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 .
Status
The present office action is in responsive to February 22, 2024 Preliminary Amendment Remarks and Comments and corresponding miscellaneous documents.
Claims 1, 3-14, 16-20, 23 and 30 are pending, claim 4 is currently amended, claims 20 and 30 are withdrawn for being directed to non-elected inventions and claims 2, 15, 21-22, 24-29 and 31-34 are cancelled in the above-identified application.
Priority
U.S. Pat. Appln. Ser. No.: 18076274, Filed: December 6, 2022 is a continuation of WO 2021/249896 A1 (i.e., PCT/EP2021/065088, Intern.’l Filing Date: June 7, 2021; Intern.’l Pub. Date: December 16, 2021), which claims foreign priority to WO 2021/017600 (i.e., PCT/CN2020/095147, Filing Date: June 9, 2020)
Information Disclosure Statement
Two (2) Information Disclosure Statements (IDS) submitted on June 5, 2024 and October 8, 2025 and are in compliance with the provisions of 37 CFR 1.97.
Accordingly, Information Disclosure Statements have been considered by the Examiner.
Election/Restriction
Applicant’s election without traverse is acknowledged of:
[A] Group I: Claims 1, 3-14, 16-19 drawn to compounds of Formula (I) or a pharmaceutically acceptable salt thereof; and
Claim 23 drawn to a pharmaceutical compositions comprising compounds of
claim 1 or a pharmaceutically acceptable salt thereof and a therapeutically inert carrier; resp., classified in multiple classes/subclasses (inc.,C07D489/00+, etc.);
[B] Species Election: Compound 35
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Because Applicants did not distinctly and specifically point out the supposed errors in the species restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
[C] Claims 1,3-14,16-19 and 23 read on the elected invention.
[D] The following claims are withdrawn from further consideration pursuant to 37 CFR
1.142(b), for being drawn to a nonelected inventions, there being no allowable generic or linking claim:
Claim 20 is directed to a process for manufacturing the compounds of formula (I); and
Claim 30 method for treatment or prevention of infections with resulting diseases caused by ESKAPE group of bacteria (i.e., Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species or E. coli, or a combination thereof).
Therefore this restriction is considered proper and thus made FINAL.
Based on the above, the requirement is still deemed proper and is therefore made FINAL
Elected Species and Broad Expanded Search
A comprehensive search of the patent and non-patent literature was conducted for:
elected species Compound 35 identified supra; and
that species election of compound 35 was withdrawn; followed by an expanded broad genus scope directed to a compound of Formula (I) or pharmaceutically acceptable salts thereof, i.e. which encompasses the elected species and other species therein.
The species compound 35 has been identified in the WO 2021/249896 A1, part of the same patent family associated with U.S. Pat. Pub. 2023/0141600, which corresponds to U.S. Appln. Ser. No. 18/076, 274 to Hoffman-La Roche, Inc. being examiner ; i.e., which is the current patent application now examined.
Search of expanded to encompass broad scope of Formula (I) or pharmaceutically acceptable salts thereof, which identified several of Applicants’ patent applications related to the instant patent application under examination identified by relevant overlapping genus, subgenus and/or compound species encompassed by generic or broad scope of Formula (I). See Citation of Prior Art before Conclusion Section (i.e., 3rd party patent literature identified related compounds that are distinguished from those compounds of the present invention due to functional group substituents on positions in the instant application that are not substituted).
No prior art was found in the patent and non-patent literature Upon above-identified expanded search, prior art was found (i.e., see Citation of Pertinent Prior Art Section herein)
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
[A] Claims 1, 3-14, 16-19 and 23 of the Present Invention
In particular, claims 1, 3-14, 16-19 and 23 are directed to a compound of formula (I) or pharmaceutically acceptable salt thereof or corresponding pharmaceutical compositions thereof; where the claim 1 is defined as follows:
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[B] Provisional Nonstatutory Obviousness-Type Double Patenting Rejections
[1] Claims 1,13-14,16-19 and 23 are provisionally rejected under the judicially created doctrine of nonstatutory obvious-type double patenting as being unpatentable over claims 1,3-6, 8-10,12-13,15, 51,54-58 and 61 of co-pending U.S. Appln. Ser. No. 17/976,651 (i.e., corresponds to US Pat. Pub.: 2023/0203043A1 Filing Date: October 28, 2022; “U.S. ‘651 Appln.")
In particular, Claim 1 and corresponding dependent claims 3-6, 8-10,12-13,15, 51,54-58 and 61 of U.S. ‘651 Appln are directed to a compound of Formula (I):
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;
Although the conflicting claims are not identical, they are not patentably distinct from
each other because:
claims of the instant application directed to a broader genus of compounds of formula (I), and claims of U.S. ‘651 Appln., respectively contain overlapping key variables with corresponding functional groups as shown below (i.e., where it is clear that overlapping compound scope exemplifies double patenting between the claims of the instant and US ‘651 Appln.);
claimed compounds of the US ‘651 Appln. read on the broader genus of Formula (I) of the instant invention or the broader claimed genus of Formula (I) of the instant invention encompasses the narrower compound scope of the US ‘‘651 Appln.
