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 filed 02/26/2026 have been fully considered but they are not persuasive. Applicant argues that surgical device is not polyaxially moveable. The Office agrees that the surgical device is not polyaxially moveable when connected to the targeting system, however in the absence of such a final clause any device alone would be capable of polyaxial movement. Therefore, the rejection is maintained. However, to advance prosecution, secondary rejections are also made.
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) 1 – 6, 8 – 14 and 16 - 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abdou (US 2006/0149278 A1).
Regarding claim 1, Abdou discloses a spinal surgical system (Abstract) comprising:
a pedicle screw (Fig. 42, ref. 4205) adapted to be inserted into a first pedicle of a first vertebra of a patient's anatomy (paragraph [0121] discloses that the anchors/screws may be placed into the pedicles);
a targeting system (refs. 120, 4110, Fig. 41) mounted to the pedicle screw and only to the pedicle screw such that the first targeting system is entirely supported by the pedicle screw (Fig. 41); and
a first surgical device (Fig. 33, ref. 2510) connected at a free end of the targeting system (the free end is best shown in Fig. 23 at ref. 2310) such that the first surgical device is positioned above a first location of the patient's anatomy remote from the first pedicle (Fig. 50), the first surgical device being capable of polyaxial movement (the device is fully capable of polyaxial movement when not connected or attached to the targeting system).
Regarding claim 2, Abdou discloses the system of claim 1, wherein the first location is above an intervertebral space (Title, paragraph [0021]).
Regarding claim 3, Abdou discloses the system of claim 1, wherein the targeting system is adjustable to move the first surgical device with respect to the pedicle screw (the targeting system is adjustable in a first plane, see Fig. 44 “L”, and in a second plane, see Fig. 46 “B”).
Regarding claim 4, Abdou discloses the system of claim 3, wherein the targeting system includes an articulating joint (Fig. 47, paragraph [0115]).
Regarding claim 5, Abdou discloses the system of claim 4, wherein the joint is lockable (best shown in Fig. 48, a set screw is used to lock the joint).
Regarding claim 6, Abdou discloses the system of claim 4, wherein the joint includes a spherical, cylindrical and/or a telescoping joint (the joint pivots about cylinders ref. 4545).
Regarding claim 8, Abdou discloses the system of claim 1, wherein the first surgical device is tubular (Fig. 33, ref. 2510).
Regarding claim 9, Abdou discloses a spinal surgical system (Title) comprising:
an anchor (Fig. 42, ref. 4205) adapted to be inserted into a first portion of a first vertebra of a patient's anatomy (Fig. 42);
a targeting system mounted to the anchor and only to the anchor such that the first targeting system is entirely supported by the anchor (Fig. 41, refs. 120, 4110); and
a first surgical device (Fig. 31) connected at a free end (located at ref. 2310 as shown in Fig. 33) of the targeting system such that the first surgical device is positioned above a first location of the patient's anatomy remote from the first portion (Fig. 33), the first surgical device being capable of polyaxial movement (the device alone is fully capable of being rotated in at least three degrees of freedom, e.g. by the surgeon).
Regarding claim 10, Abdou discloses the system of claim 9, wherein the first location is above an intervertebral space (Title, paragraph [0021]).
Regarding claim 11, Abdou discloses the system of claim 9, wherein the targeting system is adjustable to move the first surgical device with respect to the anchor (the targeting system is adjustable in a first plane, see Fig. 44 “L”, and in a second plane, see Fig. 46 “B”).
Regarding claim 12, Abdou discloses the system of claim 11, wherein the targeting system includes an articulating a joint (Fig. 47, paragraph [0115]).
Regarding claim 13, Abdou discloses the system of claim 12, wherein the joint is lockable (best shown in Fig. 48, a set screw is used to lock the joint).
Regarding claim 14, Abdou discloses the system of claim 12, wherein the joint includes a spherical, cylindrical and/or a telescoping joint (the joint pivots about cylinders ref. 4545).
Regarding claim 16, Abdou discloses the system of claim 9, wherein the first surgical device is tubular (Fig. 33, ref. 2510).
