DETAILED ACTION
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 .
Acknowledgments
In the reply, filed on June 4, 2026, Applicant amended claims 1, 6-11, 13, 15-16, and 18-19.
In the non-final rejection of April 27, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 6, 8, 11, 15-16, and 18. Applicant amended claims 1, 6, 8, 11, 15-16, and 18; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 7-8, 10-12, and 20 under 35 U.S.C. 112(b). Applicant amended claims 7 and 10, and persuasively argued against the rejections of claims 12 and 20 (Remarks, page 9). Rejection is withdrawn.
Examiner provisionally rejected claims 1, 4, 6, 13, and 20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15, and 17-18 of copending Application No. 19/420,283 (reference application). Applicant argued: Applicant submits herewith a terminal disclaimer in compliance with 37 C.F.R. § 1.321 to obviate these rejections. Applicant expressly notes that "[t]he filing of a terminal disclaimer to obviate a rejection based on nonstatutory double patenting is not an admission of the propriety of the rejection." See MPEP § 804.02. As such, Applicant respectfully requests withdrawal of the ground of nonstatutory double patenting (Remarks, page 11). However, Applicant did not file a terminal disclaimer. Rejection is maintained.
Claim Objections
Claims 1, 16, and 18 are objected to because of the following informalities:
In regards to claim 1, line 14, “a fixed positioned” should be changed to “a fixed position”.
In regards to claim 16, line 3, “from the distal port” should be changed to “out of the distal port”.
In regards to claim 18, line 6, “(CMOS))” should be changed to “(CMOS)”.
In regards to claim 18, line 6, “width” should be changed to “a width”.
In regards to claim 18, line 6, “1mm” should be changed to “1 mm”.
Appropriate correction is required.
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 1, 4, 6, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15, and 17 of copending Application No. 19/420,283 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the applications at least claim A method (A method), advancing a therapeutic gel delivery shaft of a handheld injector tool toward a cochlear implant lead through a transmastoid pathway such that a distal port of the therapeutic gel delivery shaft is proximate to a cochlear implant lead insertion site of a cochlea (inserting a therapeutic gel delivery shaft through a transmastoid pathway toward a cochlear implant lead; while the therapeutic gel delivery shaft is positioned through the transmastoid pathway such that a distal port of the therapeutic gel delivery shaft is proximate to the cochlear implant lead), depositing a therapeutic gel out of the distal port of the therapeutic gel delivery shaft onto the cochlear implant lead insertion site while the therapeutic gel delivery shaft is positioned through the transmastoid pathway (while the therapeutic gel delivery shaft is positioned through the transmastoid pathway such that a distal port of the therapeutic gel delivery shaft is proximate to the cochlear implant lead, depositing a liquid dosage of the self-gelling therapeutic composition out of the distal port of the therapeutic gel delivery shaft onto an exterior of the cochlear implant lead at the cochlear implant lead insertion site at a round window niche of the cochlea), during said depositing the therapeutic gel, using a tip-mounted image capture device fixedly mounted at a distal end of a visualization shaft of the handheld injector tool to provide direct visualization of both the therapeutic gel delivery shaft and the cochlear implant lead insertion site (wherein said using direct visualization of the cochlear implant lead insertion site comprises the capturing image data of the distal port of the therapeutic gel delivery shaft using the camera device including a tip-mounted camera fixedly mounted at a distal end of a visualization shaft and oriented toward the distal port of the therapeutic gel delivery shaft), wherein the therapeutic gel delivery shaft and the visualization shaft are side-by-side shafts fixedly mounted to a handle of the handheld injector tool such that the distal port of the therapeutic gel delivery shaft is maintained in a fixed positioned distally of the distal end of the visualization shaft during said advancing and during said depositing (wherein the therapeutic gel delivery shaft and the visualization shaft are side-by-side shafts being fixedly mounted to a handle in a stationary position relative to one another and extending distally from the handle such that the distal port of the therapeutic gel delivery shaft is positioned distally of the visualization shaft).
The table below shows the examined application claims 1, 4, 6, and 20 corresponding to claims 1, 13, 15, and 17- of copending Application No. 19/420,283:
Application claims
Application No. 19/420,283 claims
1
1, 13, 15, 17
4
1
6
1
20
1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3 and 7-19 are objected to by virtue of being dependent upon rejected claim 1.
Conclusion
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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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