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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-16) and species elections LP01 (ionizable lipid), DSPC (phospholipid), DMG-PEG-2000 (PEGylated lipid), SEQ ID NO: 9 (CAR sequence), SEQ ID NO: 21 (TCE sequence), and T-cell engager (TCE) (biomolecule) in the reply filed on 7/31/2026 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)).
Claims 17-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/2026.
Claims 1-24 are pending.
Claims 1-16 are pending and under examination.
Priority
Applicant' s claim for the benefit of a prior-filed provisional application 63/745,171 filed on 01/14/2025 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The disclosure of the prior-filed application, provisional Application No. 63/745,171 filed on 01/14/2025 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
‘171 fails to disclose instant SEQ ID NOs: 9 and 21 as recited in instant claims 9 and 10, respectively. Additionally, ‘171 fails to recite a molar ration of the ionizable lipid to one or more nucleic acids being 2:1 to 6:1, as recited in claim 3 (i.e., the molar ration disclosed in ‘171 is narrower).
Accordingly, the effective priority date of the claims 3, 9 and 10 is granted as the filing date of the instant application, 01/14/2026.
The effective priority date of claims 1, 2, 4-8, and 11-16 is 1/14/2025.
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Information Disclosure Statement
The information disclosure statements filed 1/14/2026, 4/07/2026, 5/29/2026, and 7/31/2026 fail to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Drawings
The drawings are objected to because Figures 31, 37, 40, and 41 are blurry/too difficult to discern. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification filed on 01/14/2026 is accepted.
Claim Interpretation
Claim 1 recites “A nanoparticle for selective transfection of M2 macrophages, the nanoparticle comprising a lipid phase and a core, wherein the core comprises one or more nucleic acids and the nanoparticle selectively delivers the one or more nucleic acids to M2 macrophages in vitro or in vivo”. The examiner notes that the recitation of “for selective transfection of M2 macrophages” in the preamble is interpreted as an intended use of the claimed invention and not a limitation of the claimed invention. “For selective transfection of M2 macrophages” does not limit the structure of the claimed invention; therefore, it does not provide significance to the claim construction. See MPEP § 2111.02.II.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The phrase "the nanoparticle selectively delivers the one or more nucleic acids to M2 macrophages in vitro or in vivo" is an intended use limitation, which does not contain any further structural limitations with respect to the claimed nanoparticle (see MPEP §2114).
Claim Rejections - 35 USC § 102
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.
(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, 2, 5, 11-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ye et al. (Ye Z, Chen J, Zhao X, Li Y, Harmon J, Huang C, et al. In vitro engineering chimeric antigen receptor macrophages and T cells by lipid nanoparticle-mediated mRNA delivery. ACS Biomater Sci Eng. 2022; 8: 722-733.), as evidenced by Kim et al. (Kim, Ok-Hee, et al. "Impaired phagocytosis of apoptotic cells causes accumulation of bone marrow-derived macrophages in aged mice." BMB reports 50.1 (2017): 43.).
Regarding claim 1, Ye et al. disclose a nanoparticle comprising a lipid phase and core, wherein the core comprises one or more nucleic acids (e.g., Fig. 1).
Regarding claim 2, Ye et al. discloses the lipid phase including an ionizable lipid (e.g., 9322-O16B and 76-O17Se), cholesterol, a phospholipid, and a PEGylated lipid, and the core further comprises a buffer solution (e.g., Fig. 1).
Regarding claim 5, Ye et al. disclose a DSPC phospholipid (e.g., Fig. 2D).
Regarding claim 11, Ye et al. disclose contacting macrophages (i.e., BMDM) with the nanoparticle (pg. C, “Primary Macrophage-Directed LNP Screening”). Although Ye et al. does not explicitly state the macrophages were M2, Ye et al. does refer to primary (i.e., Mφ) macrophages separate from M1 macrophages, and polarizing the primary macrophages to proinflammatory, M1-like phenotypes (e.g., pg. C, “Activation”). It is known in the art that macrophages are categorized into two phenotypes: M1 and M2, as evidenced by Kim et al. Therefore, absent evidence to the contrary, and artisan would reasonably conclude that the primary macrophages contacted in Ye et asl. Encompass M2 macrophages.
