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/Restrictions
Applicant’s election without traverse of claims 1-7 in the reply filed on 11/11/2025 is acknowledged.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Rogers et al. (US 2012/0065503, hereinafter “Rogers”).
In regards to claim 1, Rogers discloses an implantable medical device (abstract; “[a] radiopaque marker for inclusion within an implantable medical device”), the device comprising:
a metal case (par. 0114; “an inner wall of the can of the implantable medical device, which may be formed from titanium or some other biocompatible metal”) having a hermetic seal (par. 0120; "the radiopaque is enclosed in a hermetic device”); and
an identification (ID) tag arranged within the sealed metal case (element 200; abstract; “[t]he radiopaque marker may serve to provide information such as the make, model, and feature set of the device”), wherein the ID tag is readable by X-raying the device (par. 0032; “device identification markers are x-ray visible”).
In regards to claim 2, the ID tag includes tungsten (par. 0054; “[i]n some embodiments, gold, platinum, platinum/iridium, titanium, tantalum, barium silicate or tungsten are used in forming the radiopaque marker”), and the metal case includes titanium (par. 0114; “an inner wall of the can of the implantable medical device, which may be formed from titanium”).
In regards to claim 3, the ID tag is a metal plate with alphanumeric characters cut out of the metal plate (par. 0091; “alphabetical characters,” “numerical characters”; Fig. 8; Fig. 15B).
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.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Fayram et al. (US 2018/0085593, hereinafter “Fayram”). Rogers discloses the essential features of the claimed invention, including a circuit board within the metal case (see above), wherein the ID tag is glued to the circuit board/attached to the circuit board without solder (par. 0037, “the marker may be embedded within or otherwise carried by a circuit board assembly”; par. 0114, “an adhesive may be used to further affix the radiopaque articles to the object”), and wherein the ID tag is a metal ID tag that includes tungsten (par. 0054, see above). Rogers does not expressly disclose that the circuit board is a printed circuit board (PCB) including FR4 epoxy or that the device is a leadless implantable medical device. However, Fayram in the same field of endeavor of implantable medical devices (abstract, “therapy…using an implantable medical device”) teaches providing the implantable device with a circuit board in the form of a printed circuit board (PCB) including FR4 epoxy (par. 0290, “[t]he ASIC 928 can be attached to the board 930 (e.g., a printed circuit board (PCB)), such as by using a flip-chip attachment. The material for the board 930 can be a glass-reinforced epoxy laminate comprising a composite material composed of woven fiberglass cloth with an epoxy resin binder that is flame resistant (e.g., FR4 material), aluminum nitride, polyimide, or the like and that the device is a leadless implantable medical device”; see also par. 0467) to provide the predictable results of a thin dielectric circuit substrate that is flame resistant and formable in layers (pars. 0290, 0467); and that the device is a leadless implantable medical device (par. 0326, “leadless implantable device”) to provide the predictable results of locating the device in close proximity to the anatomical target (pars. 0325-0326). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Rogers by providing the implantable device with a circuit board in the form of a printed circuit board (PCB) including FR4 epoxy to provide the predictable results of a thin dielectric circuit substrate that is flame resistant and formable in layers; and that the device is a leadless implantable medical device to provide the predictable results of locating the device in close proximity to the anatomical target.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prescott et al. (US 2020/0121417) is another example of a radiopaque ID tag within an implantable medical device housing (Fig. 6C).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792