Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicants’ amendments to the claims filed on 8/24/26 have been entered. Claims 4-20 are currently pending examination, claims 1-3 have been canceled.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-6, 9-13, and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal et al (WO2005/086683; hereafter Drbal) in view of Lessar et al (US 2004/0064175; hereafter Lessar).
Claim 4: Drbal teaches a method of manufacturing a medical device (see, for example, abstract, figures) comprising:
creating a bulbed wire (ballwire) having a bulb portion (ball) and a wire portion(wire) (see, for example, abstract, [0008], [00114], Fig 13, Fig 40A-B);
placing the bulbed wire into an electrode assembly housing (such as electrode support / tip assembly) (See, for example, Fig 12-13, Fig 40A-B, [0008-0009], [00114], [00185]
and coupling the electrode assembly housing with an elongate body (shaft, 304), the bulbed wire being in communication with the elongate body. (See, for example, Fig 12-13, Fig 40A-B, [0008-0009], [00114], [0185]).
Drbal teaches the importance of the various conductive components of the device being sufficiently insulated (see, for example, [0068], [0074], [0086], [0099], [0106], [0121], [0129], [0134], [00137]), but it does not explicitly teach anodizing the wire portion of the bulbed wire. Lessar teaches a method of manufacturing a medical device (See, for example, abstract, figures). Lessar further teaches wherein electrical insulation between multiple conductors and their associated electrodes is crucial for device operation, and wherein there exists a desire in the art to minimize lead diameter while maintaining proper insulation and integrity (See, for example, [0008]). Lessar teaches flexible, high quality insulative oxide layer can predictably be provided by anodization of the metal leads providing for a reduction in lead thickness, improved metal ion induced oxidation resistance, and radiopacity (see, for example, [0016], [0034], [0046]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated anodizing the wire portion of the bulbed wire as it would provide a predictable means to establish a thin, flexible electrical insulation to the conductive wire of high quality insulative oxide layer of reduced lead thickness, improved metal ion induced oxidation resistance, and radiopacity.
Claim 5: Lessar further teaches wherein the anodizing creates a thin oxide layer on an external surface of the wire portion of the bulbed wire (see, for example, [0016], [0034], [0046]).
Claim 6: Drbal in view of Lessar teach the method of claim 4 (above), and further teach the bulb portion of the bulbed wire is composed of a non-anodized material (see, for example, the rejection of claim 4 above, wherein by combination at least the wire portion is anodized to convert only any exposed surface portion of the wire to its oxide; the core of the wire beneath remains metallic to allow conduction therethrough. Thus, even assuming the ball portion also undergoes anodization, the core of the ball portion similarly remains metallic, and thus the ball portion of each of the bulbed wire is composed of a non-anodized material (the metallic material at the core of the ball underlying any anodized region).
Claim 9: Drbal further teaches wherein the electrode assembly housing has an anterior face, when the bulb portion is placed into the electrode assembly housing the bulb portion is configured to protrude from the anterior face of the electrode assembly housing (see, for example, Fig 12-13, Fig 40A-B, [00114-00117]).
Claim 10: Drbal further teaches wherein the electrode assembly housing has an anterior face, when the bulb portion is placed into the electrode assembly housing the bulb portion is substantially flush with the anterior face of the electrode assembly housing. (see, for example, Fig 12-13, Fig 40A-B), [00114-00117]).
Claim 11: Drbal further teaches wherein the electrode assembly housing further includes a socket, the socket being sized to receive the bulb portion of the bulbed wire (see, for example, Fig 13-14, Fig 40A-B, [00114-00117]).
Claim 12: Drbal further teaches wherein the socket further includes an aperture, the aperture being sized to receive the wire portion of the bulbed wire (see, for example, Fig 13-14, Fig 40A-B, [00114-00117]).
Claim 13: Drbal further teaches affixing the bulb portion of the bulbed wire to the electrode assembly housing using at least one from the group consisting of adhesive and thermoplastics (See, for example, Fig 13-14, Fig 40A-B, [00114-00117], [0185-00186]).
Claim 17: Drbal further teaches wherein the electrode assembly housing (such as electrode support member) is composed of a material including at least one from the group consisting of polymer (such as PEEK or polysulfone), or silicone (silicone elastomer) (see, for example, [00103], [00170]).
