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 .
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 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.
Response to Amendment
Acknowledgement is made to the claims provided 05/13/2026.
Acknowledgement is made to the cancellation of claims 1-33.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 34-45 are pending. A complete action on the merits appears below.
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 26-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11559350. Although the claims at issue are not identical, they are not patentably distinct from each other because they each recite a medical device and method of manufacturing a medical device comprising a medical device body having an electrode formed of a substrate which has been treated to increase a surface area of the metallic substrate.
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 26, 28-29, and 38-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 20040220652 to Zhou et al (herein after “Zhou”).
Regarding claim 26, Zhou teaches an electrode (Fig. 8; electrode 50) for use with an electrophysiology device, the electrode comprising:
a metallic substrate (Fig. 8; rough platinum electrode 54) having a textured surface ([0056]), wherein the textured surface includes a plurality of peaks and valleys extending along at least one dimension ([0056]); and
a coating (Fig. 8; high surface area coating 52) applied to the surface of the metallic substrate.
Regarding claim 28, Zhou teaches the electrode according to claim 26, wherein the coating comprises a metallic coating ([0056]).
Regarding claim 29, Zhou teaches the electrode according to claim 28, wherein the metallic coating comprises at least one of titanium nitride, iridium oxide, platinum, and platinum iridium ([0056]).
Regarding claim 38, Zhou teaches an electrode (Fig. 8; electrode 50) for use with an electrophysiology device, the electrode comprising
a metallic substrate (Fig. 8; rough platinum electrode 54) having a textured surface ([0056]), the textured surface of the metallic substrate defining a plurality of peaks and valleys arranged in a repeating pattern along at least one dimension of the metallic substrate (the term repeat is defined as “to reproduce” and as the texture is reproduced along the length of this surface teaches this claim limitation as broadly as is currently claimed).
Regarding claim 39, Zhou teaches the electrode according to claim 38, wherein the plurality of peaks and valleys are arranged in a repeating pattern along two dimensions of the metallic substrate (as the electrode has a surface of two dimensions, the textured surface which is positioned on this electrode reads on this limitation as broadly as is currently claimed).
Regarding claim 40, Zhou teaches the electrode according to claim 38, further comprising a coating applied to the surface of the metallic substrate ([0037]).
Regarding claim 41, Zhou teaches the electrode according to claim 40, wherein the coating comprises a metallic coating ([0056]).
Regarding claim 42, Zhou teaches the electrode according to claim 41, wherein the metallic coating comprises at least one of titanium nitride, iridium oxide, platinum, and platinum iridium ([0056]).
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20040220652 to Zhou et al (herein after “Zhou”) in view of U.S. Patent Publication No. 20090118818 to Foss et al. (herein after “Foss”).
Regarding claim 27, Zhou teaches the electrode according to claim 26.
However, Zhou fails to teach the electrode wherein the surface treatment comprises a laser-etched pattern.
Zhou instead teaches treating the surface through etching, such as chemical, electrochemical or physical ([0035], [0040]).
Foss teaches a device including a surface region which defines depressions and enhanced roughness so as to comprise a coating, some of the exemplary material of the device being platinum and iridium oxide (Abstract, [0006], [0008]).
Foss further teaches the surface as being roughened through a variety of etching methods, such as chemical, electrochemical, laser, laser-assisted, etc. ([0010], [0032]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to utilize a known laser etching method, as is known in Foss, in place of the known etching methods taught by Zhou, in order to provide roughen to a surface to be utilized for coating deposition.
Claims 30 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20040220652 to Zhou et al (herein after “Zhou”) in view of U.S. Patent Publication No. in view of U.S. Patent Publication No. 20090099634 to Atanasoska et al. (herein after “Atanasoska”)
Regarding claim 30, Zhou teaches the electrode according to claim 26.
However, Zhou fails to teach the electrode wherein the coating comprises an electrically-conductive polymer coating.
