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 .
Claim Status
Applicant’s remarks and amendments, filed 9 February 2026 in response to the non-final rejection mailed DATE, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 9 February 2026 replaces all prior versions and listings of the claims.
Claims 1-10, 23, and 24 are pending. Claims 11-22 are canceled by Applicant’s amendment. Claims 23 and 24 are newly added. Claims 1-10 are amended. Claims 1-10, 23, and 24 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objection in regards to informalities. The objection to the specification has thus been withdrawn.
Applicant’s amendments to the claims have overcome the claim objection in regards to the term “system.” The objection to Claims 1-14, 21, and 22 has thus been withdrawn.
Applicant’s arguments and amendments, on page 5 of the reply filed 9 February 2026 with respect to the rejection of Claims 11-14 under 35 USC § 112(b) have been fully considered. The rejections of Claims 11-14 are withdrawn due to cancellation of the claims.
Claim Objections
Claim 23 is objected to because at line 11, the word “incture” should instead read --tincture--. Additionally, at line 12, the phrase “thejoint” should instead read --the joint--. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23 and 24 are 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.
In Claim 23, the limitation “a tincture comprising remaining herbs from the coconut oil infusion” is indefinite because it is unclear what exactly the remaining herbs are or how they are obtained. Clarification, e.g., “a tincture comprising herb particles filtered from the topical salve coconut oil infusion” or similar consistent with the disclosure, is necessary.
Additionally in Claim 23, the limitation “faster relief” is a relative term and without a comparison to another group, e.g., an untreated control or a control group undergoing a different treatment, it is indefinite.
In Claim 24, the limitation “wherein the tincture is created from the herbs, infused with the coconut oil from the salve preparation, mixed with high proof alcohol for a predetermined amount of time” is indefinite because it is unclear whether additional herbs are added to the coconut oil from the salve preparation and which herbs comprise the herbs. Additionally, it is unclear whether the herbs are infused with coconut oil and then mixed with high proof alcohol or whether both the coconut oil and herbs are mixed with high proof alcohol.
Additionally in Claim 24, the phrase “to help with how fast relief works” is indefinite because it is unclear what exactly is meant by this statement. It should instead be rephrased to indicate that the amount of time it takes for relief to occur is reduced or similar phrasing consistent with the instant disclosure and intended meaning of the claim.
Appropriate clarification is necessary.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Fealey et al. (WO 2014/083438 A2).
The instant claims are drawn to a kit (product) for the intended use as a medicinal treatment for treating arthritis and joint inflammation for internal and external use on a body.
Fealey et al. teach nutritional supplements which may be manufactured as an oral spray (a body; internal use) or ointment (salve; external use; a body) and may be used as a nutritional supplement, dietary supplement, food supplement, food additive, or combinations thereof (kit for medicinal treatment; Fealey et al., [0077]; as required for instant Claims 1, 2, and 5). Ingredients that may comprise the nutritional supplements include safflower (safflower oil; Fealey et al., [0068], page 31), evening primrose oil (eves primrose oil; Fealey et al., [0054], page 24), wheat germ (wheatgerm oil; Fealey et al., [0072], page 33), burdock (burdock root; Fealey et al., [0051], page 22; [0040], page 16), red clover (Fealey et al., [0067], page 30), yellow dock (Fealey et al., [0074], page 33), dandelion (dandelion root; Fealey et al., [0053], page 23), English chamomile (Fealey et al., [0054], page 24), cayenne (Fealey et al., [0052], page 22), meadowsweet (Fealey et al., [0062], page 28), bugleweed (Fealey et al., [0051], page 21), nettle (Fealey et al., [0063], page 28), and combinations and permutations thereof (as required for instant Claims 2 and 5).
With respect to the rejections above, please note that the intended use of the claimed
Composition (e.g., treating arthritis and joint inflammation) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fealey et al. (WO 2014/083438 A2).
The instant claims are as of record.
