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 .
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.
Claim 17 is 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 17 recites the limitation "the recess.” There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-13 & 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cleary et al. (EP 3,858,284).
Cleary et al. discloses:
1.
A stabilizing frame comprising: a base extending at least 180 degrees about an axis of the stabilizing frame to define a reception area;
E.G. via the disclosed patient stabilization system 102 comprising a robot system 102 and robot base 126 that is secured directly to the stabilization system via a linking arm 204 {[0008] & (Fig 2)}.
a plurality of anchors mounted relative to the base, wherein the plurality of anchors are configured to be embedded within a skull of a patient;
E.G. via the disclosed patient fixation apparatus 128 that is fixed to the robot base 126 via the disclosed linking arm {[0008] & (Fig 2)}.
and a registration fiducial mounted relative to the base, the registration fiducial comprising a recess configured to receive a distal tip of a registration probe of a robot.
E.G via the disclosed one or more tracking markers 208 that is directly associated with the fixation apparatus 128, such as a stereotactic frame {[0009] & (Fig 2)}.
2.
The stabilizing frame of claim 1, further comprising a plurality of arms mounted to the base, wherein each arm of the plurality of arms comprises a segment extending away from the base in a direction of the axis.
E.G. via the disclosed patient fixation apparatus 128 that is displaced on each side of the patient’s head, wherein said fixation apparatus 128 is relative to stabilization arm 306 {[0021] & (Figs 1-2)}.
3.
The stabilizing frame of claim 2, wherein a corresponding anchor of the plurality of anchors is mounted to a distal end portion of each arm of the plurality of arms.
E.G. via the disclosed adaptor 310 which is configured to attach to the distal portion 312 of said stabilization arm and further configured to attach to the patient fixation apparatus 128 {[0030] & (Fig 5)}.
4.
The stabilizing frame of claim 2, wherein each arm of the plurality of arms is adjustable relative to the base in the direction of the axis.
E.G. via the disclosed adaptor 310 which is configured to attach to the fixation apparatus 128 and at least one pivot joint 314 {[0022] & (Fig 3)}.
5.
The stabilizing frame of claim 2, wherein the registration fiducial is mounted relative a first arm of the plurality of arms.
E.G via the disclosed patient tracking device 212 that further includes one or more tracking markers 208 that is directly associated with the fixation apparatus 128, such as a stereotactic frame {[0009] & (Fig 2)}.
6.
The stabilizing frame of claim 5, wherein the registration fiducial is adjustably mounted relative to the first arm the direction of the axis.
E.G. {[0009] & (Fig 2)}.
7.
The stabilizing frame of claim 1, wherein the registration fiducial is adjustably mounted relative to the base.
E.G. {[0009] & (Fig 2)}.
8.
The stabilizing frame of claim 7, wherein the registration fiducial is adjustably mounted relative to the base in a direction of the axis.
E.G. {[0009] & (Fig 2)}.
9.
The stabilizing frame of claim 1, further comprising a bracket mounting the registration fiducial relative to the base.
E.G. via the disclosed patient tracking device 212 and the adaptor 310 which is adapted to be secured directly to the patient via the fixation apparatus 128 ([0009] & [0021]).
10.
The stabilizing frame of claim 9, further comprising a plurality of arms mounted to the base, wherein the bracket mounts the registration fiducial to a first arm of the plurality of arms.
E.G. {[0009] & (Fig 3)}.
11.
The stabilizing frame of claim 10, wherein the bracket is adjustably mounted relative to the first arm in a direction of the axis.
E.G. {[0009] & (Fig 3)}.
12.
The stabilizing frame of claim 11, wherein the bracket is adjustably keyed to the first arm for selective adjustable mounting in the direction of the axis.
E.G. via the disclosed patient stabilization system 102 actuation the locking mechanism 318 {[0023]-[0024] & (Fig 4)}.
13.
The stabilizing frame of claim 9, wherein the bracket is adjustably mounted relative to the base in a direction of the axis.
E.G. {[0023]-[0024] & (Fig 4)}.
17.
The stabilizing frame of claim 1, wherein the recess comprises an opening facing a direction of the axis.
E.G. see Fig 3 & 4
18.
The stabilizing frame of claim 1, wherein the recess comprises an opening facing an outward direction that is perpendicular to a direction of the axis.
E.G. see Fig 3 & 4
19.
The stabilizing frame of claim 1, wherein the recess of the registration fiducial comprises a spherical inner surface segment.
E.G. ([0009] & [0021]).
20.
A method of positioning a patient's head relative to a robot for a surgical procedure comprising:
E.G. via the disclosed patient stabilization system 102 to be utilized in a medical, cranial procedure [0003].
positioning a patient's head and/or neck within a reception area of a stabilizing frame comprising a registration fiducial;
E.G via the disclosed one or more tracking markers 208 that is directly associated with the fixation apparatus 128, such as a stereotactic frame, via an adaptor 310 {[0009] & (Fig 2)}.
anchoring the stabilizing frame to a skull of the head to removably fixedly attach the stabilizing frame to the skull;
removably fixedly attaching the stabilizing frame to the robot to prevent the head from moving relative to a body of the robot;
E.G. via the disclosed locking mechanism configured to selectively restrain movement of the stabilization base, wherein said locking mechanism 318 is configured to actuate between a secured and unsecured state [0023]-[0024] & (Fig 3)}.
and inserting a tip of a probe of the robot into a recess of the registration fiducial.
E.G. via the disclosed patient tracking device 212 that is secured and/or a part of the fixation apparatus 128, which is further secured by the adaptor 310 such that the stabilization system 102 is rigid in a secured state {[0009], [0022] & (Fig 3)}.
Claim Objections
Claims 14-16 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, as cited, fails to disclose, suggest and/or teach the claimed invention since the reference(s) are silent in regards to a stabilizing frame comprising a bracket comprises a plurality of apertures configured to selectively receive a shank of the registration fiducial.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796