DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of Group I, claims 1-12 and 15-20, as well as the species of
PNG
media_image1.png
152
628
media_image1.png
Greyscale
in the reply filed on 17 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The examiner notes that prior art was cited in the restriction requirement mailed on 19 August 2025, and applicant provided arguments regarding the cited prior art as of applicant’s response on 17 December 2025. However, the arguments appear to address the prior art itself rather than the restriction requirement. As such, the examiner understands applicant’s election to be without traverse, and will address the arguments related to the prior art in a “Response to Arguments” section at the end of the office action.
The examiner has decided to expand the species election to include compound I, as required by claim 10, and compound III, as required by claim 12.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 December 2025. The reason that claim 8 is withdrawn is because claim 8 requires that R1 and R10 be cyclohydrocarbyl groups, whereas in the elected species, R1 and R10 are hydrogen.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-12 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the following, wherein relevant text from claim 1 has been reproduced below with annotation by the examiner:
PNG
media_image2.png
342
620
media_image2.png
Greyscale
The above noted limitations appear to be contradictory. This is because benzene is a six membered aromatic ring comprising only carbon (in contrast, a six membered aromatic ring comprising one nitrogen and five carbons is a pyridine, which is not a benzene). As such, L2, L3, and L5, which are directly connected to the ring Q, would only be bound to carbon rather than nitrogen were Q to be a benzene ring. As such, in view of this, it is unclear if the ring that encompasses Q is limited to a benzene ring or whether it may be a different type of ring that comprises nitrogen atoms in the ring.
For the purposes of examination under prior art, the examiner will proceed with the understanding that Q is a benzene ring, and that L2, L3, and L5 are bound to carbon. Pyridine rings or other nitrogen-containing heterocycles are not understood to be within the claim scope.
Claims 1-7, 9-12 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the following limitation:
PNG
media_image3.png
52
578
media_image3.png
Greyscale
However, claim 9, which depends upon claim 1, recites various chemical structures in which it is the oxygen atom, not the carbonyl carbon, that is closer to the benzene ring that is Q. These structures are compounds V, XVII, and XXII. Compound V has been reproduced below with annotation by the examiner.
PNG
media_image4.png
257
489
media_image4.png
Greyscale
As such, it is unclear whether claim 1 requires that the carbonyl end of L1 and L4 be closest to Q, or whether the scope of claim 1 includes structures wherein the ester oxygen of L1 and L4 is closest to Q.
For the purposes of examination under prior art, the examiner will proceed with examination with the understanding that the claims require requires that the carbonyl end of L1 and L4 is closest to Q, and that compounds V, XVII, and XXII are not within the claim scope.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites that Q is selected from a benzene ring, cyclopentyl, or cyclohexyl. However, claim 1, upon which claim 2 depends, requires that Q is a benzene ring. As such, it is unclear as to whether a cyclopentyl or cyclohexyl ring is within the scope of claim 2.
For the purposes of examination under prior art, the examiner will examiner claim 2 with the understanding that it requires that Q is a benzene ring; as such, claim 2 will be understood to have the same scope of claim 1.
Claims 2 and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d). In this case, the term “preferably”, as recited by claims 2 and 19, would render the claim unclear as to whether it is drawn to the broadest limitation recited by the claim or whether it is drawn to the preferred limitation. Additionally, MPEP 2173.05(c)(I), end of first paragraph in section, indicates that claim language reciting the term “preferably” has been found to be indefinite.
For the purposes of examination under prior art, with respect to claims 19-20, the claim is understood to be drawn to the broadest limitation. For the purposes of examination under prior art of claim 2, the claim is understood to have the same scope as claim 1 upon which it depends.
Claim 8 is not rejected here because it is withdrawn from consideration; however, claim 8 also includes the term “preferably” and may be subject to this ground of rejection were it to be rejoined.
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.
Claim(s) 1-7, 9-10, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baryza et al. (US 2018/0369386 A1).
Baryza et al. (hereafter referred to as Baryza) is drawn to lipids for the delivery of active agents, as of Baryza, title and abstract. One lipid taught by Baryza has the following structure, as of Baryza, page 89, paragraphs 1025 and 1029, wherin the structure from paragraph 1029 is reproduced below.
PNG
media_image5.png
347
845
media_image5.png
Greyscale
This structure reads on most of the required features of the instant claims, as set forth in the following table that was generated by the examiner and is set forth on the next page.
