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 .
Priority
This application, filed 10/13/2023 is a National Stage entry of PCT/US2022/025387, International Filing Date: 04/19/2022. PCT/US2022/025387 Claims Priority from Provisional Application 63176488, filed 04/19/2021.
Status of Claims
Claims 1-8 are pending as of the response filed on 2/20/26. Claims 4-8 have been newly added.
Applicant’s election of invention I, claims 1-2 and 4-8 in the reply filed on 2/20/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/20/26.
Claims 1-2 and 4-8 were examined and are rejected.
Power of Attorney
Although a response filed on 2/20/26 was signed by an attorney, a power of attorney was not filed in this application. See MPEP 402.02(a): (b) A power of attorney must:
(1) Be in writing;
(2) Name one or more representatives in compliance with paragraph (c) of this section;
(3) Give the representative power to act on behalf of the principal; and
(4) Be signed by the applicant for patent (§ 1.42 ) or the patent owner. A patent owner who was not the applicant under § 1.46 must appoint any power of attorney in compliance with §§ 3.71 and 3.73 of this chapter.
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 1-2 and 4-8 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.
Independent claim 1 recites “A method for administering diarylhydantoin compounds”, as well as “including flutamide, bicalutamide, enzalutamide, apalutamide, and proxalutamide”, to treat “sepsis and conditions that mimic sepsis”, “including COVID-19”. The claim is indefinite because broad and narrow limitations are simultaneously recited in the claim, for example, “diarylhydantoin compounds” which is a broad limitation, along with “including flutamide, bicalutamide, enzalutamide, apalutamide, and proxalutamide” which is the narrow limitation. It is uncertain if the claim is limited to the broad or narrow limitations. Similarly, regarding the conditions being treated, it is uncertain if the metes and bounds of the claim are limited to the broad limitation “sepsis and conditions that mimic sepsis” or the narrow limitation, “COVID-19”. Claims 2 and 4-8 are similarly rejected as they depend from claim 1 and don’t provide additional clarity.
To provide compact prosecution, the claims were interpreted with regards to the broad limitations.
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.
Claim(s) 1-2 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cadegiani et. al., Cureus, vol. 13(2), pp. e13492, publ. 2/22/2021 (cited in the IDS).
Cadegiani discloses the anti-androgen, proxalutamide, was administered to patients diagnosed with COVID-19 and experiencing mild to moderate symptoms at a dose of 200 mg. per day (abstract, see methods section; p. 2, 2nd para & paras under Study design & Procedures). Cadegiani discloses proxalutmide treatment resulted in a significant improvement in time to clinical remission (pp. 6-7, bridging para). COVID-19 infection is associated with gender-disparate outcomes, as well-known in the art. Cadegiani thus anticipates the claims.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angele et. al., Arch. Surg., vol. 132, pp. 1207-1214, publ. 1997.
Angele discloses male mice were subjected to conditions of hemorrhagic shock caused by soft tissue trauma; additionally, sepsis was induced in the animals (abstract, see design section; p. 1208, left col., see top 3 para). Angele teaches the mice were administered flutamide at a dose of 25 mg/kg BW at 0, 24, and 48 hours after hemorrhagic shock; the administration at T=48 hours coincided with the induction of polymicrobial sepsis (p. 1208, see para under Flutamide administration & Sepsis procedure). Angele teaches flutamide administration significantly improved the survival of mice compared to vehicle (p. 1211, Survival para). Angele therefore anticipates the claims.
(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 and 6-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Goren et. al., US 20210299207 A1, publ. 9/30/2021, filed on 5/21/2020, as evidenced by Caterino et. al., Scientific Rep., vol. 11, p. 2941 (1-10), publ. 2/3/2021.
Goren discloses treatment of viral infections by administering an anti-androgen (title & abstract). In particular, Goren discloses administering 60 mg. apalutamide daily to male patients diagnosed with SARS-CoV-2 infection and experiencing mild symptoms (para [0224-0225]); additionally, Goren discloses administering 160 mg. enzalutamide q.d. to male subjects diagnosed with SARS-CoV-2 infection (para [0220-0221]). Goren further discloses there is increased prevalence of severe COVID-19 infection among males compared to females (para [0003]). Goren discloses “treatment” to encompass reduction of one or more symptoms (para [0075]). COVID-19 infection is associated with release of endogenous alarmins, as evidenced by Caterino (see abstract; p. 2, 2nd full para beginning with “Viral infection…”; p. 5, last para). Therefore, as Goren discloses administering a therapeutically effective amount of a diarylhydantoin compound, apalutamide and enzalutamide, to treat the condition that mimics sepsis, COVID-19, Goren anticipates the claims.
