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 § 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.
Claim(s) 21, 23-24, 27, 29, 32-33, 35-37, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdou (U.S. Pub. No. 2015/0032163 A1, hereinafter “Abdou”) in view of Dietze, Jr. et al. (U.S. Pub. No. 2012/0041272 A1, hereinafter “Dietze”).
Abdou discloses, regarding claim 21, a method for a single incision anterior fusion and posterior fusion spinal procedure (X, see Fig. 6, see para. [0092] “single, common skin incision”, see also para. [0059] “both implants may be placed through a single lateral skin incision”), the method comprising: making a single minimally invasive incision on a patient to provide percutaneous lateral access to a spine of the patient (X, see Fig. 6, see para. [0090], see also para. [0059] “both implants may be placed through a single lateral skin incision”); inserting, via an anterior trajectory (Y, see Fig. 6, see paras. [0092]-[0093]), through the single minimally invasive incision (see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), at least one interbody cage (305) into the intervertebral disc space (see Fig. 19A, see paras. [0092]-[0093]); and inserting, via a posterior trajectory (Z, see Fig. 6, see paras. [0092]-[0093]) and through the single minimally invasive incision (see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), an interspinous implant (105, see Fig. 26B) into the interspinous process space (see Fig. 26B, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”).
Regarding claim 23, further comprising: deploying a first wing (180) and a second wing (180) of the interspinous implant (see Fig. 2), wherein the first wing is configured to engage with a first spinous process (see Fig. 28A), and the second wing is configured to engage with a second spinous process (see Fig. 28A).
Regarding claim 24, where the interspinous implant further comprises a main body (150) and a nut (210) located on a proximal end of the main body (see Fig. 11A), and wherein the method further comprises: rotating the nut along the main body (see para. [0077]) such that a distal side (212) of the nut engages with the first spinous process and the second spinous process (via 120, see Fig. 11A, see Fig. 28A), wherein the first wing and the second wing engage the first spinous process and the second spinous process on a first lateral side of the interspinous process space and the nut engages with the first spinous process and the second spinous process (via 120) on a second lateral side of the interspinous process space (see Fig. 28A).
Regarding claim 27, further comprising: adding bone graft material to at least one of: the at least one interbody cage or the interspinous implant to promote bony fusion between the first vertebra and the second vertebra (see para. [0098] “bone graft material 405”).
Abdou discloses, regarding claim 29, a method for a single incision anterior and posterior spinal fusion procedure (X, see Fig. 6, see para. [0092] “single, common skin incision”, see also para. [0059] “both implants may be placed through a single lateral skin incision”), the method comprising: making a single minimally invasive incision on a lateral side of a patient (X, see Fig. 6, see para. [0090], see also para. [0059] “both implants may be placed through a single lateral skin incision”); inserting, via the single minimally invasive incision, a first spinous implant (305) into an intervertebral disc space (see Fig. 19A, see paras. [0092]-[0093]), wherein the first spinous implant is inserted via an anterior trajectory; inserting, via the single minimally invasive incision (Y, see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), a second spinous implant (105, see Fig. 26B) into the patient an interspinous process space (see Fig. 26B, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), wherein the second spinous implant is inserted via a posterior trajectory (Z, see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”); wherein the second spinous implant comprises a pair of deployable wings (180, see Fig. 2), and wherein the second spinous implant is configured to be inserted into the patient in a closed configuration where the deployable wings are not deployed (see Figs. 11A-B) and actuated to an open configuration within the patient to deploy the deployable wings (see Figs. 12A-13B).
Abdou discloses, regarding claim 35, a method for a single incision anterior fusion and posterior fusion spinal procedure (X, see Fig. 6, see para. [0092] “single, common skin incision”, see also para. [0059] “both implants may be placed through a single lateral skin incision”), the method comprising: making a single minimally invasive incision onto a lateral side of a patient (X, see Fig. 6, see para. [0090], see also para. [0059] “both implants may be placed through a single lateral skin incision”); inserting, via an anterior trajectory (Y, see Fig. 6, see paras. [0092]-[0093]), through the single minimally invasive incision (see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), an interbody cage (305) into the intervertebral disc space (see Fig. 19A, see paras. [0092]-[0093]), accessing, via the single minimally invasive incision (see Fig. 6, see para. [0090], see also para. [0059] “both implants may be placed through a single lateral skin incision”); inserting, via a posterior trajectory (Z, see Fig. 6, see paras. [0092]-[0093]) and through the single minimally invasive incision (see Fig. 6, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”), an interspinous implant (105, see Fig. 26B) into the interspinous process space see Fig. 26B, see paras. [0092]-[0093], see also para. [0059] “both implants may be placed through a single lateral skin incision”).
