DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed May 14, 2026 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-13 are pending.
Specification
4. The amendment filed May 14, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
On page 2, the phrase ‘The "processed orpiment" is Arsenic Trisulphide processed by boiling in slaked lime and juice of Benincasa hispida, separately for 3 hours each.’ has been inserted and does not have explicit or inherent basis in the original disclosure.
On page 5, the following has been added:
Snuhi Kshir: The term 'Snuhi Kshir' refers to "Snuhi Kshir" the term refers to the latex (milky exudate) obtained from the plant Euphorbia neriifolia Linn. (family Euphorbiaceae).
Shuddha Kapardik: The term 'Shuddha Kapardik' refers to purified cowrie (marine mollusc) shell (Kapardik), composed primarily of calcium carbonate (CaCO₃), obtained through standard Ayurvedic purification (shodhana) procedures as described in the Ayurvedic Pharmacopoeia of India."
"Shigru": the term 'Shigru' refers to the fresh juice obtained from the plant Moringa oleifera Lam. (family Moringaceae).
Suntha/Shunthi: the term 'Suntha' refers to the dried rhizome or root of Zingiber officinale (Ginger), or its processed form.
'Natural Inoculum': the term 'Natural Inoculum' refers to Dhataki flowers (Woodfordia fruticosa), which function as a natural inoculum providing the microbial culture necessary for fermentation.
This new material does not have explicit or inherent basis in the original disclosure. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
5. Claim 7, step C ii, is objected to because of the following informalities: “Arkadugdha” should be “Arka dugdha”. Appropriate correction is required.
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.
6. Claims 1-13 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.
Applicant has amended the specification to insert definitions for "processed orpiment", “Snuhi Kshir,” “Shuddha Kapardik,” "Shigru", “Suntha/Shunthi,” and “Natural Inoculum”. However, as discussed above, these new definitions do not have literal or inherent support in the original disclosure. Thus, the refer to new matter material to provide definitions for required claim ingredients also introduces new matter into the claims by reference. Therefore, the claims are considered to include new matter as they rely on new matter in the specification to provide definitions.
Claims 1-13 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.
7. Claim 1 is indefinite because, as discussed in the previous Office action, it states that each of the containers contain the various compositions in amounts per day. An amount per day is an administration limitation rather than a structural limitation placed on the compositions themselves. Thus, it is unclear if the claim is meant to recite an intended use or if the claimed amounts are structural requirements of the various compositions. The indefinite language still appears in the claims as amended.
8. Claim 4 is indefinite because, as discussed in the previous Office action, it states that the various ingredients are powders and liquids and does not specifically state that the ingredients are combined and formulated into a tablet (as required by claim 1). In addition, claim 4 is confusing in that it refers to a “first powder,” “first liquid,” “second powder,” etc. By referring to each of these separately, it appears to be implying that they are not combined together. Thus, the overall structural requirements of the claim are unclear. The indefinite language still appears in the claims as amended.
9. Claim 6 is indefinite because, as discussed in the previous Office action, it appears to conflict with claim 1. Claim 1 requires the Khadirarishta to be in liquid form. However, the ingredients listed in claim 6 are powdered and no liquid is specifically required. Claim 6 is also indefinite because it states that it is drawn to a “first powder” and a “second powder”, Jaggery and Dhataki flowers. Referring to the ingredients as separate formulations is indefinite. The claim does not state that these ingredients are combined. Thus, the actual structural requirements of claim 6 are unclear. The indefinite language still appears in the claims as amended.
10. Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 states that the SBV, MKV, TCR, and KKV are in tablet form. However, this limitation is already present in parent claim 1 which states that these formulations are in “Vati” form. The specification defines “Vati” as a tablet. Thus, claim 8 does not further limit claim 1 because tablet formulation is already required by claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
11. Claim(s) 1 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deshmukh (Support Care Cancer (2014), vol. 22, no. 1, 9 pages), Hebbar 1 (“Trailokya Chintamani Rasa Ingredients, Dose, Uses, Side effects.” accessed at https://ayurmedinfo.com/2019/03/02/trailokya-chintamani-rasa/ - reference date March 2, 2019), Hebbar 2 (“Khadirarishta Uses, Side Effects, Ingredients and Dose.” accessed at https://ayurmedinfo.com/2011/07/01/khadirarishta-uses-side-effects-ingredients-and-dose/ - reference date July 1, 2011), “Therapeutic Index” (accessed at https://ayurvedarasashala.com/wp-content/uploads/2021/07/Therapeutic.pdf - reference date December 2011) and “The Basic First Aid Kit Every Home Should Have” (accessed at https://www.marywashingtonhealthcare.com/news/2018/february/the-basic-first-aid-kit-every-home-should-have/ - reference date February 1, 2018) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues that the references do not teach the claimed invention because the references do not teach that the ingredients in the kit are useful for delaying or controlling the recurrence or occurrence of breast or ovarian cancer as recited in the claims and in the specification. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Each of the references teach the broadly claimed formulations of the kit as recited in claim 8 and provides motivation for packaging these ingredients together. Thus, the kit suggested by the references is structurally the same as the claimed kit and should be capable of performing the intended use if applicant’s invention functions as claimed.
Applicant also argues that the references do not teach using the ingredients in the same amounts claimed by applicant. However, as discussed above, the claims are not considered to require a specific amount of each formulation. Rather, claim 1 states that the formulations are in a range of amounts per day which is also an intended use limitation.
Applicant also argues that the references do not teach the limitations of claims 2-7. However, these claims are not included in the rejection. The limitations from claims 2-7 are not read into claims 1 and 8-13 because these claims do not depend from claims 2-7. In addition, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, these arguments regarding claims 2-7 are moot.
In addition, applicant argues that the subject matter of claims 8-13 is inventive because the excipients are specifically selected to “ensure stability, uniformity, and compatibility across heterogeneous dosage systems.” However, these purposes are well known for these well known excipients. Applicant has not provided any specific data to show that selection of these well known excipients for their well known purpose achieves any type of unexpected result. Thus, this argument is not persuasive.
12. 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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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