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
Claims 1-15 are currently pending and under examination. As per the amendments filed on 06/19/2026, claims 1 and 4 are amended.
Priority
The instant application (filed on 08/18/2022) is a national stage of PCT/EP2021/054086 (filed on 02/19/2021), filed under 35 USC 371. Acknowledgment is made of Applicant's claim for foreign priority based on application EP 20159226.8 (filed on 02/25/2020). Amended claims 1-15 are adequately supported in the foreign application to receive an effective filing date of 02/25/2020 for the instant application. Therefore, all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant's arguments, see Remarks page 7-9 (35 U.S.C. § 103 Rejections), filed 06/19/2026, with respect to the rejections of claims 1-15 under 35 USC § 103 been fully considered. Regarding independent claim 1, Applicant argues:
As amended, independent claim 1 recites: "wherein said electric conductor comprises a proximal portion inside of the housing and a distal portion outside of the insulator or the housing, wherein the intermediate portion is at least partly brazed to the insulator, wherein the distal portion is welded to the electrode tip, and wherein the proximal portion comprises a conductor extension brazed to the intermediate portion joined to a first terminal element in form of a bump comprising a solderable material ... "
An exemplary embodiment encompassed but this structure is described in, [0061] of Applicant's published application and illustrated in FIG. 4A:
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The PTO admits that Wengreen fails to disclose a connection to an electronics module, but alleges that Cinbis does. (See Office Action, Items 21-22, p. 11). Even if this characterization of Cinbis is accurate, which is not admitted, there is no disclosure in Wengreen or Cinbis regarding a conductor extension including the first terminal element, let alone a conductor extension brazed to an intermediate portion joined to a first terminal element in form of a bump.
Schibli, Zhou and Kronmuller fail to cure the deficiencies noted above with respect to Wengreen and Cinbis. Accordingly, independent claim 1 is submitted to be allowable over the cited art, whether considered individually or in any combination, and Applicant respectfully requests withdrawal of the§ 103 rejections. (06/19/2026 Remarks, pages 8-9)
This argument is persuasive. The Examiner agrees that neither Wengreen nor Cinbis fully discloses the amended limitation “wherein the proximal portion comprises a conductor extension brazed to the intermediate portion joined to a first terminal element in form of a bump comprising a solderable material.” Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Seitz (US 2018/0126175 A1).
Regarding dependent claims 2-15, Applicant argues:
Dependent claims 2-15 depend cognately from independent claim 1, and add further structural features which further remove the presently claimed invention from the cited art. Given at least the distinctions identified above with respect to independent claim 1, dependent claims 2-15 are allowable over the cited art and a separate discussion of them will not be belabored for the sake of brevity. (06/19/2026 Remarks, page 9)
This argument is persuasive. The rejection of claim 1 was withdrawn, so the rejections for dependent claims 2-15 are similarly withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Seitz (US 2018/0126175 A1).
Summary: The 35 U.S.C. § 103 rejections of claims 1-15 are withdrawn. New 35 U.S.C. § 103 rejections for claims 1-15 newly in view of Seitz are added.
Claim Objections
The following claims are objected to because of the following informalities:
• Claim 6: The “a conductor extension” would be better represented as “the conductor extension” to better establish this is the same conductor extension from claim 1.
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 1-15 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 1: The limitation “wherein the proximal portion comprises a conductor extension brazed to the intermediate portion joined to a first terminal element in form of a bump comprising a solderable material” renders the claim indefinite as it is unclear whether the conductor extension or intermediate portion is joined to the first terminal element. Based on Applicant’s argument when describing instant Figure 4A, the conductor extension is currently being interpreted as joined to the first terminal element.
Claims 2-15 are rejected for being dependent on rejected claim 1.
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 non-obviousness.
Claims 1, 3-6, and 12-14 are rejected under U.S.C 103 as being unpatentable over Wengreen (US 2011/0029027 A1) in view of Cinbis (US 2015/0321012 A1) and Seitz (US 2018/0126175 A1). Note Fraley (US 6,622,046 B2) is incorporated into Wengreen by reference in its entirety (see Wengreen [0037]).
