DETAILED ACTION
The amendment submitted on May 5, 2026 has been entered. Claims 1-16, 34-36, 38, 44-45, 47-49, and 56-59 are pending in the application. Claims 56 and 58 are withdrawn. Claims 1-16, 34-36, 38, 44-45, 47-49, 57, and 59 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 AIA . 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.
Election/Restrictions
Applicant’s election with traverse of Group I, drawn to a local topical preparation, in the reply filed on May 5, 2026 is acknowledged. The traversal is on the grounds that unity of inven-tion exists because “the claims are directed to a specific product, i.e. the topical preparation, a method of preparing and a method of using the same in methods of treatment,” which is “a single general inventive concept.” See applicant’s Remarks, submitted May 5, 2026, at p. 13. This is not found persuasive because at least the independent claims are prima facie obvious, as explained below. The claims therefore lack unity of invention a posteriori. See MPEP1 1850, which explains that “[l]ack of unity of invention may be directly evident ‘a priori,’ i.e., before considering the claims in relation to any prior art, or may only become apparent ‘a posteriori,’ i.e., after taking the prior art into consideration.” The requirement is still deemed proper and is therefore made FINAL. Claims 56 and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on May 5, 2026.
The requirement for a species election in the communication mailed on March 6, 2025 is hereby withdrawn. Applicant’s election thereof in the response submitted on May 5, 2026 is therefore moot.
Claim Objections
Claims 1, 13-16, and 34-35 are objected to because of the following informalities:
In claim 1, the definition of L₁, the lower case “c” should instead be upper case “C” (to designate carbon atoms).
In claim 1, “crystal form thereof” should instead be “a crystal form thereof.”
In claims 1 and 13-16, “pharmaceutically acceptable salts thereof” should instead be “a pharmaceutically acceptable salt thereof.”
In claims 13-14, and 16 “isomers thereof” should instead be “an isomer thereof.”
In claim 15, “their isomers” should instead be “an isomer thereof.”
In claim 34, “its isomer” should instead be “an isomer thereof.”
In claim 35, “a content” should instead be “the content.”
In claim 35, “a total” should instead be “the total.”
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.
Claims 1-16, 35-36, 38, 45, 47-49, 57, and 59 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 36, 38, and 59 mention VASELINE, which is a registered trademark (see the attached registration certificate for Ser. No. 71/139,846). Where a trademark 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). The claim scope is uncertain because a trademark cannot be used properly to identify any particular material or product. A trademark is used to identify a source of goods, and not the goods themselves. In the present case, the trademark VASELINE appears to be used to identify or describe a particular type of petroleum jelly or petro-latum. See MPEP 2173.05(u) (Trademarks or Trade Names in a Claim).
In claims 36 and 38, SASOL is a registered trademark and therefore indefinite.
In claims 1, 34-35, 38, 45, and 49, “the local topical preparation” lacks antecedent basis. See MPEP 2173.05(e) (Lack of Antecedent Basis).
In claims 1 and 48, the chemical compound “monoglyceryl linoleic acid” is undefined. Nowhere is this compound disclosed in the prior art, and applicant’s own specification does not provide a definition for it. Moreover, claim 49 refers to “monolinoleic acid glyceride,” but it is unclear whether this is the same thing as “monoglyceryl linoleic acid.” The examiner presumes that they refer to an ester of glycerol and linoleic acid.
Claims 35, 38, 45, 47, and 49 are directed to multiple overlapping “preferred” ranges. The use of narrow numerical ranges that fall within a broader range in the same claim renders the claim indefinite. Description preferences is properly set forth in the specification rather than in a single claim. If stated in a single claim, as in the present situation, preferences lead to confusion over the intended scope of the claim. See MPEP 2173.05(c) (Numerical Ranges and Amounts Limitations).
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 explained 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 1-16, 34-36, 38, 44-45, 47-49, 57 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/038457 A1 by Mao et al. (published Feb. 27, 2020) in view of US 2011/0288107 A1 by Parikh et al.
For convenience, this discussion refers to US 2021/0155621 A1 (published May 27, 2021), which is the equivalent reference in the English language. The actual basis for rejection, however, is the original Chinese publication, WO 2020/038457 A1 by Mao et al. (cited in applicant’s IDS2).
Mao discloses (see, e.g., para. 0007) the compounds of formula (I) as recited in claim 1. Compounds within the meaning of instant claims 2-11 are disclosed in the reference at para. 0024-0033, respectively. Compounds within the meaning of claims 12-14 are disclosed at para. 0035 and 0037-38, respectively. The reference also discloses (see, e.g., para. 0089) compounds recited in claim 15. At least the second compound recited in claim 16 is disclosed in the reference at para. 0082. At least the first compound recited in claim 34 is suggested by the first compound disclosed in the reference at para. 0039 (note that all stereoisomers are taught at para. 0049). These compounds are JAK inhibitors and are useful as pharmaceuticals for treating a wide range of diseases associated with JAK1 or TYK2 (para. 0002-05).
