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 .
Status of Claims
In the response dated April 16th, 2026, Applicant amended claims 1-5 and 11-17. Claims 1-20 are pending.
Response to Arguments
In response to the argument put forwards in the amendments, Examiner will address them in the order they were presented.
Applicant’s amendments regarding rejecting claims 1-20 under 35 U.S.C. 112(b) have been considered and are persuasive. Examiner withdraws rejections under 35 U.S.C. 112(b) regarding claims 1, 3-8, 10-12 and 14-17. However, Applicant’s amendments merit new grounds for rejection regarding claims 1-17 under 35 U.S.C. 112(b).
Applicant’s arguments have been considered regarding amendments to claims 1 and 12 have been considered and are persuasive. As indicated in Applicant’s arguments, these amendments also alter the scope of claims 2-11 and 13-17. Applicant’s amendments merit new grounds for rejection regarding claims 1-17 under 35 U.S.C. 103.
Claim Objections
Claim 5 is objected to because of the following informalities: ”the lead of claim 1, comprising” should read “the lead of claim 1, further comprising”. 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 2, 9, 10, and 13-16 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 2 recites the limitation "a thickness of the walled tube" in line 3. There is insufficient antecedent basis for this limitation in the claim. Removal of the alternative limitation is required.
Claim 9 recites the limitation "or the walled tube" in line 1. There is insufficient antecedent basis for this limitation in the claim. Removal of the alternative limitation is required. Dependent claim 10 is indefinite for the same reasons set forth for claim 9.
Claim 13 recites the limitation "a walled tube, wherein a thickness of the walled tube" in line 5. There is insufficient antecedent basis for this limitation in the claim. Removal of the alternative limitation is required. Dependent claims 14-16 are indefinite for the same reasons set forth for claim 13.
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 (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.
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) 1-5 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi et al. (US20140343644), hereinafter Shi.
Fig. 26B will be used for reference below
PNG
media_image1.png
336
505
media_image1.png
Greyscale
Regarding claim 1, Shi discloses a lead …, comprising: a lead body having a proximal end and a distal end ([Fig 26B] where arrow points from proximal to distal), the lead body defining a lumen ([Fig 26B] where circle indicated lumen); and one or more electric field generating electrodes, wherein the one or more electric field generating electrodes are disposed along a length of the lead body (([Fig 26B] electrode (88) rings disposed along the length of the body); wherein the one or more electric field generating electrodes comprise … a sputter coating, ([0019] “A thin coating may be applied to the outer surface of the electrode substrate… A Pt, TiN, IrOx coating may be applied via any suitable technique including, e.g., sputtering such as vacuum sputtering.”) wherein a thickness of the sputter coating in a radial direction ([Fig. 5] coating (76) deposited on the electrode’s radial surface) with respect to the lead body is less than 0.005 inches ([Table 1] where coating thickness is 5μm, or .0002 inches; see optionally Fig. 5).
Although Shi does not explicitly disclose that the lead is for a cancer treatment system as recite in the preamble, Examiner submits that when reading the preamble in the context of the entire claim, the recitation “for a cancer treatment system” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claims 2-4 and 9-10, Examiner submits that these limitations are bound to the optional limitation of claim 1, “wherein the one or more electric field generating electrodes comprise a ribbon wire, wherein a thickness of the ribbon wire in a radial direction with respect to the lead body is less than 0.005 inches; or a walled tube, wherein a thickness of the walled tube is less than 0.005 inches; or a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to a lead body is less than 0.005 inches”. Since the prior art rejection is based on the option of “a walled tube…” as set forth above, Examiner submits that claims 2-4 and 9-10 are met by the rejection of claim 1 above as these limitations are not required by the claim language.
Regarding claim 5, Shi discloses two electric field generating electrodes disposed along the length of the lead body ([Fig. 1] electrodes 24, 26).
Regarding claim 8, Shi discloses the one or more electric field generating electrodes comprise platinum, titanium, or a metal alloy ([0019] “A thin coating may be applied to the outer surface of the electrode substrate… A Pt, TiN, IrOx coating may be applied via any suitable technique including, e.g., sputtering such as vacuum sputtering.”)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (US20140343644), in view of Trailer (US 5154387).
Regarding claim 6, Shi does not disclose the two electric field generating electrodes are each independently from 1 cm to 4 cm in length.
Trailer, however, teaches an apparatus for emergency pacing of a patient’s heart (Abstract) wherein pacing electrodes 14 and 20 must allow sufficient current flow to cause ventricular and atrial pacing. It has been found by the inventors that the pacing electrodes should have a minimum surface area of approximately 1.5 square centimeters to achieve these results. For a standard size catheter of 2.5 millimeters diameter, this means that the pacing electrodes should be approximately 2.0 centimeters long to achieve these results (Col. 4, ll. 45-54). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Shi’s electrode system with a reasonable expectation of success such that the two electric field generating electrodes are each independently 2 cm in length, as taught and suggested by Trailer, for the purpose of facilitating sufficient current flow to cause ventricular and atrial pacing.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (US20140343644), in view of Fine et al. (US 4922927) (hereinafter Fine).
