DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 5/20/2026 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
4. 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 1-4 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?” and Clinical Policy: Goserelin Acetate (Zoladex).
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).
The reference discloses drugs such as ibuprofen have been used for treatment of endometriosis (para 0008). Hayashi et al. does not disclose fenoprofen. Clinical Policy: Goserelin Acetate (Zoladex) disclose ibuprofen and fenoprofen have been used for therapy for endometriosis (see table on page 5 of 6).
“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.
5. 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 Obrowski et al. “Endometriosis facts, fallacies, misdiagnosis and current treatments: are doctors missing something, are they undereducated or simply ignoring widespread disease?” and Clinical Policy: Goserelin Acetate (Zoladex) as applied to claims 1-4 above, and further 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.
6. Claims 1, 3-4 and 21 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?” and Taylor et al. (US 20200321077).
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).
The reference discloses drugs such as ibuprofen have been used for treatment of endometriosis (para 0008). Hayashi et al. does not disclose simvastatin.
Taylor et al. (US 20200321077) (hereinafter Taylor et al. disclose methods of treating endometriosis in females that comprises administering drugs such as simvastatin (claims 1 and 21).
“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.
7. 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 Obrowski et al. “Endometriosis facts, fallacies, misdiagnosis and current treatments: are doctors missing something, are they undereducated or simply ignoring widespread disease?” and Taylor et al. (US 20200321077) as applied to claims 1, 3-4 above, and further 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.
CONCLUSION
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
RESPONSE TO ARGUMENTS
9. Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
CORRESPONDENCE
10. 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
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