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
2. The amendment filed 12/19/2025 is acknowledged and has been entered.
Claims 1-2, 4-6 and 21 is amended. Claim 3 has been cancelled. New claim 22 has been added.
3. Claims 1-2, 4-18 and 20-22 have been examined.
Grounds of Objection and Rejection Withdrawn
4. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 07/25/2025.
Grounds of Rejection Maintained
Double Patenting
5. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1-2, 4-18 and 20-22 are/remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 and 18-20 of U.S. Patent No. 11,167,008. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-2, 4-18 and 20-22 are herein drawn to a method for treating cancer, comprising administering a first pharmaceutical composition comprising bacterial minicells to a subject with cancer, wherein the bacterial minicells express and display invasin, wherein the bacterial minicells comprise perfringolysin 0 (PFO); and administering a second pharmaceutical composition comprising one or more immune checkpoint inhibitors to the subject, wherein the one or more immune checkpoint inhibitors is an antibody, wherein the first pharmaceutical composition comprises D-trehalose.
Claims 1-15 and 18-20 of U.S. Patent No. 11,167,008 are drawn to a method for treating cancer, comprising: administering a first pharmaceutical composition comprising bacterial minicells, wherein the first pharmaceutical composition comprises D-trehalose, and wherein the bacterial minicells comprise: invasin and perfringolysin O (PFO), and administering a second pharmaceutical composition comprising one or more immune checkpoint inhibitors to a subject with cancer, wherein the one or more immune checkpoint inhibitor is an antibody.
Additionally, it is noted that 35 USC § 121 does not provide protection for continuation or continuation in-part applications, and this application is a continuation of U.S. Patent No. 11,167,008. See 92 USPQ2d 1289 Amgen Inc. v. F. Hoffmann-La Roche Ltd. (Fed. Cir. 2009) and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. 518 F.3d 1353 (Fed. Cir. 2008).
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Applicant has not filled an appropriate terminal disclaimer or overcome the rejection by a specific amendment or argument; therefor, the rejection is maintained for the reasons of record.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claim 2 is 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 pre-AIA the applicant regards as the invention.
Claim 2 is indefinite because the claim 2 recites “about”.
M.P.E.P. § 2173.05(b) III. A. states:
In determining the range encompassed by the term "about", one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). InW.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
In this case, there is nothing in the specification to provide any indication as to what range of specific activity is covered by the term "about."
Conclusion
10. No claim is allowed.
11. Applicant's amendment necessitated the new ground(s) of objection/rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642