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 .
Claim of Foreign Priority
Applicant’s claim of foreign priority and certified copy of foreign prior art application are acknowledged.
Status of the Claims
Claim 1 is pending and examined.
Note on Claim interpretation: The instant claim is interpreted as a product claim with an intended use. The claim is examined based on the structural limitations recited. The examiner has applied prior art to address the intended use in an effort to expedite prosecution on the merits, although the examiner believes that the product claim has been elected by original presentation and method claims may be withdrawn should they be properly added to a claim set. See M.P.E.P. § 818.02(a).
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schuster et al., (US2024/0165069).
Schuster teaches treating SARS-CoV-2 and COVID-19 including lingering dysgeusia by administering a lipoxin analog, such as BLXA4. Further, the treating of COVID-19 includes administering an effective amount of a specialized pro-resolving mediator (SPM) to a subject in need of treatment. See par. 26, 30, and others. The SPM can be a lipoxin, resolving, protectin, maresin, or analog thereof. See par. 31. Also see prior art claims 1-3. The SPMs can treat acute and long-lasting symptoms. See par.’s 14, 15, and others. Most patients have persistent chronic inflammation which presents as lingering symptoms.
Schuster teaches a compositions comprising a SPM compound. While not required by the claims as drafted, the composition can be used to treat acute COVID-19 and long lasting symptoms associated therewith. Persistent and lingering symptoms are taught to be treatable with SPM.
As such, claim 1 is anticipated by the prior art.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lopez Vale et al., (US2020/0038356).
Lopez Valez claims compositions comprising SPMs, including maresins, D-series resolvins, E-series resolvins, protectins, or lipoxins for treating neurodegenerative and autoimmune diseases. See prior art claim 1. The product can be a pharmaceutical composition, a nutraceutical composition, a cosmetic composition, or otherwise and it can be administered through various routes of administrations. See prior art claims 1, 9-12, e.g.
As such, claim 1 is anticipated by the prior art.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barksdale et al., “COVID‑19 and cancer: start the resolution!,” Cancer and Metastasis Review (2022) 41:1-15 (published February 21, 2022) (cited in ISR).
Barksdale teaches cytokine storm to be critical is COVID-19 due to acute SARS infection. The role of SPMs, including resolvins, protectins, lipoxins, and maresins is being figured out. “SPMs stimulate macrophage-mediated debris clearance and counter pro-inflammatory cytokine production, a process collectively termed as the ‘resolution of inflammation.’” Abstract. SPMs offer a novel approach to control SARS-CoV-2 infection. SPM levels were also found to be significantly decreased in COVID-19 patients that died of the disease compared to those that did not. Thus, the link between hyperinflammation can reflect a failure of pro-resolving pathways. See p5, 1st par. Even further, the use of SPMs therapeutically to treat conditions that appear to translate to COVID-19 and highlight their safety has been established. See p9, 1st par. “SPMs are particularly well-suited for application to treat the hyperinflammation associated with cancer and COVID 19 and may also provide an additional benefit of anti-viral and anti-thrombotic activity (Fig. 1).” Page 8, 3rd full par.
As such, a POSA would immediately envisage a composition comprising a SPM or precursor thereof.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51, 55-65, and 69-72 of copending Application No. 18/016,537. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘537 application are directed to treat a symptom of COVID-19, wherein that symptom is viral pneumonia. Further, the agents for administration include 18-HEPE, e.g., which is a precursor to a SPM. The treatment includes using a number of SPM. See claim 60 of the ‘537 application, e.g. As noted above, the claim includes an SPM and precursor to the same and the instant claim 1 is presently directed to a product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARED BARSKY/Primary Examiner, Art Unit 1628
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