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
Status of 18/709,983
Claims 19-20 and 32-57 are currently pending.
Priority
Instant application 18/709,983, filed 5/14/2024, claims priority as follows:
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Information Disclosure Statement
All references from the IDS’s submitted on 5/30/2024, 7/18/2025, 12/1/2025, and 2/27/2026 have been considered unless marked with a strikethrough.
Election/Restriction
Applicant’s election of Group I, claims 19-20 and 32-53, drawn to pharmaceutical compositions comprising monobactams of the instant claims and relebactam, in the reply filed 7/2/2026 is acknowledged. Applicant’s election of Compound 7 of Example 9:
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In the same reply, is also acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examination will begin with the elected species. In accordance with 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 examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 19, 20, 35, and 46 read on the elected species. Claims 32-34, 36-45, and 47-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
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 (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 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, 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 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 19, 20, 35, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Merck Sharp & Dohme Corp. (WO 2019/070492 A1, cited in the IDS of 5/30/2024, herein after “Merck”).
Determining the scope and contents of the prior art
The reference Merck teaches chromane monobactam compounds and compositions to treat bacterial infections (abstract and title). Specifically, Merck teaches compounds of Formula (I) (page 127, claim 1):
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And further teaches pharmaceutical compositions comprising a therapeutically effective amount of a compound of Formula (I) and a therapeutically effective amount of additional beta-lactamase inhibitor relebactam (page 146, claims 24-26). Merck teaches that all of the compounds were tested in antimicrobial assays in the presence of the relebactam (page 123, lines 22-23) by adding a 1 μL of test compound in DMSO followed by 4 μL of 50 μg/mL of relebactam in MOPS buffer. The definition of “therapeutically effective amount” of Merck is identical to that of the instant disclosure (page 72), and thus the teachings of Merck satisfy this limitation of the instant claims.
The instant elected species, Compound 7:
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Is a compound of the genus of Merck when Q is CR3, where R3 is hydrogen, R12 is C1 alkyl, R13 is C1 alkyl, W is O, R1 is C1 alkyl, R2 is -C(O)ORe, where Re is hydrogen, X is CH2, Y is CH2, Z is O, s is 0, t is 0, T is CH2, U is CH2, V is CH2, A is -C(=NH)-NH, L is absent, and M is R5, where R5 is a C3 cycloalkyl substituted with one R6, R6 is –(CH2)nNRcRd, n is 0, Rc is hydrogen, and Rd is hydrogen. One of ordinary skill would be directed to choose instant Compound 7 from the myriad of compounds available in the genus of Merck by the teaching of compounds such as 13 (page 104):
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Which shares most of the same variables with instant Compound 7. Specifically, Compound 13 of Merck and instant Compound 7 share the same following variable of Formula (I): Q is CR3, where R3 is hydrogen, R12 is C1 alkyl, R13 is C1 alkyl, W is O, X is CH2, Y is CH2, Z is O, s is 0, t is 0, T is CH2, U is CH2, V is CH2, A is -C(=NH)-NH, R6 is –(CH2)nNRcRd, n is 0, Rc is hydrogen, and Rd is hydrogen. Additional compounds of the same series teach compounds where R1 is C1 alkyl, R2 is -C(O)ORe, and Re is hydrogen as preferred embodiments in the same stereochemical configuration as instant compound 7 (pages 54-59 and 103-104), which would direct a skilled artisan to the internal quaternary center in the correct stereochemical configuration of the elected species. Furthermore, Merck teaches multiple examples of chromane monobactam antibiotics with substitutions on the chromane ring (pages 54-59), also identified as variables A, L, and M of Merck Formula (I), as preferred embodiments of the disclosure, indicating that particular site is key to medicinal chemistry exploration.
Ascertaining the differences between the prior art and the claims at issue
Merck fails to teach an anticipatory species of a pharmaceutical composition comprising the elected species and relebactam.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of pharmaceutical compositions comprising antibiotics. An artisan possess the technical knowledge necessary to make adjustments to the antibiotics to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said antibiotics and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would have been prima facie obvious to one having ordinary skill in the art to arrive at the elected pharmaceutical composition comprising compound 7 and relebactam because the reference Merck teaches chromane amidine monobactam antibiotics with a genus of Formula I, under which the instant compound 7 falls, in a pharmaceutical composition with relebactam inhibiting bacterial strains. Moreover, substituting one substituent for another on the chromane ring would expect success because structurally similar compounds are expected to have similar properties, and based on the genus, such a resulting compound would be expected to have these properties.
