1. Applicant’s election without traverse of Group V (claims 46-62, drawn to a jig) in the reply filed on 8/1/2025 is acknowledged. Claims 1-45 and 63-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
2. Claim 2 is objected to because of the following informalities: “wherein reference guide” should be ---wherein the reference guide--- to correct a minor typographical matter. Appropriate correction is required.
3. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the stand of claim 50 must be shown or the feature(s) canceled from the claim(s). The reference guide comprising a guide channel of claim 57 in combination with the offset of claim 57’s parent claim 46 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
4. 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 57 and 60 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 57 recites the limitation "the direction set by the tool aligning device" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 60 recites the limitation "the profiled hole" in line 3. There is insufficient antecedent basis for this limitation in the claim.
5. 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 46-49 and 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmieding et al. (US 2003/0229354; “Schmieding” herein).
Regarding claim 46, Schmieding discloses a jig (e.g. 50) for setting the depth of insertion of a surgical tool into a patient during surgery, the jig comprising: a tool aligning device (e.g. 54); a representative datum (e.g. 69) representing a stereoguide datum; and a reference guide (e.g. 56) moveable relative to the representative datum to set a baseline length from the representative datum to a datum surface (e.g. 61) on the reference guide; wherein the reference guide comprises at least one offset (e.g. 59) from the datum surface configured to receive a surgical tool extending from the tool aligning device; and wherein the depth of insertion of the surgical tool when used in surgery on a patient is set (e.g. via 63) on the jig by the distance from the representative datum to the offset.
Regarding claim 47, Schmieding discloses the tool aligning device comprises the representative datum (e.g. 54 comprises 69).
Regarding claim 48, Schmieding discloses a target datum (e.g. 58), representing a target position with respect to a stereoguide datum as used in a chosen stereotactic system or arrangement.
Regarding claim 49, Schmieding discloses the reference guide is moveable (e.g. by means of 51), and the representative datum fixed (e.g. 69 is fixed relative to 51; Fig. 13).
Regarding claim 58, Schmieding discloses the tool aligning device is configured to receive (e.g. via bore 67) a pilot drill (e.g. a pilot drill less than a diameter of bore 67; para. [0079]; para. [104]) for creating a pilot hole in a bone.
Claims 46, 57, and 59-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Assal et al. (US 6200327; “Assal” herein).
Regarding claim 46, Assal discloses a jig (e.g. 20) for setting the depth of insertion of a surgical tool into a patient during surgery, the jig comprising: a tool aligning device (e.g. 33); a representative datum (e.g. 34) representing a stereoguide datum; and a reference guide (e.g. 36) moveable relative to the representative datum to set a baseline length from the representative datum to a datum surface on the reference guide; wherein the reference guide comprises at least one offset (e.g. one of orifices 38) from the datum surface configured to receive a surgical tool extending from the tool aligning device; and wherein a depth of insertion of the surgical tool when used in surgery on a patient is set (e.g. using 40) on the jig by the distance from the representative datum to the offset.
Regarding claim 57, Assal discloses the reference guide comprises at least one guide channel (e.g. at least one of orifices 38) extending therethrough, for passage of a surgical tool (e.g. a tool with diameter just under 1.6 mm; col. 4, lines 23-25), the guide channel extending from the datum surface and continuing in a direction set by the tool aligning device.
Regarding claim 59, Assal discloses the reference guide comprises a hole (e.g. one of orifices 38 which has inside diameter 1.6 mm; col. 4, lines 23-25) capable of receiving a surgical guide hub (e.g. a surgical hub with diameter just under 1.6 mm) for implanting in an aperture formed in a skull and made along a trajectory to a brain target, wherein the guide hub includes: a through-bore for delivering a device therethrough and along the trajectory; at least one first formation on an external surface for securing the hub within the aperture in a skull; and at least one second formation on the surface of the through-bore for securing a guide device, an implantable device, or a cap to the hub. Claim interpretation: This claim does not require a surgical guide hub, only the capability of being used with a surgical guide hub.
Regarding claim 60, Assal discloses the reference guide includes a guide channel (e.g. one of orifices 38) therethrough for passage of a surgical tool through the reference guide and a surgical hub to be located in a profiled hole (e.g. a tool or hub of diameter just under 1.6mm; col. 4, lines 23-25). Claim interpretation: This claim does not require a surgical hub, only a guide channel that is capable of passage of a surgical hub.
Claims 46 and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiGiovanni et al. (US 12478370; “DiGiovanni” herein).
Regarding claim 46, DiGiovanni discloses a jig (e.g. 300) for setting the depth of insertion of a surgical tool into a patient during surgery, the jig comprising: a tool aligning device (e.g. a first one of blades 100); a representative datum (e.g. a surface of one of blades 100) representing a stereoguide datum; and a reference guide (e.g. a second one of blades 100) moveable relative to the representative datum to set a baseline length from the representative datum to a datum surface on the reference guide; wherein the reference guide comprises at least one offset (e.g. 118) from the datum surface configured to receive a surgical tool (e.g. having dimensions set forth in col. 5, lines 1-3) extending from the tool aligning device; and wherein the depth of insertion of the surgical tool when used in surgery on a patient is set (e.g. along 334) on the jig by a distance from the representative datum to the offset.
Regarding claim 61, DiGiovanni discloses a moveable cutting or depth measuring guide (e.g. a third one of blades 100) disposed further from the tool aligning device than the reference guide and for adjusting to a selected length or cutting to a selected length a surgical tool or tool part extending from the datum surface through the moveable reference guide.
Regarding claim 62, DiGiovanni discloses the moveable cutting or depth measuring guide comprises a bar (e.g. 102) parallel (e.g. Fig. 5) to both the aligning device and the reference guide and having a guide surface (e.g. a surface near θ per Fig. 1 or a surface that defines 118 per Fig. 1) for engaging with the distal end of a surgical tool or tool part.
6. Claims 50-56 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
7. The following is an examiner’s statement of reasons for allowance or the indication of allowable subject matter: In an exemplary prior art reference, Schmieding discloses an apparatus involving a jig (e.g. 50), a tool aligning device (e.g. 54), a representative datum (e.g. 69), and a reference guide (e.g. 56), but fails to disclose at least a stand and relationships thereof as claimed; and/or a bar, slots/grooves, and relationships thereof as claimed. There would have been no obvious reason(s) to modify the Schmieding apparatus to satisfy at least this/these and/or each of applicant’s claimed limitations, as such modification(s) would have likely rendered the Schmieding apparatus incapable of continuing to operate/behave in the particular manner set forth within the Schmieding reference, which would have been strongly indicative of an application of impermissible hindsight reasoning. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN A. SEVILLA whose telephone number is (571)270-5621. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIAN A SEVILLA/ Primary Examiner, Art Unit 3775