DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See paras 6 and 7.
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 12 is 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. There is/are no units used in the ratio so it is not clear what the units are to be used to compare so to arrive at the ratio. The claim is not futher treated.
Claim Rejections - 35 USC § 102
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1 and 3 are rejected under pre-AIA 35 U.S.C. 102a as being anticipated by Sahin et al. (Nature 586, 594–599 (2020).
Sahin et al. teach a composition comprising an mRNA od an antigen of SARS-CoV-2 s (spike) antigen and formulated in lipid nanoparticles (abstract).
Thus, Sahin et al. anticipate the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-11 and 13-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baumhof et al. (WO2018/078053) and Sahin et al. (Nature 586, 594–599 (2020).
Baumhof et al. teach teach mRNAs can be delivered by lipid nanoparticles (abstract), for claims 4 and 7, the cationic lipid can be DOTAP (page 109, line 5). For claims 5 and 8, the neutral lipid can be DSPC (page 142, line 26). For claim 6, it can include a cholesterol (see claim 84). For claims 9-11, the same ratios are taught (claim 84). For claims 13-14, the composition can include immune enhancer of CpG DNA (page 161, line 11). For claim 15, the composition can be lyophilized (page 4, line 6). For claim 16, the composition can be made by mixing (page 203 middle).
Baumhof et al. does not teach SARS CoV-2 spike antigen.
Sahin et al. teach a composition comprising an mRNA of an antigen of SARS-CoV-2 s (spike) antigen and formulated in lipid nanoparticles (abstract).
One of ordinary skill in the art before the time of invention would be able to choose lipid formulations from those known in the art as well as be able to choose antigens from those known in the art.
One of ordinary skill in the art before the time of invention would have has the expectation of success knowing both the lipid formulations and the mRNA had been used before in the art.
Thus, it would have been prima facies obvious before the time of invention to modify the mRNA lipid nanoparticle of Baumhof et al. with the mRNA of Sahin et al.
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, and 3-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-14, and 16 of copending Application No. 18566654 (reference application) in view of Sahin et al. (Nature 586, 594–599 (2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application obvious the ‘080 application.
The ‘080 application claim mRNAs can be delivered by lipid nanoparticles (the ‘080 application claims 1 and 3, reference claims 1 and 14), for claims 4 and 7, the cationic lipid can be DOTAP (ref claims 1 and 5). For claims 5 and 8, the neutral lipid can be DSPC (reference 3 and 6). For claim 6, it can include a cholesterol (ref claim 4). For claims 9-11, the same ratios are taught (ref claims 7-9). For claim 10 the ratios overlap (ref claim 12, both without units). For claims 13-14, the composition can include immune enhancer of CpG DNA (ref claims 12-13). For claim 15, the composition can be lyophilized (ref claim 16).
The reference claims refer to compositions that treat viral infections but do not teach SARS-CoV-2 S (spike) antigen.
Sahin et al. teach a composition comprising an mRNA of an antigen of SARS-CoV-2 s (spike) antigen and formulated in lipid nanoparticles (abstract).
One of ordinary skill in the art would be able to choose viral antigens to make the instant lipid nanoparticles with and have the expectation of success knowing that the mRNA of Sahin et al. had been used in lipid nanoparticle vaccines.
Thus, the claims are obvious over the reference and Sahin et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-14, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16 of copending Application No. 18279689 (reference application) and Sahin et al. (Nature 586, 594–599 (2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application obvious the ‘080 application.
The ‘080 application claim mRNAs can be delivered by lipid nanoparticles (the ‘080 application claims 1 and 3, reference claims 1, 9, and 14), for claims 4 and 7, the cationic lipid can be DOTAP (ref claims 1 and 4). For claims 5 and 8, the neutral lipid can be DSPC (reference 2 and 5). For claim 6, it can include a cholesterol (ref claim 3). For claims 9-11, the same ratios are taught (ref claims 6-8). For claim 10 the ratios overlap (ref claim 12, both without units). For claims 13-14, the composition can include immune enhancer of CpG DNA (ref claims 11-12). For claim 16, the composition can be made by a method of mixing (ref claim 16).
The reference claims refer to compositions that treat viral infections but do not teach SARS-CoV-2 S (spike) antigen.
Sahin et al. teach a composition comprising an mRNA of an antigen of SARS-CoV-2 s (spike) antigen and formulated in lipid nanoparticles (abstract).
One of ordinary skill in the art would be able to choose viral antigens to make the instant lipid nanoparticles with and have the expectation of success knowing that the mRNA of Sahin et al. had been used in lipid nanoparticle vaccines.
It would be obvious to one of ordinary skill in the art to use vaccine formulations to treat viral disease
Thus, the claims are obvious over the reference and Sahin et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671