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.
Telephonic Election/Restrictions
This application contains claims directed to the following patentably distinct species:
The examiner requested by telephone that applicant elect a species of compound to be examined.
The species are independent or distinct because the different structures may entail different capabilities in delivering a therapeutic agent. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, 101 is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The different compounds would appear to result in a different field of search.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Reid Long on 23 September 2026 a provisional election was made with traverse to prosecute the following species:
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Affirmation of this election must be made by applicant in replying to this Office action.
Election/Restrictions – Group Restriction Withdrawn
The restriction requirement between multiple groups, as set forth in the office action mailed on 23 June 2026, has been withdrawn by the examiner.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Interpretation
Claim 115 recites the following chemical structure.
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The examiner has drawn the following drawing to better explain how this is being interpreted.
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As such, the examiner will proceed in examination with an understanding that a chemical with the above-indicated structure is within the scope of claim 115.
Claim Rejections - 35 USC § 102(a)(1) – 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 101-119, 121-123, and 125-128 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Angewandte Chemie International Edition, Vol. 60, 2021, pages 5848-5853 and 26 pages of supporting information).
Lee et al. (hereafter referred to as Lee) is drawn to unsaturation in lipid nanoparticles and improved mRNA transfection, as of Lee, page 5848, title and abstract. Lee teaches the following, as of page 5849, relevant text reproduced below.
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As to claim 101, the above-reproduced chemical structures appear to anticipate the requirements of the instant claim 101.
As to claims 102-104, part “B” of the above-reproduced figure appears to teach diacyl groups exhibiting the claimed requirements.
As to claims 105-110, part A of the above-reproduced figure appears to teach cores exhibiting the claimed requirements.
As to claims 111-113, part C of the above-reproduced diagram appears to teach terminating groups exhibiting the claimed requirements.
As to claims 115-118, the above-reproduced structures appear to exhibit the claimed requirements.
As to claim 119, Lee teaches the following lipid formulation, as of Lee, page 5849, right column, second paragraph, relevant text reproduced below.
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This appears to read on the additional requirements of claim 119.
As to claims 121-122, the firefly luciferase mRNA is understood to read on the required therapeutic agent that is mRNA. This would have been coupled to the lipid nanoparticle via electrostatic interaction between the cationic lipid and the anionic mRNA.
As to claim 123, this claim is rejected for essentially the same reason that claim 119 is rejected.
As to claims 125-126, the firefly luciferase mRNA is understood to read on the required therapeutic agent that is mRNA. This would have been coupled to the lipid nanoparticle via electrostatic interaction between the cationic lipid and the anionic mRNA.
As to claims 127-128, Lee teaches in vivo administration to mice as of page 5851, figure 4, which teaches administration to mice. This would have resulted in expression of the nucleic acid in vivo.
Note Regarding Reference Date: The instant application has an earliest effective filing date of 8 February 2021 in view of priority to provisional application 63/146,858. Lee appears to have a publication date of 1 February 2021, as of Lee, page 5853, right column, relevant text reproduced below.
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Assuming a publication date of 1 February 2021, it is the case that Lee was published less than a year earlier than the filing of the instant application.
The examiner further notes that, although there are common inventors between the Lee publication and the instant application, the exceptions under AIA 35 U.S.C. 102(b)(1)(A) do not appear to be applicable. In support of this position, the examiner notes MPEP 2153.01(a), which states the following on the second paragraph.
If, however, the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies.
The examiner takes the position that the above statement appears to be an accurate description of the fact pattern in the instant application. As such, it is not readily apparent that the Lee publication is an inventor-originated disclosure and this rejection has been applied.
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) 101-110, 119, 121-122 and 127 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegwart et al. (WO 2019/246203 A1).
Siegwart et al. (hereafter referred to as Siegwart) is drawn to a lipid nanoparticle for delivery of mRNA, as of Siegwart, title and abstract. The lipid nanoparticle of Siegwart includes a structure with the following general formula, as of Siegwart, page 2, relevant text reproduced below.
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As to the required core of claim 101, Siegwart teaches the following on page 6, relevant text reproduced below.
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As to the required repeating unit of claim 101, Siegwart teaches the following as of page 10, relevant text from bottom of page and page 11, relevant text reproduced below.
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As to the terminating group of claim 101, Siegwart teaches the following as of page 38, relevant text reproduced below with annotation by the examiner.
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Siegwart also teaches that the terminating group includes a sulfur atom, as of Siegwart, page 12 lines 15-20.
