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 .
Status of the Claims
Acknowledgement is made of the response filed on August 11, 2025. In that response, claims 21-23, 28, and 30 were amended and claims 26 and 27 were cancelled. Claims 21-25 and 28-30 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Construction
The amended claim phrase “dried traditional-Chinese-medicine material” (i.e., without “raw” after “dried”) is construed as any traditional Chinese medicine material that had undergone any drying process. According to Applicant (p.8, Remarks, May 29, 2024), the “dried traditional-Chinese-medicine material” need not have been sliced or honey-fried as in the examples of “raw materials” in the disclosure (see p.4, Office action, Feb. 29, 2024).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-25 and 28-30 are rejected under 35 U.S.C. 103 as unpatentable over Danielle (Danielle, How to make delicious fruit powder at home, available at https://lovelovething.com/making-fruit-powder/#tasty-recipes-5708-jump-target, accessed on February 5, 2025, published July 22, 2013) in view of Dharmananda (Dharmananda, S., the methods of preparation of herb formulas: Decoctions, Dried Decoctions, Powders, Pills, Tablets, and Tinctures, May 1997, available at http://www.itmonline.org/arts/methprep.htm, accessed on 2/22/24).
Danielle teaches dehydrating peaches, and mixing and grinding with arrowroot powder in a blender (pp.3-4 of 67 “How to make homemade fruit powder). “Many dehydrated fruits are somewhat sticky, due to the sugar content”, so “[m]ake sure your dried fruit is dried very well” (p.6, top). Furthermore, “[i]f you’re turned off by the clumps, add 1/2 – 1 tsp of arrowroot powder(a healthy starch, similar to cornstarch) to the pile of fruit before blending, and it will go a long way to lessen clumping” (p.6, bottom). Peach is known in TCM as Tao Zi.
Danielle does not discuss size of the peach powder, other excipients, and the potency of the powder as recited in claims 21, 23-25, 29, and 30.
Dharmananda teaches preparing powder from traditional Chinese medicinal herbs (title; pp.6-8). “In modern patent medicine factories in China, powders produced by machinery are expected to pass through very fine 80-100 mesh screens” (p.6 fourth para.). Dharmananda teaches starch as a suitable carrier (p.5 second para.). Also, “powder…are used at lower dosages, to replace the higher dosage decoctions” (p.7 third para.). For example teas from boiling licorice pieces and coarsely powdered licorice “revealed that 28% more glycyrrhizin could be isolated from half as much licorice powder as cooked licorice slices” (id.). “When ingesting powders directly, one-fifth to one-tenth the weight of herb materials utilized for decoction can sometimes be used in order to obtain similar effects.” (Id.)
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to combine the teachings of Danielle and Dharmananda as recited in the instant claims. The skilled person would have been motivated to do so because Dharmananda teaches suitable particle size that can be attained from common factory machinery and that less of the powdered material is needed for the same dosage of the active agents in a medicinal material. The recitation of the specific dosages in claims 21 and 30 are not afforded patentable weight because Dharmananda teaches the reduction in quantity of the medicinal material needed for equivalent dosage that arises from powdering the material, and the specific dosage would depend on the identity of the material as well as the method of decoction or extraction.
Regarding claim 28, Danielle does not discuss using a second starch or excipient. However mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Claims 21-25 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sarala (Sarala, P., et al., Monkey jack: underutilized edible medicinal plant, nutritional attributes and traditional foods of Western Ghats, Karnataka, India, Indian Journal of Traditional Knowledge, vol. 13 (3) July 2014 508-18) in view of Dharmananda (Dharmananda, S., the methods of preparation of herb formulas: Decoctions, Dried Decoctions, Powders, Pills, Tablets, and Tinctures, May 1997, available at http://www.itmonline.org/arts/methprep.htm, accessed on 2/22/24).
Sarala describes preparation of wate pudi: Monkey jack (Artocarpus gomenzianus Wall,ex Trecul) fruit slices are “dried under direct sunlight for 8-10 days”, the seeds are removed, and then “pounded into powder along with 3-5% common salt” (p.509 right col., p.510 right col., Fig.2(f),(i), and accompanying text). The “drying under direct sunlight for 8-10 days” of the thin slices (Fig.2(f)) would result in little or no moisture that attains the fine powder shown in Fig.2(i). The powder would be in some “predefined range” of the person pounding the material. Furthermore the addition of the salt would inherently adjust the dosage of the fruit powder.
