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 .
Current Status of 17/574,781
The rejections of record are maintained below.
This Office Action is responsive to the amended claims of 7/21/2025.
Previously presented claim 1 has been examined on the merits. Claims 2-23 are canceled.
Priority
The instant application claims priority to U.S. provisional application 63/136,697, filed 01/13/2021.
The instant claims find support from 63/136,697. Therefore, the effective filing date is 1/13/2021.
Information Disclosure Statement
No IDS has been filed.
Response to Arguments
Applicants’ claim amendments and Remarks of 7/21/2025 are acknowledged and have been considered.
In regard to eh obviousness rejection, this rejection is maintained. Applicants remarks with Examiner’s reply are summarized below:
Applicants argue that Atovaquone and Niclosamide target mitochondrial functions and are antiparasitic drugs. Niclosamide has shown some antimalarial activity.
The use of these drugs does not support nonobviousness.
Applicants argue that atovaquone and Niclosamide are pharmacological equivalents.
Pharmacological equivalents does not factor into deciding nonobviousness.
Applicants submit that there is predicted synergy for the combination of atovaquone and celastrol.
These remarks are not persuasive. Applicants must show unexpected results to show synergy unless it is already established in the art. Predicted or theoretical synergy is not the same as showing unexpected results. See MPEP 716.02(A).
Though Applicant states that unexpected results have been achieved, the instant specification does not provide any unexpected or surprising results. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
The double patenting rejection, which is not addressed, is maintained.
Response to Amendment
Claim Rejections - 35 USC § 103- MAINTAINED
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over MedlinePlus (“Atovaquone”, MedlinePlus, Last Revised 11/15/2017) in view of Tasaka (“Pneumocystis Pneumonia in Human Immunodeficiency Virus-infected Adults and Adolescents: Current Concepts and Future Directions”, Sadatomo Taska, Libertas Academica, July 08, 2015) and in view of Venkatesha (“Celastrol and Its Roel in Controlling Chronic Diseases”, Adv Exp Med Biol., 2016).
MedlinePlus teaches Atovaquone is used to treat Pneumocystis jirovecii pneumonia (PCP) (page 1).
Tasaka teaches that Pneumocystis jirovecii pneumonia (PCP) is an inflammatory disease ( page 20 bottom right col). Tasaka teaches “Severe PCP is characterized by neutrophilic lung inflammation that may result in diffuse alveolar damage, impaired gas exchange, and respiratory failure” (page 20).
Tasaka teaches that treatment for PCP attenuates lung injury by blunting the inflammatory response (page 25).
Venkatesha teaches that Celastrol, a triterpenoid derived from traditional Chinese medicinal plants, has anti-inflammatory activities (abstract).
While MedlinePlus teaches Atovaquone, MedlinePlus does not teach Celastrol.
While Venkatesha teaches Celastrol, Venkatesha does not teach Atovaquone.
Claim 1 is prima facie obvious in light of the combination of references.
The artisan would be motivated to combine atovaquone and Celastrol in order to treat Pneumocystis jiroivecii pneumona (PCP). The artisan would expect Celastrol, with known anti-inflammatory activity (Venkatesha abstract), to be useful in treating PCP (Tasaka page 25).
The artisan would expect that since atovaquone, a known PCP treatment (MedlinePlus page 1), and since Celastrol, known to have anti-inflammatory properties (Venkatesha abstract) and useful in treating PCP (Tasaka page 25), that combing them would result in a functional PCP combination/composition treatment. It is prima facie obvious to combine one PCP treatment (atovaquone) with another PCP treatment (Celastrol) in order to form a composition to be used for the very same purpose (treating PCP). This teaches claim 1.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious before the effective filing date of the claimed invention to one of ordinary skill in the art, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting- MAINTAINED
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 claim 1 of copending Application No. 18/533,681 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the reference claims teaches the instant claim.
Reference claim 1, a pharmaceutical composition comprising atovaquone, and at least one substance such as celastrol, teaches instant claim 1, a combination of substances comprising Atovaquone and celastrol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625