Regarding Claim 1, Wengreen discloses an implantable medical device ([0002]), comprising:
• a housing with an electric feedthrough ([0036] – “Electrode assembly 110 includes an electrode with a feedthrough 150 such that feedthrough 150 secures an electrode 120 to the external surface of the housing 100 of IMD 10”), wherein said electric feedthrough comprises an insulator and an electric conductor extending through said insulator ([0038] – “Feedthrough 150 typically comprises a feedthrough ferrule 156, a conductive wire or pin 116, and a feedthrough insulator 158” where Fig. 5 shows the conductive wire passing through the insulator), said electric conductor comprising an electrode tip (Figure 1 of this office action: The end of the conducting wire is interpreted as a conductive tip; [0049] – describes the connection between the electrode and conductive wire) and an intermediate portion extending through the insulator (Fig. 5 – conductor 116 passes through the hermetic insulator 158 in one section), wherein said intermediate portion is joined to said insulator so as to form a hermetic seal (Fraley: col 9, lines 59-67 and col 10, lines 1-5 – the hermetic glass insulator is joined via brazing to an intermediate portion of the conductor and the ferrule; col 10, lines 23-29 – the braze forms a hermetic seal);
wherein said electric conductor further comprises a proximal portion inside of the housing (Fig. 5, [0036-0038] – internal end 134 of the proximal conductor is inside the feedthrough’s housing), and a distal portion outside of the insulator or the housing (Fig. 5, [0036-0040] – the distal surfaces of electrode 120 and conductor 116 (distal end 136) are in exposed to body tissue and outside the insulator cup 130 or insulator 158 and housing 100), wherein the intermediate portion is at least partly brazed to the insulator (Fraley: col 9, lines 59-67 and col 10, lines 1-5 – the hermetic glass insulator is joined via brazing to an intermediate portion of the conductor and the ferrule; col 10, lines 23-29 – the braze forms a hermetic seal), wherein the distal portion is welded to the electrode tip ([0049] – “FIG. 10E depicts a conductive wire 116 that was trimmed to be about flush with the surface of the electrode 120 and then welded to the electrode 120”),
• a first electrode ([0036] – “Electrode assembly 110 includes an electrode with a feedthrough”) configured to contact a body tissue, wherein the first electrode further is configured to deliver electric pulses to said body tissue and/or to sense electric pulses from said body tissue ([0035] – “To sense signals from tissue of, for example, the heart and/or deliver electrical stimuli to tissue, a low profile surface electrode assembly 110 can be connected to housing 100 of a variety of differently shaped IMDs”);
• a second sense electrode (Claim 15 – “a second sense electrode coupled with the sensing circuitry to enable sensing of electrical signals of the body”)
wherein said first electrode is formed by said electric conductor of said electric feedthrough and said electrode tip ([0038] – “A conductive element 116 runs through a hole in about the middle of the ferrule 156 such that an external end 136 (or T-shaped end) is coupled or connected to the electrode 120 while internal end 134 is connected to the electronics”; [0049] – “FIG. 10E depicts a conductive wire 116 that was trimmed to be about flush with the surface of the electrode 120 and then welded to the electrode 120”), wherein said electrode tip is a separate component joined to said electrical conductor (Fraley: col 11, lines 41-63 – a sensing electrode is attached to the tip of the conductor via the attachments shown in Figures 11A-11F).
While Wengreen’s naming conventions separately identify an electrode facing the tissue (electrode 120, Fraley: electrode disk 80) and an electrical conductor (conductive wire 116, Fraley: feedthrough conductor 75), these two conductive components in electrical contact (part of the electrode assembly) have an equivalent structure as the electrode defined in the instant application (see Figure 1 of this office action). The end of the conducting wire in Wengreen ([0049] - electrode and conducting wire facing patient tissue) is interpreted as a conductive tip. Wengreen discloses two electrodes to complete the sensing circuit (Claim 15), but does not explicitly teach the second electrode as a return electrode. Wengreen fails to disclose:
a second electrode configured to act as a return electrode for said first electrode, and
wherein the proximal portion comprises a conductor extension brazed to the intermediate portion joined to a first terminal element in form of a bump comprising a solderable material.
