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 .
Priority
Instant application 18/391,872, filed on 2023, Dec. 21, does not claim priority to any earlier filings.
Information Disclosure Statement
Applicant has elected to not submit an IDS for this invention.
Response to Restriction/Election
Applicant’s election of Group (II), claims 6-20, in the reply filed on 05/09/2026 is acknowledged. Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Because applicant did not respond completely, the Election made in the reply filed on 05/09/2026 is being treated as an election without traverse (MPEP § 818.01(a)).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over He, et al. (hereafter, He. CN 114224935A; published 2022, Mar. 25) in view of Ma et al. (hereafter, Ma. CN 101332212A; published 2008, Dec. 31), as evidenced by Yong, et al. (hereafter, Yong. Cordycepin, a Characteristic Bioactive Constituent in Cordyceps militaris, Ameliorates Hyperuricemia through URAT1 in Hyperuricemic Mice. Front. Microbiol. 2018, 9(58), doi: 10.3389/fmicb.2018.00058), as further evidenced by Hu, et al. (hereafter, Hu. Identification of Chemical markers in Cordyceps sinensis by HPLC-MS/MS. Anal. Bioanal. Chem., 2015, 407(26), 8059-8066. doi: 10.1007/s00216-015-8978-6), in further view of Soto-Maldonado, et al. (hereafter, Soto-Maldonado. Potential of Solid Wastes from the Walnut Industry: Extraction Conditions to Evaluate the Antioxidant and Bioherbicidal Activities. Electron. J. Biotechnol., 2022, 58, 25-36. https://doi.org/10.1016/j.ejbt.2022.04.005 ), as evidenced by Uğurlu, et al. (hereafter Uğurlu. Reduction of Bitterness in Green Walnuts by Conventional and Ultrasound-assisted Maceration. Ultrason. Sonochem. 2020, 66, 105094-105099. doi: 10.1016/j.ultsonch.2020.105094), further evidenced by Wang, et al. (hereafter, Wang. The Antioxidant Activities and the Xanthine Oxidase Inhibition Effects of Walnut (Juglans regia L.) Fruit, Stem, and Leaf. Int. J. Food Sci. Technol., 2015, 50, 233-239. doi:10.1111/ijfs.12672), further evidenced by Cicero, et al. (hereafter, Cicero. Clinical Effects of Xanthine Oxidase Inhibitors in Hyperuricemic Patients. Med. Princ. Pract., 2021, 30, 122-130. Doi: 10.1159/000512178), and in further view of Quan (CN 103393901A; published 2013, Nov. 20), as evidenced by Liu (CN 113318207A; published 2021, Aug. 31).
Regarding claims 6 and 19, steps 1-3 and 7, He teaches a preparation method for a cold compress spray for relieving gout (title, abstract, claim 1). The cold compress spray comprises adding baking soda into alkaline ionized water and enabling the pH to reach 12-13 after uniform stirring (claim 4, step 1), then adding L-carnitine into the soda alkaline water previously obtained and allow standing after uniform stirring (claim 4, step 2), then adding Eucommia bark water extract and the green olive juice into the solution previously obtained and filtering it. He further teaches the concentration of the obtained gout relief spray, filling the spray into a filling machine to obtain the cold compress spray (claim 4, step 5). He uses the term “filling machine” while the instant application recites the use of a “filling device”, however, one skilled in the art would know that the two terms are interchangeable as they are synonyms of each other.
The difference between He and the instant application is that He fails to teach the use of cordyceps sinensis particles with a particle size corresponding to more than 100 meshes to make a cordyceps sinensis solution. He further fails to teach the use soaking walnut shell in water for 30-60 hours, placing the walnut shell into an extraction tank after soaking, using water with a weight 10-20 times a weight of the walnut shell as a solvent to extract the walnut shell to obtain an initial walnut shell solution, and filtering the initial walnut shell solution to obtain a walnut shell solution. He further fails to teach high-temperature instant sterilization on an aloe vera leaf, removing a base and a tip of the aloe vera leaf, cutting the aloe vera leaf with the base and tip removed into pieces to obtain slices, placing the slices in a container, repeating a process for 2-3 times, the process comprising freezing the slices for 6-8 hours outdoors and thawing the slices after the slices are frozen totally, to separate aloe vera pulp from aloe vera shells of the slices naturally, and filtering the aloe vera pulp to obtain aloe vera juice.
Regarding claims 6 and 19, step 4, Ma teaches a Cordyceps micropowder tablet containing Cordyceps sinensis medicinal powder and no auxiliary material, and a preparation method thereof, which pertains to the field of medicines and health products (title, abstract). Ma further teaches that when the Cordyceps sinensis particle size is 5 – 150 μM (e.g., > 100 mesh), the dissolution rate of the particle is fastest (Tables 1 -4).
A person of ordinary skill in the art would be motivated to incorporate Cordyceps sinensis with low particle size into a compress spray to relieve gout because the fine particle size would allow it to dissolve in solution easier and thereby affording the composition with a greater therapeutic effect. Furthermore, the use of Cordyceps as a gout relief agent is evidenced by Yong, wherein it is taught that Cordycepin is a characteristic bioactive agent in Cordyceps militaris that can ameliorate hyperuricemia (e.g., gout) (title, abstract). As evidenced by Hu, it was known in the art prior to the effective filing date of the current invention that the active agent Cordycepin is also found in Cordyceps sinensis (abstract). Therefore, a reasonable expectation of success existed for a skilled artisan to include Cordyceps sinensis of small particle size as taught by Jianbin and evidenced by Yong and Hu into a compress spray for gout relief.
