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 .
Response to Amendments
Applicant’s amendments to the claims of July 20, 2026 , in response to the Office Action of March 19, 2026, are acknowledged.
Response to Arguments
Applicant argues that the claims are directed to consist of gamma tocopherol and Beinlich teaches non-alpha tocopherol compositions.
The examiner notes that Beinlich teaches compositions comprising a gamma-tocopherol enriched composition. See par. 9. Gamma-tocopherol compositions are known in the art. See par. 5. Examples include the non-tocopherol selected from a group consisting of gamma-tocopherol. See par. 16. The gamma-tocopherol is taught to comprise “at least” 90% of the composition. See par. 17. Thus, a POSA would understand this to mean and immediately envisage only gamma-tocopherol being used as an embodiment.
Applicant argues that claim 14 as amended requires separate dosage forms. The references are argued not to teach this.
The examiner notes that each claimed component is taught to be administered to the claimed subject population. It is not clear how two separate doses administered simultaneously or sequentially, e.g., would yield a patentable distinction over those components in a same dosage form. Applicant can certainly provide a showing that indicates an advantage of such distinction. Without such showing, the examiner’s position is that the claimed components are obvious to administer at a same time to a same subject and the claimed results is therefore expected to be similar. The prior art provides each component to work in a subject at a same time.
Applicant argues that Beinlich does not teach PMS symptoms to include those claimed in claim 14.
The examiner notes that Beinlich teaches treating conditions including PMS with the claimed agent. See par. 25. The compositions are taught to mitigate inflammation associated with CRP, cytokines, and others. See par. 34. Specific symptoms taught to be associated with PMS include incapacitating symptoms, including physical or mental incapacitation, etc. Thus, the subject population is the same and the listed symptoms are noted to include symptoms that would fall within the category of ameliorating a change in behavior, negative emotion, concentration ability, and others claimed.
Applicant argues that Kelly does not teach equol as the sole active isoflavone.
The examiner notes that Beinlich teaches treating PMS by administering a soy isoflavone “selected from the group consisting of” a total of 6 components one of which is equol. See prior art claims 20 and 22. This is not only a limited listing wherein each agent is taught to work independently throughout the reference, but the claim is directed to a single agent including equol. Nothing else is required.
Applicant argues that a POSA would not have combined references to administer the claimed components.
The examiner notes that the claimed components are each taught to treat the claimed subject population. Equol is taught as effective. Gamma-tocopherol is taught and shown to be a preferred tocopherol component. While the claims require separate dosages, there is no showing or allegation that administration of the same components on a basis in which they would all be active simultaneously produces an unexpectedly advantageous or even different result in a subject. As such, Applicant’s arguments are not persuasive. Rejections are set forth below.
With respect to new claim 22, the examiner cites Becker, U.S. Pat. No. 5,114,720.
Becker teaches pharmaceutical tablets can have a gelatin overcoat that imparts a low coefficient of friction and increase slipperiness and swallowability of a tablet without stickiness normally associated with gelatin type coatings. More generally, Becker teaches:
The coatings of pharmaceutical dosage forms such as pills or tablets utilizing rotating pan systems is well known. Typical coating processes include sugar coating which utilize coating powders such as sugar, acacia, flour, starch, are applied with an adhesive solution such as a viscous solution of acacia, gelatin or sugar and film coating which utilize film forming agents such as vinyl polymers, celluloses, acrylates, or natural gums and resins such as zein, gelatin, shellac and acacia. Remington, 17th Ed., p. 1623-1643.
Thus, not only are the claimed coatings common for pharmaceutical dosages forms, but a method to enhance administration with a gelatin coating is known.
With respect to new claim 23, the examiner cites Guo, “Lactose in Pharmaceutical Applications,” Drug Development and Delivery Vol. 4, No. 5 June 2004, (https://drug-dev.com/lactose-in-pharmaceutical-applications/).
Guo teaches: “Lactose is widely used as a filler or diluent in tablets and capsules, and to a more limited extent in lyophilized products, infant feed formulas, and a diluent in dry-powder inhalations.” Even further, “Lactose is widely used as a filler or filler-binder in the manufacture of pharmaceutical tablets and capsules. The general properties of lactose that contribute to its popularity as an excipient are its:
cost effectiveness;
availability;
bland taste;
low hygroscopicity;
compatibility with active ingredients and other excipients;
excellent physical and chemical stability; and
water solubility
Various lactose grades are commercially available that have different physical properties, such as particle size distribution and flow characteristics.”