Regarding claims 12 and 13, Ye et al. discloses the nanoparticle comprising an mRNA encoding CAR (e.g., pg. C, col 1, para 1).
Regarding claim 16, Ye et al. disclose a therapeutic compound comprising the nanoparticle and a pharmaceutically acceptable excipient (e.g., formulation delivered to culture medium) (e.g., pg. D, “Bone Marrow-Derived Macrophages”).
Claim(s) 1, 2 and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fred Hutchinson (US20230331804A1, published 10/19/2023).
Regarding claims 1, 11, and 13, Fred Hutchinson discloses lipid nanoparticles (LNPs) comprising a lipid phase and a core for delivery to macrophages. For example, the core comprises one or more nucleic acids, wherein the nanoparticle selectively delivers the one or more nucleic acids, such as mRNA (claim 13) (e.g., claim 6 of Hutchinson- “wherein the RNA includes messenger RNA (mRNA”), to M2 macrophages in vitro or in vivo (“In particular embodiments, systems and methods disclosed herein include administering nanoparticles to a subject in need thereof. The nanoparticles are directed to monocytes in the bloodstream and/or macrophages present in tumors in the subject and are designed to be internalized by the monocytes/macrophages ... In M2 macrophages that have internalized one or more nucleotides…” e.g., [0043]; claim 18 - "wherein the nanoparticle is a liposome, a liposomal nanoparticle, a lipid nanoparticle"; "a nanoparticle having nucleotides encoding transcription factors and a bi-specific antibody are encapsulated within a positively-charged cure" e.g., [0044]; "In particular embodiments, nanoparticles can include binding domain targeting ligands that bind cellular markers present on the surface of monocytes and/or macrophages" e.g., [0205]; “M2 Binding Domains"- e.g., [0206]).
Regarding claim 2, Fred Hutchinson discloses the lipid phase including an ionizable lipid (e.g., DORI) (e.g., [0184]), cholesterol (e.g., [0196]), a phospholipid (e.g., [0196]), and a PEGylated lipid (e.g., [0189], [0196]), and the core further comprises a buffer solution (e.g., [0195]).
Regarding claim 12, Fred Hutchinson discloses the nucleic acids encoding a T cell engager (e.g., claim 12 of Hutchinson).
Regarding claims 14 and 15, Fred Hutchinson discloses delivering the nanoparticle to tissue-resident macrophages (e.g., [0055]) as well as targeting tumor-associated immunosuppressive macrophages (TAMs) (aka M2 macrophages) in solid malignant tumors (e.g., [0038], [0043], [0246]).
Regarding claim 16, Fred Hutchinson discloses a therapeutic composition comprising the nanoparticle and a pharmaceutically acceptable excipient (e.g., [0223]).
Claim(s) 1, 2, 4 and 7 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by University of California (US20260209803A1, filed 01/05/2026, published 07/23/2026).
Regarding claim 1, University of California discloses a nanoparticle comprising a lipid phase and core, wherein the core comprises one or more nucleic acids (e.g., [0121]).
Regarding claim 2, University of California discloses the lipid phase including an ionizable lipid, cholesterol, a phospholipid, and a PEGylated lipid (e.g., DMG-PEG-2000 – claim 6), and the core further comprises a buffer solution (e.g., [0121], [0310]).
Regarding claim 4, University od California discloses LP01 as an ionizable lipid that may be used in the nanoparticle (e.g., [0124]).
Regarding claim 7, University of California discloses the LNP comprising one or more PEGylated lipids (e.g., [0121]).
