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 .
Change of Examiner
Applicant is advised that the Examiner assigned to the prosecution of the instant application has changed.
Response to Amendment
The Applicant's amendments and/or arguments filed 01/08/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 10 April 2025, it is noted that claims 11-21 have been amended or newly added. No new matter has been added.
Terminal Disclaimer
The terminal disclaimer filed on 01/08/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 9750716 has been reviewed and is accepted. The terminal disclaimer has been recorded.
35 U.S.C. 101
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 10-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature. These claims are to a composition that comprises a catechin component containing epigallocatechin and/or epigallocatechin gallate (in water) that are found in naturally occurring tea catechin extract. Musial is cited as a supporting evidence that tea extract contains gallocatechin, epicatechin, epigallocatechin, epicatechin gallate and/or epigallocatechin gallate. (Musial et al., “Beneficial Properties of Green Tea Catechins”, Int J Mol Sci, 2020, Mar 4;21(5):1744).
This judicial exception is not integrated into a practical application because the claims do not recite anything more than a catechin component comprised of gallocatechin, epicatechin, epigallocatechin, epicatechin gallate and/or epigallocatechin gallate. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed composition comprising the catechin component(s) is/are found in nature.
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 14, 16 and 20 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 14 and 16 recite “further comprises epigallocatechin” and “further comprises epigallocatechin gallate (EGCg),” respectively. The term “catechin” refers to a class of polyphenolic phytochemicals that includes species/derivatives such as epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECG), and/or epigallocatechin gallate (EGCg). The specification states that the catechin component “constitutes 85–95% (by weight) of the total drug substance and includes more than 55% of epigallocatechin gallate (EGCg), other catechin derivatives such as epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECG)….” In view of the specification and the state of the art, EGC and EGCg are species within the catechin class. However, the use of “further comprises” renders the claims ambiguous as to whether EGC/EGCg are (i) additional components in addition to the recited catechin component in claim 10, or (ii) a species limitation of the recited catechin in claim 10. Clarification is required.
For the purpose of examination, epigallocatechin and epigallocatechin gallate are intended as a species of the catechin component.
Claim 20 recites “further comprises a combination of a SERM and an estrogen hormone.” As with the analysis for claims 14 and 16, the use of “further comprises” renders the claim ambiguous as to whether “a SERM” is (i) an additional SERM in addition to the SERM recited in claim 17, or (ii) applicants are intended to a further limit the composition of claim 10 to include a combination of a SERM and an estrogen hormone. Clarification is required.
For purposes of examination, claim 20 is construed as further limiting the subject matter of claim 10 to require a combination of a SERM and an estrogen hormone.
Claim Rejections - 35 USC § 102
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 10-16 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cheng et al. (US 5795911, hereinafter “Cheng’911”).
Cheng’911 teaches or suggests a composition comprising tea catechin component containing epigallocatechin, epicatechin gallate, epigallocatechin gallate and/or gallocatechin gallate wherein said composition is prepared in ointment, cream jelly, emulsion and suppository (abstract; column 2, lines 1-40). The reference also teaches that for ointment the content of tea chatechin should be between 5-20% by wegith, preferably between 12-18% by weight, more preferably 15% by weight (column 2, lines 43-58 and test Example 1, claims1-3, 5, 6-7); and wherein the composition is applied directly to the infected area of the external genital organs, vagina or cervix (column 2, lines 49-57; claims 11-15) for the treatment of HPV-infected condyloma acuminata.
With respect to “for treating a female sexual disorder (FSD)” and “for topical application to an individual’s vulvovaginal area….” in claim 10, such statements in the preamble reciting the purpose or intended of the claimed invention is not automatically limiting or entitled to patentable weight: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference. In the instant application, when reading the preamble in the context of the entire claim, such recitation is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. V. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. See also MPEP § 2112 - MPEP § 2112.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"
Claims 10-16 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cheng et al. (US 5968973, hereinafter “Cheng’973”).
Cheng’973 teaches or suggests a composition comprising tea catechin component containing epigallocatechin, epicatechin gallate, epigallocatechin gallate and/or gallocatechin gallate wherein said composition is prepared in ointment, cream jelly, emulsion and suppository (abstract; column 2, lines 1-65). The reference also teaches that for ointment the content of tea chatechin should be between 5-20% by wegith, preferably between 12-18% by weight, more preferably 15% by weight (column 2, line 65 through column 3, line 4 and test Example 1, claims 1-10); and wherein the composition is applied directly to the infected area of the external genital organs, vagina or cervix (column 3, lines 5-13; claims 11 and 15-19).
With respect to claim 10, the preamble phrases “for treating a female sexual disorder (FSD)” and “for topical application to an individual’s vulvovaginal area” merely recite intended use and therefore are not limiting for purposes of claim construction, as discussed above. Accordingly, Cheng ’973 anticipates claim 10.
