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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/11/2025 has been entered.
Response to Amendment
Applicant's amendment and argument filed10/11/2025 in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3, 5, 7 and 21-22 are pending and being 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.
Claims 1, 3, 5, 7, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yang Hong (CN103120309A), Kyu et. al. (KR20180061062A) and Pan Qingyang (CN107029093A). This is a new rejection based on the arguments and amendments filed on 10/11/2025.
Hong teaches compositions for diabetes patients (see abstract) and teaches the composition to comprise Chinese yam 1 ~ 5, lotus seeds 1 ~ 5, Gorgon fruit 1 ~ 5, heart of a lotus seed benevolence 1 ~ 5, Poria cocos 1 ~ 5 (see Summary of the invention, page 2, and claim 1).
Hong teaches that Chinese yam: supplementing qi and nourishing yin, tonifying lung spleen kidney and has blood sugar reducing function.
Lotus seeds tonifying spleen by supplementing the kidney to control the nocturnal, and mental-tranquilization, relieving restlessness clears away heart-fire.
Gorgon fruit, newly organized the saying of book on Chinese herbal medicine: Gorgon fruit, help the envoy also, its merit is dried in kidney tonifying entirely. The Gorgon fruit bowl spares is dried, and property is not dry again, mends true water therefore can uncharm water, with the same use of all yin tonics, especially can help to add essence. With Chinese yam and use, be respectively the end, everyday rice is taken after mixing with liquid. Has the effect of moistening of nourishing.
Heart of a lotus seed benevolence is for invigorating spleen and reinforcing stomach, wind prevailing over dampness is removed in the tonifying lung heat-clearing.
Poria cocos: clearing heat and promoting diuresis, calm the nerves, invigorating the spleen. Compendium of Materia Medica namely has the prescription of the diabetes for the treatment of.
Hong does not specifically teach using Paeonia Lactiflora, Endothelium Corneum Gigeriae Galli or Semen Coicis in the composition.
Kyu’s composition is for preventing or improving diabetes mellitus (see abstract).
Kyu teaches that “Paeonia lactiflora is the root of the perennial herbaceous plant of the buttercups and is mainly used as a medicinal plant. Peonies include, but are not limited to, Paeoniflorin, Paeonel, Paeonin, Tannin, β-sitosterol, triterpenoid, essential oils, It is used for prevention and treatment of diseases due to antioxidant, inflammation, analgesic effect, blood reinforcement and immunity strengthening” (see page 6).
Solid formulations for oral administration include tablets, pills, powders, granules, capsules and teaches the preferred dosage of the pharmaceutical composition according to the present invention varies depending on the condition and the weight of the patient, the degree of the disease, the drug form, the administration route and the period, but can be appropriately selected by those skilled in the art (see page 7). Furthermore. Kyu teaches that peony has the glucose uptake inhibition (see pages 10-14).
Qingyang teaches of medicines for treating diabetes (see abstract).
Qingyang teaches “The membrane of a chicken's gizzard can disperse accumulations it is stagnant, strengthening the spleen and stomach. Dyspepsia turgor is controlled, vomiting gastric disorder causing nausea, rush down dysentery, infantile malnutrition due to digestive disturbances or intestinal parasites is quenched one's thirst, lose and drown, larynx numbness (see page 5 at top).
Therefore it would have been obvious to persons of ordinary skill in the art before the effective filing date to combine each instantly claimed ingredient to from a TCM composition for treating diabetes because each ingredient is known in the art for having a particular effect for such a treatment. It would have also been obvious to add each component to the composition in a weight of 1-20g as this only appears to be a matter of judicious selection. Additionally, each ingredient is known to be an active ingredient with specific properties and optimizing each to find the range of greatest optimal effects and lowest potential negative effects is well within the purview of any artisan. Furthermore, 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.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art because the art recognizes the diabetic potential of each ingredient and combining them into a composition for said effect would have been prima facie obvious.
Response to Arguments
Applicant's arguments filed 10/11/2025 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655