Claims 9-12, and 14-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar as applied to claim 4 above, and further in view of Lau et al (US 2011/0028820; hereafter Lau).
Claim 14: Drbal in view of Lessar teach the method of claim 4 above wherein Drbal further teaches placing the electrode assembly housing in electrical communication with an energy source, the electrode assembly housing being composed of an electrically conductive material so the electrode assembly housing may be used for ablating tissue (See, for example, Fig 13-14, Fig 40A-B, [0002], [0046], [0070], [0081], [0088], [0096-97], [00114-00117], [0185-00186]), but it does not explicitly teach wherein the bulb portion of the bulbed wire may be used for mapping tissue. Lau teaches a method of manufacturing a medical device, further one associated with mapping and ablation (See, for example, abstract, Figures, [0009], [0032-0033]). Lau further teaches wherein bulbous electrodes reside within sockets of a housing (22), wherein the housing serves as an ablation electrode (See, for example, [0033]). Lau further teaches wherein such bulbous structures can be configured to operate as recording electrodes providing a means for obtaining MAP electrograms allowing for improvement in mapping, identifying, and characterizing electrical activity of the anatomy to assist locating proper and improper electrically functioning areas (see, for example, [0008-00010], [0029-0030], Figures). By the combination they effectively map and treat, via ablation, areas of the tissue operating improperly (See, for example, [0008-0009], [0033]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated using the bulbed wire(s) as electrodes for mapping tissue since the orientation of such bulbed conductive features situated among ablation electrodes are well known in the art to perform mapping of tissues for ablative devices and since the combination of mapping and ablation would predictably enhance the ability to target and treat improperly operating tissue.
Claim 15-16: Drbal in view of Lessar and Lau teach the method of claim 14 above and Lau further teaches wherein incorporating an insulative layer (interpreted as the claimed outer layer) to electrically isolate the bulb portion of the bulbed wire from the electrode assembly housing (see, for example, [0033] wherein electrically insulating material is positioned between the recording electrodes and sockets of the housing). Drbal similarly teaches Drbal teaches the importance of the various conductive components of the device being sufficiently insulated (see, for example, [0068], [0074], [0086], [0099], [0106], [0121], [0129], [0134], [00137], and the rejection of claim 4 above).
Claim 9: refer the rejection of claim 14-16 above, the combination of Drbal and Lau further teaches wherein the electrode assembly housing has an anterior face, when the bulb portion is placed into the electrode assembly housing the bulb portion is configured to protrude from the anterior face of the electrode assembly housing (see, for example, Fig 12-13, Fig 40A-B), [00114-00117] of Drbal and Fig 1-9 of Lau).
Claim 10: refer the rejection of claim 14-16 above, the combination of Drbal and Lau further teaches the electrode assembly housing has an anterior face, when the bulb portion is placed into the electrode assembly housing the bulb portion is substantially flush with the anterior face of the electrode assembly housing. (see, for example, Fig 12-13, Fig 40A-B), [00114-00117] and Fig 1-9 of Lau).
Claim 11: refer the rejection of claim 14-16 above, the combination of Drbal and Lau further teaches wherein the electrode assembly housing further includes a socket, the socket being sized to receive the bulb portion of the bulbed wire (see, for example, Fig 13-14, Fig 40A-B, [00114-00117] and Fig 1-9 of Lau).
Claim 12: refer the rejection of claim 14-16 above, the combination of Drbal and Lau further teaches wherein the socket further includes an aperture, the aperture being sized to receive the wire portion of the bulbed wire (see, for example, Fig 13-14, Fig 40A-B, [00114-00117] and Fig 1-9 of Lau).
Claims 6-7 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar and Lau as applied to claim 14 above, and further in view of Avitall et al (US 2006/0095030; hereafter Avitall).
Claim 19: Drbal in view of Lessar and Lau teach the method of claim 14 above, Drbal teaches wherein electrically conductive materials within its device are commonly formed from metals such as platinum, titanium alloys, nickel alloys [0099]); and Lau further teaches wherein its MAP recording electrodes can be formed of platinum, gold, iridium etc (See, for example, [0037]). But they don’t explicitly teach depositing at least one of iridium oxide, nickel-titanium alloy, gold, gold alloy, platinum, and platinum-based alloy onto the bulb portion of the wire. Avitall teaches a method of manufacturing a medical device, further a catheter suitable for mapping and ablation (See, for example, abstract, Figures, [0036-0038]). Avitall further teaches wherein mapping electrodes are commonly formed from platinum or gold or alternatively can formed by sputtering electrically conductive material like platinum or gold (See, for example, [0060]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated sputtering gold, or platinum onto the bulb portion of the wire since such a coating would predictably ensure the electrode to achieve the intended mapping functionality and since where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious. In re Fout, 675 F.2d 297,301 (CCPA 1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967).
