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 007 in the reply filed on 2026 April 1 is acknowledged. The traversal is on the ground(s) that the structural moiety of a nitrogen-containing ring connected to a phenyl ring is present. After conducting an initial search, searching the entire genus of formula I does not constitute an undue burden. Claims 2-13, 15, 16,, and 21-26 are pending and examined in their entirety on the merits.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2024 May 15 and 2025 August 19 have been submitted 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 2, 3, 6, 13, 15, 16, 21-26 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.
What substituents are attached to the ring containing variables X1 and X2 when examined variable m is zero? Variable R2 is defined as H, two instances of methyl attached to X1, or an instance when a cycloalkyl group is present of X1. Variable m is an integer of 0-2 inclusive.
When a double bond is present between variables X1 and X2, each of the ring elements is non-neutral. When the ring element is CRaRb, the carbon is pentavalent and anionic. When the ring element is NRa or S, the ring element is cationic with a formal charge of +1. In each of these situations, what is the corresponding counterion to make the compound neutral as it is claimed?
In claim 24, what are compounds 001-014? None of the structures for these compounds are recited.
Claim Rejections - 35 USC § 102
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.
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) 2-4, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHEN (CA 3101226, published 2019 November 28). Chen describes several compounds (page 7:row 1, columns 3 and 4; column 2, rows 1 and 4; row 3, columns 1-4; row 4, column 1 and 2; page 8, row 1, columns 1-3; page 8, row 2, columns 3 and 4; and page 8, row 3, columns 1-2). In these compounds the following examined definitions apply: ring A is thiophene, unsubstituted or substituted with chloro or fluoro; X1-X2 is -CH2-CH2-; R5 and R7 are each Me; R4 and R6 are each H; Z-R3 is CH2-C(Me)3. Pharmaceutical compositions and methods of using the same are described (page 11, line 15 to page 13, line 22). Table 1 shows texting of several of these compounds (page 44, line 19 to page 48, line 14)..
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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 2-4, 13, and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over CHEN (CA 3101226, published 2019 November 28).
Determining the scope and contents of the prior art
Chen describes several compound 03058 (page 46). Pharmaceutical compositions and methods of using the same are described (page 11, line 15 to page 13, line 22). Table 1 (page 44, line 19 to page 48, line 14) shows texting of several of these compounds. Based on the testing of compounds in table 1 (pages 46-47), compound 03058 shows that an -O-CH2- is an alternative group for -CH2-CH2- for variables -X1-X2- (page 2, lines 21-32). Compounds of table 1 are tested as potassium ion channel openers.
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Ascertaining the differences between the prior art and the claims at issue
In the prior art, an intramolecular an -O-CH2- is an alternative group for -CH2-CH2- for variables -X1-X2-. compounds that are potassium ion channel openers.
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
Chen describes that an intramolecular -O-CH2- is an alternative group for -CH2-CH2- for variables -X1-X2- in potassium ion channel opening compounds. Consequently there is a reasonable expectation of success to replace a methylene group with an O in 2,3,4,5‐tetrahydro‐1H‐2‐benzazepine ring to form an 2,3,4,5‐tetrahydro‐1,4‐benzoxazepine ring.
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 2, 3, 6, 13, 15, 16, and 21-26 are not allowed.
Claims 4, 5, and 7-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: CHEN (CA 3101226, published 2019 November 28) does not describe compounds in which examined variable R1 is selected from a group recited in claims 4-6 or a compound in which examined variable X2 is CMe2.
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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