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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/11/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 05/13/2026 in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 12-15, 17-30 are pending.
Election/Restrictions
Claims 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/13/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-15 and 17-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended claim 12 does not have support in the originally filed application for the ranges claimed: “Suvarna Bhasmadi Vati (SBV) in a dosage in the range of 700mg/day to 900mg/day”, “Mouktikukta Kamdudha Vati (MKV) in a dosage in the range of 800mg/day to 1200mg/day”, “Shatavari Vati (SV) in a dosage in the range of 800mg/day to 1200 mg/day”, “Arogyavardhini Vati (AVV) in a dosage in the range of 800mg/day to 1200mg/day”, “Triphala Guggul Vati (TGV) in a dosage in the range of 800mg/day to 1200mg/day”. Additionally, the phrases “and is administered twice a day in the morning after breakfast and in the evening after snacks”, and “and is administered twice a day after lunch and after dinner”, and “is administered as head massage at bedtime”, and “wherein each said container is said kit containing doses equivalent upto 1 month” are all new matter which was not previously described in the patent application as originally filed. The term “upto” is not a word and is interpreted to mean the phrase “up to”.
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 12-15 and 17-28 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.
Claim 12 is indefinite for reciting a kit comprising six containers each containing a dosage form comprising a composition. The said dosage forms are present in an amount … mg/day. This is indefinite because the daily dose is not the amount present in each composition. That is, this is not the concentration of a compound in a composition but the amount delivered to a subject in a dose/day. The claims are directed to a product, not a method of treatment.
Specification
The newly submitted specifications filed on 05/13/2026 introduces new matter from the originally filed application. The new limitations rejected under 112(a), for instance, are recited at pages 6-7, 12, 14. The applicant should indicate where this matter was originally filed for the applicant to overcome the 112(a) rejection or remove it from the application.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive. The applicant argues that the new limitation of claim 12, pertaining to wherein each said container in said kit containing doses equivalent up to 1 month corrects the indefinite dosage formulation. This is not the case because the claims still recite mg/day.
The declarations under 37 CFR 1.132 filed 05/13/2026 are insufficient to overcome the rejection of claims 12-15 and 17-28 based upon the recited rejections as set forth in the last Office action because: the declaration addresses prior art which was not relied upon in the last Office Action.
Conclusion
Currently no claims are allowed.
The applicant argues that adding the limitation ‘wherein each said container in said kit containing doses equivalent up to 1 month” addresses the 112(b) indefinite issue pertaining to the dosing. A dose in a composition is to a specific unit. A dose in units per time would be for a method of treatment. The examination for this application is to a composition and not a method of treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