Regarding claim 7, Shi does not disclose the two electric field generating electrodes are separated by a non-conducting gap portion of from 0.1 cm to 2 cm.
Fine, however, teaches a defibrillating lead (Abstract) wherein the pacing electrode is separated from the closest end of the coil electrode by a distance of approximately one centimeter and is electrically insulated therefrom (Col. 4, ll. 53-55). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Shi’s electrode system with a reasonable expectation of success such that the two electric field generating electrodes are separated by a non-conducting gap portion of 1 cm, as taught and suggested by Fine, for the purpose of providing sufficient insulation between electrodes.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (US20140343644), in view of Williams et al. (US 5016645) (hereinafter Williams).
Regarding claim 11, Shi does not disclose the one or more electric field generating electrodes comprise from two to six conductive paths arranged in parallel.
Williams, however, teaches a medical electrode lead (Abstract) wherein although in the context of a defibrillation electrode, it is believed that the electrode coils illustrated provide an appropriate electrode surface, in other applications, other conductive metallic or nonmetallic materials may be used to provide corresponding electrode surfaces. For example, conductive polymers, metallization layers, braided or tinsel wires, wire mesh or carbon fibers may be appropriate, provided that the electrode surfaces define a plurality of parallel electrode paths, and that means for increasing the flexibility of the electrode, such as grooves, are located between the electrode paths (Col. 6, ll. 57-68).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Shi’s electrode system with a reasonable expectation of success such that the one or more electric field generating electrodes comprise from two to six conductive paths arranged in parallel. Making this modification would be useful for providing an electrode surface which is appropriate for a particular application, as well as increasing the flexibility of the electrode, as taught and suggested by Williams.
Claims 12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba et al. (US 2017/0348049) (hereinafter Vrba) in view of Shi et al. (US20140343644).
Regarding claim 12, Vrba discloses a method of treating a patient previously diagnosed with cancer ([0195], “the catheters described herein may also be used … for treating conditions including: uterine fibroids, benign prostate hyperplasia, prostate cancer”) comprising: implanting a first lead within a patient; the first lead comprising a first lead body comprising a proximal end and a distal end; and one or more electric field generating electrodes disposed along a length of the lead body (Fig. 24 depicts lead catheter 24002 implanted within a blood vessel and electrode 24003 disposed at distal end of lead body; para. 310); positioning the lead at or near a site of a cancerous tumor ([0045] catheter is placed in a body lumen and navigated proximate to an organ”; see also [0195] treating prostate cancer); and generating one or more electric fields with the one or more electric field generating electrodes (para. 17, last sentence discloses applying various types of electromagnetic energy; para. 397, 2nd sentence discloses electric field). Vrba does not disclose a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to the lead body is less than 0.005 inches. Shi, however, teaches a sputter coating, ([0019] “A thin coating may be applied to the outer surface of the electrode substrate… A Pt, TiN, IrOx coating may be applied via any suitable technique including, e.g., sputtering such as vacuum sputtering.”) wherein a thickness of the sputter coating in a radial direction ([Fig. 5] coating (76) deposited on the electrode’s radial surface) with respect to the lead body is less than 0.005 inches ([Table 1] where coating thickness is 5μm, or .0002 inches; see optionally Fig. 5). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Vrba’s method such that the one or more electric field generating electrodes comprise a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to the lead body is less than 0.005 inches. Making this modification would be useful for increasing the effective surface area, thus reducing energy consumption and increasing device life, as taught and suggested by Shi in [0048].
Regarding claim 18, Vrba discloses a medical device system for treating a cancerous tissue ([Fig. 23]; [0195], “the catheters described herein may also be used … for treating conditions including: uterine fibroids, benign prostate hyperplasia, prostate cancer”)comprising: an electric field generating circuit configured to generate one or more electric fields at or near a site of the cancerous tissue ([Fig. 23] controller 23904 comprises both generator and control circuitry); control circuitry in communication with the electric field generating circuit, the control circuitry configured to control delivery of the one or more electric fields from the electric field generating circuit to the site of the cancerous tissue ([0308] “The treatment system further comprises a controller 23904 (e.g., RF generator having one or more processing devices configured to regulate power delivery to the ablation catheter 23902”); and an implantable first lead, the implantable first lead comprising a lead body having a proximal end and a distal end (lead 23902), the lead body defining a lumen (para. 11, 2nd sentence discloses the catheter may have a lumen); and one or more electric field generating electrodes disposed along a length of the lead body (electrode 23903). Vrba does not disclose wherein the one or more electric field generating electrodes comprise a sputter coating, wherein a thickness of the sputter coating in a radial direction with respect to the lead body is less than 0.005 inches. Shi, however, teaches a sputter coating, ([0019] “A thin coating may be applied to the outer surface of the electrode substrate… A Pt, TiN, IrOx coating may be applied via any suitable technique including, e.g., sputtering such as vacuum sputtering.”) wherein a thickness of the sputter coating in a radial direction ([Fig. 5] coating (76) deposited on the electrode’s radial surface) with respect to the lead body is less than 0.005 inches ([Table 1] where coating thickness is 5μm, or .0002 inches; see optionally Fig. 5).
