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 2, 2025 and September 24, 2025. In the response, claims 1, 4, and 5 were amended. Claims 1-10 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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 107362229A; citations rely on the attached machine translation) in view of Shukla (US 20140112971).
Sun teaches a traditional Chinese medicine for treating bone pain, comprising 15-25 grams of Eucommia bark and 6-20g of Psoralea corylifolia (title; abstract; claim 2) which are ground and then decocted by boiling in water (p.2 last para.-p.3 first para.). The decoction in liquid form is administered (p.3 first-second paras.). The ratio of 15-25 grams to 6-20 g includes 2:2.
Regarding claim 3 which recites a process, i.e., heating Eucommia bark and Psoralea corylifolia, it is noted that the “patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP §2113 (citations omitted). Sun teaches boiling the medicines in water, i.e., 100 °C or higher, to obtain a decoction, for treating bone pain. Therefore the composition obtained from the process of claim 3 is obvious from Sun’s composition.
Sun does not specifically teach using pecan kernels, walnut kernels, or a sweetener as in claims 1, 5, and 10.
Shukla is drawn to orally administered edible products designed for single oral “dose” of lipophilic ingredients for treatment of bone and joint diseases, including pecan kernel and walnut kernel (title; abstract; paras.0007-08, 0019-22, 0024; claim 1-3, 8-11). Shukla teaches using a sweetener (paras.0020, 0025). Shukla refers to conventional oral dosage forms including liquid, capsule, and pills (abstract; para.0001), and its edible product has various shapes which have a coating, i.e., capsules (paras.0014-17, 0028-29, Figs.1A-4B and accompanying text).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Sun and Shukla and combine pecan and walnut kernels with Eucommia bark and Psoralea corylifolia seeds as recited in the instant claims. The skilled person would have been motivated to do so because both are drawn to treating bone diseases, and Sun and Shukla each teach therapeutic substances for that purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).
Regarding the ratio of the pecan kernels to the Eucommia bark and Psoralea corylifolia in claim 2, Sun teaches the ratio of 15-25 grams to 6-20 g which includes 2:2. Shukla teaches non-limiting mixture of different parts and forms of plant-based active ingredients, e.g., seeds, bark, their extract, etc. (paras.0021, 0027), with different weight ranges. Thus the ordinarily skilled person could experiment within their guidelines to arrive at the optimal ratio. For result-effective variables such as relative concentrations of active agents, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claim 9, Sun teaches administering the decoction over several days, and therefore it would be stored in a container. Without more it is not seen that storage of a liquid dosage form in a sachet versus some other container, e.g., a bottle, would result in a patentable difference.
Response to Arguments
Applicant's arguments filed August 2, 2025 have been fully considered but they are not persuasive. Applicant argues that the “independent claims require (i) a composition consisting of exactly three botanicals; Pecan Kernels, Eucommia bark, and Psoralea fruit, and (ii) those botanicals being present in the specific weight ratios recited in the claims”. (Remarks, 4, August 2, 2025 (emphasis in original).)
In response it is noted the following are noted. First, there is a single independent claim 1. Second, claim 1 recites “pharmaceutical composition …joint strain comprising”, not “consisting of” as Applicant argues. The term “comprising” is open-ended, meaning other components are not excluded. he term “consisting of” does exclude all other components from the scope of the claim. Because claim 1 recites “comprising”, it reads on Sun’s composition, even though Sun teaches including many medicines other than Eucommia bark and Psoralea fruit, but for the pecan kernel, in its pain medicine composition.
Third, only dependent claim 2 recites the ratio of 1:2:2, and furthermore it does not specify the ratio by weight as Applicant argues. “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim”. MPEP § 2111.01.II (citations omitted). Because claims are given the broadest reasonable interpretation, the ratio could be by volume, number of pieces, etc.
Applicant further argues that neither Sun (D1) nor Shukla (D2) “teaches a three-ingredient system”, there is no motivation to combine or a reasonable expectation of success, and only a hindsight reconstruction would arrive at the “weight ratios of 1: 1: 1 or 1:2:2”. (Remarks, 4, 5, August 2, 2025.)
In response it is again noted that independent claim 1 and all the dependent claims are not limited to “a three-ingredient system” due to the claim term “comprising”. Moreover the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the skilled person would have been motivated to combine Sun and Shukla because both are drawn to treating bone diseases, and Sun and Shukla each teach therapeutic substances for that purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).
Regarding the ratio, it is unclear why the ratio of 1:1:1 is mentioned, as that ratio is not recited in any of the claims. At any rate as discussed above Sun teaches the ratio of 15-25 grams of Eucommia bark and 6-20 g of Psoralea corylifolia which includes 2:2. Shukla teaches combining different parts and forms of plant-based active ingredients, e.g., seeds, bark, their extract, etc. (paras.0021, 0027), in various weight ranges. Thus the ordinarily skilled person could experiment within their guidelines to arrive at the optimal ratio. Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Applicant next refers to a comparative study in Attachment 3 entitled “Table of Test Results Demonstrating Synergistic Effect” to establish non-obviousness. (Remarks, 5.)
In response, first, the evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). Only claim 2 recites the ratio of 1:2:2. Also claim 1 is not limited to the ratio of 1:1:1 as implied in the Table but includes any combination of bark of Eucommia, Psoralea corylifolia, and pecan kernel, in any ratio.
Second, in order to determine a scope of that which might be synergistic and/or overcome prima facie obviousness, more detail is needed on the test conducted. The manner of preparing the combinations tested would be useful, specifically including whether the claimed combinations were ground medicines (Example 1) or a liquid formulation as disclosed (Example 2 part B). It is common knowledge that a botanical material and its decoction differ in chemical composition and its bioabsorption. Also needed is whether the subjects had “pain from muscle and joint strain”, whether the study was random and/or blinded, and the doses used.
CONCLUSION
THIS ACTION IS MADE FINAL. 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614