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.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority based on three applications filed in China at various timepoints in 2021. Certified copies appear to have been provided of all three documents; however, it is noted, however, the order of pages in all of the certified copies appears to have been reversed in their placement in the file record. Nevertheless, the examiner takes the position that this meets the requirements of 37 CFR 1.55 because all of the pages of the priority documents have been provided.
Election/Restrictions
Applicant’s election without traverse of the following species
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in the reply filed on 8 June 2026 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim.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 8 June 2026.
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 3-4 and 32-35 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 3 recites that the PEG chain length is from 20 to 100 and more specifically it is 40, 45, 50, or 60. 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. In this case, in view of the claim language reciting “more specifically”, it is unclear whether claim 3 is drawn to the broader range of from 20 to 100 or to the narrower range of 40, 45, 50, or 60. Similar issues apply to claim 4 and 32-35.
For the purposes of examination under prior art, the claims will be interpreted as if they are drawn to their broader ranges.
Claim 28 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 28 recites the following:
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It is unclear from this claim requirement as to whether the number of units of G1 is represented by the variable j or the variable k+1. As such, it is unclear how the limitation
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further limits the claim scope.
For the purposes of examination under prior art, the examiner will proceed in examination by interpreting the claim in a manner that
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is not understood to have been recited by the claim.
Although claim 29 depends from claim 28, the examiner has not rejected claim 29 because claim 29 recites the structures of specific cationic lipids.
Claim Rejections - 35 USC § 112(d) – Failure to Further Limit Parent Claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 requires that R1 and R2 are each independently a C5-30 aliphatic hydrocarbon group. However, claim 5 depends upon claim 1, and this feature has already been recited by claim 1. As such, claim 5 does not appear to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
The examiner notes that in claim 1, L3 may be –(CH2)t-. In this case, Z is not present. As such, the scope of claim 1 covers cases wherein Z is not present.
Additionally, in claim 1, L3 may be –(CH2)t- wherein t=0. As such, no atoms are required to be part of the group that is L3, and L3 may therefore be a linking bond.
The examiner further notes that the scope of instant claim 1 includes both
chemical structures wherein the nitrogen is an amine nitrogen and would have been protonated at acidic pH values and may have been protonated at neutral pH values; and
chemical structures wherein the recited nitrogen is an amide and/or carbamate nitrogen and would not have been protonated in an aqueous environment.
The examiner also clarifies that the lipid recited by claim 28 is understood to be a separate lipid as compared with the lipid recited by claim 1. As such, to meet the requirements of claim 28, a cationic liposome would need to include both the lipid recited by claim 1 and also the lipid recited by the additional limitations of claim 28, as well as other requirements of claim 25, upon which claim 28 depends.
Regarding claim 24 and claims dependent thereon, the examiner understands a cationic liposome to be a liposome that has a positive zeta potential at least at some pH values, at least when not including anionic drug. A liposome that has a positive zeta potential at lower pH values and a neutral or negative zeta potential at higher pH values is understood to be a cationic liposome. This is because a liposome exhibiting these properties would likely have included ionizable cationic lipids which would have been positively charged at lower pH and neutral at higher pH. A liposome which would have been positively charged in the absence of anionic cargo but neutral or negatively charged in the presence of anionic cargo (wherein DNA, siRNA, mRNA, or other nucleic acids may be anionic cargo) is understood by the examiner to be a cationic liposome. This is because such a liposome would have comprised cationic lipids that would have engaged in electrostatic interactions with the anionic lipids.
Claim Rejections - 35 USC § 102(a)(2) – Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 11-12, 15, and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Heyes et al. (US 2024/0148663 A1).
Heyes et al. (hereafter referred to as Heyes) is drawn to lipid nanoparticles for delivering siRNA and mRNA. Heyes teaches various lipids on page 42, relevant structures reproduced below.
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The uppermost structure reads on the claimed invention in the following manner, as of the following table, which is reproduced on the next page.
Claimed Variable
Teaching in Heyes
R
Methoxy (e.g. alkoxy)
(A)n1
(OCH2CH2)a wherein a is about 44-45 to achieve 2000 Daltons
L3
-Z(CH2)t wherein Z is -C(O)O- and t is 2
B3 and B4
Both linking bonds
L7
Linking bond
L8
Linking bond
R1 and R2
-C14H29
As to claims 2-4, Heyes teaches PEG with a molecular weight of 2000 Daltons. Given that the molecular weight of the repeating (OCH2CH2) unit in PEG is about 44 Daltons, this would appear to be about 45 repeat units, which is within the scope of claims 2-4. As best understood by the examiner, the molecular weight range taught by Heyes of ~2000 g/mol in paragraph 0353 would appear to teach either polydispersity or monodispersity.