PRESENT INVENTION
US PAT. APPLN. 17/976,651
Claims 1,13-14,16-19 and 23
Compound Formula Correlations
Claims 1,3-6, 8-10,12-13,15, 51,54-58 and 61
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(I)
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(I)
The moiety
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attached to the phenyl group of the instant invention, where a Rx =
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(i.e., RxC(O) = X) encompasses the corresponding moiety
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attached to phenyl group therein of the U.S. ‘651 Appln
The R3 and R5 functional groups are attached to the phenyl moiety
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i.e., where R3 and R5 of the instant application corresponds to R3 and R9 and R4 and R8 = hydrogen attached to the phenyl moiety
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of U.S. ‘651 Appln that is substituted with X is as defined above and R3 and R9 and R4 and R8 = hydrogen
The 1R6,3R5,5R7substituted pyrazole R4 moiety as attached to this group
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, where
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(i.e., R4 = 1,3,5 substituted pyrazole) and corresponds to the 1R6,3R5,5R7substituted pyrazole
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of the U.S. ‘651 Appln
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Below is a schematic chart visually showing how each of the functional groups between the claimed invention and the US ‘561 Appln. correlated with each other:
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[2] Claims 1,13-14, 16-19 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8,10,12, 14, 19, 21-25 and 29 of co-pending U.S. Appln. Ser. No. 18/076,383 (i.e., corresponds to U.S. Pat. Pub. 2023/0141403 A1 Filing Date: December 6, 2022; U.S. ‘383 Appln.)
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Claims of the U.S. ‘383 recites compounds of formula (I) thereof or a pharmaceutically acceptable salt thereof and corresponding pharmaceutical compositions as defined as shown:
where:
X = carbonyl,
R1 =
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A is selected from the group consisting of 3- to 14-membered heterocyclyl, 5- to 14- membered heteroaryl, C6-C14-aryl, and C3-C10-cycloalkyl;
L1 = covalent bond
R2, R3, R7, R8 and R9 definitions overlap with those of claimed invention;
m = 1 and n = 1,2 or 3
Although the conflicting claims are not identical, they are not patentably distinct from
each other because:
claims of the instant application are directed to a broader genus of compounds of formula (I) of the present invention, while claimed compounds of formula (I) of U.S. ‘.383 Appln., respectively, which have corresponding and overlapping functional group scope as defined by key variables and functional groups as discussed and shown.
Claimed compounds of the US ‘383 Appln. read on the broader genus of Formula (I) of the instant invention or the broader claimed genus of Formula (I) of the instant invention encompasses the narrower compound scope of the US ‘383 Appln
Formula (I) of Present Invention
Formula (I) or US ‘383 Appln
Claims 1,13-14, 16-19 and 23
claims 1-8,10,12, 14, 19, 21-25 and 29
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Compound Formula Correlations
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The
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moiety, Rx =
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attached to phenyl group of Formula (I) of the instant invention (i.e., RxC(O) = R1-X- = R1C(O) which encompasses the group
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attached to the phenyl group, where R1 is defined as
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and
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R3 and R5 substituents on the
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of the instant invention (i.e.,R3 and R5 = (R2)m) encompasses the corresponding phenyl group substituted with (R2)m, where R2 is defined as
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and m = 1 to 4 as shown by o
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of the US ‘383 Appln; and
The R4 group attached to the imidazo(1,2-a)pyrazine
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moiety, is defined as
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of the instant invention , where F is C6-C10-aryl substituted with R23, R24 or R25 (i.e., R4 = phenyl substituted with (R3)n), which encompasses the phenyl substituted imidazo(1,2-a)pyrazine
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of the US ’383 Appln (i.e., where
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.
Below is a schematic chart visually showing how each of the functional groups between the claimed invention and the US ‘383 Appln. correlated with each other:
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In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a non-statutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
However, one skilled in the art would recognize that the claims of U.S. ‘383 Appln
One having ordinary skill in the art at the time of the invention would have noted that subject matter exists in both the instant invention and the co-pending applications that is not patentably distinct from each other. It has also been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
Appropriate action is required accordingly.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, because:
The references cited below represent close prior art that teach unsubstituted Rx (= B = 3 to 14 membered heterocycle) and unsubstituted R4 (= F= 5 to 14 membered heteroaryl) variable or functional groups, which is distinguished from compounds of the instant invention have substituted Rx and R4 functional group variables at the same positions:
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and
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Zeng et al., Bioorg. & Med. Chem. Lett. (2011), 21-5875:
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Thakur et al., India Biochem. and Biophys. Res. Comm. (2017), 482 (4), 1289-1295:
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CONCLUSION
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to GRACE C HSU whose telephone number is (571) 270-1689.
The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicants 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, KORTNEY L. KLINKEL can be reached on 571-270-5239. 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.
/G.C.H./
Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627