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 .
Election/Restrictions
Claim 19 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 21, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 19 and 21, submitted on 16 April 2026, represent all claims currently under consideration.
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.
Response to Amendment
The 35 U.S.C. § 112(b) rejection of Claim 19 is withdrawn. Applicant has amended the claim to recite “poloxamer 188” and removed the tradename PLURONIC F68, obviating the indefiniteness.
Claim Rejections - 35 USC § 112(a)- NEW GROUNDS OF REJECTION
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of non-small cell lung cancers which overexpress cannabinoid receptor type I (CB1), it does not reasonably provide enablement for all forms of non-small cell lung cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth below:
The nature of the invention and breadth of the claims:
The claims are directed towards a method of treating non-small cell lung cancer, comprising administering to a patient in need a therapeutically effective amount of the drug of Claim 19. Claim 19 claims a formulation of ACPA, a CB1 agonist. Thus, the claims are directed to a method which can be used to treat all forms of non-small cell lung cancer using the formulation of the invention to agonize CB1 in non-small cell lung cancer cells.
The state of the prior art and the predictability or unpredictability of the art:
Preet (Cancer Prevention Research, 4, 1, January 2011) studied the role of cannabinoid receptors CB1 and CB2 in non-small cell lung cancer and observed that 24% of NSCLC patients expressed CB1 (Abstract). They further demonstrated that treatment of the NSCLC lines A549 and SW-1573 with CB1/CB2 and CB2 specific agonists attenuated growth factor-directed chemotaxis and invasion of cells in vitro. CB1 agonists inhibited in vivo tumor growth and lung metastasis. The results suggest that CB1 and CB2 could be used as novel therapeutic targets against NSCLC (Abstract). Milian (PLoS ONE, 15(2), 12 February 2020) explored the relationship between expression of CB1 and CB2 in patients with NSCLC and the effect of THC and CBD on the proliferation of NSCLC lines in vitro. Patients with high expression of CB1, CB2, and CB1/CB2 showed increased survival compared to those with low levels. Both cannabinoid agonists tested inhibited the proliferation and expression of EGFR in lung cancer cells. The cannabinoids also reduced the in vitro migration of the lung cancer cell lines tested. The authors conclude that expression of CB1 and CB2 can have a potential use as markers of survival in patients with NSCLC (Abstract). However, as these studies demonstrate, not all patients express CB1 at high levels, and thus would not be expected to respond to treatment with a CB1 agonist.
The relative skill of those in the art:
The artisan would generally have an advanced degree related to the treatment or study of various cancers; however, their high level of training and knowledge would not be sufficient to overcome the lack of understanding of how to use the claimed compounds to treat all forms of non-small cell lung cancer, as not all forms of this cancer express CNR1/CB1, and would not be expected to respond to agonism of this receptor as a result.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification demonstrates that certain non-small cell cancer cell lines (A549, H838, H1299, and H358) express CNR1 (CB1) at high levels, and are shown to have their growth inhibited using the formulations of the invention in vitro (Figure 1, Figure 2). However, two other non-small cell lung cancer cell lines which were screened (H1975 and SW-1573) do not express CNR1 at a high level, and were not shown to have their growth inhibited using the formulations of the invention. Thus, the specification enables the treatment of non-small cell lung cancers which express CNR1 or CB1, but does not enable the treatment of all forms of non-small cell lung cancer as not all forms of this cancer express CNR1/CB1.
The quantity of experimentation necessary:
Considering the state of the art as described above, in particular with regards to the lack of a panacea for the treatment of cancer due to the heterogenous nature of the disease, and the high unpredictability of the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate with the scope of the claims.
Double Patenting- NEW GROUNDS OF REJECTION
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.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/367,872 (Amended Claims of 24 October 2025) (‘872).
Claim 1 of ‘872 is drawn to a method of treating NSCLC comprising administering ACPA to a subject, wherein a dose is in the range of 10-12- 10-9 M and the ACPA is effective on a plurality of NSCLC types. Claim 2 of ‘872 is drawn to the method of claim 1 wherein the drug further comprises at least a pharmaceutically acceptable carrier wherein the carrier is polymeric nanoparticle comprising PCL. Claim 3 of ‘872 is drawn to the method of Claim 2 wherein the ACPA is released into a body after being loaded into the carrier. Claim 4 of ‘872 is drawn to the method of claim 2 wherein the drug is in a form of a tablet, capsule, powder, granule, pill, or inhaler. Claim 5 of ‘872 is drawn to the method of claim 2 wherein the drug is formulated as a lyophilized particle or nanoparticle dispersion having a shell, comprising PCL containing ACPA. Claim 6 of ‘872 is drawn to the method of claim 5 wherein the drug is formulated as a nanoparticle dispersion and PCL are present in identical ratios as those claimed in the examined application. Claim 7 of ‘872 is drawn to the method of claim 6 wherein the nanoparticle comprises ultrapure water and a non-ionic surfactant. Claim 8 of ‘872 is drawn to the method of claim 7 wherein the nanoparticle has a non-ionic surfactant of 1% w/v Pluronic F68. Claim 9 is drawn to the method of claim 5 wherein the nanoparticle dispersion is passed through a 45 µm pore size filter. Claim 10 of ‘872 is drawn to the method of claim 9 wherein the nanoparticle dispersion is lyophilized for 48 hours to obtain a nanoparticle powder product.
The claims are not identical but are not patentably distinct because each claim set is drawn to the treatment of non-small cell lung cancer using identical formulations of ACPA in PCL nanoparticle formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 19 is allowed.
The following is an examiner’s statement of reasons for allowance: Claim 19 is allowed for the reasons of record in the non-final office action mailed on 2 April 2026.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claim 19 is allowed.
Claim 21 is rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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