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
1. Claims 1-19 are under consideration. It is noted the claims were examined with respect to SEQ ID NOs: 1, 55, 98, 152, 219, 231.
Priority
2. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Since a certified English translation has not been provided for CHINA 202110323564.9, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 3/25/2022.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 9/25/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
4. Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification on pages 26, 27, 29 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
5. Claims 4, 5, 9 are objected to because of the following informalities:
As to claim 4, for improved clarity, the claim should recite “influenza virus and other molecules” (instead of “the other molecules”), as well as “active ingredients” (instead of “the active”).
As to claim 5, for improved grammar and clarity, the claim should recite “reducing viral titers, and inhibiting infection…”.
As to claim 9, the claim starts a new sentence in the middle of it (“Further preferably”). For consistency with the other claims, the claim should instead recite a semi colon similar to claims 3, 5, 14.
Appropriate correction is required.
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.
6. Claims 3, 5, 7, 8, 9, 12, 13, 14, 16, 17, 19 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.
See claims 3, 5, 7, 8, 9, 12, 13, 14, 16, 17, 19 as submitted 9/25/2023.
As to claims 3, 7, 9, 13, 16, the claims recite “preferably”. It is not clear if the ensuing language after “preferably” is required or not (See MPEP 2173.05(d)).
As to claim 5, the claim recites “key genes”. The term is a relative term which renders the claim indefinite. The term “key genes” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 8 recites “the reactive groups”. There is insufficient antecedent basis for this limitation in the claim.
Further as to claim 9, it is not clear what the metes and bounds of “the homologous sequences between a human … gene and a mouse … gene” are.
As to claim 12, the claim recites “application”. It is not clear if application is a method or a use, as the claim does not recite any actual steps (See MPEP 2173.05(q)). In view of the uncertainty, application is interpreted as “use of the siRNA-small…”.
As to claims 13, 16, the claims recite “the pharmaceutical composition”, “the … conjugate” and “the pharmaceutically acceptable carrier”. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 12, 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 12, 19 as submitted 9/25/2023.
See also the 35 U.S.C. 112(b) rejection above.
Claims 12, 19 appear to recite a use without any actual steps. “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(See MPEP 2173.05(q)).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1-8, 11-19 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Jadhav et al. (US20070099858-A1)(See PTO-892: Notice of References Cited).
See claims 1-8, 11-19 as submitted 9/25/2023.
See also the 35 U.S.C. 112(b) rejections above.
Jadhav et al. teaches: siRNA, used to modulate expression of influenza virus genes (abstract); wherein molecules comprise antisense strand and sense strand [0030]; including influenza A virus RNA interference RNA SEQ ID NO: 35, which has 100% identity with instant SEQ ID NO: 1 (See Result 2 of STIC Sequence Search Result 20260126_154858_us-18-284-025a-1.rng in Supplemental Content Tab); as well as complementary strand (See Result 2 of STIC Sequence Search Result 20260126_154946_us-18-284-025a-98.rng in Supplemental Content Tab); as well as influenza A virus RNA interference RNA SEQ ID NO: 1049, which has 100% identity with instant SEQ ID NO: 98 (See Result 1 of STIC Sequence Search Result 20260126_154946_us-18-284-025a-98.rng in Supplemental Content Tab); as well as complementary strand (See Result 2 of STIC Sequence Search Result 20260126_154858_us-18-284-025a-1.rng in Supplemental Content Tab)(as recited in claims 1, 5, 6); in drugs [0482](as recited in claim 2); in carrier [0071](as recited in claims 13, 16); use of liposomes [286](as recited in claims 13, 16); nanoparticles [0257](as recited in claims 14, 17); administered orally, transdermally, by injection [0468](as recited in claims 14, 17); H1N1 [0272](as recited in claims 5, 15, 18, 19).
Jadhav et al. also teaches: administering anti-influenza virus small molecule compound such as antiviral such as zanamivir [0183](as recited in claims 4, 7); including conjugates of siNA molecules [428], including conjugates including small molecules [0428](as recited in claims 8, 11, 12); wherein conjugate moieties include polyamines such as PEI [0078]; including covalent attachment of conjugates [0121](as recited in claims 8, 11, 12); wherein nucleic acid molecules are used in combination or in conjunction with other drugs [0296].
Jadhav et al. also teaches: SEQ ID NO: 6287, which has 100% identity with instant SEQ ID NO: 55 (See Result 1 of STIC Sequence Search Result 20260202_025707_us-18-284-025a-55.rng in Supplemental Content Tab)(as recited in claim 3); as well as complementary strand with 100% identity with instant SEQ ID NO: 152 (See Result 1 of STIC Sequence Search Result 20260202_025736_us-18-284-025a-152.rng in Supplemental Content Tab)(as recited in claim 3); as well as SEQ ID NO: 7633 with 100% identity with instant SEQ ID NO: 152 (See Result 4 of STIC Sequence Search Result 20260202_025736_us-18-284-025a-152.rng in Supplemental Content Tab); as well as complementary strand with 100% identity with instant SEQ ID NO: 55 (See Result 4 of STIC Sequence Search Result 20260202_025707_us-18-284-025a-55.rng in Supplemental Content Tab)(as recited in claim 3).
