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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2025 was filed after the mailing date of the non-final on 09/17/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the claims
Claims 13-39 are pending in this application. Claims 1-12 have been cancelled by applicant.
Allowable Subject Matter
Claim 16 and 30-31 are allowed.
Claim Objections
Claims 24-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
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.
Claims 13-15, 17, 19-23, and 32-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kuenzer et al. (US 7,109,360 B1 – cited in IDS – previously cited).
Regarding claims 13-15, 20-23, and 32-39, Kuenzer discloses the compounds below (col. 3-4), which read on the instantly claimed compounds of Formula I-A2.1 and I-A4.1 when: all dashed lines are a single bond except the one between C8 and C14; R1, 2, 4 (corresponding to instant RA) can be H, alkyl, hydroxy, etc.; R9, 13 (corresponding to instant R9 and R13, respectively) can be H, Me, Et, etc.; R7-8, 11, 14-16 can be H; R17 can be chained or branched alkyl, H, or -OH.
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(Kuenzer Formula I)
Kuenzer specifically discloses the preferred embodiments
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and
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having the structures below (col. 12, lines 28 and 51). While the instant compounds require H at the position corresponding to Kuenzer’s R7, Kuenzer teaches their R7 group may also be H (instead of Ph, as shown in the structures below). Thus, Kuenzer discloses a relatively broad genus of compounds which encompass the instant subgenus.
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Therefore, regarding claims 13-15, 20-23, and 32-39, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Kuenzer’s disclosed formula and preferred embodiments; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Kuenzer. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Further regarding claims 14-15 and 32, the compound 100 below, for example, is particularly obvious in view of Kuenzer’s disclosure.
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Further regarding claims 14-15, 21-23, and 32-39, while Kuenzer’s preferred embodiments above do not show a methyl in the group corresponding to instant R9, or alkyl for instant RAX (as in claims 21-23), Kuenzer teaches that in Formula I above, R9 can be Me. Furthermore, Applicant is advised that H vs. Me (C1 alkyl) is an obvious modification in the absence of superior, unexpected results. Note In re Wood 199 USPQ 137; In re Lohr 187 USPQ 548 and In re Bowers 149 USPQ 573. Note also In re Fauque 121 USPQ 425 in which differences were 2H’s vs 2 methyl groups. Also see MPEP 2144.09.
Further regarding claims 20 and 36-39, Applicant is advised, with respect to stereoisomerism, it is noted that in Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007), the court also relied on the settled principle that in chemical cases, structural similarity can provide the necessary reason to modify prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an explicitly stated prior art-based motivation, explaining that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular utility. The Federal Circuit cautioned that requiring such a clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to the Supreme Court' s decision in KSR. The court stated: [r]equiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM test that was criticized in KSR. Id. at 1301 (See MPEP 2143).
Regarding claim 17, Kuenzer discloses their compounds for the treatment of neurodegenerative diseases, such as Alzheimer’s (col. 17, lines 9-10). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Kuenzer’s compounds for the treatment of neurodegenerative diseases. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kuenzer’s disclosure of their compounds of Formula I and their teachings that their compounds can be used for the treatment and prophylaxis for neurodegenerative diseases, such as Alzheimer’s.
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Regarding claim 19, Kuenzer discloses pharmaceutical compositions for oral and parenteral administration comprising their compounds comprising commonly used adjuvants and diluents (col. 17, lines 43-55; and col. 18, lines 5-18).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kuenzer et al. (US 7,109,360 B1 – cited in IDS) (“Kuenzer”); as applied to claims 13-15, 17, 19-23, and 32-39; in view of Christoforou et al. (Mol. Med., 20, 2014, 427-434) (“Christoforou”).
The teachings of Kuenzer et al. are disclosed in the 103 section above and incorporated herein.
Kuenzer discloses their 16α- and 16β-hydroxy-estra-1,3,5(10), 8(14)-tetraene preferred embodiments, and teaches that 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) than to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
While Kuenzer does not specifically teach their compounds for the treatment of cancers, such as prostate cancer or breast cancer; the teachings of Christoforou are relied upon for these disclosures.
Christoforou teaches ERβ splice variants have been associated with prostate cancer initiation and progression, and discloses that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer (abstract, last 3 lines).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Kuenzer’s 16α-hydroxyestrone compounds for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kuenzer’s disclosure of their 16α-hydroxyestrone compounds of Formula I, which are known to bind to the human estrogen receptor β (ERβ); and Christoforou’s teachings that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Double Patenting
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.