Cinbis, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0005]), teaches a second electrode configured to act as a return electrode for the first electrode ([0141] – “Pulse generator 452 delivers one or more pacing pulses via electrode 462 and a return anode electrode, e.g., a ring electrode (not shown) around housing 450 or any portion or the entirety of housing 450) in response to the Pout signal from control module 406”). Cinbis teaches “Pacemaker 100 includes electrodes 162 and 164 spaced apart along the housing 150 of pacemaker 100. Electrode 164 is shown as a tip electrode extending from a distal end 102 of pacemaker 100, and electrode 162 is shown as a ring electrode along a mid-portion of housing 150, for example adjacent proximal end 104” ([0109]) with the ring electrode acting as a return electrode to complete the circuit ([0141]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device featuring at least two electrodes by incorporating the return electrode configuration used as an anode in relation to the cathode tip electrode in Cinbis. This would have been obvious because both Wengreen and Cinbis discuss implantable feedthrough devices for sensing and stimulation and Cinbis provides a solution/improvement for completing the circuit back to the pulse generator. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the cathode/anode configuration with the anode return electrode in Cinbis.
Seitz, in the same field of endeavor of a hermetically sealed implantable feedthrough device (Abstract), teaches the conductive path can be constructed from multiple conductive portions, such as lead wires 118 (body fluid side), 118’ (device side), and 117 (intermediate lead wire), which are co-brazed, co-welded, or both (Fig. 8, [0213]). Seitz further teaches: “In general, body fluid side lead wires 118 must be of biocompatible, non-toxic and biostable materials. This limits the materials to platinum, palladium, niobium, tantalum, titanium and equivalents or combinations thereof” ([0213]). Lead wire 118’ does not need to be biocompatible since it is completely contained within the hermetic seal on the device side ([0216]). Seitz teaches:
Referring once again to FIG. 8, it will be appreciated that the device side leadwire 118' can now be of very low cost materials, including copper, tin, or the like. This leadwire 118' could be a solid wire, can be a stranded wire, can be a braided wire and the like. It will be appreciated that, in the prior art, a high cost platinum-iridium or palladium wire would be in a single piece all the way to the device side to the body fluid side […] The novel two part co-welded or co-brazed leadwires of the present invention, allow one to then use very low cost leadwires 118' on the inside of the device or the device side, which route a filter feedthrough assembly 116 to device electronics circuits, including a circuit board 126, as previously illustrated in FIG. 2. [0216]
Note that titanium can form oxide layers which render it nearly impossible for solder to be used without a gold braze intermediary ([0275]). Fig. 24T shows how a solderable metallization 119’’ can be used to extend lead wire 117 to connect with the internal electronics ([0275-0276]). Claim 5 lists types of electrically conductive materials: “wherein the first electrically conductive material is selected from the group consisting of a solder, a solder BGA, a solder paste, an epoxy, and a polyimide.” Use of a solder ball grid array (BGA) to form a connection would be considered a solder bump.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device with a single conductive element by incorporating (1) the separation of the conductor into multiple components, which are brazed together, and (2) using a BGA on a compatible metal to connect to the internal electronics in Seitz. Both Wengreen and Seitz discuss a feedthrough with a conductive wire and Seitz provides a solution/improvement of a cheaper/disposable proximal metal lead wire (which does not need to be biocompatible since it is within the hermetic seal) to attach to the internal electronics. Seitz also provides a solution/improvement of a solderable element on the terminal metallic wire to connect to the internal electronics, which is useful because Wengreen does not disclose the details of how this connection between the conductive element and internal electronics module is established and the connection provides a degree of flexibility for soldering to a variety of internal connections. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating (1) Seitz’s conductor wire made of multiple discrete components into the conductive wire of Wengreen and (2) Seitz’s solderable BGA (bump) onto the proximal end of the conductive wire in Wengreen.
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Figure 1 – Comparison of the electrode and conductive wire in Wengreen and the electrode/conductor in the instant application (Modifications by Examiner in Red)
Regarding Claim 3, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen discloses a surface electrode connected to the feedthrough ([0038]), but Wengreen does not disclose the material composition of the electrode conductor or tip.
