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 § 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.
(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.
Claim(s) 1-2, 4, 7-16, 18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melkent (U.S. Pub. No. 2019/0365476 A1, hereinafter “Melkent”).
Melkent discloses, regarding claim 1, a method for treating a spine (see para. [0008]), the method comprising the steps of: inserting a surgical instrument (16) into a tissue cavity (20d, see Fig. 3B, see para. [0045]), the surgical instrument including an image guide (56) oriented relative to a sensor (82) to communicate a signal representative of a position of the surgical instrument relative to the tissue cavity (see paras. [0019]-[0020]); displaying a selected configuration (e.g. geometry of distal end, see para. [0047]) with a distal end (244) of the surgical instrument in the tissue cavity (see para. [0047]); tracking movement of the selected configuration in the tissue cavity with a tracking device (40) that communicates with a processor (70) to generate data for display of the movement (see para. [0056]); and determining a volume of the tissue cavity based on the data (see para. [0046]).
Regarding claim 2, wherein the selected configuration includes a sphere (see para. [0047]).
Regarding claim 4, wherein the selected configuration includes a first dimension, a second dimension and a third dimension (see para. [0047], note that a sphere is three dimensional and therefore has first, second and third dimensions).
Regarding claim 7, wherein the step of tracking includes movement in a plane of the tissue cavity (see para. [0048] “moved through the void”, note that the vertebral disc and therefore the void are within a plane).
Regarding claim 8, wherein the step of tracking includes movement in a first dimension, a second dimension and a third dimension of the tissue cavity (see para. [0047], note that a sphere is three dimensional and therefore has first, second and third dimensions).
Regarding claim 9, wherein the step of tracking includes acquiring data corresponding to at least one image of the selected configuration in the tissue cavity. (see paras. [0055]-[0056]).
Regarding claim 10, wherein the tracking includes acquiring data corresponding to a plurality of images of the selected configuration in the tissue cavity captured at discrete time intervals (see paras. [0055]-[0056]).
Regarding claim 11, wherein the step of determining the volume includes a calculation based on the images (see para. [0062]).
Regarding claim 12, wherein the step of determining the volume includes adding volumes of the images (see paras. [0055]-[0056]).
Regarding claim 13, wherein the step of determining the volume includes calculating bone graft for disposal with tissue cavity based on the volume (see para. [0057]).
Regarding claim 14, wherein the tissue cavity includes an intervertebral cavity (see Fig. 3B, see para. [0045]).
Melkent discloses, regarding claim 15, a method for treating a spine (see para. [0008]), the method comprising the steps of: inserting a distal end (244) of a surgical instrument (16) into an intervertebral cavity (20d, see Fig. 3B, see para. [0045]), the surgical instrument including a surgical navigation emitter (56) oriented relative to a sensor (82) to communicate a signal representative of a position of the surgical instrument relative to the intervertebral cavity (see paras. [0019]-[0020]); displaying a sphere with the distal end in the intervertebral cavity from a computer monitor (see paras. [0047]-[0048]); tracking movement of the surgical instrument in the intervertebral cavity with a tracking device (40) and communicating with a processor (70) to generate data for display of the movement from the computer monitor (see para. [0056]) including generating a plurality of images of the sphere in the intervertebral cavity at discrete time intervals based on movement of the surgical instrument (see paras. [0055]-[0056]); and determining a volume of the intervertebral cavity based on the data (see paras. [0055]-[0056]).
Melkent discloses, regarding claim 16, a method for treating a spine (see para. [0008]), the method comprising the steps of: disposing a surgical instrument (16) adjacent to a tissue cavity (see para. [0045]), the surgical instrument including an image guide (56) oriented relative to a sensor (82) to communicate a signal representative of a position of the surgical instrument relative to the tissue cavity (see paras. [0019]-[0020]); displaying at least one trial (16) with a distal end (244) of the surgical instrument in the tissue cavity (see para. [0047]); tracking the surgical instrument relative to the tissue cavity with a tracking device (40) that communicates with a processor (70) to generate data for display of the at least one trial relative to the tissue cavity (see para. [0056]); and comparing the at least one trial relative to the tissue cavity to determine a volume of the tissue cavity (see paras. [0055]-[0056]).
Regarding claim 18, wherein the display of the at least one trial includes an axial view and a lateral view (see para. [0044] “axial view”).
Regarding claim 20, wherein the step of determining includes calculating bone graft for disposal with the tissue cavity based on volume (see para. [0057]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3, 5-6, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melkent, as applied to claims 1 and 16 above, and in view of Dewey et al. (U.S. Pub. No. 2018/0116824 A1, hereinafter “Dewey”).
Melkent discloses all of the features of the claimed invention, as previously set forth above. Melkent further discloses wherein the selected configuration may be any appropriate shape or geometry (see para. [0047]); however, fails to explicitly disclose, regarding claim 3, wherein the selected configuration includes a polygonal shape; regarding claim 5, wherein the distal end includes a linear configuration; regarding claim 6, wherein the distal end includes an angled configuration; and regarding claim 19, wherein the trial is selected from a plurality of alternate trials.
Dewey discloses a trial (10, see Fig. 2), wherein the selected configuration of the trial includes a polygonal shape (see Fig. 1, note multiple sides 12, 14, 24, 26 and 28), with a linear configuration (see para. [0022] “straight”) with an angled configuration (see para. [0022] “hook shape”), wherein the trial is selected from a plurality of alternative trials (see paras. [0020] and [0030]) in order to provide different sized trials for aiding in appropriate sizing of the interbody space (see para. [0020]) and prevent the trial from dragging the placed graft material out from the disc space (see para. [0022]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the selected configuration of the distal end / trial in Melkent to have a polygonal shape, to have a linear or angled configuration and selected from a plurality of alternative distal ends / trials in order to provide different sized trials for aiding in appropriate sizing of the interbody space and prevent the trial from dragging the placed graft material out from the disc space.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melkent, as applied to claim 16 above, and in view of Nguyen (U.S. Pub. No. 2008/0077241 A1, hereinafter “Nguyen”).
Melkent discloses all of the features of the claimed invention, as previously set forth above. Melkent further discloses wherein the selected configuration may be any appropriate shape or geometry (see para. [0047]); however, fails to explicitly disclose, regarding claim 17, wherein the trial includes a kidney bean shape.
Nguyen discloses a trail member (102, see Fig. 3), wherein the trial member is kidney shaped with a chamfer (see Fig. 3, see para. [0051]) in order to aid in insertion of the trail member (see para. [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the selected configuration of the trial in Melkent to be kidney bean shape in order to aid in insertion of the trail member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Clayton (U.S. Pub. No. 2005/0245817 A1) discloses a surgical tracking system for the vertebra where a disc or nucleus implant may be selected depending upon an image acquired of a patient and various measurements, such as size, shape, volume, location in the spine, (cervical, thoracic, lumbar), range of motion, and others, relating to the disc or nucleus to be replaced.
Sherman et al. (U.S. Pub. No. 2007/0167741 A1) and Urquhart et al. (U.S. Pub. No. 2005/0049486 A1) disclose trackable surgeries / tools.
Marrapode et al. (U.S. Pub. No. 2020/0323654 A1) discloses a navigated surgical implant template for sizing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773