DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of compound I/124, TBP-333, in the reply filed on 2025 December 29 is acknowledged. The traversal is on the ground(s) that there is a single inventive concept. This is not found persuasive because the central tricyclic structure is known within the art. The features that define patentability of a compound of formula (I) are variables X, Y, and Z based on the way the claims are written. Due to compound I/124 being free of the prior art of record, a search of compound of formula (I) in which a phenyl ring is substituted with at least one halogen, CF3, amino, or a cyano group of claim 4.
Claims 1-3 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2025 December 29.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2023 December 13 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 4-15 are objected to because of the following informalities:
in claims 4 and 12-15, the text “The compounds of formula (I)” should be written as –-A compound of formula (I)—because claim 4 is independent of claim 1 and does not rely on any previous claims;
in claim 5, the text “one or more compounds” should be --a compound-- because claim 4 is drawn to a singular formula;
in claim 6 and 7, the text “the compounds of formula (I)” should be written as –-a compound of formula (I)-- because claim 6 is independent and does not rely on any previous claims; and
In claims 8-11, the text “The compounds according to claim 4” should be written as –-The compound of claim 4-- because claim 4 is drawn to singular formula (I).
Appropriate correction is required.
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.
Claim 4 is 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. The usage of the term “The” as the first word lacks antecedent basis because claim 4 is an independent claim. This issue would be corrected if the preamble of claim 4 said --A compound of formula (I)--.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 4-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over XU (US 20180141946, 2018 May 24, cited in IDS).
Determining the scope and contents of the prior art
Xu describes examples 28 and 29 (page 10, paragraphs [0164] to [0173]). In these compounds, the following examined variable definitions apply: variable Y is 3-Br-phenyl; variable Z is H; and variable Z is 2-[chloro or methyl]-phenyl. These compounds are used antitumor agents (abstract). Variable R can be any halogen (page 1, paragraphs [0009]-[0011]). Variable Ar, equivalent to variable X of the examined application, can be mono or di-substituted with halogen or a C1-4 alkyl group (page 1, paragraphs [0009]-[0011]). Examples 28 and 29 show that 2-chlorophenyl and 2-methylphenyl are alternative embodiments within this art. These two examples show that variables R and Ar can be varied when attached to an 11‐benzyl‐7‐CH2‐2,5,7,11‐tetraazatricyclo[7.4.0.02,6]trideca‐1(9),5‐dien‐8‐one core structure. The synthetic process of converting compound 1 to the target product shows that variable R is not critical to the synthetic sequence (page 2, column 1). Pharmaceutical compositions are described (page 2, paragraph [0024] to page 3, paragraph [0030]; page 25, claim 18). Cancer is treated (abstract; page 1, paragraph [0007[; page 20, table 1, paragraph [343]; page 25, claims 16 and 17).
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Ascertaining the differences between the prior art and the claims at issue
In the prior art, a compound in which variable Y is 3-Br-phenyl is described.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in preparation of compounds of the elected group).
Considering objective evidence present in the application indicating obviousness or nonobviousness
Xu shows that an 11‐benzyl‐7‐CH2‐2,5,7,11‐tetraazatricyclo[7.4.0.02,6]trideca‐1(9),5‐dien‐8‐one core structure can be modified on both sides and be expected to work therapeutically as antitumor agent. Xu also describes that a 2-chlorophenyl group is an alternative embodiment to a 2-methylphenyl group.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Conclusion
Claims 4-15 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: compound I/124 is free of the prior art of record because Xu does not describe a compound in which examined variable Y is a 3,5-difluorophenyl group.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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