As stated in claim 1, the proposed combination with Seitz yields a conductive wire broken into constituent segments which are brazed together where an inexpensive and common metal segment serves as a proximal extension of the intermediate conductor segment. The intermediate segment 117 and body fluid side 118 can be made of “platinum, palladium, niobium, tantalum, titanium and equivalents or combinations thereof” ([0213]) while the proximal extension segment can be made of “very low cost materials, including copper, tin, or the like” ([0216]).
Regarding Claim 4, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen further discloses wherein said distal portion at least partly has a larger diameter than said intermediate portion (Figure 2 of this office action – where electrode 120’s and tip 136’s cross-section, which are situated out of the insulator which contacts the intermediate portion of conductive wire 116, has a larger diameter than conductive wire 116’s cross section).
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Figure 2 – Modified Figure 5 in Wengreen (Modifications by Examiner in Red)
Regarding Claim 5, the implantable medical device in Claim 4 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen discloses said distal portion comprises a circumferential protrusion having a larger diameter than said intermediate portion (Figure 5, [0038] – “A conductive element 116 runs through a hole in about the middle of the ferrule 156 such that an external end 136 (or T-shaped end) is coupled or connected to the electrode 120 while internal end 134 is connected to the electronics”; Fraley: col 11, lines 41-63 – the conductor passes through an electrode disk where the electrode disk has a greater diameter than the conductor in Figure 11F) and
- a distal tip having a smaller diameter than said circumferential protrusion, wherein said electrode tip comprises a receptacle configured to receive said distal tip (Fraley: col 11, lines 41-63 – a distal end of a conductor passing through the electrode disk in Figure 11F presents an interface to be received by the proximal attachable electrode receptables in Figures 11B-11D; col 10, lines 31-47 – increases in electrode surface area are desired to increase the accuracy of the measurement via the electrode), or
- a distal receptacle configured to receive a proximal protrusion of said electrode tip (Fraley: col 11, lines 41-63 – a proximal end of a sensing electrode is attached to the distal tip of the conductor via the attachments shown in Figures 11B-11D).
Regarding Claim 6, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen discloses said intermediate portion is joined to an electronic module comprised within said housing (Fig. 5, [0038] – “A conductive element 116 runs through a hole in about the middle of the ferrule 156 such that an external end 136 (or T-shaped end) is coupled or connected to the electrode 120 while internal end 134 is connected to the electronics”), and wherein said proximal portion of said electric conductor comprises a proximal tip ([0038] - 134 is the proximal tip of the conducting wire), and said electronic module is joined with said electric conductor ([0038]). Wengreen does not disclose (1) the conductor extension from claim 1 as an intermediary between the intermediate portion and electronic module and (2) electronic module is joined with said electric conductor via a first terminal element, having a receptacle configured to receive said proximal tip, wherein said first terminal element is solderable.
As stated in claim 1, the proposed combination with Seitz yields a conductive wire broken into constituent segments which are brazed together where an inexpensive and more common metal segment serves as a proximal extension of the intermediate conductor segment. The connection between the conductive lead wires and internal electronics are established via soldering, where a BGA serves as a solder bump to establish a connection between the proximal lead wire segment and internal electronics in a manner where the connection can be changed via additional soldering.
Regarding Claim 12, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen fails to disclose a return (second) electrode.
As stated in claim 1, the proposed combination with Cinbis yields a second electrode configured to act as a return electrode for the first electrode which is part of the housing ([0141] – “Pulse generator 452 delivers one or more pacing pulses via electrode 462 and a return anode electrode, e.g., a ring electrode (not shown) around housing 450 or any portion or the entirety of housing 450 in response to the Pout signal from control module 406”).
Regarding Claim 13, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen further discloses a securing assembly to facilitate electrode contact with the patient’s tissue ([0039] – “securing assembly 302 supports and/or connects electrode assembly 110 to housing 100. In one or more embodiments, securing assembly 302 comprises an insulator cup 130 and a bracket 310 that are configured to conform to the housing of IMD 10, 150 and 190, respectively … Domed-shaped securing assembly 302 also helps push the electrodes 160 away from the housing 180 and into the patient's 12 tissue”). Wengreen fails to disclose an anchor structure comprised of a base ring connected to tines.
