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 the invention of Species 1, Figures 1, 2, 8 and 9 in the reply filed on March 17, 2026 is acknowledged. Applicant has indicated claims 1-10 read on the elected invention. However, claim 4 is drawn to non-elected Figure 3, claim 6 is drawn to non-elected Figure 5 and claim 8 is drawn to non-elected Figure 6. As such, claims 4, 6 and 8 are withdrawn from further consideration.
Claim Objections
Claim 6 is objected to because of the following informalities: “he first” in line 1 should read “the first”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is unclear with the recitation of “a third thermocouple”, particularly since there is no first or second thermocouple in order to reference a “third”. It is noted that a first and second thermocouple are recited in claim 3. However, claim 7 depends from claim 2 and therefore does not include the recitation of claim 3. Claim 9 is rejected based on its dependency from claim 7.
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, 2 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hata et al (2010/0286684).
Hata et al provide an RF catheter comprising a catheter body (10) an at least one heating unit (42) and at least one electrode (14) coupled to the catheter body. It is noted there is no specific structure for a “heating unit”, and the examiner maintains that any element that heats tissue (e.g. electrodes 42) read on the broad recitation. The at least one heating unit (42) is configured to perform ablation on a target tissue in a superficial vein, and the electrode is configured to perform ablation on a target tissue in a perforating vein. That is, the electrodes are sufficiently spaced such that they could be placed to treat those tissue sites. There is no structure in the claims that distinguishes over the structure provided by Hata et al. The heating unit and the electrode is in a corresponding target operation mode in accordance with an operating mode. Hata et al teach that the electrodes may be individually activated in any order (para. [0009] and [0050], for example) such that a first mode may operate the electrode (14), a second mode may operate at least two heating units (42) may be operated and a third mode where only one heating unit (42) may be operated.
Regarding claim 2, the at least one heating unit comprises a first and second heating unit arranged side by side (i.e. the two adjacent electrodes 42 next to tip electrode 15) with the lengths of the heating units being the same. See, for example, Figure 4. The first heating unit is adjacent the electrode (15) and the second heating unit is spaced apart from the first heating unit by a predetermined distance (Figure 4). Regarding claim 7, the at least one electrode comprises a first electrode (42) and a second electrode (14 adjacent to electrode 42) arranged side by side with the first electrode arranged adjacent to the first heating unit (middle electrode 42) and the second electrode (14) is spaced from the second electrode (42 adjacent 14) by a predetermined distance. It is noted the recitation of a “third thermocouple” is unclear, but Hata et al do disclose the use of a thermocouple fixed on the inner walls of the electrodes (para. [0010] and Figure 10, sensors 80).
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 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hata et al (2010/0286684) in view of the teaching of Swanson et al (5,582,609).
Regarding claim 3, Hata et al provide a first thermocouple (80) and a second thermocouple coupled to each of the heating units (i.e. electrodes). See paragraph [0045]. However, Hata et al fail to teach the thermocouple is insulated from the heating unit (i.e. electrode).
Swanson et al provide another catheter device having a plurality of electrodes. Each electrode is provided with a temperature sensor, similar to Hata et al. Swanson et al specifically teach that the thermocouples may be provided with an insulative coating to insulate the thermocouple from the electrode (col. 17, lines 25-30, for example).
To have provided the Hata et al temperature sensors as thermocouples coupled to the heating units (i.e. electrodes) with an insulative epoxy to insulate the thermocouple from the electrode would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Swanson et al fairly teach it is known to attach a thermocouple to an electrode and insulate the thermocouple junction from the electrode.
Regarding claim 5, Hata et al teach the heating units are coils (42- Figure 4) that are wound around a winding tube (40).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hata et al (2010/0286684) in view of the teachings of Kordis (5,725,525) and Swanson et al (5,991,650).
Hata et al provide a handle and an integrated cable extending from the handle for connection to an RF generator (Figure 14) as well as a circular plug arranged at an end of the second electrode (14), but fail to expressly disclose an integrated circuit in the handle as well as a thermally-shrinkable tube enclosing the heating units (i.e. electrodes).
Regarding the integrated circuit, the examiner maintains it is generally well known to provide such a circuit in a handle or handpiece of such a device, and Kordis fairly teaches the use of an integrated circuit board in a catheter handle to provide connections to the heating units/electrodes on the catheter body. See Figure 55 and associated description which shows the circuit board and connections for the electrode leads.
To have provided the Hata et al device with an integrated circuit board in the handle to provide electrical connections to the multiple electrodes would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Kordis fairly teaches it is known to use an integrated circuit board in the handle of a catheter device for providing electrical connection to the electrodes on the catheter.
Regarding the thermally-shrinkable tube, Swanson et al provide another catheter device having a tip electrode and proximally located electrodes similar to the Hata et al device. In particular, Swanson et al teach that it is known to provide a coating over the electrodes to enclose the electrodes. The coating may be a heat-shrinkable material (col. 6, lines 15-50) and provides a smooth outer surface for better movement of the catheter within the body.
To have provided the Hata et al device with a heat-shrinkable tube over the electrodes to provide a smoother outer surface for the device would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Swanson et al fairly teach it is known to use such a heat-shrinkable tube enclosing electrodes on a similar catheter device.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hata et al (2010/0286684) in view of the teaching of Wizeman et al (7,931,647).
Hata et al fail to disclose the use of marking tape and a locating ring on the catheter body to indicate the movement and/or insertion depth of the catheter. The examiner maintains it is generally well-known in the art to provide various different types of markings on catheters to indicate insertion depth.
Wizeman et al provide a catheter and specifically teach it is known to provide rings/bands around the catheter body to serve as a visual indicator of the insertion depth and/or movement of the catheter (col. 4, lines 27-39). To have used any type of known marker (e.g. tape) would have been an obvious consideration for one of ordinary skill in the art.
To have provided the Hata et al device with markers on the catheter body to indicate insertion depth and/or movement of the catheter within the body would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Wizeman et al fairly teach it is known to use such markers on a catheter body.
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 1-3, 5, 7, 9 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-10 of copending Application No. 18/664,576 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘576 anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the ‘576 application claims. Here, the more specific ‘576 application claims encompass the broader instant 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Thompson et al (12,539,161) and Macaraeg et al (2021/0330370) and Eum et al (2018/0214196) disclose other catheter devices having electrodes/heating units to treat venous tissue. Curley (8,702,697) disclose a catheter device having a heating unit and an electrode for the treatment of tissue.
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/ April 18, 2026
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