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 15 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 15 recites the limitation "the channel engager" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. No channel engager has been introduced prior to this recitation in the claims. For examination purposes, the office will interpret this recitation to read, “a channel engager”.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray et al. (US 20200360091 A1) (hereon referred to as Murray).
Regarding claim 1, Murray teaches an apparatus (see Fig. 1) comprising:
a reference array (100);
a bone anchor (270);
a receiver assembly (202) coupled to the bone anchor (270) and including:
at least two receiver arms (208) defining a channel (210) therebetween configured to receive a spinal rod (see Para. [0034]); and
one or more tool engagers (228); and
an adapter (300) axially locked with the receiver assembly (202) having:
a channel engager (306) configured to engage within the channel (210);
a channel engager pin (360) removably coupled to the channel engager (306, see Para. [0047]);
one or more receiver assembly engagers (314) coupled with the one or more tool engagers (228); a proximal end (304) coupled to the reference array (100, see Fig. 1); and
a distal end (312) coupled to the receiver assembly (202, see Fig. 1).
Regarding claim 2, Murray teaches the apparatus of claim 1, wherein the channel engager (306) includes: a channel engager shaft having a distal end (see labelled diagram of Fig. 5 below); and
a bar having a length that extends perpendicularly from the distal end of the channel engager shaft (see labelled diagram of Fig. 5 below).
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Regarding claim 3, Murray teaches the apparatus of claim 2, wherein the bar defines a flat distal surface (see labelled diagram of Fig. 5 above).
Regarding claim 4, Murray teaches the apparatus of claim 2, wherein the bar defines a convex distal surface (see labelled diagram of Fig. 5 above).
Regarding claim 5, Murray teaches the apparatus of claim 2, wherein the bar mimics a shape and diameter of a spinal rod (see Para. [0043]).
Regarding claim 6, Murray teaches the apparatus of claim 1, wherein the one or more receiver assembly engagers (314) each include:
at least one tab (spaced apart by portion 316) extending toward a central axis of the adapter, the tab having a ramped distal surface (see labelled diagram of Fig. 5 below).
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Regarding claim 7, Murray teaches the apparatus of The apparatus of wherein the adapter (306) includes a driver (350) configured to advance the channel engager (306) into the channel (210) and withdraw the channel engager from the channel (see Para. [0046]).
Regarding claim 8, Murray teaches an apparatus (see Fig. 1) comprising:
a proximal end (304) having a reference array coupler (100);
a distal end (312) defining an opening (316) configured to receive a receiver assembly (202; see Para. [0047]);
a channel engager (306) configured to engage within a channel (210) formed by the receiver assembly (202);
a channel engager pin (360) removably coupled to the channel engager (306); and
one or more receiver assembly engagers (314) configured to engage with the receiver assembly (202).
Regarding claim 9, Murray teaches the apparatus of The apparatus of wherein the one or more receiver assembly engagers (314) include one or more arms (see tabs in labelled diagram of Fig. 5 above) biased into a locked position (note that the arms are biased in a locked position via the fixed orientation thereof); and
wherein the one or more arms include one or more tabs (see labelled diagram of Fig. 5 above) configured to fit within one or more tool engagers (228) of the receiver assembly (see Para. [0048]).
Regarding claim 10, Murray teaches the apparatus of The apparatus of wherein the channel engager (306) includes a channel engager shaft (see labelled diagram of Fig. 5 above) having a channel engager bar extending perpendicular to a length of the channel engager shaft (see labelled diagram of Fig. 5 above); and
wherein the channel engager bar is a portion of the channel engager that engages within the channel (see Para. [0048]).
Regarding claim 11, Murray teaches the apparatus of claim 8, further comprising: wherein a distal end of the channel engager bar has a flat or convex distal surface (see labelled diagram of Fig. 5 above).
Regarding claim 12, Murray teaches the apparatus of claim 11, wherein the channel engager bar mimics a shape and diameter of a spinal rod (see Para. [0043]).
Regarding claim 13, Murray teaches the apparatus of claims 10, further comprising:
a driver (350) configured to advance the channel engager (306) into the channel (210) and withdraw the channel engager from the channel (see Para. [0046]).
Regarding claim 14, Murray teaches the apparatus of The apparatus of wherein the driver (350) is configured as a lead screw (see Para. [0048], describing the threaded configuration) configured to translate rotational force applied to the driver to advance or withdraw the channel engager (see Para. [0048]).
