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 .
Election/Restrictions
Applicant’s election without traverse of the Group I, claims 1-9, in the reply filed on 5/14/2026 is acknowledged.
Claims 10-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on5/14/2026.
Claims 1-9 as filed on 5/14/2026 are under examination in the instant office action.
Claim Rejections - 35 USC § 112
Claim 6 is 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 6 recites a relative density number without units of density as intended, thus, claim is indefinite as claimed and in the lack of specification definitions.
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (“Compatibility of Fuzi and Ginseng Significantly Increase the Exposure of Aconitines”. Frontiers in Pharmacology. April 2022, Vol.13, article 883898, pages 1-12) in view of Liu et al (“A review of traditional and current methods used to potentially reduce toxicity of Aconitum roots in Traditional Chinese Medicine”. Journal of Ethnopharmacology, 2017, 2207, pages 237-250) and CN 110934983 (Chen et al).
The cited reference by Chen teaches a method for reducing toxicity and retaining/increasing therapeutic efficacy of Chinese herbal medicine Fuzi (decoction of Radix Aconiti Lateralis Preparata) by combining Fuzi with ginseng (Radix Ginseng), thus, providing a herb-pair ginseng-Fuzi (named “Shenfu”) decoction (see abstract at page 1). The Radix Aconiti Lateralis Preparata is a preparation made from root of plant Aconitum carmichaelii; and aconites are its main active ingredients which have both therapeutic effects and poisoning side effects (see paragraph bridging pages 1 and 2). The reference by Chen acknowledges that decoction of Radix Aconiti Lateralis Preparata (named Fuzi) is commonly used for treatment of rheumatism, heart failure and renal failure (see page 1, last 3 lines).
In particular, as applied to a method of making a Fuzi decoction, the cited reference discloses steps of subjecting Radix Aconiti Lateralis Preparata (Fuzi powder) to immersion for about 30 min in water (mass ratio 1: 10) and to further decoction (boiling) in water twice for a total of about 60 min (see page 3, col. 2, section 2.4, lines 1-5); thus, the same protocol as encompassed by the claim 1, step (1) and claim 3. The decoction was filtered and concentrated. As for a combination of herb-pair Fuzi and Ginseng, the mass ratio was 1:1 (page 5, col.1, line 1) and the steps were the same as for Fuzi extract as disclosed by the cited reference; thereby, immersing in water, decocting, filtering and concentrating as encompassed by the claim 1 for a combination of herbs.
Thus, the cited reference by Chen teaches making a combination of Fuzi with Ginseng by substantially the same protocol. But it is silent about additional herbs of Traditional Chinese Medicine (TMC).
However, the prior art discloses that addition of Radix Paeoniae Alba have been knonw and used for reduction of aconite toxicity in a combination with Fuzi and Chuanwu, which are preparations from the roots of the same plant Aconitum carmichaelii (see Liu at page 238, col. 2, lines 9-13; see page 239, col.1, par. 1)
Further, providing a combination of all claimed-recited herb as intended for treating rheumatism has been knonw in the prior art; for example: see CN 110934983 (Chen et al) Derwent English translation. The cited document teaches (see section “Description”) providing a combination of herbs including Poria (same/synonym “China root”), Ginseng, Rhizoma Atractylodis, Radix Paeoniae Alba, Radix Paeoniae Rubra (same as “red peony root”) and Ramulus Cinnamomi (same as “cinnamon”) with “aconite”, which is a main active therapeutic and toxic ingredient of pending claim-recited Fuzi. The cited preparation method comprises immersing herbs in water and extracting at boiling temperature (decoction) for 1-3 hours and further making decoction granule or pills of 1 mm size or about 16 mesh (see last 2 lines of section “equivalent abstract, pharmaceuticals”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add or to mix Poria (same/synonym “china root”), Ginseng, Rhizoma Atractylodis, Radix Paeoniae Alba, Radix Paeoniae Rubra (same as “red peony root”) and Ramulus Cinnamomi (same as “cinnamon”) taught by CN 110934983 (Chen et al) into the Fuzi decoction in the method of Chen for reducing toxicity but retaining/increasing therapeutic efficacy of Chinese herbal medicine Fuzi with a reasonable expectation of success in reducing toxicity of aconite as main component of Fuzi while retaining/increasing therapeutic efficacy of Fuzi because prior art explicitly teaches that addition of Ginseng and Radix Paeoniae Alba reduces toxicity of aconite and because all pending clam-recited traditional Chinese medicinal herbs including Fuzi decoction and decoction of additional herbs have knonw and/or provided for treatment of same condition such as rheumatism, for example, as acknowledged by both cited documents including reference by Chen and CN 110934983.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
With regard to limitations drawn to maltodextrin as carrier and spray drying it is noted that these are common and well-established practices in pharmacology. One of skill in the art would be able to optimize mass ratio of herbs depending on specific sources and conditions of particular herbs and on desired effectiveness of medicinal herbs.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
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Vera Afremova
July 15, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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