Claim Rejections - 35 USC § 103
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, 2, 3, (4- University of California), 5, 6, (7- University of California) 11, 12, 13, (14, 15 – Fred Hutchinson) and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. as applied to claims 1, 2, 5, 11-13, and 16 above, or over Fred Hutchinson, as applied to claims 1, 2, and 11-16 above, or University of California, as applied to claims 1, 2, and 7 above, and further in view of Kauffman et al. (Kauffman, Kevin J., et al. "Optimization of lipid nanoparticle formulations for mRNA delivery in vivo with fractional factorial and definitive screening designs." Nano letters 15.11 (2015): 7300-7306.) and Mendonca et al. (Mendonça, Monique CP, et al. "Design of lipid-based nanoparticles for delivery of therapeutic nucleic acids." Drug Discovery Today 28.3 (2023): 103505.).
As shown above, the base claims are anticipated by the base art, and thus, are also obvious over the base art.
Ye et al., Fred Hutchinson, and University of California do not explicitly state the mole percentages and molar ratios of the nanoparticle.
An artisan, interested in the formulations of LNPs for delivering mRNA, would be aware of Mendonca et al. for revieing the design of LNPs for delivery of therapeutic nucleic acids.
Regarding claim 3, Table 2 Mendonca et al. reviews formulations previously taught in the prior art. Two of these formulations comprised a molar ratio (%) of 50% SM-102 (e.g., an ionizable lipid), 10% DSPC (claim 5), 38% cholesterol, and 1.5% PEG-DMG 2000 (claim 6) (Spikevax formulation). Another comprised 46.3% ALC-03125 (e.g., an ionizable lipid), 9.4% DSPC, 42.7% cholesterol, and 1.6% ALC-0159 (e.g., a PEGylated lipid).
Mendonca et al. also teaches that generally, LNP composition is reported in molar ratios between each lipid component, varying between certain ranges depending on the incorporated nucleic acid: 40–50 mol% for the ICL, 10–12 mol% for the phospholipid, 38–45 mol% for cholesterol and1-2 mol% for the PEGylated lipid (e.g., pg. 8, col 1, “Lipid composition and molar ratio”).
Additionally, Mendonca et al. teaches optimization of LNP formulations for mRNA delivery have been developed using design of experiment (DoE) principles including definitive screening and fractional factorial designs (e.g., pg. 12, col 2). One study by Kauffman et al. referenced by Mendonca et al., aimed to develop an optimized formulation by simultaneously varying lipid ratios and structures (e.g., Abstract of Kauffman et al.). In Table 1 of Kauffman et al., molar ratios between the ionizable lipid C12-200 and mRNA in the formulations are 5:1 (original) and 2.5:1 to 7.5:1 (Library A), for example.
It would have been obvious to an artisan before the effective filing date of the current invention to substitute the mole percentages and molar ratio taught by Mendonca et al. and Kauffman et al. for the percentages and ratios taught by Ye et al. with a reasonable expectation of success. As taught by Mendonca et al. and Kauffman et al., it is routine in the art to optimize component amounts to arrive at an optimal product that is superior for its intended use. Since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would be motivated to apply the percentages and ratios taught by Mendonca et al. and Kauffman et al. because both teach these formulations successfully delivering nucleic acids via LNPs.
Claim(s) 1, 2, 4, 5, 11-13, (14, 15 – Fred Hutchinson), and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. as applied to claims 1, 2, 5, 11-13, and 16 above, or over Fred Hutchinson, as applied to claims 1, 2, and 11-16 above, and further in view of Chen et al. (Chen, Kai, et al. "Lung and liver editing by lipid nanoparticle delivery of a stable CRISPR–Cas9 ribonucleoprotein." Nature biotechnology 43.9 (2025): 1445-1457.) (note: Chen et al. was first published online 10/16/2024).
As shown above, the base claims are anticipated by the base art, and thus, are also obvious over the base art.
Ye et al. and Fred Hutchinson do not teach LP01 as an ionizable lipid.
An Artisan, interested in LNP formulations for delivering nucleic acids, would be aware of Chen et al. for teaching LNPs delivering CRISPR-Cas9 ribonucleoprotein.
Chen et al. developed two general formulations, FX and FC for LNP screening. Out of the 13 ionizable lipids, evaluated in the FX and FC, lipids LP01 and BP lipid 312, a structural analog of LP01, were most effective in RNP delivery (e.g., pg. 1450).