Claims 10, 14, 15, 16-17, 19 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Morre et al. (US 2003/0072821 A1, hereinafter “Morre”) as evidenced by Lim et al. (US20150283132 A1, hereinafter “Lim”) and/or Keown et al. (EP 2390260 A2, hereinafter “Keown”).
Morre teaches or suggests a composition comprising tea catechin component containing epigallocatechin gallate (EGCg), epicatechin (EC, epicatechin gallate (ECG) and/or epigallocatechin (EGC) (abstract; para. [0052]), vanilloids, and at least one other anticancer drug such as tamoxifen and ethinyl estradiol (para. [0076]-[0077]; claims 14-15), wherein said composition is prepared in liquid form (e.g., solutions, syrups or suspension) including aqueous solution (para. [0103], [108], [0113], [0124], [0128]).
With respect to claim 10, the preamble phrases “for treating a female sexual disorder (FSD)” and “for topical application to an individual’s vulvovaginal area” merely recite intended use and therefore are not limiting for purposes of claim construction, as discussed above. Accordingly, Cheng ’973 anticipates claim 10.
With respect to claims 17, 19 and 20,
Although Morre does not expressly identify tamoxifen as a selective estrogen receptor modulator (SERM), Lim is cited as evidentiary support to show that tamoxifen is well known selective estrogen receptor modulators (see para. [0217]). Accordingly, Morre anticipates claim 17.
Although Morre does not expressly identify ethinyl estradiol as estrogen, Keown is cited as evidentiary support to show that ethinyl estradiol is well known synthetic estrogen/estrogen hormone (para. [0003]). Furthermore, the specification discloses that “various forms of esterogens are currently available to treat women…Sources of estrogen maybe synthetic, animal source, or plant” (para. [0016]). Accordingly, Morre anticipates claim 19.
Although Morre does not expressly spell out the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference would “at once envisage” the claimed combination from the limited species disclosed in claim 15. Accordingly, Morre anticipates claims 17, 19 and 20.
Even assuming arguendo, Morre does not anticipate claims 17, 19 and 20, selecting tamoxifen and ethinyl estradiol from the finite number of species disclosed in claim 15 would have obvious under the meaning of 103 rejection as below.
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 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Morre et al. (US 2003/0072821 A1, hereinafter “Morre”) as evidenced by Lim et al. (US20150283132 A1, hereinafter “Lim”) and/or Keown et al. (EP 2390260 A2, hereinafter “Keown”), as applied to claim 10, 14-16 and 21 above.
As discussed above, Morre (claim 14) expressly provides a finite number of identified, predictable options for achieving the claimed objective. Where the prior art discloses a limited number of known alternatives, selection of one of those alternatives amounts to routine optimization within the level of one of ordinary skill in the art (see MPEP 2143 – Obvious to try when a finite number of identified, predictable solutions are found in the prior art). A person of ordinary skill in the art would have been motivated to pursue these known options with a reasonable expectation of success particular when each of the alternatives is taught as suitable for the same purposes (see MPEP 2143 and MPEP 2144.06). The claimed selection, therefore, represents no more than the predictable use of prior art elements according to their established functions, and does not confer patentable distinction (see MPEP 2143; KSR Int’l Co v Teleflex Inc).
Claims 10-14 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Empie et al. (US 6261565 B1, hereinafter “Empie”) in view of Labrie (US 20020198179 A1, hereinafter “Labrie”).
Empie teaches or suggests a phytochemical extract from comprising catechins and/or phenolic acids comprised of epigallocatechin, catechin, epicatechin and gallocatechin in combination with isoflavones, lignans, saponins and/or phenolic acids where the composition can be delivered as topical application in a cream or lotion (entire documents; column 3, lines 51-55; claims 1-2, 12 and 21; and the catechins comprises at least 10% by weight of the composition (claim 3) for the treatment of vaginal dryness (claim 53).
Empie differs from the claimed invention in that it does not disclose combining the phytochemical composition with a selective estrogen receptor modulator (SERM), such as ospemifene, and an estrogen. However, Labrie teaches or suggests the use of a composition comprising a SERM and an estrogen for treating vaginal dryness (see, e.g., abstract; ¶¶ [0002]–[0004]; claims 1–2, 7, 9, 19–20). Labrie identifies suitable SERMs including tamoxifen, droloxifene, toremifene, FC‑1271 (also known as ospemifene), GW5638, and raloxifene (see, e.g., claims 7 and 9).
It would have been obvious to a person of ordinary skill in the art to modify Empie’s vaginal‑dryness composition by incorporating the SERM‑and‑estrogen combination taught by Labrie, with a reasonable expectation of success, because both references teach compositions useful for treating the same condition (vaginal dryness). Combining known components each taught for the same purpose to yield a composition for that same purpose represents a predictable variation. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (predictable use of prior art elements according to their established functions) and In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“[I]t 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 which is to be used for the very same purpose.”).
