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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 25th, 2026 has been entered.
Status of the claims
Claims 14-20, 24-32, and 40-43 are pending in this application. Claims 1-13, 21-23, and 33-39 have been cancelled by applicant.
Allowable Subject Matter
Claim 16 and 30-31 are allowed.
Claims 27-29 are free of the prior art, but stand objected herein.
Claims 24-26 are free of the prior art, but stand rejected and objected over formal matters.
Claim Objections
Claims 24-29 are objected to because of the following informalities:
Claims 24-26 are objected to because claim 24 states n can be 0-4, however, there are only three possible positions where substitution of RA can occur, therefore n cannot be greater than 3. Furthermore, RA is defined as H, alkyl, etc. Therefore, there have to necessarily be 3 RA groups on the cyclohexenone – n should be defined as being 3 only (see 112(b)).
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Claims 27-29 are objected because claim 27 states the following limitation:
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Since the bond between C1 and C2 is always a double bond, to avoid redundance and for clarity and brevity, Applicant is required to amend the structure III-D3 to reflect a solid double bond between C1 and C2.
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 24-26 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 24-26 are indefinite because claim 24 states n can be 0-4, however, there are only three possible positions where substitution of RA can occur, therefore n cannot be greater than 3. Furthermore, regarding claims 24-25, RA is defined as H, alkyl, etc., therefore, there have to necessarily be 3 RA groups on the cyclohexenone – n should be defined as being 3 only – and it is impossible to have 0 substituents on the cyclohexenone. Thus, it is unclear what Applicant intended by these limitations.
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Claim 26 is rejected for depending upon the limitations of claim 25.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15 and 17-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 fails to further limit claim 14, from which it depends, because the cyclohexenone compounds are not listed among the compounds in claim 14. Thus, claim 15 is broader than claim 14 in that regard.
Claims 17-20 are rejected for depending upon the limitations of claim 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 14-15, 17, 19-20, 32, 40 and 42-43 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 14-15, 19-20, 32, and 42-43, Kuenzer discloses the compounds below (col. 3-4) as selective human estrogen receptor β (ERβ) inhibitors (see col. 3), which read on the instantly claimed compounds 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 below (col. 9, lines 37 and 59). While Kuenzer’s 3,16-esteradiols compounds have H in the position corresponding to R9, Kuenzer specifically discloses this position can be Me. Thus, Kuenzer discloses a relatively broad genus of compounds which encompasses the instant subgenus.
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Therefore, regarding claims 14-15, 19-20, 32, and 42-43, one having ordinary skill in the art would have found the claimed compounds prima facie obvious (particularly compounds 100 and 101, shown below) 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 selective human estrogen receptor β (ERβ) inhibitors 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.
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Furthermore, Applicant is advised that H vs. Me (C1 alkyl) is an obvious modification in the absence of superior, unexpected results. Note MPEP 2144.09.
Further regarding claims 14-15, 19-20, 32, and 42-43, 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 claims 17 and 40, 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)).
Further regarding claims 19, 20, and 42-43, 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).
Claims 18 and 41 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) (“Kuenzer”); as applied to claims 14-15, 17, 19-20, 32, 40 and 42-43; in view of Christoforou et al. (Mol. Med., 20, 2014, 427-434 – previously cited) (“Christoforou”).
The teachings of Kuenzer are disclosed above and incorporated herein.
Kuenzer discloses their 3,16-esteradiols 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 14-15, 17, 19-20, 32, 40 and 42-43 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) (“Kuenzer”).
Regarding instant claim 14-15, 19-20, 32, and 42-43, 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 US ‘465’s compounds have a double bond across C11-C12, where the instant compounds have a single bond; the teachings of Kuenzer are relied upon to leverage these differences.
Kuenzer discloses the related compounds below (col. 3-4), wherein all dashed lines are a single or double bond. Kuenzer specifically teaches the bond across C11 and C12 may be a single or double bond. Kuenzer discloses their 3,16-esteradiols and teaches that 16α-hydroxyestrones bind 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
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(Kuenzer Formula I)
Therefore, regarding instant claim 14-15, 19-20, 32, and 42-43, one having ordinary skill in the art would have found the claimed compounds prima facie obvious (particularly instant compounds 100 and 101) since they are generically embraced by US ‘465’s compounds in view of Kuenzer’s disclosed 16α-hydroxyestrones, which can have a double or single bond across C11-C12 and retain display the same activity. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘465 in view of 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.
Regarding claims 17 and 40, 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 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.
Further regarding claims 19-20, and 42-43, 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).
Claims 18 and 41 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) (“Kuenzer”); as applied to claims 14-15, 17, 19-20, 32, 40 and 42-43; further in view of Christoforou et al. (Mol. Med., 20, 2014, 427-434) (“Christoforou”).
The teachings of US ‘465 and Kuenzer are disclosed above and incorporated herein.
