DETAILED ACTION
Applicants’ arguments, filed 11 December 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1, 11, 13-14, 18, 21, 25, 28-29, 33-34, 36, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barz et al. (WO 2020/070040 A1) in view of Brown et al. (US 2015/0374842 A1).
Barz et al. (hereafter referred to as Barz) is drawn to particles for delivery of RNA comprising polysarcosine, as of Barz, title and abstract. The particles of Barz comprise the following, as of Barz, page 6, relevant text reproduced below.
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Barz teaches a variety of lipids or lipid-like materials to which the polysarcosine may be conjugated, as of Barz, page 29, relevant text reproduced below.
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As such, Barz teaches a number of chemical groups to which the polysarcosine may be conjugated, as of Barz, page 29, lines 14-17.
Barz differs from the claimed invention for the following reason.
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As such, Barz does not teach the indicated double bond required by the instant claims.
Brown et al. (hereafter referred to as Brown) is drawn to a lipid particle for formulating an anionic agent, as of Brown, title and abstract, wherein said anionic agent may be RNA, as of Brown, paragraph 0107. Brown teaches the use of oleoyl groups and stearoyl groups as alternatives regarding being bound to a PEGylated lipid, as of Brown, paragraph 0234. In this case, the term “stearoyl” refers to an 18 carbon saturated group, whereas “oleoyl” refers to an 18 carbon unsaturated group with a double bond in a particular location and configuration, and “PEG” refers to polyethylene glycol.
Brown does not teach polysarcosine.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the polysarcosine-lipid conjugate in Barz to have had a double bond in an “oleoyl” and/or “oleic” configuration. Barz is drawn to a saturated polysarcosine-lipid conjugate for use in a lipid nanoparticle for delivery of RNA. While Barz does not teach an unsaturated polysarcosine-lipid conjugate, the examiner notes that unsaturated lipids and lipid conjugates have been used for other, non-polysarcosine lipids, as in Brown, paragraph 0234 as well as Barz, page 24, in which Barz teaches multiple cationic lipids with oleic groups. As such, the skilled artisan would have been motivated to have modified the saturated polysarcosine taught by Barz to have formed an unsaturated polysarcosine with an oleic-type group in place of the saturated group for predictable use in the lipid nanoparticle of Barz to predictably delivery an RNA payload with a reasonable expectation of success.
As to claim 1, an obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. See MPEP 2144.09(I). In this case, a saturated polysarcosine lipid conjugate and an unsaturated polysarcosine lipid conjugate are understood to have similar properties because unsaturated and saturated lipid conjugates to materials other than polysarcosine have similar properties. In support of this position, the examiner notes that Brown teaches that unsaturated DOPE-PEG has similar properties as saturated DSPE-PEG; as such, there would have been a reasonable expectation that saturated and unsaturated polysarcosine conjugates would have had similar properties.
As to claim 1, the claim recites variables R7, R8, and n. Barz teaches that the chemical group at the position that reads on R7 is hydrogen, the chemical group at the position that reads on R8 may be hydrogen, as of Barz, page 29, relevant text reproduced above. Barz teaches that the number of repeat units of sarcosine as being from 11-65 repeat units, as of Barz, page 58, Table between lines 15-20, reproduced below.
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As to claim 1, the claim recites variables R6, R9a, R9b, R10a, R10b, x, and y. It is the examiner’s position that an oleic group would have resulted in all of R6, R9a, R9b, R10a, R10b being hydrogen, y being 8, and x being 8.
As to claim 1 part (ii) and claim 2, Barz teaches DSPC, as of page 58, relevant text reproduced above. This reads on the required phospholipid as DSPC refers to distearoyl phosphatidylcholine.
As to claim 1 part (iii) and claim 3, Barz teaches cholesterol, as of the above-reproduced text from page 58.
As to claim 1 part (iv) and claim 4, Barz teaches RNA, as of the title of Barz; this reads on the required payload.
As to claim 1 part (v) and claim 5, Barz teaches DODMA, as of the above-reproduced table. This is a cationic lipid which reads on the required additional lipid component.
As to claim 11, Barz teaches 5 mol% of the polysarcosine-lipid conjugate as of page 58 lines 14-15, relevant text reproduced above. Barz also teaches mole fractions ranging between 1 mol% and 20 mol%, as of Barz, pages 57-58, Example 2, including the table on page 57.
As to claim 13, Barz teaches lipid nanoparticles (abbreviated as “LNPs”) as of page 9 lines 3-5.
As to claim 14, Barz teaches DSPC (a phosphatidylcholine) and cholesterol, as of Barz, page 58, relevant text reproduced above.
As to claim 18, Barz teaches RNA as of the title; this reads on the required nucleic acid.