Regarding claims 11-13, as discussed above, Empie teaches or suggests that the catechins comprises at least 10% by weight of the composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing “at a concentration of between about 1% and 20% weight per weight of the total composition”, “at a concentration of between about 2.5% and 15% weight per weight of the total composition”, “at a concentration of between about 4% and 12% weight per weight of the total composition” respectively. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Accordingly, the combination of Empie and Labrie renders claims 10–14 and 17–21 obvious under 35 U.S.C. § 103. If any dependent claim recites additional features (e.g., specific catechin percentages, topical dosage forms), those features are taught or suggested by Empie and/or Labrie as cited above and would have been selected as a matter of routine optimization with predictable results. This reflects the principle that optimizing a result‑effective variable is ordinarily obvious absent evidence of unexpected results (see MPEP 2144.05(II); In re Aller, 220 F.2d 454, 456 (CCPA 1955); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Claims 1–4 are rejected under 35 U.S.C. § 103 as being unpatentable over Cheng et al. (US 5,968,973; hereinafter “Cheng ’973”) in view of Empie et al. (US 6,261,565 B1; hereinafter “Empie”), and further in view of Tamarkin et al. (US 2008/0069779; hereinafter “Tamarkin”), as evidenced by MacBride et al., “Volvovaginal Atrophy,” Mayo Clin Proc. 2010;85(1):87–94 (“MacBride”).
The teachings of Cheng ’973 are discussed above.
Empie teaches or suggests phytochemical extracts comprising catechins and/or phenolic acids, including epigallocatechin, catechin, epicatechin, and gallocatechin, in combination with isoflavones, lignans, saponins, phenolic acids, and/or vitamins. Empie further teaches topical delivery in a cream or lotion (see, e.g., the entire document; col. 3, lines 51–55; claims 1–2, 12, 21, and 28), wherein the catechins comprise at least 10% by weight of the composition (claim 3), and use of such compositions for treating vaginal dryness (claim 53).
Cheng ’973 differs from the claimed invention in that it does not disclose using the composition for the treatment of female sexual dysfunction (FSD), such as vulvovaginal atrophy (VVA) or dyspareunia, as recited in claim 1. However, Empie discloses the use of catechin‑containing compositions for treating vaginal dryness, and Tamarkin teaches a composition comprising vitamins and flavonoids (e.g., catechin, gallocatechin, epicatechin, and epigallocatechin) for treating disorders including vaginal dryness and dyspareunia (see, e.g., Tamarkin paras. [0100]–[0101], [01920], [0439], [0520]; claims 8, 33, 55, and 67).
MacBride is cited to evidence that vaginal dryness and dyspareunia are among the most common symptoms of VVA (see abstract). The present specification likewise states that common symptoms of VVA include vulvar pain (vulvodynia) and dryness (para. [0011]), and that resolution of pain and dryness helps improve VVA.
Accordingly, one of ordinary skill in the art would have been motivated to apply the Cheng ’973 composition to treat patients with VVA presenting with vaginal dryness and/or dyspareunia, with a reasonable expectation of success, in view of Empie and Tamarkin’s teachings that catechin‑containing topical compositions are useful for treating vaginal dryness and dyspareunia. Therefore, claims 1–9 are unpatentable under 35 U.S.C. § 103 over Cheng ’973 in view of Empie and further in view of Tamarkin, as evidenced by MacBride.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 5968973, hereinafter “Cheng’973”) in view of Empie et al. (US 6,261,565 B1; hereinafter “Empie”), and further in view of Tamarkin et al. (US 2008/0069779; hereinafter “Tamarkin”) and Labrie (US 2009/0054383 A1, hereinafter “Labrie’383”, as evidenced by MacBride et al., “Volvovaginal Atrophy,” Mayo Clin Proc. 2010;85(1):87–94 (“MacBride”).
The modified teaching of Cheng’973 has been discussed above.
The modified teaching of Cheng’973 differs from the claimed invention in i) the application of said composition to the targeted area “a substantially daily basis” (claim 5), ii) about 2-3 times per week” (claim 6), iii) “a treatment period of about 4-12 weeks” (claim 7), iv) “a thickness of vaginal mucosa remains substantially unchanged during the treatment” (claim 8) and v) “a vaginal maturation index remains substantially unaltered during treatment” (claim 9).
With respect to the frequency or duration of administration, timing differences alone generally do not establish patentability absent persuasive evidence of unexpected or superior results attributable to the claimed schedule. This reflects the principle that optimizing a result‑effective variable is ordinarily obvious absent evidence of unexpected results (see MPEP 2144.05(II); In re Aller, 220 F.2d 454, 456 (CCPA 1955); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
With respect to the measurement of vaginal epithelial thickness and the use of a vaginal maturation index to monitor treatment progress, Labrie ’383 is cited to show that these measurements are well known in the art (see abstract; paras. [0023], [00224], [0239], [0293], [0340]–[0344]; claims). Because these measurement methods and endpoints are conventional, merely relying on them or optimizing measurement timing does not overcome obviousness absent persuasive evidence of unexpected properties or superior clinical results attributable to the claimed regimen (see authorities cited above).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
Claims 10-13, 15-18 and 21 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-9 of prior U.S. Patent No. 10624843. This is a statutory double patenting rejection.
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 10-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-20 of U.S. Patent No. 10624843 in view of Labrie (US 20020198179 A1, hereinafter “Labrie”), as evidenced by Morre et al. (US 2003/0072821 A1, hereinafter “Morre”)
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed composition containing a catechin component is fully disclosed in the patented claims 10-20 and the addition of estrogen and SERM such as ospemifene would have been prima facie obvious in light of Labrie as discussed in above 103 rejection. Combining known components each taught for the same purpose to yield a composition for that same purpose represents a predictable variation. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (predictable use of prior art elements according to their established functions) and In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“[I]t 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 which is to be used for the very same purpose.”).
Morre is cited an evidentiary reference to show that tea catechin contains epigallocatechin gallate (EGCg), epicatechin (EC, epicatechin gallate (ECG) and/or epigallocatechin (EGC). Thus, the patented claimed composition containing catechin component from tea catechin makes obvious the instant claim 14.
Claims 10-18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11395814 in view Labrie (US 20020198179 A1, hereinafter “Labrie”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed composition containing a catechin component is fully disclosed in the patented claims 1-16.
Regarding claims 12-13, as discussed above, the patented claim 2 discloses “at a concentration of between about 1% and 20% weight of total composition (w/w)”. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing “at a concentration of between about 2.5% and 15% weight per weight of the total composition”, “at a concentration of between about 4% and 12% weight per weight of the total composition” respectively. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
With respect to claim 18, Labrie makes obvious that FC‑1271 (also known as ospemifene) is well know SERM. Combining known components each taught for the same purpose to yield a composition for that same purpose represents a predictable variation. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (predictable use of prior art elements according to their established functions) and In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“[I]t 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 which is to be used for the very same purpose.”).
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12029723 in view of Morre et al. (US 2003/0072821 A1, hereinafter “Morre”) and Labrie (US 20020198179 A1, hereinafter “Labrie”) and Labrie (US 2009/0054383 A1, hereinafter “Labrie’383”.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claimed composition containing a catechin component that is useful for the treatment of female sexual disorder selected from the group consisting of genitopelvic pain disorder, vestibulodynia, dyspareunia, sexual interest arousal disorder and female orgasmic disorder is fully disclosed in the patented claims 1-2.
With respect to the frequency or duration of administration recited in claims 5-7, timing differences alone generally do not establish patentability absent persuasive evidence of unexpected or superior results attributable to the claimed schedule. This reflects the principle that optimizing a result‑effective variable is ordinarily obvious absent evidence of unexpected results (see MPEP 2144.05(II); In re Aller, 220 F.2d 454, 456 (CCPA 1955); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
With respect to the measurement of vaginal epithelial thickness and the use of a vaginal maturation index to monitor treatment progress recited in claim 7-8, Labrie ’383 is cited to show that these measurements are well known in the art (see abstract; paras. [0023], [00224], [0239], [0293], [0340]–[0344]; claims). Because these measurement methods and endpoints are conventional, merely relying on them or optimizing measurement timing does not overcome obviousness absent persuasive evidence of unexpected properties or superior clinical results attributable to the claimed regimen (see authorities cited above).
Regarding claims 2 and 11-13, as discussed above, the patented claims 1-2 discloses “at a concentration of between about 1% and 10% weight of total composition (w/w)”. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing “at a concentration of between about 1% and 20% weight per weight of total composition’, “at a concentration of between about 2.5% and 15% weight per weight of the total composition”, “at a concentration of between about 4% and 12% weight per weight of the total composition” respectively. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
With respect to claim 14 and 15, Morre is cited a reference to show that tea catechin composition contains epigallocatechin gallate (EGCg), epicatechin (EC, epicatechin gallate (ECG) and/or epigallocatechin (EGC). Thus, one having ordinary skill in the art would have been motivated to use tea catechin as a source of catechin or epigallocatechin gallate with reasonable expectation of success to arrive at the instantly claimed invention.
With respect to the combination of SERM and estrogen, Labrie makes obvious that such selection is well within the skill of artisan as discussed above. Combining known components each taught for the same purpose to yield a composition for that same purpose represents a predictable variation. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (predictable use of prior art elements according to their established functions) and In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“[I]t 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 which is to be used for the very same purpose.”).
Conclusion
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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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