DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The examiner acknowledges receipt of amendment and response to restriction requirement filed 06/03/2026; preliminary amendment filed 04/11/2024; and IDS filed 06/15/2026, 07/30/2025, 05/02/2025, 03/31/2025, 06/05/2024 and 11/21/2023.
Claims 1, 3-9, 12, 14-15, 19, 21, 24, 27, 49 and 112-113 were amended on 04/11/2024.
Claims 2,10-11, 13, 16-18, 25-26, 28-48, 50-111 and 114-119 were canceled on 04/11/2024.
Claims 1, 3, 23-24, 27 and 112 are amended on 06/03/2026.
Claims 15 and 19-23 are canceled on 06/03/2026.
New claims 120-124 are added.
Claims 1, 3-9, 12, 14, 23-24, 27, 49, 112-113 and 120-124 are pending.
Election/Restrictions
Applicant’s election without traverse of (1) cholesterol as the one specific disclosed steroid, (2) 4A3-SC7 as the one specific disclosed ionizable cationic lipid, (3) pegylated myristoyl diglyceride (DMG-PEG) as the one specific disclosed polymer conjugated lipid, (4) 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC) or pharmaceutically acceptable salt as the one specific discloses selective organ targeting (SORT) lipid in the reply filed on 06/03/2026 is acknowledged.
Applicant identifies claims 1, 3-9, 12, 14, 15, 19-23, 49, 112, 113 and 120-124 a reading on the elected species. Claim 1 is generic and has not been amended to recite the elected species.
In amended claim 1, formula (IA) A is generic to the elected 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC), the one specific SORT lipid.
Because applicant elected 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC) which is species of the claimed SORT below, claims 24 and 27 are withdrawn from consideration.
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Therefore, claims 24 and 27 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/03/2026.
Priority
This application is a 371 of PCT/US2022/021442 filed 03/22/2022 and which claims benefit of 63/164,523 filed 03/22/2021, 63/229,497 filed 08/04/2021 and 63/305,426 filed 02/01/2022.
Information Disclosure Statement
The IDS filed 06/15/2026, 07/30/2025, 05/02/2025, 03/31/2025, 06/05/2024 and 11/21/2023 have been considered.
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 49 and 113 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.
Claim 49 selects ionizable cationic lipid “from those set forth in Table 4, ….” This claim does not set forth the limits of the ionizable cationic lipid but refers back to the specification. It has been settled in Ex parte Fressola, 27 USPQ2d 1608 (Bd. Pat. App. & Inter. 1993 that a claim must stand by itself and must be complete in itself to define the invention without relying on the text of the specification.
Correction is respectfully requested.
Regarding claim113, the phrase "for example" (e.g.) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 3-9, 12, 14, 23, 49, 112-113 and 120-124 is/are rejected under 35 U.S.C. 103 as being unpatentable over CHENG et al. (WO 2020051220 A1) in view of Michael W. Sims, “Aerosol Therapy for Obstructive Lung Diseases Device Selection and Practice Management Issues,” in CHEST, Topics in Practice Management, 2011 and Surber et al (US 20200040560 A1).
CHENG teaches composition comprising therapeutic agent and lipid nanoparticle {LNP) composition; the LNP composition comprises (1) permanently cationic lipid; (2) ionizable cationic lipid; (3) phospholipid; (4) selective organ targeting compound (SORT); (5) steroid; and (6) PEG lipid (see the whole document with emphasis on paragraphs [0007], [0008]; [0045]-[0056]). One of the target organs is the lungs (paragraphs [0008], [0009], [0047], [0048], [0053], [0054], [0058] ) and the composition can be administered via inhalation therapy (paragraph [0038]). CHENG defines the permanently cationic lipid as phosphatidylcholine having structure (IA):
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(Claims 11, 21; paragraph [00141] on page 67).
