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 .
A Preliminary amendment was filed on 04/30/2024.
Information Disclosure Statement
Information disclosure statements were filed on 04/30/2024, 08/12/2024, and 11/19/2025.
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.
Claims 26-28 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.
Claim 22 sets out a method of delivering mRNA. Claims 26-28 then further set out a method of treating. Applicant must set out which method is being claimed.
Clams 27 and 28 depend upon claim 26 which sets out an autoimmune disease. However, claims 27 and 28 are directed to an infectious disease and cancer, neither of which is an autoimmune disease. Clarification is requested.
Claims 26-28 recites the limitation "a method of treating" in claim 22. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 sets out a method of delivering mRNA. Applicant is requested to select whether a method of delivering or method of treatment is being claimed.
Claims 27-28 recite the limitation " infectious disease " and “cancer”. respectively ,in claim 26. There is insufficient antecedent basis for this limitation in the claim. Neither is considered an autoimmune disease. Correction is requested.
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 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-28 of copending Application No. 19/225,705 (US’70(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because US’705 set out the same method of delivering and this is an anticipatory obvious-type rejection:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/251953 (WO953) , claiming priority to 63/195,269 (01 June 2021.
WO953 teaches a method of delivery of mRNA to a hepatic or extrahepatic tissue or organ (claim 15). The lipid nanoparticle is for delivery to the spleen, bone marrow, and liver (claims 16-17). The lipid nanoparticle may be used to treat a viral infection or cancer (claims 18 and 19). The method uses a lipid nanoparticle (IcLNP) (ESM-40) comprising 33% ionizable, cationic lipid/ 25.5 % chol/40% ESM/1.5% PEG-DMG or IcLNP (ESM-40) : 20% ionizable cationic lipid/38.5% chol/40% ESM/1.5% PEG-DMG. The lipid nanoparticle comprises encapsulated mRNA (page 3, last paragraph). At page 19, 4th paragraph, DSPC and ESM are listed, as well as a sphingolipid content of 30-60 mol% of the total lipid at page 3, last paragraph. Page 11, paragraphs 1 and 2 , teach similar concentrations of lipids. The cationic lipid may be in ionizable form (pages 11 to 12).at page 4 , second paragraph the mol% based on total lipid nanoparticle. The LNP wherein the cationic lipid has a pKa of between 6.0 and 7.2. Figure 1 shows data for an LNO having 40% ESM substituted with 40% DSPC. Page 19, 4th paragraph sets out DSPC and ESM, wherein the ESM is phospatidylcholine . Page 3 , last paragraph and page 11, paragraphs 1 and 2 show a sphingolipid content of from 30 – 60 mol%. At page 3, second full paragraph, the ionizable lipid/DSPC/cholesterol/PEG-lipid has a concentration of 50/10/38.5/1.5, which is the same ration as instantly claimed. Figures 4-9 display the gene expression of mRNA in vivo. The expression of mRNA in macrophages, monocytes and/or T-cells is found in Figure 3B. The cationic, ionizable lipid is substantially neutral at physiological pH (pages 11-12). As such the ordinary practitioner would have found it well within his or her skill not only to claim the method of delivering mRN to hepatic and extra hepatic tissues, and with the same expectation for expression of the mRNA as taught by WO’953. The instantly claimed method would have therefore been obvious to one of ordinary skill in the art at the time of filing given the teachings of WO’953.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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