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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/16/2026 has been entered. Claims 11-14 and 17-18 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 2/16/2026 canceling claim 16 and amending claim 18 to clarify the language the 112 rejections made against claims 16 and 18 in the office action of 10/29/2025 have been withdrawn.
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) 11-14 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 7,047,082 to Schrom (Schrom) (previously cited) in view of US 2018/0229031 to Searfoss et al. (Searfoss), US 2010/0234929 to Scheuermann (Scheuermann) (previously cited) and US 2013/0184550 to Forslund et al. (Forslund) (previously cited).
In reference to at least claim 11
Schrom discloses a method of manufacturing a lead for an active implantable medical device (e.g. lead, Fig. 1) comprising: forming a multi-lumen elongated, biocompatible, electrically non-conductive body, the body having a center section between a first portion at a proximal end and a body extension at a distal end (e.g. first portion near end 40, a center section containing lead body 12 and a body extension near tip 16, Fig. 1), locating a plurality of electrical connectors at the first portion (e.g. conductive contact rings 44,46, 48,50, Fig. 1, Col. 6, ll. 30-39; apply contact rings, Fig. 8), wherein each of the electrical connectors are electrically connected to respective electrically conductive filaments (e.g. conductive contact rings 44,46, 48,50, connected to plurality of electrical conductors formed within the wall of the body member, 20,22,24,26, Figs. 1-2, Col. 4, ll. 21-41, Col. 6, ll. 30-39), locating the plurality of electrically conductive filaments through the lumens of the elongated body (e.g. electrical conductors 20,22,24 and 26 within the lumens of the body member 12, Fig. 2, spiral wound conductors, embed conductors, Fig. 8); forming a plurality of electrodes separately from the plurality of electrically conductive filaments (e.g. apply multi-layer, thin film electrodes to tubing, Fig. 8, “Using the method set out in the aforereferenced Champeau patent application, multiple electrodes are vacuum-deposited onto the proximal and distal end portions of the lead, with suitable masking techniques being used to establish the respective lengths and shape configurations of the electrodes and the spaces therebetween.”, Col. 7, ll. 41-46; “the conductive links joining the conductors 20 26 to the thin film electrodes 32 are identified by numeral 38.”, Col. 5, ll. 63-67)); locating each of the separately formed plurality of electrodes at a second portion of the elongated body (e.g. electrodes 28,30, 32,34 are located at a second portion of the elongated body, Fig. 1), wherein the second portion is between the center section and the body extension (e.g. electrodes 28,30, 32,34 are located between a center section containing lead body 12 and a body extension near tip 16), connecting the plurality of electrodes to the electrically conductive filaments, the plurality of electrodes being connected via corresponding plurality of electrically conductive filaments to corresponding electrical connectors (e.g. conductive contact rings 44,46, 48,50, connected to plurality of electrical conductors formed within the wall of the body member, 20,22,24,26 and electrodes 28,30, 32,34, Figs. 1-2, Col. 4, ll. 21-41, Col. 6, ll. 30-39; “the conductive links joining the conductors 20 26 to the thin film electrodes 32 are identified by numeral 38.”, Col. 5, ll. 63-67), wherein the plurality of electrically conductive filaments include corresponding filament extension sections in the body extension that extend towards the distal end beyond a most distal electrode of the plurality of electrodes (e.g. plurality of electrical conductors 20,22,24,26 extend from proximal end 14 to distal end 16 therefore the conductors extend past the most distal electrode 34, Fig. 1 Col. 4, ll. 28-32)., wherein the filament extension sections are configured to move a reflection point of electromagnetic wave excited along the lead away from the most distal electrode (e.g. plurality of electrical conductors 20,22,24,26 extend from proximal end 14 to distal end 16 therefore the conductors extend past the most distal electrode 34 within the “body extension”, Fig. 1 Col. 4, ll. 28-32, therefore the filament extension sections are configured to “move a reflection point of electromagnetic wave excited along the lead away from the most distal electrode”, Fig. 9, 10b,10d).
