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 40-59 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 2/21/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 77.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
4. Claims 40-42, 46, 48, 49, 50, 53, 55-59 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jangra et al. (“A Combination Adjuvant for the Induction of Potent Antiviral Immune Responses for a Recombinant SARS-CoV-2 Protein Vaccine,” bioRxiv preprint, retrieved at https://biondv.org/content/10/1101/2021/02/18.431484v2 (2021))(cited in applicant’s IDS submitted 2/21/2024).
See claims 40-42, 46, 48, 49, 50, 53, 55-59 as submitted 6/19/2024.
Jangra et al. teaches: nanoemulsion (p. 1); RIG-1 agonist (p. 1); spike protein antigen eliciting responses to SARS-CoV-2 in mice (pp. 1-2)(as recited in claims 40, 41, 50, 58); DI RNA of Sendai (p. 2)(as recited in claims 42, 53); spike protein subunit vaccine (p. 15)(as recited in claim 46); combination adjuvant with spike protein antigen (abstract)(as recited in claim 49); administration (p. 17)(as recited in claim 48); intranasal (p. 1)(as recited in claim 55).
As to claims 56, 57, 59, absent evidence to the contrary, such results are considered to flow from the composition and steps as recited in claims 48 and 58 on which they depend (see also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In view of the foregoing, all the claimed limitations are found in one reference and are taught as well as taught to be used and are optional variations to a ‘base’ product or method they exemplify. As such, the claimed composition and method is within the scope of Jangra et al., and thus Jangra et al. teaches the composition or renders the composition and method prima facie obvious. The rationale to also support a conclusion of obviousness is that Jangra et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed composition and method exhibits any unexpected results compared to the prior art.
Therefore the invention as a whole is anticipated or also would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
5. Claims 43, 44, 54 are rejected under 35 U.S.C. 103 as being unpatentable over Jangra
et al. as applied to claims 40-42, 46, 48, 49, 50, 53, 55-59 above, and further in view of Hao et al. (CN 101890161 B)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN 101890161 B)(See PTO-892: Notice of References Cited).
See claims 43, 44, 54 as submitted 6/19/2024.
See the teachings of Jangra et al. above.
Jangra et al. does not teach: wherein the agonist of a TLR is an agonist of TLR3; wherein the TLR3 agonist is a synthetic double-stranded RNA polyriboinosinic polyribocytidylic acid (pIC).
Hao et al. teaches: polyriboinosinic-polyribiocytidilic acid as an adjuvant for antigen-specific humoral and cellular immunity ([0012] of English translation); under the mediation of TLR3, PIC causes the release of cytokines [0008].
One of ordinary skill in the art would have been motivated to use pIC as taught by Hao et al. with the composition and method as taught by Jangra et al. Jangra et al. teaches the use of TLR agonist, and Hao et al. teaches such an agonist (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 pIC as taught by Hao et al. with the composition and method as taught by Jangra et al. There would have been a reasonable expectation of success given the underlying materials (adjuvant as taught by Hao et al. and Jangra 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.
6. Claims 45, 51, 52 are rejected under 35 U.S.C. 103 as being unpatentable over Jangra
et al. as applied to claims 40-42, 46, 48, 49, 50, 53, 55-59 above, and further in view of, and further in view of Khader et al. (US20200113990A1)(See PTO-892: Notice of References Cited).
See claims 45, 51, 52 as submitted 6/19/2024.
See the teachings of Jangra et al. above.
Jangra et al. does not teach: wherein the nanoemulsion comprises: (a) a poloxamer surfactant or polysorbate surfactant; (b) an organic solvent; (c) a halogen containing compound;
(d) oil, and (e) water; wherein the nanoemulsion comprises: (a) Tween 80; (b) ethanol; (c) cetylpyridinium chloride (CPC); (d) soybean oil; and (e) water.
Khader et al. teaches: nanoemulsion [0007]; poloxamer [0038]; organic solvent [0028]; halogen containing compound [0048]; soybean oil [0049]; water (claim 4 of Khader); Tween 80 ]0037]; CPC [0049].
One of ordinary skill in the art would have been motivated to use components as taught by Khader et al. with the composition and method as taught by Jangra et al. Jangra et al. teaches or suggests use of nanoemulsion, and Khader et al. teaches such a nanoemulsion (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 components as taught by Khader et al. with the composition and method as taught by Jangra et al. There would have been a reasonable expectation of success given the underlying materials (nanoemulsions as taught by Khader et al. and Jangra 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.
7. Claims 46, 47, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Jangra et al. as applied to claims 40-42, 46, 48, 49, 50, 53, 55-59 above, and further in view of Sahin et al. (“BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans,” Nature, Vol. 595: 572-577 (2021))(See PTO-892: Notice of References Cited).
See claims 46, 47, 50 as submitted 6/19/2024.
See the teachings of Jangra et al. above.
Jangra et al. does not teach: wherein the coronavirus vaccine is mRNA-1273 or BNT162b2.
Sahin et al. teaches: BNT162b2 vaccine (title); encoding SARS-CoV-2 spike glycoprotein (abstract).
One of ordinary skill in the art would have been motivated to use vaccine as taught by Sahin et al. with the composition and method as taught by Jangra et al. Jangra et al. teaches or suggests use of coronavirus vaccine, and Sahin et al. teaches such a vaccine (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 vaccine as taught by Sahin et al. with the composition and method as taught by Jangra et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus vaccines as taught by Sahin et al. and Jangra 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.
8. Claims 40, 48, 49, 55-59 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Agrawal et al. (WO 2015104656 A1)(See PTO-892: Notice of References Cited)
See claims 40, 48, 49, 55-59 as submitted 6/19/2024.
