DETAILED ACTION
Claims 1-17, submitted on August 21, 2024, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. 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.
Claim Rejections – 35 USC § 112
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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particu-larly point out and distinctly claim the subject matter which the inventor regards as the invention. The claims require a “sufficient amount” of various ingredients, but it is unclear what “sufficient” means. The most relevant disclosure in applicant’s specification appears to be the following:
During production, the composition is formulated including amounts of ingredients which provide the aforementioned bene-fits. Sufficient amounts for each ingredient are provided in the below description. However, one skilled in the arts will readily understand that the specific amounts may be modified without departing from the scope of the embodiments described herein.
Specification at p. 8. Although applicant makes a general assertion that one would “readily understand” what is meant by “sufficient,” the search of the prior art reveals that this word does not have an established meaning in the art. The dependent claims (see, e.g., claims 6 and 15) are drawn to embodiments in which some of the amounts are specifically recited, but one would be left to speculate what other amounts would be “sufficient” within the meaning of the claims. See MPEP1 2173.05(b) (relative terminology).
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 discussed in MPEP 2141 et seq. They 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 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0322338 A1 by Layani et al. in view of US 2021/0361552 A1 by Medina et al. and US 2023/0049319 A1 by Persaud.
Layani discloses (para. 0011) pharmaceutical compositions that include CBD oil, including “topical compositions useful in the treatment and alleviation of cutaneous symptoms associated with skin asthma, psoriasis, dermatitis and other dermatological conditions characterized by the appearance of ulcers or lesions.” The reference also discloses (para. 0066) using these composi-tions in the treatment of pain and other soft-tissue conditions within the meaning of claims 1 and 11. According to Layani (para. 0083), the compositions further include dimethyl sulfoxide (DMSO) or methylsulfonylmethane (MSM), as well as a vitamin (para. 0163).
The differences between the prior art and the claims at issue are that Layani does not specifically disclose that the composition further includes gold and one or more minerals.
Medina, however, discloses that it is beneficial to include 24 karat gold dust in topical dermatological compositions because it provides “sparkle” and it has “light-reflective” properties that “provide[] a visual satisfaction” (para. 0010; see also para. 0007-08). It therefore would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to include edible gold as taught by Medina in the compositions of Layani in order to take advantage of the beneficial visual or aesthetic properties that are afforded by gold. One would have had a reason-able expectation of success because Layani discloses that its compositions may include any of a wide range of different ingredients “that are compatible with pharmaceutical administration” (para. 0057), and one would have understood that gold as taught by Medina is such a compatible ingredient.
Persaud discloses that magnesium chloride, which is a mineral within the meaning of the instant claims, is known to be useful as “viscosity increasing agent” (para. 0161) in CBD-contain-ing topical compositions. It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to include magnesium chloride in the composition of Layani/Medina as described above and thereby arrive at subject matter within the scope of at least instant claim 1. One would have been motivated to use magnesium chloride as taught by Persaud because Layani discloses (para. 0137) compositions having various types of viscosity, including “solutions, lotions, gels, emulsions of liquid or semi-liquid consistency,” and so forth. One would therefore have looked to the prior art for known techniques to modify viscosity in this technology area, and Persaud provides an answer to this question.
The examiner therefore concludes that at least instant claim 1 is drawn to compositions that are prima facie obvious over Layani in view of Medina and Persaud. The teachings of these three references as they relate to the other claims are discussed below.
With respect to claims 2-3, Layani discloses that the “composition comprises 20-55%, typically 25-45%, e.g. about 40% by weight DMSO and/or MSM” (para. 0023). Even though the 10% concentration recited in claim 2 is—strictly speaking—outside the range taught by Layani, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I) (“The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). The examiner finds claim 3 to be prima facie obvious for substantially the same reasons. See MPEP 2144.05(II), which explains that differences in amounts “will not support the patentability of subject matter encompassed by the prior art” unless there is evidence indicating that it is critical.
Claim 4 has not been accorded patentable weight because it simply recites an inherent property of DMSO. See MPEP 2111.04(I) and 2112.
With respect to claims 5-6, Medina discloses using “24-karat edible gold dust” (para. 0007). The amount referred to in claim 6 is prima facie obvious for the reasons discussed in MPEP 2144.05(II).
With respect to claims 7 and 11, Persaud discloses using vitamins B1, B6, B12, and C (para. 0098).
With respect to claim 8, Layani discloses using coconut oil (para. 0159).
With respect to claim 9, Layani discloses using CBD isolated from the Cannabis plant (para. 0074).
The quantities referred to in claims 12-15 would have been regarded as being a matter of routine experimentation within the general teachings of the references and therefore prima facie obvious. See MPEP 2144.05(II).
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Layani, Medina, and Persaud as applied above to claims 1-9 and 11-15, and further in view of US 2022/0347245 A1 by Crisler.
The disclosures of Layani, Medina, and Persaud are relied upon as set forth above. With respect to claims 10 and 16, note that Persaud teaches or suggests using the following ingredi-ents: ginger (para. 0116 and 0134), cloves (0112 and 0134), chamomile (para. 0089-90), turmeric (para. 0134), black pepper (para. 0090), and Boswellia (para. 0116 and 0134).
The difference between the prior art and the claims at issue is that none of Layani, Medina, or Persaud teaches or suggests using feverfew flowers, capsaicin, or alpha lipoic acid. Crisler, however, is cited as evidence that these ingredients were known in CBD-containing topical compositions. See, e.g., Crisler at para. 0078, 0068, and 0064, respectively.
The implicit disclosures of Layani and Persaud are that a wide range of different ingredi-ents may be used in CBD-containing compositions. See, e.g., Layani at para. 0034-35 and 0057-59, as well as Persaud at para. 0060-117. One would have viewed feverfew, capsaicin, and alpha lipoic acid as taught by Crisler as being still other ingredients that are known to be useful in CBD-containing compositions. Generally, it is prima facie obvious to use existing ingredients in accordance with their art-recognized purposes. See 2144.07 (art-recognized suitability for an intended purpose). One would therefore have viewed incorporating feverfew, capsaicin, or alpha lipoic acid as taught by Crisler into the composition of Layani/Medina/Persaud as described above as being prima facie obvious.
Finally, one would have viewed the amounts of ingredients that are recited in claims 3, 6, and 12-16 as being a matter of optimization within the general teachings of the references and therefore prima facie obvious. See MPEP 2144.05(II), which explains that the “normal desire of scientists or artisans to improve upon what is already generally known” provides the motivation to determine optimal or workable quantities of ingredients.
The examiner therefore concludes that the subject matter of claims 1-17 is prima facie obvious over the teachings of the applied references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
June 11, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
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