As to claim 21, Barz teaches a cationic lipid as of page 24 line 9 through page 25 and page 26 line 6.
As to claim 25, this is an independent claim reciting polysarcosine-lipid conjugates with oleic groups and 15, 25, 30, 35, or 45 repeat units of polysarcosine. The claim also recites a particle with one or more of a phospholipid, steroid, payload, or additional lipid component. The skilled artisan would have been motivated to have made an oleyl-polysarcosine conjugate in a lipid nanoparticle comprising a phospholipid, cholesterol, RNA payload, and cationic lipid; see the above rejection of claim 1 of Barz. Regarding the number of repeat units of polysarcosine, Barz teaches a range from 11 to 65 repeat units on page 58 of Barz. This overlaps with the required number of repeat units. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 28, Barz teaches DSPC as of the table on page 58.
As to claim 29, Brown teaches PEGylated lipids such as PEG2000-DMG as of paragraphs 0234-0235 of Brown.
As to claim 33, this claim is rejected for essentially the same reason that claim 25 is rejected.
As to claim 34, Barz teaches 5 mol% of the polysarcosine-lipid conjugate as of page 58 lines 14-15, relevant text reproduced above. Barz also teaches mole fractions ranging between 1 mol% and 20 mol%, as of Barz, pages 57-58, Example 2, including the table on page 57. This overlaps with the claimed mole fraction. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 36, Barz teaches 50 nm particle size as of at least page 11, lines 1-2; size is also discussed elsewhere in the reference of Barzn.
As to claim 38, Barz teaches delivering an RNA payload, as of Barz, title and abstract.
Correction of Error from Prior Office Action
Previously in the prosecution history, the examiner previously took the following position as of page 13 of the office action mailed on 11 September 2025.
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Upon further review of this, the examiner takes the position that the examiner’s designation of y as 7 in an oleic group was in error. In contrast, y should have been designated as 8. This is because the prior art was previously cited to teach an oleic group; see page 11, top paragraph of the office action mailed on 11 September 2025 in which the examiner discussed an oleoyl (i.e. oleic) group, as well as the explanation of why claim 25 was rejected on page 14 of the prior office action mailed on 11 September 2025.
In the case of an oleic group, the functional group has 18 carbons total, with two carbons forming the double bond present in the structure of oleic acid. The two carbons forming the double bond are not part of either the “x” or “y” designations of claim 1. In contrast, the end carbon bound to three hydrogen atoms is part of x and the carbon closest to the polar group is part of y. As such, for there to be 18 carbon atoms, both x and y must be 8. This results in 8 carbon atoms of y, 2 carbon atoms engaged in the double bond, and 8 carbon atoms of x, resulting in 18 carbon atoms.
The examiner notes that despite this error, the above-applied rejection is not considered a new ground of rejection and this office action has been made final. This is because it was previously the examiner’s position that a polysarcosine with an oleic group would have been prima facie obvious. This determination is made in view of the fact that claim 25 was rejected over the combination of Barz in view of Brown in the Non-final rejection mailed on 11 September 2025. See the statement of rejection on page 9 of the office action on 11 September 2025, as well as the explanation of why claim 25 is rejected as of page 14 of the office action on 11 September 2025. Additionally, the examiner notes that the value of “y” does not appear to have been specifically addressed in the response on 11 December 2025.
Response to Arguments Regarding Obviousness Rejection
Applicant has presented arguments regarding the previously applied obviousness rejection, as of applicant’s response on 11 December 2025 (hereafter referred to as applicant’s response). These arguments are addressed below.
In applicant’s response, paragraphs bridging pages 7-8, applicant argues that Brown fails to teach polysarcosine and that Barz is limited to polysarcosine polymers having a saturated tail. These arguments are reiterated as of the first full paragraph of page 8 of applicant’s response.
This is not persuasive. Applicant’s arguments appear to address Barz and Brown by themselves rather than the combination of references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV).
Non-Statutory 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, 11, 13-14, 18, 21, 25, 28-29, 33-34, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,692,099 in view of Barz et al. (WO 2020/070040 A1).
Claims 1, 11, 13-14, 18, 21, 25, 28-29, 33-34, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,718,754 in view of Barz et al. (WO 2020/070040 A1).
The instant claims require a particle comprising an alkylated polysarcosine wherein the alkyl group is unsaturated comprising a double bond. The particle also comprises a phospholipid, steroid, payload, and/or additional lipid component.
The claims of both the ‘099 and ‘754 patents recite a polymer comprising an alkylated polysarcosine wherein the alkyl group is unsaturated comporising a double bond. See the following representative structure from claim 10 of the ‘099 patent.
