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 .
Specification
The amendment filed 01/27/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The amendment incorporates by reference a foreign priority document ZA 2023/05711. Incorporations by reference to foreign priority documents when added by amendment at the time of entry to the national stage are objected to as adding new matter because this is after the filing date. The filing date of this application is not the date of filing the national stage application, rather it is the filing date of the international stage application. See MPEP 608.01(p) I B and 1893.03(b).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 13-16 are objected to because of the following informalities:
Claim 13, line 2, insert “the” before “first”.
Claims 14-16, variables “h1”, “h2” and “α” should be in parentheses.
Appropriate correction is required.
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) 1-13, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (“Unilateral approach with two-cage insertion for full endoscopic transforaminal lumbar interbody fusion: technical report”, Acta Neuroochirurgica, published 3/1/2022) in view of Lamborne et al. (US Publication No. 2016/0022438 A1) and Baynham (US Publication No. 2011/0004314 A1).
Regarding Claim 1, Lee discloses a transforaminal lumbar interbody fusion implant device (“cage” discussed on page 1524 and shown in Fig 4a, b) comprising: an elongate implant body having opposed first and second ends (leading and trailing ends, see figure below) the implant body having a longitudinal axis (see figure below) and a first surface (top surface, see figure below) which in use, and when the body is located in an intervertebral space, faces in a first direction towards a first vertebra and a second surface (bottom surface, see figure below) which in use, and when the body is located in the intervertebral space, faces in an opposite direction and towards a second vertebra which is adjacent to the first vertebra.
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Lee is silent to the implant body defining a slot between the first end and second end dividing the implant body into: a first body part having the first surface and a second body part having the second surface, the first and second body parts being biased towards a first configuration wherein the first and second surfaces are relatively closer to each other,
the slot being configured to receive an actuator for urging the first and second body parts to a second configuration wherein the first and second surfaces are relatively further away from each other; and
However, Lee does disclose that multiple trial cages are inserted into the disc space to distract the disc space and determine the appropriate cage size during the procedure (page 1524).
Lamborne teaches an interbody fusion cage (100) in the same field of endeavor which comprises a slot (150, Fig. 1A) between the first end and second end (111, 112) dividing the implant body into a first body part (110) having the first surface and a second body part (120) having the second surface, the first and second body parts being biased towards a first configuration (shown in Fig. 1A) wherein the first and second surfaces are relatively closer to each other, the slot (150) being configured to receive an actuator (140 and associated tool, [0057]) for urging the first and second body parts to a second configuration wherein the first and second surfaces are relatively further away from each other (shown in Fig. 7A). Lamborne teaches the expandable cage configuration allows the surgeon to provide adjustable lordosis with appropriate flexibility, strength and stiffness [0046, 0054] and provide multiple steps of distraction [0069]. 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 static cage of Lee with an expandable cage as taught by Lamborne in order to provide adjustable lordosis with multiple steps of distraction to make the implant more adaptable to the requirements of the patient’s anatomy.
Lee discloses the procedure involves first inserting the cage deeply into the midline and contralateral sides then repositioning the cage more longitudinally over to the contralateral side using an impactor to push the second end about the first end (page 1524, see figure below). However, Lee is silent to first and second pivot formations on an axis transverse to the longitudinal axis of the implant body and on the first and second surfaces respectively for enabling pivotal movement of the implant body about the transverse axis.
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Baynham teaches an intervertebral cage in the same field of endeavor which has first and second pivot formations (high points 4A, 2A) on an axis transverse to the longitudinal axis of the implant body (transverse axis which runs through pin 26) and on the first and second surfaces respectively for facilitating pivotal movement of the implant body about the transverse axis during positioning within the intervertebral space [0035]. 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 cage of Lee to have pivot formations on the first and second surfaces as taught by Baynham in the location about which the implant is intended to pivot (towards the front end) in order to enabling pivotal movement of the implant body about the transverse axis to facilitate the repositioning of the implant.
Regarding Claim 2, the transverse axis is perpendicular to the longitudinal axis (as taught by Baynham, the formations are located on the top and bottom surfaces, the transverse axis being perpendicular to the longitudinal axis).
Regarding Claim 3, as modified by Lamborne, the implant body is of unitary construction [0056, Lamborne].
