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 1-9 and 12-20 are presented for examination.
Applicants’ drawings, information disclosure statement, and preliminary amendment filed June 27, 2024 have been received and entered.
Applicants’ election filed September 4, 2026 in response to the restriction requirement of July 16, 2026 has been received and entered. The applicants elected the invention described in claims 1, 2 and 14-20 (Group I) with traverse. Applicants’ traverse is noted but is not deemed persuasive for reasons set forth in the previous Office action dated July 16, 2026; therefore, the restriction requirement is hereby made Final.
Claims 3-9, 12 and 13 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad term: a coronavirus. The mere fact that Applicant may have discovered one type of coronavirus is treated with topotecan is not sufficient to claim the entire genus that includes SARS-CoV, MERS-CoV, SARS-CoV2, and 229E, NL63, OC43 and HKU1.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 1 and 16-20 are not allowed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al., “TOP1 inhibition therapy protects against SARS-CoV-2-induced lethal inflammation”, bioRxiv (Dec. 2020) 1-36 (www.biorxiv.org).
Ho et al. teach the administration of topoisomerase inhibitor, topotecan, is effective in the treatment of SARS-CoV-2 and its associated complications (See the Summary). Note topotecan therapeutic treatment with two doses. Note topotecan can also be administered to the subject as late as 4 days post-infection. Note the preferred dosage amount is 2 mg/kg. Note the active agent is administered to the subject intraperitoneally or intraperitoneal injection..
Clearly, the cited reference anticipates applicants’ instant invention; therefore, applicants’ instant invention unpatentable.
Claims 1, 2 and 14-20 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629