Cinbis, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0005]), teaches an anchor structure configured to anchor said implantable medical device in a body tissue ([0139] – “Tip electrode 462 is urged against or proximate the heart chamber wall by fixation tines 466. As such, distal face 402 will be oriented in a generally outward direction from the heart chamber blood pool, toward the thoracic wall”), wherein said anchor structure comprises a plurality of tines and a base ring, wherein said plurality of tines is arranged at said base ring, (Figure 8A, [0138-0139] - tines 466 are attached to a ring structure embedded in distal face 402) and wherein said plurality of tines and said base ring are integrally formed in one piece (Figure 8A, [0138-0139] - tines 466 and the distal surface 402 form one piece as part of the pacemaker structure).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device with the attachment mechanism made of tines attached via a base ring in Cinbis. This would have been obvious because both Wengreen and Cinbis discuss mechanisms to establish contact between the electrode and patient tissue and Cinbis provides a solution/improvement for attachment which involves direct mechanical restraint. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the attachment mechanism made of tines attached via a base ring in Cinbis.
Regarding Claim 14, the implantable medical device in Claim 13 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen further discloses a securing assembly to facilitate electrode contact with the patient’s tissue ([0039]). Wengreen fails to disclose the anchor structure is attached to said implantable medical device by a retention component.
As stated in claim 13, the proposed combination with Cinbis yields the anchor structure maintained within the overall implantable medical device by a retention component (Figure 8A, [0138-0139] - tines 466 are attached to a ring structure embedded in distal face 402 where the ring and tines are integrated and held within the device structure by a retention mechanism).
Claims 7, 10-11, and 15 are rejected under U.S.C 103 as being unpatentable over Wengreen (US 2011/0029027 A1) in view of Cinbis (US 2015/0321012 A1), Seitz (US 2018/0126175 A1), and Schibli (US 2017/0136245 A1). Note Fraley (US 6,622,046 B2) is incorporated into Wengreen by reference in its entirety (see Wengreen [0037]).
Regarding Claim 7, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen discloses a securing assembly to connect the electrode assembly to the housing ([0039] – “A securing assembly 302 supports and/or connects electrode assembly 110 to housing 100. In one or more embodiments, securing assembly 302 comprises an insulator cup 130 and a bracket 310 that are configured to conform to the housing of IMD 10, 150 and 190, respectively. For example, FIG. 7 shows that securing assembly 302 surrounds domed-shaped electrodes 160, which prevents electrodes 160 from inadvertently electrically shorting to the pill-shaped hermetic housing 180”) with a securing assembly diameter similar to the housing diameter (Figure 7 - compare the securing assembly 302 diameter with housing). Wengreen does not specifically disclose a flange joined to the housing.
Schibli, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0020]), teaches a flange which is welded to the housing ([0066] – “the first component comprises an attachment flange comprising a flange opening; wherein the flange opening comprises the second component; wherein the second component is a frame comprising a frame opening; wherein the electrode penetrates the frame opening. The attachment flange is preferably fitted into an opening of the housing and welded into place”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device by incorporating the flange in Schibli. This would have been obvious because both Wengreen and Schibli discuss implantable feedthrough devices featuring electrodes for sensing and stimulation and Schibli provides a solution/improvement in a flange for better attachment between the electrode assembly and housing. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the flange in Schibli.
Regarding Claim 10, the implantable medical device in Claim 7 is obvious over Wengreen in view of Cinbis, Seitz, and Schibli, as indicated hereinabove. Wengreen fails to disclose a flange.
As stated in claim 7, the proposed combination with Schibli yields a flange which is welded to the housing ([0006]). The flange configured to receive a part of the housing ([0184] – “The housing 105 is electrically conductive. The housing is made of a biocompatible titanium alloy for medical purposes (available from Hempel Special Metals AG). An attachment flange 110 is welded into a housing opening. The attachment flange 110 is made of a biocompatible titanium alloy for medical purposes (available from Hempel Special Metals AG”). The term “receive” is interpreted broadly in the sense that contact and connection between the flange and housing could be considered as receiving a part of the housing.