Atanasoska teaches an implantable electrode usable for medical applications, this electrode including an electrode coating of iridium oxide (Abstract).
Atanasoska further teaches the iridium oxide as being utilized in a composite material with a polymer matrix which allows for safe delivery of charge densities within a patient’s heart (Abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching or the iridium oxide coating comprising an iridium oxide composite material with a polymer matrix, as is taught by Atanasoska, into the iridium oxide coating of Zhou, as Atanasoska teaches the composite material being for delivering charge densities within a patient’s heart.
Regarding claim 43, in accordance with the above rejection of claim 30, Atanasoska teaches the electrode according to claim 40, wherein the coating comprises an electrically-conductive polymer coating (Abstract).
Claims 31-33 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20040220652 to Zhou et al (herein after “Zhou”) in view of U.S. Patent No. 5,632,770 to Schaldach (herein after “Schaldach”).
Regarding claim 31, Zhou teaches the electrode according to claim 26.
However, Zhou fails to teach the electrode wherein the coating comprises a physical vapor deposition layer.
Schaldach teaches an electrode device having an increased surface area (Abstract). This electrode having a biocompatible surface coating of an inert material such as iridium oxide (Col. 3, Lines 14-33).
Schaldach further teaches this application of this inert material as preferably being vapor deposition, such as physical vapor deposition, chemical vapor deposition, etc. (Col. 3, Lines 14-33)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of utilizing physical vapor deposition to coat the electrode surface with iridium oxide, as is taught by Schaldach, into the device of Zhou, which uses deposition for depositing iridium oxide onto the electrode, in order to provide a known manner of depositing iridium oxide onto an electrode surface.
Regarding claim 32, in accordance with the above rejection of claim 31, Schaldach teaches the electrode according to claim 26, wherein the coating comprises a chemical vapor deposition layer (Col. 3, Lines 14-33).
Regarding claim 33, in accordance with the above rejection of claim 31, Schaldach teaches the electrode according to claim 26, wherein the coating comprises an electrochemical deposition layer (Col. 3, Lines 14-33).
Regarding claim 44, in accordance with the above rejection of claim 31, Schaldach teaches the electrode according to claim 40, wherein the coating comprises a physical vapor deposition layer (Col. 3, Lines 14-33).
Regarding claim 45, in accordance with the above rejection of claim 32, Schaldach teaches the electrode according to claim 40, wherein the coating comprises a chemical vapor deposition layer (Col. 3, Lines 14-33).
Allowable Subject Matter
Claims 34-37 are allowable.
The following is a statement of reasons for the indication of allowable subject matter: a medical device and method of manufacturing containing an electrode having a substrate which is metallically coated so as to increase a surface area of the electrode and subsequently reduce the resistance is taught in the art, as can be shown by the above rejection of Zhou. There are additionally references which utilize uniformly provided posts and valleys, such as that taught by Hung (US 7676724 B2). However, these refences fail to teach alone or in combination a medical device comprising an electrode including a metallic substrate, wherein a surface of the substrate is modified in a manner that increases its effective surface area, the surface of the substrate forming a plurality of peaks and valleys extending uniformly along at least one dimension of the surface.
Response to Arguments
In response to applicant’s arguments that Zhou does not teach a repeating pattern, attention is further brought to the definitions of the terms “repeat” and “pattern” as the term “repeat” is defined in the Cambridge online dictionary as “to happen … more than once” and the term “pattern” is defined in the Cambridge online dictionary as “a particular way in which something … is organized or happens” and as the texture of the surface is capable of happening or being organized in a pattern of peaks and valleys which happen more than once, a texture of a surface which has, for example, a pattern of a peak next to a valley followed by that same pattern again of another peak followed by another valley, such as can be found in the cited Fig. 8 of Zhou, is taught by this limitation as broadly as is currently claimed, as there are currently no limitations to the degree or manner in which this pattern of the textured surface is provided as broadly as is currently claimed.
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 extension fee 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 date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
