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 .
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 Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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)).
Status of the Claims
The status of the claims are as follows.
Claims 1-20 are pending.
Claims 1-5 are withdrawn.
Claims 6-20 are rejected.
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 Amendment/Arguments
The amendment filed 08/12/2026 has been entered. Claims 6 and 19 are amended. No claims have been cancelled. No new claims have been added.
Applicant’s arguments (Remarked 08/12/2026) traversing the rejection claims 6-20 under 35 U.S.C. § 103 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). Applicant’s assertions are as follows:
Each of the cited references does not disclose the specific combination of eight components in the claimed weight ratios of currently amended claim 6, either alone or in combination.
There is no motivation to combine the disparate references because a person of ordinary skill in the art would have no motivation to “improve” upon an already functional composition (disclosed by He) by adding three additional components from different technical fields. Furthermore, the combination of ten separate references is impermissible hindsight bias.
The cited references teach away from the proposed combination, particularly in regards to Ma and Ugurlu.
Objective evidence of non-obviousness is demonstrated in the specification of the Instant Application. In particular, Table 1 provides evidence that the composition of currently amended claim 6 is non-obvious. Furthermore, a person of ordinary skill in the art would not have reasonably predicted that the specific eight-component combination in the claimed weight ratios would produce a statistically significant therapeutic effect, while formulations missing even two components would not.
The Instant Application provides additional support from the analgesic test. In particular, Table 2 provides evidence that the complete formulation approximately doubled the pain threshold in mice over comparative examples.
The technical solution of currently amended claim 6 could not be arrived at by “routine optimization” from the reference teachings, specifically maceration of walnut shells as taught by Ugurlu.
The above arguments have been fully considered but are not found persuasive for the following reasons.
He teaches a cold compress spray for relieving gout and preparation methods thereof (title). The cold compress spray consists of 6 components, as transcribed from claim 1 to the table below
Table 1. Gout relieving spray of He
Component
Alkaline ionized water
Sodium bicarbonate
L-carnitine
Eucommia bark water extract
Green olive juice
Monosodium Glutamate
Part by weight
97-99
0.2-1.8
0.1-0.5
0.1-0.5
0.01-0.1
0.01-0.1
The Instant Application recites a cold compress spray for relieving gout and preparation method thereof. The cold compress spray of currently amended claim 6 comprises the following five components from the composition of He.
Table 2. Gout relieving spray of currently amended claim 6
Component
Alkaline ionized water
Sodium bicarbonate
L-carnitine
Eucommia bark water extract
Olive juice
Part by weight
97-99
0.2-1.8
0.1-0.5
0.1-0.5
0.01-0.1
Currently amended claim 6 further comprises the following three components that deviate from the composition of He.
Table 3. Additional components of Instant gout relief spray
Component
Cordyceps sinensis
Walnut shell
Aloe vera leaf
Part by weight
0.2-1
0.1-1
0.1-0.5
Regarding Applicant assertion a from above, the rejection of record is not over any one individual reference, but is rather based on He as modified by Ma as evidenced by Yong as evidenced by Hu and modified by Soto-Maldonado as evidenced by Ugurlu, and as evidenced by Wang, and as evidenced by Cicero and modified by Quan as evidenced by Liu. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The gout relief spray of He and the gout relief spray of the Instant Application overlap in five out of eight components, both in component identity and component weight ratio. The difference between the gout relief spray of He and the Instant Application is that He fails to teach the use of cordyceps sinensis, walnut shell, and aloe vera leaf.
However, as stated in the argument of record, the teaching of Ma as evidenced by Yong as evidenced by Hu renders obvious the use of cordyceps sinensis to treat gout, the teaching of Soto-Maldonado as evidenced by Ugurlu, and evidenced by Wang, and evidenced by Cicero renders obvious the use of walnut shell extract to treat gout, and the teaching of Quan as evidenced by Liu renders obvious the use of aloe vera leaf extract to treat gout.