Agrawal et al. teaches: nanoemulsions [00145]; use of TLR agonists and RIG-I agonists [00172]; coronavirus antigen [00104](as recited in claims 40, 48, 49); intranasal administration [00280](as recited in claims 48, 55, 58).
As to claims 56, 57, 59, absent evidence to the contrary, such results are considered to flow from the composition and steps as recited in claims 48 and 58 on which they depend (see also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In view of the foregoing, all the claimed limitations are found in one reference and are taught as well as taught to be used and are optional variations to a ‘base’ product or method they exemplify. As such, the claimed composition and method is within the scope of Agrawal et al., and thus Agrawal et al. teaches the composition or renders the composition and method prima facie obvious. The rationale to also support a conclusion of obviousness is that Agrawal et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed composition and method exhibits any unexpected results compared to the prior art.
Therefore the invention as a whole is anticipated or also would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claims 41, 42, 53 are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. as applied to claims 40, 48, 49, 55-59 above, and further in view of Fox et al. (KR-20200028395-A)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of KR-20200028395-A)(See PTO-892: Notice of References Cited).
See claims 41, 42, 53 as submitted 6/19/2024.
See the teachings of Agrawal et al. above.
Agrawal et al. does not teach: wherein the agonist of RIG-I is an RNA agonist; wherein the RNA agonist is a defective interfering (DI) RNA of a Sendai virus (SeV) or a defective interfering (DI) RNA of influenza virus.
Fox et al. teaches: emulsions (title); use of SEVDI (Sendai virus defective interference), dsRNA RIG-1 agonist [0652].
One of ordinary skill in the art would have been motivated to use agonist as taught by Fox et al. with the composition and method as taught by Agrawal et al. Agrawal et al. teaches the use of RIG-I agonist, and Fox et al. teaches such an agonist (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 agonist as taught by Fox et al. with the composition and method as taught by Agrawal et al. There would have been a reasonable expectation of success given the underlying materials (adjuvant as taught by Fox et al. and Agrawal 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 43, 44, 54 are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. as applied to claims 40, 48, 49, 55-59 above, and further in view of Hao et al. (CN 101890161 B)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN 101890161 B)(See PTO-892: Notice of References Cited).
See claims 43, 44, 54 as submitted 6/19/2024.
See the teachings of Agrawal et al. above.
Agrawal et al. does not teach: wherein the agonist of a TLR is an agonist of TLR3; wherein the TLR3 agonist is a synthetic double-stranded RNA polyriboinosinic polyribocytidylic acid (pIC).
Hao et al. teaches: polyriboinosinic-polyribiocytidilic acid as an adjuvant for antigen-specific humoral and cellular immunity ([0012] of English translation); under the mediation of TLR3, PIC causes the release of cytokines [0008].
One of ordinary skill in the art would have been motivated to use pIC as taught by Hao et al. with the composition and method as taught by Agrawal et al. Agrawal et al. teaches the use of TLR agonist, and Hao et al. teaches such an agonist (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 pIC as taught by Hao et al. with the composition and method as taught by Agrawal et al. There would have been a reasonable expectation of success given the underlying materials (adjuvant as taught by Hao et al. and Agrawal 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.
11. Claims 45, 51, 52 are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. as applied to claims 40, 48, 49, 55-59 above, and further in view of Khader et al. (US20200113990A1)(See PTO-892: Notice of References Cited).
See claims 45, 51, 52 as submitted 6/19/2024.
See the teachings of Agrawal et al. above.
Agrawal et al. does not teach: wherein the nanoemulsion comprises: (a) a poloxamer surfactant or polysorbate surfactant; (b) an organic solvent; (c) a halogen containing compound;
(d) oil, and (e) water; wherein the nanoemulsion comprises: (a) Tween 80; (b) ethanol; (c) cetylpyridinium chloride (CPC); (d) soybean oil; and (e) water.
Khader et al. teaches: nanoemulsion [0007]; poloxamer [0038]; organic solvent [0028]; halogen containing compound [0048]; soybean oil [0049]; water (claim 4 of Khader); Tween 80 ]0037]; CPC [0049].
One of ordinary skill in the art would have been motivated to use components as taught by Khader et al. with the composition and method as taught by Agrawal et al. Agrawal et al. teaches or suggests use of nanoemulsion, and Khader et al. teaches such a nanoemulsion (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 components as taught by Khader et al. with the composition and method as taught by Agrawal et al. There would have been a reasonable expectation of success given the underlying materials (nanoemulsions as taught by Khader et al. and Agrawal 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.
12. Claims 46, 47, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal et al. as applied to claims 40, 48, 49, 55-59 above, and further in view of Sahin et al. (“BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans,” Nature, Vol. 595: 572-577 (2021))(See PTO-892: Notice of References Cited).
See claims 46, 47, 50 as submitted 6/19/2024.
See the teachings of Agrawal et al. above.
Agrawal et al. does not teach: wherein the coronavirus vaccine is mRNA-1273 or BNT162b2.
Sahin et al. teaches: BNT162b2 vaccine (title); encoding SARS-CoV-2 spike glycoprotein (abstract).
One of ordinary skill in the art would have been motivated to use vaccine as taught by Sahin et al. with the composition and method as taught by Agrawal et al. Agrawal et al. teaches or suggests use of coronavirus vaccine, and Sahin et al. teaches such a vaccine (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 vaccine as taught by Sahin et al. with the composition and method as taught by Agrawal et al. There would have been a reasonable expectation of success given the underlying materials (coronavirus vaccines as taught by Sahin et al. and Agrawal 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
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
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