Claimed Variable
Feature in Baryza [1029]
Q
Benzene ring
L2 and L3
-O(CH2)x wherein x=1
R4, R5, R6, and R7
All hydrogen
b and c
b=4 and c=4 when x=1
L1 and L4
Both -C(=O)O- wherein the carbon faces the benzene ring
R2, R3, R8, and R9
All hydrogen
a and d
Both 11
R1 and R10
Both methyl groups
L5, R11, and e
Not taught by Baryza
R12 and R13
Both C1 hydrocarbyl (i.e. methyl)
As such, the structure on paragraph 1029 of Baryza differs from the claimed invention because it lacks the required L5, R11, and e. However, Baryza teaches the following structure on page 59, paragraph 0746, relevant structure reproduced below with annotation by the examiner.
PNG
media_image6.png
250
732
media_image6.png
Greyscale
The above-noted portion of the structure reads on the claim requirements in the following manner:
Claimed Element
Feature in Baryza [0746]
L5
-(CH2)y-OC(=O)- wherein y=1
R11
Hydrogen
e
2
R12 and R13
Both C1 hydrocarbyl (i.e. methyl)
The structure as of Baryza, paragraph 0746, differs from the claimed structure because it does not include both (L2 and L3) and (L1 and L4) together in the same molecule.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the amine-containing headgroup of the structure of paragraph 0746 of Baryza in place of the amine-containing headgroup of the structure of paragraph 1029 on the lipid of paragraph 1029 of Baryza. Both the headgroups of the lipid of paragraph 0746 of Baryza and of paragraph 1029 of Baryza are ionizable cationic lipid headgroups which would have been useful for forming a composition for delivery of siRNA or mRNA, as of paragraph 0013 of Baryza. As such, the skilled artisan would have been motivated to have substituted the headgroup of the compound of paragraph 0746 of Baryza in place of that of paragraph 1029 of Baryza in order to have predictably formed a cationic lipid capable of delivering RNA with a reasonable expectation of success. The simple substitution of one element (e.g. the headgroup of paragraph 0746 of Baryza) in place of another (e.g. the headgroup of the structure of paragraph 1029 of Baryza) to obtain predictable results (formation of an ionizable cationic lipid to deliver RNA) is prima facie obvious. See MPEP 2143, Exemplary Rationale B. The examiner clarifies that the resultant structure produced from this substitution would have been the following:
PNG
media_image7.png
192
734
media_image7.png
Greyscale
As to claim 2, Baryza teaches a benzene ring in the structure of paragraph 1029.
As to claim 3, Baryza teaches 1,3,5-trisubstitution in the structures of both paragraphs 1029 and 0746.
As to claim 4, the structure of Baryza, paragraph 0746, teaches that y=2.
As to claim 5, the structure of Baryza teaches that a and d are 11, which exceeds the claimed requirements. Nevertheless, elsewhere in the document, Baryza teaches lipids with shorter groups in the positions of a and d. One example of this is Baryza, paragraph 0779, relevant structure reproduced below.
PNG
media_image8.png
222
752
media_image8.png
Greyscale
This structure of paragraph 0779 of Baryza differs from the claimed structure because it lacks the required L5 and because the carbonyl groups face the opposite direction as compared with what is required by the instant claims. Nevertheless, the structure of paragraph 0779 of Baryza appears to comprise a and d as 6. As such, Baryza appears to teach a value for a and d that ranges from 6, as in the structure of paragraph 0779 to 11, as in the structure of paragraph 1029. This overlaps with the claimed requirement. 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 6, Baryza teaches b=4 in paragraph 1029.
As to claim 7, Baryza teaches e=2 in paragraph 0746.
As to claim 9, the structure of Baryza that would have been made via the combination of Baryza, paragraphs 1029 and 0746 differs from the structure of compound I of claim due to the lengths of various alkyl chains. Specifically, the alkyl chain between the phenolic oxygens (L2 and L3) and the ester group (L1 and L4) is longer than what is required by the instant claims, the alkyl group between the ester groups (L1 and L4) is shorter than what is required by the instant claims, and the alkyl group represented by “e” is one carbon shorter in Baryza, paragraph 0746 as compared with the instantly claimed structure. Nevertheless, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. 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, especially MPEP 2144.09(I). In this case, both the structure of Baryza and the instantly claimed structure are used as ionizable cationic lipids in lipid nanoparticles for delivering RNA. As such, differences in carbon chain lengths would have been close structural similarity, and the particles of these different chain lengths would have been expected to have been useful in forming lipid nanoparticles for delivery of RNA. Also, while the majority of examples of Baryza teach 1,3,5 substitution around the benzene ring, Baryza also suggests other substitution patterns as of at least the structure on paragraph 1061; as such, the skilled artisan would have been motivated to have optimized the substitution pattern around the benzene ring.