Regarding Applicant assertion b above, applying prong (A) of the KSR rationale, one of ordinary skill in the art would have a reasonable expectation of success to combine elements of the prior art according to known methods to yield predictable results. Furthermore, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The difference between the combined teachings and the Instant Application is that the combined teachings fail to teach using cordyceps sinensis in 0.1-1 parts by weight, walnut shell in 0.1-1 parts by weight, and aloe vera lead in 0.1-0.5 parts by weight.
However, MPEP 2144.05 notes that differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result effective variable is critical. The Instant Specification provides no evidence of such criticality over the teaching of He.
Applicant asserts Table 1 (page 13, paragraph 0028, Table 1) provides evidence of the objective non-obviousness of the composition of currently amended claim 6 (Applicant assertion d).
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He teaches the effects of sodium urate on ankle joint swelling of rats, as transcribed below from Table 1 (paragraph 0073) (X±SD，n＝9).
Group
Dosage (g/kg)
Pre-modeling volume (mL)
Volume after modeling (mL)
6 h
12 h
24 h
48 h
Modeling control
Equal volumes
2.09±0.14
2.84±0.29
2.97±0.31
2.72±0.34
2.33±0.30
Indomethacin
0.0045
2.12±0.21
2.42±0.15
2.29±0.30
2.18±0.09
2.16±0.14
Experiment 1 group
0.1L/each
2.01±0.17
2.57±0.29
2.43±0.24
2.22±0.30
2.11±0.19
Experiment 2 group
0.1L/each
2.03±0.12
2.62±0.17
2.47±0.18
2.29±0.24
2.15±0.11
Experiment 3 group
0.1L/each
2.03±0.20
2.49±0.42
2.39±0.25
2.18±0.23
2.14±0.19
Comparative example 1 group
0.1L/each
2.04±0.09
2.70±0.30
2.87±0.24
2.60±0.24
2.26±0.23
Comparative example 2 group
0.1L/each
1.98±0.14
2.74±0.28
2.85±0.19
2.64±0.18
2.30±0.24
The effects of sodium urate on ankle joint swelling of rats of the Instant Specification show a negligible difference, if any at all, compared to the formulation of He. Therefore, Table 1 of the Instant Specification fails to show the criticality of the cordyceps sinensis, walnut shell, and/or aloe vera components, as well as their weight ratios, in view of the composition of He.
Applicant further asserts Tabe 2 provides additional support for object non-obviousness based on the synergetic effect of the claimed composition (Applicant assertion e)
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He further teaches the effects of the gout relief spray on pain threshold values of mice, as transcribed below from Table 2 (paragraph 0087).
Group
Amount
Pain threshold (S, X±SD)
Before administration
After administration
15 min
30 min
60 min
Matrix group
10
9.4±1.8
9.4±2.6
9.0±1.9
9.0±1.8
Experiment 1 group
10
10.6±2.4
21.8±2.1
19.7±2.5
19.5±1.9
Experiment 2 group
10
10.5±2.8
22.1±1.8
19.4±2.1
19.7±1.0
Experiment 3 group
10
10.7±1.7
22.3±0.9
21.3±1.6
21.7±1.8
Comparative example 1 group
10
9.9±2.1
10.8±2.6
12.4±2.4
12.2±2.2
Comparative example 2 group
10
10.2±2.3
11.3±1.7
12.0±2.1
12.2±1.9
Applicant asserts support for objective non-obviousness arises from the approximately doubled pain threshold in mice (from ~10s to ~20s), while comparative examples showed only marginal improvement (from ~10s to ~12 s). However, the gout relief spray of He delivers the same analgesic effect. Therefore, Table 2 of the Instant Specification fails to show the criticality of the cordyceps sinensis, walnut shell, and/or aloe vera components, as well as their weight ratios, in view of the composition of He.
Regarding Applicant assertion c above, Examiner acknowledges that Applicant’s interpretation of the teaching of Ma and the teaching of Ugurlu is true but respectfully disagrees that they teach away from the proposed combination.
Ma teaches cordyceps micropowder tablet aimed at providing a tablet containing cordyceps sinensis medicinal powder and no auxiliary material and the granule diameter of 1 µm to 150 µm (abstract). Table 1 shows the dissolution rate of cordyceps sinensis based on particle size compared to whole plant (5g cordyceps sinensis per 100 mL water), wherein grade I powder is 150-420 µm diameter; grade II powder is 33-44 µm diameter; and grade III is 15-20 µm diameter. It should be emphasized that the data below is based on cordyceps sinensis in the powder form and not the tablet form.
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Ma interprets these results as dissolution rate of cordyceps sinensis grade III powder is very fast, which is conductive to the rapid dissolution of the active ingredients of cordyceps sinensis, and can achieve the purpose of fast dissolution and rapid effect (page 6, paragraph 4). Therefore, a skilled artisan would have found it obvious to incorporate cordyceps sinensis grade III powder (15-20 µm diameter; between 100-2000 mesh) into an aqueous composition with a reasonable expectation of success. Regarding Applicant’s assertion that the fine particle sizes may cause nozzle clogging, agglomeration, or instability in an alkaline liquid formulation, Ma fails to teach any precipitation of cordyceps sinensis. However, Ma teaches the opposite. The dissolution rate of cordyceps III grade powder is said to be so fast that it is of little practical significance to decrease the particle size any smaller, in terms of efficacy and cost control (page 6, paragraph 4). Cordyceps sinensis of such a small particle that so readily dissolves in water is unlikely to cause the asserted issues.
Ugurlu teaches maceration of walnut shells to maximize extraction of the active phenolic compounds, whereby maximum extraction occurred at 10 days, compared to 6 days and 8 days. Applicant asserts that a person of ordinary skill in the art could not have arrived at the claimed 30-60 hour soaking time through routine optimization of Ugurlu’s 10-day maceration. Applicant further asserts a person of ordinary skill in the art following Ugurlu’s teaching would extend, not shorten, the extraction time. As minor point of correction, Ugurlu teaches the maximum amount of phenolic extraction occurs at 6 days, not 10 days.
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However, the assertion that Ugurlu teaches maximum phenolic compound extraction occurs over 6 days, and up to 10 days is true only for conventional maceration methods. As stated in the rejection of record, Ugurlu further teaches extraction up to 14 hours using ultrasound-assisted maceration (page 5, Table 3). All macerations methods must be considered equally by broadest reasonable interpretation because currently amended claim 6 does not exclude maceration methods alternative to conventional soaking.
Table 3 further teaches the amount of extracted phenolic contents vary by time and identity. For example, the maximum amount of gallic acid was extracted at 8 hours of ultrasound-assisted maceration, while no gallic acid was extracted by conventional maceration. Additionally, the maximum amount of neochlorogenic acid extracted by conventional maceration occurred over 6 days (12.09 mg/kg), which is far below the maximum amount of neochlorogenic acid extracted by ultrasound-assisted maceration at 6 hours (147 mg/kg). That is to say that maceration is a results-effective variable that is dependent on at least maceration method, time, and identity of extract. Accordingly, one of ordinary skill in the art would be able to routinely optimize maceration parameters to arrive at a soaking time of between 30-60 hours from the teaching of Ugurlu.
Reconsidering the entire record and weighing Applicant’s evidence together with the evidence supporting the prima facie case, the examiner finds that the rebuttal evidence does not outweigh the evidence of obviousness. Therefore, in view of the foregoing, the rejection of claims 6-20 are maintained.
Claim Rejections - 35 USC § 103 – Maintained
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).
Conclusions
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 Paul Arcoria whose telephone number is (571)272-8719. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/P.A./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
