DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-8 are currently pending and under examination on the merits in the instant application.
Specification
The disclosure is objected to because of the following informalities: The brief description of FIG.1 fails to describe what each of the numerical values (e.g., “108”, “104”) represents.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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.
The instant claims recite “consisting of nucleotides including uracil, cytosine, adenine, and guanine”. It is noted that the transitional phrase “consisting of” and the open-ended phrase “including” conflict with each other, thereby rendering the metes and bounds of the “open reading frame” unclear.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.’’
Claims 1-2 and 5-7 are rejected under pre-AIA 35 U.S.C. 102(a) and 102(e) as being anticipated by Guild et al. (US 2011/0244026 A1).
Guild teaches making a pharmaceutical composition comprising “lipid nanoparticles” and polynucleotide construct comprising a 5’ cap structure (“Cap1”), a 5’-UTR, an open reading frame (ORF) for an mRNA encoding a therapeutic polypeptide that is useful for treating “cancer”, a 3’ UTR, and “a long poly A tail” of about 200 nucleotides, wherein the lipid nanoparticle having a size that is less than about “150 nm” and comprises “DLinDMA”, DSPC, cholesterol, and a PEG lipid (e.g., PEG-DMG). See paragraphs 0039-0041, 0051-0063, 0070, and 0116.
Accordingly, claims 1-2 and 5-7 are described by Guild et al.
Claims 1-7 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Schrum et al. (US 2012/0251618 A1).
Schrum teaches making a pharmaceutical composition comprising a “lipid nanoparticle” and polynucleotide construct comprising a “5’ cap” (“Cap1”), a 5’-UTR, an open reading frame (ORF) (e.g., “G-CSF mmRNA”) that is “useful for treating cancer”, a 3’ UTR, and “a polyA tail of approximately 160 nucleotides”, wherein the lipid nanoparticle having “a particle size of less than 150 nm” and comprises “DLin-MC3-DMA” inherently comprising a terminal ester linkage, “dsteroylphosphatidyl choline”, cholesterol, and a PEG lipid (e.g., PEG-DMG). See paragraphs 0061, 0079-0082, 0098, 0127-0133 0154, 0353, and 0496.
Accordingly, claims 1-7 are described by Schrum et al.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schrum et al. (US 2012/0251618 A1) in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Schrum teaches making a pharmaceutical composition comprising a “lipid nanoparticle” and polynucleotide construct comprising a “5’ cap” (“Cap1”), a 5’-UTR, an open reading frame (ORF) (e.g., “G-CSF mmRNA”) that is “useful for treating “cancer”, a 3’ UTR, and “a polyA tail of approximately 160 nucleotides”, wherein the lipid nanoparticle having “a particle size of less than 150 nm” and comprises “DLin-DMA”, “dsteroylphosphatidyl choline”, cholesterol, and a PEG lipid (e.g., PEG-DMG). See paragraphs 0061, 0079-0082, 0098, 0127-0133 0154, 0353, and 0496.
Schrum does not teach that the ORF comprises at least two stop codons. Schrum does not teach that the cationic lipid is DLin-DMA with an internal or terminal ester.
Weiner teaches that “two stop codons were added” into the “synthetic highly codon/RNA optimized” sequence in order “to ensure efficient termination.” See paragraph 0198.
Yaworski teaches that “serum-stable nucleic acid-lipid particles (SNALP)” of less than about 150 nm, especially “tumor-directed SNALP formulation” is useful for “preferentially delivering the nucleic acid payload to cells of solid tumors”, wherein the “nucleic acid” includes “mRNA” and SNALP comprises a cationic lipid, a phospholipid, a cholesterol, and a PEG-lipid, wherein the cationic lipid “comprises ester linkages between the amino head group and one or both of the alkyl chains”, or the cationic lipid is “C2-DLinDAP”, which is C2-DLinDMA having internal/terminal ester linkages. See paragraphs 0010-0013, 0057, 0402, 0421, and 0536.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate two stop codons into Schrum’s ORF. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success so as to ensure the translation termination of the cancer-therapeutic mRNA of Schrum because inclusion of two stop codons in a synthetic RNA was known to be useful “to ensure efficient termination” as taught by Weiner. It would also have been obvious to incorporate “ester linkages between the amino head group and one or both of the alkyl chains” of the cationic lipid (e.g., “DLin-DMA”) of Schrum with a reasonable expectation of success because such incorporation of ester linkages into cationic lipids forming a lipid nanoparticle that delivers a nucleic acid (e.g., mRNA) into tumor cells was an art-recognized design option as evidenced by the teachings of Yaworski.