Thus, Jadhav et al. anticipates the instant 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.
9. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jadhav et al. as applied to claims 1-8, 11-19 above, and further in view of Gao et al. (CN1837365A)(See PTO-892: Notice of References Cited)(See also the WIPO translation of CN1837365A)(See PTO-892: Notice of References Cited).
See claim 9 as submitted 9/25/2023.
See the teachings of Jadhav et al. above, including as to antiviral compounds [0183].
Jadhav et al. does not teach: ribavirin.
Gao et al. teaches: use of siRNA and ribavirin to inhibit replication of influenza virus in cells [0255].
One of ordinary skill in the art would have been motivated to use ribavirin as taught by Gao et al. with the composition as taught by Jadhav et al. Jadhav et al. teaches administration of siNA with antiviral, and Gao et al., which also teaches administration of siNA with antiviral, teaches such a known antiviral (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using ribavirin as taught by Gao et al. with the composition as taught by Jadhav et al. There would have been a reasonable expectation of success given the underlying materials (siRNAs and antivirals as taught by Jadhav et al. and Gao et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. Claims 4-9, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jadhav et al. (US20070099858-A1)(cited above) in view of Beigelmann et al. (WO2021173811A1)(See PTO-892: Notice of References Cited).
See claims 4-9, 16-18 as submitted 9/25/2023.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Jadhav et al. above, including as to antivirals.
Jadhav et al. does not teach: siRNA molecule for inhibiting the expression of PD-L1.
Beigelmann et al. teaches: siRNAs for treatment of PD-L1 related diseases including cancer, viral diseases (abstract); including antiviral medication to treat influenza virus infection [0114]; using siRNA in combination with antiviral therapy (claim 24 of Beigelmann et al.); wherein viruses modulate PD-1/PD-L1 pathway to improve infectivity [0025]. Further, as to the “is designed based on” language, such language is interpreted as a product by process reading on the siRNA molecule (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
One of ordinary skill in the art would have been motivated to combine siRNAs for inhibiting expression of PD-L1 as taught by Beigelmann et al. with the composition as taught by Jadhav et al. Jadhav et al. teaches use of siRNA for treating virus infection and use of antivirals, and Beigelmann et al., which teaches also use of siRNAs with antivirals, teaches the benefit of using siRNAs for inhibiting expression of PD-L1 for treating viral infections (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
One of ordinary skill in the art would have had a reasonable expectation of success for combining siRNAs for inhibiting expression of PD-L1 as taught by Beigelmann et al. with the composition as taught by Jadhav et al. There would have been a reasonable expectation of success given the underlying materials and methods (treating viral infections as taught by Jadhav et al. and Beigelmann et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
11. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jadhav et al. in view of Beigelmann et al. as applied to claims 4-9, 16-18 above, and further in view of Evans et al. (WO2021061437)(See PTO-892: Notice of References Cited).
See claim 10 as submitted 9/25/2023.
See the teachings of Jadhav et al. in view of Beigelmann et al. above.
Jadhav et al. in view of Beigelmann et al. does not teach: the siRNA(s) for inhibiting PD-L1 expression are selected from one or more of the following siRNA molecules: the sequence of the sense strand is selected from any one of SEQ ID Nos. 219-230, and the antisense strand is selected from any one of SEQ ID Nos. 231-242, which is complementary to the sense strand.
Evans et al. teaches: anti-PD-L1 antisense siRNA sequence SEQ ID NO: 40, which has 100% identity with instant SEQ ID NO: 231 (See Result 2 of STIC Sequence Search Result 20260202_025926_us-18-284-025a-231.rng in Supplemental Content Tab); anti-PD-L1 sense siRNA sequence SEQ ID NO: 39, which has 100% identity with instant SEQ ID NO: 219 (See Duplicate, Result 1 of STIC Sequence Search Result 20260202_025907_us-18-284-025a-219.rng in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use siRNA as taught by Evans et al. with the composition as taught by Jadhav et al. in view of Beigelmann et al. Jadhav et al. in view of Beigelmann et al. teaches use of siRNA inhibiting PD-L1 expression for use in treating cancer and viral infections, and Evans et al., which also teaches inhibiting PD-L1 expression for use in treating cancer, teaches such a siRNA (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using siRNA as taught by Evans et al. with the composition as taught by Jadhav et al. in view of Beigelmann et al. There would have been a reasonable expectation of success given the underlying materials (siRNA for inhibiting PD-L1 expression as taught by Evans et al. and Jadhav et al. in view of Beigelmann et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
12. SEQ ID NO: 195-206, 207-218 (as recited in claim 10) are free of the prior art of record.
13. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672