DETAILED ACTION
Currently, claims 1-16 are being examined, while claims 17-20 remain withdrawn.
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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ‘heater positioned within the inner cavity and between the conduit and the shell’ (claim 15) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 recites the limitation “wherein the heater is positioned within the inner cavity and between the conduit and the shell”. However, there does not appear to be sufficient support for this specific claim limitation in Applicant’s disclosure. 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 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/186,527 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the copending claims. Here, the more specific copending claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1, 2, 5-8, and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee, U.S. 2017/0135742 (hereinafter Lee).
Regarding claim 1, Lee discloses (note figs. 1-2) an ablation probe comprising: a shell (12) configured to be positioned at a target tissue in a patient; a conduit (i.e., inner-most lumen) positioned inside the shell, the conduit capable of supplying a cryo-fluid toward a ‘tip’ of the shell (i.e., distal region of ‘12’ including the section containing a distal portion of ‘38’); and a heater (38) necessarily positioned radially outward of an outer surface of the conduit, the heater configured to heat the ablation probe to perform thermal ablation, wherein the heater is necessarily positioned around a ‘main shaft portion’ of the shell (i.e., proximal region of ‘12’ including the section containing a proximal portion of ‘38’) and ‘around’ the tip of the shell (see above). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Lee discloses (see above) an ablation probe wherein the heater is necessarily ‘embedded in’ a layer of coating (82) positioned on an external surface of the shell.
Regarding claim 5, Lee discloses (see above) an ablation probe wherein the heater comprises a resistive heating wire ‘wrapped around’ the conduit.
Regarding claim 6, Lee discloses (see above) an ablation probe wherein the heater is coupled to a power line (44) configured to supply a power signal to the heater, the power line necessarily positioned ‘externally’ to the shell (e.g., at the proximal end of the probe).
Regarding claim 7, Lee discloses (see above) an ablation probe wherein the layer of coating is necessarily positioned ‘over’ the power line (e.g., at terminal ‘48’ – junction between ‘38’ and ‘44’) externally to the shell (see fig. 2).
Regarding claim 8, Lee discloses (see above) an ablation probe comprising two or more measurement contacts (‘50’ and ‘56’) on an external surface of the ablation probe.
Regarding claim 13, Lee discloses (see above) an ablation probe wherein the conduit includes at least one opening at or near the tip to allow fluid to exit an interior of the conduit and flow in a return direction between an outer surface of the conduit and an inner surface of the shell (see figs. 1-2).
Regarding claim 14, Lee discloses (see above) an ablation probe wherein the shell necessarily has a tube shape extending from a proximal end to a distal end at the tip (see figs. 1-2); and the shell necessarily forms an inner cavity in which the conduit (i.e., inner-most lumen) is positioned.
Regarding claims 1, 14, and 15, Lee discloses (note figs. 1-2; as best understood by Examiner) an ablation probe comprising: a shell (82) configured to be positioned at a target tissue in a patient; a conduit (i.e., inner-most lumen) positioned inside the shell, the conduit capable of supplying a cryo-fluid ‘toward’ a ‘tip of the shell’ (i.e., distal region of ‘82’); and a heater (38) necessarily positioned radially outward of an outer surface of the conduit, the heater configured to heat the ablation probe to perform thermal ablation, wherein the heater is necessarily positioned around a ‘main shaft portion’ of the shell (i.e., proximal region of ‘82’) and ‘around’ the tip of the shell (see above); wherein the shell necessarily has a tube shape extending from a proximal end to a distal end at the tip (see figs. 1-2); and the shell necessarily forms an inner cavity (i.e., inner space defined by ‘82’) in which the conduit (i.e., inner-most lumen) is positioned; and wherein the heater is necessarily positioned within the inner cavity and between the conduit and the shell. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 16, Lee discloses (note figs. 1-2) an ablation probe comprising: an inner conduit (i.e., inner-most lumen) extending axially along an axis; an outer shell (12) positioned radially outward of the inner conduit and extending along the axis and terminating at a ‘tip’ of the outer shell (i.e., distal region of ‘12’ including the section containing a distal portion of ‘38’); a coil of resistive wire (38) positioned externally to the outer shell (note paragraph 41), the coil configured to heat the ablation probe to a predetermined temperature sufficient to perform thermal ablation, wherein the coil of resistive wire is necessarily positioned around a ‘main shaft portion’ of the outer shell (i.e., proximal region of ‘12’ including the section containing a proximal portion of ‘38’) and ‘around’ the tip of the outer shell (see above); and a layer of coating (82) positioned around the coil of resistive wire separating the coil of resistive wire from an external surface of the ablation probe.
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Sporri, U.S. 6,042,590 (hereinafter Sporri).
Regarding claims 3-4, Lee discloses (see above) an ablation probe comprising a layer of coating, but fails to explicitly disclose wherein this layer of coating comprises a thermally conductive heat shrink material. Sporri teaches (note figs. 3-4) a similar instrument comprising a probe with a layer of coating (48) thereon, wherein this layer of coating necessarily comprises a thermally conductive heat shrink material (note col. 6, line 19). It is well known in the art that these different coating configurations are widely considered to be interchangeable, and that this specific configuration results in increased safety since it has been utilized to “inhibit[s] the heating element from sticking to the body tissue” (note col. 6, line 19). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Lee to comprise a thermally conductive heat shrink coating (as taught by Sporri) in order to increase safety. It should also be noted that 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.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee.
Regarding claims 9-12, Lee discloses (see above) an ablation probe comprising multiple external ‘measurement contacts’ (i.e., thermocouples), wherein one of them (50) is disposed in the layer of coating between adjacent wraps of a resistive heating coil (‘38’ – note paragraph 41). While Lee discloses an ablation probe comprising three measurement contacts (i.e., thermocouples), and further teaches that this probe could include “additional thermocouples” (note paragraph 73), Lee fails to explicitly disclose a probe comprising a second measurement contact disposed in the layer of coating between adjacent wraps of the resistive heating coil. It is well known in the art (as can be seen by Lee) that the use of additional feedback sensors (e.g., disposed along the length and/or around the circumference of the probe) would result in increased efficiency and safety. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Lee to comprise additional thermocouples disposed at any of a variety of locations along the probe (including at the claimed location in the layer of coating between adjacent wraps of the resistive heating coil), in order to increase efficiency and safety. It should be noted that the remaining claim limitations would necessarily have been met by this modified device.
Response to Arguments
Applicant's arguments filed February 3, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments concerning Lee, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met as they are currently written, due to the breadth of limitations such as “shell”, “tip”, “main shaft portion”, and “around” (see above rejections for current interpretation). Therefore, despite Applicant’s arguments, Examiner asserts that the claims are still met by Lee.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794