Accordingly, claims 1-8 taken as a whole would have been prima facie obvious at the time the invention was made.
Claims 1-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sahin et al. (US 2012/0195917 A1) in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Sahin teaches making a pharmaceutical composition for treating cancer comprising a pharmaceutically acceptable carrier and a polynucleotide comprising “a 5’-cap analog” (e.g., “ARCA”) having “the ability to stabilize RNA”, “a 5’-UTR”, an mRNA encoding “a tumor antigen”, “a 3’-UTR”, and “a long poly-A sequence of about 120 nucleotides”, which “results in optimal transcript stability and translation efficiency.” See paragraphs 0040-0042, 0046, 0080-0083, 0120-0136; Figure 1.
Sahin does not teach that the mRNA comprises two stop codons. Sahin also does not teach that the pharmaceutically acceptable carrier is the instantly claimed lipid nanoparticle.
Weiner teaches that “two stop codons were added” into the “synthetic highly codon/RNA optimized” sequence in order “to ensure efficient termination.” See paragraph 0198.
Yaworski teaches that “serum-stable nucleic acid-lipid particles (SNALP)” of less than 150 nm, especially “tumor-directed SNALP formulation” is useful for “preferentially delivering the nucleic acid payload to cells of solid tumors”, wherein the “nucleic acid” includes “mRNA” and SNALP comprises a cationic lipid, a phospholipid, a cholesterol, and a PEG-lipid, wherein the cationic lipid “comprises ester linkages between the amino head group and one or both of the alkyl chains”, or the cationic lipid is “C2-DLinDAP”, which is C2-DLinDMA having internal/terminal ester linkages. See paragraphs 0010-0013, 0057, 0402, 0421, and 0536.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate two stop codons into Sahin’s mRNA. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success so as to ensure the translation termination of the cancer-therapeutic mRNA of Sahin because inclusion of two stop codons in a synthetic RNA was known to be useful “to ensure efficient termination” as taught by Weiner. It would also have been obvious to use Yaworski’s lipid nanoparticle formulation as the pharmaceutically acceptable carrier of Sahin. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to formulate Sahin’s composition as a tumor cell-specific composition because Yaworski’s lipid nanoparticle of less than about 150 nm comprising ester linkage-containing DLin-DMA was taught to be useful as a “tumor-directed” formulation, and the lipid nanoparticle was known to be useful for delivering an mRNA.
Accordingly, claims 1-8 taken as a whole would have been prima facie obvious at the time the invention was made.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11of U.S. Patent No. 8,664,194 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
It is noted that the instant specification discloses that EPO (erythropoietin) is an oncology-related polypeptide. See paragraphs 000713-000737.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘194 patent claims drawn to a method that produces an mRNA encoding EPO, wherein the mRNA comprises “Cap1” and a polyA tail of approximately 160 nucleotides in length, wherein mRNA is in a “lipid nanoparticle” comprising a cationic lipid, DSPC, cholesterol, and a PEG lipid, wherein the “cationic lipid” claimed in the ‘194 patent claims is defined to read on “DLin-MC3-DMA” as evidenced by column 2 of the ‘194 patent specification, wherein “DLin-MC3-DMA” inherently comprises a terminal ester linkage as evidenced by Figure 1 of the ‘194 patent, wherein the cationic lipid is also defined to read on a “reLNP” comprising “DLin-DMA with an internal or terminal ester” as disclosed in column 3 of the ‘194 patent specification. Note that it is proper to consult the specification of the reference patent in order to ascertain the meaning of the words in the claim to interpret the patented claims’ proper scope. See Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010). See also Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 518 F3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008). It would have been obvious to include a 5’ UTR, 3’ UTR, and two stop codons in view of the teachings of Schrum and Weiner as explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,680,069 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
It is noted that the instant specification discloses that G-CSF is an oncology-related polypeptide. See paragraphs 000713-000737 and 0001097.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘069 patent drawn to a composition comprising “a lipid formulation” and an mRNA encoding G-CSF comprising “Cap 1” and a “polyA tail” that is “at least 140 nucleotides in length”, wherein the “lipid formulation” claimed in the ‘069 patent claims is defined to read on DLin-DMA with an internal or terminal ester”, “DSPC”, “PEG-c-DOMG”, and “cholesterol”. See column 3 of the ‘069 patent specification. It would have been obvious to include a 5’ UTR, 3’ UTR, and two stop codons in view of the teachings of Schrum and Weiner as explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 8,710,200 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘200 patent claims drawn to and require a pharmaceutical composition comprising “a lipid formulation” comprising an mRNA encoding EPO, wherein the mRNA comprises “a 5’Cap1 structure and a polyA tail of approximately 160 nucleotides in length”, wherein the “lipid formulation” claimed