DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 11 February 2025. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 11 February 2025 are accepted 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 1-3, 5, 7, 9-10, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pimenta (U.S. Patent 8,313,430).
Pimenta discloses (as to claim 1) a method of using a tissue retraction and neuromonitoring system (i.e. system defined by 10, 40, electrodes, and a nerve surveillance system) comprising penetrating spinal disc tissue of a patient with an initial dilator (42), wherein the initial dilator is non-cannulated (i.e. due to it being a K-wire) and is capable of performing neuromonitoring (see column 14, lines 36-42) (see column 14, lines 26-36); inserting at least one dilator (44, 52 and 54) over the initial dilator, wherein the at least one dilator is capable of performing neuromonitoring (see column 14, lines 36-42), is cannulated (i.e. 54 cannulated to receive 52, 52 cannulated to receive 44, and 44 cannulated to receive 42), and creates an operative corridor to a surgical site (see column 14, lines 26-36); and inserting a tissue retractor (10) over the at least one dilator, wherein the tissue retractor is capable of performing neuromonitoring (see column 10, lines 31-53) (see column 14, lines 43-48), wherein (as to claim 2) the method further comprises performing, during the penetrating spinal disc tissue step, neuromonitoring with the initial dilator (see column 14, lines 22-30), wherein (as to claim 3) the method further comprises removing the initial dilator and the at least one dilator (see column 14, lines 48-52); and retracting patient tissue with the tissue retractor while performing neuromonitoring (see column 10, lines 31-53 and column 14, lines 53-64), wherein (as to claim 5) the tissue retractor has a blade (12, 16, or 18) with an integrated shim (25); and the method further comprises pre-loading the integrated shim within a cavity (21) of the blade (see column 10, lines 14-19), wherein (as to claim 7) the tissue retractor has a blade (12) with an integrated shim (25); and the method further comprises extending the integrated shim; and fixing the integrated shim and blade to patient anatomy (see column 14, lines 48-52), wherein (as to claim 9) the method further comprises inserting at least one auxiliary probe (25, see Note 1 below regarding the term “probe”) into the surgical site, wherein the at least one auxiliary probe includes a conductive tip (45, i.e. where 23 is conductive) capable of sending information to an external neuromonitoring device (170) during a surgical procedure (see column 15, line 65 – column 16, line 42), wherein (as to claim 10) the at least one auxiliary probe is capable of being secured to the retractor with a clip (i.e. clip defined by interaction between 29 and 49) on the retractor, wherein (as to claim 15) the method further comprising providing an indication of nerve position in distance and direction relative to a conductive element of at least one of: the initial dilator or the at least one dilator (see column 10, lines 31-53), wherein (as to claim 16) the tissue retractor further comprises a first blade (16); a second blade (18); and a third blade (12) having a posterior blade shaft and a slot (21) on a lateral side (i.e. side defining 21, see Figure 1) thereof capable of receiving a probe configured for performing neuromonitoring (the “probe” is only functionally claimed and is not being treated as a positively claimed limitation, see Note 2 below regarding functional language), wherein (as to claim 17) the method further comprises inserting a probe (25, see Note 1 below regarding the term “probe”) capable of performing neuromonitoring (i.e. via 23) into a slot (21) of a retractor blade (12) (see column 14, lines 48-52), wherein (as to claim 18) the probe is an insulated probe having a conductive tip (45, i.e. where 23 is conductive) and the probe is received in the slot of the retractor blade so that only a distal portion (45) of the probe including the conductive tip is exposed to patient anatomy (see column 9, lines 33-37), wherein (as to claim 19) each of the initial dilator and the at least one dilator are capable of performing neuromonitoring through a conductive element (23) on a distal end thereof, the conductive element comprising a conductive material (i.e. inherent for an electrode); and a geometry extending along a sidewall (e.g. sidewall of 25 shown in Figure 7 including 23) of the distal end of a respective one of the initial dilator and at least one dilator (i.e. although not explicitly shown, it is the examiner’s opinion that, given the disclosure, the conductive material would be similarly shaped and located with respect to each dilator) (see column 10, lines 31-53), and wherein (as to claim 20) the method further comprises removing the initial dilator and the at least one dilator (see column 14, lines 48-52); and performing, after the removing the initial dilator step, neuromonitoring via a probe (e.g. 198, or 210) while retracting patient tissue (see column 15, line 65 – column 16, line 42) (see Figures 1-60, and column 8, line 28 – column 18, line 3).
Note 1: For examination purposes and in light of the broadest reasonable interpretation, the term “probe” is being interpreted as an electrode or other device that can be placed inside something to take and convey measurements (definition retrieved from https://www.thefreedictionary.com/probe).
Note 2: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (U.S. Patent 8,313,430), as applied to claim 1 above, in view of Holthuizen et al. (U.S. Patent 11,497,562).
Pimenta discloses the claimed method except for wherein the initial dilator includes a threaded distal end and the threaded distal end facilitates penetrating spinal disc tissue.
Holthuizen et al. teach the use of an element (202, i.e. an element similar in structure to the interpreted initial dilator disclosed by Pimenta) including a threaded end (204) (see Figure 2, and column 6, lines 47-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Pimenta with wherein the initial dilator includes a threaded distal end in view of Holthuizen et al. in order to provide a well-known, obvious means for facilitating insertion into a desired tissue to yield predictable results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (U.S. Patent 8,313,430), as applied to claim 1 above.
Pimenta discloses wherein (as to part of claim 6) the tissue retractor has a blade (12) with an integrated shim (25); and the method further comprises impacting the integrated shim into disc space of the patient (see column 14, lines 48-52); however, fails to explicitly disclose wherein (as to the remainder of claim 6) the integrated shim is impacted into the disc space of the patient while the at least one dilator is positioned in nearby patient anatomy.