Regarding claim 17, Abdou discloses a spinal surgical system (Abstract) comprising:
a pedicle screw (Fig. 42, ref. 4205) adapted to be inserted into a first pedicle of a first vertebra of a patient's anatomy (paragraph [0121] discloses that the anchors/screws may be placed into the pedicles);
an adjustable targeting system mounted to the pedicle screw and only to the pedicle screw such that the targeting system is entirely supported by the pedicle screw (Fig. 41, refs. 120, 4110), the targeting system including an articulating joint (Fig. 47, paragraph [0115]); and
a tubular surgical device (Fig. 33, ref. 2510) connected at a free end (best shown at ref. 2310 in Fig. 33) of the targeting system such that the tubular surgical device is positioned above an intervertebral space of the patient's anatomy remote from the first pedicle (Fig. 33), the first surgical device being capable of polyaxial movement (the device alone, is fully capable of being rotated polyaxially).
Regarding claim 18, Abdou discloses the system of claim 17, wherein the articulating joint is lockable (best shown in Fig. 48, a set screw is used to lock the joint).
Regarding claim 19, Abdou discloses the system of claim 17, wherein the articulating joint includes a spherical, cylindrical and/or a telescoping joint (the joint pivots about cylinders ref. 4545).
Claim(s) 1 - 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Copp et al. (US 2008/0183214 A1).
Regarding claim 1, Copp discloses a spinal surgical system (Abstract) comprising:
a pedicle screw adapted to be inserted into a first pedicle of a first vertebra of a patient's anatomy (Fig. 19, ref. 16);
a targeting system mounted to the pedicle screw and only to the pedicle screw such that the first targeting system is entirely supported by the pedicle screw (paragraph [0053] discloses targeting system ref. 30 which is shown in Fig. 19 as being solely supported by the screw); and
a first surgical device (paragraph [0050], ref. 14) connected at a free end of the targeting system such that the first surgical device is positioned above a first location of the patient's anatomy remote from the first pedicle (as shown in Figs. 21 – 26, the first surgical device ref. 14 is fully capable of being connected at a variety of different locations and ends of the targeting system, wherein the top of the targeting system is taken to be a free end and an end of the first surgical device is located at the free end and extends laterally away from the screw and targeting system, see Fig. 23), the first surgical device being capable of polyaxial movement (the first surgical device is capable of polyaxial movement through ends ref. 28 which are spherical and also when connected to the polyaxial screw itself which is able to pivot).
Regarding claim 2, Copp discloses the system of claim 1, wherein the first location is above an intervertebral space (Fig. 23).
Regarding claim 3, Copp discloses the system of claim 1, wherein the targeting system is adjustable to move the first surgical device with respect to the pedicle screw (the targeting system is able to pivot relative to the screw, see Fig. 24, thus fully capable of moving the surgical device with respect to the screw).
Regarding claim 4, Copp discloses the system of claim 3, wherein the targeting system includes an articulating joint (the targeting system ref. 30 comprising a plurality of joints, such as the distal end of ref. 38 which is a threaded joint, see Fig. 5 or the joint to connect to the receiver of the screw).
Regarding claim 5, Copp discloses the system of claim 4, wherein the joint is lockable (if the threaded joint is selected from claim 4, then the threads are considered a locking mechanism of the joint).
Regarding claim 6 Copp discloses the system of claim 4, wherein the joint includes a spherical, cylindrical and/or a telescoping joint (if the threaded joint is selected from claim 4, then Fig. 5 shows the joint being cylindrical).
Regarding claim 7 Copp discloses the system of claim 4, wherein the joint permits movement in at least three degrees of freedom relative to the pedicle screw (if the joint connecting the targeting system to the receiver is chosen, then the targeting system and screw are able to move in multiples planes relative to one another due to the ball and socket of the screw head relative to the receiver).
Regarding claim 8 Copp discloses the system of claim 1, wherein the first surgical device is tubular (Fig. 3B, ref. 31 shows a tubular portion of the surgical device).
Regarding claim 9 Copp discloses a spinal surgical system (Abstract) comprising:
an anchor adapted to be inserted into a first portion of a first vertebra of a patient's anatomy (Fig. 19, ref. 16);
a targeting system mounted to the anchor and only to the anchor such that the first targeting system is entirely supported by the anchor (paragraph [0053] discloses targeting system ref. 30 which is shown in Fig. 19 as being solely supported by the screw); and
a first surgical device connected at a free end of the targeting system such that the first surgical device is positioned above a first location of the patient's anatomy remote from the first portion (as shown in Figs. 21 – 26, the first surgical device ref. 14 is fully capable of being connected at a variety of different locations and ends of the targeting system, wherein the top of the targeting system is taken to be a free end and an end of the first surgical device is located at the free end and extends laterally away from the screw and targeting system, see Fig. 23),the first surgical device being capable of polyaxial movement (the first surgical device is capable of polyaxial movement through ends ref. 28 which are spherical and also when connected to the polyaxial screw itself which is able to pivot).