It would have been obvious to an artisan before the effective filing date of the current invention to substitute the ionizable lipid taught by Ye et al. with the LP01 ionizable lipid taught by Chen et al. with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06. One would be motivated to make this substitution because Chen et al. teaches LP01 and its analog as the most effective ionizable lipids in RNP delivery.
Claim(s) 1, 2, 3, (4- University of California), 5, 6, (7- University of California) 11, 12, 13, (14, 15 – Fred Hutchinson) and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. as applied to claims 1, 2, 5, 11-13, and 16 above, or over Fred Hutchinson, as applied to claims 1, 2, and 11-16 above, or University of California, as applied to claims 1, 2, and 7 above, and further in view of Simcere (US20220160766A1, published 05/26/2022).
As shown above, the base claims are anticipated by the base art, and thus, are also obvious over the base art.
Ye et al., Fred Hutchinson, and University of California do not teach a nanoparticle comprising one or more nucleic acids encoding a CAR and TCE.
An Artisan, interested in dual CAR and TCE compositions, would be aware Simcere for teaching compositions comprising a sequence encoding a chimeric antigen receptor (CAR) and a T-cell engager (TCE).
Simcere teaches a polynucleotide comprising a sequence encoding a chimeric antigen receptor (CAR) and a T-cell engager, wherein the CAR is capable of binding to one or more first tumor associated antigens (TAAs) and the T-cell engager is capable of binding to T-cell and a second TAA (claim 1 of Simcere).
Before the effective filing date of the claimed invention, it would have been obvious to substitute the nucleic acids of the nanoparticles taught in Ye et al., Fred Hutchinson, or University of California with the polynucleotide encoding CAR and TCE taught by Simcere with a reasonable expectation for success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06. One would be motivated to make this substitution because. Simcere demonstrates that before the effective filing date of the claimed invention, nucleic acids that encode a chimeric antigen receptor (CAR) and a T-cell engager (TCE) were also known in the art. One would be motivated to make this substitution because as taught by Simcere, a polynucleotide encoding CAR and TCE may be used to treat cancer (e.g., [0018]).
Additionally, the recitation “the CAR, TCE, and therapeutic gene are expressed in the M2 macrophage” does not structurally modify/further limit the structure of the claimed nanoparticle. Instead, it describes a functional result. Thus, the combination of Ye et al., Fred Hutchinson, or University of California in view of Simcere teaches all the structures of claim 8.
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, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 12, and 13 of copending Application No. 19/448,692 (reference application).
Claims 1-8, 11, 12, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 2, and 13 of copending Application No. 19/448,660 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and co-pending applications are drawn to overlapping subject matter.
While it is noted that the claims of copending Applications 19/448,692 and 19/448,660 are drawn to a nanoparticle for treating glioblastoma multiforme (GBM) and a nanoparticle for treating hepatocellular carcinoma (HCC), respectively, and the nanoparticle of the instant application is drawn to a nanoparticle for selective transfection of M2 macrophages, Applicant should note that such is nothing more than an intended use. Applicant is reminded that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Reference Application No. 19/448,692:
Claims 1 and 8: claim 1 of reference application ‘692 teaches nanoparticle for treating glioblastoma multiforme (GBM), the nanoparticle comprising a lipid phase and a core, the core comprising one or more nucleic acids that encode a chimeric antigen receptor (CAR), a T-cell engager (TCE), and, optionally, a therapeutic gene, wherein the CAR and the TCE each bind specifically to a GBM tumor-associated antigen and the nanoparticle selectively delivers the one or more nucleic acids to M2 macrophages in vitro or in vivo.
Claim 2: claim 2 of reference application ‘692 teaches the nanoparticle of claim 1, wherein the lipid phase includes: an ionizable lipid; cholesterol or its derivative; a phospholipid; and a polyethylene glycol-conjugated lipid (pegylated lipid), and the core further comprises a buffer solution.