As to claim 5, in the structure of Heyes, R1 and R2 are C14 aliphatic groups.
As to claim 6, in the structure of Heyes, L7 and L8 are linking bonds.
As to claim 7, in the structure of Heyes, B3 and B4 are linking bonds.
As to claim 8, in the structure of Heyes, Z is C(=O)O and L3 is (CH2)t wherein t=2.
As to claim 11, the structure of Heyes would appear to read at least structure 1-1 recited by claim 11.
As to claim 12, Heyes teaches linear C14 alkyl groups that read on R1 and R2.
As to claim 15, the methoxy terminus of the PEG of Heyes would appear to read on the requirements of this claim.
As to claim 17, the structure of Heyes would appear to read on the following structure recited by instant claim 17.
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Note Regarding Reference Date: The instant application claims foreign priority to multiple Chinese applications, the earliest of which has a filing date of 8 April 2021. Heyes claims benefit of a US provisional application having a filing date of 18 December 2020. In view of this, Heyes is understood to have been effectively filed earlier than the effective filing date of the instant application. Therefore, Heyes is prior art under AIA 35 U.S.C. 102(a)(2). There does not appear to be a common inventor or assignee between the instant application and Heyes; and as such, the exceptions under AIA 35 U.S.C. 102(b)(2)(A) and/or 102(b)(2)(C) do not appear to be applicable.
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) 1-8, 11-12, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uemura (KR 101476656 B1).
As an initial matter, Uemura is written in Korean. The examiner has provided an English translation as of Google Patents (https://patents.google.com/patent/KR101476656B1/en?oq=CN+101275065 accessed 15 April 2026). Page and paragraph citations are to the English translation; however, the material cited therein is understood by the examiner to have been present in the original Korean document.
Uemura is drawn to a polishing liquid, as of Uemura, page 1, title and abstract. Uemura teaches the following compounds as of page 6 of the translation, reproduced in part below.
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In the case of compounds D10, D11, and D12 of Uemura, these compounds read on the claimed invention in the following manner, as of the table set forth below.
Claimed Variable
Teaching in Uemura D1, D2, D3, and D4
R
Hydrogen
(A)n1
(CH2CH2O)a
L3
Linking Bond –(CH2)t- wherein t=0 or t=2
B3 and B4
Both linking bonds
L7
Linking bond
L8
Linking bond
R1 and R2
-C12H25 (D1) -C16H33 (D2) -C18H37 (D3) -C20H41 (D4)
As to claim 1, as best understood by the examiner, Uemura is not anticipatory because it is not clear that “a” in the examples of Uemura (i.e. the number of ethylene glycol repeat units) is between 20 and 250, as required by the instant claims. Nevertheless, Uemura teaches that the polyethylene glycol chain preferably has a molecular weight of 200 to 5000, as of Uemura, page 5. Given a molecular weight of 44 Daltons per repeat unit, a chain length of 200 is about 4-5 repeat units, whereas a molecular weight of 5000 is about 113-114 repeat units. This does not read on, but overlaps with the claim requirement that n1 be from 20 to 250. 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 2, Uemura teaches that the polyethylene glycol chain preferably has a molecular weight of 200 to 5000, as of Uemura, page 5. This overlaps with the molecular weight requirement of the instant claims. 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 claims 3-4, the optimization/overlap rationale provided by the examiner regarding the PEG chain length in the above-applied rejection of claim 1 is also understood to be relevant regarding claims 3-4.
As to claim 5 Uemura teaches C12, C16, and C18 alkyl groups for R1 and R2.
As to claim 6, in the case of structures D1, D2, D3, and D4 of Uemura, both L7 and L8 are linking bonds.
As to claim 7, in the case of structures D1, D2, D3, and D4 of Uemura, both B3 and B4 are linking bonds.
As to claim 8, the claim recites that L3 may be –(CH2)t- wherein t=2. As best understood by the examiner, the compound of Uemura may be considered to read on this requirement.
As to claim 11, the teachings of Uemura would appear to read on at least structure 1-1 of Uemura wherein R1 and R2 are 12-20 carbon alkyl groups, R is hydrogen, and L3 is –(CH2)t- wherein t=zero.
As to claim 12, Uemura teaches R1 and R2 are 12-20 carbon linear alkyl groups in structures D1, D2, D3, and D4.
As to claim 15, in the structure of Uemura, structures D1, D2, D3, and D4, R is hydrogen.