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The claims of the ‘099 and ‘754 patents fail to recite a particle comprising a phospholipid, sterol, and additional lipid.
Barz et al. (hereafter referred to as Barz) is drawn to particles for delivery of RNA comprising polysarcosine, as of Barz, title and abstract. The particles of Barz comprise the following, as of Barz, page 6, relevant text reproduced below.
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It would have been prima facie obvious for one of ordinary skill in the art to have used the polysarcosine conjugates of the claims of the ‘099 and ‘754 patents in the lipid nanoparticle for mRNA delivery of Barz. The lipid nanoparticle of Barz comprises a polysarcosine conjugate to a long alkyl group that has lipidic properties. The polymers of the claims of the ‘099 and ‘754 patents comprise a polysarcosine conjugate to a long alkyl group. The skilled artisan would have been motivated to substituted the polymers recited by the claims of the ‘099 and ‘754 in place of the polysarcosine conjugates taught by Barz, page 6, for predictable formulation of a lipid nanoparticle capable of delivering mRNA with a reasonable expectation of success. The simple substitution of one known element (e.g. the unsaturated polysarcosine-lipid conjugate of the claims of the ‘099 and ‘754 patents) in place of another (e.g. the saturated polysarcosine-lipid conjugate of) in order to achieve predictable results (formulation into a particle to deliver mRNA, as taught by Barz) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Claims 1, 11, 13-14, 18, 21, 25, 28-29, 33-34, 36, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 25-26, 29-32, 41-43, and 50-56 of copending Application No. 18/207,494 in view of Barz et al. (WO 2020/070040 A1).
The instant claims require a particle comprising an alkylated polysarcosine wherein the alkyl group is unsaturated comprising a double bond. The particle also comprises a phospholipid, steroid, payload, and/or additional lipid component.
The copending claims recite a conjugate of a polysarcosine, including the following, as of copending claim 42, relevant structure reproduced below.
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The copending claims do not recite a particle.
Barz et al. (hereafter referred to as Barz) is drawn to particles for delivery of RNA comprising polysarcosine, as of Barz, title and abstract. The particles of Barz comprise the following, as of Barz, page 6, relevant text reproduced below.
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It would have been prima facie obvious for one of ordinary skill in the art to have used the polysarcosine conjugates of the copending claims in the lipid nanoparticle for mRNA delivery of Barz. The lipid nanoparticle of Barz comprises a polysarcosine conjugate to a long alkyl group that has lipidic properties. The polymers of the copending claims comprise a polysarcosine conjugate to a long alkyl group. The skilled artisan would have been motivated to substituted the polymers recited by the copending claims in place of the polysarcosine conjugates taught by Barz, page 6, for predictable formulation of a lipid nanoparticle capable of delivering mRNA with a reasonable expectation of success. The simple substitution of one known element (e.g. the unsaturated polysarcosine-lipid conjugate of the copending claims) in place of another (e.g. the saturated polysarcosine-lipid conjugate of) in order to achieve predictable results (formulation into a particle to deliver mRNA, as taught by Barz) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments Regarding Double Patenting Rejections
In applicant’s response on 11 December 2025 (hereafter referred to as applicant’s response), applicant requests that the double patenting rejections be held in abeyance until an indication of (otherwise) allowable claim scope is acknowledged. In this case, there is no claim scope that would be allowable if not for the double patenting rejections. As applicant has not presented arguments specific to the double patenting rejections, these rejections have been maintained.
Note Regarding Data in the Specification
Direct and indirect comparative testing can be probative of non-obviousness. See MPEP 716, especially MPEP 716.02(b)(III). In an attempt to achieve compact prosecution, the examiner reviewed the instant specification for evidence of comparative testing that could potentially be probative of non-obviousness based upon secondary considerations.
As a relevant portion of the specification, the examiner cites page 80, Table 2, which is reproduced below.
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In order to overcome a prima facie case of obviousness based upon secondary considerations, applicant must compare the claimed invention to the closest subject matter that actually exists in the prior art. See MPEP 716.02(e). It is the examiner’s position that LNP-01 and LNP-02 fail to meet this requirement. This is because the closest subject matter to actually exist in the prior art is a lipid nanoparticle comprising a derivatized polysarcosine that is derivatized in the absence of the required double bond; see e.g. Barz, page 57, Example 2, table. In contrast, LNP-01 and LNP-02 completely lack a derivatized polysarcosine. As such, LNP-01 and LNP-02 are not as close to the claimed invention as the closest prior art. As such, even if, purely en arguendo, applicant was to have compared the claimed invention against LNP-01 and LNP-02 and found that the claimed invention was to have produced superior results, this would not be probative of non-obviousness because LNP-01 and LNP-02 are not as close to the claimed invention as the closest prior art.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612