DETAILED ACTION
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
Claims 24,26, 31, 41, 44, 48, 50 and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/7/2026.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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
Claims 3 and 11 are objected to because of the following informalities: estrogen is not a proper noun and does not need to be capitalized. Appropriate correction is required.
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 2-7, 14 and 16 is 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.
Claims 2-6 are indefinite because it is unclear if the claim is describing an inherent interaction that occurs as a result of the method, or if the method relies on the administration of interacting components. For the sake of examining the claims on their merit, the former interpretation will be used.
Claim 7 is indefinite because it is unclear if the claimed modulation requires the use of a RNA polymerase, which would necessarily require a specifically claimed SEQ ID NO, or if the modulation inherently causes the claimed polymerase to coexist with the SRC-1 condensate.
The term “significantly” in claim 15 is a relative term which renders the claim indefinite. The term “significantly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of dissolution would be considered “significant.”
Claim 16 provides for limitations contained within a parenthesis and preceded by “e.g.” It is unclear to what extent this should be interpreted as a limitation. For the sake of examining the claim on its merit, it will be assumed that the limitation “at least 30%” will apply, since it necessarily comprises all of the examples in the parenthesis.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-23 are rejected under 35 U.S.C. 101 because the disclosed invention is inoperative and therefore lacks utility. The claims are drawn to a method, but there are no clear method steps to provide for the claimed modulation. A method without method steps must be an inoperative invention.
Briefly, the claims are drawn to a method of modulating a transcription factor, by modulating the transcription factor, wherein the transcription factor regulates transcription. There are no steps provided for administering any types of transcription factors to any types of cells or subjects, and as such, there is no clear method to examine. Claim 1 does not provide for any steps of providing any compound, wherein all of the claims that follow appear to provide for inherent behaviors that could occur if a step of administering was provided. Although there are some applied examples in the specification, it is unclear which examples would apply to the selected group, and which examples would apply to the groups that were restricted out of the claim-set. Furthermore, there are examples that include nucleic acid constructs, which would necessarily require specific sequence identifications to properly claim these types of methods.
Claim Rejections - 35 USC § 102/103
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.
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) 1-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Badowski, et al (Drugs in Context, 8, 212550, 2019) Ramanathan, et al (Clinical Pharmacokinetics. 50, 229-244, 2011) and Liu (CN112022850 [Machine translation is attached]). As discussed in the 35 USC 101 rejection above, the claims do not appear to have a clear method of administering a composition; however, when looking at the claims, it appears as though the claimed compound of interest can include elvitegravir. As such, given the lack of clear administration steps, it seems apparent that any method that involves the administration of elvitegravir would inherently cause the claimed modulation. This administration can be shown in Badowski Ramanathan, and Liu. Badowski shows the use of the drug for methods of treating cancers, and states that the drug is used as an antiretroviral, Ramanathan explicitly describes the antiretroviral activity of the compound, and Liu provides the drug as an anti-tumor compound. See Badowski, page 1, “Abstract” section; Ramanathan, page 229, “Abstract” section; Liu, 1st page.
Given the fact that the prior art has administered the claimed compound, all of the claimed modulation must have inherently occurred. See MPEP 2112. Additionally, the cited prior art, in light of the assumed knowledge of the ordinary artisan (see MPEP 2141.03) would make it obvious to the ordinary artisan that other compounds that modulate SRC-1, in a manner consistent with elvitegravir, would perform equally well. As such, the use of other compounds that are known to modulate SRC-1 would be obvious to use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rao, et al (PGPub 2013/0259925.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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