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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/03/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2025 is being considered by the examiner.
Status of Claims
Claims 1-15 are currently pending and under examination. As per the amendments filed on 11/03/2025, claims 1 and 6 are amended.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-8 (Regarding Independent Claim 1), filed 11/03/2025, with respect to the 35 U.S.C. § 103 rejection of claim 1 over Wengreen (US PG Pub 2011/0029027 A1) in view of Cinbis (US PG Pub 2015/0321012 A1) and Schibli (US PG Pub 2017/0136245 A1) have been fully considered. Regarding Claim 1, Applicant argues:
As amended, independent claim 1 recites "said electric conductor comprising an
electrode tip and an intermediate portion, wherein said intermediate portion is joined to said insulator so as to form a hermetic seal, ..." Support for this feature can be found at [0057] of Applicant's published application, reproduced below […] This is also shown in FIG. 4A, reproduced below […] None of the art cited by the PTO discloses this structural arrangement of a feedthrough pin having several distinct regions, with the intermediate portion being hermitically sealed. Thus, independent claim 1 is believed to be allowable over the cited art. Accordingly, Applicant respectfully requests withdrawal of the§ 103 rejections. (pages 7-8, 11/03/2025 Remarks)
This argument is not persuasive. This amendment to claim 1 in question (“said electric conductor comprising an electrode tip and an intermediate portion, wherein said intermediate portion is joined to said insulator so as to form a hermetic seal”) is an importation of an alternative limitation in claim 6 where the limitation is now required as part of claim 1. Wengreen teaches:
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. The area between the conductive wire 116 and the ferrule 156 is filled with a hermetic insulator 158 such as glass and/or other suitable material. ([0038])
Wengreen also teaches:
Feedthrough 150 can be inserted or placed through the housing 100. An example of a feedthrough 150 passing through an electrode may be seen with respect to U.S. Pat. No. 6,622,046 to Fraley et al. issued Sep. 16, 2003, and assigned to the assignee of the present invention, the disclosure of which is incorporated by reference in its entirety herein. ([0037])
Fraley (US 6622046 B2) teaches:
FIGS. 5A and 5B illustrate simple subcutaneous ECG electrode assemblies. FIG. 5A shows feedthrough conductor 75, mounted in ferrule 73 with optional welding notch 70 to accommodate the welding of the pacemaker casing (not shown) to ferrule 73. Glass insulator 85 joins feedthrough conductor 75 and ferrule 73. Preferably, feedthrough conductor 75 is machined to function as an ECG sensing electrode. P-8787, Thin Film Electrodes for Sensing Cardiac Depolarization Signals, by Guck et al, filed on Dec. 13, 2000, Ser. No. 09/736,046, disclosed a manufacturing process for conversion of feedthrough conductors to ECG electrodes. FIG. 5B displays brazed feedthrough 84 with a conductor 75 that is supported by insulator 76 and ferrule 73. These components are joined with gold braze 77. (col 9, lines 59-67 and col 10, lines 1-5, emphasis added)
Feedthrough conductor 75 fits through opening in insulator 76 to which it is joined by braze 77.
Insulator 76 maintains electrical isolation of the ECG signal as it circuits from sensing electrode 74 through feedthrough conductor 75 that is electrically connected to SEA circuitry within pacemaker 10. Braze 77 serves to hermetically seal the assembly and prevent the intrusion of body fluid that fills the cavity around electrode 74. (col 10, lines 23-29)
Wengreen teaches an in-between or intermediate conductor is surrounded by a hermetic insulation layer. Fraley, which has been incorporated in its entirety, teaches the glass hermetic insulator is joined to the conductor and ferrule via brazing where the brazing forms a hermetic seal. Given this, the amended limitations are taught by Wengreen. Therefore, the prior art rejection of claim 1 is maintained.
Applicant’s arguments, see Remarks page 9 (Regarding Dependent Claims 2-15), filed 11/03/2025, with respect to the 35 U.S.C. § 103 rejections of claims 2-15 have been fully considered. 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 believed allowable over the cited art and a separate discussion of them will not be belabored for the sake of brevity. (page 9, 11/03/2025 Remarks)
This argument is not persuasive. The rejection of claim 1 was maintained where the rejections of dependent claims 2-15 would similarly be maintained.
Summary: The 35 U.S.C. § 103 rejections of claims 1-15 are maintained. However, claims 1 and 5 have been modified based on the teachings of Fraley (incorporated into Wengreen) which read on subject matter previously provided by Schibli with the electrode attachment to the distal end of the conductor.
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 PG Pub 2011/0029027 A1, see 08/18/2022 IDS) in view of Cinbis (US PG Pub 2015/0321012 A1, see previously cited). Note Fraley (US 6622046 B2, see “Notice of References Cited”) 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 a 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”), wherein insulator is joined with said electric conductor ([0038] – “The area between the conductive wire 116 and the ferrule 156 is filled with a hermetic insulator 158 such as glass and/or other suitable material”), 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, 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);
- 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.
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. 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.
Therefore, Claim 1 is obvious over Wengreen in view of Cinbis.
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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, 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.
Cinbis, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0005]), teaches electrodes are potentially made of platinum, platinum/iridium, or titanium ([0109] – “In alternative embodiments, pacemaker 100 may include two or more ring electrodes or other types of electrodes exposed along pacemaker housing 150 for delivering electrical stimulation to heart 26. Electrodes 162 and 164 may be, without limitation, titanium, platinum, iridium or alloys thereof and may include a low polarizing coating, such as titanium nitride, iridium oxide, ruthenium oxide, platinum black among others”).
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, by incorporating the electrodes of defined conductive material composition 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 materials which can be used as conductors in an electrode in a feedthrough system. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the conductive electrode materials in Cinbis.
Therefore, Claim 3 is obvious over Wengreen in view of Cinbis.
Regarding Claim 4, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis, as indicated hereinabove. Wengreen further discloses an electric conductor comprises an intermediate portion joined to said insulator ([0038] – “area between the conductive wire 116 and the ferrule 156 is filled with a hermetic insulator 158 such as glass and/or other suitable material” where the intermediate portion can be seen in Figure 2 of this office action; 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), and a distal portion, protruding out of said insulator, 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 cross-section, which is 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).
Therefore, Claim 4 is obvious over Wengreen in view of Cinbis.
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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, 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).
Therefore, Claim 5 is obvious over Wengreen in view of Cinbis.
Regarding Claim 6, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis, as indicated hereinabove. Wengreen discloses said intermediate portion is also joined to a conductor extension (Fig. 5 - intermediate portion of conductive element 116 is connected to end 134), wherein said conductor extension 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 the 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.
Cinbis, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0005]), teaches an intermediate conductive material, such as a titanium ferrule, can be used to connect elements in the apparatus to the electronics module as an alternative to simply soldering directly between the element and electronics module ([0114] – “In one example, window 180 is a sapphire ring that is gold brazed to the control electronics subassembly 152, either directly or using a titanium ferrule that is welded to the control electronics subassembly, and to the battery assembly, either directly or indirectly using a second titanium ferrule that is welded to the battery subassembly 160”).
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 including an intermediate connection between a device element and electronics module 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 providing an intermediate connector between the proximal tip of the conductive wire and the electronics module to facilitate a stronger connection. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the intermediate connection between a device element and electronics module in Cinbis.
Therefore, Claim 6 is obvious over Wengreen in view of Cinbis.
Regarding Claim 12, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis, as indicated hereinabove. Wengreen fails to disclose a return (second) electrode.
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 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”).
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 as part of the housing 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 with an electrode as part of the housing. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Wengreen by incorporating the return electrode configuration as part of the housing in Cinbis.
Therefore, Claim 12 is obvious over Wengreen in view of Cinbis.
Regarding Claim 13, the implantable medical device in Claim 1 is obvious over Wengreen in view of Cinbis, 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.
Therefore, Claim 13 is obvious over Wengreen in view of Cinbis.
Regarding Claim 14, the implantable medical device in Claim 13 is obvious over Wengreen in view of Cinbis, 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.
Cinbis, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0005]), teaches the anchor structure (as described in Claim 13’s rejection) is 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).
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.
Therefore, Claim 14 is obvious over Wengreen in view of Cinbis.
Claims 7, 10-11, and 15 are rejected under U.S.C 103 as being unpatentable over Wengreen (US PG Pub 2011/0029027 A1, see 08/18/2022 IDS) in view of Cinbis (US PG Pub 2015/0321012 A1, see previously cited) and Schibli (US PG Pub 2017/0136245 A1, see 08/18/2022 IDS). Note Fraley (US 6622046 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, 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.
Therefore, Claim 7 is obvious over Wengreen in view of Cinbis and Schibli.
Regarding Claim 10, the implantable medical device in Claim 7 is obvious over Wengreen in view of Cinbis and Schibli, 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]), further teaches the flange (described in Claim 7’s rejection) is 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.
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.
Therefore, Claim 10 is obvious over Wengreen in view of Cinbis and Schibli.
Regarding Claim 11, the implantable medical device in Claim 7 is obvious over Wengreen in view of Cinbis and Schibli, 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]), with respect to the flange described in Claim 7’s rejection, 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]).
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.
Therefore, Claim 11 is obvious over Wengreen in view of Cinbis and Schibli.
Regarding Claim 15, the implantable medical device in Claim 14 is obvious over Wengreen in view of Cinbis, 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 (described in Claim 7’s rejection) for connecting the electrode assembly and 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 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.
Therefore, Claim 15 is obvious over Wengreen in view of Cinbis.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wengreen (US PG Pub 2011/0029027 A1, see 08/18/2022 IDS) in view of Cinbis (US PG Pub 2015/0321012 A1, see previously cited), and Zhou (US PG Pub 2004/0220652 A1, see previously cited). Note Fraley (US 6622046 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, 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.
Therefore, Claim 2 is obvious over Wengreen in view of Cinbis and Zhou.
Claims 8-9 are rejected under U.S.C 103 as being unpatentable over Wengreen (US PG Pub 2011/0029027 A1, see 08/18/2022 IDS) in view of Cinbis (US PG Pub 2015/0321012 A1, see previously cited), Schibli (US PG Pub 2017/0136245 A1, see 08/18/2022 IDS) and Kronmuller (EP 3069758 A1, see previously cited). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Kronmuller (EP 3069758 A1 - see previously attached for copy of the Description translation). Note Fraley (US 6622046 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 and Schibli, as indicated hereinabove. Wengreen fails to disclose a flange. Schibli teaches a flange ([0066]), as shown in the rejection for Claim 7, but fails to disclose 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.
Therefore, Claim 8 is obvious over Wengreen in view of Cinbis, Schibli, and Kronmuller.
Regarding Claim 9, the implantable medical device in Claim 8 is obvious over Wengreen in view of Cinbis, Schibli, and Kronmuller, as indicated hereinabove. Wengreen fails to disclose a flange. Schibli teaches a flange ([0066]), as shown in Claim 7, but fails to disclose at least one of the following:
(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.
Kronmuller, in the same field of endeavor of sensing and stimulation with an implantable feedthrough device ([0001]), teaches 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.
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.
Therefore, Claim 9 is obvious over Wengreen in view of Cinbis, Schibli, and Kronmuller.
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 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796