As such, it is not clear that providing for a most common and known excipient used in capsules and tablets with numerous known benefits and/or providing for a gelatin coating that is known to bestow advantages for tablets, e.g., provides a non-obvious distinction over the cited prior art. As noted above, unexpected results are not alleged and shown.
Status of the Claims
Claims 14-23 are pending and examined.
Claim Rejections - 35 USC § 112
Claims 22 and 23 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 “the optional component is selected from the group consisting of…a coating agent….”
The claim appears to be requiring components that are referred to as “optional.” To overcome this, Applicant should simply claim wherein the composition comprises…lactose and/or gelatin. Explicitly including specific components will obviate the need to refer to component that are intended to be required, as optional.
For purposes of examination, the examiner does apply prior art that addresses claims 22 and 23 as if the “optional” components are required components.
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).
The examiner notes that claim 14 defines an excipient as specific agents. However, the excipient, coating, and oil each remain optional despite the specific limitations as to what they can be.
Claim 22 appears to require a coating.
Claim 23 requires an excipient and an “optional” component.
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.
Claims 14-23 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), as applied to claims 14-21 above, and in further view of Becker, U.S. Pat. No. 5,114,720, and in view of Guo, “Lactose in Pharmaceutical Applications,” Drug Development and Delivery Vol. 4, No. 5 June 2004, (https://drug-dev.com/lactose-in-pharmaceutical-applications/).
Beinlich, Kelly, Kimura, Thys-Jacob, and Aso do not teach a specific type of coating or excipient claimed.
Becker teaches pharmaceutical tablets can have a gelatin overcoat that imparts a low coefficient of friction and increase slipperiness and swallowability of a tablet without stickiness normally associated with gelatin type coatings. More generally, Becker teaches:
The coatings of pharmaceutical dosage forms such as pills or tablets utilizing rotating pan systems is well known. Typical coating processes include sugar coating which utilize coating powders such as sugar, acacia, flour, starch, are applied with an adhesive solution such as a viscous solution of acacia, gelatin or sugar and film coating which utilize film forming agents such as vinyl polymers, celluloses, acrylates, or natural gums and resins such as zein, gelatin, shellac and acacia. Remington, 17th Ed., p. 1623-1643.
Thus, not only are the claimed coatings common for pharmaceutical dosages forms, but a method to enhance administration with a gelatin coating is known.
With respect to new claim 23, the examiner notes that lactose, e.g., is one of the most commonly used excipients in pharmaceutical formulations.
Guo teaches:
“Lactose is widely used as a filler or diluent in tablets and capsules, and to a more limited extent in lyophilized products, infant feed formulas, and a diluent in dry-powder inhalations.” Even further, “Lactose is widely used as a filler or filler-binder in the manufacture of pharmaceutical tablets and capsules. The general properties of lactose that contribute to its popularity as an excipient are its:
cost effectiveness;
availability;
bland taste;
low hygroscopicity;
compatibility with active ingredients and other excipients;
excellent physical and chemical stability; and
water solubility
Various lactose grades are commercially available that have different physical properties, such as particle size distribution and flow characteristics.”
As such, it is not clear that providing for a most common and known excipient in lactose, e.g., used in capsules and tablets with numerous known benefits and including a coating that is gelatin, e.g., that is known to bestow advantages also on a tablet, e.g., provides a non-obvious distinction over the cited prior art.
Overall, the further incorporation of a most common filler with known advantages for tables and the incorporation of a gelatin coating to assist in provided even more known advantages to a tablet formulation, e.g., do not appear to provide a patentable distinction over the rejection made above.
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 with those of Becker and Guo. One would be motivated to do so because using a gelatin coating would make a composition swallowable by decreasing the coefficient of friction and using lactose as an excipient in a tablet would be expected to increase physical and chemical stability, water solubility, and provide other known advantages as an excipient. The incorporation of excipients and/or coatings known to provide benefits to unit dosage formulations, such as tablets, does not obviate prior art that as a whole teaches each claimed agent for use in treating the claimed subject population.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. 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
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