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 .
Non-Final Rejection
The Status of Claims:
Claims 1-26 are pending.
Claims 1-26 are rejected.
DETAILED ACTION
1. Claims 1-26 are under consideration in this Office Action.
Priority
2 It is noted that this application is a continuation of 18176048 02/28/2023ABN , which is a continuation of 16895033 06/08/2020 (ABN), which is
a continuation of 16/654,281 10/16/2019 PAT 10722521
, which is a continuation of16/116,489 08/29/2018 PAT 10500211,,which is a continuation of 15/934,497 03/23/2018 PAT 10085999, which claims benefit of 62/551,043 08/28/2017 and claims benefit of 62/504,523 05/10/2017.
Drawings
3. None.
IDS
4. None.
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.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 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.
6. Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5, 7, 23-26, and 28-29 of U.S. Patent No.10,085,999. Although the claims at issue are not identical, they are not patentably distinct from each other because of their genus-species relation relationship in the followings:
The claims 1, 5, 7 of and 28-29 of U.S. Patent No.10,085,999 are in the followings:
PNG
media_image1.png
354
551
media_image1.png
Greyscale
PNG
media_image2.png
353
565
media_image2.png
Greyscale
PNG
media_image3.png
52
576
media_image3.png
Greyscale
3-(((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropyl benzoate (2);
2-methoxyethyl 3-(((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (15);
oxetan-3-yl 3-(((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (16);
ethyl 1-((((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)methyl)cyclohexanecarboxylate (17);
ethyl 1-((((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)methyl)cyclopropanecarboxylate (18);
ethyl 1-((((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)methyl)cyclobutanecarboxylate (19);
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ((3-methyl-2-oxotetrahydrofuran-3-yl)methyl) sulfate (42);
S-(3-(((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropyl) ethanethioate (53);
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 3-(((((2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (59);
a pharmaceutically acceptable salt of any of the foregoing; and
a combination of any of the foregoing.
28. A method of treating a bacterial infection in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of the compound of claim 1 or a pharmaceutically acceptable salt thereof; and a therapeutically effective amount of a β-lactam antibiotic, wherein bacteria causing the bacterial infection produce a β-lactamase.
29. The method of claim 28, wherein administering comprises orally administering.
, whereas some of the current claims 1, and 10-18 do disclose the followings as shown below:
1. A compound selected from: 2-methoxyethyl 3-(((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1 ]octan-6- yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (15); oxetan-3-yl 3-(((((1R,2S,5R)-2-carbamoyl-7-oxo- 1,6-diazabicyclo[3.2.1 ]octan-6- yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (16); ethyl 1-((((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1 ]octan-6- yl)oxy)sulfonyl)oxy)methyl)cyclohexanecarboxylate (17); ethyl 1-((((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1 ]octan-6- yl)oxy)sulfonyl)oxy)methyl)cyclopentane-1-carboxylate (18); ethyl 1-((((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1 ]octan-6- yl)oxy)sulfonyl)oxy)methyl)cyclobutanecarboxylate (19); (1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ((3-methyl-2- oxotetrahydrofuran-3-yl)methyl) sulfate (42); S-(3-(((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1 ]octan-6-yl)oxy)sulfonyl)oxy)- 2,2-dimethylpropyl) ethanethioate (53); and (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 3-(((((1R,2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl)oxy)sulfonyl)oxy)-2,2-dimethylpropanoate (59); or a pharmaceutically acceptable salt of any of the foregoing.
10. A pharmaceutical composition comprising the compound of claim 1 or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable vehicle.
11. The pharmaceutical composition of claim 10, further comprising an antibiotic.
12. The pharmaceutical composition of claim 11, wherein the antibiotic comprises a 3- lactam antibiotic.
13. The pharmaceutical composition of claim 11, wherein the antibiotic comprises ceftibuten, amoxicillin, or a combination thereof.
14. The pharmaceutical composition of claim 10, wherein the pharmaceutical composition is an oral dosage formulation.
15. A method of treating a bacterial infection in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of the compound of claim 1 or a pharmaceutically acceptable salt thereof; and a therapeutically effective amount of a 3-lactam antibiotic, wherein bacteria causing the bacterial infection produce a 3-lactamase.
16. The method of claim 15, wherein administering comprises orally administering.
17. The method of claim 15, wherein the 3-lactam antibiotic comprises ceftibuten, amoxicillin, or a combination thereof.
18. A method of treating a bacterial infection in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of the compound of claim 1 or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of a 3-lactam antibiotic, wherein the bacterial infection is capable of being treated with a therapeutically effective amount of the 3-lactam antibiotic when co-administered with a therapeutically effective amount of avibactam.
However, the current claims differ from the US patented application in that
each of the compounds (15)-(19),(42), (53), and (59) is not claimed separately
in the claims of the U.S. Patent No.10,085,999 and the example of antibiotic comprising ceftibuten, amoxicillin, or a combination thereof is unspecified in some of the claims of the U.S. Patent No..
Regarding the lack of disclosing antibiotics comprising ceftibuten, and amoxicillin, the specification does teach that antibiotics include, for example, ceftibuten (see col. 58, line 37), amoxicillin (see col. 58, line 40). From these teachings, it seems reasonable for the skilled artisan in the art to incorporate the particular limitations into the claims in order to make the claims narrowed. So, it would have been obvious to the skilled artisan in the art to be motivated to narrow the claimed invention by incorporate the specific antibiotics of ceftibuten and amoxicillin into the claims in order to protect the particular aspects of the claimed invention.
Regarding the lack of claiming each of the compounds (15)-(19),(42), (53), and (59) in the different dependent claims in the U.S. Patent No.10,085,999, this type of the adjustment in the claims can be arranged by the skilled artisan in the art who would like to emphasize the particular aspects of the claimed invention.
In addition, rearranging or recombining or dividing the independent claim into several dependent claims, each of which can contain an individual compound; this is an obvious variant over the instant claimed invention. Such a limitation can be anticipated; there is very little difference as to the patentable distinction. Thus, it would have been obvious to the skilled artisan in the art to be motivated to narrow the claimed invention by dividing the independent claim 1 into dependent claims, each of the claims containing each of the specific and individual compounds of (15)-(19), (42), (53), and (59) in order to protect the particular aspect of the claimed invention. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the claims in the patented application.
Conclusion
Claims 1-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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, Andrew Kosar can be reached on 571-272-0913. 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.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 8/20/2026
Prosecution Insights