Sarala does not specifically refer to Monkey jack as a traditional-Chinese-medicine material.
However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to use Sarala’s method in a traditional Chinese medicine material as recited in the instant claims. The skilled person would have been motivated to do so because traditional Chinese medicine material includes fruits such as jujube, and Sarala’s method yields dried and salted product that would be more storage-stable relative to the initial product.
Regarding “for reducing the stickiness …”, it is noted that the “reducing the stickiness” is not a separate action performed, i.e., as a step comprising the method claimed. Rather it would occur as the grinding of the mixture is performed, and depending on the nature of the dried traditional-Chinese-medicine material and the excipient such as their chemical makeup, e.g., moisture content, and physical structure. Thus the clause raises a question as to the limiting effect of the claim language. Such a clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”, as in the instant claim. MPEP § 2111.04 (citations omitted).
Specifically the present claims do not specify any of these features in the dried traditional Chinese medicine material, excipient, or the mixture that confers patentable weight on the “for reducing the stickiness…”. As just one example, the “one or more dried traditional-Chinese-medicine material” is not further defined: it includes material that has been completely dried such as tea leaves, which are not sticky. In the vacuum of any features regarding the dried traditional-Chinese-medicine material, excipient, or the mixture, the phrase is not given weight.
Regarding claim 28, Sarala does not discuss using a second excipient. However mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Sarala does not discuss size of the Monkey jack fruit powder, other excipients, and the potency of the powder as recited in claims 21, 23-25, 29, and 30.
Dharmananda teaches preparing powder from traditional Chinese medicinal herbs (title; pp.6-8). “In modern patent medicine factories in China, powders produced by machinery are expected to pass through very fine 80-100 mesh screens” (p.6 fourth para.). Dharmananda teaches starch as a suitable carrier (p.5 second para.). Also, “powder…are used at lower dosages, to replace the higher dosage decoctions” (p.7 third para.). For example teas from boiling licorice pieces and coarsely powdered licorice “revealed that 28% more glycyrrhizin could be isolated from half as much licorice powder as cooked licorice slices” (id. (emphases added)). “When ingesting powders directly, one-fifth to one-tenth the weight of herb materials utilized for decoction can sometimes be used in order to obtain similar effects.” (Id. (emphases added).)
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to combine the teachings of Sarala and Dharmananda as recited in the instant claims. The skilled person would have been motivated to do so because Dharmananda teaches suitable particle size that can be attained from common factory machinery, an alternative carrier for powdered medicine, and that less of the powdered material is needed for the same dosage of the active agents in a medicinal material. The recitation of the specific dosages in claims 21 and 30 are not afforded patentable weight because Dharmananda teaches the reduction in quantity of the medicinal material needed for equivalent dosage that arises from powdering the material, and the specific dosage would depend on the identity of the material as well as the method of decoction or extraction.
Response to Arguments
Applicant's arguments filed August 11, 2025 have been fully considered but they are not persuasive. Applicant argues that the present disclosure solves problems of stickiness and accurate dosing encountered in traditional Chinese medicines. (Remarks, 3-4, August 11, 2025.)
In response it is noted that Danielle expressly notes the clumping while grinding which is a manifestation of stickiness of the dried peach, and teaches using starch during the grinding process to combat that issue.
As for the argument regarding “ensuring accurate dosage taken each time” (Remarks, 11 referencing Specification para.[0061]), it is not seen that the present claims, in reciting “wherein said predefined amount of the one or more selected first edible excipients is such that a dosage of 1 gram (g)… is equivalent to a dosage of 5g …in the non-powder forms” resulting in “ensuring accurate dosage taken each time”. Ensuring accurate dosage of a medicinal product would depend on quality control measures such as standardizing an extract or analyzing samples from different batches of a raw medicinal material for consistent active agent concentration, among others. For example an herbal medicine grown in different soils or geographic regions could differ in the active agent concentration.
As noted above Dharmananda teaches that using a powder can yield similar results as using a five- or ten-fold quantity of non-powder material (“powder…are used at lower dosages, to replace the higher dosage decoctions” (p.7 third para.)). For example teas from boiling licorice pieces and coarsely powdered licorice “revealed that 28% more glycyrrhizin could be isolated from half as much licorice powder as cooked licorice slices” (id. (emphases added)). “When ingesting powders directly, one-fifth to one-tenth the weight of herb materials utilized for decoction can sometimes be used in order to obtain similar effects.” (Id. (emphases added).)
CONCLUSION
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.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614