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 Amendment
Applicant's amendment and argument filed 01/29/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 12-15, 17-19 and 20-30 are pending.
Election/Restrictions
Newly submitted claims 29-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The original set of claims are directed to a kit or composition, whereas the new claims 29 and 30 are directed to methods which require administration steps and presumably patient specific populations.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 29 and 30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 12-15, 17-19 and 20-28 are being examined on the merits.
Claim Objections
Claim 19 is objected to because of the following informalities: The claim recites “wherein said dosage form of SBV, MKV, SV, AVV and TGV is tablet” and this is not proper English or a complete sentence. Appropriate correction is required.
Claim Interpretation
Claim 12 is directed to a kit comprising six containers each comprising a different composition. A) The term “A kit” has not been defined by the specification. As such it is given the usual and normal meaning in the art. It is defined as “a set of articles or equipment needed for a specific purpose. "a first-aid kit"” (See Oxford dictionary). B) the term “A kit” is in preamble. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. (See MPEP 707.07(f) and 2141.02 |; In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and MPEP 2111.02 Il; Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)). C) many of the recited elements/compounds are presented in a foreign language and not in their English form. D) The claim does not indicate what components are present in each composition. Claim interpretation is based on the examination of copending patent application 18/015,577 and to help with consistency during examination for the applicant.
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 12-15 and 17-27 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 because it is unclear what Suvarna Bhasmadi is or is supposed to contain and/or not contain. It is not listed in the definitions section of the specifications and is indefinite.
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.
Claim 12 is indefinite because the phrase “Triphala Guggul Vati” is not defined and is generally understood as a traditional Ayurvedic herbo-mineral formulation used to enhance overall health and address specific ailments which can comprise of different formulations depending on which source is being relied on which makes the ingredients unclear. Since the phrase is not defined the phrase is therefore indefinite.
Claim 14, is indefinite because the claim recites “wherein said Mouktikyukta Kamdudha Vati (MKV) is prepared from:” and reciting “prepared from” suggests to the reader this is a product-by-process which would entail steps, however no steps are described. Furthermore it is unclear if the components listed are required and in what form or derivative, for instance can an extract of the component be allowed or is it raw material?
Claim 19 recites the limitation "solid dosage form" in line 1. There is insufficient antecedent basis for this limitation in the claim 12 does not require such a from.
Claim 23 is rejected for being dependent on a canceled claim.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. The applicant argues that each Ayurvedic term is defined in the specifications and generally directs attention to the specifications. However the current application’s definitions are on the second page of the instant specifications. Each term rejected in the 112(b) section is not defined as claimed and so these limitations are deemed indefinite. The applicant argues that these are terms any skilled artisan would know, however there are varying ways in which they can be interpreted as appreciated by the applicants own need to define the general phrases in their own terms. The issues of dosage have not been amended or corrected as discussed in the above and previous rejections. The claims are directed to a composition and not a method of treatment thus having a dosage in range from X mg/day to Y mg/day would not make sense unless it were being administered to a subject, such as in a method of treatment.
The declaration under 37 CFR 1.132 filed 01/29/2026 is insufficient to overcome the rejection of the claims based upon 112(b) issues as set forth in the last Office action because: the declaration does not fix any of the outstanding issues. The declaration has been considered but many parts of it are illegible (page 3 at top and bottom) and does not hold much persuasion to the cases outstanding issues.
Conclusion
Currently no claims are allowed.
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.
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