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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 07 Oct 2025 has been entered.
Claims 1-3, 5-7, 10-12, 18-20, 24-26, 28-30, 32, and 33 remain pending in the application.
Claims 1, 7, 10, 11, 12 and 18 are amended.
Claims 4, 8, 9, 13-17, 21-23, 27 and 31 are cancelled.
Claims 6, 7, 10-15, 17, 20, 30, 32 and 33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. It is noted that claim 20 is withdrawn as the elected PEG lipid of PEG-1 does not fit within one of the PEG lipid genus groups listed.
Claims 1-3, 5, 18, 19, 24-26, 28 and 29 are under consideration to the extent of the elected species, i.e., that the compound of Formula (A-1) is compound 66, the phospholipid is DSPC, the structural lipid is cholesterol, the PEG lipid is PEG-1 and the therapeutic agent is mRNA.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 62/902,928, the applicant failed to provide adequate written description support for claims 1-7, 18, 19, 24-26, 28 and 29. Accordingly, priority cannot be granted at this time, thus claims 1-7, 18, 19, 24-26, 28 and 29 are granted the filing date of PCT/US2020/051629 (18 Sep 2020).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/902,928, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application ‘928 fails to provide support for compounds of the instant claims. For example, the ‘928 application does not disclose the sulfated headgroups (e.g. NRS(O)2RSX) as required per the instant claims. Accordingly, claims 1-7, 18, 19, 24-26, 28 and 29 are not entitled to the benefit of the prior application.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 07 Apr 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 07 Apr 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Maintained
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 3, 5, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2017/049245, published 23 Mar 2017, listed in IDS filed 15 Nov 2022).
Benenato teaches lipid nanoparticle compositions ([0004]) and that the nanoparticle compositions include a lipid component such as Formula (II) ([0017]). The structure of Formula (II) is
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([0014]). Benenato teaches options for the variables in the formula where l is 5, M and M1 may be -C(O)O-, and R2 and R3 may be C8 alkyl ([0014]) and R’ may be branched undecan-3-yl ([0092]). Benenato teaches that R4 is –(CH2)nQ where n may be 3 ([0014]) and Q may be -N(H)S(O)2R ([0109]) and R may be C2 alkyl ([00126]).
When the variables discussed above are selected, the resulting structure is
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which is the same as the elected species of compound 66 and claims 1, 2, 3, 5 and 18.
Benenato does not expressly teach selecting the functional groups for each of the variable of Formula (II) with sufficient specificity to rise to the level of anticipation for compound 66 of the instant claims.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have a compound with the structure of compound 66. One of ordinary skill in the art would have been motivated to do so as lipid nanoparticle compositions comprising compounds of Formula (II) are taught by Benenato and functional groups for the l, M, M1, R1, R2, R3 and R4 variables include groups that render the structure of compound 66 when selected. One of ordinary skill in the art would have a reasonable expectation of success in forming the structure described above as each of the functional groups are suitable for the structures of the nanoparticle compositions, as taught by Benenato, and thus the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Benenato.
Response to Arguments
Applicant's arguments filed 07 Oct 2025 have been fully considered but they are not persuasive. Applicant states that the rejection does not establish a prima facie case of obviousness when analyzed from a “lead compound analysis” framework as outlined in MPEP 2133(I)(B). The examiner does not find this persuasive. The lead compound analysis refers to substituting functional groups of a “lead compound” with alternative groups. The rejection, however, is not based on the substitution of one component of a specific lead compound for a different component. Benenato teaches a generic structure and functional groups that are suitable for the structure. There is nothing in Benenato to indicate that one of the functional groups taught shouldn’t be used and thus each of the various groups taught by Benenato are understood to be suitable for the component and the combination of the various groups is understood as obvious. The applicant argues that the rejection is hindsight recreation as Benenato does not recite the species of compound 66 (page 19 of remarks). The examiner acknowledges that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The structure of the instant claims is obvious as a generic formula with components that combine to result in the instant compounds is known from the teachings of Benenato. The examiner notes that the rejection with Benenato was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Benenato may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious over Benenato for the reasons described above. The applicant further argues that “the Office is not permitted to rely upon the generic disclosure of Benenator’s Formula (II) to recreate an anticipatory species” (page 19 of remarks). The examiner does not find this persuasive as the rejection was not based on anticipation under 35 USC 102 but rather obviousness under 35 USC 103. The instantly claimed compound is obvious over the prior art, as noted in the rejection and reiterated in the response above.
Claims 19, 24-26, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2017/049245, published 23 Mar 2017, listed in IDS filed 15 Nov 2022) as applied to claims 1-7 and 18 above, and further in view of Himansu et al. (WO 2019/136241, published 1 July 2019).
The teachings of Benenato are described supra.
Benenato further teaches that the nanoparticle compositions may further include phospholipids, PEG lipids, structural lipids ([0002], [0022]) and that the phospholipids may include DSPC ([00193]) and the structural lipids may include cholesterol ([00191]). Benenato thus renders obvious the form of empty lipid nanoparticles comprising a phospholipid a structural lipid and a PEG lipid as in claims 19 and 24. Benenato teaches that the nanoparticle composition may be used for delivering therapeutic and/or prophylactic agents such as mRNA ([0022]), rendering obvious the loaded nanoparticle of claims 25, 26 and 28. Benenato teaches the inclusion of a pharmaceutically acceptable carrier ([00332]), rendering obvious instant claim 29.
Benenato does not teach the specific PEG-lipid of PEG-1 (i.e. the elected species of PEG lipid). This deficiency is made up for in the teachings of Himansu.
Himansu teaches the delivery of mRNAs via a lipid nanoparticle delivery system (page 2 lines 28-30). Himansu teaches nanoparticle delivery agents that include ionizable lipids, PEG-modified lipids, phospholipids and structural lipids (page 138 lines 6-8). Himansu teaches that PEG lipids used in the compositions include compounds of Formula (VI) (page 160 lines 6-9) such as compound I
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(page 161 lines 4-5). Himansu teaches an embodiment where the delivery agent includes the PEG lipid compound I in combination with components such as DSPC and cholesterol (page 211 lines 25-26).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a PEG modified lipid such as Compound I (i.e the same compound as PEG-1 of the instant claims) as taught by Himansu as the PEG lipid in the compositions of Benenato. Lipid nanoparticles comprising PEG lipids for delivering mRNA are known, as taught by Benenato, and a PEG lipid such as Compound I is known as a suitable PEG lipid for constructing mRNA delivery nanoparticles, as taught by Himansu, rendering it obvious to have included the compound I PEG lipid in the nanoparticles of Benenato. The compound I PEG is even taught as suitable in combination with components such as DSPC and cholesterol, which are taught by Benenato and further renders obvious the combination. One would have a reasonable expectation of success as the PEG compound I is known for use in similar mRNA delivery nanoparticle compositions as those of Benenato and thus the use of the PEG lipid compound I of Himansu merely represents using a known prior art element for the same purpose of forming a mRNA delivery nanoparticle.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 18, 19, 24-26, 28 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment filed 07 Oct 2025 has introduced new matter into the claims. Amended claim 1 recites that the RSX group is a 3-14 membered heterocycloalkyl. The response did not point out where support for newly added limitation of “a 3-14 membered heterocycloalkyl” could be found in the originally filed disclosure. The disclosure provides support for a 4-12 membered heterocycloalky ([0030]) but not a 3-14 membered heterocycloalkyl. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Instant claim 1 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly amended claim 1, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 1 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600