Regarding Claim 4, as modified by Lamborne, the implant body is manufactured of a resiliently deformable material [0054, 0056, Lamborne].
Regarding Claim 5, as modified by Lamborne, the device comprises an actuator (140, Lamborne) which is selectively manipulatable to urge the first and second body parts to the second configuration [0050-0052, Lamborne].
Regarding Claim 6, as modified by Lamborne, the slot (150, Lamborne) extends from the first end 111 towards the second end 112 (Fig. 1A Lamborne).
Regarding Claim 7-8, as modified by Lamborne, the implant body comprises at least one link (hinge 130, Fig. 1A [0050, Lamborne]) between the first body part and the second body part which is integrally formed with the body [0056, Lamborne].
Regarding Claim 9, as modified by Lamborne, the at least one link is resiliently deformable [0054, 0056, Lamborne].
Regarding Claim 10, as modified by Lamborne, the implant body defines an opening (132) at the second end for receiving the actuator [0057, Lamborne].
Regarding Claim 11, as modified by Lamborne, wherein the actuator comprises a bolt (Lamborne shows the threaded distal end of the instrument in Fig. 31) having an external thread and the implant body comprises an internal thread (thread of opening 132) located adjacent the opening for cooperating with the external thread (Fig. 31, [0062], Lamborne).
Regarding Claim 12, as modified by Baynham in claim 1, the first and second pivot formations are located towards the first end (the modification adds the formations at the front end of the implant because Lee shows the device will pivot about the front end).
Regarding Claim 13, as modified by Baynham in claim 1, the first and second pivot formations comprise at least one of: pins and circular formations (high points are considered circular formations).
Regarding Claim 17, the implant device of Lee in view of Lamborne and Baynham is disclosed above in the rejection of claim 1. Lamborne further discloses the use of a tool 300, Fig. 29 [0061-0063] to insert and actuate the implant. Lamborne discloses that the tool and implant are provided in a system (claim 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the implant with the inserter tool as taught by Lamborne in order to provide the surgeon with all the appropriate tools for the procedure (the system) packaged as a kit which would help organize the surgical room inventory.
Regarding Claim 18, Lee discloses a method of implanting a transforaminal lumbar interbody fusion implant device (“cage” discussed on page 1524 and shown in Fig 4a, b) the device comprising: an elongate implant body having opposed first and second ends (leading and trailing ends, see figure below) the implant body having a longitudinal axis (see figure below) and a first surface (top surface, see figure below) which in use, and when the body is located in an intervertebral space, faces in a first direction towards a first vertebra and a second surface (bottom surface, see figure below) which in use, and when the body is located in the intervertebral space, faces in an opposite direction and towards a second vertebra which is adjacent to the first vertebra.
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Lee discloses the method comprising:
creating a first posterior passage extending from a position on a first side of a midline of a vertebra to an intervertebral space (shown in Fig. 4a where the working channel exists);
inserting the transforaminal lumbar interbody fusion implant device through the first passage (shown in Fig. 4a) (“The first cage was obliquely inserted deeply into the midline and contralateral sides”, page 1524);
locating the transforaminal lumbar interbody fusion implant device in an initial position in the intervertebral space with the leading end on an opposed side of the midline (shown in Fig. 4a, “The first cage was obliquely inserted deeply into the midline and contralateral sides”, page 1524); and
pivoting the transforaminal lumbar interbody fusion implant device about the transverse axis to a final position (Fig. 4b, “ The endoscope was used to access the first cage through the cage guide, and the cage was then repositioned more longitudinally to the contralateral side using cage impactors “, page 1524).
Lee is silent to the implant body comprising a first body part and a second body part and an actuator for urging the first and second body parts away from each other; and Lee is silent to the method comprising manipulating the actuator to urge the first and second body parts away from each other.
However, Lee does disclose that multiple trial cages are inserted into the disc space to distract the disc space and determine the appropriate cage size during the procedure (page 1524).