Claims 13-15, 17-23, and 32-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,065,465 B2 (US ‘465); in view of Kuenzer et al. (US 7,109,360 B1 – cited in IDS); and Christoforou et al. (Mol. Med., 20, 2014, 427-434).
Regarding instant claim 13-15, 17-23, and 32-39, US ‘465 claims their 16α-hydroxyestrone compounds of Formula X-A1 below; wherein RA can be -ORAX, wherein RAX (corresponding to instant RAX) can be H or alkyl; R9, 13 (corresponding to instant R9, 13) can be alkyl; and RD (corresponding to instant RD) can be H, alkyl, etc.
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While the instant compounds don’t have the double bond across carbons 11-12, as in the structure above, Applicant is reminded that Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
While US ‘465 does not speak to the treatment of prostatic cancer (claims 17-18), the teachings of Kuenzer and Christoforou et al. are relied upon for these disclosures.
Kuenzer discloses 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
Christoforou teaches ERβ splice variants have been associated with prostate cancer initiation and progression, and discloses that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer (abstract, last 3 lines).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ‘465’s 16α-hydroxyestrone compounds for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘465’s disclosure of their 16α-hydroxyestrone compounds of Formula I; Kuenzer’s teachings that 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα); and Christoforou’s teachings that ERβ is promising as an anticancer therapy in the prevention of prostate cancer.
Claims 13-15, 17-23, and 32-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,512,107 B2 (US ‘107); in view of Kuenzer et al. (US 7,109,360 B1 – cited in IDS); and Christoforou et al. (Mol. Med., 20, 2014, 427-434).
Regarding instant claim 13-15, 17-23, and 32-39, US ‘107 claims the method of making the tetracyclic 16α-hydroxyestrone compounds of Formula (ii) below, wherein RA can be -ORAX, wherein RAX (corresponding to instant RAX) can be H or alkyl; R9, 13 (corresponding to instant R9, 13) can be alkyl; and RD (corresponding to instant RD) can be H, alkyl, etc. (US ‘107 claim 2). These compounds read on the compounds of the instant application when the dashed line represents a single bond.
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While US ‘107 does not claim the treatment of prostatic cancer (claims 17-18), the teachings of Kuenzer and Christoforou et al. are relied upon for these disclosures.
Kuenzer discloses 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
Christoforou teaches ERβ splice variants have been associated with prostate cancer initiation and progression, and discloses that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer (abstract, last 3 lines).
Therefore, regarding claims 17-18, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ‘107’s 16α-hydroxyestrone compounds for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘107’s disclosure of their 16α-hydroxyestrone compounds of Formula I; Kuenzer’s teachings that 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα); and Christoforou’s teachings that ERβ is promising as an anticancer therapy in the prevention of prostate cancer.
Claims 13-15, 17-23, and 32-39 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/556,033 (Copending ‘033); in view of Kuenzer et al. (US 7,109,360 B1 – cited in IDS); and Christoforou et al. (Mol. Med., 20, 2014, 427-434).
Regarding instant claim 13-15, 17-23, and 32-39, Copending ‘033 claims a method of making a steroid-like compounds with a skeleton having the formulas below as well as the steroid-like compound:
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Wherein rings A, B, C, or D can be saturated, partially unsaturated, or unsaturated (aromatic) (Copending ‘033 claims 2 and 13).
Regarding instant claim 19, Copending ‘033 speaks to a pharmaceutical composition comprising their compounds (Copending ‘033 claim 14).
While Copending ‘033 does not claim the treatment prostatic cancer (claims 17-18), the teachings of Kuenzer and Christoforou are relied upon for these disclosures.
Kuenzer discloses 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
Christoforou teaches ERβ splice variants have been associated with prostate cancer initiation and progression, and discloses that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer (abstract, last 3 lines).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Copending ‘033’s 16α-hydroxyestrone compounds for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘033’s disclosure of their 16α-hydroxyestrone compounds of Formula I; Kuenzer’s teachings that 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα); and Christoforou’s teachings that ERβ is promising as an anticancer therapy in the prevention of prostate cancer.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13-15, 17-23, and 32-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18 of copending Application No. 18/551,249 (Copending ‘249); in view of Kuenzer et al. (US 7,109,360 B1 – cited in IDS); and Christoforou et al. (Mol. Med., 20, 2014, 427-434).