The particle size of the LNP is generally uniform (paragraph [0012]). CHENG teaches 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC) (lines 29, 30 of page 104; line 24 of page 112) meeting the limitation of the elected SORT. Pegylated lipid in CHENG is DMG-PEG (Example 1 on page 87; line 3, page 88; Table 1; lines 3 and 9, page 90; lines 11 and 13, page 96; line 30, page 100). 5A2-SC8 is ionizable cationic lipid (line 20 of page 101). Cholesterol is steroid (line 15 of page 16). In one embodiment, the composition comprises 5A2-SC8 (ionizable cationic), DOPE, cholesterol DMG-PEG, and extra 5A2-SC8 (paragraph []0022] at page 102 of CHENG).
The therapeutic agents are nucleic acids and nucleic acid based therapeutic agents (see at least item E on page 71).
Thus for claims 1, 23, 49, 112, 121, 122, 123 and 124, CHENG teaches all the elements of these claims, CHENG differs from these claims because CHENG does not say that the inhalation therapy is done by aerosol device.
However, it is known in the art that aerosol devices deliver drugs rapidly and directly into the airways allowing high local drug concentration while limiting systemic toxicity (see at least the abstract in Michael W. Sims). Therefore, before the effective date of the invention, the ordinary skilled artisan, guided by the teachings of Michael W. Sims would be motivated to deliver the composition of CHENG using aerosol device with the expectation of predictably delivering the active agent rapidly and directly into the airways allowing high local drug concentration while limiting systemic toxicity.
Form claim 3, while he production of aerosol drops by nebulizer is the process of producing the aerosol, Michael W, Sims teaches nebulizer in aerosol devices (see the whole document with emphasis on the abstract, pages 782-783) and Surber teaches that jet nebulizer utilizes air pressure breakage of aqueous solution into aerosol droplets (paragraph [0159]).
For claim 4, it is known in the art that liquid or dry powder aerosol has a mean mass median aerodynamic diameter (MMAD) of from about 1 micron to 10 micron, 2 micron to about 5 micron, less than or equal to about 2 micron or less than or equal to 1.8 micron (paragraph [0024], claims 1-10 of Surber) such that the artisan would reasonably expect the MMAD to fall within from about 1 micron to 10 micron.
Form claim 5, the varying of the droplet size is inherent to the droplet in question formed during the delivery.
For claim 6, Surber teaches that generation of particle size with limited geometric standard deviation (GSD) may optimize deposition and tolerability and GSD of less than or equal to about 2.5 is expected (paragraph [0156]) such that the artisan would expect the GSD to be less than or equal to 2.5 with the expectation of predictably optimizing deposition and tolerability.
For claim 7, EPC SORT, in some compositions is present at 40 and 50% (see Table 1 in CHENG) and the 40% and 50% are specific points within the claimed range.
For claim 8, the ionizable cationic lipid is present at from about 5% to about 30% (paragraph [0028] at page 8 of CHENG) with this range meeting the claimed range.
For claim 9, the phospholipid is present from about 8% to about 20% (paragraph [0030] at page 15 of CHENG) with this range being specific point range within the claimed range.
Form claim 12, the steroid is present at from about 15% to about 39% (paragraph [0031] at page 16 of CHENG) with this range being specific point range within the claimed range.
For claim 14, in one embodiment, the pegylated lipid is present at from about 4% to about 4.6% (paragraph [00150] in paragraph [00150] at page 70 of CHENG).
For claim 113, effective amount is any amount deemed effective by the artisan.
For claim 120, 4A3-SC7 and 5A2-SC8 are each ionizable cationic lipid. Therefore, before the effective date of the invention, one having ordinary skill in the art would be guided such that one ionizable cationic lipid can be used in place of the other with the expectation that the 4A3-SC7 would predictably be effective in the delivery of nucleic acid.
Thus, CHENG in combination with Michael W. Sims and Surber renders claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124 prima facie obvious.