However, Pimenta teaches that the at least one dilator may be removed and the integrated shim impacted into disc space (see column 14, lines 43-64). One of ordinary skill in the art would recognize that the only alternative (i.e. give the use of the phrase “may be removed”) would include leaving the at least one dilator positioned in nearby anatomy (i.e. anatomy in the vicinity of 44, 52 and 54 and near to 25) while the integrated shim is impacted into the disc space of the patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Pimenta with wherein the integrated shim is impacted into the disc space of the patient while the at least one dilator is positioned in nearby patient anatomy in view of the teaching of Pimenta as it would be obvious to try (i.e. given a finite number of identified, predictable solutions) impacting the integrated shim while leaving the at least one dilator positioned in nearby anatomy when there exists a reasonable expectation of success (see MPEP 2141).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (U.S. Patent 8,313,430), as applied to claim 1 above, in view of Pappalardo et al. (U.S. Patent 8,936,615).
Pimenta discloses the claimed method except for wherein a distal end of the initial dilator includes a stop surface extending radially from a center of the initial dilator; and the method further comprises restricting the initial dilator from penetrating spinal disc tissue beyond a distance when the stop surface contacts patient tissue.
Pappalardo et al. teach the use of an element (24, i.e. an element similar in structure to the interpreted initial dilator disclosed by Pimenta) including a distal end (216) defining a stop surface (218) extending radially from a center of the element, wherein the stop surface restricts the element from penetrating tissue beyond a desired distance when the stop surface contacts another element (e.g. 22) (see Figures 6A and 6B, and column 18, line 1 – column 19, line 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Pimenta with wherein a distal end of the initial dilator includes a stop surface extending radially from a center of the initial dilator; and the method further comprises restricting the initial dilator from penetrating spinal disc tissue beyond a distance when the stop surface contacts patient tissue in view of Pappalardo et al. in order to provide a well-known, obvious means for limiting the insertion depth of the initial dilator in underlying tissue to yield predictable results.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (U.S. Patent 8,313,430), as applied to claim 1 above, in view of Bowman et al. (U.S. Patent 9,265,490).
Regarding claims 12 and 13, Pimenta discloses wherein (as to part of claim 12) each of the at least one dilator comprise a first cross-section (i.e. cross-section defined by upper-most portion as best seen in Figure 46); a tip (i.e. tip defined by lower-most portion as best seen in Figure 46) having a second cross-section (i.e. cross-section defined by lower-most portion as best seen in Figure 46); and a surface (i.e. surface defined by lower-most, conical shape as best seen in Figure 46) having a changing diameter that tapers along a transition from the first cross-section to the second cross-section to facilitate insertion into the surgical site (see annotated Figure below) (the examiner is interpreting each dilator as having the same overall shape, with different sizes), wherein (as to part of claim 13) the first cross-section has a first diameter (see annotated Figure below) and the second cross-section has a second diameter (see annotated Figure below), the first diameter being larger than the second diameter (see annotated Figure below); however, fails to explicitly disclose wherein (as to the remainder of claim 12) the initial dilator comprises a first cross-section; a tip having a second cross-section; and a surface having a changing diameter that tapers along a transition from the first cross-section to the second cross-section to facilitate insertion into the surgical site, wherein (as to the remainder of claim 13) the first cross-section of the initial dilator has a first diameter and the second cross-section of the initial dilator has a second diameter, the first diameter being larger than the second diameter.
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Bowman et al. teach the use of an initial dilator (604) and at least one dilator (606 and 608), wherein each of the initial dilator and the at least one dilator comprise a first cross-section (i.e. cross-sections defined by upper-most portions as best seen in Figure 17A); a tip (698, 690, and 710) having a second cross-section (i.e. cross-sections defined by lower-most portions as best seen in Figure 17A); and a surface (i.e. surfaces defined by lower-most, conical shapes as best seen in Figure 17A) having a changing diameter that tapers along a transition (see annotated Figure below) from the first cross-section to the second cross-section to facilitate insertion into the surgical site, wherein the first cross-section has a first diameter (see annotated Figure below) and the second cross-section has a second diameter (see annotated Figure below), the first diameter being larger than the second diameter (see annotated Figure below) (see annotated Figure below, Figure 17A, and column 21, line 1 – column 22, line 48).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Pimenta with wherein the initial dilator comprises a first cross-section; a tip having a second cross-section; and a surface having a changing diameter that tapers along a transition from the first cross-section to the second cross-section to facilitate insertion into the surgical site, wherein the first cross-section of the initial dilator has a first diameter and the second cross-section of the initial dilator has a second diameter, the first diameter being larger than the second diameter in view of Bowman et al. in order to provide a well-known, obvious shape/configuration allowing for dilation of body tissue to yield predictable results.
Regarding claim 14, Pimenta in view of Bowman et al. disclose the claimed invention except for wherein the first diameter and the second diameter are sized relative to one another by a ratio of 1:2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Pimenta in view of Bowman et al. with wherein the first diameter and the second diameter are sized relative to one another by a ratio of 1:2 in order to provide a desired shape/configuration allowing for dilation of body tissue, since such a modification would have involved a mere change in the size (i.e. a change in diameter) of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955)).
Allowable Subject Matter
Claim 11 is 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.
Claim 11 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the limitations required by claim 1, wherein the method further comprises inserting an auxiliary probe into a slot of a retractor blade that extends longitudinally down a length of the retractor blade, wherein the auxiliary probe includes a conductive tip configured to send information to an external neuromonitoring device during a surgical procedure; and wherein the auxiliary probe includes a diameter and a bend configured to form a friction fit within the slot of the retractor blade.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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