Fealey et al. teach nutritional supplements which may be manufactured as an oral spray (a body; internal use) or ointment (salve; external use; a body) and may be used as a nutritional supplement, dietary supplement, food supplement, food additive, or combinations thereof (system for medicinal treatment; Fealey et al., [0077]; as required for instant Claims 1, 2, 5, and 23). Ingredients that may comprise the nutritional supplements include safflower (safflower oil; Fealey et al., [0068], page 31), evening primrose oil (eves primrose oil; Fealey et al., [0054], page 24), wheat germ (wheatgerm oil; Fealey et al., [0072], page 33), burdock (burdock root; Fealey et al., [0051], page 22; [0040], page 16), red clover (Fealey et al., [0067], page 30), yellow dock (Fealey et al., [0074], page 33), dandelion (dandelion root; Fealey et al., [0053], page 23), English chamomile (Fealey et al., [0054], page 24), cayenne (Fealey et al., [0052], page 22), meadowsweet (Fealey et al., [0062], page 28), bugleweed (Fealey et al., [0051], page 21), nettle (Fealey et al., [0063], page 28), and combinations and permutations thereof (as required for instant Claims 2, 5, and 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the plant compositions in the relative amounts and forms and claimed to arrive at the instantly claimed invention from the ordinary skill and knowledge of one in the art and from the teachings of Fealey et al, including that the nutritional supplement may include one or more of the ingredients in various relative amounts, combinations, extracts, solutions, powders, liquids, or solids (Fealey et al., [0022], page 7). Therefore, if not expressly taught by Fealey et al., based upon the overall beneficial teaching provided by this reference with respect to nutritional supplements comprising various ingredients in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ratios or volumes in which to make such a composition (as required for instant Claims 3, 4, 6, and 7)), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Additionally, it would be obvious to a person of ordinary skill in the art to scale up or scale down a mixture volume (e.g., milliliters or tablespoons of Claims 4, and 7).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fealey et al. (WO 2014/083438 A2) as applied to Claims 1-7 above, and further in view of Bailey (Maine Organic Farmers and Gardeners, 2020, 10 pages).
The claims and teachings of Fealey et al. are as of record.
Fealey et al. do not teach ground, dried, or chopped herbs, decarboxylation, or coconut oil infusion.
Bailey, however, teaches a method for making topical cannabis salves comprising decarboxylation of buds trimmed from plants (fresh herb), which may also be ground (ground herb; Bailey, page 2; as required for instant Claims 8, 9, and 22). The herbs are then infused in oil, including coconut oil, by covering the plant material with 16 ounces of oil (poured onto the herbs; an amount) in a crock pot or double boiler (melted down; Bailey, pages 2-3; as required for instant Claims 10 and 22). The oil is then strained to remove the plant material (remaining herbs; Bailey, page 3; as required for instant Claims 11 and 22). Please also note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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. See MPEP § 2113.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to utilize the plant compositions of Fealey et al. with the method of making a salve taught by Bailey to arrive at the instantly claimed invention. Salves are beneficial because they can be used for various skin conditions and topically applied during massage therapy (Bailey, page 1). A skilled artisan could reasonably substitute the cannabis of Bailey with the various herbal combinations of Fealey et al. for different purposes to create topical salves with a reasonable expectation of success.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fealey et al. (WO 2014/083438 A2) in view of Bailey (Maine Organic Farmers and Gardeners, 2020, 10 pages), Parziale (Basic Tools of Herbalism, 2004, 9 pages), Khalid et al. (Tend Food Sci Technol, 2017, 176-186), Versus Arthritis (Evening Primrose Oil, 2020, 4 pages), and Ghafoor et al. (Eur J Lipid Sci Technol, 2017, 9 pages).
Fealey et al. teach nutritional supplements which may be manufactured as an ointment (topical salve) or an oral spray and may be used as a nutritional supplement, dietary supplement, food supplement, food additive, or combinations thereof (kit; Fealey et al., [0077]). Ingredients that may comprise the nutritional supplements include safflower (safflower oil; Fealey et al., [0068], page 31), evening primrose oil (eves primrose oil; Fealey et al., [0054], page 24), wheat germ (wheatgerm oil; Fealey et al., [0072], page 33), burdock (burdock root; Fealey et al., [0051], page 22; [0040], page 16), red clover (Fealey et al., [0067], page 30), yellow dock (Fealey et al., [0074], page 33), dandelion (dandelion root; Fealey et al., [0053], page 23), English chamomile (Fealey et al., [0054], page 24), cayenne (Fealey et al., [0052], page 22), meadowsweet (Fealey et al., [0062], page 28), bugleweed (Fealey et al., [0051], page 21), nettle (Fealey et al., [0063], page 28), and combinations and permutations thereof.
Fealey et al. do not teach a topical spray, a tincture, specific functions of safflower, evening primrose, and wheatgerm oils, decarboxylation, specific containers, or the specific method of making a tincture.
