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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 32 – 39 and 52 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the rejections under Hainard, the terms “proximal” and “distal” are relative terms, e.g. proximal to what? Therefore, the interpretations of Hainard are maintained.
Regarding the negative surface, any surface that has minimal clearance and partially surrounds or hugs is considered to be a negative surface.
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.
Claims 32 -39, 52 and 54 are 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 32 , line 8, “wherein the distal portion has a distal surface substantially parallel to it’s proximal surface” should read “wherein the distal portion has a distal surface substantially parallel to a proximal surface” because it is the first recitation of the proximal surface.
Claim 32, line 12, “respect to the distal surface” should read “respect to a distal surface”.
Claim 32, line 14, “wherein a proximal surface of the distal portion is distal to a distal surface” should read “wherein the proximal surface of the distal portion is distal to the distal surface”.
Claim 54, “wherein a proximal surface of the distal portion” should read “wherein the proximal surface of the distal portion”.
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.
Claim(s) 32 – 37, 39, 52, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hainard et al. (US 2013/0085534 A1).
Regarding claim 32, Hainard discloses a bone anchor coupling (Abstract), comprising:
a body (ref. 118, Fig. 14) that includes a proximal portion, a distal portion, and a spanning portion that connects the proximal and distal portions (see remarked Fig. 14 below), the proximal portion defining an opening configured to receive at least a portion of an implant therethrough along a first trajectory into a first vertebral level (paragraph [0044] and Fig. 16 shows the proximal portion at ref. 152 having an opening to receive implant ref. 14), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a sidewall of the implant (best shown in Fig. 14), the distal portion extending outward from a distal end of the spanning portion (Fig. 14);
wherein the distal portion has a distal surface substantially parallel to its proximal surface (see remarked Fig. 14 below which shows a distal and proximal surface being substantially parallel to one another) and defines a bone anchor opening configured to receive an auxiliary bone anchor therethrough along a second trajectory such that the auxiliary bone anchor extends through the first vertebral level and into a vertebral level adjacent to the first vertebral level (the distal portion is configured to receive an auxiliary bone anchor ref. 16 and is fully capable of being used in such a manner depending upon orientation and relative size of the coupling and implant);
wherein the proximal surface of the distal portion is obliquely angled with respect to the distal surface of the proximal portion (see remarked Fig. 14 below); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion (see remarked Fig. 14 below).
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Regarding claim 33, Hainard discloses the bone anchor coupling of claim 32, wherein the distal surface of the distal portion is angled relative to a proximal-distal axis of the spanning portion and faces one of a direction to the left or a direction to the right of the proximal-distal axis when viewed from a perspective that visualizes the lateral surface of the spanning portion (Fig. 14 shows the distal surface of the distal portion being angled relative to the proximal-distal axis of the device).
Regarding claim 34, Hainard discloses the bone anchor coupling of claim 33, wherein the second trajectory is substantially perpendicular to the distal surface of the distal portion such that the second trajectory extends into a vertebral level to one of the right or the left of the first vertebral level when viewed from a perspective that visualizes the lateral surface of the spanning portion (the trajectories of the implants are able to angulate due the ball and socket type of the connection, thus the trajectories are fully capable of functioning and extending in such a manner).
Regarding claim 35, Hainard discloses the bone anchor coupling of claim 32, wherein the second trajectory is configured to extends into a vertebral level in one of the caudal or cephalad directions relative to the first vertebral level (this is considered a functional limitation in which the body and anchors/implants may be implanted in any a number of orientations such as in a caudal/cephalad direction).
Regarding claim 36, Hainard discloses the bone anchor coupling of claim 32, wherein the second trajectory extends at an angle one of outward away from a proximal-distal axis of the spanning portion or inward towards the proximal-distal axis of the spanning portion (the ball and socket type joint allows for a plurality or polyaxial angulation).
Regarding claim 37, Hainard discloses the bone anchor coupling of claim 32, wherein the bone anchor opening has a partially threaded interior surface (Fig. 4, ref. 94 shows the opening to be threaded) configured to engage a threaded proximal head of an auxiliary bone anchor such that the auxiliary bone anchor is capable of being locked at any angle amongst a plurality of selectable angles relative to a central axis of the bone anchor opening (the bone anchor is not positively recited, thus the threaded opening is fully capable of interfacing with a threaded head of a bone anchor which are known in the art).
Regarding claim 39, Hainard discloses the bone anchor coupling of claim 32, wherein the proximal portion includes one or more grooves or surface projections, wherein the one or more grooves or surface projections are configured to enable a surgical instrument to hold onto one side of the wing (Fig. 8, ref. 72).