Further, according to MPEP § 2144.08:
In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
One of ordinary skill in the art would have reasonably predicted that a pharmaceutical composition comprising instant compound 7 and relebactam would be capable of treating bacterial infections in view of the teachings of Merck. The Examiner notes this argument can be expanded to encompass multiple compounds of the instant invention, and that expanding to different species using the art and substitution argument will lead to a final rejection.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.-
Claims 19, 20, 35, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, and 19-21 of U.S. Patent No. 11,433,055 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘055 Patent teaches compounds of Formula (I) (col 133, claim 1):
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And further teaches pharmaceutical compositions comprising a therapeutically effective amount of a compound of Formula (I) and a therapeutically effective amount of additional beta-lactamase inhibitor relebactam (col 144, claims 19-21). The compound of the instant elected species, Compound 7:
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Is a compound of the genus of Merck when Q is CR3, where R3 is hydrogen, R12 is C1 alkyl, R13 is C1 alkyl, W is O, R1 is C1 alkyl, R2 is -C(O)ORe, where Re is hydrogen, X is CH2, Y is CH2, Z is O, s is 0, t is 0, T is CH2, U is CH2, V is CH2, A is -C(=NH)-NH, L is absent, and M is R5, where R5 is a C3 cycloalkyl substituted with one R6, R6 is –(CH2)nNRcRd, n is 0, Rc is hydrogen, and Rd is hydrogen.
Though the ‘055 Patent fails to teach a anticipatory species of pharmaceutical composition comprising the instant elected species compound 7, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the elected pharmaceutical composition comprising compound 7 and relebactam because the ‘055 Patent teaches chromane amidine monobactam antibiotics with a genus of Formula I, under which the instant compound 7 falls, in a pharmaceutical composition with relebactam, and structurally similar compounds are expected to have similar properties. Further, according to MPEP § 2144.08:
In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
One of ordinary skill in the art would have reasonably predicted that a pharmaceutical composition comprising instant compound 7 and relebactam would be capable of treating bacterial infections in view of the ‘055 Patent.
Claims 19, 20, 35, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23, 31, and 42 of U.S. Patent No. 11,932,637 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘637 Patent teaches compounds of Formula (I) (col 319, claim 1):
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And further teaches pharmaceutical compositions comprising a therapeutically effective amount of a compound of Formula (I) and a therapeutically effective amount of additional beta-lactamase inhibitor relebactam (col 337, claims 21-23). The compound of the instant elected species, Compound 7:
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Is a compound of the genus of the ‘637 Patent when R6 is hydrogen, R7 is hydrogen, Q is CR8, where R8 is hydrogen, R9 is C1 alkyl, R10 is C1 alkyl, W is O, R4 is C1 alkyl, R5 is -CO2H, X is CH2, Y is CH2, Z is O, s is 0, t is 0, T is CH, U is CH, V is CH, R3 is hydrogen, R2 is hydrogen, R1 is C3 cycloalkyl substituted with one Ra, where Ra is -C0alkylNRkRl, Rk is hydrogen, and Rl is hydrogen.
Though the ‘637 Patent fails to teach a anticipatory species of pharmaceutical composition comprising the instant elected species compound 7, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the elected pharmaceutical composition comprising compound 7 and relebactam because the ‘637 Patent teaches chromane amidine monobactam antibiotics with a genus of Formula I, under which the instant compound 7 falls, in a pharmaceutical composition with relebactam, and structurally similar compounds are expected to have similar properties. Further, according to MPEP § 2144.08:
In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
One of ordinary skill in the art would have reasonably predicted that a pharmaceutical composition comprising instant compound 7 and relebactam would be capable of treating bacterial infections in view of the ‘637 Patent.
Conclusion
Claims 19, 20, 35, and 46 are rejected. Claims 32-34, 36-45, and 47-57 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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