As to claim 101, Siegwart is not understood to be anticipatory because Siegwart does not include an example structure with an alkanethiol terminating group. 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 claim 102, Siegwart teaches a degradable diacyl group on the bottom of page 10 and onto page 11. In the degradable diacyl group, three of the four relevant locations are hydrogen and the other is R9. R9 may be alkyl with the number of carbons equal to or less than 8, as of page 11 about line 12. This would appear to overlap with the requirement that alkyl group be 3 or fewer carbons. 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 103, Siegwart teaches Y3 that is 12 or fewer carbon atoms, as of Siegwart, page 11, lines 1-4. This overlaps with the instantly claimed requirement that Y3 be 1-6 carbon atoms. 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 104, Siegwart teaches the following as of page 7, relevant chemical structure reproduced below.
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This would appear to read on the claimed requirements.
As to claims 105-110, Siegwart teaches the following in regard to the core, as of page 6, relevant figure reproduced below.
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These chemical structures, upon further reaction with the repeating unit (i.e. diacyl group), would have yielded the required structure.
As to claim 119, Siegwart teaches a lipid nanoparticle, as of the title. The teachings of Siegwart are understood to render the dendrimer of claim 101 prima facie obvious for the reasons set forth above. As to the required phospholipid, Siegwart teaches DSPC and DOPE on page 94, claims 48-49 of Siegwart. Siegwart teaches cholesterol on page 95, claim 52. Siegwart teaches a PEGylated lipid on page 95, claims 55-57.
As to claims 121-122, Siegwart teaches mRNA, as of the title of Siegwart. The skilled artisan would have expected that mRNA would have coupled to the lipid nanoparticle of Siegwart due to electrostatic attraction between positively charged cationic lipids and negatively charged mRNA.
As to claim 127, Siegwart teaches that administration of luciferase mRNA using the lipid nanoparticle of Siegwart results in gene expression of luciferase, indicating intracellular delivery of mRNA, as of Siegwart, page 56, relevant text reproduced below.
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As such, Siegwart is understood to teach intracellular delivery.
Claim(s) 111-113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegwart et al. (WO 2019/246203 A1) in view of Arpicco et al. (Il Farmaco, Vol. 59, 2004, pages 869-878).
Siegwart is drawn to a dendrimer cationic lipid in a lipid nanoparticle for delivery of a nucleic acid. See the rejection above over Siegwart by itself. Siegwart teaches an alkenyl group as the terminating group.
Siegwart does not teach a farnesyl group (i.e.
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).
Arpicco et al. (hereafter referred to as Arpicco) is drawn to various cationic lipids, as of Arpicco, page 869, title and abstract. Arpicco teaches a lipid with a farnesyl group, as of Arpicco, page 869, second to last line of abstract and third to last line of abstract, reproduced below with annotation by the examiner.
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Arpicco differs from the claimed invention because in Arpicco, the farnesyl group is not bound to a sulfur atom.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the farnesyl group of Arpicco for the terminating group in the dendrimer of Siegwart. Siegwart is drawn to a compound with an alkenyl group as a terminating group, wherein the compound of Siegwart is a cationic lipid. Arpicco is drawn to a cationic lipid having a terminal farnesyl group. As such, the skilled artisan would have been motivated to have substituted the farnesyl group of Arpicco in place of the alkenyl group of Siegwart to have predictably produced an ionizable cationic lipid with a reasonable expectation of success. The simple substitution of one known element (e.g. a farnesyl group) in place of another (e.g. the alkenyl group of Siegwart) to achieve a predictable result (e.g. formation of a cationic lipid capable of delivering a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B. The skilled artisan would have been further motivated to have made this modification because the skilled artisan would have been aware that a farnesyl group, as of Arpicco, is a species in the genus of alkenyl groups because a farnesyl group comprises carbon-carbon double bonds, which are alkenes.
The examiner notes here that Arpicco also teaches dihydrofarnesyl groups, as of page 869, abstract, and page 871, scheme 1. The examiner acknowledges that a dihydrofarnesyl group is not the same as a farnesyl group. Nevertheless, the fact that Arpicco teaches a dihydrofarnesyl group does not teach away from the farnesyl group that is also taught by Arpicco. 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 2123(II).
As to claims 111-113, these claims require the following functional group.
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The result of the substitution proposed by the examiner would have resulted in a functional group with the above-indicated chemical structure. This is because, as best understood by the examiner, the recited sulfur atom is already taught by Siegwart, with the farnesyl group being taught by Arpicco.
Claim(s) 101-119, 121-123, and 125-128 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Angewandte Chemie International Edition, Vol. 60, 2021, pages 5848-5853 and 26 pages of supporting information).