Regarding the electrodes being separately formed from the elongated body and the plurality of filaments and subsequent to forming the plurality of electrodes locating the electrodes at a second portion of the elongated body, Schrom discloses that manufacturing using pre-formed band electrodes is known within the art and has use in widespread applications despite their functional design and performance limitations (e.g. “The use of pre-formed metallic band electrodes manufactured from noble metals, such as gold or platinum and various other conductive alloys has found widespread application despite their functional design and performance limitations.”, Col. 1, ll. 44-54). Therefore, it would have been well within the level of ordinary skill in the art to utilize pre-formed band electrodes as the separately formed electrodes when manufacturing the lead in applications that do not require steerability and selective placement. Alternatively, Searfoss discloses a manufacturing method that includes forming a lead that includes an elongated biocompatible body (e.g. elongated tubular body 101 of medical device 100, Figs. 1-3) that has a plurality of electrically conductive filaments (e.g. 110), locating the plurality of electrically conductive filaments through lumens of the elongated body (e.g. conductors 110 are located within lumen of tubular body 106, Figs. 1-2, “Electrical conductors 110 extend through the interior lumen 106 of tubular body 101. Each electrical conductor 110 is operatively associated with one of electrode rings 108.”, para. [0030]); forming a plurality of electrodes separately from the plurality of electrically conductive filaments (e.g. electrode rings 108, Figs. 1-3), subsequent to forming the plurality of electrodes locating each of the separately formed plurality of electrodes at a portion of the elongated body (e.g. electrodes rings 108 are placed on the tubular body 1010, Figs. 1-3) and connecting the plurality of electrodes to the electrically conductive filaments (e.g. “Electrical conductors 110 extend through the interior lumen 106 of tubular body 101. Each electrical conductor 110 is operatively associated with one of electrode rings 108.”, para. [0030]). Searfoss discloses that the electrodes and construction techniques disclose provide improved integrity and reliability while reducing electromagnetic induction and interference (e.g. “reduce the electromagnetic induction and interference of implantable electrical devices, conductors and electrodes.”, para. [0008]) and ensure reliable connection of the electrode rings and conductors that avoids ingress of water or other bodily fluids (e.g. “embodiments of the present invention provide for adhesive materials and methods of adhering conductors 110 to electrode rings 108 that overcome the challenges previously presented.”, para. [0035], [0040]). Therefore, it would have been obvious to one having ordinary skill in the art to modify the method of Schrom to include separately forming from the elongated body and the plurality of filaments the electrodes as ring electrodes made from bismuth, pyrolytic graphite and/or highly ordered pyrolytic graphite (HOPG) and subsequent to forming the plurality of electrodes locating the electrodes at a second portion of the elongated body and connecting the plurality of electrodes to the electrically conductive filaments, as taught by Searfoss, in order to provide construction techniques of the implantable lead that provide improved integrity and reliability while reducing electromagnetic induction and interference and ensure reliable connection of the electrode rings and conductors that avoids ingress of water or other bodily fluids (e.g. ‘031, para. [0035], [0040]).
Regarding the filament extension section being configured to move a reflection point, as stated within the specification “The purpose of the body extension 11 is to extend the electrically conductive filaments 5, by a Length L4 of the filament extension section 13, past the most distal electrode 10 of the plurality of electrodes 8. The Length L4 moves the reflection point 16 of an electromagnetic wave propagating along the lead 1 away from the most distal electrode 10.” see para. [0061]. It is the length of the body extension with the filaments which extends past the most distal electrode that moves the reflection point of an electromagnetic wave propagating along the lead away from the most distal electrode, therefore Schrom which discloses a plurality of electrical conductors 20,22,24,26 extending from proximal end 14 to distal end 16, i.e. extend past the most distal electrode 34 within the “body extension” (e.g. Fig. 1 Col. 4, ll. 28-32) would be configured to “move a reflection point of electromagnetic wave excited along the lead away from the most distal electrode”. Schrom further discloses the conductors being embedded within the body 12 (e.g. Fig. 2, Col. 4, ll. 21-41), therefore the lead body 12 disclosed within Schrom has the conductors being embedded within “lumens” of the lead body. Alternatively, it was well-known in the art before the effective filing date of the claimed invention to form lumens within the lead body and then feed the conductors within the lumens to form a medical electrical lead as evidence by Scheuermann (e.g. para. [0003]) or Forslund (e.g. conductors introduced into lumens, para. [0014],[0016], [0054]), therefore it would have been well within the level of ordinary skill in the art to form the lumens within the body and then feed the conductors within the lumens as such technique was well-known within the art for forming medical electrical leads.
In reference to at least claim 12
Schrom further discloses sizing each of the plurality of electrically conductive filaments to a common overall length (e.g. plurality of electrical conductors having a common overall length 20,22,24,26, Figs. 1-2, Col. 4, ll. 21-41).
In reference to at least claim 13
Schrom further discloses extruding the biocompatible, electrically non-conductive material with the multi-lumens (e.g. extruder to form the body member, Col. 7, ll. 6-15).
In reference to at least claim 14
Schrom further discloses sealing an end of the body extension to insulate the filament extension sections (e.g. plurality of electrical conductors 20,22,24,26 extending from the proximal to distal end are buried or submerged within polymer insulating them from one another, therefore the conductors have a “seal” at the “body extension”, Col. 4, ll. 28-36; the polymer is a suitable medical grade polymer “biocompatible, electrically non-conductive”, Col. 4, ll. 14-16).