As to claim 17, the claim requires the following chemical structure:
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This chemical structure appears to have R1 and R2 groups of 14 carbons. The teachings of compound D1 of Uemura differ from that of the above-reproduced chemical structure in that the compound of Uemura has 12 carbons for R1 and R2 whereas the claimed structure has 14 carbons for R1 and R2. The teachings of compound D1 of Uemura differ from that of the above-reproduced chemical structure in that the compound of Uemura has 16 carbons for R1 and R2 whereas the claimed structure has 14 carbons for R1 and R2. Nevertheless, the chain lengths in Uemura overlap with those required by the instant claims. 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).
This rejection does not apply to claim 24 and claims dependent thereon. This is because the composition of Uemura is drawn to chemical mechanical polishing. In contrast, claim 24 is drawn to a cationic liposome. Cationic liposomes are generally used in drug delivery of an anionic drug such as a nucleic acid, and are not used in chemical mechanical polishing. As such, the skilled artisan would not have been motivated to have modified the composition of Uemura to have been in the form of a cationic liposome.
Additionally, the composition of Uemura appears to differ from the elected specie because the elected specie comprises the following carbonyl group, not present in Uemura.
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As such, Uemura does not appear to render the elected specie to be prima facie obvious.
Claim(s) 1-8, 11-12, 15, 17, 24-27, and 30-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heyes et al. (US 2024/0148663 A1).
Heyes et al. (hereafter referred to as Heyes) is drawn to lipid nanoparticles for delivering siRNA and mRNA. Heyes teaches various lipids on page 42, relevant structures reproduced below.
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The uppermost structure reads on the claimed invention in the following manner, as of the following table, which is reproduced below.
Claimed Variable
Teaching in Heyes
R
Methoxy (e.g. alkoxy)
(A)n1
(OCH2CH2)a wherein a is about 44-45 to achieve 2000 Daltons
L3
-Z(CH2)t wherein Z is -C(O)O- and t is 2
B3 and B4
Both linking bonds
L7
Linking bond
L8
Linking bond
R1 and R2
-C14H29
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner has proceeded with the understanding that Heyes teaches all of the claimed requirements but not in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claims 2-4, Heyes teaches PEG with a molecular weight of 2000 Daltons. Given that the molecular weight of the repeating (OCH2CH2) unit in PEG is about 44 Daltons, this would appear to be about 45 repeat units, which is within the scope of claims 2-4. As best understood by the examiner, the molecular weight range taught by Heyes of ~2000 g/mol in paragraph 0353 would appear to teach either polydispersity or monodispersity. Nevertheless, in the alternative, the skilled artisan would have been motivated to have optimized the molecular weight profile of the polymers in Heyes in order to have predictably used these in a composition for predictably delivering a nucleic acid with a reasonable expectation of success. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a PEGylated lipid have been taught by Heyes. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of PEG molecular weight dispersity via routine experimentation.
As to claim 5, in the structure of Heyes, R1 and R2 are C14 aliphatic groups.
As to claim 6, in the structure of Heyes, L7 and L8 are linking bonds.
As to claim 7, in the structure of Heyes, B3 and B4 are linking bonds.
As to claim 8, in the structure of Heyes, Z is C(=O)O and L3 is (CH2)t wherein t=2.
As to claim 11, the structure of Heyes would appear to read at least structure 1-1 recited by claim 11.
As to claim 12, Heyes teaches linear C14 alkyl groups that read on R1 and R2.
As to claim 15, the methoxy terminus of the PEG of Heyes would appear to read on the requirements of this claim.
As to claim 17, the structure of Heyes would appear to read on the following structure recited by instant claim 17.
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As to claim 24, Heyes teaches a cationic lipid that would have resulted in a cationic lipid nanoparticle, as of at least Heyes, paragraphs 0103-0104. The skilled artisan would have understood the cationic lipid nanoparticle of Heyes to have read on the required cationic liposome because the particle of Heyes would have been expected to have been in the form of bilayers and/or an aqueous interior and would not have been a micelle with a lipidic interior. Heyes also uses the term “liposome” in paragraph 0265.
As to claim 25, Heyes teaches the following as of page 39, relevant text reproduced below.
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This includes the PEG-lipid of Heyes, ionizable cationic lipid, cholesterol (a neutral lipid), and DSPC (a phospholipid).
As to claim 26, Heyes teaches DSPC in the above-reproduced paragraph, which reads on 1,2-distearoyl-sn-glycero-3-phosphocholine.
As to claim 27, Heyes teaches cholesterol in the above-reproduced paragraph.
As to claim 30, Heyes teaches DOTAP in paragraph 0103, which reads on the requirement of the claims.
