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 .
Election/Restrictions
Claims 2-5, and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/2025.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
Regarding the 112(b) rejection. The Applicant argues that a person having ordinary skill in the art would understand the difference between a coil filar having a substantially smooth surface vs a coil filar having an irregular surface. The examiner agrees that a smooth surface and an irregular surface are something that a person having ordinary skill in the art would understand. The problem is that a substantially smooth surface is not clearly linked to anything and is subjective. MPEP 2173.05(b) states “[c]laim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention.” How is the diameter of a substantially smooth surface filar being defined? What is substantially smooth? For instance is a substantially smooth surface, using figure 12 of the instant application for refence, is the substantially smooth surface a larger area before material was removed to make it irregular? How big was the diameter of 1268 before material was removed to make it irregular. Alternatively, would sanding the structure to remove some of the irregularities be “a substantially smooth surface”, but then all structures would be smaller because they are sanded and material is removed. Or is the claim just trying to recite the filar surface is irregular? Because the “otherwise identical conductive coil filar having a substantially smooth surface” is subjective and unrestrained, the rejection is maintained.
Regarding the 103 rejection Applicant argues Arai is related to phototherapy not ablation therapy and person having ordinary skill in the art would not turn to Arai. The examiner respectfully disagrees as Arai is related to the treatment of cancer (e.g. Paragraph [0063]).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Arai utilizes coil electrodes to measure electric potential, not for ablation therapy, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Azure teaches the use of electrodes to provide ablation, however does not explicitly disclose a conductive filar disposed around the lead body. Arai is a cancer treatment tool and teaches the use of a lead with coil electrodes disclosed around the lead body which improves the flexibility of the electrode and enables steering of electrical energy to improve targeting of tissue. Applicant opines that a person having ordinary skill in the art would have no reason to think the coil electrodes of Arai would be sufficient for ablation therapy. However, there is no evidence to support this opinion and Azure discloses low-power/non-thermal ablative electric fields (e.g. Paragraph [0010]). Azure is relied upon for teaching of electrodes that deliver sufficient energy for ablation and Arai is relied upon as being a cancer treatment device that has a conductive coil filar (electrode) disposed around the lead body which improves the flexibility of the electrode and enables steering of electrical energy to improve targeting of tissue. Lastly, the Applicant argues the coil electrodes of Arai are not sufficient for ablation therapy nor any evidence on how to arrange the coil electrodes to provide effective ablation treatment. This argument is not persuasive as one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Azure is relied upon for teaching of electrodes to provide ablation energy (e.g. Paragraph [0003]). Arai is a cancer treating device and teaches the use of electrodes having a conductive coil filar (electrode) disposed around the lead body which improves the flexibility of the electrode and enables steering of electrical energy to improve targeting of tissue. Regarding claim 6, Applicant argues the surface irregularities are embedded within the housing 16 and then references the instant disclosure. The examiner notes that the claim as currently written does not preclude the irregularities from being in the housing only that “the conductive coil filar comprises an irregular surface with increased surface area compared with otherwise identical conductive coil filars having a substantially smooth surface area. In this case the filar of Friedman is irregular and has a larger surface area than a smooth surface.
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 6 and 21 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 6 requires “increased surface area compared with otherwise identical conductive coil filars having substantially smooth surface” this is unclear what is meant by otherwise identical having a smooth surface. The irregular surface includes smooth surfaces how are these surfaces different? What is the shape of this otherwise identical filar, is it a square or oblong? Since the otherwise identical conductive coil filar is not claimed it is unclear is being used in comparison for determining the surface area of the irregular surface.
Claim 21 requires increased surface area f 200 to 1000 percent greater compared with otherwise identical conductive coil filars having substantially smooth surface”. The irregular surface includes smooth surfaces how are these surfaces different? What is the shape of this otherwise identical filar, is it a square or oblong? Since the otherwise identical conductive coil filar is not claimed it is unclear is being used in comparison for determining the surface area of the irregular surface.
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) 1, 7-8, 10, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azure (US Publication 2008/0071265) in view of Arai et al (US Publication 2016/0278863).
Referring to Claim 1, Azure teaches a medical device system for treating a cancerous tissue (e.g. Paragraph [0003], comprising: an electric field generating circuit configured to generate one or more electric fields at or near a site of the cancerous tissue (e.g. Paragraph [0010] and Figure 16, Element 210); a 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 (e.g. Figure 16, control unit 240); wherein the 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 (e.g. Paragraph [0030]); an implantable lead comprising: a lead body comprising a proximal end and a distal end, the lead body comprising a first electrical conductor disposed within the lead body (e.g. Figure 1, Element 12 with conductors 20); a first electrode coupled to the lead body, the first electrode in electrical communication with the first electrical conductor, wherein the first electrical conductor forms part of an electrical circuit by which the electric fields from the electric field generating circuit are delivered to the site of the cancerous tissue (e.g. Paragraph [0039] discloses electrodes 22 are positioned or fixed at the distal end of the lead 12);. However, Azure does not explicitly disclose the first electrode comprising a conductive coil filar disposed around the lead body.