in the ‘200 patent claims is defined to read on a formulation comprising “DLin-MC3-DMA”, cholesterol, DSPC, and a PEG lipid. See columns 21-22. It would have been obvious to include a 5’ UTR, 3’ UTR, and two stop codons in view of the teachings of Schrum and Weiner and also to include internal/terminal ester linkages into DLin-DMA in view of Yaworski as explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,050,297 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘297 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:3901, which is aryl hydrocarbon receptor nuclear translocator (see title), wherein the mRNA comprises a 5’ UTR and a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘297 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 198-202 of the ‘297 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,095,552 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘552 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:927, which is copper metabolism (MURR1) domain containing 1 (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘552 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 261-264 of the ‘552 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,107,886 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘886 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:873, which is basic helix-loop-helix family member E41 (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘886 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 265-266 of the ‘886 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,114,113 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘113 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:980, which is CITED4 (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘113 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 264-267 of the ‘113 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,149,506 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘506 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:8328, which is Septin-4 (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘506 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 197-201 of the ‘506 patent specification. In addition, Septin-4 is disclosed as being “oncology-related” in the ‘506 patent specification. See column 4. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,216,205 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘205 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:6373, which is granulysin (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘205 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 196-201 of the ‘205 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,254,311 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the ‘311 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:13267, which is KRBA1, wherein the mRNA further comprises “Cap0”, 5’ UTR, 3’ UTR, and “a poly-A tail of approximately 160 nucleotides”. It is further noted that “reLNPs” claimed in the ‘311 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 207-208 of the ‘311 patent specification, wherein the mRNA “of the invention” is associated with “oncology”. See also column 36. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,255,129 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘129 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:8368, which is SIAH E3 ubiquitin protein ligase 1 (see title), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “the mRNA comprises at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘129 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 195-199 of the ‘129 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,283,287 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘287 patent drawn to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:3906, which is BMAL2, wherein the mRNA further comprises a 5’ UTR, 3’ UTR, and “at least two stop codons”, wherein “reLNPs” claimed in the ‘287 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 198-199 of the ‘287 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,301,993 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘993 patent drawn to a composition comprising a “lipid nanoparticle” and an mRNA encoding SEQ ID NO:4868, which is defined as an “oncology-related polypeptide sequence” (see columns 18-19 of the ‘993 patent specification), wherein the mRNA comprises a 5’ UTR, a 3’ UTR, and “at least two stop codons.” It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘993 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “an enzymatically degraded ester linkage” that is “internally located” or “terminally located” in view of the description/definition of the term “lipid nanoparticle” as disclosed in the’993 patent specification. See column 200. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,303,079 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the ‘079 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:4947, which is kynureninase (KYNU), wherein the mRNA further comprises “Cap0”, 5’ UTR, 3’ UTR, “two stop codons”, and “a poly-A tail of approximately 160 nucleotides”. It is further noted that “reLNPs” claimed in the ‘079 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 187-191 of the ‘079 patent specification. Also note that the mRNA “of the invention” is disclosed as being associated with “oncology”. See column 27 of the specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,504,734 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘734 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:7559, which is ZXDC, wherein the mRNA further comprises a 5’ UTR, 3’ UTR, and “at least two stop codons”, wherein “reLNPs” claimed in the ‘734 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 203-204 of the ‘734 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,587,003 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘003 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:7572, which is defined as an “oncology-related polypeptide sequence” (see columns 19 and 23 of the ‘003 patent specification), wherein the mRNA is claimed to comprise a 5’ UTR, a 3’ UTR, and “two stop codons.” It is further noted that “reLNPs” claimed in the ‘003 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 202-203 of the ‘003 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,782,462 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘462 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:44182, which is DDC, wherein the mRNA further comprises a 5’ UTR, 3’ UTR, and “at least two stop codons”, wherein “reLNPs” claimed in the ‘462 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See column 264 of the ‘462 patent specification. It would have been obvious to further include a “5’ cap” (“Cap1”) and “a polyA tail of approximately 160 nucleotides” of Schrum because inclusion of the aforementioned structural features was an art-recognized design for making a lipid nanoparticle-encapsulated mRNA as evidenced by Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,814,760 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of the ‘760 patent drawn to a composition comprising “lipid nanoparticle” and an mRNA encoding SEQ ID NO:967, which is erythropoietin (see Table 6), wherein the mRNA further comprises a 5’ UTR, a 3’ UTR, “Cap0”, and “a poly-A tail of approximately 160 nucleotides”. It would have been obvious to one of ordinary skill in the art would have reasonably interpreted that the “lipid nanoparticle” in the ‘760 patent fully encompasses “rapidly eliminated lipid nanoparticle (reLNP)” comprising “DLin-DMA” having an “ester linkage” that is “internally located” or “terminally located” “DSPC”, “PEG-c-DOMG”, and “cholesterol” in view of the definition/description pertaining to “lipid nanoparticle (LNP)”. See columns 268-272 of the ‘760 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9,827,332 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the ‘332 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:9254, which is APOBEC-3A, wherein the mRNA further comprises “Cap0”, 5’ UTR, 3’ UTR, and “a poly-A tail of approximately 160 nucleotides”. It is further noted that “reLNPs” claimed in the ‘332 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 187-191 of the ‘079 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,828,416 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the ‘416 patent directed to a composition comprising “reLNPs” and an mRNA encoding SEQ ID NO:2630, which is IGHG1, wherein the mRNA further comprises “Cap0”, 5’ UTR, 3’ UTR, and “a poly-A tail of approximately 160 nucleotides”. It is further noted that “reLNPs” claimed in the ‘416 patent are defined to comprise “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See columns 198-199 of the ‘416 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,323,076 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘076 patent claims directed to a composition comprising an mRNA encoding LDLR and “a lipid nanoparticle”, wherein the mRNA comprises “5’ terminal cap”, which is defined to read on “cap 0” in the ‘076 patent specification (see column 58), wherein the “lipid nanoparticle” is defined to read on a “reLNP”, wherein the “ester linkage can be internally located” within DlinDMA as disclosed in the ‘076 patent specification (see column 108). It would have been obvious to further include a 5’ UTR, two stop codons, 3’ UTR, and a polyA of at least 160 nucleotides in length in view of the teachings of Schrum ad Weiner, which are explained in the §103 rejection above, which is fully incorporated by reference herein.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,385,106 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘106 patent claims directed to a composition comprising “a plurality of lipid nanoparticles” and an mRNA encoding a polypeptide, wherein the mRNA comprises “cap0”, “5’-UTR”, “3’-UTR”, “a poly-A region of at least 100 nucleotides in length”, wherein the nanoparticles comprise “DLin-DMA with an internal ester”, wherein the “polypeptide” is defined to be useful for treatment of “cancer”. See columns 247-248 of the ‘106 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,463,751 B2 in view of Schrum et al. (US 2012/0251618 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over ‘751 patent claims directed to a composition comprising a lipid nanoparticle whose cationic lipid comprises an ester linkage and an mRNA comprising “Cap0”, 5’ UTR, 3’ UTR, and “two stop codons”, wherein the mRNA encodes “a cytoskeletal protein”. It is noted that the cationic lipid comprising “at least one ester linkage” claimed in the ‘751 patent is defined to read on “DLinDMA” comprising an “internal ester linkage”. See columns 200-201 of the ‘751 patent specification. Note that “cytoskeletal protein”, which is encoded by the mRNA of the invention, is defined to be associated with “oncology”. See column 25 of the ‘751 patent specification. It would have been obvious to include a polyA sequence of at least 160 nucleotides in length in view of the teachings of Schrum.