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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 16-21, drawn to medical device with a housing, electrodes and dielectric coating.
Group II, claim(s) 22-31, drawn to a method of manufacturing a medical device.
Group III, claim(s) 32-35, drawn to a method of manufacturing a medical device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I, II and III lack unity of invention because even though the inventions of these groups require the technical feature of a housing configured to house processing circuitry, wherein the processing circuitry is configured to control functioning of the implantable medical device, wherein the housing comprises: an electrically conductive portion defining a cavity configured to receive the processing circuitry; and a dielectric cover configured to cover the cavity and enclose the processing circuitry within the cavity; an electrode positioned on an outer surface of the dielectric cover and connected to the processing circuitry, wherein the processing circuitry is configured to monitor a physiological parameter of a patient via the electrode; and a biocompatible electrical insulator disposed on an outer surface of the dielectric cover, wherein the biocompatible electrical insulator is configured to not be disposed on the electrode, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Klimovitch et al. (2016/0250483). Klimovitch discloses a housing 310 having processing circuitry that controls sensing and stimulation (see elements 312, 332, 316 in Fig. 4; par. [0047])). Klimovitch discloses a metallic housing (par. [0029]) and electrodes 308 formed on said housing that can be used for stimulation, sensing and/or communication (par. [0047-0048]). Klimovitch further discloses layers of insulative material that can be layered (at least one insulator layer deposited over another as required by the claim) over some electrodes and completely absent over others (see Fig, 5, 6; par. [0012, 0039, 0058]; openings 408, 508. For instance, Klimovitch discloses embedding some electrodes within multiple insulative layers to control capacitance that is used to selectively steer a communication vector (thus these embedded electrodes are effectively antennas), see par. [0029, 0059]
During a telephone conversation with Nihal Parkar on 7/7/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 16-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 22-35 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Klimovitch et al. (2016/0250483).
Regarding Claims 16 and 17, Klimovitch discloses a housing 310 having processing circuitry that controls sensing and stimulation (see elements 312, 332, 316 in Fig. 4; par. [0047])). Klimovitch discloses a metallic housing (par. [0029]) and electrodes 308 formed on said housing that can be used for stimulation, sensing and/or communication (par. [0047-0048]). Klimovitch further discloses layers of insulative material that can be layered (at least one insulator layer deposited over another as required by the claim) over some electrodes and completely absent over others (see Fig, 5, 6; par. [0012, 0039, 0058]; openings 408, 508. For instance, Klimovitch discloses embedding some electrodes within multiple insulative layers to control capacitance that is used to selectively steer a communication vector (thus these embedded electrodes are effectively antennas), see par. [0029, 0059]
With regard to Claim 18, Klimovitch discloses sensing electrical activity of the heart with the sensing circuitry and electrodes (par. [0030])
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Reinke et al. (2018/0207429) in view of Klimovitch et al. (2016/0250483).
Regarding Claim 16, Reinke discloses an implantable medical device 81 having a housing 80 for housing processing circuitry (not shown but described in par. [0068, 0070, 0113-0114]) and wherein the housing 80 comprises an electrically conductive portion (formed of metal such as titanium) defining the cavity that holds the processing circuitry (par. [0070]); a dielectric cover 66 configured to cover the cavity and enclose the processing circuitry (par. [0070]); and an electrode 60A or 60B positioned on an outer surface of the dielectric cover and electrically connected to the processing circuitry that is configured to monitor a physiological parameter (Fig. 3, par. [0070. Reinke is silent regarding another insulative/dielectric layer on an outer surface of the dielectric cover and not disposed on the electrode. However, in the same field of endeavor of implantable medical devices having a leadless design with stimulation and sensing capability, Klimovitch discloses layering dielectric coatings (an insulative layer over a dielectric/insulating layer) over portions of the housing while leaving some electrodes exposed for the purpose of providing capacitive layers of controlled capacitance over the body of the device (par. [0028] ) and thus aiding in steering communications from antennas within the device along desired vectors (par. [0007, 0066]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Reinke reference to include multiple insulative layers stacked on each other, as taught and suggested by Klimovitch, for the purpose of providing capacitive layers of controlled capacitance over the body of the device and thus aiding in steering communications from antennas within the device along desired vectors.
In regard to Claims 19 and 20, Reinke discloses an insulator over a vast majority of the outer surface of the housing and not over the electrodes (Fig. 4) but fails to disclose encapsulating the entire housing with the insulative layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to extend the insulative covering to encapsulating all of the housing, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Doing so would provide the predictable result of electrically isolating the can from conductive fluids in the body.
With regard to Claim 21, Reinke discloses the electrical insulator can be parylene (par. [0084]).
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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