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 .
Response to Amendment
The Amendments filed August 18, 2025 have been entered. Currently, claims 1 and 13 have been amended, and claims 1-24 are pending in the application.
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.
(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, 11-17, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Robinson (U.S. Application No. 20190090934 A1).
Regarding independent claim 1, Robinson discloses an electrosurgical system (610) (pa. 0072), comprising:
an electrosurgical device (10) (pa. 0047 & Fig. 1), including:
an electrode (i.e., active and return electrode on the jaw members 110, 120) (pa. 0072);
a coating (400) covering at least a portion of the electrodes (pa. 0053 & Fig. 3B);
a waveform generator (700) configured to be coupled to the electrosurgical device (pa. 0072, 0074, 0080 & Fig. 7); and
a controller (724) coupled to the waveform generator (pa. 0079 & Fig. 9), the controller configured to modify a generated waveform multiple times for the coating to compensate for changes in the coating and to apply a consistent delta in the generated waveform between a first waveform value and a second waveform value (pa. 0021, 0087).
Examiner is interpreting the resistance as an impedance parameter as since impedance is a broader term that includes resistance. Moreover, Applicant has not made a distinction between both terms, as either may be used interchangeably as stated in the specification of the instant invention (pa. 0022). Moreover, Robinson discloses a controller that is capable of being utilized multiple times (i.e., it is not a one-time use device that only works a single time). As such, every time the surgical device with the coating on the electrode is attached to the generator (700), the controller (724) is capable of reading the respective stored information/data (i.e., the sensed impedance that is affected by the wear/tear of the coating on the electrode) about the coating covering the electrode, and make the desired change to at least one parameter of the electrosurgical energy compensate for any changes in the coating (pa. 0078, 0087). Examiner is interpreting the combination of every new procedure cycle as the ability of the controller to be configured to modify a generated waveform multiple times for the coating to compensate for changes in the coating.
Regarding claim 2, Robinson discloses wherein the first waveform value includes a baseline resistance, and wherein the controller is configured to change the baseline resistance of the electrode based on a predicted coating wear (pa. 0087). Examiner is interpreting the resistance as the impedance parameter as since impedance is a broader term that includes resistance. Moreover, Applicant has not made a distinction between both terms, as either may be used interchangeably as stated in the specifications of the instant invention (pa. 0022).
Regarding claim 3, Robinson discloses wherein the first waveform value includes a baseline resistance, and the controller is configured to measure a baseline resistance (pa. 0078 & Fig. 8). Examiner continues to use the same interpretation of resistance as stated above.
Regarding claim 4, Robinson discloses wherein the first waveform value includes a baseline resistance, and the controller is configured to measure a baseline resistance at least once with each use (pa. 0078 & Fig. 8). Examiner continues to use the same interpretation of resistance as stated above.
Regarding claim 5, Robinson discloses wherein the electrode is included as a component of an electrosurgical forceps (pa. 0047).
Regarding claim 6, Robinson discloses wherein the first waveform value includes an electrical value (pa. 0082).
Regarding claim 7, Robinson discloses wherein the first waveform value includes a thermal value (pa. 0048, 0078).
Regarding claim 8, Robinson discloses wherein the coating includes a polymer (pa. 0040).
Regarding claim 11, Robinson discloses wherein the coating includes a hydrophobic physical structure (i.e., non-stick) (pa. 0040). Examiner is interpreting a non-stick property of the coating to be equivalent to a hydrophobic property since they both repel water due to their low surface energy.
Regarding claim 12, Robinson discloses wherein the waveform generator is configured to provide radio frequency (RF) energy (pa. 0042).
Regarding independent claim 13, Robinson discloses an electrosurgical waveform generator (700) (pa. 0080 & Fig. 7), comprising:
an output to send a generated waveform to an electrosurgical device (pa. 0075);
an input to receive measurements of an electrical property at a coated electrode of the electrosurgical device (pa. 0083); and
a controller (724) configured to modify the generated waveform multiple times for the coating to adjust a baseline value of the electrical property to correlate with changes in the coated electrode (pa. 0021, 0082, 0087).
Robinson discloses a controller that is capable of being utilized multiple times (i.e., it is not a one-time use device that only works a single time). As such, every time the surgical device with the coating on the electrode is attached to the generator (700), the controller (724) is capable of reading the respective stored information/data (i.e., the sensed impedance that is affected by the wear/tear of the coating on the electrode) about the coating covering the electrode, and make the desired change to at least one parameter of the electrosurgical energy compensate for any changes in the coating (pa. 0078, 0087). Examiner is interpreting the combination of every new procedure cycle as the ability of the controller to be configured to modify a generated waveform multiple times for the coating to compensate for changes in the coating.