As to claim 10, this claim is rejected for essentially the same reason that claim 9 is rejected.
As to claim 15, Baryza teaches siRNA and mRNA in paragraph 0013; these are understood to read on the required therapeutic agent.
As to claim 16, Baryza teaches siRNA and mRNA in paragraph 0013; these are understood to read on the required nucleic acid.
As to claim 17, Baryza teaches siRNA and mRNA in paragraph 0013; these are understood to read on the requirements of claim 17.
As to claim 18, Baryza teaches self-replicating mRNA in paragraph 0418.
As to claim 19, Baryza teaches a formulation comprising I), a helper lipid, for example cholesterol, a neutral lipid, for example DSPC, and a stealth lipid, for example PEG-DMG in paragraph 0302.
As to claim 20, Baryza teaches the following in paragraph 0303, reproduced below.
PNG
media_image9.png
350
504
media_image9.png
Greyscale
Baryza also teaches adjusting the ratios of the different lipids, as of paragraph 0308. As such, the skilled artisan would have been motivated to have optimized the ratios of the different lipids in the nanoparticle of Baryza to have achieved the claimed ratio. Optimization of a result-effective variable is prima facie obvious; see MPEP 2144.05(II)(B). In this case, the teachings of paragraph 0308 of Baryza would appear to indicate that the amounts of various lipids is a result-effective variable.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baryza et al. (US 2018/0369386 A1) in view of Beckwith et al. (US 2017/0275243 A1).
Baryza is drawn to various cationic lipids comprising a benzene ring. See the above rejection over Baryza by itself.
For the purposes of this rejection, the examiner understands that Baryza differs from the claimed invention because the structures taught by Baryza have a 1,3,5 orientation around the benzene ring, whereas the claimed compound referred to as “compound I” has a 1,2,5 orientation around the benzene ring.
Beckwith et al. (hereafter referred to as Beckwith) is drawn to a lipid for the delivery of active agents, as of Beckwith, title and abstract, and teaches nucleic acid delivery in paragraph 0061. Beckwith teaches a number of lipids with a benzene ring in the center and a 1,2,5 orientation around the benzene ring, including but not limited to the following chemical structure as of Beckwith, page 47, structure at bottom of page, reproduced below.
PNG
media_image10.png
200
746
media_image10.png
Greyscale
Beckwith differs from the claimed invention because Beckwith does not teach the required variables L1 and L4. in contrast, at the positions where L1 and L4 are located, there is an ester group wherein the oxygen faces the benzene ring; in contrast, the claimed invention requires an ester group where the carbonyl carbon faces the benzene ring. The examiner notes that this deficiency appears to be present in all of the structures of Beckwith that have an ester at this position; see e.g. Beckwith, paragraphs 0480, 0483, 0485, and 0487 for other examples of this.
It would have been prima facie obvious for one of ordinary skill in the art to have rearranged the structure of Baryza to have had oriented the substituents on the benzene ring in a 1,2,5 manner rather than a 1,3,5 manner. Both Baryza and Beckwith are drawn to ionizable cationic lipids for delivery of nucleic acids having a benzene ring with three substituents thereon. Baryza teaches these substituents oriented in a 1,3,5 manner; however, Beckwith teaches orienting these substituents in a 1,2,5 manner. As such, the skilled artisan would have been motivated to have used a 1,2,5 substitution around the benzene ring in place of a 1,3,5 substitution in order to have predictably formed an ionizable cationic lipid capable of delivery of a nucleic acid with a reasonable expectation of success. The simple substitution of one element (a 1,2,5 substitution pattern) in place of another (a 1,3,5 substitution pattern) in order to achieve predictable results (formation of a cationic lipid capable of delivery of a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
Claims 11-12 Are Not Rejected Over Prior Art
Claims 11-12 are not rejected over prior art.
