DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I in the reply filed on 3/16/2026 is acknowledged. Applicants further election of fenoprofen, simvastatin, intravaginal administration and ½ endometriosis is acknowledged.
Claims 6-7 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/16/2026.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 8/10/2023 is acknowledged.
Claim Rejections- 35 USC § 112
3. 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 1-5 and 8-13 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.
Claims 1-2, 5, recite a table. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). In the instant case, there is a more practical way to define the invention without the use of a table. The dependent claims do not cure the deficiency of the recitation of the table of claim 1.
Claim Rejections- 35 USC § 102
4. 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.
Claims 1-2 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayashi et al. (US 2020/0315996).
Hayashi et al. (US 2020/0315996) disclose a method of modulating gene expression levels in an individual identified as having endometrioses comprising administering a drug from Table 2 (e.g., niclosamide) in an amount to modulate gene expression levels ( abstract, paras 0027, 0094 and claim 1).
Claim Rejections- 35 USC § 103
5. 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al. (US 2020/0315996) in view of Obrowski et al. “Endometriosis facts, fallacies, misdiagnosis and current treatments: are doctors missing something, are they undereducated or simply ignoring widespread disease?”.
Hayashi et al. has been discussed supra. The reference discloses drugs such as ibuprofen have been used for treatment of endometriosis (para 0008). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…. [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960).
Hayashi et al. does not disclose administering to an individual that has stage 1/2 endometriosis.
Obrowski et al. “Endometriosis facts, fallacies, misdiagnosis and current treatments: are doctors missing something, are they undereducated or simply ignoring widespread disease?” (hereinafter Obrowski et al.) disclose the severity of endometriosis is disclosed at minimum stage 1 and mild stage 2 (page 150 and 154). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer the composition of Hayashi et al. for treatment of stage 1 or 2 endometriosis. One would have been motivated to do so because it is the early stage of endometriosis and it would be obvious to one of ordinary skill in the art to treat early before the severity of endometriosis becomes more severe.
6. Claims 1 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al. (US 2020/0315996) in view of Gotteland et al. (US Patent 10441534). Hayashi et al. disclose administration methods that include vaginal (para 0186). Hayashi et al. does not disclose intranational ring or vaginal suppository. Gotteland et al. (US Patent 10441534) (hereinafter Gotteland et al.) disclose formulations for treatment of gynecological diseases such as endometriosis that are suitable for vaginal administration and include vaginal suppositories and rings (col. 7, lines 44-55 and col. 8, lines 25-35). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer the composition of Hayashi et al. in the form of a vaginal ring or suppository. One would have been motivated to do so because these are known methods of administration for the release of drugs for treatment of gynecological diseases such as endometriosis. The mode of administration selected will depend on the acuteness and severity of the condition being treated, and the dosage required. Hayashi et al. discloses that any mode of administration that produces desired therapeutic effect without unacceptable adverse effects is relevant in practicing the invention.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615