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 33, 35 and 38-72 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group IV,
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and the species of Compound 152, disclosed on page 210 of the instant specification (reproduced below),
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in the reply filed on June 26, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 55-62 and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 26, 2026.
Information Disclosure Statement (IDS)
The Examiner has considered the Information Disclosure Statements (IDSs) filed on August 23, 2024,
March 18, 2025, April 18, 2025, December 17, 2025, January 7, 2026 and June 26, 2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Applicant has filed an 18 page IDS on
August 23, 2024, a 12 page IDS on June 26, 2026 and four other IDSs. The Examiner has given a cursory review of each of the references cited on these IDSs.
The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC., et. al. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. District Court Northern District of Indiana, July 22, 1992), Molins PLC v. Textron, Inc., 48 F.3d 1172, 1184, 33 USPQ2d 1823 (Fed. Cir. 1995).
Claim Interpretation
In claim 35, the definition of variable R72 is being interpreted as that this variable can only represent a 3- to 10-membered heterocycle, which is optionally substituted, even though “selected from” is used in the definition (page 6, lines 3-10 of the page).
Claim Objections
Claims 33, 35, 38-50, 53, 54 and 63-71 are objected to because of the following informalities:
in claim 33, under the definition of variable R51, an “and” should be added before “C2-6 alkynyl,” (line 10 of the claim);
in claim 33, under the definition of variable R52, an “and” should be added before “C2-6 alkynyl,” (line 8 of page 3);
in claim 33, under the definition of variable R53, an “and” should be added after “-CN,” (the 8th line from the end of page 3);
in claim 33, under the definition of variable R54, “independently” should be deleted because there is only one occurrence of a R54 substituent in Formula (VI) (the 5th line from the end of page 3);
in claim 33, under the definition of variable R55, an “and” should be added before “C2-6 alkynyl,” (line 4 of page 4);
in claim 33, under the definition of variable R56, an “and” should be added before “C2-6 alkynyl,” (line 11 of page 4);
in claim 33, under the definition of variable R56, an “comma” should be added after “-SH” (line 17 of page 4);
in claim 35, under the definition of variable R71, an “and” should be added before “C2-6 alkynyl,” (line 10 of the claim);
in claim 35, under the definition of variable R72, “selected from” should be replaced by “a” since the R72 variable can only represent an optionally substituted 3- to 10-membered heterocycle (line 3 of page 6);
in claim 35, under the definition of variable R74, “independently” should be deleted because there is only one occurrence of a R74 substituent in Formula (VIII) (the 14th line of page 6);
in claim 35, under the definition of variable R75, an “and” should be added before “C2-3 alkynyl,” (the 9th line from the end of page 6);
in claim 35, under the definition of variable R76, an “and” should be added before “C2-6 alkynyl,” (the next to the last line of page 6);
in claim 35, under the definition of variable R76, an “comma” should be added after “-SH” (line 5 of page 7);
in claim 38, “or salt” should be changed to “or a salt thereof”;
in claim 39, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 39, under the definition of variable R51, an “and” should be added before “C2-6 alkynyl,” (the next to the last line of page 6);
in claim 40, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 41, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 41, under the definition of variable R51, an “comma” should be added after “-SH” (line 4 of the claim);
in claim 42, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 42, under the definition of variable R51, an “comma” should be added after “-SH” (line 3 of the claim);
in claim 43, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 44, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 45, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 45, under the definition of variable R52, an “and” should be added before “C2-6 alkynyl,” (line 2 of the claim);
in claim 46, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 47, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 48, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 48, under the definition of variable R54, an “comma” should be added after “-SH” (line 2 of the claim);
in claim 49, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 50, “or salt” should be changed to “or a salt thereof”;
in claim 53, the chemical structure is not completely legible;
in claim 54, “or salt” should be changed to “or a salt thereof”;
in claim 63, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 63, under the definition of variable R54, an “comma” should be added after “-SH” (line 4 of the claim);
in claim 64, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 65, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 65, under the definition of variable R72, “selected from” should be replaced by “a” since the R72 variable can only represent an optionally substituted 5-membered heterocycle (line 1 of the claim);
in claim 65, under the definition of variable R72, an “comma” should be added after “-SH” (line 3 of the claim);
in claim 66, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 66, under the definition of variable R72, an “comma” should be added after “-SH”, both occurrences (line 4 of the claim and the last line of the claim);
in claim 67, “or salt” should be changed to “or a salt thereof”;
in claim 68, under the definition of variable R72, an “comma” should be added after “-SH” (line 2 of the claim);
in claim 69, “or salt” should be changed to “or a salt thereof” (line 1 of the claim);
in claim 70, “or salt” should be changed to “or a salt thereof” (line 1 of the claim); and
in claim 71, “or salt” should be changed to “or a salt thereof”.