The difference between the prior art and the claims at issue is that Mao does not specifi-cally disclose that the compounds are formulated in a topical pharmaceutical composition.
Parikh, however, discloses a topical formulation for JAK inhibitors (see the Title of the reference). “[T]he therapeutic agent is present in an amount of about 0.5% to about 1.5% by weight of the formulation” (para. 0089), which suggests the concentration of JAK inhibitor recited in claims 1 and 35. The topical composition comprises an oil component, a water component, and an additive, such as an emulsifier component (para. 0030). The oil component is, among other things, petrolatum (para. 0041), which appears to be within the meaning of VASELINE as recited in at least claim 1. The water component includes, among other things, “polyethylene glycol-400” (para. 0219), i.e., PEG 400 as recited in at least claim 1. The additive comprises, among other things, “glyceryl fatty esters” (para. 0073), which refers to monoglycerides of fatty acids (para. 0216), such as linoleic acid (para. 0210) and therefore appears to be within the mean-ing of “monoglyceryl linoleic acid” recited in claim 1.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to formulate the JAK inhibitors of Mao using the techniques of Parikh and thereby arrive at subject matter within the scope of the instant claims. Note that Mao does not describe any particular dosage forms or pharmaceutical compositions, although it does explain that they would have been known to a person of ordinary skill in the art (para. 0046), it being implicit that such a person would have been competent to look up a suitable dosage form in the prior art. Parikh provides an answer to this question. Specifically, Parikh explains how one would formu-late a JAK inhibitor as a pharmaceutical formulation for topical application to the skin. One would have had a reasonable expectation of success because Parikh (para. 0036) explains that “the formulations described [therein] are relatively simple to manufacture with a repeatable process of formulation. The resultant product is easily packaged. The formulations appear to have good stability and relatively consistent permeation profiles.”
With respect to claim 36, 38, and 59, Parikh disclose that the oil component is petrolatum (para. 0040), such as white petrolatum (para. 0041), which appears to be within the meaning of white VASELINE. The amount of the oil component is up to “about 40% by weight” (para. 0037), which suggests the concentration of white VASELINE recited in claim 38. Note that even though the white VASLINE concentration ranges recited in claim 38 do not, strictly speaking, overlap with the corresponding concentrations in Parikh (para. 0037-39), they are nevertheless close. In cases like this, “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) (Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions). The disclosure of “about 40% by weight” in Parikh is close to “45%” recited in claim 38, so the examiner concludes that claims 36 and 38 read on subject matter that is prima facie obvious over the teachings of the two cited references.
With respect to claims 44-45 and 47, Parikh discloses (para. 0219) that the “molecular weight of the polyethylene glycol is about 400,” i.e., “polyethylene glycol-400,” which is within the meaning of “PEG 400” as recite in claim 44. More generally, Parikh discloses (para. 0219) that “average molecular weight of the polyethylene glycol is from about 200 to about 9000,” which encompasses PEG 3350 as recited in claims 44-45. One would have viewed selecting the molecular weight of 3350 as being a matter of routine optimization within the range of 200-9000 taught by the reference. See MPEP 2144.05(II)(A) (Optimization Within Prior Art Conditions or Through Routine Experimentation). The reference refers to the polyethyleneglycol as a solvent component (para. 0087-88) and it states that the concentration is “about 10% to about 35% by weight of the formulation” (para. 0083), which overlaps with the “10% to 40%” recited in claim 45, so the examiner concludes that the concentration ranges of claims 45 and 47 are prima facie obvious.
With respect to claim 48-49, Parikh discloses that the additive comprises “glyceryl fatty esters” (para. 0073), i.e., monoglycerides of fatty acids (para. 0216), such as linoleic acid (para. 0210). This appears to be within the meaning of “monoglyceryl linoleic acid” recited in claim 48. Parikh refers to this component as an emulsifier (para. 0073), and it explains “the emulsifier component is present in an amount of about 1% to about 9% by weight of the formulation” (para. 0073). This overlaps with the concentration range for monolinolenic acid glyceride recited in claim 49, so the examiner concludes that claims 48-49 read on subject matter that is prima facie obvious over. See MPEP 2144.05(I) (Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions), which explains that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Finally, with respect to claim 57, Parikh discloses cream formulations (see Example 3 at para. 0252) and ointment formulations (see Example 5 at para. 0275).
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
July 6, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 See the information disclosure statement (IDS) submitted on February 8, 2024.
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