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 of Claims
Claims 1, 4, 25, 28, 30, 33, 38, and 40-41 are currently pending.
WITHDRAWN OBJECTIONS AND/OR REJECTIONS
Applicant’s arguments and/or amendments, filed May 12, 2025, with respect to:
Rejection of claim 38 under 35 U.S.C. § 112(a) (see pg. 4 in the first full ¶), and
Rejection of claims 1, 4, 25, 28, 30, 33, 38, 40, and 41 on the grounds of provisional nonstatutory double patenting over App. No. 19/029,079 (see Terminal Disclaimer filed 9/9/2025)
have been fully considered and are persuasive. The aforementioned grounds of objection and/or rejection have been withdrawn.
Claims 1, 4, 25, 28, 30, 38, and 41 stand and claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-33 of copending Application No. 16/482,603 in view of Irving et al. in US 2016/0194399 A1 published on July 7, 2016.
Claim 33 is directed to liquid and lyophilized compositions stable after storage for, inter alia, 0 weeks. Accordingly, the scope of claim 33 includes stability after storage for, e.g. 1 second, which is necessarily true of the composition rendered obvious by ‘603 in view of Irving.
Claims 1, 4, 28, 30, 38, 40, and 41 stand and claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 7-8, 11-12, 15-16, 18, 20-30 of copending Application No. 17/921,794 in view of Irving et al. in US 2016/0194399 A1 published on July 7, 2016.
Claim 33 is directed to liquid and lyophilized compositions stable after storage for, inter alia, 0 weeks. Accordingly, the scope of claim 33 includes stability after storage for, e.g. 1 second, which is necessarily true of the composition rendered obvious by ‘603 in view of Irving.
Claims 1, 4, 28, 30, 38, 40, and 41 stand and claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 9, 21, 27-32, 37-38, 41, 44-45,47, 50, 52, 56-57, 59 of copending Application No. 18/024,893 in view of Irving et al. in US 2016/0194399 A1 published on July 7, 2016.
Claim 33 is directed to liquid and lyophilized compositions stable after storage for, inter alia, 0 weeks. Accordingly, the scope of claim 33 includes stability after storage for, e.g. 1 second, which is necessarily true of the composition rendered obvious by ‘603 in view of Irving.
Claims 1, 4, 25, 28, 30, 38, and 40 stand and claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/024,641 in view of Irving et al. in US 2016/0194399 A1 published on July 7, 2016.
Claim 33 is directed to liquid and lyophilized compositions stable after storage for, inter alia, 0 weeks. Accordingly, the scope of claim 33 includes stability after storage for, e.g. 1 second, which is necessarily true of the composition rendered obvious by ‘603 in view of Irving.
Applicant's arguments filed August 8, 2025 have been fully considered but they are not persuasive.
On pg. 5 in the first full ¶, Applicant argues “Applicant submits herewith terminal disclaimers over copending Application Nos. 16/482,603, 19/024,641, and 19/029,641.” However, no terminal disclaimers were present in the file on 8/8/2025. Examiner’s attempts clarify the Remarks on 9/9/2025 and 9/11/2025 via telephonic communication were met with no reply.
A terminal disclaimer for 19/029,641 was placed in the Application on 9/9/2025. However, attempts to clarify the omission of terminal disclaimers over 16/482,603 and 19/024,641 made on 9/11/2025 via telephonic communication have been met with no reply. The communicated deadline for reply was Friday 9/12/2025. Accordingly, the aforementioned grounds of nonstatutory double patenting have been maintained.
With respect to Applicant arguments regarding the nonstatutory double patenting rejections over 17/921,794 and 18/024,893, “if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the Office should withdraw the rejection in the application having the earlier patent term filing date (M.P.E.P. § 804.I.B.1.b.)” (Remarks on pg. 4 in the last ¶ spanning pg. 5), Examiner respectfully notes that since the nonstatutory double patenting rejections over 16/482,603 and 19/024,641 are maintained, the rejections over 17/921,794 and 18/024,893 are not the only remaining rejections. Thus, the provisions of M.P.E.P. § 804.I.B.1.b. do not apply and the rejections over 17/921,794 and 18/024,893 are maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA K SWARTWOUT whose telephone number is (703)756-4672. The examiner can normally be reached Monday-Friday 8-5.
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, Daniel Kolker can be reached at (571) 272-3181. 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.
/B.K.S./Examiner, Art Unit 1644
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683