The difference between the combined teachings of He and Ma and the instant application is that the combined teachings fail to teach the use soaking walnut shell in water for 30-60 hours, placing the walnut shell into an extraction tank after soaking, using water with a weight 10-20 times a weight of the walnut shell as a solvent to extract the walnut shell to obtain an initial walnut shell solution, and filtering the initial walnut shell solution to obtain a walnut shell solution. The combined teachings of He and Ma further fails to teach high-temperature instant sterilization on an aloe vera leaf, removing a base and a tip of the aloe vera leaf, cutting the aloe vera leaf with the base and tip removed into pieces to obtain slices, placing the slices in a container, repeating a process for 2-3 times, the process comprising freezing the slices for 6-8 hours outdoors and thawing the slices after the slices are frozen totally, to separate aloe vera pulp from aloe vera shells of the slices naturally, and filtering the aloe vera pulp to obtain aloe vera juice.
Regarding claims 6 and 19, step 5, Soto-Maldonado teaches extraction conditions to evaluate the antioxidant and bioherbicidal activities of walnut husk and shell (title, abstract). The extraction process involves ground walnut shell and carried out using a solid/solvent ratio of 1/20g /mL (page 27, left column, section 2.2, paragraph 1). The extracting solvents are taught to be organic solvent/water ratios of varying ratios up to 0/100 (page 27, left column, section 2.2, paragraph 1). The effect antioxidant and bioherbicidal extraction in water is evidenced in Uğurlu, wherein it is taught that the phenolic and antioxidant content in walnuts is extracted for up to 14 hours using ultrasound-assisted maceration and up to 10 days using a conventional maceration method (page 5, Table 4). Using the parameters disclosed by Uğurlu, a person with ordinary skill in the art would have been able to arrive at the claimed soaking time of 30-60 hours through routine optimization.
A skilled artisan would have been motivated to use a concentrated walnut shell solution in a compress spray for relieving gout because the medicinal properties of walnut shell extract on gout relief was known in the art prior to the effective filing date of the current invention. For example, Wang teaches the antioxidant activities and the xanthine oxidase inhibition effects of walnut fruit, stem, and leaf (title). Wang further teaches that the walnut shell extract has the highest phenolic content compared to other parts of the nut (abstract). Wang further teaches the walnut shell extract had the highest antioxidant activity and showed >50% inhibition of xanthine oxidase at 2 mg/mL (abstract). As evidenced by Cicero, inhibition of xanthine oxidase has shown clinical efficacy in chronic hyperuricemia (e.g., gout relief) (title, abstract). Therefore, one with ordinary skill in the art would have had a reasonable expectation of success to produce an effective compress spray for relieve gout by using walnut shell extract as taught by Soto-Maldonado and evidenced by Uğurlu, Wang, and Cicero.
The combined teachings of He, Ma, and Soto-Maldonado fails to teach high-temperature instant sterilization on an aloe vera leaf, removing a base and a tip of the aloe vera leaf, cutting the aloe vera leaf with the base and tip removed into pieces to obtain slices, placing the slices in a container, repeating a process for 2-3 times, the process comprising freezing the slices for 6-8 hours outdoors and thawing the slices after the slices are frozen totally, to separate aloe vera pulp from aloe vera shells of the slices naturally, and filtering the aloe vera pulp to obtain aloe vera juice.
Regarding claims 6 and 19, step 6, Quan teaches a method used for preparing aloe juice by refrigeration, wherein the method is comprised of first and second extraction steps (title, abstract). Quan teaches that the first extraction step comprises the following: the aloe leaves are washed, and treated by instant high temperature sterilization, and blade base and blade tip are removed; the processed aloe leaves are cut into pieces, and then are added into a container, and are pressed as being added; the container filled with aloe leaves is placed outside at –10 to –30 °C for 6 to 8 h of refrigeration, and then is thawed after complete refrigeration; the refrigeration and thawing process is repeated for 2 to 3 times so that pulp and juice of aloe will separate from leaf skin naturally, and the mixture is filtered so as to obtain aloe juice of excellent quality, high freshness, low production cost, and is not polluted (abstract).
A person of ordinary skill in the art would have been motivated to combine the teachings of Quan into a compress spray for gout relief because aloe was known in the art as being an effective gout relief agent prior to the effective filing date of the current invention, as evidenced by Liu. Liu teaches a cold compress gel for relieving gout and preparation method thereof, wherein the raw materials are comprised aloe. Therefore, there was a reasonable expectation that the aloe juice as prepared by Quan and evidenced by Liu would have been effective in a cold compress spray.
Accordingly, a person with ordinary skill in the art prior to the effective filing date of the combined inventions would have been able to combined the teachings of He, Ma, Soto-Maldonado, and Quan to arrive at instant claims 6 and 19.
Regarding claims 7, 17, and 18, Quan teaches the aloe vera leaves are placed outside at –10 to –30 °C (abstract).
Regarding claims 8, 15, 16, and 20, He teaches a cold compress spray with relative density of the concentrated solution is 1.10 – 1.15 (claim 4, step 5)
Regarding claim 9, Quan teaches the aloe vera leaves are placed outdoors for 6 to 8 hours (abstract).
Regarding claims 10 and 11, He teaches the soda alkaline water, after uniformly stirring, to have pH value of 12-13 (claim 4, step 1).
Regarding claims 12-14, Soto-Maldonado teaches an extraction process involving ground walnut shell and carried out using a solid/solvent ratio of 1/20g /mL (page 27, left column, section 2.2, paragraph 1).
Conclusion
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/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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