Regarding claim 36, further comprising: adding bone graft to the interbody cage and to the intervertebral disc space (see para. [0098] “Bone graft material can be employed in the posterior column to supplement the fixation and bone graft material of the anterior column”).
Regarding claim 40, wherein the interspinous implant comprises a pair of deployable wings (180, see Fig. 2) configured to engage with spinous processes of the interspinous process space (see Fig. 28A).
Abdou fails to explicitly disclose, regarding claim 21, advancing a guidewire through the single minimally invasive incision, through Kambin's triangle, and into an intervertebral disc space located between a first vertebra and a second vertebra of the spine; advancing at least one dilator through the single minimally invasive incision and over the guidewire to dilate the intervertebral disc space; removing at least a portion of an intervertebral disc from the intervertebral disc space; wherein the at least one interbody cage is inserted through Kambin’s triangle; and repositioning the guidewire to access an interspinous process space between the first vertebra and the second vertebra. Abdou fails to explicitly disclose, regarding claim 29, inserting the first spinous implant through Kambin's triangle; regarding claim 32, further comprising: inserting a guidewire into the intervertebral disc space via Kambin's triangle for inserting of the first spinous implant; and inserting the guidewire into the interspinous process space for inserting the second spinous implant; and regarding claim 33, further comprising: dilating the intervertebral disc space and the interspinous process space using a common set of instruments. Abdou fails to explicitly disclose, regarding claim 35, accessing an intervertebral disc space of a spine of the patient using a guidewire, wherein the guidewire is inserted through Kambin's triangle; inserting the interbody cage Kambin's triangle; accessing an interspinous process space of the spine of the patient using the guidewire; and removing the guidewire from the patient; and regarding claim 37, wherein at least a portion of the single incision anterior fusion and posterior fusion spinal procedure is performed under fluoroscopy.
Dietze discloses a method for a single incision anterior fusion and posterior fusion spinal procedure (see paras. [0004]-[0005]), wherein the method includes advancing a guidewire (see para. [0114], “target wire”) through the minimally invasive incision and into an intervertebral disc space located between a first vertebra and a second vertebra of the spine (98, see para. [0114]); advance at least one dilator through the minimally invasive incision and over the guidewire to dilate the intervertebral disc space (see para. [0114] “One or more tissue dilators”); advance at least one sleeve through the minimally invasive incision and over the at least one dilator (see para. [0114] “retractor blades 56, 55”); wherein the trajectory for inserting the interbody cage is an anterior trajectory (32, see Fig. 13) and through an access point defined by Kambin’s triangle (see para. [0040]); wherein the trajectory for inserting the spinal fusion implant is a posterior trajectory (see Fig. 13, note trajectory to insert 100 is posterior); and wherein the guidewire is repositioned to access a target space between the first vertebra and the second vertebra (see para. [0089] “guide wire”); and wherein prior to inserting the interbody cage into the intervertebral disc space (see para. [0121]), removing at least a portion of an intervertebral disc disposed in the intervertebral disc space (see para. [0121]), wherein the procedure is performed under fluoroscopy (see para. [0083]) in order to provide safe passage into the intervertebral disc space (see para. [0040]) and soft tissue retraction of the disc space and enable the surgeon to conduct the surgery through a working channel (see para. [0073]) and to insure / verify proper positioning in the vertebra (see para. [0083]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Abdou to include advancing a guidewire, advancing at least one dilator, advancing at least one sleeve, wherein the trajectory for inserting the interbody cage is an anterior trajectory and through an access point defined by Kambin’s triangle, and wherein the trajectory for inserting the spinal fusion implant is a posterior trajectory, and removing at least a portion of an intervertebral disc disposed in the intervertebral disc space in view of Dietze in order to provide safe passage into the intervertebral disc space and soft tissue retraction of the disc space and enable the surgeon to conduct the surgery through a working channel.
Claim(s) 22, 30, 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdou in view of Dietze, as applied to claims 21, 29, 35 above, and in further view of Attali et al. (U.S. Pub. No. 2002/0040243 A1, hereinafter “Attali”).
