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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-15, in the reply filed on 17 June 2026 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,167,125 and claims 1-22 of U.S. Patent No. 12,128,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims overlap in scope and claim the same novel features.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rea et al. (US 2012/0130269; hereinafter “Rea”).
Regarding claim 1, Rea discloses a treatment applicator for delivery of electrical energy comprising: a treatment tip housing (e.g. Fig. 2); an electrode housing extending from a distal end of the treatment tip housing and configured to retract proximally into the treatment tip housing (e.g. Fig. 2G – where the examiner considers elements 51 and 56 to be components of the electrode housing); and a plurality of treatment electrodes at least partially within the electrode housing (e.g. ¶¶ 32-36; Fig. 2H; where the examiner notes 34-35 discuss a plurality of electrode configurations), wherein the electrode housing is configured to deploy the plurality of treatment electrodes by retracting proximally into the treatment tip housing when pushed against a tissue to be treated (e.g. ¶¶ 31-32 – where the insulative portion retracts in the proximal direction and remains at the skin surface).
Regarding claim 2, Rea discloses the device further comprising a bias exerting a bias return force on the electrode housing to oppose deploying and un-deploying of the plurality of treatment electrodes (e.g. ¶¶ 37 – “shaft 49 may be spring loaded..”).
Regarding claim 3, Rea discloses the bias comprises one or more of the following: a mechanical resistor, a spring, a detent, a catch, a piston, a mechanical dampener, a compressible material, a release, a friction release, a deflectable release, a frangible release, and a frictional coupling (e.g. ¶¶ 37 – “shaft 49 may be spring loaded..”).
Regarding claim 4, Rea discloses the plurality of treatment electrodes are non-penetrating electrodes (e.g. ¶¶ 22-23, 35).
Regarding claim 5, Rea discloses the electrical energy comprises electrical pulses (e.g. ¶¶ 39).
Regarding claim 6, Rea discloses the electrical pulses are microsecond or sub-microsecond electrical pulses (e.g. ¶¶ 39 – 1-50Hz).
Regarding claim 7, Rea discloses the device comprising a soft, electrically insulating material at a distal face of the electrode housing (e.g. ¶¶ 26).
Regarding claim 8, Rea discloses the soft, electrically insulating material comprises one or more of: silicon, santoprene, or other TPE (Thermoplastic Elastomer) materials (e.g. ¶¶ 26).
Regarding claim 10, Rea discloses the plurality of treatment electrodes comprises penetrating electrodes (e.g. ¶¶ 35).
Regarding claim 11, Rea discloses retracting proximally the electrode housing into the treatment tip housing causes distal ends of the plurality of treatment electrodes to penetrate the tissue to be treated (e.g. ¶¶ 24, 26, 32).
Regarding claim 12, Rea discloses the treatment tip housing comprises a control configured to allow an electrode length of the plurality of treatment electrodes to be adjusted (e.g. ¶¶ 36 - “handpiece 42 may be configured to limit the travel”).
Regarding claim 13, Rea discloses the plurality of treatment electrodes are fixed relative to the treatment tip housing (e.g. ¶¶ 22-23, 35).
Regarding claim 14, Rea discloses a release element configured to prevent the electrode housing from retracting proximally until the release element is released (e.g. ¶¶ 37 – “shaft 49 may be spring loaded such that user control 66 releases compressed spring energy to cause skin marker 47 to deploy distally”).
Regarding claim 15, Rea discloses the device has an un-deployed configuration in which distal ends of the plurality of electrodes are within the electrode housing and do not extend beyond a distal end face of the electrode housing, and a deployed configuration in which the plurality of electrodes extend beyond the distal end face of the electrode housing (e.g. ¶¶ 37 – “shaft 49 may be spring loaded such that user control 66 releases compressed spring energy to cause skin marker 47 to deploy distally”).
Claim Rejections - 35 USC § 103
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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rea. Rea discloses that element 51 is plastically deformable but fails to expressly disclose that it has a durometer of 60 or less on the Shore A hardness scale against the subject's tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the element to have a specific durometer of 60 or less, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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