Regarding Claim 11, the implantable medical device in Claim 7 is obvious over Wengreen in view of Cinbis, Seitz, and Schibli, as indicated hereinabove. Wengreen fails to disclose a flange.
As stated in claim 7, the proposed combination with Schibli yields a flange which is welded to the housing ([0006]). Schibli further teaches the housing and flange are of or comprise the same material, namely titanium or a titanium alloy ([0184] – “The housing 105 is electrically conductive. The housing is made of a biocompatible titanium alloy for medical purposes (available from Hempel Special Metals AG). An attachment flange 110 is welded into a housing opening. The attachment flange 110 is made of a biocompatible titanium alloy for medical purposes (available from Hempel Special Metals AG”). Note that Wengreen discloses the housing as able to be made of titanium ([0028]).
Regarding Claim 15, the implantable medical device in Claim 14 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen fails to disclose a flange.
Schibli, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0020]), teaches a flange which is welded to the housing ([0066] – “the first component comprises an attachment flange comprising a flange opening; wherein the flange opening comprises the second component; wherein the second component is a frame comprising a frame opening; wherein the electrode penetrates the frame opening. The attachment flange is preferably fitted into an opening of the housing and welded into place. The frame is preferably fitted into the flange opening and soldered into place”). The retention component (the ring and tines in Cinbis as displayed in Figure 8A) would be maintained within the inner electrode assembly, which would then be fitted onto the housing via the flange (Schibli – Figure 8 where the flange is 110 and allows for attachment between the electrode assembly and housing).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device by incorporating the flange in Schibli. This would have been obvious because both Wengreen and Schibli discuss implantable feedthrough devices featuring electrodes for sensing and stimulation and Schibli provides a solution/improvement in a flange for better attachment between the electrode assembly and housing. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the flange in Schibli.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wengreen (US 2011/0029027 A1) in view of Cinbis (US 2015/0321012 A1), Seitz (US 2018/0126175 A1), and Zhou (US 2004/0220652 A1). Note Fraley (US 6,622,046 B2) is incorporated into Wengreen by reference in its entirety (see Wengreen [0037]).
Regarding Claim 2, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis and Seitz, as indicated hereinabove. Wengreen discloses a surface electrode connected to the feedthrough ([0038]), where the “electrode 120 can be coated with iridium oxide to increase the surface area” ([0036]). However, Wengreen fails to disclose the electrode tip is coated with iridium or titanium nitride, wherein the coating has a thickness in the range of 1 µm to 10 µm.
Zhou, in the same field of endeavor of sensing and stimulation with an implantable stimulation device (such as a pacemaker – [0004]), teaches an electrode tip with a coating of iridium oxide or titanium nitride (Abstract - “An implantable electrode and method for manufacturing the electrode wherein the electrode has a strong, adherent surface coating of iridium oxide or titanium nitride on a platinum surface”) with an at least 1 micron coating thickness (Claim 13 – “wherein said surface coating has a thickness of at least 1 micron”). The at least 1 micron coating would fall within the 1 µm to 10 µm coating thickness range according to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Zhou teaches: “An implantable electrode and method for manufacturing the electrode wherein the electrode has a strong, adherent surface coating of iridium oxide or titanium nitride on a platinum surface, which demonstrates an increase in surface area of at least five times when compared to smooth platinum of the same geometry” (Abstract). Zhou also teaches: “Numerous types of cardiac pacing and defibrillation electrodes have been developed with these factors in mind, utilizing various configurations and materials asserted to promote lower stimulation thresholds and to improve electrical efficiencies. Thus, for implantable electrode applications, it is desirable to minimize the electrical impedance at the electrode-tissue interface by increasing the intrinsic surface area of the electrode or by reducing formation of the capsule of inactive tissue that surrounds and isolates the electrode from living tissue” ([0007]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device, which does not disclose electrode material composition but does disclose an electrode surface coating, by incorporating the electrode coating in Zhou. This would have been obvious because both Wengreen and Zhou discuss implantable devices featuring electrodes for sensing and stimulation and Zhou provides a solution/improvement for electrode coating which can increase electrode surface area (thereby enhancing signal quality). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the electrode coating in Zhou.