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,501,512 B2 as evidenced by Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the claims of the ‘512 patent directed to a composition comprising “lipid nanoparticles” and an mRNA encoding “factor IX”, wherein the mRNA further comprises “Cap0”, 5’ UTR, 3’ UTR, and “a poly-A tail of approximately 160 nucleotides”. It is further noted that “lipid nanoparticles” claimed in the ‘512 patent are defined to read on DLinDMA comprising “an enzymatically degraded ester linkage” that is “internally located” or “terminally located”. See column 191 of the ‘512 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,501,513 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘513 patent claims directed to a composition comprising a lipid nanoparticle whose cationic lipid comprises an ester linkage and an mRNA satisfying all of the structural limitations set forth in the instant claims as evidenced by the limitations of 5’ cap of “Cap0”, 5’ UTR, an ORF “encoding an oncology-related protein”, a 3’ UTR, “a poly-A tail”, and “at least two stop codons” recited in the ‘513 patent claims. It is noted that the “poly-A tail” claimed in the ‘513 patent claims is defined to read on “a poly-A tail of approximately 130 nucleotides”. See column 3. It is also noted that the cationic lipid comprising “at least one ester linkage” claimed in the ‘513 patent is defined to read on “DLinDMA” comprising an “internal ester linkage”. See columns 203-204 of the ‘513 patent specification. Note that it is proper to consult the specification to ascertain the meaning/scope of the claimed limitation.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,577,403 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘403 patent claims directed to a composition comprising “a plurality of lipid nanoparticles” and an mRNA encoding a “plasma membrane protein”, wherein the mRNA comprises “cap1”, “5’-UTR”, “3’-UTR”, “a poly-A region of at least 100 nucleotides in length”, wherein the nanoparticles comprise “DLin-DMA with an internal ester”. Note that it is art-recognized knowledge that a “plasma membrane protein” is described to be associated with “oncology”. See column 23 of the ‘403 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,695,419 B2 as evidenced by Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘419 patent claims directed to a “human cytomegalovirus (hCMV) vaccine” composition comprising an mRNA encoding hCMV antigenic polypeptides and a “lipid nanoparticle”, wherein the mRNA further comprises “7mG(5)ppp(5’)N1mpNp”, 5’ UTR, 3’ UTR, and “a polyA tail” that “is 100 nucleotides in length.” It is noted that the “lipid nanoparticle” claimed in the hCMV vaccine of the ‘419 patent reads on “a rapidly eliminated lipid nanoparticle (reLNP)” comprising an ester linkage that “internally located” or “terminally located”. See column 103 of the ‘419 patent specification. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,703,789 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘789 patent claims directed to a composition comprising “a plurality of lipid nanoparticles” and an mRNA encoding a polypeptide, wherein the mRNA comprises “cap1”, “5’-UTR”, “3’-UTR”, “a poly-A region of at least 100 nucleotides in length”, wherein the nanoparticles comprise “DLin-DMA with an internal ester”. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,772,975 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘975 patent claims directed to a composition comprising an mRNA and “lipid nanoparticles” satisfying all of the structural limitations set forth in the instant claims, wherein the mRNA also satisfy all of the structural limitations set forth in the instant claims, except two stop codons, and the ORF encoding an oncology-related polypeptide. It would have been obvious to use an mRNA encoding a “tumor antigen-associated” protein and to include two stop codons in view of the teachings of Schrum and Weiner as explained in the §103 rejection above, which is fully incorporated by reference herein.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 10,881,730 B2 in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘730 patent claims directed to composition comprising an mRNA formulated in a lipid nanoparticle, wherein the mRNA encodes “KRAS activating oncogene mutation peptides” thus “oncology-related” as claimed in the instant case. It is also noted that the “lipid nanoparticle” claimed to comprise “Compound 25”, DSPC, cholesterol, and PEG-DMG in the ‘730 patent claims satisfies all of the instantly recited elements in the instant claims. In addition, the “mRNA” comprising SEQ ID NO:167 is described to include “Cap 1”, 5’ UTR, 3’ UTR, a 100-nt polyA tail. See column 320. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner. Further, the broadly claimed “lipid nanoparticle” in the ‘730 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,925,935 B2 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘935 patent claims directed to a “lipid nanoparticle” comprising an mRNA encoding “a therapeutic protein”, which comprises a “Cap 1”, 5’ UTR, 3’ UTR, and “a poly A tail of at least 100 nucleosides”. It is noted that the “lipid nanoparticle” of the ‘935 patent claims is defined/described to read on “a rapidly eliminated lipid nanoparticle (reLNP)” comprising DLinDMA that comprises an “ester linkage” that is “internally located” or “terminally located”. See columns 314-315 of the ‘935 patent specification. Further, the “therapeutic protein” encoded by the ‘935 patent claims is defined to be used for treatment of “cancer”. See column 300. Hence, the “therapeutic protein” encoded by the mRNA of the ‘935 patent claims inherently reads on “oncology-related” protein. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,973,917 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘917 patent claims directed to a “lipid nanoparticle (LNP)” comprising an mRNA encoding a human IL-15Ra, which is defined/described to be useful for “reducing the size of a tumor” (see column 3 of the ‘917 patent specification) thus is “oncology-related” as claimed in the instant case. It is also noted that the “ionizable amino lipid” and “Compound 25” claimed in the ‘917 patent claims reads on a cationic lipid comprising ester linkages as disclosed in the ‘917 patent specification. See columns 817-850. It would have been obvious to include a 5’ cap, 5’ UTR, 160-nt polyA tail, and two stop codons in the mRNA of the ‘917 patent claims in view of the teachings of Schrum and Weiner. Further, the broadly claimed “lipid nanoparticle” in the ‘917 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,311,602 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘602 patent claims directed to a “lipid nanoparticle (LNP)” comprising an mRNA encoding a fusion protein of human IL-12B and IL-12A, which is defined/described to be useful for “immuno-oncology” (see column 2 of the ‘602 patent specification) thus is “oncology-related” as claimed in the instant case, wherein the mRNA further a 5’ UTR, a polyA tail, a 3’ UTR, and a “polyA tail”, which is defined to be approximately 250 residues long. See column 246. It is also noted that the “ionizable amino lipid” included in the LNP of the ‘602 patent claims is defined to read on a cationic lipid comprising ester linkages as supported by the ‘602 patent specification. See columns 279-350. It would have been obvious to further include a 5’ cap and two stop codons in view of the teachings of Schrum and Weiner. Further, the broadly claimed “lipid nanoparticle” in the ‘602 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,406,703 B2 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘703 patent claims, which are drawn to an LNP encapsulating an oncology-related mRNA encoding a hCMV gH polypeptide, wherein the mRNA comprises a 5’-cap and the LNP comprises a cationic lipid comprising an internal ester linkage, DSPC, cholesterol, and DMG-PEG. Further, the broadly claimed “lipid nanoparticle” in the ‘602 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski. It would have been obvious to further include a 5’ UTR, two stop codons, 3’ UTR, and a polyA sequence of at least 160 nucleotides in view of the teachings of Schrum and Weiner,
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 11,421,011 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘011 patent claims directed to a “lipid nanoparticle (LNP)” comprising an mRNA encoding a fusion protein of human IL-12B and IL-12A, which is defined/described to be useful for “anti-tumor activity” (see column 2 of the ‘011 patent specification) thus is “oncology-related” as claimed in the instant case, wherein the mRNA further a 5’ UTR, a polyA tail, a 3’ UTR, and a “polyA tail”, which is defined to be approximately 250 residues long. See column 110. It is also noted that the “ionizable amino lipid” included in the LNP of the ‘011 patent claims is defined to read on a cationic lipid comprising ester linkages as supported by the ‘011 patent specification. See columns 124, 130, 137-138. It would have been obvious to include a 5’ cap and two stop codons in view of the teachings of Schrum and Weiner. Further, the broadly claimed “lipid nanoparticle” in the ‘011 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,485,972 B2 in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘972 patent claims directed to a composition comprising a “lipid nanoparticle” and an mRNA encoding a polypeptide, wherein the mRNA further “a 5’ Cap 1 structure”, 5’ UTR, a polyA tail that “is about 100 nucleotides”, and a 3’ UTR, wherein the “lipid nanoparticle” is defined to have “a mean diameter from about 70 nm to about 120 nm” and comprise an ionizable cationic lipid, DOPE, cholesterol, and a PEG lipid, wherein the ionizable cationic lipid comprises ester linkages. See columns 104-106 of the ‘972 patent specification. It would have been obvious to further include two stop codons in view of the teachings of Weiner, and the broadly claimed “lipid nanoparticle” in the ‘972 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,696,892 B2 in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘892 patent claims directed to a lipid nanoparticle comprising a modified mRNA encoding a VEGF-A polypeptide. It is noted that the “lipid nanoparticle” claimed in the ‘892 patent claims is defined to comprise all of the instantly recited elements in the instant claims (see columns 2-3) and the “mRNA” of SEQ ID NO:1 claimed in the ‘892 patent claims comprises all of the instantly recited elements in the instant claims, wherein the “mRNA” is described to include “a coding region, a 5’ untranslated region (UTR), a 3’ untranslated region (UTR), a 5’ cap and a poly-(A) tail”. See the description of Figure 2A in the ‘892 patent. See also SEQ ID NO:1 containing a 100-nt polyA. Note that