Double Patenting
The non-1234Z`statutory 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 non-statutory 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 non-statutory 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 non-statutory 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, 3-9, 12, 14, 23, 49, 112-113, 120 and 122-124 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12121610 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:-
US 12121610 B2: The issued claims teach aerosol composition comprising therapeutic agent, dendrimer ionizable cationic lipid, ethylphosphocholine defined in claims 15-32, phospholipid, cholesterol which is steroid, and polyethylene glycol conjugated lipid; the dendrimer ionizable cationic lipid in claim 1 is the ionizable cationic lipid 4A3-SC7 having the chemical structure in claim 120. The composition of the issued claims of US 12121610 B2 is delivered to the lung. The issued claims of US 12121610 B2 teaches all the elements of examined claims 1, 3-9, 12, 14, 23, 49, 112-113, 120 and 122-124 .
Claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-25; 1-28; 1-39; and 1-33 of U.S. Patent Nos. 12133923 B2; 12337068 B2; 12364773 B2; and 12582611 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because:-
US 12133923 B2: The issued method delivers aerosolized composition to lungs, the composition comprises therapeutic agent, ionizable lipid, phospholipid, DMG-PEG which is a pegylated lipid, sterol/cholesterol; the ionizable lipid 4A3-SC7 which is the claimed ionizable cationic lipid of examined claim 120. The composition administered to the lungs also contains permanently cationic lipid (issued claim 18) that is 1,2-dimyristoyl-sn-glydero-3-ethylphosphocholine (14:0 EPC meeting examined claim 124) (in issued claims 18-25) meets the limitation of selective organ targeting (SORT) lipid of the examined claims, DOPE meeting examined claim 121, and cholesterol meeting examined claim 122.
Therefore, the composition used in the claims of US 12133923 B2 teaches all the elements of examined composition in claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124.
US 12337068 B2: The issued method delivers therapeutic agent using aerosolized composition comprising lipid nanoparticles (LNP) comprising ionizable lipid that is 4A3-SC7, DOPE phospholipid, cholesterol, sterol, DMG-PEG pegylated lipid, permanently cationic lipid 14:0 EPC that meets the selective organ targeting (SORT) lipid of the examined claims.
Therefore, the composition used in the claims of US 12337068 B2 teaches all the elements of examined composition in claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124.
US 12364773 B2: The issued lipid nanoparticle (LNP) composition comprising aerosolized composition comprising 4A3-SC7 ionizable cationic lipid, DOPE meets examined claim 121, cholesterol which is a steroid, DMG-PEG pegylated lipid, 1,2-dimyristoyl-sn-glydero-3-ethylphosphocholine (14:0 EPC meeting examined claim 124), 4A3-SC7 is the specific ionizable cationic lipid of examined claim 120; the 14:0 EPC meets the limitation of selective organ targeting (SORT) lipid of the examined claims.
Therefore, the aerosolized composition of the claims of US 12364773 B2 teaches all the elements of examined composition in claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124.
US 12582611 B2: The method of US 12582611 B2 uses aerosolized composition comprising lipid nanoparticles (LPN) comprising 4A3-SC7 ionizable cationic lipid meeting the ionizable cationic lipid of claims 1 and 120; DOPE phospholipid meeting the phospholipid of claims 1 and 121; DMG-PEG pegylated lipid meeting the polymer conjugated lipid of claims 1 and 123; cholesterol sterol meeting the steroid of claims 1 and 122; and DODAP ionizable cationic lipid. The claims of US 12582611 B2 differs from the examined claims in that claims of US 12582611 B2 do not teach the phosphotidylcholine of the claims. But DODAP and the phosphotidylcholine of the examined claims are functionally equivalent though not equivalent structurally. However, one functionally equivalent ionizable cationic lipid can be used in place of the other with the expectation of predictably delivering the LNP’s to the lungs. There is no evidence that DODAP cannot be used in the delivery of LNP to the lungs.
Therefore, the aerosolized composition of the claims of US 12582611 B2 used in the delivery of LNP’s to the lungs renders the examined composition in claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124 prima facie obvious.
Claim 1, 3-9, 12, 14, 23, 49, 112-113 and 122-124 are rejected on the ground of non-statutory double patenting as being unpatentable over claim claims 1, 2, 4-28 of U.S. Patent No. 11766408 B2 in view of in view of Michael W. Sims, “Aerosol Therapy for Obstructive Lung Diseases Device Selection and Practice Management Issues,” in CHEST, Topics in Practice Management, 2011.