In reference to at least claim 17
Schrom further discloses wherein the step of locating the plurality of electrodes comprises positioning each of the electrodes to surround the plurality of conductive filaments (e.g. “apply multi-layer, thin-film electrodes to tubing”, Fig. 8, these multi-layer, thin-film electrodes which are applied surround the conductive filaments, Figs. 1 and 3). Additionally, modification of Schrom with Searfoss includes positioning each of the electrodes to surround the plurality of conductive filaments (e.g. ‘031, Figs. 1-2, “Electrical conductors 110 extend through the interior lumen 106 of tubular body 101. Each electrical conductor 110 is operatively associated with one of electrode rings 108.”, para. [0030]), see further details in the rejection of claim 11 above.
In reference to at least claim 18
As recited above, Schrom discloses that manufacturing using pre-formed band electrodes is known within the art and has use in widespread applications despite their functional design and performance limitations (e.g. “The use of pre-formed metallic band electrodes manufactured from noble metals, such as gold or platinum and various other conductive alloys has found widespread application despite their functional design and performance limitations.”, Col. 1, ll. 44-54). Therefore, it would have been well within the level of ordinary skill in the art to utilize pre-formed band electrodes for manufacturing the lead in applications that do not require steerability and selective placement. Alternatively, modification of Schrom with Searfoss includes forming each of the plurality of electrodes into a ring electrode (e.g. ‘031, electrode rings 108, Figs. 1-3), see further details in the rejection of claim 11 above.
Response to Arguments
Rejections under 35 USC 102
Applicant’s arguments, see pg. 5, filed 2/16/2026, with respect to claims 1,4-10 and 15 using Schrom have been withdrawn in view of the cancellation of claims 1,4-10 and 15 within the claim amendment received on 2/16/2026.
Rejections under 35 USC 103
Independent claim 11
Applicant’s argues “ the recited method includes forming the electrodes separately from the elongated body and the plurality of electrically conductive filament and, subsequent to forming the electrodes, locating each of the separately formed electrodes at a second portion of the elongated body…For example, those features recited in claim 11 are not disclosed by Schrom. Rather, Schrom discloses (via Champeau) depositing metallic layers onto the proximal and distal end portions, where the deposited electrodes bond to conductive links formed in tunnels in the lead body to electrically connect the conductors and the electrodes”, see pg. 6-7 of response filed 2/16/2026, the examiner respectfully disagrees. It is noted that the rejection has been updated in view of the claim amendments. As stated within the rejection above, Schrom discloses that manufacturing using pre-formed band electrodes is known within the art and has use in widespread applications despite their functional design and performance limitations (e.g. “The use of pre-formed metallic band electrodes manufactured from noble metals, such as gold or platinum and various other conductive alloys has found widespread application despite their functional design and performance limitations.”, Col. 1, ll. 44-54). Therefore, it would have been well within the level of ordinary skill in the art to utilize pre-formed band electrodes as the separately formed electrodes when manufacturing the lead in applications that do not require steerability and selective placement. Alternatively, Searfoss discloses a manufacturing method that includes forming a lead that includes an elongated biocompatible body (e.g. elongated tubular body 101 of medical device 100, Figs. 1-3) that has a plurality of electrically conductive filaments (e.g. 110), locating the plurality of electrically conductive filaments through lumens of the elongated body (e.g. conductors 110 are located within lumen of tubular body 106, Figs. 1-2, “Electrical conductors 110 extend through the interior lumen 106 of tubular body 101. Each electrical conductor 110 is operatively associated with one of electrode rings 108.”, para. [0030]); forming a plurality of electrodes separately from the plurality of electrically conductive filaments (e.g. electrode rings 108, Figs. 1-3), subsequent to forming the plurality of electrodes locating each of the separately formed plurality of electrodes at a portion of the elongated body (e.g. electrodes rings 108 are placed on the tubular body 1010, Figs. 1-3) and connecting the plurality of electrodes to the electrically conductive filaments (e.g. “Electrical conductors 110 extend through the interior lumen 106 of tubular body 101. Each electrical conductor 110 is operatively associated with one of electrode rings 108.”, para. [0030]). Therefore, it would have been obvious to one having ordinary skill in the art to modify the method of Schrom to include separately forming from the elongated body and the plurality of filaments the electrodes as ring electrodes made from bismuth, pyrolytic graphite and/or highly ordered pyrolytic graphite (HOPG) and subsequent to forming the plurality of electrodes locating the electrodes at a second portion of the elongated body and connecting the plurality of electrodes to the electrically conductive filaments, as taught by Searfoss, in order to provide construction techniques of the implantable lead that provide improved integrity and reliability while reducing electromagnetic induction and interference and ensure reliable connection of the electrode rings and conductors that avoids ingress of water or other bodily fluids (e.g. ‘031, para. [0035], [0040]).
Dependent claims 12-14 and 17-18
Applicant does not provide separate arguments for dependent claims 12-14 and 17-18, therefore claims 12-14 and 17-18 appear to be addressed above with regards to claim 11.
Conclusion
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/JENNIFER L GHAND/ Examiner, Art Unit 3796
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