Regarding claim 14, Robinson discloses wherein the electrical property includes resistance (pa. 0087). Examiner is interpreting the resistance as the impedance parameter as since impedance is a broader term that includes resistance. Moreover, Applicant has not made a distinction between both terms, as either may be used interchangeably as stated in the specifications of the instant invention (pa. 0022).
Regarding claim 15, Robinson discloses wherein the electrical property includes impedance (pa. 0087).
Regarding claim 16, Robinson discloses wherein the electrical property includes phase angle (pa. 0087).
Regarding claim 17, Robinson discloses wherein the controller is configured to change a baseline resistance of the coated electrode based on a predicted coating wear (pa. 0087). Examiner continues to use the same interpretation of resistance as stated above.
Regarding claim 20, Robinson discloses wherein the controller is configured to measure a baseline resistance of the coated electrode at least once with each use of the electrosurgical device (pa. 0087). Examiner continues to use the same interpretation of resistance as stated above.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson as applied to claim 1 above, and further in view of Greep (U.S. Application No. 20030109865 A1).
Regarding claim 9, Robinson discloses a non-limiting selection of materials in (pa. 0040).
However, Robinson does not disclose wherein the coating includes a monomer.
Greep, in the same field of endeavor, teaches an electrosurgical instrument (116) comprising an electrode tip (130) (pa. 0038 & Fig. 1) coated with a hydrophilic monomer material (pa. 0012).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the coating of Robinson to include a monomer in order to assist in cooling and/or lubricating an electrosurgical tip (abstract).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson as applied to claim 1 above, and further in view of Patel (C.N. Application No. 108472073 A).
Regarding claim 10, Robinson discloses a non-limiting selection of materials in (pa. 0040).
However, Robinson does not disclose wherein the coating includes a glass.
Patel, in the same field of endeavor, teaches an electrosurgical device comprising a conductive element (180) with coating (182) including a glass (page 3, lines 32-33 & Fig. 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Robinson to include glass in order to serve as a hear shield that protects the tissue region from heat damage (page 3, lines 34-35).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson as applied to claim 13 above, and further in view of Woloszko (U.S. Application No. 20140257269 A1).
Regarding claim 18, Robinson discloses the invention substantially as claimed in claims 1 and 17 discussed above.
However, Robinson does not disclose quantifying a duration of use in an electrosurgical device.
Woloszko, in the same field of endeavor, teaches an electrosurgical system (100) comprising an electrosurgical wand (102) coupled to a controller (104) (pa. 0035 & Fig. 1). The distal end of the wand includes a plurality of electrodes for the application of radio frequency (RF) signals to the tissue (pa. 0040). The controller is able to measure the impedance of the electrodes in order to determine a scale of its “useful life”, specifically being able to estimate a duration time of use before the impedance increases to an unacceptable level (pa. 0101), signifying that the electrode has eroded or cracked over time and is no longer viable/useable (pa. 0099).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included this method of determining the duration of use since using defective devices may lead to serious complications or decreased therapeutic effects (pa. 0098).
Regarding claim 19, Robinson discloses the invention substantially as claimed in claims 1 and 17 discussed above.
However, Robinson does not disclose quantifying a number of procedures in an electrosurgical device.
Woloszko, in the same field of endeavor, teaches the controller being able to calculate or estimate the remaining useful life of the active electrode based on the current ablation mode (e.g., on the provided energy level). The controller then uses a display device (130) to show the surgeon, during or after each procedure, the calculated or estimated value of the remaining useful life of the electrode (pa. 0102-0103), so that they may make informed decisions about how many more procedures the device can handle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included this method of determining the number of procedures since using defective devices may lead to serious complications or decreased therapeutic effects (pa. 0098).
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, 5-6, 8, 11, 13-14, 17, and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 26 of U.S. Application No. 17/932,770 in view of Robinson (U.S. Application No. 20190090934 A1).
Regarding instant claim 1, it is the Examiner’s position that copending independent claims 1, 11, and 26 are narrower in some aspects given that the copending claims recite a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claims 1 and 13. These narrower aspects include the claimed coating on the electrode, the waveform generator, and portions of the functionality of the controller. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 1 and the copending claims 1, 11, and 26 exist in that the copending claims 1, 11, and 26 fail to provide that the controller functions “to modify a generated waveform multiple times for the coating to compensate for changes in the coating and to apply a consistent delta in the generated waveform between a first waveform value and a second waveform value.” Robinson, however, provides for a similar system as that of the copending claim and specifically contemplates the modifying of a waveform multiple times for the coating to compensate for changes in the coating and to apply a consistent delta in the generated waveform between a first waveform value and a second waveform value (pa. 0021, 0087). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the controller functionality of Robinson in combination with the system and controller in copending claim 1 to provide for a combined controller functionality that changes the applied waveform to the electrode based on the coating on the electrode.