Regarding claim 15, Murray teaches a method comprising:
coupling an adapter (300) with a receiver assembly (202) that is coupled to a bone anchor (270) disposed in bone (see Para. [0028] and Fig. 1), wherein the coupling includes disposing one or more tabs of an arm (see labelled diagram of Fig. 5 above) of the adapter (300) within one or more tool engagers (228) of the receiver assembly (202, see Para. [0044]);
coupling a reference array (100) to a proximal end (304) of the adapter (202, see Para. [0028] and Fig. 1); and
adjusting an angle of the receiver assembly (202) with respect to the bone anchor (270, see Para. [0032]),
wherein the adjusting simultaneously adjusts an angle of the adapter with respect to the bone anchor (see Para. [0042-0043]),
wherein the adapter (300) includes a channel engager pin (360) removably coupled to a channel engager (see Para. [0047]).
Regarding claim 17, Murray teaches the method of claim 15, further comprising:
after adjusting the angle, advancing a channel engager (306) of the adapter (300) into a channel (210) of the receiver assembly (202), thereby locking an angle of the receiver assembly (202) with respect to the bone anchor (270; see Para. [0048]).
Regarding claim 18, Murray teaches the method of claim 15, further comprising:
advancing a channel engager (306) of the adapter toward a channel (210) of the receiver assembly (202) such that the channel engager (306) contacts a set screw (350) or rod disposed in the receiver assembly (see Para. [0048]).
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.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Murray as applied to claim 15 above, and further in view of Rezach et al. (US 20200268452 A1) (hereon referred to as Rezach).
Murray teaches a method as outlined in the rejection of claim 15 above, however fails to teach wherein the method is performed during a revision spinal surgery; and wherein the bone anchor was placed during a prior spinal surgery (claim 19), wherein the method further comprises: uncoupling the adapter from the receiver assembly; and connecting the receiver assembly with another receiver assembly via a rod (claim 20).
Rezach teaches a spinal implant system (10), comprising a reference array (58), a screw (22), and an adaptor (18); wherein the device is configured to be used in methods treating patients undergoing revisional procedures such that an existing screw is already present (see Para. [0047]). Rezach also teaches uncoupling of the adapter (18) from the screw (see Para. [0085]) and inserting a rod (see Para. [0103]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Murray such that it is applied to a revision procedure (claim 19) as taught by Rezach, as this would enable correction as needed for certain patients (see Para. [0047]), and furthermore to modify the method of Murray to comprise of the method steps of uncoupling the adapter and connecting a rod (claim 20) as taught by Rezach, as this would enable vertebral fixation (see Para. [0103]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Reitblat et al. (US 10568669 B2) (hereon referred to as Reitblat) in view of Murray.
Reitblat teaches a method comprising: coupling an adapter (60) with a receiver assembly (53) that is coupled to a bone anchor (51) disposed in bone (see Col. 2, ll. 37-51), wherein the coupling includes disposing one or more tabs of an arm (52) of the adapter (60) within one or more tool engagers (100) of the receiver assembly (53);
Further comprising a proximal end (61) of the adapter (60); and
wherein the adapter (60) includes a channel engager pin (105) removably coupled to a channel engager (110, see Col. 11, ll. 55-61) (claim 15), wherein disposing one or more tabs (68) of an arm (64) of the adapter (60) within one or more tool engagers (56) of the receiver assembly (53) includes:
pushing a ramped distal surface of the one or more tabs (68) onto a proximal end of the receiver assembly (53), thereby causing the distal end of the arm (64) to be pushed outward and then fall into the one or more tool engagers of the receiver assembly (see Col. 10, ll. 45-57) (claim 16), however fails to teach the step of coupling a reference array to the proximal end and adjusting an angle of the receiver assembly with respect to the bone anchor, wherein the adjusting simultaneously adjusts an angle of the adapter with respect to the bone anchor (claim 15).
Murray teaches a method comprising: coupling an adapter (300) with a receiver assembly (202) that is coupled to a bone anchor (270) disposed in bone (see Para. [0028] and Fig. 1), wherein the coupling includes disposing one or more tabs of an arm (see labelled diagram of Fig. 5 above) of the adapter (300) within one or more tool engagers (228) of the receiver assembly (202, see Para. [0044]); coupling a reference array (100) to a proximal end (304) of the adapter (202, see Para. [0028] and Fig. 1); and adjusting an angle of the receiver assembly (202) with respect to the bone anchor (270, see Para. [0032]), wherein the adjusting simultaneously adjusts an angle of the adapter with respect to the bone anchor (see Para. [0042-0043]), wherein the adapter (300) includes a channel engager pin (360) removably coupled to a channel engager (see Para. [0047]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Reitblat such that it further comprises the steps of coupling a reference array to the proximal end and adjusting an angle of the receiver assembly with respect to the bone anchor, wherein the adjusting simultaneously adjusts an angle of the adapter with respect to the bone anchor as taught by Murray, as this would enable more precise positioning and angling of the implant (see Para. [0001]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10918423 B2: This reference teaches a system for computer-assisted spinal surgery.
US 20070055291 A1: This reference teaches a system for optimal implant placement.
US 20100234725 A1: This reference teaches a surgical targeting system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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