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 .
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 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.
Election/Restriction
Applicant’s election without traverse of Invention II in the reply filed on June 16, 2026 is acknowledged.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 16, 2024 and June 16, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 16-20 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 16 depends from claim 15 and recites “the contour of the bottom surface” in lines 2-3. However, claim 16 is unclear as to whether this bottom surface refers to the bottom surface of the medical device or the bottom surface of the medical device template recited in claim 15, thus rendering the claim indefinite. For examination purposes, claim 16 is interpreted as referring to the contour of the bottom surface of the medical device.
Claim 17 ultimately depends from claim 15 and recites “wherein the medical device template is a first medical device” in lines 1-2. However, claim 17 is unclear as to whether this limitation creates a positive structural recitation of the medical device recited in claim 15 or creates a recitation of an additional medical device, thus rendering the claim indefinite.
Claims 18-19 are rejected as being dependent upon rejected claim 17 and failing to remedy the indefiniteness issue.
Claim 20 depends from claim 15 and recites “the contour of the bottom surface” in line 2. However, claim 20 is unclear as to whether this bottom surface refers to the bottom surface of the medical device or the bottom surface of the medical device template recited in claim 15, thus rendering the claim indefinite. For examination purposes, claim 20 is interpreted as referring to the contour of the bottom surface of the medical device.
Claim Rejections - 35 USC § 102
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.
Claims 15, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swennen et al. (U.S. Patent No. 11147600; hereinafter “Swennen”).
Regarding claim 15, Swennen discloses a system, comprising a medical device template (4) for use to implant a medical device having a bottom surface with a periphery and a contour to follow an anatomical feature (as base body (4) is sized and configured to be capable of use for implanting a medical device col.5, ln. 52 – col. 6, ln. 21), such as another base body (4) or a cover device for an opening in a patient’s skull), wherein the medical device template includes a bottom surface (5) with a periphery and a contour that correspond to the periphery and the contour of the bottom surface of the medical device (col. 5, ll. 52-62), wherein the medical device template is configured to be positioned and orientated over the anatomical feature (Fig. 5; col. 7, ll. 22-26) to facilitate marking skin over the anatomical feature used to determine where to make an incision to implant the medical device (as base body (4) is sized and configured to be positioned on cranial bone to facilitate marking bone (col. 7, ll. 22-35), the base body has the dimensions and shape to be capable of positioning on skin on a patient’s skull to facilitate marking the skin over an anatomical feature used to determine where to make an incision to implant a medical device).
Regarding claim 16, Swennen discloses wherein the bottom surface of the medical device (e.g., another base body (4)) has at least a first plane (formed by lower side (5); Figs. 2-3) and a second plane (formed by the lower side of lugs (21); Figs. 2-4) that form an obtuse angle such that the contour of the bottom surface is at least partially defined by the first plane, the second plane and the obtuse angle (Figs. 2-4).
Regarding claim 20, Swennen discloses wherein the medical device (e.g., another base body (4)) is configured to be subcutaneously implanted over a skull (Figs. 11-12; col. 7, ll. 42-60), and the contour of the bottom surface corresponds to a contour of the skull (col. 7, ll. 8-11).
Claims 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dhanasingh et al (U.S. Patent No. 9788914; hereinafter “Dhanasingh”).
Regarding claim 15, Dhanasingh discloses a system (Figs. 2A-2B), comprising a medical device template (including processor template (206) and stimulator template (208)) for use to implant a medical device having a bottom surface with a periphery and a contour to follow an anatomical feature (col. 4, ll. 14-29), wherein the medical device template includes a bottom surface (e.g., surface facing toward the patient’s head) with a periphery and a contour that correspond to the periphery and the contour of the bottom surface of the medical device (col. 4, ll. 14-29), wherein the medical device template is configured to be positioned and orientated over the anatomical feature to facilitate marking skin over the anatomical feature used to determine where to make an incision to implant the medical device (col. 5,ln. 63 – col. 6, ln. 9).
Regarding claim 16, Dhanasingh discloses the system wherein the medical device template is sized and configured (Figs. 2A-2B; col. 4, ll. 14-29) to be capable of use for implanting a medical device wherein the bottom surface of the medical device has at least a first plane and a second plane that form an obtuse angle such that the contour of the bottom surface is at least partially defined by the first plane, the second plane and the obtuse angle (Examiner notes that claim 16 depends from claim 15 and recites further limitations of the medical device which is merely functionally recited in claim 15).
Regarding claim 17, Dhanasingh discloses they system further comprising a frame (203) configured to be positioned on a subject (Figs. 2A-2B; col. 5, ln. 63 – col. 6, ln. 9), the frame including an adjustable attachment (col. 4, ll. 30-39) for attaching to the medical device (the flexible attachment connecting head piece (203) with templates (206, 208) is dimensioned and structured to be capable of attaching to a medical device having similar shape and dimensions as the templates (col. 4, ll. 14-29), wherein the adjustable attachment of the frame is configured to enable the medical device to be repositioned and reoriented with respect to the frame that is positioned on the subject (col. 4, ll. 30-39).
Regarding claim 18, Dhanasingh discloses wherein the medical device template is a first medical device (the templates (206, 208) are capable of functioning as a device relating to or concerned with the practice of medicine), the system further comprising at least one additional medical device template including a second medical device template (col. 4, ll. 14-29), wherein the frame includes corresponding adjustable attachments for each of the at least one medical device template (col. 4, ll. 30-39).
Regarding claim 19, Dhanasingh discloses wherein the frame is configured to be worn on a head, the frame and the adjustable attachments being configured for use to bilaterally position and orientate the medical device templates against the head symmetrically to a midline passing through an inion and above a nuchal ridge (Figs. 2A-2B; col. 4, ll. 1-4).
Regarding claim 20, Dhanasingh discloses the system wherein the medical device template is sized and configured (Figs. 2A-2B; col. 4, ll. 14-29; col. 5, ln. 63 – col. 6, ln. 9) to be capable of use for implanting a medical device wherein the medical device is configured to be subcutaneously implanted over a skull, and the contour of the bottom surface corresponds to a contour of the skull (Examiner notes that claim 20 depends from claim 15 and recites further limitations of the medical device which is merely functionally recited in claim 15).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mooney (U.S. Patent No. 4957124) disclosing a template for making a person’s face.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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