Regarding claim 52, Hainard discloses the bone anchor coupling of claim 32, wherein the lateral surface of the spanning portion is configured to abut the sidewall of the implant (Fig. 16).
Regarding claim 54, Hainard discloses a bone anchor coupling (Abstract), comprising:
a body that includes a proximal portion, a distal portion, and a spanning portion that connects the proximal and distal portions (see remarked Fig. 14 above), the proximal portion defining an opening configured to receive at least a portion of an implant therethrough along a first trajectory into a first vertebral level (opening in portion ref. 152 is fully capable of receiving an implant such as ref. 24 along a first trajectory), the spanning portion extending longitudinally from the proximal portion to the distal portion (Fig. 14) with a lateral surface of the spanning portion configured to face a sidewall of the implant (Fig. 14), the distal portion extending outward from a distal end of the spanning portion (Fig. 14);
wherein the distal portion has a distal surface substantially parallel to its proximal surface (see remarked Fig. 14 above) and defines a bone anchor opening (ref. 154) configured to receive an auxiliary bone anchor therethrough along a second trajectory such that the auxiliary bone anchor extends through the first vertebral level and into a vertebral level adjacent to the first vertebral level (please note that the vertebral levels and the associated trajectories are considered to be intended use limitations in which the anchors are full capable of being implanted in a plurality of different orientations and angles);
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion (Fig. 14); and
wherein the lateral surface of the spanning portion is configured to abut the sidewall of the implant (Fig. 14).
Claim Rejections - 35 USC § 103
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 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(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Lai et al. (US 12,144,530 B2).
Regarding claim 38, Hainard discloses the bone anchor coupling of claim 32, except wherein the bone anchor opening defined in the distal portion comprises a plurality of bone anchor openings.
Ray teaches an orthopedic coupling (Abstract) configured to couple to an implant (ref. 46) and a plurality of auxiliary bone anchors (ref. 188, Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of Hainard to comprise a plurality of openings, as taught by Ray, for the purpose of stronger anchoring into bone.
Claim(s) 40 – 42, 44, 49, 50 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1).
Regarding claim 40, Hainard discloses a bone anchor assembly (Abstract), comprising:
a bone anchor (ref. 24);
an auxiliary bone anchor (ref. 16);
a receiver member (ref. 31) coupled to a proximal end of the bone anchor and defining a rod seat configured to receive a rod (Figs. 16);
a threaded post threadably mated to the receiver member (Fig. 16, ref. 26);
a wing (ref. 118, Fig. 16) that includes a proximal portion (ref. 152), a distal portion (ref. 154), and a spanning portion that connects the proximal and distal portions (see remarked Fig. 16 below), the proximal portion defining an opening through which at least part of the threaded post or a proximal terminal end of the receiver member is disposed (Fig. 16), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a side wall of the receiver member (Fig. 16), the distal portion extending outward from a distal end of the spanning portion (Fig. 16); and
wherein the opening of the proximal portion defines a first trajectory into a first vertebral level (Fig. 18, ref. 164) and the distal portion of the wing defines a bone anchor opening through which the auxiliary bone anchor is disposed (Fig. 18), the bone anchor opening defining a second trajectory such that the auxiliary bone anchor extends through the first vertebral level and into a second vertebral level adjacent to the first vertebral level (ref. 184) (please note that the vertebral levels and the associated trajectories are considered to be intended use limitations in which the anchors are full capable of being implanted in a plurality of different orientations and angles);
wherein the lateral surface of the spanning portion forms a negative surface of the sidewall of the receiver member (best shown in Fig. 14, the side wall of the spanning portion is shown to partially surround or hug the receiver member with minimal distance between the two, thus functioning as a negative surface); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion (Fig. 14).
Hainard is silent regarding a nut configured to threadably engage the threaded post to secure the proximal portion of the wing to the receiver member
Stein teaches a bone anchor assembly in the related field of endeavor comprising a receiver member (Fig. 3, ref. 12), a wing (Fig. 3, ref. 30), a closure mechanism threadably mated to the receiver (Fig. 3, ref. 54) and a nut configured to threadably engage the closure mechanism to secure a proximal portion of the wing to the receiver member (Fig. 3, ref. 58). Stein discloses that use of the nut in combination with the closure mechanism ensures that the wing is held to bone screws and prevents rotation of between the receiver and wing (paragraph [0033]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the closure mechanism of Hainard to include the closure mechanism and nut, as taught by Stein, for the purpose of better ensuring that the wing is held in pace relative the anchors and receiver.
