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 . Claims 1-11 and 14-22 are pending in this application.
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 8/04/2026 Applicant's election with traverse of Group I is acknowledged. The traversal is on the ground(s) that “the examination of the elected claims of Group I will significantly overlap, if not totally encompass, the search required for examination groups of the claims of Groups II and III. Thus, no serious burden is imposed in examining the method and device claims together”. The examiner disagrees with applicant’s argument. First, there is no device claim in the case. Group II is drawn to a method of producing a pharmaceutical composition and Group III is drawn to a method of treatment and/or prevention of a virus infection. Second, as set forth in the Restriction Requirement the special technical feature of Groups II-III involves a synthetic procedure and therapeutic techniques that is not present in the special technical feature of Group I. Furthermore coexamination of each of the additional groups would require search of subclasses unnecessary for the examination of the elected claims. Therefore, coexamination of each of these additional inventions would require a serious additional burden of search.
The requirement is still deemed proper and is therefore made FINAL.
Note that if the invention of Group I is found allowable, the examiner would rejoin the invention of Groups II-III.
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 1-7 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 15 and 19-22 of recently allowed copending Application No. 17/802,558. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and claims 1-6, 15 and 19-22 of recently allowed copending Application No. 17/802,558 in view of Gupta et al. Molecules 2018, 23, 1719 (15 pages).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-7 and 16-20 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:
a. Claim 1 and claims dependent thereon are drawn to a pharmaceutical composition, but the claims lack a pharmaceutical acceptable carrier that is part of a pharmaceutical composition. The examiner recommends that applicants amend the claims so that the pharmaceutical composition includes a pharmaceutical acceptable carrier.
b. In claim 1, it is recited “potassium ions” but is unclear how the potassium ions are part of the chemical structure. What is the source of potassium ions? How are they attached to the compound as counter ions? The compound of formula (I) is not negatively charged, and it is unclear how the potassium ions as counter ions are connected to compound.
c. In claim 1, the phrase “capable of exhibiting a pH” is not clear. What is it? How is it capable of exhibiting a pH? Note that “capable” is an intended use and has no patentable weight. It is recommended that applicants delete “capable” from the claims.
d. In claim 7, the term “buffer” is indefinite. What is covered and what is not? What is the nature of the buffer? Is the buffer a result of adding other substance? How can one tell if a given buffer is not part of the claim? It is recommended that applicants recite specific buffers to overcome this rejection. Note that there is no guidance in the specification.
Information Disclosure Statement
7. Applicant’s Information Disclosure Statement, filed on 01/21/2026 and 06/20/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
August 18, 2026
Prosecution Insights