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 .
Priority
Instant application 18730175 filed on 07/18/2024 claims benefit as follows:
CONTINUING DATA:
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19
365
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36
383
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Status of the Application
Claims 30-49 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 07/24/2026 is acknowledged.
Claims 48 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/24/2026.
Regarding species election, Applicant’s election without traverse of compound KH14 in the reply filed on 07/24/2026 is acknowledged.
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640
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of prior art.
The examiner has moved onto alternative species embodied within the general formula recited in the instant claim 30, and subsequent examination is based on this species expansion.
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 34-46 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.
The phrase "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The dependent claims are rejected because the scope of those claims is also not clear.
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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30, 31, 32, 33 and 47 are rejected under 35 U.S.C. 102(a)((1) as being anticipated by WO-2013033037-A2.
WO-2013033037-A2 teaches and claims (see claim 50):
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125
402
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Specifically, WO-2013033037-A2 teaches and claims the following compound (see claim 55, page 369, last row):
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150
178
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The above compound falls under instant Formula I:
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223
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wherein X1 is N, X2 is C, Z1 is C, Z2 is C; R1 is hydrogen; A is substituted benzene ring (substituted with F and triazole moiety); B is 6 membered aliphatic heterocyclic ring (piperidine ring).
WO-2013033037-A2 teaches that the disclosed compounds may be used in treatments of various diseases and conditions, including chronic pain and pain associated with gastroesophageal reflux disease (see paragraph [0162], lines 21-22).
Further, regarding instant claim 47, WO-2013033037-A2 teaches and claims a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient (see claim 37).
Claims 30, 31, 32, 33, 34, 35, 36, 39 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 1287975-95-4 (STN, CAS Registry Number, 1287975-95-4, Entered to STN 01 May 2011).
STN (CAS Registry Number, 1287975-95-4) teaches:
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823
956
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The above compound 1287975-95-4 falls under instant Formula II:
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144
236
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wherein R1 is H, X1 is N, X2 is C, A is six membered aryl substituted by halogen, Y is N, n is 1, R5 is hydrogen.
Further, the above compound 1287975-95-4 falls under Formula III
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163
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wherein R1 is H, X1 is N, X2 is C, T is CR6, R6 is halogen, R9 is hydrogen, Y is N, n is 1, R5 is hydrogen.
Regarding instant claim 36, it should be noted that instant claim 36 recites n is integer from 1-4, preferably, n is 3. Therefore, a compound wherein n is 1 meets the claim limitation.
The 1287975-95-4 compound was entered to STN on 05/01/2011. MPEP 2128 (I)(B) states “Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted”.
Claims 30, 31, 32, 33, 34, 35, 36, 39, 40, 41 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 1625521-99-4 (STN, CAS Registry Number, 1625521-99-4) evidenced by UkrOrgSyntez website (printed 02/23/2025).
STN (CAS Registry Number, 1625521-99-4) teaches:
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835
963
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The above compound 1625521-99-4 falls under instant Formula III
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163
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wherein R1 is H, X1 is N, X2 is C, T is CR6, R6 is hydrogen, R9 is SO2R2, R2 is C2- alkyl, Y is N, n is 1, R5 is hydrogen.
Regarding instant claim 36, it should be noted that instant claim 36 recites n is integer from 1-4, preferably, n is 3. Therefore, a compound wherein n is 1 meets the claim limitation.
Regarding instant claim 41, it should be noted that R9 is SO2R2, R2 is C2- alkyl.
The above compound 1625521-99-4 was entered to STN on 09/24/2014. MPEP 2128 (I)(B) states “Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted”.
Regarding claim 47, As evidenced by UkrOrgSyntez website (printed 12/11/2024), Ukrorgsyntez is a screening library that provides “screening libraries and building blocks for small molecule drug discovery.” Since the above compound is registered in the screening library, one of ordinary skill in the art would ‘at once envisage’ formulating compound 1625521-99-4 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Claims 30, 31, 32, 33, 34, 35, 36, 39 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 1317439-49-8 (STN, CAS Registry Number, 1317439-49-8) evidenced by UkrOrgSyntez website (printed 02/23/2025).
STN (CAS Registry Number, 1317439-49-8) teaches:
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858
958
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The compound 1317439-49-8 falls under Formula III
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163
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wherein R1 is H, X1 is N, X2 is C, T is CR6, R6 is C1 alkyl, R9 is SO2R2, R2 is NH2, Y is N, n is 1, R5 is hydrogen.
Regarding instant claim 36, it should be noted that instant claim 36 recites n is integer from 1-4, preferably, n is 3. Therefore, a compound wherein n is 1 meets the claim limitation.
Regarding instant claim 41, it should be noted that R9 is SO2R2, R2 is NH2.
The above compound 1317439-49-8 was entered to STN on 08/14/2011. MPEP 2128 (I)(B) states “Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted”.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
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