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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 20, 2025 has been entered. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. The declarations of Vineeta Deshmukh and Sadanand Sardeshmukh, both filed May 20, 2025, have been received and considered.
4. Claims 10 and 12-22 are currently pending.
Election/Restrictions
5. In the reply filed on August 1, 2024, applicant elected Group I, now claims 10, 17, and 20 with traverse.
6. Claims 12-15, 18, 19, 21, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
7. Claims 10, 17, and 20 are examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claim(s) 10, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande ("Assessment of Effect of CG4 (An Ayurvedic Formulation) in the Management of Side Effects of hemotherapy in Breast Cancer", a thesis submitted to Tilak Maharashtra Vidvaoeeth, Pune For the Degree of Doctor of Philosophy (Ph. D.) Month & Year: December 2016) in view of Deshmukh (Supportive Care in Cancer (2014), vol. 22, no. 11, pp. 3007-3015).
Deshpande teaches Mouktikyukta Kamdudha, Padmakadi Ghrut, and Ananta are all known to be useful for the treatment of side effects of chemotherapy (see pages 67, 69, and 74). Page 67 depicts Mouktikyukta Kamdudha as a tablet (“vati” as defined by applicant). The reference does not specifically teach that the Padmakadi Ghrut is in “thick, viscous form” or that the Ananta is in a tablet form (“vati”). However, thick liquids such as syrups and tablets are well known pharmaceutical dosage forms that would be obvious to employ. The reference does not teach that Suvarna Bhasmadi is useful for treating the side effects of chemotherapy.
However, Deshmukh teaches that Suvarna Bhasmadi is useful for treating the side effects of chemotherapy. The reference teaches using this in combination of Mouktikyukta Kamdudha. The reference teaches that Suvarna bhasma, Mouktick bhasma, and Guduchi sattva are useful ingredients during the treatment of cancer with chemotherapy (see Introduction and Ayuvedic drugs sections). The reference does not teach that the ingredients are in tablet form using a binder such as gum acacia, guar gum, or xanthan gum. However, tablets and these binders are well known to be useful in the formulation of pharmaceuticals and would be obvious to employ.
Thus, it was known in the art at the time of the invention that each of Suvarna Bhasmadi, Mouktikyukta Kamdudha, Padmakadi Ghrut, and Ananta were useful individually for the treatment of chemotherapy patients. Therefore, an artisan of ordinary skill would expect that packaging these formulations together into a kit form would create a product that would be useful for the treatment of chemotherapy side effects. This reasonable expectation of success would have motivated the artisan to package these individually known compositions into a single kit.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant in claim 10. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Response to Arguments
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues that the claimed invention is allowable over the prior art due to unexpected, synergistic effects that are seen when the claimed compositions are used to treat the side effects of chemotherapy. Applicant argues that these effects are shown in the examples in the declarations of Vineeta Deshmukh and Sadanand Sardeshmukh which demonstrate the effects when the claimed compositions are administered to a patient. However, as discussed in MPEP section 716.02(c), unexpected results must be commensurate in scope with the claimed invention. The results are shown for when the claimed compositions are administered to an individual. Applicant’s claims do not require that the different compositions are combined into a single composition or administered to an individual. Thus, the evidence provided in the declarations is not commensurate in scope with the claimed invention because the claims are drawn to a kit where each composition is separated into a distinct container. The claims specifically require that each composition is placed in separate containers. Thus, any unexpected results would not be seen because each composition is kept separate as required by the kit. Each composition is packaged separately but placed in the same box. This boxed composition itself would not display any unexpected results because each of the individual compositions was known in the art. Thus, each of the individual compositions would display the same effects as the prior art compositions. Therefore, this argument is not persuasive.
Applicant also argues that the claimed concentrations of ingredients recited in claim 10 produces unexpected results. However, as discussed in MPEP section 716.02(d-II), “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range…”. The declarations do not show test results both inside and outside of the claimed ranges. Thus, the evidence does not establish that the claimed ranges are critical. In the absence of evidence to the contrary, a difference in concentration is not considered to support patentability (see MPEP section 2144.05(II)(A). Therefore, this argument is not persuasive.
Double Patenting
9. Claims 10, 17, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 8, 10-12 of copending Application No. 18/015,577 in view of Deshpande ("Assessment of Effect of CG4 (An Ayurvedic Formulation) in the Management of Side Effects of hemotherapy in Breast Cancer", a thesis submitted to Tilak Maharashtra Vidvaoeeth, Pune For the Degree of Doctor of Philosophy (Ph. D.) Month & Year: December 2016).
The claims of Appl. No. ‘577 are drawn to a pharmaceutical kit comprising a first container comprising Suvarna Bhasmadi Vati, a second container comprising Mouktikyukta Kamdudha Vati, and a fourth container comprising Ananta Vati. Claim 2 states that the Suvarna Bhasmadi Vati contains the same ingredients in the same concentrations as currently claimed. The claims of Appl. No. ‘577 do not recite the presence of Padmakadi Ghrut in the kit.
However, Deshpande teaches Mouktikyukta Kamdudha, Padmakadi Ghrut, and Ananta are all known to be useful for the treatment of side effects of chemotherapy (see pages 67, 69, and 74). Thus, it was known in the art that Padmakadi Ghrut and other compositions within the claims of Appl. No. ‘577 were useful for the treatment of chemotherapy patients. Therefore, an artisan of ordinary skill would expect that adding Padmakadi Ghrut to the kit of Appl. No. ‘577 would create a product that would be useful for the treatment of chemotherapy side effects. This reasonable expectation of success would have motivated the artisan to add Padmakadi Ghrut to the kit of Appl. No. ‘577.
This is a provisional nonstatutory double patenting rejection.
10. No claims are allowed.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655