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
Information Disclosure Statement
The information disclosure statements (IDS) filed on 12/02/2025 and 03/27/2024 have been considered here.
Election/Restriction
Applicant's election with traverse of group I (claims 1-5) in the reply filed on 04/01/2026 is acknowledged. The traversal is on the ground(s) that the special technical feature has been amended to be suitable for topical administration to the skin and as such groups V and VI should be examined with the elected group. This is not found persuasive because the unity of invention and special technical feature analysis was done with the claims as presented before the amendments. Further, while groups V and VI are drawn to topically administered compositions, they are different forms (i.e., a gel) as the elected claims. The search system and the focus of the invention are completely different, requiring an undue burden on the patent examiner. While searches may seem to be overlapping, however extensive since the patent examiner searches the databases mostly literally. Rarely do applicants present claims to an inventions where the distinctness of the invention are readily clear such as a chemical compound and a gene sequence. It is the responsibility of the examiner to enforce 35 USC 101, which allows the applicant to obtain a patent for a single invention. In the opinion of the examiner the applicants present three distinct inventions in these groups.
The requirement is still deemed proper and is therefore made FINAL. Claims 1-5 and 16 will be examined and the subject of this action.
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 1-5 and 16 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 regards to claims 1-4 and 16, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the instant case, it is not clear whether the limitations are drawn to the generic teachings of “the emulsifier is one or more of polyoxyethylene alkyl aryl ether, polyoxyethylene monolaurate, polyoxyethylene lauryl ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene plant oil, polyoxyethylene monooleate, and vitamin E succinate” in claim 1 or the more specific “one or more of polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, and vitamin E succinate”. Similar issues are presented in claim 2-4 and 16 where a range or list of compounds is given along with another narrower list. One with ordinary skill in the art would not understand the metes and bound of the claims as written, thus the claims are indefinite. The claims are rendered indefinite by raising a question or doubt introduced by the limitations following the expressions “preferably” and “more preferably” because it is subject of more than one interpretation, and one interpretation would render the claim unpatentable over the prior art. For purposes of search and consideration, the broader, more generic limitation is understood to be the limitation of the claims (i.e., the larger list and/or range provided in the claims).
Claim 5 is indefinite as it depends from an indefinite claim.
Claim 2 contains the trademark/trade names RH20, RH30, RH40, RH50, and RH60, as well as “EL20…and EL60”. 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 various forms of polyoxyethylene hydrogenated castor oil (e.g., RH40 is polyoxyl 40 hydrogenated castor oil) and polyoxyethylene castor oil (e.g., EL20 is PEG-20 castor oil), and, accordingly, the identification/description is indefinite.
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.
Claims 1-5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over TW 202015686 A (Liu, 2020; machine translation provided by PE2E via FIT) in view of CN 109640958 A (Ceva, 2019; machine translation provided by PE2E via FIT).
Regarding claims 1 and 16, Liu teaches a composition comprising from about 1 wt% to about 80 wt% of a kinase inhibitor (see Liu, page 11, final paragraph), wherein the kinase inhibitor is ruxolitinub (see Liu, pages 17-18, embodiments A, B, C, or D), and a polyoxyethylene castor oil or polyoxyethylene hydrogenated castor oil as an emulsifier (see Liu, page 18, embodiment C or embodiment D). MPEP 2144.05 states 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" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 2 and 16, the polyoxyethylene hydrogenated castor oil is taught to be polyoxyl 40 hydrogenated castor oil (i.e., RH40), polyoxyl 35 castor oil (i.e., EL35), or polyoxyl 60 hydrogenated castor oil (i.e., RH60). It is also taught that the emulsifier is used in an amount from 3-12%, as well as in broader amounts from 2-30% by weight (see Liu, paragraph bridging pages 11-12). MPEP 2144.05 states 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" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 3 and 16, as the amount of co-emuslifier is taught to be from 0-10% by weight of the composition and Liu is silent on the use of propylene glycol monocaprylate, it would be understood that the amount of co-emulsifier is 0% by weight. MPEP 2144.05 states 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" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 4 and 16, as the amount of solvent in the claim is taught to be from 0-60% by weight of the composition, it is noted that the presence of the listed compounds is not needed to meet the limitations of the claims. However, Liu does teach the use of ethanol (see Liu, page 51, paragraph 3) and diethylene glycol monoethyl ether in an amount of 1920 mg (see Liu, page 32, example 23). MPEP 2144.05 states 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" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 5 and 16, the composition is taught to comprise water in an amount from about 1 wt% to about 90 wt% (see Liu, page 15, paragraph 5). pH adjusting agents are also taught to be in the composition (see Liu, page 15, paragraphs 3-4). MPEP 2144.05 states 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" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Liu is directed towards compositions for oral administration and the claims are drawn towards a composition suitable for topical administration to the skin. However it is noted that the limitation of being “suitable for topical administration” is a future intended use. The future intended use of a product is not considered to contribute to the overall patentability of the instant invention, particularly when the product itself is claimed and that same product is taught in the prior art. As such, it is the position of the examiner that Liu teaches all of the limitations of the instant claims and renders the claims obvious. However, in the interest in compact prosecution, Ceva is included in the rejection to show that it would be obvious to use the composition of Liu in a topical administration.
Ceva teaches a composition for topical administration (see Ceva, page 3, final paragraph) or a tablet form (see Ceva, page 45, paragraph 9). The composition is taught to comprise ruxolitinib (see Ceva, page 44, paragraph 1), PEG-40 hydrogenated castor oil (see Ceva, page 9, final paragraph), polyoxyethylene castor oil (see Ceva, page 40, paragraph 1), and propylene glycol monocaprylate as a lipophilic emulsifier (see Ceva, page 19, final paragraph). It is taught that when one or more lipophilic emulsifier is used in the composition then the second emulsifier is used in an amount that does not exceed 10% (see Ceva, page 20, paragraph 4).
In regards to claims 1-5 and 16, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Liu with Ceva to formulate a composition as instantly claimed as both references teach compositions comprising similar ingredients that are used in similar methods. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would understand that as the composition of Ceva is taught to be either a tablet or a topical cream, it is within the purview of one with ordinary skill in the art to use teachings of Liu and formulate a topical composition. One with ordinary skill in the art would be motivated to combine the teachings of Liu with the method of making a topical composition using ruxolitinib to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
Prosecution Insights