Claim 6: refer to the rejection of claim 19 above, wherein by combination the bulb portion of each of the bulbed wire is composed of a non-anodized material (gold or platinum).
Claim 7: refer to the rejection of claim 19 above, wherein by combination the bulb portion of each of the bulbed wire is at least one from the group consisting of sputtered with a corrosion resistant material (gold or platinum).
Claims 6-8 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar and Lau as applied to claim 14 above, and further in view of Strom et al (US 2006/0217777; hereafter Strom).
Claims 7-8: Drbal in view of Lessar and Lau teach the method of claim 14 above, Drbal further teaches wherein electrode components can comprise tantalum (See, for example, [00182]), and Lessar further teaches wherein tantalum serves as a suitable metal for the conductive metal wire, and most preferably is formed of an inner core of tantalum-tungsten and an outer layer of tantalum (corrosion resistant material (see for example, [0011-0012]. But they do not explicitly teach wherein the bulb-wire including the bulbed portion is sputtered electroplated, sputtered, or iron-embedded with a corrosion resistant material, further tantalum. Strom teaches a method of manufacturing a medical device further comprising electrodes (See, for example, abstract). Strom similarly teaches wherein electrodes in such devices are well known to be fabricated from tantalum, and further notes that sputter coating with tantalum can predictably provide the electrode with a larger specific surface area to improve the devices overall efficiency (See, for example, [0031], [0077]). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated sputter coating tantalum on the surface of ball of the ball wire electrode since such a material is desired and as the sputtered material would predictably enhance the specific surface area of the electrode improving the devices overall efficiency.
Claim 19: refer to the rejection of claim 7 above, Strom further teaches wherein electrodes can be provided with coatings, such as platinum black, iridium oxide to enhance signal conducting, de-and re-polarization sensing properties, and reduce polarization voltages (See, for example, [0031]]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated coating platinum black or iridium oxide on the surface of ball of the ball wire electrode since such a material is desired and as the sputtered material would predictably enhance signal conducting, de-and re-polarization sensing properties, and reduce polarization voltages.
Claim 6: refer to the rejection of claims 7-8 or 19 above, wherein by combination the bulb portion of each of the bulbed wire is composed of a non-anodized material (sputtered tantalum, or platinum black or iridium oxide).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar as applied to claim 4 above, and further in view of Saadat et al (WO 2005/058239; hereafter Saadat).
Claim 18: Drbal in view of Lessar teaches the method of claim 4 (above), and Drbal further teaches the bulbed wire possesses volume of metal such that the bulb portion is a substantially spherical shape (ball wire) (see, for example, Fig 13-14, Fig 40A-B, [00114-00117]). But Drbal is silent as to the specifics for forming the ball wire, therefore it does not explicitly teach molding thereof. Saadat teaches a method of manufacturing and using a medical device (See, for example, abstract). Saadat like Drbal further teaches the implementation of ball wires to aid in assembling and connection of components of the medical device, further catheters (see, for example, abstract, Fig 37, [0237]). Saadat further teaches wherein such ball wires can conventionally be formed via molding (See, for example, [0237]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated forming the ball wire by molding since such a method of formation is well known in the art to predictably yield a ball wire structure suitable for performing attachment within medical devices, further catheters, and further since when a primary reference is silent as to a certain detail, one of ordinary skill would be motivated to consult a secondary reference which satisfies the deficiencies of the primary reference.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar, Lau and Avitall as applied to claim 19 above and further in view of Saadat.
Claim 20: refer to the rejections of claims 4-6, 9-13, and 17 (particularly claims 4-5 and 11-12) over Drbal in view of Lessar, the rejections of claims 9-12 and 14-16 (particularly claims 11-12 and 14) over Drbal in view of Lessar and Lau, the rejections of claims 6-7 and 19 (particularly claim 19) over Drbal in view of Lessar, Lau, and Avitall, and the rejection of claim 18 over Drbal in view of Lessar and Saadat.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drbal in view of Lessar, Lau and Strom as applied to claim 19 above and further in view of Saadat.
