DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 4 May 2026 has been entered, and the arguments presented therein 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 25, parts (ii), (iii), (iv), and (v), these are rejected for the same reason as parts (ii), (iii), (iv), and (v) of claim 1.
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 Barz.
As to claim 38, Barz teaches delivering an RNA payload, as of Barz, title and abstract.
Response to Arguments Regarding Obviousness Rejection
Applicant has provided arguments regarding the previously applied rejection, as of applicant’s response on 4 May 2026 (hereafter referred to as applicant’s response). Applicant’s arguments have been addressed below.
Applicant makes the following arguments on page 6, reproduced below.
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These arguments by themselves are not persuasive. This is because applicant appears to address the deficiencies of Barz and Brown by themselves. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV). The above-reproduced arguments appear to address Barz and Brown by themselves rather than their combination.
Applicant then makes the following arguments regarding Brown, which are reproduced below.
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This argument continues on page 7, wherein relevant text is reproduced below.
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As an initial matter, the examiner disputes applicant’s position that L-14, L-21, and L-36 are the preferred lipids in Brown. Brown’s teachings regarding these lipids has been presented in paragraph 0055 of Brown, which is reproduced below.
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This does not appear to support applicant’s position that L-14, L-21, and L-36 are preferred by Brown. This is because (a) Brown does not use the term “preferred” and (b) Brown does not present evidence as to why Brown believes L-14, L-21, and L-36 to be superior to other lipids.
Otherwise, applicant’s arguments appear to be that Brown teaches a variety of lipids, the majority of which have a tail comprising either zero double bonds (i.e. saturated) or more than one double bond (i.e. polyunsaturated), rather than a tail with a single double bond, as required by the instant claims. These arguments are not persuasive. The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. See MPEP 2145(X)(D)(1), second paragraph in section. In this case, Brown does not criticize, discredit, or otherwise discourage using a lipid comprising a tail with a single double bond.
Additionally, even if, purely en arguendo, L-14, L-21, and L-36 were actually the lipids preferred by Brown, this would still not be sufficient to overcome the applied rejection. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2145(X)(D)(1), first paragraph in section. The examiner clarifies that the citation of this section of the MPEP should not be construed as an admission that Brown teaches that L-14, L-21, and L-36 are the preferred lipids and other lipids are somewhat inferior.
Applicant also argues that the lipids taught by Brown have two lipid tails, as of applicant’s arguments on page 7. Applicant appears to argue that this differs from the instantly claimed invention, which requires a lipid with a single lipid tail. This argument is not persuasive because Barz teaches a lipid with a single lipid tail. See the structure on page 6 of Barz, reproduced below.
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As such, this argument appears to address Brown by itself rather than the combination of Barz with Brown. Such arguments are not persuasive; see MPEP 2145(IV).
Applicant then makes the following argument, as of the top of page 8, relevant text reproduced below.
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This argument appears to relate to the “lead compound” analysis regarding obviousness of chemical structures. This issue of obviousness and a lead compound discussed as of MPEP 2143(I)(B), Examples 8-11 of section.
It is the examiner’s position that the compound of page 6 of Barz, that was reproduced on page 4 of the prior office action mailed on 2 January 2026 can serve as a lead compound. This lead compound includes a saturated lipophilic group of 12-16 carbon atoms. It would have been prima facie obvious for the skilled artisan to have modified this saturated lipid chain with an unsaturated lipid chain as taught by Brown because both carbon chains are useful for the formation of lipids. A rationale for this has been presented as of page 6, last full paragraph of the prior office action mailed on 2 January 2026.
To the extent that applicant is arguing that the examiner failed to provide rationale as to why a particular compound in the prior art was chosen as a lead compound, this argument is not persuasive. MPEP 2143(I)(B), Example 9, beginning of last paragraph in section states that
The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound.”
Similarly, in MPEP 2143(I)(B), Example 10, the fourth paragraph in this example states the following.
The Federal Circuit affirmed the district court’s decision. The Federal Circuit did not deem it necessary in this case to consider the question of whether 2-pyr EHDP had been appropriately selected as a lead compound. Rather, the Federal Circuit reasoned that, if 2-pyr EHDP is presumed to be an appropriate lead compound, there must be both a reason to modify it so as to make risedronate and a reasonable expectation of success.
As such, applicant’s argument that the examiner chose the wrong compound in the prior art as a lead compound or that the examiner failed to justify why a particular compound from the prior art was assigned to be a lead compound in accordance with the examiner’s analysis are not persuasive. This is because the MPEP appears to indicate that the examiner may choose any compound in the prior art to serve as a lead compound for the purpose of analysis in order to set forth a prima facie case of obviousness.
Applicant then makes the following argument, as of the first full paragraph of page 8, reproduced below.
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The examiner reviewed the above-cited case and has noted that it is discussed in MPEP 2143(I)(A), Example 4. The discussion in the MPEP points to the following text from the cited case.
The record shows that the prior art would actually discourage and teach away from the use of foam straps. An ordinary artisan in this field would not add a foam strap to the foam Aqua Clog because foam was likely to stretch and deform, in addition to causing discomfort for a wearer. The prior art depicts foam as unsuitable for straps.
As such, it appears that there is an issue related to teaching away in the cited case that does not exist in the fact pattern in the instant application. As such, applicant’s citation of Crocs, Inc. v. U.S. Int'l Trade Comm'n, 598 F.3d 1294, 93 USPQ 1777 (Fed. Cir. 2010) does not appear to be relevant to the examiner’s decision in the instant application due to significant differences in the fact pattern of the cited case as compared with that of the instant application.
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 same structure is also recited by claim 16 of the ‘754 patent.
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.
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, both the ‘099 and ‘754 patent teach x as between 5-90. This overlaps with the structure required by the claim, requiring 15, 20, 25, 30, 35, or 45 repeat units of the sarcosine group. 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 25, parts (ii), (iii), (iv), and (v), these are rejected for the same reason as parts (ii), (iii), (iv), and (v) of claim 1.
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 Barz.
As to claim 38, Barz teaches delivering an RNA payload, as of Barz, title and abstract.
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.
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, copending claim 43 recites x as being 10, 15, 20, 25, 30, 35, 40, or 45. This overlaps with the structure required by the claim, requiring 15, 20, 25, 30, 35, or 45 repeat units of the sarcosine group. 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 25, parts (ii), (iii), (iv), and (v), these are rejected for the same reason as parts (ii), (iii), (iv), and (v) of claim 1.
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 Barz.
As to claim 38, Barz teaches delivering an RNA payload, as of Barz, title and abstract.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments Regarding Double Patenting Rejections
In applicant’s response on 4 May 2026 (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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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