US 11766408 B2: The issued claims teaching composition that comprises therapeutic agent, ionizable cationic lipid, permanently cationic selective organ targeting (SORT) lipid where the sort lipid is EPC (claim 24), phospholipid (claim 6), PEG- Lipid (claim 11), steroid (claims 11 and 12) and the steroid encompasses cholesterol. Issued claim 1 contemplates administering the composition to lung. The issued claims differ from the examined claims in that the issued claims fail to teach aerosol composition.
However, it is known in the art that aerosol devices deliver drugs rapidly and directly into the airways allowing high local drug concentration while limiting systemic toxicity (see at least the abstract in Michael W. Sims). Therefore, before the effective date of the invention, the ordinary skilled artisan, guided by the teachings of Michael W. Sims would be motivated to deliver the composition of CHENG using aerosol device with the expectation of predictably delivering the active agent rapidly and directly into the airways allowing high local drug concentration while limiting systemic toxicity.
US 11766408 B2 in view of Michael W. Sims renders 1, 3-9, 12, 14, 23, 49, 112-113 and 122-124 prima facie obvious.
Claims 1, 3-9, 12, 14, 23, 49, 112-113 and 120-124 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-12, 14 and 18-29; 22-25, 27-28 and 31-49; 31-59; 1-30; 1-14 and 18-29 of co-pending Application Nos. 18596148; 19182477; 19400701; 18778746; 18778429 (reference application) respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because:-
The co-pending claims of co-pending 18596148 teach aerosol composition comprising ionizable cationic lipid of group I-1 that is defined as 4A3-SC7 in co-pending claims 18-20, as 5A2-1-SC8, 5A2-2-SC8, 5A2-4-SC8,5 arm, 5A2-4-SC8, 6 arm, 5A2-6-SC8 of co-pending claims 21-23; 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC), DOPE phospholipid, PEG modified dimyristoyl-sn-glycerol. Cholesterol is a steroid. The 4A3-SC7 meets the ionizable cationic lipid of examined claim 120, DOPE meets the DOPE of examined claim 121, PEG modified dimyristoyl-sn-glycerol meets examined claim 123, 14:0 EPC meets the SORT lipid of claim 124 and cholesterol meets claim 122.
The co-pending claims or 19182477 teach aerosolized composition comprising lipid nanoparticle (LPN) composition comprising 4A3-SC7 ionizable cationic lipid, 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC), cholesterol or sitosterol, DOPE or DSPC phospholipid, DMG-PEG pegylated lipid, and therapeutic agent (see co-pending claims 22-25, 27-28 and 31-49).
The co-pending claims of 19400701 teach aerosolized composition comprising lipid nanoparticle (LPN) composition comprising 4A3-SC7 ionizable cationic lipid, 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC), sterol, DOPE phospholipid, DMG-PEG pegylated lipid, and therapeutic agent (see co-pending claims 31-59). The comprising language is open.
The co-pending claims of 18778746 teach aerosol composition comprising lipid nanoparticle (LPN) that comprises therapeutic agent, dendrimer ionizable cationic lipid having the structure of 4A3-SC7, ethylphosphocholine defined as 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC) in co-pending claims 11-13, 22-24. 26-27, phospholipid, cholesterol and polyethylene glycol conjugated lipid (see claims 1-24) and method of claims 25-30 uses the composition of claims 1-24.
The co-pending claims of 18778429 teach aerosol composition comprising ionizable cationic lipid of group I-1 that is defined as 4A3-SC7 in co-pending claims 18-20, as 5A2-1-SC8, 5A2-2-SC8, 5A2-4-SC8,5 arm, 5A2-4-SC8, 6 arm, 5A2-6-SC8 of co-pending claims 21-23; 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (14:0 EPC), DOPE or DSPC phospholipid, PEG modified dimyristoyl-sn-glycerol and Cholesterol which is a steroid.
The comprising language is open.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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