Lee et al. (hereafter referred to as Lee) is drawn to unsaturation in lipid nanoparticles and improved mRNA transfection, as of Lee, page 5848, title and abstract. Lee teaches the following, as of page 5849, relevant text reproduced below.
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As to claim 101, the above-reproduced chemical structures appear to anticipate the requirements of the instant claim 101.
As to claim 101, purely en arguendo and for the purposes of this ground of rejection only, the examiner has proceeded with the understanding that Lee teaches all of the claimed requirements, but not in the same embodiment. As such, while the prior art teaches all of the claimed components, for the purposes of this ground of rejection only, the prior art is not understood to be 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 102-104, part “B” of the above-reproduced figure appears to teach diacyl groups exhibiting the claimed requirements.
As to claims 105-110, part A of the above-reproduced figure appears to teach cores exhibiting the claimed requirements.
As to claims 111-113, part C of the above-reproduced diagram appears to teach terminating groups exhibiting the claimed requirements.
As to claims 115-118, the above-reproduced structures appear to exhibit the claimed requirements.
As to claim 119, Lee teaches the following lipid formulation, as of Lee, page 5849, right column, second paragraph, relevant text reproduced below.
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This appears to read on the additional requirements of claim 119.
As to claims 121-122, the firefly luciferase mRNA is understood to read on the required therapeutic agent that is mRNA. This would have been coupled to the lipid nanoparticle via electrostatic interaction between the cationic lipid and the anionic mRNA.
As to claim 123, this claim is rejected for essentially the same reason that claim 119 is rejected.
As to claims 125-126, the firefly luciferase mRNA is understood to read on the required therapeutic agent that is mRNA. This would have been coupled to the lipid nanoparticle via electrostatic interaction between the cationic lipid and the anionic mRNA.
As to claims 127-128, Lee teaches in vivo administration to mice as of page 5851, figure 4, which teaches administration to mice. This would have resulted in expression of the nucleic acid in vivo.
Claim(s) 120 and 124 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Angewandte Chemie International Edition, Vol. 60, 2021, pages 5848-5853 and 26 pages of supporting information) in view of Lee (US 2016/0081944 A1).
Claim(s) 120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegwart et al. (WO 2019/246203 A1) in view of Lee (US 2016/0081944 A1).
Siegwart is drawn to an ionizable cationic lipid comprising a core, a repeating group which may be a diacyl group, and a terminating unit. See the rejection above over Siegwart by itself.
Lee is also drawn to an ionizable cationic lipid comprising a core, a repeating group which may be a diacyl group, and a terminating unit. See the rejection above over Lee by itself. Both references are intended for the delivery of mRNA.
Neither Siegwart nor Lee et al. (Angewandte Chemie International Edition, Vol. 60, 2021, pages 5848-5853 and 26 pages of supporting information) teach a permanently cationic lipid in the same lipid nanoparticle as the dendrimer taught by these references.
Lee (US 2016/0081944 A1) (hereafter referred to as Robert to distinguish from other references called “Lee”) is drawn to a composition comprising an oligonucleotide lipid nanoparticle, as of Robert, title and abstract. The composition of Robert includes both quaternary cationic lipids and tertiary cationic lipids, as of Robert, paragraphs 0020-0022. Robert teaches DOTAP as the quaternary cationic lipid, as of Robert, paragraphs 0026 and 0030. The composition of Robert is for delivering oligonucleotides, as of Robert, title.
Robert differs from the claimed invention because the tertiary cationic lipid taught by Robert does not have the chemical structure required by the instant claims.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the DOTAP of Robert with the composition of Siegwart and/or Lee. Siegwart and Lee are drawn to compositions intended for delivery of a nucleic acid. Lee is also drawn to a composition intended for the delivery of a nucleic acid. As such, the skilled artisan would have been motivated to have combined the quaternary ammonium lipid such as DOTAP, as of Robert with the nanoparticle of Siegwart and/or Lee, in order to have predictably delivered a nucleic acid to a cell with a reasonable expectation of success. Combining prior art elements (e.g. the lipid nanoparticles of Siegwart and Lee, which comprise a tertiary cationic lipid and the quaternary lipid such as DOTAP of Robert) according to known methods to yield predictable results (e.g. formation of a nanoparticle for predictable delivery of a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale A. See also MPEP 2144.06(I).
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 101-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-81 of copending Application No. 18/553,975 (reference application).
Claims 101-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-88 of copending Application No. 18/419,370 (reference application).
Claims 101-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, 31, 33-35, 44, 77, 80, 101, 106, 116, 125, 145, 152, 156, and 160 of copending Application No. 18/862,512 (reference application).
Claims 101-110 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140 and 142-159 of copending Application No. 18/556,614 (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 dendrimer having the structure of Core-(diacyl group)-terminating group having a particular structure. Of particular relevance is that the claims require an alkenylthiol terminating group, wherein the term “alkenylthiol” indicates the presence of a double bond.
The copending claims of all of the above-indicated cases recite the structure “core-(repeating unit)-(terminating group).” The repeating unit appears to be a diacyl group, as of claim 73 of the ‘975 application, claim 81 of the ‘370 application, claim 33 of the ‘512 application, and claim 140 of the ‘614 application. The terminating group may comprise an alkene in that it forms an alkenylthiol group, as of claim 73 part (e) of the ‘975 application, claim 81 part (e) of the ‘370 application, claim 35 of the ‘512 application, and claim 140 of the ‘614 application.
The copending claims differ from the instant claims because the copending claims recite various limitations not required by the instant claims. The copending claims of the ‘975 application recite a method for enhancing the expression of a cystic fibrosis transmembrane conductance regulator protein in a cell, which is not required by the instant claims. The copending claims of the ‘370 application recite a nucleic acid editing system, which is not recited by the instant claims. The copending claims of the ‘512 require an interfering polynucleotide and a second polynucleotide which may be a guide polynucleotide or a sequence encoding a guided nuclease; this is not required by the instant claims. The copending claims of the ‘614 application recite a method for performing homology directed repair.
Nevertheless, the structure recited by the copending claims appears to have all of the features required by instant claim 101, thereby effectively rendering the subject matter of instant claim 101 to be prima facie obvious. This would have resulted in a prima facie case of obviousness-type non-statutory double patenting.
As to claims 102-104, the copending claims recite a diacyl group, as of copending claim 73 of the ‘975 application, copending claim 81 of the ‘370 application, copending claim 32 of the ‘512 application, and copending claim 140 of the ‘614 application.
As to claims 105-110, the copending claims recite a core comprising multiple nitrogen atoms (e.g. as of the second option recited by instant claim 110), as of copending claim 73 of the ‘975 application, copending claim 81 of the ‘370 application, copending claim 32 of the ‘512 application, and copending claim 140 of the ‘614 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 111-113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-81 of copending Application No. 18/553,975 (reference application) in view of Arpicco et al. (Il Farmaco, Vol. 59, 2004, pages 869-878).
Claims 111-113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-88 of copending Application No. 18/419,370 (reference application) in view of Arpicco et al. (Il Farmaco, Vol. 59, 2004, pages 869-878).
Claims 111-113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, 31, 33-35, 44, 77, 80, 101, 106, 116, 125, 145, 152, 156, and 160 of copending Application No. 18/862,512 (reference application) in view of Arpicco et al. (Il Farmaco, Vol. 59, 2004, pages 869-878).
Claims 111-113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140 and 142-159 of copending Application No. 18/556,614 (reference application) in view of Arpicco et al. (Il Farmaco, Vol. 59, 2004, pages 869-878).
The instant claims are drawn to a dendrimer having the structure of Core-(diacyl group)-terminating group having a particular structure. Of particular relevance is that the claims require an alkenylthiol terminating group, wherein the term “alkenylthiol” indicates the presence of a double bond. The instant claims such as claim 119 also require that this structure be combined with a lipid nanoparticle having a phospholipid, steroid/sterol, and PEG-lipid, as well as a quaternary cationic lipid required by instant claim 120.
The copending claims of all of the above-indicated cases recite the structure “core-(repeating unit)-(terminating group).” See additional explanation in the rejection above.
The copending claims do not recite the specific terminating group required by the instant claims.
Arpicco et al. (hereafter referred to as Arpicco) is drawn to various cationic lipids, as of Arpicco, page 869, title and abstract. Arpicco teaches a lipid with a farnesyl group, as of Arpicco, page 869, second to last line of abstract and third to last line of abstract, reproduced below with annotation by the examiner.
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Arpicco differs from the claimed invention because in Arpicco, the farnesyl group is not bound to a sulfur atom.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the farnesyl group of Arpicco for the terminating group in the dendrimer of the copending claims. The copending claims of the above-indicated applications are drawn to a compound with an alkenyl group as a terminating group (along with a core and a diacyl group), wherein the compound recited by the copending claims is a cationic lipid. Arpicco is drawn to a cationic lipid having a terminal farnesyl group. As such, the skilled artisan would have been motivated to have substituted the farnesyl group of Arpicco in place of the alkenyl group recited by the copending claims to have predictably produced an ionizable cationic lipid with a reasonable expectation of success. The simple substitution of one known element (e.g. a farnesyl group) in place of another (e.g. the alkenyl group recited by the copending claims) to achieve a predictable result (e.g. formation of a cationic lipid capable of delivering a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B. The skilled artisan would have been further motivated to have made this modification because the skilled artisan would have been aware that a farnesyl group, as of Arpicco, is a species in the genus of alkenyl groups because a farnesyl group comprises carbon-carbon double bonds, which are alkenes.