Lamborne teaches an interbody fusion cage (100) in the same field of endeavor which comprises a slot (150, Fig. 1A) between the first end and second end (111, 112) dividing the implant body into a first body part (110) having the first surface and a second body part (120) having the second surface, the first and second body parts being biased towards a first configuration (shown in Fig. 1A) wherein the first and second surfaces are relatively closer to each other, the slot (150) being configured to receive an actuator (140 and associated tool, [0057]) for urging the first and second body parts to a second configuration wherein the first and second surfaces are relatively further away from each other (shown in Fig. 7A). Lamborne teaches the expandable cage configuration allows the surgeon to provide adjustable lordosis with appropriate flexibility, strength and stiffness [0046, 0054] and provide multiple steps of distraction [0069]. 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 static cage of Lee with an expandable cage with actuator as taught by Lamborne in order to provide adjustable lordosis with multiple steps of distraction to make the implant more adaptable to the requirements of the patient’s anatomy. It would have been obvious to manipulate the actuator as taught by Lamborne to provide the desired lordosis of the implant.
Lee discloses the procedure involves first inserting the cage deeply into the midline and contralateral sides then repositioning the cage more longitudinally over to the contralateral side using an impactor to push the second end about the first end (page 1524, see figure below). However, Lee is silent to first and second pivot formations on an axis transverse to the longitudinal axis of the implant body and on the first and second surfaces respectively for enabling pivotal movement of the implant body about the transverse axis.
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Baynham teaches an intervertebral cage in the same field of endeavor which has first and second pivot formations (high points 4A, 2A) on an axis transverse to the longitudinal axis of the implant body (transverse axis which runs through pin 26) and on the first and second surfaces respectively for facilitating pivotal movement of the implant body about the transverse axis during positioning within the intervertebral space [0035]. 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 cage of Lee to have pivot formations on the first and second surfaces as taught by Baynham in the location about which the implant is intended to pivot (on the leading end on the opposed side of the midline) in order to enabling pivotal movement of the implant body about the transverse axis to facilitate the repositioning of the implant.
Regarding Claim 19, Lee further discloses inserting a second transforaminal lumbar interbody fusion implant device through the first passage (fig. 4d, Lee); and locating the second transforaminal lumbar interbody fusion implant device in a position in the intervertebral space on the first side of the midline (shown in Fig. 4d, Lee).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (“Unilateral approach with two-cage insertion for full endoscopic transforaminal lumbar interbody fusion: technical report”, Acta Neuroochirurgica, published 3/1/2022) in view of Lamborne et al. (US Publication No. 2016/0022438 A1) and Baynham (US Publication No. 2011/0004314 A1) in further view of Ensign (US Publication No. 2006/0129244 A1).
Regarding Claim 14-15, the implant device of Lee in view of Lamborne and Baynham is disclosed above in the rejection of claim 1. The references are silent to the implant body having first and second opposed sides, each side located between the first and second ends and between the first and second surfaces, and the first and second surfaces are sloped from the first side having a first height (h1) towards the second side having a second height (h2) which is more than the first height, wherein the first and second body parts are tapered from the second side towards the first side such that an angle a is formed between the first and second surface.
Ensign discloses an expandable interbody fusion implant (fig. 22-26) in the same field of endeavor which has tapered top and bottom members (614, 615) with one side having a smaller height (h1) than the other (h2, see figure below) such that an angle “L” is formed between the first and second surface (Fig. 26) for the purpose of creating lordosis [0080].
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to taper the first and second body parts of the implant of Lee in view of Lamborne and Baynham with a taller side and a shorter side forming an angle therebetween as taught by Ensign in order to create lordosis.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (“Unilateral approach with two-cage insertion for full endoscopic transforaminal lumbar interbody fusion: technical report”, Acta Neuroochirurgica, published 3/1/2022) in view of Lamborne et al. (US Publication No. 2016/0022438 A1) and Baynham (US Publication No. 2011/0004314 A1) in further view of Ensign (US Publication No. 2006/0129244 A1) and in further view of Clauss et al. (US Publication No. 2022/0241089 A1).
Regarding Claim 16, the implant of Lee in view of Lamborne and Baynham and Ensign is described above in the rejection of claim 15. Ensign is silent to a measurement for the angle “L” providing lordosis being 11degrees however does show the angle as a shallow, acute angle (Fig. 26, Ensign).
Clauss discloses a TLIF expandable interbody implant (100) in the same field of endeavor and discloses the lordosis angle can be 11 degrees [0103]. It would have been obvious to one having ordinary skill in the art to create the implant with a lordosis angle of 11 degrees as taught by Clauss in order to provide an appropriate lordosis angle to treat a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773