Claim Rejections-35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goren et. al., US 20210299207 A1, publ. 9/30/2021, filed on 5/21/2020, as evidenced by Caterino et. al., Scientific Rep., vol. 11, p. 2941 (1-11), publ. 2/3/2021, as applied to claims 1 and 6-8.
The disclosure of Goren as discussed previously is incorporated herein. Furthermore, in addition to apalutamide and enzalutamide, Goren teaches other suitable anti-androgens for treatment of a COVID-19 patient include flutamide, bicalutamide, and proxalutamide in therapeutically effective amounts (para [0046], [0066-0068], [0102]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claim to have treated COVID-19 infection in a patient by administering an effective amount of an anti-androgen such as flutamide, bicalutamide, or proxalutamide. One of ordinary skill in the art would have had a reasonable expectation of success in administering either flutamide, bicalutamide, or proxalutamide to treat COVID-19 in a patient in need thereof, given the teachings of Goren of apalutamide, enzalutamide, flutamide, bicalutamide, and proxalutamide being equivalent anti-androgens for the treatment of COVID-19.
Claim Rejections-Nonstatutory 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 1-2 and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US Patent 11058647 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass treating the condition that mimics sepsis, SARS-CoV-2 infection by administering an anti-androgen agent selected from flutamide, bicalutamide, enzalutamide, apalutamide, and proxalutamide. SARS-CoV-2 infection is well-known in the art to exhibit gender-disparate outcomes, as recited by instant claim 7. Therefore, the instant and patented claims are not patentably distinct, being drawn to treatment of the same condition, SARS-CoV-2 or COVID-19 infection by administering the same anti-androgen agent.
Claims 1-2 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-14, and 16-20 of copending Application No. 19088607 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass treating sepsis or a condition associated with sepsis in a subject by administering an anti-androgen selected from flutamide, bicalutamide, enzalutamide, apalutamide, and proxalutamide (see instant claim 1 and claims 1 and 3 of US ‘607). Additionally, both sets of claims encompass treating COVID-19 (instant claim 1 and copending claim 9). Claim 1 of US ‘607 recites the step of executing an analytical test, and claim 3 recites the analytical test as a COVID-19 test. Although this step is not explicitly recited by the instant claims, it would have been prima facie obvious to have added this step to the instant claims as part of diagnosing a subject with COVID-19 prior to administering the anti-androgen. COVID-19 infection is well-known in the art to exhibit gender-disparate outcomes, as recited by instant claim 7. Therefore, the instant and copending claims are not patentably distinct, being drawn to treatment of the same condition, sepsis or COVID-19 infection by administering the same anti-androgen agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-14, and 16-20 of copending Application No. 19081887 (reference application) in view of Goren et. al., US 20210299207 A1, publ. 9/30/2021. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass treating sepsis or a condition associated with sepsis in a subject by administering an anti-androgen. Additionally, both sets of claims encompass treating COVID-19 (instant claim 1 and copending claim 9). Although the copending claims don’t explicitly recite the anti-androgens flutamide, bicalutamide, enzalutamide, apalutamide, and proxalutamide, these agents are known anti-androgens in view of Goren. Goren teaches other suitable anti-androgens for treatment of a COVID-19 patient include enzalutamide, apalutamide, flutamide, bicalutamide, and proxalutamide in therapeutically effective amounts (para [0046], [0066-0068], [0102]). Therefore, it would have been prima facie obvious that the method of the copending claims would involve administering an anti-androgen selected from enzalutamide, apalutamide, flutamide, bicalutamide, and proxalutamide.
Claim 1 of US ‘887 recites the step of executing an analytical test, and claim 2 recites the analytical test as a COVID-19 test. Although this step is not explicitly recited by the instant claims, it would have been prima facie obvious to have added this step to the instant claims as part of diagnosing a subject with COVID-19 prior to administering the anti-androgen. COVID-19 infection is well-known in the art to exhibit gender-disparate outcomes, as recited by instant claim 7. Therefore, the instant and copending claims are not patentably distinct, being drawn to treatment of the same condition, sepsis or COVID-19 infection by administering the same anti-androgen agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Information Disclosure Statement
The IDS filed on 10/13/23 has been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
