DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 02/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Examiner’s Note
The Examiner notes the present rejection, a second Non-Final office action, as an attempt to clarify the Examiner’s position.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103 - Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12, 15-17, 20, 22, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (WO 2020/051220 A1), in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Cheng taught intravenous administration [0038], to subjects or patients in need of treating [00108], of therapeutic agents [00133] preferentially delivered to the lung [see claims 1 and 2; see also ¶ 0007 for a teaching of delivery to alveolar basal cells], wherein the therapeutic agent was in composition with a lipid nanoparticle comprising an ionizable cationic lipid, a selective organ targeting (SORT) compound, a phospholipid, a steroid and a PEGylated lipid [claims 1, 34 and 37]. In some embodiments, the SORT compound was a lipid [00135].
Although Cheng taught delivery to lung alveolar basal cells, Cheng was not specific detectability in at least about 5 % of cells, as recited in claim 12.
Goldman taught a model for lung disease (e.g., human bronchial xenograft cells (reads on lung basal cells) [page 127, 1st ¶; page 128, ¶; page 131, 1st ¶]), wherein following gene transfer, 5 % of the cells were transduced, which was an amount of cells sufficient to restore an essential protein function in the lung [abstract].
Since Cheng taught delivery to lung basal cells, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Cheng, the detection of an agent within at least about 5 % of basal lung cells, as taught by Goldman [abstract; page 127, 1st ¶; page 128, ¶; page 131, 1st ¶]. The ordinarily skilled artisan would have been motivated to provide an amount of cells sufficient to restore an essential protein function in the lung, as taught by Goldman [abstract; page 127, 1st ¶; page 128, ¶; page 131, 1st ¶].
The instant claim 12 recites at least about 5 % detection of therapeutic agent in basal cells of lung.
Goldman taught delivery to lung basal cells and 5 % detection in the lungs. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 15 is rendered prima facie obvious because Cheng taught that the SORT compound was present in the composition in a molar ratio from about 2%, 4%, 5%, 10%, 15%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 45%, 50%, 55%, 60%, 65%, to about 70%, or any range derivable therein [00134].
The instant claim 15 recites a molar percentage from about 20 % to about 65 %.
Cheng taught a molar percentage from about 2 % to about 70 %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 16 is rendered prima facie obvious because Cheng taught the ionizable cationic lipid present in a molar percentage from about 5 % to about 30 % [0028].
Claim 17 is rendered prima facie obvious because Cheng taught the phospholipid present in a molar percentage from about 8 % to about 20 % [0030].
The instant claim 17 recites a molar percentage of phospholipid at 8 % to about 23 %.
Cheng taught the phospholipid present in a molar percentage from about 8 % to about 20 %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 20 is rendered prima facie obvious because Cheng taught the steroid present in a molar percentage from about 15 % to about 46 % [claims 35-36].
Claim 22 is rendered prima facie obvious because Cheng taught the PEGylated lipid present at a molar percentage from about 0.5 % to about 10 % [claim 38].
The instant claim 22 recites the polymer-conjugated lipid in a molar percentage from about 0.5 % to about 10 %.
Cheng taught the PEGylated lipid present at a molar percentage from about 0.5 % to about 10 %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 25 is rendered prima facie obvious because Cheng taught a ratio of the lipids to the therapeutic agent from about 1:1 to about 1:100 [claims 41-44].
The instant claim 25 recites a molar ratio of therapeutic agent to total lipids of no more than about 1:1.
Cheng taught a ratio of lipids to therapeutic agent from about 1:1 to about 1:100. A prima facie case of obviousness exists because of overlap, as previously discussed. Further regarding claim 25, it appears that Cheng’s ratio refers to a weight ratio, rather than the instantly recited molar ratio. However, it is prima facie obvious to one of ordinary skill in the art to mathematically determine the molar amounts, from the weights provided therein by Cheng et al.
Claim 26 is rendered prima facie obvious because Cheng taught at least about 85 % encapsulation of the therapeutic agent [Example 2, ¶ 0005].
Claim 27 is rendered prima facie obvious because Cheng taught a zeta potential from 0.25 mV to about -10 mV [0036].
The instant claim 27 recites a zeta potential of -10 mV to 0 mV.
Cheng taught a zeta potential from 0.25 mV to about -10 mV. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 28 is rendered prima facie obvious because Cheng taught an apparent pKa from about 3 to about 6; or, from about 8 to about 13 [0060-0061].
The instant claim 28 recites a pKa outside a range of 6 to 7. Cheng taught an apparent pKa from about 3 to about 6; or, from about 8 to about 13. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 64, Cheng taught that given that epithelial cells are a primary target for correction of mutations in CFTR that cause cystic fibrosis, this result (e.g., results disclosed therein) establishes lung-specific SORT LNPs as a compelling delivery system with immediate application for correcting CFTR mutations. While Cheng did not specifically teach a subject who had been determined to have a mutation in a target gene associated with a genetic disease or disorder, it would be prima facie obvious to one of ordinary skill in the art to include said subject within the teachings of Cheng, based on Cheng’s statement that results disclosed therein provided a compelling delivery system with immediate application for correcting mutations. The ordinarily skilled artisan would be motivated to correct the mutation.