Regarding claim 10 Copp discloses the system of claim 9, wherein the first location is above an intervertebral space (Fig. 23).
Regarding claim 11 Copp discloses the system of claim 9, wherein the targeting system is adjustable to move the first surgical device with respect to the anchor (the targeting system is able to pivot relative to the screw, see Fig. 24, thus fully capable of moving the surgical device with respect to the screw).
Regarding claim 12 Copp discloses the system of claim 11, wherein the targeting system includes an articulating joint (the targeting system ref. 30 comprising a plurality of joints, such as the distal end of ref. 38 which is a threaded joint, see Fig. 5, or if the joint connecting the targeting system to the screw may also be chosen).
Regarding claim 13 Copp discloses the system of claim 12, wherein the joint is lockable (the threads are considered a locking mechanism of the joint).
Regarding claim 14 Copp discloses the system of claim 12, wherein the joint includes a spherical, cylindrical and/or a telescoping joint (Fig. 5 shows the joint as spherical).
Regarding claim 15 Copp discloses the system of claim 12, wherein the joint permits movement in at least three degrees of freedom relative to the pedicle screw (if the joint connecting the targeting system to the receiver is chosen, then the targeting system and screw are able to move in multiples planes relative to one another due to the ball and socket of the screw head relative to the receiver).
Regarding claim 16 Copp discloses the system of claim 9, wherein the first surgical device is tubular (Fig. 3B, ref. 31 shows a tubular portion of the surgical device).
Regarding claim 17 Copp discloses a spinal surgical system (Asbtract) comprising:
a pedicle screw adapted to be inserted into a first pedicle of a first vertebra of a patient's anatomy (Fig. 19, ref. 16);
an adjustable targeting system mounted to the pedicle screw and only to the pedicle screw such that the first targeting system is entirely supported by the pedicle screw (paragraph [0053] discloses targeting system ref. 30 which is shown in Fig. 19 as being solely supported by the screw), the targeting system including an articulating joint (any joint connecting two components of the system together which articulate or have movement is considered a joint, thus the targeting system has a joint connecting to ref. 14 and to the screw, either of which may be considered the joint); and
a tubular surgical device connected at a free end of the targeting system such that the tubular surgical device is positioned above an intervertebral space of the patient's anatomy remote from the first pedicle, the first surgical device being capable of polyaxial movement (the other of ref. 36, as shown in Fig. 23, is considered the tubular surgical device which is connected to the targeting system via ref. 14 and is capable of polyaxial movement since it is connected to a second polyaxial screw ref. 16).
Regarding claim 18 Copp discloses the system of claim 17, wherein the articulating joint is lockable (the joint connected to the screw is lockable via threading as shown in Fig. 5 ref. 38).
Regarding claim 19 Copp discloses the system of claim 17, wherein the articulating joint includes a spherical, cylindrical and/or a telescoping joint (the joint as shown in Fig. 5 is cylindrical).
Regarding claim 20 Copp discloses the system of claim 17, wherein the articulating joint permits movement in at least three degrees of freedom relative to the pedicle screw (because the screw is polyaxial moveable, when the targeting system is connected to the receiver via the threading it is also polyaxial moveable relative to the screw and thus able to move in at least three degrees of freedom).
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) 7, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdou (US 2006/0149278 A1) in view of Rutschmann et al. (US 2014/0039556 A1).
Regarding claim 7, Abdou discloses the system of claim 4, except wherein the joint permits movement in at least three degrees of freedom relative to the pedicle screw.
Regarding claim 15, Abdou discloses the system of claim 12, except wherein the joint permits movement in at least three degrees of freedom relative to the anchor.
Regarding claim 20, Abdou discloses the system of claim 17, except wherein the articulating joint permits movement in at least three degrees of freedom relative to the pedicle screw.
Rutschmann teaches spine derotation system in the related field of spinal surgical systems, comprising a joint that permits movement in at least three degrees of freedom (Fig. 16 shows a joint that translates axial and has a spherical component with allows pivoting in multiple planes, see remarked Fig. 16 below). 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 joint of Abdou with the joint as taught by Rutschmann, such that the joint permits movement in at least three degrees of freedom relative to the pedicle screw for the purpose of greater positioning options.
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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.
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, 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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