Claim 20: refer to the rejections of claims 4-6, 9-13, and 17 (particularly claims 4-5 and 11-12) over Drbal in view of Lessar, the rejections of claims 9-12 and 14-16 (particularly claims 11-12 and 14) over Drbal in view of Lessar and Lau, the rejections of claims 6-8 and 19 (particularly claim 19) over Drbal in view of Lessar, Lau, and Strom, and the rejection of claim 18 over Drbal in view of Lessar and Saadat.
Response to Arguments
Applicants’ amendments to claims 7 and 8, filed 8/20/26, have been fully considered and are persuasive with respect to the 35 USC 112 (b) rejections of claims 7 and 8, therefore they have been withdrawn.
Applicants' arguments filed 8/20/26 directed to the art rejections have been fully considered but they are not persuasive.
In response to Applicant's arguments (pg 6-8) that the combination Drbal and Lessar is improper because Lessar only teaches anodizing / insulating the entire length of the wire to electrically isolate the wires from others, so applying Lessar's anodization to Drbals' ball wire would defeat the purpose of Drbals' ball wire and render Drbal unsatisfactory for its intended purpose in that forming an insulating oxide layer on the entire ball wire would electrically insulate the very portion that the cited portions of Drbal require to conduct current from the connector to the active screen electrode. The examiner disagrees, and notes that Applicant’s arguments directly contradict the teaching of Lessar, in that Lessar explicitly teaches at [0030]: its wires, such as 202 A-D, which similarly receive the insulating oxide layer operate as intended to electrically couple proximal ring electrode 126 and distal tip electrode 128 with conductive ring element 110 and conductive connector pin 108 of the connector assembly 106. Thus, the teaching of Lessar would not result in “electrically insulating the very portions of Drbal intended to conduct, as such similar portions exist in Lessar which similarly retain their ability to conduct. Thus, contrary to Applicant’s argument, as both Lessar and Drbal are interested in and achieve conduction to serve to electrically couple articles through such wires, Lessar would not only teach anodizing the entirety of the ball wire of Drbal; therefore, the examiner maintains the combination is apt.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The Supreme Court in KSR reaffirmed the familiar framework for determining obviousness as set forth in Graham v. John Deere Co. (383 U.S. 1, 148 USPQ 459 (1966)), but stated that the Federal Circuit had erred by applying the teaching- suggestion-motivation (TSM) test in an overly rigid and formalistic way. KSR, 550 U.S. at ___, 82 USPQ2d at 1391. Specifically, the Supreme Court stated that the Federal Circuit had erred including “by holding that courts and patent examiners should look only to the problem the patentee was trying to solve ” (Id. at ___, 82 USPQ2d at 1397); Further when considering obviousness of a combination of known elements, the operative question is thus “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id . at ___, 82 USPQ2d at 1396. (MPEP 2441 I). In this case, prior art Lessar explicitly teaches wherein electrical insulation between multiple conductors and their associated electrodes is crucial for device operation, and wherein there exists a desire in the art to minimize lead diameter while maintaining proper insulation and integrity (See, for example, [0008]). This is not solely a problem faced by Lessar but a statement with respect to the prior art as a whole. Lessar further teaches flexible, high quality insulative oxide layer can predictably be provided by anodization of the metal leads results in a reduction in lead thickness, improved metal ion induced oxidation resistance, and radiopacity ([0016], [0034], [0046]). Contrary to Applicant’s assertion that Drbal only teaches a single ball wire (and further implying that such singularity would not necessitate electrical insulation), the examiner notes that Drbal has taught devices with a plurality of ball wires, and wherein such wires are interfacing and contacting numerous components of the overall device (see, for example, figures, [00114-00117], [00185]], thus, any / all of the various benefits explicitly taught and commonly understood as attributable to providing wire insulation would be relevant and applicable to Drbal. Thus, the examiner maintains combination of Drbal and Lessar is properly motivated and is apt.
As to the remaining dependent claims they remain rejected as no additional separate arguments are provided.
Conclusion
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 NATHAN H EMPIE whose telephone number is (571)270-1886. The examiner can normally be reached Monday-Thursday 5:30AM - 4 PM.
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/NATHAN H EMPIE/Primary Examiner, Art Unit 1712