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.
Claims 42 and 66 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 claim 42, there is a valence problem raised when the phenyl or pyridinyl defined by the R51 variable is substituted with “=O” or with “=S” (lines 3-4 of the claim).
In claim 66, there is a valence problem raised when heteroaryl rings defined by the R72 variable in the claim are substituted with “=O” or with “=S” (lines 4-5 of the claim).
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 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.
Claims 35, 67-69 and 71 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
the compound of Chemical Abstracts Registry Number 2640977-58-6 {indexed in the Registry file on STN CAS ONLINE May 20, 2021},
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{a compound of instant Formula (VIII),
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wherein
X71 = S;
R71 = C1 alkyl (i.e., methyl);
R72 = 6-membered heterocycle (i.e., piperidinyl), which is substituted with
a 6-membered heterocycle (i.e., pyrimidinyl), which is substituted
with one R75;
R74 = C1 alkyl (i.e., methyl);
R75 = halogen (i.e., chloro); and
p = 0};
the compound of Chemical Abstracts Registry Number 2640950-78-1 {indexed in the Registry file on STN CAS ONLINE May 20, 2021},
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{a compound of instant Formula (VIII),
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wherein
X71 = S;
R71 = C1 alkyl (i.e., methyl);
R72 = 6-membered heterocycle (i.e., piperidinyl), which is substituted with
a 6-membered heterocycle (i.e., pyrimidinyl);
R74 = C1 alkyl (i.e., methyl); and
p = 0};
and
the compound of Chemical Abstracts Registry Number 2640866-79-9 {indexed in the Registry file on STN CAS ONLINE May 19, 2021},
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{a compound of instant Formula (VIII),
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wherein
X71 = S;
R71 = C1 alkyl (i.e., methyl);
R72 = 6-membered heterocycle (i.e., piperidinyl);
R74 = C1 alkyl (i.e., methyl); and
p = 0}.
Each of the above cited compounds are embraced by the instant claimed invention. Further, the Registry record of each of the compounds discloses the predictability of the compound in unbuffered water. Therefore, each of the above cited compounds anticipate the instant claimed invention.
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33, 38, 39, 44, 45, 47-50 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Parks et al. {US 2019/0248779}
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant claims compounds of Formula (VI),
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wherein
X51 can represent S;
R51 can represent halogen;
R52 can represent a C3-10 carbocycle, which carbocycle
can be substituted with a C1-6 alkyl, which C1-6
alkyl can be substituted with one or more R55;
R54 can represent hydrogen or C1-6 alkyl;
R55 can represent halogen;
R57 can represent hydrogen; and
p can represent 0.
Parks et al. {paragraphs [0012]-[0025] on page 2} teach compounds represented by,
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wherein
Ring A can represent a 5-6 membered monocyclic
heteroaryl having 2 heteroatoms,
Ring B can represent phenyl, which can be
substituted by R6,
R6 can represent an alkyl, which can be substituted
with halogen,
RC can independently represent hydrogen or alkyl,
RL can independently represent hydrogen, methyl,
ethyl, propyl or butyl, and
RN can represent hydrogen, methyl or ethyl;
which compounds of Parks et al. are structurally similar to the instant claimed compounds. Further, Parks et al. disclose Compound #27 on page 25,
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Additionally, Parks et al. teach pharmaceutical compositions comprising his compounds together with pharmaceutically acceptable carriers or excipients {paragraph [0102] on page 12}.
Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between the compounds of Parks et al. and the compounds instantly claimed is that the instant claimed compounds are generically described in Parks et al.
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
The indiscriminate selection of “some” among “many” is prima facie obvious, In re Lemin, 141 USPQ 814 (C.C.P.A. 1964). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity {e.g., increasing cystic fibrosis transmembrane conductance regulator (CFTR) activity}.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the instant claimed invention, to prepare products embraced by Parks et al. A person of ordinary skill in the art would have been motivated to prepare products embraced by Parks et al. to arrive at the instant claimed products with the expectation of obtaining additional beneficial products which would be useful in treating, for example, cystic fibrosis. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Note to Applicant: Not every piece of prior art found in the database search or class/subclass search which would anticipate and/or render obvious the instant claimed invention under examination has been applied against the instant currently pending claims under examination. See MPEP 904.03.
Allowable Subject Matter
The elected species of Compound 152, disclosed on page 210 of the instant specification, is allowable over the prior art of record.
Claims 51 and 52 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.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
September 4, 2026
Book XXIX, page 83
Prosecution Insights