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
Applicant's reply to the Restriction Requirement, dated October 30, 2025, has been received. By way of this reply, Applicant has amended claims 1-3, 28, 38, and 43, and elected, without traverse, the species of valsartan and Cyclic Prolyl Glycine (cPG).
Claims 14-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 30, 2025.
Claims 1-3, 6-13, 28, 32-33, 38-39, and 42-43 are therefore under examination before the Office.
Priority
The claims are given a priority date of May 29, 2025, which is the earliest filed provisional application that discloses the claimed subject matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 29, 31, 32, 33, 34, 35, 37, 39, 40, 42, 43, 44, 45, 47 and 52. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: the word “Atazanavir” should not be capitalized, as it refers to a generic drug and not a brand name. Appropriate correction is required.
Claims 2 and 3 are objected to because of the following informalities: the claims are missing a space following the term “SARS-CoV-2”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the word “comprising” is in the wrong verb tense; the proper word should be “comprises”. Appropriate correction is required.
Claim Interpretation
Claims 1 is interpreted as providing at least one cPG compound in combination with atazanavir sulfate, valsartan, or both atazanavir sulfate and valsartan.
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, 6-13, 28, 32-33, 38-39, and 42-43 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 and 28-58 of U.S. Patent No. 12,239,629 in view of Glick (U.S. patent 10,980,756).
The '432 patent claims a method of prophylaxis or treatment of severe acute respiratory syndrome caused by SARS-CoV2, comprising:
a. providing a subject in need of said prophylaxis or treatment of severe acute respiratory syndrome caused by SARS-CoV2;
b. providing at least one pharmaceutical composition comprising one or more of the following components:
1) at least one cPG compound;
2) donepezil; or
3) a combination thereof;
wherein said components are administered together or separately; and
further wherein said components are provided in a pharmaceutically acceptable diluent, adjuvant, excipient, or a combination thereof;
c. administering a pharmaceutically effective amount of said at least one pharmaceutical composition to said subject;
wherein said subject is provided prophylaxis or treatment of severe acute respiratory syndrome caused by SARS-CoV2 (claim 1).
The '432 patent further claims said prophylaxis or treatment of severe acute respiratory syndrome caused by SARS-CoV2 addresses high lung viral titer, weight loss, acute respiratory distress syndrome, impaired pulmonary function, acute lung injury, fever, coughing, severe respiratory conditions, or a combination thereof (claim 2).
The '432 patent further claims said at least one pharmaceutical composition comprising at least one nanoparticle formulation (claim 6), and said at least one nanoparticle formulation comprises chitosan (claim 7).
The '432 patent further claims said at least one cPG compound comprises Cyclic Prolyl Glycine, Cyclic Glycyl-2-Allyl Proline, Cyclic (glycyl-L-prolylglycyl-L-prolylglycyl-L-prolyl), or a combination thereof (claim 8).
The '432 patent further claims dosages of about 10 mg to about 50 mg (claim 10) or about 0.1 to about 1.0 mg/kg (claim 11).
The '432 patent further claims said prophylaxis or treatment further comprises neuroprotection (claim 28), and said neuroprotection is mediated by said at least one cPG compound (claim 29).
However, the '432 patent does not claim valsartan.
Glick teaches a method of treating COVID-19 in a subject in need thereof, comprising administering an angiotensin receptor inhibitor such as valsartan (col. 31, lines 34-46).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of the '432 patent and Glick to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both the '432 patent and Glick are concerned with treatments for SARS-CoV-2 and related lung distress. Starting from the claimed subject matter of the '432 patent, one of ordinary skill could readily envision a combination of treatment with cPG and valsartan, as Glick teaches that valsartan is useful for the treatment of SARS-CoV-2 infection. Each component of the combination would perform its known, usual function, and the combination would yield nothing more than predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu (https://www.medrxiv.org/content/10.1101/2020.03.20.20039586v1.article-info, dated March 27, 2020) teaches that treatments that reduce angiotensin II levels may be useful in treatment of acute respiratory distress syndrome as a consequence of SARS-CoV-2 infection (page 9, third paragraph). Liu further teaches the drug valsartan (page 6). Additionally, Applicant's specification at page 24 and 37 define valsartan as an angiotensin II receptor antagonist.
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644