As to claim 31, Heyes teaches about 54.6 mol% cationic lipid, 32.8 mol% cholesterol, 10.9% DSPC (i.e. zwitterionic neutral phospholipid) and 1.6 mol% PEGylated lipid; this appears to be within the claim scope.
As to claim 32, Heyes teaches about 54.6 mol% cationic lipid, as explained in the above rejection of claim 31.
As to claim 33, Heyes teaches about 10.9% DSPC (zwitterionic neutral phospholipid), which is within the claim scope.
As to claim 34, Heyes teaches about 38.5 mol% cholesterol in paragraph 0357; this is within the claim scope.
As to claim 35, Heyes teaches 1.6 mol% PEGylated lipid in paragraph 0341; this is within the claim scope.
As to claims 36-38, Heyes teaches an anti-cancer mRNA vaccine in paragraph 0263.
The examiner notes the following regarding reference dates: The instant application claims foreign priority to multiple Chinese applications, the earliest having a filing date of 8 April 2021. Heyes claims benefit of a US provisional application having a filing date of 18 December 2020. In view of this, Heyes is understood to have been effectively filed earlier than the effective filing date of the instant application. Therefore, Heyes is prior art under AIA 35 U.S.C. 102(a)(2). There does not appear to be a common inventor or assignee between the instant application and Heyes.
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 1-8, 11-12, 15, 17, and 24-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12,648,908. 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 a PEGylated lipid having the following structure.
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The instant claims recite a cationic liposome, as of instant claim 24 and claims dependent thereon.
The conflicting claims recite the following:
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The variable “A” in the conflicting claims may be represented by the following, as of conflicting claim 1.
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The instant and conflicting claims differ because the instant claims require 20-250 repeat units of (A), whereas the conflicting claims require only 2-6 repeat units of (A). Nevertheless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a lipid comprising repeating ethylene glycol groups has been recited by the conflicting claims. Therefore, it would not have been inventive for the skilled artisan to have discovered the optimum or workable number of repeat units via routine experimentation.
The examiner notes that the instant claims recite “A PEGylated lipid” in the first line of the claim, whereas the conflicting claims recite “[a] cationic lipid” in the first line of the claim. Nevertheless, in the case of more than half of the compounds recited by instant claim 17, the branching nitrogen is an amine nitrogen and would have been protonated at low pH. As such, the majority of compounds recited by the instant claims are ionizable cationic lipids. Therefore, the scope of the instant claims includes ionizable cationic lipids that would have read on the cationic lipid recited by the conflicting claims.
The instant and conflicting claims differ because L1 in the conflicting claims may be one of the following groups:
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In contrast, L7 and L8, which are the corresponding structures required by the instant claims, are limited to a linking bond or esters. As such there are differences in what this functional group may be. Nevertheless, this functional group may be an ester in the conflicting claims, which reads on the instantly claimed requirement, thereby resulting in a prima facie case of obviousness-type non-statutory double patenting.
Claims 1-8, 11-12, 15, 17, and 24-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13, 17-18, and 25-37 of copending Application No. 18/284,740 (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 a PEGylated lipid having the following structure.
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The instant claims recite a cationic liposome, as of instant claim 24 and claims dependent thereon.
The copending claims are drawn to a PEGylated lipid having the following structure.
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The copending claims also recite a cationic liposome comprising this structure, as of instant claim 25 and claims dependent thereon.
The instant and copending claims differ because the copending claims recite that L7 and L8 are a wide variety of functional groups, in contrast, the instant claims limit L7 and L8 to only a linking bond or ester groups. Nevertheless, the subject matter of the copending claims appears to be within the scope of the instant claims and effectively anticipates the subject matter of the instant claims. This results in a prima facie case of anticipatory-type provisional non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 11-12, 15, 17, and 24-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-50 of copending Application No. 18/839,059 (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 a PEGylated lipid having the following structure.
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The instant claims also recite a cationic liposome comprising this structure, as of instant claim 24 and claims dependent thereon.
The copending claims recite a lipid with the following structure.
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The copending claims also recite a lipid composition further comprising a phospholipid, steroid, and/or cationic lipid, as of copending claim 42; this would have formed a liposome had all three of these been present.
The instant and copending claims differ because the copending claims recite that L1 and L2 may be one of various functional groups such as amino acid containing groups, whereas the instant claims limit these functional groups to esters or linking bonds . Nevertheless, the subject matter of the copending claims appears to be within the scope of the instant claims in the case where these functional groups are linking bonds. This effectively anticipates the subject matter of the instant claims. This results in a prima facie case of anticipatory-type provisional 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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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