Claim 68 is rendered prima facie obvious because Cheng taught the subject as selected from the group consisting of mouse, rat, monkey, and human [00111].
Claims 71-72 are rendered prima facie obvious because Cheng taught siRNA and mRNA [claim 43].
Claim 82 is rendered prima facie obvious because Cheng taught CRISPR/Cas9 gene editing using modified mDLNPs that co-delivered Cas9 mRNA and sgRNA, where lung specific CRISPR/CAS gene editing was achieved [Example 4].
Claim 97 is rendered prima facie obvious because Cheng taught [Example 3, ¶s 0009-0010] a dose of 0.1 or 0.5 mg/kg.
The instant claim 97 recites a dose of no more than about 2 mg/kg.
Cheng taught a dose of 0.1 or 0.5 mg/kg. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 101-103 are rendered prima facie obvious because Cheng taught DOTAP, cholesterol and 5A2-SC8 [0033].
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (WO 2020/051220 A1), in view of Goldman et al (Nature Genetics, 9, 1995, 126-131) and further in view of Geall et al (US 2014/0141070 A1).
The 35 U.S.C. 103 rejection over Cheng and Goldman was previously described.
Additionally, Cheng taught that the therapeutic agent was a nucleic acid (e.g., mRNA) [claims 41-43]; however, Cheng was not specific the N/P ratio, as recited in claim 23.
Geall taught that nucleic acid immunization is achieved by delivering a RNA encapsulated within a lipid composition comprising a cationic lipid, wherein the lipid composition and the RNA have a N:P ratio of between 1:1 and 20:1 [abstract].
Since Cheng taught nucleic acid delivery, it would have been prima facie obvious to one of ordinary skill in the art to include, within Cheng, a N/P ratio of between 1:1 and 20:1, as taught by Geall. The ordinarily skilled artisan would have been motivated to deliver the RNA, as taught by Geall et al at the abstract.
The instant claim 23 recites a N/P ratio of no more than about 20:1.
Geall taught a N:P ratio of between 1:1 and 20:1. A prima facie case of obviousness exists because of overlap, as discussed above.
Nonstatutory Double Patenting
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 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 11,229,609, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,766,408, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,304,911, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,590,085, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,510,880, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,648,209, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,648,210, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,257,318, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. No. 12,133,924, in view of Goldman et al (Nature Genetics, 9, 1995, 126-131).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require an amount of activity of therapeutic agent detectable in at least about 5 % of basal cells in the lungs of a subject, which is not required of the issued claims.
Goldman taught a model for lung disease (e.g., human bronchial xenograft cells (reads on lung basal cells), wherein following gene transfer, 5 % of the cells were transduced, an amount of cells sufficient to restore an essential protein function in the lung [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, the detection of an agent within at least about 5 % of basal lung cells, as taught by Goldman. The ordinarily skilled artisan would have been motivated to restore protein function in a sufficient amount of cells, as taught by Goldman.
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11, 858,884, in view of Cheng et al (WO 2020/051220 A1), in view of Goldman et al (Nature Genetics, 9, 1995, 126-131) .
Claims 12, 15-17, 20, 22-23, 25-28, 64, 68, 71-72, 82, 97 and 101-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,357,580, in view of Cheng et al (WO 2020/051220 A1), in view of Goldman et al (Nature Genetics, 9, 1995, 126-131) .
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require a SORT lipid, which is not required of the issued claims. The instant claims also require an amount of activity of therapeutic agent detectable in at least about 5 % of basal cells in the lungs of a subject, which is not required of the issued claims
Cheng taught intravenous administration, to subjects or patients in need of treating, of therapeutic agents preferentially delivered to the lung to alveolar basal cells, wherein the therapeutic agent was in composition with a lipid nanoparticle comprising an ionizable cationic lipid, a selective organ targeting (SORT) compound, a phospholipid, a steroid and a PEGylated lipid. In some embodiments, the SORT compound was a lipid.
Goldman taught a model for lung disease (e.g., human bronchial xenograft cells (reads on lung basal cells), wherein following gene transfer, 5 % of the cells were transduced, which was an amount of cells sufficient to restore an essential protein function in the lung [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, the teachings of Cheng. The ordinarily skilled artisan would have been motivated to achieve preferential delivery of the therapeutic agent, as taught by Cheng et al.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, the detection of an agent within at least about 5 % of basal lung cells, as taught by Goldman. The ordinarily skilled artisan would have been motivated to provide an amount of cells sufficient to restore an essential protein function the lungs, as taught by Goldman.
Conclusion
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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