Bailey teaches a method for making topical cannabis salves comprising decarboxylation of buds trimmed from plants (fresh herb), which may also be ground (ground herb; Bailey, page 2). The herbs are then infused in oil, including coconut oil, by covering the plant material with 16 ounces of oil (poured onto the herbs; an amount) in a crock pot or double boiler (melted down; Bailey, pages 2-3). The oil is then strained to remove the plant material (remaining herbs; Bailey, page 3).
Parziale teaches that tinctures are made by combining powdered or crushed herbs with alcohol of varying proofs depending upon the herbs used and allowing the mixture to stand in a warm place for two weeks (Parziale, page 9). The alcohol can range from 40 to 190 proof (Parziale, Table, pages 2-4).
Khalid et al. teach that safflower oil has a high stability index, is high in oleic and linoleic acids, has anti-inflammatory activities, and has been used for rheumatological problems, joint movement, and arthritis (Khalid et al., Abstract, page 176; Table 5, page 182). Versus Arthritis teaches that evening primrose oil is rich in omega-6 fatty acids and can help control pain and inflammation, help maintain joint cell structure and function, and reduce pain and morning stiffness in patients with rheumatoid arthritis (Versus Arthritis, pages 1-3). Finally, Ghafoor et al. teach that wheat germ oil comprises high levels of linoleic and linolenic acid, which have anti-inflammatory (broadly comprising pain relief) properties (Ghafoor et al., Table 6, page 7).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the herbal compositions of Fealey et al. with the methods of making salves and tinctures as taught by Bailey and Parziale and the teachings of Khalid et al., Versus Arthritis, and Ghafoor et al. in order to arrive at the instantly claimed invention. Tinctures can be applied directly to the skin or used in various other medicaments such as salves, ointments, or suppositories and the solvents and necessary alcohol proofs allow for important compounds to be extracted (Parziale, entire document). Salves are beneficial because they can be used for various skin conditions and topically applied during massage therapy (Bailey, page 1). A skilled artisan could reasonably substitute the cannabis of Bailey with the various herbal combinations of Fealey et al. for different purposes to create topical salves with a reasonable expectation of success. Finally, even though the references do not specifically teach dissolving lactic and uric acid buildup in joints, evening primrose oil and safflower oil are both known in the art for use for treating arthritis, and thus would be given to the same patient population and inherently have the claimed intended use. Additionally, a skilled artisan would be motivated to combine three ingredients known to be useful for pain relief and treatment of joint pain, stiffness, rheumatoid arthritis, and inflammation and could do so with a reasonable expectation of success.
Finally, if not expressly taught by the prior art, based upon the overall beneficial teaching provided by these references with respect to nutritional supplements comprising various ingredients in the manner disclosed therein, methods for making various salves and tinctures, and known uses of different ingredients, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ratios or volumes in which to make such a composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Additionally, it would be obvious to a person of ordinary skill in the art to provide various containers for storing and making compositions, adjust amounts to scale production up or down, and provide different topical formulations, e.g., a spray in addition to a salve.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Please also note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production or the container within which it is contained. 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. See MPEP § 2113.
Response to Arguments
Applicant's arguments filed 9 February 2026 have been fully considered but they are not persuasive.
Applicant argues that the instant invention provides unexpected results due to a synergistic effect of safflower oil, evening primrose oil, and wheatgerm oil in equal parts which is not taught or suggested by the prior art.
Evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately. However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP § 716.02(a). In the instant case, there is no data provided indicating a synergistic effect of the claimed composition.
Applicant additionally argues that decarboxylation is an essential step for the speed of relief, however no data or indication of a specific speed of relief is indicated in the claims or the disclosure. “Faster relief” is a relative term and without a comparison to another group, e.g., an untreated control or a control group undergoing a different treatment, this term is indefinite as described above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., safer alternative relative to conventional treatments) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner’s Comment
The following proposed claim amendment is presented for applicant’s consideration and would put the claims in better condition for allowance:
Claims 1-23 are cancelled.
24. A kit for treating arthritis and joint inflammation comprising:
a) a topical spray consisting of equal parts safflower oil, evening primrose oil, and wheatgerm oil;
b) a topical salve consisting of coconut oil infused with equal parts of decarboxylated burdock root, red clover, yellow dock, dandelion root, chamomile, cayenne, meadowsweet, bugleweed, and nettle; and
c) a tincture made by mixing particles filtered from the topical salve with 150 proof alcohol in a 1:4 ratio, extracting the mixture for three weeks, and then straining the extract to obtain the tincture.
Conclusion
No claims are allowed.
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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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655