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
Claims 7-21 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 7-16, drawn to compounds of formula (1)) and the elected species T105e
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in the reply filed on 9/04/2026 is acknowledged.
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-IV or unelected species, there being no allowable generic or linking claim. Thus, Claims 7-16 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
T105e was searched according to the structure as drawn in the claims. The compound was determined to be free of the art. The scope of search and consideration was expanded to T107e according to the structure of Claim 8.
Specification
The disclosure is objected to because of the following informalities:
Throughout the specification, images are unclear and indecipherable. For example, Page 18 contains the following:
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. All such warped, unreadable images must be corrected.
All compounds which are named in the claims and specification but do not share a common structure must be corrected. For example, Claim 8 depicts T112e as follows:
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whereas T112e or ZE33-0115 as depicted in the specification on Page 26 has a different structure:
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(additional methylene between amide and terminal ester). See also T117e as claimed:
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and as drawn in the specification:
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;
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(the ketone attached to terminal ethoxy through a methylene is instead an ester). All the structures of the disclosure must be standardized so that a single name corresponds to a single structure. Appropriate correction is required.
Claim interpretation
In Claim 7, the parenthetical in “oxo groups (=O)” is interpreted merely to depict the oxo structure rather than be exemplary of a type of oxo group because oxo exclusively refers to the structure enclosed in the parenthetical. Therefore, “(=O)” is not exemplary and not unclear.
All claimed structures are interpreted as drawn in the claims, not as depicted in the specification. (See objection to the specification above.)
Claim Objections
Claim 7 is objected to because of the following informalities:
The lists of substituents and substituents thereof should use semicolons, indentation, and conjunctions to denote which groups are acceptable R1, R2, or R3 groups and which functional groups are intended to be substituents of R1, R2, or R3 groups or substituents thereof. The long list of groups separated only by commas to denote different groups and levels of substitution must be corrected with semicolons, indentation, and/or conjunctions. For example, in “-N-alkyl, oxo groups”, “and” or “or” should precede “oxo”, the final embodiment in the list.
All instances of “(linear and branched)” in reference to an alkyl group or a derivative alkyl group should be removed. All instances of alkyl, alkenyl, etc. are understood to encompass both linear and branched embodiments unless otherwise specified.
“that a double bond” should instead read “a double bond”.
A semicolon should follow “oxo groups (=O)” preceding the proviso.
Claim 8 is objected to because the proper form of a claim is such that “each claim must be the object of a sentence…[and thus] Each claim begins with a capital letter and ends with a period.” See MPEP 608.01(m). Claim 8 must end in a period.
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 7, 9, and 11-13 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 regards as the invention.
Claim 7 recites a long list of potential groups of R1, R2, and R3 as well as including groups substituting said R groups. It is unclear which functional groups are intended to embody said R groups or substitute said R groups. It is suggested that applicant use indentation, conjunctions, semicolons, or more precise language to establish which groups are acceptably R groups or substitute the R groups. Further regarding Claim 7, Claim 8 depicts the following structure:
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, wherein the following moiety
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reads on that of formula (1)
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as follows: either (1) R1 is a C1alkyl, R2 is an oxo, and R3 is an alkoxy, which is not an acceptable group or (2) R1 is a methyl ester and R2 and R3 are both H, neither of which are acceptable. Only one of the R groups may be H, and R1 (according to the language of Claim 1 as written) appears to possibly be an alkyl group substituted by an esterified carboxylic group but R1 cannot itself be an ester. Claim 8, depicting the structure, depends on Claim 7, so it is unclear if such a structure is intended to be permissible according to formula (1) of Claim 1 or not.
Claims 9 and 11-13 are rejected by virtue of dependency.
For the purpose of compact prosecution, it is interpreted that formula (1) is intended to encompass compounds of Claim 8. Prior art rejections are issued accordingly below.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8, 10, and 14-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Several structures of Claim 8 do not comport with the definition of formula (1) as written in Claim 7, upon which 8 depends. For example, Claim 8 depicts the following structure:
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, wherein the following moiety
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reads on that of formula (1)
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as follows: either (1) R1 is a C1alkyl, R2 is an oxo, and R3 is an alkoxy, which is not an acceptable group or (2) R1 is a methyl ester and R2 and R3 are both H, none of which are acceptable. Only one of the R groups may be H, and R1 (according to the language of Claim 1 as written) appears to possibly be a C1alkyl group substituted by an esterified carboxylic group but R1 itself cannot be an ester.
Claims 10 and 14-16 are rejected by virtue of dependency.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 § 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.
Claims 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (WO2018022797; 9/12/2024 IDS).
Shaw teaches a “drug product composition” (or a preparation) comprising a compound according to Formula (Ia):
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(Page 4). “A more specific embodiment provides a dermatological formulation comprising a compound of Formula (Ia) for use in a method of treating acne vulgaris,…characterized in that the compound of Formula (Ia) is present in the dermatological formulation at a concentration of 5% (w/w) or less” (Page 6).
Formula (Ia) differs from examined T107e
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(wherein R is n-tetradecyloxy) in that the methylene of Shaw, linking the core ester and amide, is instead an ethylene in the claimed structure. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. Therefore, one of skill in the art seeking to form a dermatological agent for the treatment of acne vulgaris before the effective filing date of the examined application would find it obvious to vary the number of successive methylenes at the limited number of alkylene positions on the Formula (Ia) compound, resulting in a compound of examined formula T107e for use in a dermatological composition. One of skill in the art would do so and expect success in forming the agent because “homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”.
Regarding claims directed to compositions and the claimed ranges of API therein, the discrete value taught by Shaw, 5.00%, falls squarely in the narrowest range claimed which is “0.005%-6.00%”.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
