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 I, Claims 1-13 in the reply filed on October 31, 2025 is acknowledged.
Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 statement (IDS) submitted on November 19, 2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-7 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piferi et al. (U.S. Patent Application Publication No. 20090112084; hereinafter “Piferi”).
Regarding claim 1, Piferi discloses a brain implant placement apparatus (100; annotated Fig. 3A below)), comprising:
a base member (110) having a bearing surface contoured to rest against a cranium of a patient proximal to an implant placement site (para. [0152]);
a pivot arm (120) hingedly coupled to the base member, wherein the pivot arm is configured to rotate from a first configuration to a second configuration (paras. [0147]-[0148]);
an implant attachment member (130) coupled to the pivot arm via a rotating attachment mechanism (paras. [0147], [0155]), wherein the implant attachment member comprises a receiving portion (204) configured to removably couple with a brain implant and rotate the brain implant (para. [0178]);
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wherein in the first configuration the pivot arm is positioned such that the receiving portion of the implant attachment member is facing substantially upwards, away from the cranium (e.g., yoke (120) has sufficient range of motion (para. [0147]) to be positionable such that tubular member (204) faces substantially upwards, away from a cranium); and
wherein in the second configuration the pivot arm is positioned such that the receiving portion of the implant attachment member is facing substantially downwards, toward the cranium (Figs. 3A-4, 17-18).
Regarding claim 2, Piferi discloses the apparatus further comprising:
a lowering assembly (Fig. 12) coupled to the implant attachment member, the lowering assembly including a lowering bolt (146) with screw threads (148), wherein in the second configuration the implant attachment member is moveable toward or away from the cranium (e.g., platform (130) moves toward or away from the cranium as it is rotated about pitch axis (PA); Fig. 12; para. [0155]).
Regarding claim 3, Piferi discloses the apparatus further comprising:
a mount attachment (210) removably coupled to the base member (via removable connection with tubular member (204); Figs. 20-26; par. [0180]), the mount attachment configured to couple to the cranium of the patient (e.g., via base (110) being coupled to a cranium), wherein the mount attachment comprises a nozzle holder (e.g., sheath (212) is capable of holding a nozzle sized and configured to pass through the sheath).
Regarding claim 4, Piferi discloses wherein the nozzle holder is moveable vertically relative to the mount attachment (Figs. 20-21; paras. [0180]-[0181]).
Regarding claim 5, Piferi discloses wherein the pivot arm further comprises:
a locking screw (142), wherein in the first configuration the locking screw fastens the pivot arm to the base member, preventing rotation of the pivot arm (e.g., when not being rotated, teeth of worm (142) engage thread pattern (118) to prevent rotation of the pivot arm; para. [0154]).
Regarding claim 6, Piferi discloses the apparatus further comprising:
a cover (132) removably attached to the pivot arm (e.g., support table (132) is capable of removable attachment to yoke (120) via its connection with platform (130); Fig. 19A) ; when the pivot arm is in the first configuration and configured to protect the brain implant (e.g., support table (132) is capable of preventing an external element from contacting a brain implant passing therethrough, thus protecting the brain implant).
Regarding claim 7, Piferi discloses wherein the cover further comprises:
a bullseye level (combination of markings (136, 137, 138); Fig. 19A) configured to measure a tilt of the brain implant (as indicators (138) and graduation scales (136, 137) provide visual indication of movement of plate (134; para. [0156]) and frame (100) is fixed relative to an instrument insertion hole (para. [0152]), then the markings (136, 137, 138) are capable of functioning as a bullseye level measuring tilt of a brain implant along a trajectory (A, D; Figs. 17-18)) .
Regarding claim 9, Piferi discloses further comprising:
the brain implant (230) removably coupled with the receiving portion of the implant attachment member (Fig. 25; para. [0186]);
a plurality of flexible electrodes (para. [0004]) electrically connected with the brain implant by a plurality of wires (“conductors;” para. [0004]); and
a cartridge (200) removably coupled to the brain implant (para. [0191]),
the cartridge configured to position each of the plurality of electrodes into a linear array (e.g., as arranged along the axis of device (230); Fig. 25).
Regarding claim 10, Piferi discloses wherein a pivot axis (RA; Fig. 3A; para. [0145]) of the pivot arm extends through the flexible electrodes (Figs. 3A and 26A).
Regarding claim 11, Piferi discloses wherein the cartridge further comprises:
an identification pattern on an external face of the cartridge (formed by fluid or segment thickness providing a high contrast MRI image; para. [0189]), the pattern configured to be scannable by a sensor of a computer and configured to provide the computer with the position of the plurality of electrodes (e.g., cannula (200) is capable of being scanned by an MRI scanner to indicate a position of electrodes within the cannula; para. [0189]).
Regarding claim 12, Piferi discloses wherein the base member further comprises:
attachment holes (114) for inserting screws to attach the base member to the cranium (Figs. 6-7; para. [0152]), the attachment holes being positioned to be accessible while the pivot arm is in the first configuration and the second configuration (Figs. 6-7).
Regarding claim 13, Piferi discloses the apparatus further comprising:
the screws (17; Fig. 6), dimensioned to be insertable into the attachment holes to secure the base member to the cranium, the screws being biocompatible (screws positioned through each aperture (114) are biocompatible as evidenced by their use to secure base (110) to biological skull tissue of a patient; para. [0152]).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Gowda et al. (U.S. Patent Application Publication No. 20150202011; hereinafter “Gowda”).
Regarding claim 8, the device of Piferi discloses the invention substantially as claimed except for the cover being transparent.
Gowda, a reference in the stereotactic device field of endeavor, teaches configuring a cover portion (102) of a frame (120) to be transparent to facilitate visualizing the frame and patients body underneath (para. [0064]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention configure the cover to be transparent such that the cover is configured to allow for positioning of the base member relative to the implant placement site, in view of Gowda, in order to facilitate accurate placement of the frame with respect to a burr hole in a patient’s skull.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wagner et al. (U.S. Patent Application Publication No. 20170296295) disclosing a hinged surgical placement device (Fig. 8);
Hasulak (U.S. Patent No. 8914118) disclosing a hinged brain implant placement device (Figs. 4A-7F); and
Gildenberg (U.S. Patent No. 5855582) disclosing a hinged stereotactic device (Figs. 2-3).
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