Claim 3: claim 3 of ‘692 teaches the nanoparticle of claim 2, wherein a mole percentage of the ionizable lipid, the cholesterol or derivative, the phospholipid, and the pegylated lipid in the nanoparticle is 37% to 47%, 42% to 50%, 7% to 12%, and 1.5% to 5.5%, respectively, and a molar ratio of the ionizable lipid to the one or more nucleic acids is 2:1 to 6:1.
Claim 4: claim 4 of ‘692 teaches the ionizable lipid is selected from D-Lin-MC3-DMA, SM102, LP01, ALC-0315, and analogs thereof.
Claim 5: claim 5 of ‘692 teaches the phospholipid is selected from DLPC, DPPC, DSPA, DPPA, DSPC, DMPE, DHPC, DMPC, SPPC, and DAPC.
Claim 6: claim 6 of ‘692 teaches the pegylated lipid is selected from DSPE-PEG 2000, DMG-PEG-2000, DSPE-PEG 2000-Mannose, and DMG-PEG-2000-Mannose.
Claim 7: claim 7 of ‘692 teaches at least two PEGylated lipids.
Claims 11 and 12: claim 13 of ‘692 teaches a method for converting GBM tumor-resident M2 macrophages into M1 macrophages, the method comprising contacting the M2 macrophages with a plurality of the nanoparticle of claim 1.
Claim 16: claim 12 of ‘692 teaches a therapeutic composition for treating GBM, comprising a plurality of the nanoparticle of claim 1 and a pharmaceutically acceptable excipient.
Reference Application No: 19/448,660:
Claims 1 and 8: claim 1 of reference application ‘660 teaches nanoparticle for treating HCC, the nanoparticle comprising a lipid phase and a core, the core comprising one or more nucleic acids that encode a chimeric antigen receptor (CAR), a T-cell engager (TCE), and, optionally, a therapeutic gene, wherein the CAR and the TCE each bind specifically to a GBM tumor-associated antigen and the nanoparticle selectively delivers the one or more nucleic acids to M2 macrophages in vitro or in vivo.
Claim 2: claim 2 of reference application ‘660 teaches the nanoparticle of claim 1, wherein the lipid phase includes: an ionizable lipid; cholesterol or its derivative; a phospholipid; and a polyethylene glycol-conjugated lipid (pegylated lipid), and the core further comprises a buffer solution.
Claim 3: claim 3 of ‘660 teaches the nanoparticle of claim 2, wherein a mole percentage of the ionizable lipid, the cholesterol or derivative, the phospholipid, and the pegylated lipid in the nanoparticle is 37% to 47%, 42% to 50%, 7% to 12%, and 1.5% to 5.5%, respectively, and a molar ratio of the ionizable lipid to the one or more nucleic acids is 2:1 to 6:1.
Claim 4: claim 4 of ‘660 teaches the ionizable lipid is selected from D-Lin-MC3-DMA, SM102, LP01, ALC-0315, and analogs thereof.
Claim 5: claim 5 of ‘660 teaches the phospholipid is selected from DLPC, DPPC, DSPA, DPPA, DSPC, DMPE, DHPC, DMPC, SPPC, and DAPC.
Claim 6: claim 6 of ‘660 teaches the pegylated lipid is selected from DSPE-PEG 2000, DMG-PEG-2000, DSPE-PEG 2000-Mannose, and DMG-PEG-2000-Mannose.
Claim 7: claim 7 of ‘660 teaches at least two PEGylated lipids.
Claims 11 and 12: claim 13 of ‘660 teaches a method for converting GBM tumor-resident M2 macrophages into M1 macrophages, the method comprising contacting the M2 macrophages with a plurality of the nanoparticle of claim 1.
Claim 16: claim 12 of ‘660 teaches a therapeutic composition for treating GBM, comprising a plurality of the nanoparticle of claim 1 and a pharmaceutically acceptable excipient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Instant SEQ ID NOs: 9 and 21 were found to be free of the art.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-5pm.
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ALLISON M. JOHNSON
Examiner
Art Unit 1638
/ALLISON MARIE JOHNSON/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
Prosecution Insights