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 .
Applicant’s amendments and comments, submitted with the response of December 9, 2025, have been fully considered by the examiner. The following is a complete response to the December 9, 2025 communication.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 4, 8-13, 15, 17-19 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asconeguy (2012/0239019).
Regarding claim 1, Asconeguy provides a probe for ablation comprising a shell (20) defining an outer surface (Figure 1), a cooling path positioned in the shell and defining a supply conduit (22) and an outflow path (28 - para. [0022]). A plurality of RF electrode pads (30) are positioned at different locations on the shell (Figure 1) and are configured to deliver RF energy to tissue (Abstract, for example). Figure 1 shows the electrode pads as ring electrodes. However, paragraph [0024] of Asconeguy specifically states the electrodes “may be positioned at discrete, spaced locations on the distal portion 20, and may surround or encircle substantially all or only a fractional portion of the elongate body”. As such, if the ring electrodes (30) of Figure 1 may be at discrete locations that encircle only a fraction of the body (20) such that the electrodes would have the same axial location relative to a distal end of the shell but at a different circumferential location (i.e. encircling different fractions of the body). The electrodes deliver RF energy and are individually controllable such that they would be capable of various functions, including coagulation, thawing and the alleviation of pain. See, for example, paragraph [0033].
Regarding claim 3, the cooling path is radially inward of the shell (Figure 1). Regarding claim 4, Asconeguy show 3 ring electrodes in Figure 1, but paragraph [0024] makes clear the electrodes may have any reasonable number, arrangement or shape.
Regarding claim 8, Asconeguy provide a system including the probe of claim 1 (as addressed above), and a RF-cryo controller (14 – Figure 1) configured to control the operation of the cryogen and the delivery of RF energy (para. [0032-0033], for example).
Regarding claim 9, the controller (14) includes a computing device and data bus to control the independent delivery of RF energy to each electrode (para. [0033], for example). Regarding claim 10, see Figure 1 which shows a housing (14) for the RF-cryo controller and the connections for the probe.
Regarding claim 11, Asconeguy discloses a method comprising cooling a target tissue by moving a cryogen through a shell of a probe (Figure 1, for example) and heating the target with RF energy with a plurality of RF pads positioned on the shell as addressed with respect to claim 1 above. Again, the electrodes are individually adjustable and capable of the functions of thawing ice, coagulating (i.e. ablating) tissue and alleviating pain.
Regarding claim 12, the steps performed by the Asconeguy device are deemed to be directed to a “common procedure”, particularly since there is no definition of what would be encompassed by a “common procedure”. Regarding claim 13, Asconeguy again provide a cryo-controller (14) capable on controlling the delivery of a cryogen to form an iceball and capable of delivering RF energy to the electrodes individually as at paragraphs {0032-0034]. Regarding claim 15, see, again, paragraph [0024] of Asconeguy. Regarding claims 17-19, Asconeguy expressly disclose the use of the RF electrodes to ablate tissue, and, given their controllable nature, they are also inherently deemed capable of coagulating tissue and denaturing proteins (particularly since these are known characteristics of ablation electrodes). Regarding claims 21-23, see again paragraph [0033] of Asconeguy which discloses individual control of each of the electrodes requiring individual leads to each electrode as is generally known in the art.
Claim Rejections - 35 USC § 103
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, 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.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Asconeguy (‘019) in view of the teaching of Arless et al (7,097,641).
Regarding claims 7 and 16, Asconeguy disclose the use of RF energy, among others, delivered to the electrodes (para. [0019], for example), but fail to expressly disclose the use of microwave energy. The examiner maintains that the use of any well-known energy modality would be an obvious consideration for one of ordinary skill in the art. To that end, Arless et al disclose another cryosurgical device that includes electrodes for the delivery of RF energy. In particular, Arless et al specifically disclose that it is known to use a variety of energy modalities including RF energy in the microwave spectrum (Abstract, for example).
To have provided the Asconeguy system with an RF energy source that operates in the microwave spectrum for the treatment of tissue would have been an obvious alternative to one of ordinary skill in the art at the time of the invention since Arless et al fairly teach it is known to use RF energy in the microwave spectrum for the treatment of tissue in an analogous device.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Asconeguy (‘019) in view of the teaching of Abboud et al (2004/0158237).
Asconeguy discloses the use of liquid and gas cryogens, but fails to expressly disclose the use of liquid or gaseous nitrogen. The examiner maintains that the various different types of cryogen are generally well-known in the art, and Abboud et al provide the specific teaching that it is known to use various different types of cryogenic materials including liquid and gaseous nitrogen (para. [0036]) to cool tissue with a similar cryogenic probe.
To have provided the Asconeguy system with a cryogen comprising gaseous or liquid nitrogen to cool the probe would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Abboud et al teach that it is known to use such materials for cooling cryogenic probes.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Asconeguy (‘019) in view of the teaching of Cosman et al (9,717,552).
Asconeguy fails to disclose the delivery of a cement to a body structure during the procedure, but disclose the use of the device for various different types of treatment.
Cosman et al provide a device to deliver both RF and cryogenic energy to treat tissue, and specifically teach that it may be advantageous to deliver a cement to tissue during or after the procedure (col. 117, lines 5-10).
To have provided the Asconeguy procedure with a means to administer a cement to tissue during a procedure would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Cosman et al fairly teach it is known to provide such a step in a similar device used in similar types of procedures.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection. The examiner has now applied the Asconeguy reference which clearly provides a cryogen-cooled probe that also includes electrodes provided in a variety of shapes and arrangements to provide heating of tissue during the cooling procedure.
Conclusion
Applicant's amendment necessitated the new ground(s) of 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 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 MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/February 15, 2026