Regarding claim 20, Vrba-Shi as a combination teaches all of the claims of claim 18. Regarding claim 20, Vrba also teaches control circuitry causes the electric field generating circuit to generate one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz (Vrba para. 388).
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba et al. (US 2017/0348049) in view of Shi et al. (US20140343644) (the combination hereafter referenced as modified Vrba) as applied to claims 12 and 18 above, and further in view of Zarembo et al. (US20070038278)
Regarding claim 13, Vrba teaches implanting a second lead within the patient ([0032] “a first electrode and a second electrode”), wherein the second lead comprises a second lead body comprising a proximal end and a distal end; ([0046] “ablation catheter comprising an elongate shaft having a proximal and distal end. An electrode is positioned near the distal end of the elongate shaft”)
Regarding claim 13, Vrba does not explicitly teach, as taught by Zarembo, and wherein the one or more electric field generating electrodes comprise ([0029] “each of the electrode arrays comprising a plurality of spaced-apart electrodes”) … a walled tube, wherein a thickness of the walled tube is less than 0.005 inches ([0055]). Zarembo further teaches one advantage of tubular electrodes is the increased strength provided by a tube compared to a solid electrode of equal cross-sectional area. Another advantage is the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending at least partially into the tube (para. 50). It would have been prima facie obvious to a person having ordinary skill in the art to have modified Vrbo’s electrode structures to explicitly comprise a walled tube, wherein a thickness of the walled tube is less than 0.005 inches for the purpose of providing a tube electrode which has increased strength compared to a solid electrode of equal cross-sectional area, and the ability to make a strong joint and/or a robust electrical connection between a tube and a conductor extending
Regarding claim 19, modified Vrba teaches an implantable second lead, the implantable second lead comprising ([0032] “a first electrode and a second electrode”), a lead body having a proximal end and a distal end, ([0046] “ablation catheter comprising an elongate shaft having a proximal and distal end. An electrode is positioned near the distal end of the elongate shaft”) the lead body defining a lumen ([0027] “ablation catheter (e.g., hollow”) and one or more electric field generating electrodes disposed along a length of the lead body, wherein the one or more electric field generating electrodes comprise ([0029] “each of the electrode arrays comprising a plurality of spaced-apart electrodes”) … a walled tube, wherein a thickness of the walled tube is less than 0.005 inches ([0055]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba in view of Zarembo as applied to claim 13 above, and further in view of Palti (US 2006/0282122).
Regarding claim 14, modified Vrba in view of Zarembo teaches generating one or more electric fields with the one or more electrodes comprises generating an electrical field at the treatment site at one or more frequencies selected from a range of between 100 kHz to 300 kHz (Vrba para. 388), using currents ranging from 20 mAmp to 500 mAmp (Vrba para. 389). Modified Vrba does not disclose the electric field having a field strength of between 1 V/cm to 10 V/cm. Palti, however, teaches treating cancer with electric field (Abstract) wherein for many types of cancers, frequencies between 100 kHz and 300 kHz at field strengths between 1 and 10 V/cm have been shown to be helpful (para. 55). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to modify the method of modified Vrba in view of Zarembo such that the electric field having a field strength of between 1 V/cm to 10 V/cm, as taught by Palti. Making this modification would be useful for improving selective tissue destruction [0003].
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba in view of Zarembo as applied to claim 13 above, and further in view of Schmidt et al. (US 2019/0117971) (hereinafter Schmidt).
Regarding claims 15-16, modified Vrba in view of Zarembo does not teach the one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another. Schmidt, however, teaches leads for treatment of cancer with electric fields (Abstract) wherein one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another (para. 18-19; claims 15-16). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to adjust the method of modified Vrba in view of Zarembo such that the one or more electrodes forming electrode pairs defining at least two different electrical field vectors, the two different electrical field vectors angled by at least 10 degrees with respect to one another, as taught by Schmidt. Making this modification would be useful for treating cancer with electric fields by increasing electric field densities [0046].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over modified Vrba as applied to claim 12 above, and further in view of Trikha et al. (US 2020/0085789) (hereinafter Trikha).
Regarding claim 17, modified Vrba does not teach obtaining MRI of the cancerous tumor to determine a progression or regression of the cancerous tumor. Trikha, however, teaches that MRI assessment may indicate tumor progression (para. 478). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of this invention to alter modified Vrba’s method to include obtaining MRI of the cancerous tumor to determine a progression or regression of the cancerous tumor for the purpose of providing an indication of tumor progression, as taught by Trikha.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Champeau et al. (Pat. 6208881) discloses an electrical lead for sensing electrical activity with the body of the patient and for applying electrical energization to selected body tissue.
Tolosa et al. (US20200085375) discloses biocompatible multi-electrode devices capable of being implanted in sensitive tissue with micrometer level precision.
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 ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights