DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see applicant remarks, filed 11/21/2025, with respect to the rejection(s) of claim(s) 1,4-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stevenson et al (US 20200121935 A1); hereinafter Stevenson.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,5-8,10,11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bobgan et al (US20220111218A1); hereinafter Bobgan, Armstrong et al (US 20110288615 A1); hereinafter Armstrong (both cited previously), and Kreft et al (US20210008377A1); hereinafter Kreft (all cited previously) in view of Stevenson et al (US 20200121935 A1); hereinafter Stevenson.
Regarding claims 1 and 11, Bobgan teaches a medical device ([0004] implantable medical device), comprising:
a) a non-conductive housing ([0082] housing 404, [0060] non-conductive) having a housing sidewall comprising a housing sidewall thickness extending from a housing body fluid side surface to a housing device side surface, the housing sidewall extending from a proximal housing rim defining a housing open end (fig 4 part 406 open end) leading to an interior of the housing sidewall thickness and to a closed distal housing end (fig 4), wherein at least two vias extend through the housing sidewall thickness ([105] a feedthrough 622 may extend through the conduit 620 of the header 602 ), the proximal housing rim supports a housing metallization, and wherein a metallic flange ([0082] flange 424, brazed) is brazed to the proximal housing rim at the housing metallization (shown in figure below),
b) at least two spaced-apart electrodes ([0054] 2 electrodes 112 and 114) supported on the body fluid side surface of the non-conductive housing ([0005] header is made of non-conductive material so it would be obvious to make the housing non-conductive as well) and aligned with a respective one of the at least two vias ([0105] the number of feedthroughs 622 may be equal to the number of conduits 620 and the number of electrodes 616 may equal the number of feedthroughs 622 - the numbers of feedthroughs and conduits and electrodes being the same implies alignment);
c) a printed circuit board (PCB) assembly ([0117] internal circuitry) contained in the interior of the non-conductive housing, the PCB assembly comprising a printed circuit board supporting a plurality of electronic components (210,310, and/or 408);
d)… from the body fluid side surface to the device side surface of the non-conductive housing ([0005] header is made of non-conductive material so it would be obvious to make the housing non-conductive as well), wherein a body fluid side end of each of the at least two sintered platinum-containing conductive pathways is in electrical continuity with a respective one of the electrodes, and wherein a device side end of each of the at least two sintered platinum-containing conductive pathways is in electrical continuity with the PCB (internal circuitry) assembly; and
e) an electrical power source powering the PCB assembly ([0005] the feedthrough is configured to be coupled to internal circuitry housed within the IMD - obvious that internal circuitry must include a power source, parts 204,304,404),
the power source comprising a ceramic casing having a proximal casing rim supporting a casing metallization, wherein a metallic casing ferrule is brazed to the proximal casing rim at the casing metallization ([0082] end housing portion 416 so the IMD 400 forms a hermetically sealed package) to a metallic ferrule (coupling member 418).
f) wherein, with the electrical power source connected to the PCB assembly to power the plurality of electronic components, a weld secures the metallic casing ferrule of the power source to the metallic housing flange of the non-conductive housing (flange 424) to close the housing open end ([0082] discusses coupling the header with the housing to form a package) (fig. 3 shows that the outside of the housing can contact body fluids).
Bobgan fails to teach that the electrically conductive pathways contain platinum. Armstrong teaches at least two sintered platinum- containing electrically conductive pathways ([0117] solderable/brazeable materials - platinum is solderable/brazeable, [0117] - [0118] metallizations). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan with Armstrong because there is some teaching, suggestion, or motivation to do so. Armstrong teaches the circuit metallization may be connected to hermetically sealed vias that travel through the substrate to circuit pads on the opposite side of the substrate ([0117]). Therefore, the pathways have to be solderable/brazeable which aluminum is.
The combination of Bobgan and Armstrong fails to teach that the pathways are hermetically sealed directly to the thickness of the housing sidewall. Kreft teaches pathways extending through a respective one of the at least two vias and hermetically sealed directly to the thickness of the housing sidewall ([0058] an electrically insulating body 71 (for example out of a ceramic material) is connected, particularly brazed, to the metallic flange 50 to form a feed-through. A metallic pin 70 extends through and is connected, particularly brazed with, this body 71). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan and Armstrong with Kreft because there is some teaching, suggestion, or motivation to do so. Kreft teaches that the purpose of hermetically sealing the conductive pathways directly to the non-conductive material is “to connect the battery and electrical circuit housed in housing 5 to the electrode 7 ([0063])”.
The above combination fails to teach that the conductive pathways are hermitically sealed directly through a mutually conformal interface to the thickness of the housing sidewall from the body fluid side surface to the device side surface of the non-conductive housing. Stevenson teaches “the platinum fill forms a tortuous and mutually conformal knitline or interface between the alumina substrate and the platinum fill. The hermetically sealed and electrically conductive pathway may include a second hermetic seal between the platinum fill and the platinum insert, wherein the platinum fill forms a second tortuous and mutually conformal knitline or interface between the platinum fill and the platinum insert. At least a portion of an outer surface of the platinum insert may be forming the second tortuous and mutually conformal knitline or interface comprises a substantially irregular surface” ([0024]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination with Stevenson because there is some teaching, suggestion, or motivation to do so. Stevenson teaches that the mutually conforming interface allows the pathways to “interconnect with the already tortuous members prevalent in ceramic/particulate formation” ([0127]).
Regarding claims 5 and 14, the combination of Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1 and 11. Armstrong further teaches the at least two electrodes are made of platinum ([0121]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the generic electrodes of Bobgan with the platinum containing ones of Armstrong because there is some teaching, suggestion, or motivation to do so. Armstrong teaches that using platinum will “assure biocompatibility of the implantable device” ([0120]).
Regarding claims 6 and 13, the combination of Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1 and the medical device of claim. Armstrong further teaches each of the at least two electrodes is a ring-shaped electrode (fig 1 part 110). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan to make the electrodes ring shaped because this constitutes simple substitution of one known element for another to obtain predictable results. Ring electrodes and non-ring shaped electrodes can both sense physiological parameters and deliver stimulation. Therefore, substituting one for the other will not significantly affect the functioning of the device.
Regarding claim 7, the combination of Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1 however the combination fails to teach that one electrode is ring-shaped and the other is discrete but not ring-shaped. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan to make one electrode non-ring shaped because it is an obvious matter of design choice to make the electrodes of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claims 8 and 15, the combination of Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1 and the medical device of claim 11. Armstrong further teaches the power source is a rechargeable power source ([0072] rechargeable batteries). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan to include a power source because medical devices with electronic components require a power source to function and making it rechargeable will prevent challenges with removing an implanted device to change batteries.
Regarding claim 10, the combination of Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1. Bobgan further teaches the non- conductive housing is made of alumina ([0009]).
Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bobgan, Armstrong, Kreft, and Stevenson in view of Askarinya et al (US20120303105A1); hereinafter Askarinya (cited previously).
Regarding claim 4, Bobgan, Armstrong, Kreft, and Stevenson teaches the medical device of claim 1. The combination fails to teach the specific method of electrical connection between the conductive pathways and the PCB. Askarinya teaches a medical device wherein a solder or a leaf spring ([0090] electrical feedthroughs connected using soldering) electrically connects the PCB assembly ([0047] printed board (PB)) to the device side end of at least one of the at least conductive pathways in electrical continuity with a respective one of the at least two electrodes ([0047] PB 42 electrically connected to electrical feedthroughs). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan with the teachings of Askarinya because there is some teaching, suggestion, or motivation to do so. Askarinya teaches that these electrical feedthroughs “facilitate formation of a hermetic seal between the electrical feedthrough and the LCP outer housing and may substantially prevent moisture ingress into the interior (e.g., the space defined by the outer housing) of the IMD” ([0004]). Therefore, there at the time of the filing date of this invention, there was an established motivation to improve the method of electrically connecting electrodes to the PCB.
The combination of Bobgan and Askarinya fails to teach that the pathways contain platinum. Armstrong teaches two sintered platinum-containing [0117] solderable/brazeable materials - platinum is solderable/brazeable, [0117] - [0118] metallizations) pathways. ). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan and Askarinya with Armstrong because there is some teaching, suggestion, or motivation to do so. Armstrong teaches the circuit metallization may be connected to hermetically sealed vias that travel through the substrate to circuit pads on the opposite side of the substrate ([0117]). Therefore, the pathways have to be solderable/brazeable which aluminum is.
Regarding claim 12, the combination of Bobgan, Armstrong, and Kreft teaches the medical device of claim 11. The combination fails to teach the specific method of electrical connection between the conductive pathways and the PCB. Askarinya teaches a medical device wherein a solder or a leaf spring ([0090] electrical feedthroughs connected using soldering) electrically connects the PCB assembly ([0047] printed board (PB)) to the device side end of at least one of the at least two conductive pathways in electrical continuity with a respective one of the at least two electrodes ([0047] PB 42 electrically connected to electrical feedthroughs). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Bobgan, Armstrong, and Kreft with the teachings of Askarinya because there is some teaching, suggestion, or motivation to do so. Askarinya teaches that these electrical feedthroughs “facilitate formation of a hermetic seal between the electrical feedthrough and the LCP outer housing and may substantially prevent moisture ingress into the interior (e.g., the space defined by the outer housing) of the IMD” ([0004]). Therefore, there at the time of the filing date of this invention, there was an established motivation to improve the method of electrically connecting electrodes to the PCB.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bobgan, Armstrong, Kreft, and Stevenson in view of Schmidt et al (US 20190117973 A1); hereinafter Schmidt (cited previously).
Regarding claims 9 and 16, Bobgan, Armstrong, Kreft, and Stevenson teaches the devices of claim 8 and 15. They fail to teach a charging coil and circuit to convert RF or inductive energy into a direct current voltage. Schmidt teaches a charging coil ([0124] receiver coil) connected to a charging circuit ([0124] recharge circuit), wherein the charging circuit is configured to convert RF or inductive energy ([0124] transcutaneous recharging, communicate wirelessly, [0061] inductive energy receiver coil) received from the charging coil into a direct current voltage to charge the rechargeable power source powering the PCB assembly. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Bobgan with the charging coil of Schmidt because there is some teaching, suggestion, or motivation to do so. Schmidt discloses that that the coil interface allows for transcutaneous recharging of the medical device ([0079]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796