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 .
DETAILED ACTION
The Amendments filed on 6/13/2026 has been received and entered.
Claims 15-29 and 31-38 are pending. Claims 15-16 and 18-29 are examined on the merits. Claims 17 and 31-38 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 15-30), the species free of preservatives, glyceryl behenate and glycerol monostearate in the reply filed on 6/13/2026 is acknowledged.
Claims 17 and 31-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/13/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 15-16 and 18-29 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.
Claim 15 contains the trademark/trade name “Vaseline”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe petrolatum or petroleum jelly and, accordingly, the identification/description is indefinite.
The term “advantageously” is indefinite. It is not clear what is meant by the substance need to be present in order for the compositions to be considered “advantageously” in these compounds.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-16 and 18-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 15-16 and 18-29 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims fruits and vegetables, which are food or beverages. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, in claim 15, the homogenized form the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. As for Claim 21 with roll-on applicator and application device, the devices do not change the ingredients composition property. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
In this case, claim 20, the form of an oil does not make the castor oil and coconut oil have markedly different characteristic. Oil form is found in nature in the seeds.
In this case, Claims 26-29, further comprising glyceryl behenate and glycerol monstearate, is not an additional element that renders the claim markedly different from the natural oils found in seed oils.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application.
The homogenized composition of the different oils together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application.
Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” If the claimed composition is a combination of two nature-based components, which combination is not found together in nature, each of which imparts a different characteristic to the overall composition, then the claimed composition having those two characteristics are compared to each of the nature-based components separately, then because in that comparison (in my example) the composition has a different set of characteristics compared to the individual components, then the claimed composition is markedly different from either of the nature-based components. In the instant case, claims 15 and 26 have no amounts, so even if the combinations of extracts (at particular amounts) had markedly different characteristics when in combination, because there are no claimed amounts, the claimed composition does not necessarily have any markedly different characteristics when the amounts of the components are too low to impart any characteristics. However, when specific amounts being claimed, those amounts might or might not impart markedly different characteristics. The ingredients are known for cosmetic uses (see rejection below); thus, there is no markedly different characteristic from its natural counterparts.
A change in the ratio or amount of extract does not transform the claims into an exemption of the ‘judicial exception’ because amounts/ratios/percentages do not set forth a ‘markedly different’ structure as compared to the naturally-occurring product (see; e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Therefore, all of the ingredients recited in the claims are natural products; thus, the claims involve the use of judicial exceptions.
Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
Claim(s) 15-16, 18-20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eyeliner (from IDS).
Eyeliner teaches an eyeliner pencil comprising Ricinus communis (Castor) seed oil, Cocos Nucifera oil (Coconut oil derived), and petrolatum (Ingredients). An eyeliner pencil would be an application device for topical application to the eyelines; therefore, Claims 19 and 22 are met. No preservative is taught; therefore, limitation of Claim 18 is met. Cocos Nucifera oil (Coconut oil derived) would be refined coconut oil; therefore, Claim 16 is met.
Claim(s) 15-16, 18-20, 22, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US 20070190124 A1).
Zhang et al. teaches a formulation for topical skin that is easy to apply as a semisolid dosage form. Additionally, upon volatile solvent system evaporation, the resulting solidified layer is relatively thick and can contain much more active drug than a typical layer of traditional cream, gel, lotion, ointment, paste, etc., and further, is not as subject to unintentional removal. Further, as the solidified layer remains adhesive and can be peelable, easy removal of the solidified layer can occur, usually without the aid of a solvent or surfactant. In some embodiments, the adhesion to skin and elasticity of the material is such that the solidified layer will not separate from the skin upon skin stretching at highly stretchable skin areas, such as over joints and muscles. For example, in one embodiment, the solidified layer can be stretched by 5%, or even 10% or greater, in at least one direction without cracking, breaking, and/or separating form a skin surface to which the layer is applied. Still further, the solidified layer can be formulated to advantageously deliver drug and protect sensitive skin areas without cracking or breaking [0072]. The formulation comprises castor oil, coconut oil, petrolatum, glyceryl behenate, glyceryl stearate (Claim 13). An adhesive formulation for dermal delivery of a drug, comprising: a) a drug; b) a solvent vehicle, comprising: i) a volatile solvent system including at least one volatile solvent, and ii) a non-volatile solvent system including at least one non-volatile solvent, and c) at least two solidifying agents, wherein the formulation has a viscosity suitable for application and adhesion to a skin surface prior to evaporation of the volatile solvent system, wherein the formulation applied to the skin surface forms a solidified layer after at least partial evaporation of the volatile solvent system, and wherein the drug continues to be dermally delivered after the volatile solvent system is substantially evaporated (Claim 1).
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 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.
Claim(s) 15-16 and 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over クロッグ アン エム Kroguan Em et al. (JP H10512299 A).
クロッグ アン エム et al. teaches a cosmetic stick composition comprising non-volatile oils from about 0.1-30% by weight such as castor oil, coconut oil, glyceryl stearate, petrolatum, 0.1-10% glyceryl behenate (pages 4-5).
However, クロッグ アン エム et al. does not teach the claimed amounts, roll-on applicator.
The reference does not specifically teach adding the ingredients in the amounts claimed by applicant for topical application. However, the reference does teach the composition for cosmetic application. クロッグ アン エム et al. teaches a cosmetic composition comprising non-volatile oils from about 0.1-30% by weight such as castor oil, coconut oil, glyceryl stearate, petrolatum, 0.1-10% glyceryl behenate (pages 4-5).
The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant as a roll-on application. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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