the instant specification describes that the instantly claimed “oncology-related polypeptide” includes VEGF or VEGF-A. See paragraphs 000195, 000895, and 0001267. Note that it is proper to consult the specification to ascertain the meaning/scope of the claimed limitation. It would have been obvious to further include two stop codons in view of the teachings of Weiner, and the broadly claimed “lipid nanoparticle” in the ‘892 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,042,527 B2 in view of Weiner et al. (US 2013/0017224 A1) and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘527 patent claims, which require an LNP encapsulating an oncology-related mRNA (SEQ ID NO:37) encoding SEQ ID NO:35, wherein the mRNA comprises a 5’-cap, 5’ UTR, ORF, 3’UTR, and a 100-nt polyA sequence. It is noted that the “LNP” claimed in the ‘527 patent claims is defined to read on an LNP comprising an ionizable amino lipid comprising an internal ester linkage, a phospholipid, a cholesterol, and a PEG lipid as evidenced by columns 86-88 of the ‘527 patent specification. It would have been obvious to further include two stop codons in view of the teachings of Weiner, and the broadly claimed “lipid nanoparticle” in the ‘527 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,090,235 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘235 patent claims, which produce an LNP encapsulating an mRNA, wherein the LNP comprises a cationic lipid comprising an ester linkage, a phospholipid, a cholesterol, and a PEG lipid. It would have been obvious to use Schrum’s polynucleotide for the “mRNA” claimed in the ‘235 patent claims, wherein the polynucleotide is further modified to comprise two stop codons in view of the teachings of Weiner, because making an LNP encapsulating Schrum’s polynucleotide was an art-recognized goal. Further, the broadly claimed “lipid nanoparticle” in the ‘235 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,357,575 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘575 patent claims, which produce an LNP encapsulating an mRNA, wherein the LNP comprises a cationic lipid, a phospholipid, a cholesterol, and a PEG lipid, wherein the cationic lipid claimed in the ‘575 patent claims is defined to read on an ionizable amino lipid comprising an internal ester linkage as evidenced by columns 25-26 of the ‘575 patent specification. It would have been obvious to use Schrum’s polynucleotide for the “mRNA” claimed in the ‘575 patent claims, wherein the polynucleotide is further modified to comprise two stop codons in view of the teachings of Weiner, because making an LNP encapsulating Schrum’s polynucleotide was an art-recognized goal. Further, the broadly claimed “lipid nanoparticle” in the ‘575 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,508,278 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘278 patent claims, which require an LNP encapsulating an mRNA, wherein the LNP comprises a cationic lipid comprising an internal ester linkage, a phospholipid, a cholesterol, and a PEG lipid. It would have been obvious to use Schrum’s polynucleotide for the “mRNA” claimed in the ‘278 patent claims, wherein the polynucleotide is further modified to comprise two stop codons in view of the teachings of Weiner, because making an LNP encapsulating Schrum’s polynucleotide was an art-recognized goal. Further, the broadly claimed “lipid nanoparticle” in the ‘278 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,582,609 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘609 patent claims drawn to a “cancer vaccine” comprising a lipid nanoparticle and an mRNA having an ORF encoding cancer antigen epitopes, wherein the lipid nanoparticle of the ‘609 patent claims satisfies the structural limitations claimed in the instant application. It would have been obvious to further include a 5’ cap, 5’ UTR, two stop codons, a 3’ UTR, and a 160-nt polyA sequence in the mRNA claimed in the ’609 patent claims in view of the teachings of Schrum and Weiner as explained in the §103 rejection above, which is fully incorporated by reference herein. Further, for the broadly claimed “lipid nanoparticle” in the ‘609 patent claims, it would have been obvious to use a lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage in view of the teachings of Yaworski.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,667,543 B2 in view of Schrum et al. (US 2012/0251618 A1), Weiner et al. (US 2013/0017224 A1), and Yaworski et al. (US 2011/0076335 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘575 patent claims, which produce an LNP of less than about 100 nm encapsulating an mRNA, wherein the LNP comprises a cationic lipid comprising an internal ester linkage, a phospholipid, a cholesterol, and a PEG lipid. It would have been obvious to use Schrum’s polynucleotide for the “mRNA” claimed in the ‘543 patent claims, wherein the polynucleotide is further modified to comprise two stop codons in view of the teachings of Weiner, because making an LNP encapsulating Schrum’s polynucleotide was an art-recognized goal. Further, the broadly claimed “lipid nanoparticle” in the ‘543 patent claims reads on an art-recognized lipid nanoparticle whose cationic lipid comprises DLin-DMA comprising internal/terminal ester linkage as evidenced by Yaworski.