Arai et al teaches that it is known to use a lead with coil electrodes disposed around the lead body as set forth in Figure 10 and Paragraphs [0193] and [0196] to provide flexible electrodes that enables steering of electrical energy to improve targeting of tissue. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Azure, with the first electrode comprising a conductive coil filar disposed around the lead body as taught by Arai et al, since such a modification would provide the predictable results of flexible electrodes that enables steering of electrical energy to improve targeting of tissue
Referring to Claim 7, Azure in view of Arai et al teaches the medical device system of claim 1, except wherein the conductive coil filar comprise an etched surface.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to comprise an etched surface, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 8, Azure in view of Arai et al teaches the medical device system of claim 1, except wherein the conductive coil filar comprise a laser-cut surface. It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to comprise a laser-cut surface, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 10, Azure in view of Arai et al teaches the medical device system of claim 1, the conductive coil filar configured to expand in outer diameter after removal of a delivery device from over the conductive coil filars (the examiner notes this is a material property that all materials have some ability to flex and the claim does not set forth any specific on the expansion of the filar).
Referring to Claim 22, Azure in view of Arai et al teaches the medical device system of claim 1, wherein the one or more electric fields use currents ranging from 1 mAmp to 1000 mAmp (e.g. Paragraph [0077] discloses using 20-30 mA).
Claim(s) 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azure (US Publication 2008/0071265) in view of Arai et al (US Publication 2016/0278863) as applied to claim 1 above, and further in view of Friedman (US Patent 4,369,791).
Referring to Claim 6, Azure in view of Arai et al teaches the medical device system of claim 1, except wherein the conductive coil filar comprise an irregular surface with increased surface area compared with otherwise identical conductive coil filars having a substantially smooth surface, wherein the surface area of each of the substantially smooth surface coil filars is calculated according to the equation Surface Area = 2πrl, wherein r is the radius of each of the substantially smooth surface coil filars and l is the length of each of the substantially smooth surface coil filars. Friedman teaches that it is known to use a conductor with an irregular surface as set forth in Figure 3 and Column 3 lines 3-9 to provide improved retention of the conductor to the lead body. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Azure, with the conductive coil filar comprise an irregular surface with increased surface area compared with otherwise identical conductive coil filars having a substantially smooth surface as taught by Friedman, since such a modification would provide the predictable results of improved retention of the conductor to the lead body.
Referring to Claim 21, Azure in view of Arai et al teaches the medical device system of claim 1, except wherein the conductive coil filar comprises an irregular surface with an increased surface area of 200 to 1000 percent greater compared with otherwise identical conductive coil filars having a substantially smooth surface, wherein the surface area of each of the substantially smooth surface coil filars is calculated according to the equation Surface Area = 2πrl, wherein r is the radius of each of the substantially smooth surface coil filars and l is the length of each of the substantially smooth surface coil filars..
Friedman teaches that it is known to use a conductor with an irregular surface as set forth in Figure 3 and Column 3 lines 3-9 to provide improved retention of the conductor to the lead body. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Azure, with the conductive coil filar comprise an irregular surface with increased surface area compared with otherwise identical conductive coil filars having a substantially smooth surface as taught by Friedman, since such a modification would provide the predictable results of improved retention of the conductor to the lead body.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Azure in view of Arai et al and Friedman with an increased surface area of 200 to 1000 percent greater, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azure (US Publication 2008/0071265) in view of Arai et al (US Publication 2016/0278863) as applied to claim 1 above, and further in view of Edwards et al (US Patent 6,569,159).
Referring to Claims 11-13, Azure in view of Arai et al teaches the medical device system of claim 1, except further comprising a conductive fluid or gel disposed over the conductive coil filar; comprising an active agent disposed with the conductive fluid or gel; and the active agent comprising a chemotherapeutic agent or an anti-bacterial agent.
Edwards et al teaches that it is known to use a conductive fluid or gel disposed over the electrode; comprising an active agent disposed with the conductive fluid or gel; and the active agent comprising a chemotherapeutic agent or an anti-bacterial agent as set forth in Figure 8 and Column 9 lines 43-56 to provide improved treatment of the tumor/cancer. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Azure, with a conductive fluid or gel disposed over the electrode; comprising an active agent disposed with the conductive fluid or gel; and the active agent comprising a chemotherapeutic agent or an anti-bacterial agent as taught by Edwards et al, since such a modification would provide the predictable results of improved treatment of the tumor/cancer.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796