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
Applicant’s election without traverse of claims 1-6, 12, 19, 26, 28, 30, and 33 in the reply filed on 03/03/2026 is acknowledged. Claims 1-6, 12, 19, 26, 28, 30, and 33 are currently under examination and the subject of the present Office Action. Claims 37, 40-42, 46-47, 49, and 51 are withdrawn from consideration without traverse. Claims 7-11, 13-18, 20-25, 27, 29, 31-32, 34-36, 38-39, 43-45, 48, and 50 are cancelled.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 03/26/2024 and 11/12/2025 have been considered here.
Claim Objections
Claim 2 is objected to because of the following informalities: The last clause of claim 2 reads “each occurrence of m, n, o, p, q, r, s, t, u, v, w, and x are is independently 0, 1, 2; 3, 4, or 5” which should read, “each occurrence of m, n, o, p, q, r, s, t, u, v, w, and x is independently 0, 1, 2, 3, 4, or 5.” Appropriate correction is required.
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.
Claims 1, 5-6, 12, 19, 26, 28, 30, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Billingsley” (2020; as submitted in the IDS of 03/26/2024).
In regards to claims 1, 6, 26, 28, and 30, Billingsley teaches a lipid nanoparticle designed for ex vivo mRNA delivery (see Billingsley, abstract) comprising an ionizable lipid, 1,2-distearoyl-snglycero-3-phosphoe-thanolamine (DOPE) (i.e., helper lipid) (note: claim 6 short-hands this to DSPC), cholesterol, and lipid-anchored PEG in a molar ratio of 35%, 16%, 46.5% and 2.5% respectively (see Billingsley, page H, Lipid Nanoparticle (LNP) formulation and characterization).
In regards to claims 5, Figure 2 describes the structure of the alkyl chains (a) and the polyamine cores (b) that are used to generate the ionizable lipid library, as well as a sample reaction scheme (c). Specifically C14-4 is taught (see Billingsley, page C, Figure 2).
In regards to claims 12 and 19, the helper lipid is taught to be dioleoylphosphatidylethanolamine (DOPE) (see Billingsley, page C, characterization of LNP library).
In regards to claim 33, it is taught that the lipid nanoparticles are formulated for targeting/binding to tumor cells using mRNA (see Billingsley, page B, caption of Figure 1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 12, 19, 26, 28, 30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over “Billingsley” (2020; as submitted in the IDS of 03/26/2024).
In regards to claims 1, 6, 26, 28, and 30, Billingsley teaches a lipid nanoparticle designed for ex vivo mRNA delivery (see Billingsley, abstract) comprising an ionizable lipid, 1,2-distearoyl-snglycero-3-phosphoe-thanolamine (DOPE) (i.e., helper lipid) (note: claim 6 short-hands this to DSPC), cholesterol, and lipid-anchored PEG in a molar ratio of 35%, 16%, 46.5% and 2.5% respectively (see Billingsley, page H, Lipid Nanoparticle (LNP) formulation and characterization).
In regards to claims 2-5, Figure 2 describes the structure of the alkyl chains (a) and the polyamine cores (b) that are used to generate the ionizable lipid library, as well as a sample reaction scheme (c). Using these reaction schemes, it is possible for one with ordinary skill in the art to formulate the ionizable lipids as claimed, specifically formulas III, XI, and C14-4 (see Billingsley, page C, Figure 2).
In regards to claims 12 and 19, the helper lipid is taught to be dioleoylphosphatidylethanolamine (DOPE) (see Billingsley, page C, characterization of LNP library).
In regards to claim 33, it is taught that the lipid nanoparticles are formulated for targeting/binding to tumor cells using mRNA (see Billingsley, page B, caption of Figure 1).
Billingsley does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Billingsley with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
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 1-6, 12, 19, 26, 28, 30, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 8-9, 12, 18-19, 22, 26, and 48 of copending Application No. 17/769893 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant and reference application recite limitations that are identical or substantially identical, such as the structure of the ionizable lipid and the use of mRNA, as well as the additional limitations of the use of DOPE, PEG, and cholesterol.
The reference application does not claim with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of the reference application with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 12, 19, 26, 28, 30, and 33 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 and 50 of copending Application No. 17/769858 in view of “Billingsley” (2020; as submitted in the IDS of 03/26/2024).
The claims of the referenced application ae directed to a compound of identical structure to the ionizable lipid of the instant claims.
The claims of the reference application is silent on the composition comprising lipid nanoparticles, the use of additional components such as cholesterol, PEG, and a helper lipid.
The teachings of Billingsley have been described supra.
In regards to claims 1-6, 12, 19, 26, 28, 30, and 33, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Billingsley with the reference application as they teach identical structures of the lipid. "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 with ordinary skill in the art would be motivated to combine the structure of the reference application with Billingsley according to the method of making lipid nanoparticles (see Billingsley, Materials and Methods) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 12, 19, 26, 28, 30, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-9, 11, 13, and 18 of copending Application No. 18/695487 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant and reference application recite limitations that are identical or substantially identical, such as the structure of the ionizable lipid and the use of mRNA, as well as the additional limitations of the use of DOPE, PEG, and cholesterol.
The claims of the reference application do not claim with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of the reference application with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 12, 19, 26, 28, 30, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, 13-14, 17, and 19 of copending Application No. 19/518491 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant and reference application recite limitations that are identical or substantially identical, such as the structure of the ionizable lipid and the use of mRNA, as well as the additional limitations of the use of DOPE, PEG, and cholesterol.
The claims of the reference application does not claim with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of the reference application with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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