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 16/860,121 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘121 claims drawn to a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, a 5’ UTR, an ORF encoding a polypeptide, a 3’ UTR, and a polyA of at least 160 nucleotides in length, wherein the lipid nanoparticle comprises a cationic lipid. It is noted that the “secreted protein” claimed in the ‘930 claims reads on an “oncology-related polypeptide” as evidenced by the fact that that the ‘930 specification discloses that the mRNA reads on “G-CSF”, which is “useful in Her2+ breast cancer patients”. See paragraph 000747. It is also noted that the cationic lipid claimed in the ‘121 claims reads on “DLinDMA” comprising an “ester linkage” that “can be internally located” or “terminally located”. See paragraph 0520. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 93-111 of copending Application No. 18/161,598.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘598 claims that require a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, a 5’ UTR, an ORF encoding a secreted protein, at least two stop codons, a 3’ UTR, and a polyA of at least 100 nucleotides in length, wherein the lipid nanoparticle comprises a cationic lipid, which “comprises an ester linkage.” It is noted that the “secreted protein” claimed in the ‘598 claims reads on an “oncology-related polypeptide” as evidenced by the fact that that the ‘598 specification discloses that the mRNA reads on “G-CSF”, which is “useful in Her2+ breast cancer patients”. See paragraph 000739. Further, the “cationic lipid” claimed in the ‘598 claims is defined to read on “DLin-DMA” comprising an “ester linkage” that “can be internally located” or “terminally located”. See paragraph 0514.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 93-106 of copending Application No. 18/543,930 in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘930 claims drawn to a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, a 5’ UTR, an ORF encoding a secreted protein, a 3’ UTR, and a polyA of at least 100 nucleotides in length, wherein the lipid nanoparticle comprises “DLin-DMA with an internal ester”. It is noted that the “secreted protein” claimed in the ‘930 claims reads on an “oncology-related polypeptide” as evidenced by the fact that that the ‘930 specification discloses that the mRNA reads on “G-CSF”, which is “useful in Her2+ breast cancer patients”. See paragraph 000747. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-39 of copending Application No. 18/634,220 as evidenced by Lao et al. (Journal of Hepatology, 2024, 81:847-861) and in view of Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘220 claims drawn to a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, a 5’ UTR, an ORF encoding a GCDH polypeptide, a 3’ UTR, and a polyA tail of at least 100 nucleotides in length, wherein the lipid nanoparticle comprises “DLin-DMA with an internal ester”. It is a scientific fact that GCDH is useful for treating hepatocellular carcinoma as evidenced by Lao et al. Note that a post-filing reference can be cited to show a scientific fact. See MPEP §1843.01: “Documents which do not qualify as prior art because they post-date the claimed invention may nevertheless be cited to show a universal fact, such as characteristics or properties of a material, or a specific scientific fact, or to show the level of ordinary skill in the art.” It is noted that the lipid nanoparticle as broadly claimed in the ‘220 claims is defined to read on “reLNP”, which comprises DSPC, PEG-c-DOMG, cholesterol, and “DLin-DMA with an internal ester” as evidenced by paragraph 0001289. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 93-104 of copending Application No. 18/760,652 as evidenced by He (WO 2026/161468 A1) and in view of Weiner et al. (US 2013/0017224 A1)
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘652 claims drawn to and require a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, a 5’ UTR, an ORF encoding a G6PC polypeptide, a 3’ UTR, and a polyA tail of at least 100 nucleotides in length. It is a scientific fact that G6PC is useful for treating cancer as evidenced by He. Note that a post-filing reference can be cited to show a scientific fact. See MPEP §1843.01. It is noted that the lipid nanoparticle as broadly claimed in the ‘652 claims is defined to read on “reLNP”, which comprises DSPC, PEG-c-DOMG, cholesterol, and “DLin-DMA with an internal ester” as evidenced by paragraph 0001402. It would have been obvious to further include two stop codons “to ensure efficient termination” in view of the teachings of Weiner.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 19/272,655 in view of Schrum et al. (US 2012/0251618 A1) and Weiner et al. (US 2013/0017224 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and rendered obvious by the ‘655 claims that require a pharmaceutical composition comprising a lipid nanoparticle and an mRNA, wherein the mRNA comprises a 5’ cap1, an ORF encoding a GCSF polypeptide, a 3’ tailing sequence of about 160 nucleotides in length, wherein the lipid nanoparticle comprises “reLNPs”, which are defined to comprise DSPC, PEG-c-DOMG, cholesterol, and “DLin-DMA with an internal ester” as evidenced by paragraph 0001308. It would have been obvious to further include a 5’ UTR, two stop codons, a 3’ UTR, and a 160-nt polyA sequence as the 3’ tailing sequence in view of the teachings of Schrum and Weiner, which are explained in the §103 rejection above, which is fully incorporated by reference herein.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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