Claims 8-9 are rejected under U.S.C 103 as being unpatentable over Wengreen (US 2011/0029027 A1) in view of Cinbis (US 2015/0321012 A1), Seitz (US 2018/0126175 A1), Schibli (US 2017/0136245 A1) and Kronmuller (EP 3,069,758 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Kronmuller (EP 3,069,758 A1 - see previously attached for copy of the Description translation). Note Fraley (US 6,622,046 B2) is incorporated into Wengreen by reference in its entirety (see Wengreen [0037]).
Regarding Claim 8, the implantable medical device in Claim 7 is obvious over Wengreen in view of Cinbis, Seitz, and Schibli, as indicated hereinabove. Wengreen fails to disclose a flange.
As stated in claim 7, the proposed combination with Schibli yields a flange which is welded to the housing ([0006]). However, Schibli fails to teach at least one ground contact joined to said flange.
Kronmuller, in the same field of endeavor of an implantable feedthrough device ([0001]), teaches a flange featuring a ground contact ([0001] – “a feedthrough flange surrounding the insulating body and at least one connection element penetrating the insulating body for the external connection of an electrical or electronic component of the device”) where the ground contact can be welded to the flange or housing ([0005] – “The electrical connection between the housing and the circuit board is created after welding or soldering the ground pin on the circuit board and welding the flange to the housing. Alternatively, the ground connection is made by means of a pin, which is mounted in a blind hole during assembly and soldered to the flange using a high-temperature soldering process. The electrical connection through the housing is created after soft-soldering the feedthrough on the circuit board and welding the flange to the housing”).
Kronmuller teaches “the electronic/electrical functional units inside the device must be connected to the external electrodes or electrode lead connections in a manner that ensures absolutely and permanently reliable function under the specific conditions of the implanted state. The connectors or electrode lines can also be used to specifically measure electrical impulses and stimuli in the patient's body and to record or evaluate them over a longer period of time in order to select an individually adapted therapy and to check the success of the treatment” ([0003]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Wengreen’s implantable feedthrough device by incorporating the ground contact in a flange in Kronmuller. This would have been obvious because both Wengreen and Kronmuller discuss implantable feedthrough devices featuring electrodes for sensing and stimulation and Kronmuller provides a solution/improvement to ensure a continuous connection for electrical sensing in an implantable device. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the ground contact in a flange in Kronmuller.
Regarding Claim 9, the implantable medical device in Claim 8 is obvious over Wengreen in view of Cinbis, Seitz, Schibli, and Kronmuller, as indicated hereinabove. Wengreen fails to disclose a flange.
As stated in claim 7, the proposed combination with Schibli yields a flange which is welded to the housing ([0006]). However, Schibli fails to teach:
(1) the flange comprises a protrusion, and said at least one ground contact is joined to said protrusion via a second terminal element having a receptacle configured to receive said protrusion, wherein said second terminal element is solderable, or
(2) said flange comprises a receptacle configured to receive a second terminal element, and said at least one ground contact is joined to said flange via said second terminal element, wherein said second terminal element is solderable, or
(3) said flange is joined to a flange extension, and said at least one ground contacted is joined to said flange via said flange extension, wherein said flange comprises a receptacle configured to receive said flange extension, or
(4) said flange is joined with said at least one ground contact via a second terminal element, wherein said second terminal element is solderable.
As stated in claim 8, the proposed combination with Kronmuller yields a flange featuring a ground contact ([0001]) where the flange is joined ([0008] – “Alternatively, the ground connection is integrated with the other contact elements by means of brazing”) to a flange extension where at least one ground contact is joined to the flange via the flange extension ([0015] – “Furthermore, the invention includes the aspect that the feedthrough flange has at least one prepunched and bent and/or folded and/or deep-drawn sheet metal part, in particular made of a titanium sheet or titanium alloy sheet. Finally, in combination with the two aforementioned aspects, it is proposed that the sheet metal part has an integrally formed extension which is designed as a ground connection surface”). Note this corresponds to limitation option 3 above.
Conclusions
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights