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 .
The amendment filed 16 June 2026 is acknowledged and has been entered.
Status of the Claims
Claims 1-22 and 28 have been cancelled.
New claims 43 and 44 have been submitted.
Claims 32, 36 and 38 have been withdrawn as being directed to a nonelected invention.
Claims 23-27, 29-31, 33-35, 37 and 39-44 are presented for examination on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23-27, 29-31, 33-35, 37 and 39-44 are rejected under 35 U.S.C. 103 as being unpatentable over Frin (WO2020/229412) [cited by Applicant in IDS filed 7/10/24] and Gaudout et al. (US2019/0160133). [cited by Applicant in IDS filed 1/24/24].
Frin beneficially discloses compositions useful in the treatment of female subjects suffering from premenstrual syndrome and/or menstrual discomfort. Specifically the compositions comprise chasteberry fruit extract: (page 40, line 26); crocus sativus (saffron) stigma, wherein the extract includes 30-50% wt of maltodextrin, which would
intrinsically result in it being encapsulated by maltodextrin (page 40, lines 28-29, table 1): and C. an excipient such as magnesium citrate and calcium carbonate (excipients) as they are pH-adjusting agents (page 40, lines 27-29). Frin further discloses that the composition contains weight to weight ratio of vitex agnus-castus extract from 15:1 to 1:15, which encompasses the 6:1 extraction ratio (page 28, lines 34-36), and the Vitus agnus castus extracts can be produced with ethanol, wherein the levels of ethanol can range between 10-95%(v/v/v): (page 11. line 36, page 12, lines 5-7) and the composition contains weight to weight ratio of vitex agnus-castus extract from 5:1 to 1:1, which encompasses the 3.33:1 extraction ratio, additionally wherein the composition comprises one or more crocins, wherein the total corcins content is at least 2% wt of the extract; (page 16, lines 8-11, page 28, lines 34-36), and the Vitex agnus-castus extracts can be produced with ethanoi, wherein the levels of ethanol can range between 10-95%(v/v); (page 11, line 36, page 12, lines 5-7).
Frin further discloses a method of using the compositions as defined before for the treatment of premenstrual syndrome and/or menstrual discomfort; (page 33, lines 6-15), comprising orally consuming a tablet composition taken orally 2-3 times a day to optimize response, wherein the tablet contains vitex agnus-castus (chesteberry fruit) extract; (page 41, table 1, page 42, lines 7-9); wherein the tablet contains Crocus sativus stigma extract, wherein the dosage includes 30-50% wt of maltodextrin, thereby encapsulating it, and allowing for efficacious treatment; (page 41, table 1, page 42, lines 7-9, page 43, lines 8-11).
Gaudout et al. beneficially teaches encapsulation by maltodextrin. As applicant points out in the instant Specification at paragraph [0061]: In a preferred embodiment, the saffron for use in the described composition is derived from red sargol saffron stigma. Unlike other saffron extracts, the saffron used in this composition is processed by a unique extraction and drying technology to encapsulate the saffron extract by maltodextrin in order to retain saffron active metabolites (e.g., crocins, safranal) and to protect potency and stability of the active components. One example of the extraction and drying technology was previously described in U.S. Patent Publication No. 2019/0160133 AI, which is incorporated herein in its entirety. Specifically, as described in U.S. Patent Publication No, 2019/0160133 AI, after impregnation step, the procedure can also include an emulsion step and/or an encapsulation step for the obtained extract. This step consists of high-speed stirring of the extraction solution containing the bulking agent and, possibly, the auxiliary substance. It can be carried out using auxiliary substances such as acacia gum, cyclodextrins, or fatty substances.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: each of the ingredients: chasteberry extract and saffron extract are known to be traditionally used in treating menstrual disorders, as stated by Applicant in the Specification (see, e.g., paragraphs [0006] and [0007] and references cited therein). In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. V. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) As both dosages, routes of administration, dosage frequency and timing are known to the ordinary artisan, it would have been obvious to optimize the mode of administration as well as dosage amounts and frequency. It also would have been prima facie obvious to optimize the dosage regimen for an additive or synergistic therapeutic result because the general conditions of the dosages are disclosed in the prior art and it is not inventive to discover the optimum or workable ranges by routine experimentation and the art expects that dosages of the invention will vary depending upon such factors as the subject's age, weight, height, sex, general medical conditions and previous medical conditions.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant’s amendments/arguments, with respect to the rejection(s) of the claim(s) under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gaudout et al. Applicant’s assertion that the cited reference does not teach the encapsulation by maltodextrin is correct, though such is known in the prior art as cited by Applicant in the instant Specification.
Applicant further asserts that unexpected results were obtained and points to examples within the specification. However, with respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Finally, with respect to the mechanism of action by which administration of the effective amount of the composition prevents and/or ameliorates menstrual cycle symptoms and/or discomforts in a subject, such would be a necessary consequence of such administration and intrinsic to any administration. Thus the effect recited in new claims 43 and 44 do not effectively limit the claimed method (see e.g., Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) ( “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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