in the instant application. That is, adequate written description support does not exist to practice the full scope of the invention claimed. The specification nor the art discloses neither a representative number of species compounds nor any structure/function correlation that would enable one of skill to immediately envision the genus of compounds that specifically inhibit expression, activity, and/or stability of SHP-1, Cbl-b; and c-Cbl required to practice the full scope of the invention. Only the specific siRNA nucleic acid compounds (e.g. SEQ ID NOs.) have been reduced to practice.
The above position is further supported by In re Clarke, 148 USPQ 665, (CCPA 1966), which held that:
“It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of a small genus such as halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably large number of reductions to practice would probably be necessary.”
As stated above, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic claim. Given the breadth of the claims and Applicant’s explicit definition, the Specification lacks sufficient variety of species to reflect the variance in the genus.
In conclusion, the Specification and the prior art as filed does not provide sufficient descriptive support for the myriad of compounds embraced by the claims. For the reasons discussed above, the 35 USC § 112 rejection for written description is applicable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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