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 the Claims
Per Applicant’s amendment to the claims, submitted on 12/31/2024, claim 1 is amended. Currently, claims 1-19 are pending in the instant application.
It is herein noted that correspondence to Applicant’s most recent remarks and amendments were delayed due to an error in the electronic docketing system. During the interim between Applicant’s previous correspondence (12/31/2024) and the instant Office Action, co-pending Applications 19/184,689, 19/184,766, and 19/184,838 were filed, and necessitate additional provisional double patenting rejections detailed herein.
Terminal Disclaimer
Applicant has submitted Terminal Disclaimer over US patent 12064430 on 12/31/2024.The Terminal Disclaimer is hereby acknowledged and accepted.
Double Patenting – Withdrawn
Rejections of claims 1-19 over US patent 12064430:
In light of Applicant’s submission of Terminal Disclaimer over US patent 12064430, the rejections are hereby withdrawn.
Double Patenting – New Grounds of Rejection
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/184,689 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to exceedingly overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of the instant application recites the following:
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Claim 1 of the reference application recites the following:
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Claim 7 of the reference application recites the following:
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Claim 13 of the reference application recites the following:
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300
634
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As can be seen from the claims above, the method of the instant application and the methods of the reference application have significant overlap in their subject matter. More specifically, that each of the above methods are drawn to the administration of a composition comprising cabozantinib lauryl sulfate and identical excipients with the same HLB values. Furthermore, the amount range of cabozantinib lauryl sulfate of claim 1 of the instant application appears to encompass the amount ranges of the same material in claims 1, 7, and 13 of the reference application. As each of the provided methods above are drawn to materials and processes with exceedingly overlapping claim scope, the claims at hand cannot be considered to be patentably distinct from one another.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/184,766 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to exceedingly overlapping subject matter.
Claim 1 of the instant application recites the following:
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Claim 1 of the reference application recites the following:
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Claim 7 of the reference application recites the following:
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Claim 14 of the reference application recites the following:
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134
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As can be seen from the claims above, the method of the instant application and the methods of the reference application have significant overlap in their subject matter. More specifically, that each of the above methods are drawn to the administration of a composition comprising cabozantinib lauryl sulfate and identical excipients with the same HLB values. Furthermore, the amount range of cabozantinib lauryl sulfate of claim 1 of the instant application appears to encompass the amount ranges of the same material in claims 1, 7, and 14 of the reference application. As each of the provided methods above are drawn to materials and processes with exceedingly overlapping claim scope, the claims at hand cannot be considered to be patentably distinct from one another.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/184,838 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to exceedingly overlapping subject matter.
Claim 1 of the instant application recites the following:
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Claim 1 of the reference application recites the following:
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Claim 8 of the reference application recites the following:
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Claim 15 of the reference application recites the following:
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As can be seen from the claims above, the method of the instant application and the methods of the reference application have significant overlap in their subject matter. More specifically, that each of the above methods are drawn to the administration of a composition comprising cabozantinib lauryl sulfate and identical excipients with the same HLB values. Furthermore, the amount range of cabozantinib lauryl sulfate of claim 1 of the instant application appears to encompass the amount ranges of the same material in claims 1, 8, and 15 of the reference application. As each of the provided methods above are drawn to materials and processes with exceedingly overlapping claim scope, the claims at hand cannot be considered to be patentably distinct from one another.
Conclusion
Claims 1-19 are rejected.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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