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Regarding claim 41, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein a distal surface of the distal portion is angled relative to a proximal-distal axis of the spanning portion within a plane that extends through the proximal distal axis of the spanning portion parallel to the lateral surface of the spanning portion (this is interpreted broadly, the proximal-distal axis is shown in remarked Fig. 16 above, any plane that extends through the axis at any angle could include a distal surface of the distal portion).
Regarding claim 42, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the second trajectory is substantially perpendicular to the distal surface of the distal portion such that the second trajectory extends at an angle relative to a proximal-distal axis of the spanning portion.
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Regarding claim 44, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the second trajectory extends at an angle one of outward away from a proximal-distal axis of the spanning portion or inward towards the proximal-distal axis of the spanning portion (Fig. 18 shows an inwards direction along the proximal-distal axis).
Regarding claim 40 (in a second different interpretation), Hainard discloses a bone anchor assembly (Abstract), comprising:
a bone anchor (ref. 24);
an auxiliary bone anchor (ref. 16);
a receiver member (ref. 31) coupled to a proximal end of the bone anchor and defining a rod seat configured to receive a rod (Figs. 16);
a threaded post threadably mated to the receiver member (Fig. 16, ref. 26);
a wing (ref. 118, Fig. 18) that includes a proximal portion (ref. 152), a distal portion (ref. 154), and a spanning portion that connects the proximal and distal portions (see remarked Fig. 16 below), the proximal portion defining an opening through which at least of the threaded post or a proximal terminal end of the receiver member is disposed (Figs. 16, 18), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a side wall of the receiver member (Figs. 16, 18), the distal portion extending outward from a distal end of the spanning portion (Figs. 16, 18); and
wherein the opening of the proximal portion defines a first trajectory into a first vertebral level (Fig. 18, ref. 164) and the distal portion of the wing defines a bone anchor opening through which the auxiliary bone anchor is disposed (Fig. 18), the bone anchor opening defining a second trajectory such that the auxiliary bone anchor extends through the first vertebral level and into a second vertebral level adjacent to the first vertebral level (ref. 184) (please note that the vertebral levels and the associated trajectories are considered to be intended use limitations in which the anchors are full capable of being implanted in a pluralities of different orientations and angles);
wherein the lateral surface of the spanning portion forms a negative surface of the sidewall of the receiver member (best shown in Fig. 14, the side wall of the spanning portion is shown to partially surround or hug the receiver member with minimal distance between the two, thus functioning as a negative surface); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion.
Hainard is silent regarding a nut configured to threadably engage the threaded post to secure the proximal portion of the wing to the receiver member
Stein teaches a bone anchor assembly in the related field of endeavor comprising a receiver member (Fig. 3, ref. 12), a wing (Fig. 3, ref. 30), a closure mechanism threadably mated to the receiver (Fig. 3, ref. 54) and a nut configured to threadably engage the closure mechanism to secure a proximal portion of the wing to the receiver member (Fig. 3, ref. 58). Stein discloses that use of the nut in combination with the closure mechanism ensures that the wing is held to bone screws and prevents rotation of between the receiver and wing (paragraph [0033]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the closure mechanism of Hainard to include the closure mechanism and nut, as taught by Stein, for the purpose of better ensuring that the wing is held in pace relative the anchors and receiver.
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Regarding claim 49, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the wing includes one or more grooves or surface projections, wherein the one or more grooves or surface projections configured to enable a surgical instrument to hold onto one side of the wing (Fig. 8, ref. 72).
Regarding claim 50, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the first trajectory extends substantially parallel to a proximal-distal axis of the spanning portion (see remarked Fig. 18 above).
Regarding claim 51, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein a distal-facing surface of the proximal portion opposes a proximal terminal end of the receiver member (Fig. 16).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1) and in view of Lai et al. (US 12,144,530 B2).
Regarding claim 46, Hainard in view of Stein discloses the bone anchor assembly of claim 40, except wherein the auxiliary bone anchor has a threaded proximal head and the bone anchor opening has a partially threaded interior surface configured to engage the threaded proximal head of the auxiliary bone anchor such that the auxiliary bone anchor is capable of being locked at any angle amongst a plurality of selectable angles relative to a central axis of the bone anchor opening.
Lai teaches an orthopedic implant (Abstract) comprising a hole (ref. 14) with a partially threaded interior surface (Figs. 3 – 4, ref. 17, 78) and a threaded proximal head of an anchor (Fig. 6) such that a bone anchor (ref. 16) may be a non-locking or variable angle bone anchor while still achieving a strong wedging engagement. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bone anchor opening of Hainard in view of Stein to be partially threaded on the interior surface, as taught by Lai, to better allow for non-locking or variable angle bone anchors to be used.
Allowable Subject Matter
Claims 47 and 53 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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