Moreover, the Examiner notes that the difference between the instant claim 13 and the copending claims 1, 11, and 26 exist in that the copending claims 1, 11, and 26 fail to provide that the controller functions to “modify the generated waveform multiple times for the coating to adjust a baseline value of the electrical property to correlate with changes in the coated electrode.” Robinson, however, provides for a similar system as that of the copending claim and specifically contemplates the controller being able to modify the generated waveform multiple times for the coating to adjust a baseline value of the electrical property to correlate with changes in the coated electrode (pa. 0021, 0082, 0087). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the controller functionality of Robinson in combination with the system and controller in copending claim 1 to provide for a combined controller functionality that changes the applied waveform to the electrode based on the coating on the electrode.
This is a provisional nonstatutory double patenting rejection.
With respect to dependent claims 5-6, 8, 11, 14 see copending application dependent claims 2, 8-10, 13.
Claims 1-6, 8, 11, 13-17, 19-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S Application No. 17/812017 in view of Robinson (U.S. Application No. 20190090934 A1).
Regarding instant claim 1, it is the Examiner’s position that copending independent claims 1 and 15 are narrower in some aspects given that the copending claims recite a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claims 1 and 13. These narrower aspects include the claimed electrosurgical device, the coating on the electrode, the waveform generator, and portions of the functionality of the controller. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claims, the Examiner notes that the difference between the instant claim 1 and the copending claims 1 and 15 exist in that the copending claims 1 and 15 fail to provide that the controller functions “to modify a generated waveform multiple times for the coating to compensate for changes in the coating and to apply a consistent delta in the generated waveform between a first waveform value and a second waveform value.” Robinson, however, provides for a similar system as that of the copending claim and specifically contemplates the modifying of a waveform multiple times for the coating to compensate for changes in the coating and to apply a consistent delta in the generated waveform between a first waveform value and a second waveform value (pa. 0021, 0087). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the controller functionality of Robinson in combination with the system and controller in copending claim 1 to provide for a combined controller functionality that changes the applied waveform to the electrode based on the coating on the electrode.
Moreover, the Examiner notes that the difference between the instant claim 1 and the copending claims 1 and 15 exist in that the copending claims 1 and 15 fail to provide that the controller functions to “modify the generated waveform multiple times for the coating to adjust a baseline value of the electrical property to correlate with changes in the coated electrode.” Robinson, however, provides for a similar system as that of the copending claim and specifically contemplates the controller being able to modify the generated waveform multiple times for the coating to adjust a baseline value of the electrical property to correlate with changes in the coated electrode (pa. 0021, 0082, 0087). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the controller functionality of Robinson in combination with the system and controller in copending claim 1 to provide for a combined controller functionality that changes the applied waveform to the electrode based on the coating on the electrode.
This is a provisional nonstatutory double patenting rejection.
With respect to dependent claims 2-6, 8, 11, 14-17, 19-20 see copending application dependent claims 2, 4-5, 11, 18.
Response to Arguments
Applicant's arguments filed 08/18/2025 have been fully considered but they are not persuasive.
With regards to newly amended independent claims 1 and 13, Applicant argues that the primary reference of Robison does not disclose, “the controller configured to modify a generated waveform multiple times for the coating to compensate for changes in the coating”. Specifically, Applicant explains how even though Robison does recite adjusting “one or more parameters of the vessel sealing algorithm, based on the coating properties extracted from the storage” that the data in the storage is “static for a given coating”. However, Examiner, respectfully disagrees.
Under the broadest reasonable interpretation, the controller as claimed is not specifically configured to modify a generated waveform multiple times during the same procedure for the coating to compensate for changes in the coating. In view of this, Robinson discloses a controller that is capable of being utilized multiple times (i.e., it is not a one-time use device that only works a single time). As such, every time the surgical device with the coating on the electrode is attached to the generator (700), the controller (724) is capable of reading the respective stored information/data (i.e., the sensed impedance that is affected by the wear/tear of the coating on the electrode) about the coating covering the electrode, and make the desired change to at least one parameter of the electrosurgical energy compensate for any changes in the coating (pa. 0078, 0087). Examiner is interpreting the combination of every new procedure cycle as the ability of the controller to be configured to modify a generated waveform multiple times for the coating to compensate for changes in the coating. Therefore, the rejection set-forth above is maintained.
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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794