DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 6-5-26.
Claims 1-3, 11, 17, 23, 27, 28, 30, 52, 66, 72, 80, 81, 107-109, 117, 131, 147, 166, 229-231 are pending in the instant application.
Election/Restrictions
Claims 80, 107-109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6-5-26.
Applicant’s election without traverse of Group I, the molar ratios for the lipid components: a) about 47%-60% cationic lipid, b) about 10%-22.5% non-cationic lipid, c) about 3%-5% PEG-modified lipid, and d) the remainder is cholesterol; the cationic lipid Formula IIID, the non- cationic lipid DOPE, the PEG-modified lipid DMG-PEG2K, and cholesterol, claims 1-3, 11, 17, 23, 27, 28, 30, 52, 66, 72, 81, 117, 131, 147, 166, 229-231, in the reply filed on 6-5-26, is acknowledged.
Claim Objections
Claim 72 is objected to because of the following informalities: In line 1 of claim 72, “of any claim 1” appears to be a typographical error (e.g., perhaps deleting “any” would be remedial).
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 117 and 166 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.
Regarding claim 166, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 117 recites the terms “PE lipid” and “PC lipid.” It is unclear what these terms represent.
Appropriate corrections are required.
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 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, and 229-230 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Abrams et al (WO 2018/006052).
Abrams et al (WO 2018/006052) teach compositions comprising lipid nanoparticles comprising an mRNA encapsulated with the lipid nanoparticles, which nanoparticles comprising a cationic lipid (page 20, third full paragraph, page 25, first full paragraph, pages 41-42), a non-cationic lipid (page 25, second full paragraph, pages 53-54), and a PEG-lipid conjugate of at least 3 mole percent (See Abstract and pages 3 and 9, paragraph bridging pages 18-19, page 25 last full paragraph, pages 57-58), which lipid;mRNA has a mass ratio of from about 9:1 to about 20:1 (page 4, second full paragraph), which cationic lipid optionally comprises about 45%-60% of the lipid nanoparticle, which non-cationic lipid optionally comprises about 7% or about 10% to 60%, or about 25%-40% (pages 27-28, 54), and which nanoparticles comprise cholesterol at about 25% to about 45% (pages 55-56). Abrams teaches an array of lipid nanoparticle formulations, including peg-LIPID AT 1.1%, Cationic lipid at 54.9%, cholesterol at 33%, and non-cationic lipid at 11% (page 80, last paragraph).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al (WO 2018/006052) in view of Heartlein et al (WO 2018/213476).
The claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and a cationic lipid of about 45%-60%, a non-cationic lipid at about 10%-22.5%, a PEG modified lipid at about 3%-5%, and the remainder is cholesterol, which total lipid:mRNA ratio is between 11:1 and 19:1, which compositions are formulated for pulmonary delivery by nebulization and further comprises a disaccharide optionally comprising sucrose at about 3-10% w/v.
Abrams et al (WO 2018/006052) teach compositions comprising lipid nanoparticles comprising an mRNA encapsulated with the lipid nanoparticles, which nanoparticles comprising a cationic lipid (page 20, third full paragraph, page 25, first full paragraph, pages 41-42), a non-cationic lipid (page 25, second full paragraph, pages 53-54), and a PEG-lipid conjugate of at least 3 mole percent (See Abstract and pages 3 and 9, paragraph bridging pages 18-19, page 25 last full paragraph, pages 57-58), which lipid;mRNA has a mass ratio of from about 9:1 to about 20:1 (page 4, second full paragraph), which cationic lipid optionally comprises about 45%-60% of the lipid nanoparticle, which non-cationic lipid optionally comprises about 7% or about 10% to 60%, or about 25%-40% (pages 27-28, 54), and which nanoparticles comprise cholesterol at about 25% to about 45% (pages 55-56). Abrams teaches an array of lipid nanoparticle formulations, including peg-LIPID AT 1.1%, Cationic lipid at 54.9%, cholesterol at 33%, and non-cationic lipid at 11% (page 80, last paragraph).
Abrams does not teach nebulized formulations comprising sucrose for lung delivery.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed and previously taught by Abrams for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
For these and the aforementioned reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention.
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 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-16 of U.S. Patent No. 12,655,095 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid of about 45%-60%, a non-cationic lipid at about 10%-22.5%, a PEG modified lipid at about 3%-5%, and the remainder is cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 5, 12 of U.S. Patent No. 12,076,439 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-7, 9, 9, 11, 16, 17 of U.S. Patent No. 11,547,666 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,240,824 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-19 of U.S. Patent No. 12,377,053 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-12 of U.S. Patent No. 11,427,535 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-20 of U.S. Patent No. 10,961,184 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Claims 1-3, 11, 23, 27, 28, 30, 52, 66, 72, 117, 131, 147, 166, and 229-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-14 of U.S. Patent No. 11,964,051 in view of Heartlein et al (WO 2018/213476) because both sets of claims are drawn to compositions comprising lipid nanoparticles comprising an mRNA encapsulated within the lipid nanoparticle and which lipid nanoparticles further comprise a cationic lipid, a non-cationic lipid, a PEG modified lipid, and cholesterol.
Heartlein et al (WO 2018/213476) teach lipid nanoparticle compositions formulated for pulmonary delivery by nebulization and further comprising a disaccharide optionally comprising sucrose at about 3-10% w/v (see esp. pages 119-121).
It would have been obvious to provide lipid nanoparticle formulations as instantly claimed for nebulization with an added disaccharide optionally comprising sucrose because nebulization of lipid nanoparticles comprising sucrose is a standard technique for lung delivery, as taught by Hearlein. Sucrose is well known to provide stability to the nebulizing formulations.
Allowable Subject Matter
Claims 17 and 81 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
7-28-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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