While US ‘465 in view of Kuenzer does not speak to the treatment of prostatic cancer (claims 17-18), the teachings of Christoforou are relied upon for these disclosures.
Kuenzer discloses their 3,16-esteradiols and teaches that 16α-hydroxyestrones bind 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 14-15, 17, 19-20, 32, 40 and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, and 7 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) (“Kuenzer”).
Regarding instant claim 14-15, 19-20, 32, and 42-43, US ‘107 claims a 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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(X-A1)
While US ‘107’s preferred embodiments (like compound X-A1) have a double bond across C11-C12, where the instant compounds have a single bond; the teachings of Kuenzer are relied upon to leverage these differences.
Kuenzer discloses the related compounds below (col. 3-4), wherein all dashed lines are a single or double bond. Kuenzer specifically teaches the bond across C11 and C12 may be a single or double bond. Kuenzer discloses their 3,16-esteradiols and teaches that 16α-hydroxyestrones bind 3 times better to the human estrogen receptor β (ERβ) that to the human estrogen receptor α (ERα) (col. 3, lines 1-3).
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(Kuenzer Formula I)
Therefore, regarding instant claim 14-15, 19-20, 32, and 42-43, one having ordinary skill in the art would have found the claimed compounds prima facie obvious (particularly instant compounds 100 and 101) since they are generically embraced by US ‘107’s compounds in view of Kuenzer’s disclosed 16α-hydroxyestrones, which can have a double or single bond across C11-C12 and retain display the same activity. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘107 in view of 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.
Regarding claims 17 and 40, 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 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.
Further regarding claims 19, 20, and 42-43, 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).
Claims 18 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, and 7 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) (“Kuenzer”); as applied to claims 14-15, 17, 19-20, 32, 40 and 42-43; further in view of Christoforou et al. (Mol. Med., 20, 2014, 427-434) (“Christoforou”).
The teachings of US ‘107 and Kuenzer are disclosed above and incorporated herein.
While US ‘107 in view of Kuenzer does not speak to the treatment of prostatic cancer (claims 17-18), the teachings of Christoforou are relied upon for these disclosures.
Kuenzer discloses their 3,16-esteradiols and teaches that 16α-hydroxyestrones bind 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 ‘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.
Response to Arguments
Claims
Claim amendments and new claims are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 03/25/2026 have been fully considered but they are not persuasive.
Applicant is advised MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
Applicant argues that because Kuenzer fails to teach or suggest instant compounds with non-hydrogen substitution on C9 and C13. Applicant argues the Office cites cases that are over 40 years old to support rejections. Applicant argues the Office has failed establish a prima facie case of obviousness and to provide a reason to modify a lead compound in Kuenzer to arrive at the instant invention. Applicant argues that instant compounds 100-101 were demonstrated to be potent and highly selective agonists of ERβ, citing examples 6-7 of the spec. (page 37, [0172], and Figure 1) in which compounds are compared to 17β-estradiol as control. Applicant states the following:
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In response to applicant's argument based upon the age of the references, contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Kuenzer discloses the compounds below (col. 3-4), as selective human estrogen receptor β (ERβ) inhibitors (see col. 3), which read on the instantly claimed compounds 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 below (col. 9, lines 37 and 59). While Kuenzer’s compounds have H in the position corresponding to R9, Kuenzer specifically discloses this position can be Me. Thus, Kuenzer discloses a relatively broad genus of compounds which encompasses the instant subgenus.
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious (particularly compounds 100 and 101, shown below) 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 selective human estrogen receptor β (ERβ) inhibitors 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.
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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.
In response to Applicant’s arguments that the instant compounds 100-101 were demonstrated to be potent and highly selective agonists of ERβ, citing examples 6-7 of the spec. (page 37, [0172], and Figure 1) in which compounds are compared to 17β-estradiol as control – These results are not sufficient to overcome the obviousness rejections of record. The structure of 17β-estradiol (shown below) has a hydroxy at the 17-position, not the 16-position, like Kuenzer’s compounds or the instant compounds 100-101. Thus, Applicant’s arguments are not commensurate with the scope of the claims.
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Kuenzer specifically teaches the following (col. 3, para. 1):
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256
625
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Thus, the results presented in the specification are not unexpected, since Kuenzer suggests a special property of their 16-hydroxy-substituted steroids, and discloses their 3,16-esteradiols. In order for Applicant’s arguments to be persuasive, Applicant needs to demonstrate superior activity/ potency of the instant compounds with non-hydrogen substitution at C9, when compared to Kuenzer’s 3,16-esteradiols shown herein.
Double Patenting
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Upon further consideration, in view of claim amendments, the provisional non-statutory double patenting (NSDP) rejections over copending Application No. 18/556,033 (Copending ‘033) and 18/551,249 (Copending ‘249) have been withdrawn.
Regarding the NSDP rejection over US Patent No. US ‘465 and US ‘107; Applicant states they disagree with reasoning for the reasons outlined above. Applicant is directed to the response to those arguments above.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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