Regarding instant claim 13-15, 17-23, and 32-39, Copending ‘249 claims a method of making a steroid-like compound with a skeleton having the formulas below as well as the steroid-like compound (Copending ‘249 claims 11 and 13).
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While Copending ‘249 does not speak to the treatment of ovarian or prostatic cancer (claims 17-18), the teachings of Kuenzer and Christoforou et al. are relied upon for these disclosures.
Kuenzer discloses 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
Christoforou teaches ERβ splice variants have been associated with prostate cancer initiation and progression, and discloses that ERβ is promising as an anticancer therapy and in the prevention of prostate cancer (abstract, last 3 lines).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Copending ‘249’s 16α-hydroxyestrone compounds for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘249’s disclosure of their 16α-hydroxyestrone compounds of Formula I; Kuenzer’s teachings that 16α-hydroxyestrone binds 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα); and Christoforou’s teachings that ERβ is promising as an anticancer therapy in the prevention of prostate cancer.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments and new claims are acknowledged. No new matter has been introduced.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Applicant argues: (i) the mere fact that claims recite a sub-genus encompassed by a genus of the art is not by itself sufficient to establish a prima facie case of obviousness; (ii) a person of ordinary skill would need to make many specific choices to narrow Kuenzer’s generic formula to arrive at the instant claims. Applicant asserts there’s no teaching that would lead to the claimed compounds. Applicant states that after careful consideration of the disclosure they never found a compound wherein R9 and R13 are non-hydrogen substituents.
Regarding Applicant’s arguments about the rejections of claims 25-29 with Kuenzer, Applicant is advised that claims 25-29 were not rejected over Kuenzer in the non-final action mailed 09/17/2025, therefore, these arguments were not considered.
In response to Applicant’s arguments; Kuenzer discloses the compounds below (col. 3-4) as estrogen receptor inhibitors (abstract), which is one of the uses of the instant compounds (see [008] of the instant specification). Kuenzer’s compounds render the instantly claimed compounds of Formula I-A2.1 and I-A4.1 obvious when: all dashed lines are a single bond except the one between C8 and C14; R1, 2, 4 (corresponding to instant RA) can be H, alkyl, hydroxy, etc.; R9, 13 (corresponding to instant R9 and R13, respectively) can be H, Me, Et, etc.; R7-8, 11, 14-16 can be H; R17 can be chained or branched alkyl, H, or -OH.
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(Kuenzer Formula I)
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having the structures below (col. 12, lines 28 and 51). While the instant compounds require H at the position corresponding to Kuenzer’s R7, Kuenzer teaches their R7 group may also be H (instead of Ph, as shown in the structures below). Therefore, one of ordinary skill would not need to make many selections, as purported by Applicant, to arrive at the instant invention. Thus, Kuenzer discloses a relatively broad genus of compounds which encompass the instant subgenus.
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Kuenzer’s disclosed formula and preferred embodiments. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Kuenzer. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is advised that “[A] prior art reference must be considered in its entirety, i.e., as a whole” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983) (see MPEP 2141.02 VI). Thus, while the rejections listed above present a modified interpretation of the teachings of the previously cited prior solely for the purpose of clarity, the claims remain rejected over the prior art of record.
Regarding Applicant’s arguments that none of Kuenzer’s compounds show R9 and R13 are non-hydrogen substituents; Applicant is reminded that H vs. Me (C1 alkyl) is an obvious modification in the absence of superior, unexpected results. Therefore, since Kuenzer discloses preferred embodiments wherein their R13 group is methyl, and since Kuenzer teaches that their R9 group can be methyl; the instant claims are obvious.
Double Patenting
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Regarding provisional obviousness-type non-statutory double patenting (ODP) rejections (over copending Applications of record); Applicant is advised that the provisional ODP rejections are not the only rejections that remain, therefore, the provisional ODP rejections disclosed in this final office action stand.
Upon further consideration, the ODP rejection over copending Application No. 18/560,179 (Copending ‘179), has been withdrawn.
Regarding the ODP rejection over US Patent No. US ‘465 and US ‘107; Applicant fails to specifically outline how the rejections are improper. Claims stand rejected under the ODP rejections of record.
Conclusion
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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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