Claims 119-122 and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-81 of copending Application No. 18/553,975 (reference application) in view of Benenato et al. (US 2019/0167811 A1).
Claims 119-122 and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-88 of copending Application No. 18/419,370 (reference application) in view of Benenato et al. (US 2019/0167811 A1).
Claims 119-122 and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, 31, 33-35, 44, 77, 80, 101, 106, 116, 125, 145, 152, 156, and 160 of copending Application No. 18/862,512 (reference application) in view of Benenato et al. (US 2019/0167811 A1).
Claims 119-122 and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140 and 142-159 of copending Application No. 18/556,614 (reference application) in view of Benenato et al. (US 2019/0167811 A1).
The instant claims are drawn to a dendrimer having the structure of Core-(diacyl group)-terminating group having a particular structure. Of particular relevance is that the claims require an alkenylthiol terminating group, wherein the term “alkenylthiol” indicates the presence of a double bond. The instant claims such as claim 119 also require that this structure be combined with a lipid nanoparticle having a phospholipid, steroid/sterol, and PEG-lipid, as well as a quaternary cationic lipid required by instant claim 120.
The copending claims of all of the above-indicated cases recite the structure “core-(repeating unit)-(terminating group).” See additional explanation in the rejection above.
For the purposes of this rejection, the examiner takes the position that the copending claims do not recite all of the requirements of the nanoparticle of the instant claims rejected here.
Benenato et al. (hereafter referred to as Benenato) is drawn to a lipid nanoparticle comprising an ionizable amino lipid and a quaternary amino compound, as of Benenato, title and abstract. The composition of Benenato is for delivering mRNA, as of Benenato, abstract. Benenato teaches the formulations of individual lipid nanoparticles on page 112, Example 3.
Benenato differs from the claimed invention because the ionizable cationic lipid of Benenato has a different chemical structure than the ionizable cationic lipid recited by the instant claims.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the ionizable cationic lipid of the copending claims in place of that of Benenato to have been used in the nanoparticle of Benenato. Benenato is drawn to a lipid nanoparticle comprising a phospholipid, cholesterol, a PEGylated lipid, an ionizable amino cationic lipid, and optionally a quaternary cationic lipid. The compound used in the methods of the copending claims is an ionizable amino cationic lipid. As such, the skilled artisan would have been motivated to have substituted the compound of the copending claims with the ionizable cationic lipid of Benenato to have predictably formed a particle useful for delivery of a nucleic acid with a reasonable expectation of success. The simple substitution of one known element (e.g. the ionizable cationic dendrimer lipid of the copending claims) in place of another (e.g. the ionizable cationic lipid of Benenato) in order to achieve predictable results (e.g. delivery of a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 119, Benenato teaches multiple nanoparticles on page 112.
As to claim 120, Benenato teaches DOTAP on various examples on the table on page 112.
As to claims 121-122, Benenato teaches mRNA in the abstract. The skilled artisan would have expected that mRNA would have been non-covalently coupled to the nanoparticle via electrostatic interactions between the negatively charged mRNA and the positively charged cationic lipid.
As to claim 127, Benenato teaches a method of administering the lipid nanoparticle, as of paragraphs 0003-0004.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Patent – No Double Patenting Rejection
As a relevant patent over which no double patenting rejection has been written, the examiner cites US Patent 11,766,408. This patent has common inventors with the instant application and is drawn to similar subject matter. However, no double patenting rejection has been written for at least the following reasons.
Claim 1 of the ‘408 patent is drawn to a composition comprising an ionizable cationic lipid having the structure of “Core-Repeating Unit-Terminating Group.” However, claim 1 of the ‘408 patent recites that the terminating group is the following, wherein relevant text has been reproduced below with annotation by the examiner.
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As such, the claim recites that the terminating group is an alkanediyl. This would appear to be a saturated carbon chain and would not appear to include the required degrees of unsaturation recited by the “alkenylthiol” group of the last line of instant claim 101. In view of this difference, the composition recited by the claims of the ‘408 patent differs from the claimed composition. There would have been no motivation for the skilled artisan to have modified the composition of the ‘408 patent to have included an alkene-containing terminating group.
The examiner has not rejected the instant claims over the claims of US Patent 11,247,968 and 11,858,884 for essentially the same reason as the examiner has not rejected the instant claims over the claims of US Patent 11,766,408.
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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