As relevant prior art, the examiner cites Baryza et al. (US 2018/0369386 A1), which was cited in the obviousness rejection above. The teachings of Baryza are insufficient to render claims 11-12 prima facie obvious at least because Baryza does not teach the combination of a molecule comprising a) a carbonyl group between the benzene ring and the amine (L5), two phenolic oxygen atoms on the carbon chains lacking the amine (i.e. L2 and L3), a 1,2,5 substitution pattern around the ring (wherein the “1” refers to the chain with the amine), ester groups between the phenolic oxygen and the end of the carbon chains in which the carbonyl carbon faces the benzene ring (i.e. L1 and L4), as well as an asymmetric molecule wherein one functional group of R1-3 splits into two chains whereas the other functional group of R8-10 remains a single chain. There would have been no motivation for the skilled artisan to have picked and chosen different features in Baryza to have achieved the structures recited by claims 11-12.
As an additional relevant prior art reference, the examiner cites Strodiot et al. (WO 2018/220553 A1). Strodiot et al. (hereafter referred to as Strodiot) is drawn to a liposome encapsulated RNA and a method of making such a liposome, as of Strodiot, title and abstract. Strodiot teaches the following lipid, as of page 25, relevant structure reproduced below.
PNG
media_image11.png
150
338
media_image11.png
Greyscale
Strodiot also teaches the following lipid, as of page 26, relevant structure reproduced below.
PNG
media_image12.png
178
344
media_image12.png
Greyscale
These structures differ from the claimed invention at least in the same manner that the structures of Baryza differ from the claimed invention. As such, instant claims 11-12 have not been rejected as obvious over Strodiot for essentially the same reason that these claims have not been rejected as obvious over Baryza.
As additional relevant prior art, the examiner cites Beckwith et al. (US 2017/0275243 A1), over which the claims are rejected above. One relevant structure taught by Beckwith is the following from page 59, paragraph 0558, which is reproduced below with annotation by the examiner.
PNG
media_image13.png
360
549
media_image13.png
Greyscale
The above-reproduced structure differs from the structures of claims 11-12. This is because a) the above-reproduced structure does not teach the required L1 and L4 because in the above-reproduced structure, the oxygen faces the benzene ring, whereas the claims require carbon atoms facing the benzene ring, b) the above-reproduced structure teaches various ether oxygen atoms not recited by the claims, and c) the above-reproduced structure is not an asymmetric molecule wherein one functional group of R1-3 splits into two chains whereas the other functional group of R8-10 remains a single chain. In view of this, instant claims 11-12 have not been rejected over Beckwith.
The examiner clarifies that claims 11-12 are not allowable because they remain subject to non-prior art rejections.
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 1-7, 9-12, and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 19, 30-31, 34, 47, 53, 63, 72, 76, 86, 93, 112, 117, and 123-126 of copending Application No. 18/667,934 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an ionizable lipid with a particular chemical structure.
The copending claims recite an ionizable lipid with the following chemical structures, as of copending claim 76, relevant structures reproduced below.
PNG
media_image14.png
392
558
media_image14.png
Greyscale
The instant claims and copending claims differ because the copending claims include various claims drawn to a self-replicating RNA vector, which are not recited by the instant claims. Nevertheless, the above-reproduced chemical structures from the copending claims appear to be within the scope of the structures recited by the instant claims. Thereby the structures from the copending claims effectively anticipate the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-11, and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 13, 15, 21-23, 28-29, 35, 39, 42-43, 45-46, and 80-82 of copending Application No. 18/667,939 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an ionizable lipid with a particular chemical structure.
The copending claims recite an ionizable lipid with the following chemical structures, as of copending claim 1, relevant structure reproduced below.
PNG
media_image15.png
174
652
media_image15.png
Greyscale
The instant claims and copending claims differ because the copending claims include various claims drawn to a self-replicating RNA vector, which are not recited by the instant claims. Nevertheless, the above-reproduced chemical structures from the copending claims appear to be within the scope of the structures recited by the instant claims. Thereby the structures from the copending claims effectively anticipate the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-12, and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8, 10, 12-13, 16, 19, 22-23, 27-33, 36, and 42 of copending Application No. 19/231,051 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an ionizable lipid with a particular chemical structure.
The copending claims recite an ionizable lipid with the following chemical structures, as of copending claim 30, relevant structures reproduced below.
PNG
media_image16.png
546
554
media_image16.png
Greyscale
The instant claims and copending claims differ because the copending claims include various claims drawn to a self-replicating RNA vector, which are not recited by the instant claims. Nevertheless, the above-reproduced chemical structures from the copending claims appear to be within the scope of the structures recited by the instant claims. Thereby the structures from the copending claims effectively anticipate the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612