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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 27, 2026, has been entered.
Response to Arguments
Applicant has amended the claims to identify the oil that can be included in the composition. Applicant argues that the claims now exclude a PUFA and Dreon requires this. In view of these amendments to the claims, the examiner conducted an additional search for the use of gamma tocopherol without an oil that is required by Dreon. In response to this amendment, new prior art is applied below and Dreon is removed as prior art.
The examiner now applies Beinlich et al., (US2003/0100603). Beinlich teaches compositions for treating conditions including PMS wherein the active agent is a non-alpha tocopherol enriched tocopherol. See Abstract. Inflammatory conditions that can be treated include pre-menstrual syndrome. See par.’s 25 and 31. The tocopherol is to include and be enriched with gamma tocopherol. See par. 9. Capsules can be used and a typical dose of vitamin E can be 100-600 mg/day in adult humans. See par.’s 185 and 188. Moreover, soft-gel-capsules were prepared in one example. See par. 240. In view of Beinlich, a composition comprising gamma tocopherol and other vitamins or minerals can be used. The composition can be administered alone or with other components. See par. 182.
Beinlich does not require PUFA, such as DHA.
Kelly teaches administration of a phytoestrogen to treat and/or ameliorate a condition at a dose of about 20-200 mg as a preferred amount “on a daily basis.” See col. 10, lines 9-13. This means the amount taught by Kelly overlaps the claimed dosage. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). This teaching establishes a prima facie showing for the claimed dosage.
Kimura teaches equol from soybean hypocotyl to treat menopausal disorders, postmenopausal osteoporosis, and more. The hypocotyl can contain 0.1 to 20% equol by weight. Equol can be 1 to 20 mg and preferably 2 to 10 mg. See par. 57. Kimura shows tablets containing 10.9 mg per tablet were made. See par. 80. Tablets can be administered to treat and prevent symptoms of menopausal disorder, including complaints, osteoporosis, and hyperlipidemia, e.g. See par. 69. Kimura indicates a daily doe can be 0.5 to 6 g of soybean hypocotyl. See par. 70. This would mean that 1 to 20 mg equol per 1 g soybean hypocotyl equates to a daily dose of a range that overlaps the claimed range. For example, 0.5 g soybean hypocotyl would equate to 0.5 mg to 10 mg equol.
Even further, it would be obvious to optimize the amount of equol because it is known to treat the claimed symptoms and conditions through known mechanisms of action. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In view of this, Kelly and Kimura each render obvious the claimed daily dose of equol.
Status of the Claims
Claims 14-21 are pending and examined.
Claim Rejections - 35 USC § 112
Claims 14-21 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. The claim include ameliorating “change in behavior.” It is not clear how to ameliorate change in behavior as some behavioral changes are beneficial, e.g.
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 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Beinlich et al., (US2003/0100603), in view of Kelly (U.S. Pat. No. 6,562,380), in view of Kimura et al., (US2012/0277303), and in view of Thys-Jacobs et al., (U.S. Pat. No. 4,946,679), and in view of Aso, “Equol Improves Menopausal Symptoms in Japanese Women,” Journal of Nutrition Supplement: Equol, Soy, and Menopause (2010) (cited in IDS).
Beinlich teaches compositions for treating conditions including PMS wherein the active agent is a non-alpha tocopherol enriched tocopherol. See Abstract. Inflammatory conditions that can be treated include pre-menstrual syndrome. See par.’s 25 and 31. The tocopherol is to include gamma tocopherol. See par. 9. Capsules can be used and a typical dose of vitamin E can be 100-600 mg/day in adult humans. See par.’s 185 and 188. Moreover, soft-gel-capsules were prepared in one example. See par. 240. In view of Beinlich, a composition comprising gamma tocopherol and other vitamins or minerals can be used. The composition can be administered alone or with other components. See par. 182.
Beinlich does not teach administration of equol.
Kelly teaches a method of treating or reducing predisposition to pre-menstrual syndrome or symptoms associated with menopause by administering equol. See prior art claims 20, 21, and 22, e.g. Kelly teaches embodiments in which equol is administered without excluding or requiring other components. See prior art claim 14. Kelly also teaches the formulations can be in the form of a vitamin supplement. The composition can be in the form of a tablet. See Example 1.
Beinlich and Kelly do not teach a soybean fermented hypocotyl material comprising equol.
Kimura teaches an equol containing fermented soybean hypocotyl material that is useful for pharmaceutical preparations. See abstract. Specifically, soybean isoflavones are known to produce anti-estrogen effects on menopausal disorders, postmenopausal osteoporosis, and other conditions. See par. 3. Further, the active principal responsible for these effects may be equol. The invention comprises a method to produce an equol-containing fermented soybean hypocotyl material that is useful as an allergen reduced material. See par. 14. The equol-containing fermented soybean hypocotyl material has reduced allergens. See par. 37. The compositions are taught for use in treating menopausal disorders. See par. 26. Further, Kimura teaches using 1 to 20 mg equol, and preferably 2 to 10 mg. See par. 57. This falls within the claimed concentrations. The microorganisms used have an equol-producing capability when fermented and the material is then allergen-reduced. Kimura explains that using at least one equol producing microorganism will allow for obtaining an allergen reduced equol containing fermented soybean hypocotyl material.
Thys-Jacobs teaches treating premenstrual symptoms (PMS) by administering calcium at a dose of 250 mg to 2,000 mg per day. See prior art claims 1-3. Common symptoms include cramps, edema, neurotic behavior, anxiety, and others. See col. 1, lines 45-55. A form administered includes a tablet form.
Aso teaches natural S-equol developed by Otsuka Pharmaceutical for use on menopausal symptoms at a daily dose of 10 mg. See Abstract.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
It would have been prima facie obvious to a person of ordinary skill in the art prior to filing the instant application to combine the teachings of Beinlich, Kelly, Kimura, and Thys-Jacobs to arrive at the claimed compositions and intended methods claimed. One would be motivated to do so because both gamma-tocopherol and equol are taught to be administered to a subject experiencing symptoms associated with pre-menstrual syndrome, e.g. Further, a product containing soybean hypocotyl comprising equol produced through fermentation of equol-producing microorganisms is taught for a same use and to bestow advantages, including having less allergens. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Even further, dosages that are similar to those claimed and optimizable are taught by the cited prior art. Thys-Jacobs teaches using the claimed amount of calcium for treating premenstrual symptoms. Additionally, equol and calcium are taught for administration as a tablet and gamma tocopherol can be administered in the form of a soft capsule. Vitamins and minerals can be included in the compositions. The prior art teaches administration of the claimed APIs, including gamma tocopherol, calcium mineral, and equol for treating PMS and other conditions at claimed dosages and daily. Thus, the distinction between the prior art and the claims is the separate dosages. However, as noted above, the same agents are taught for daily administration to a same subject in the same form. As such, the prior art teaches having each of the claimed agents working in a same subject at a same time. Absent evidence of a criticality, merely claiming separate dosages is not a patentable distinction as it is not clear that such requirement would have any bearing on the claimed method as a whole.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628