Abdou in view of Dietze discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 22, wherein the at least one interbody cage comprises an externally threaded body having a first set of flats configured to contact the first vertebra and a second set of flats configured to contact the second vertebra; regarding claim 30, wherein the first spinous implant comprises an externally threaded body having a first set of flats configured to contact a superior vertebra of the intervertebral disc space and a second set of flats configured to contact an inferior vertebra of the intervertebral disc space; and regarding claim 38, wherein the interbody cage comprises an opposing pair of flats on external threads of the interbody cage, wherein the opposing pair of flats are configured to an inferior vertebra and a superior vertebra of the intervertebral disc space; and regarding claim 39, wherein the interbody cage further comprises a pair of deployable wings located between the pair of opposing flats.
Attali discloses a interbody cage (1, see Figs. 1-2), wherein the interbody cage comprises: a first wing (e.g. upper 5) and a second wing (e.g. lower 5), wherein the first wing and the second wing are configured to engage with a superior vertebra and an inferior vertebra of the intervertebral disc space (see Fig. 2, note when deployed e.g. expanded by 2, the wings are configured to engage the superior / inferior vertebrae), and wherein the interbody cage comprises external threads (11), the external threads comprising a pair of opposing flats (6), and wherein the wings are disposed between the flats (see Figs. 4A and 5A, note that wings 5 are disposed between flats 6) in order to provide an interbody cage that fits the profile of the vertebrae more closely (see para. [0034]) while minimizing the stress concentration on the vertebrae (see para. [0032]), and increase the bearing surface area to provide greater strength (see para. [0039]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the interbody cage in Abdou in view of Dietze to comprise external threads and a pair of opposing flats and deployable wings in further view of Attali in order to provide an interbody cage that fits the profile of the vertebrae more closely, while minimizing the stress concentration on the vertebrae, and increase the bearing surface area to provide greater strength.
Claim(s) 25-26, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdou in view of Dietze, as applied to claims 21 above, and in further view of Hansen et al. (U.S. Pub. No. 2016/0045326 A1, hereinafter “Hansen”).
Abdou in view of Dietze discloses all of the features of the claimed invention, except regarding claim 25, further comprising: deploying a first wing and a second wing of the at least one interbody cage, wherein the first wing and the second wing are configured to engage with the first vertebra and the second vertebra in the intervertebral disc space; regarding claim 26, further comprising: wherein the first wing and the second wing comprise fangs or teeth for engaging with the first vertebra and the second vertebra; and regarding claim 31, wherein the first spinous implant comprises a second pair of deployable wings, and wherein the second pair of deployable wings further comprises fangs or teeth for engaging with vertebrae of the intervertebral disc space.
Hansen discloses an interbody cage (100, see Fig. 11A), wherein the interbody cage includes a first wing (upper wing extension of 300, see Fig. 12) and a second wing (e.g. lower wing extension of 300, see Fig. 12), wherein the first wing and the second wing comprise fangs or teeth ( for engaging with the first vertebra and the second vertebra (e.g. serrated edges, see para. [0069]) in order to enable penetration into the boney upper and lower plates of the vertebra (see para. [0069]) to prevent migration of the interbody cage after installation (see para. [0074]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of the interbody cage in Abdou in view of Dietze to include deploying a first wing and second wing that engage the superior and inferior vertebra of the intervertebral disc space in further view of Hansen in order to enable penetration into the boney upper and lower plates of the vertebra to prevent migration of the interbody cage after installation.
Claim(s) 28 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdou in view of Dietze, as applied to claims 21 and 29 above, and in further view of Schell et al. (U.S. Pub. No. 2016/0095721 A1, hereinafter “Schell”).
Abdou in view of Dietze, as applied to claims 21 above, Abdou further discloses that the single incision anterior fusion and posterior fusion spinal procedure is performed at an L4-L5 level of the spine or that a different level of the spine can be targeted for immobilization (see para. [0093]). Abdou in view of Dietze however fails to explicitly disclose, regarding claim 28, wherein the single incision anterior fusion and posterior fusion spinal procedure is performed at an L5-S1 level of the spine; and regarding claim 34, wherein the single incision anterior fusion and posterior fusion spinal procedure is performed at an L5-S1 level of a spine of the patient.
Schell disclose performing fusion on the L5-S1 level of a spine (see Fig. 5, see para. [0100]) in order to provide treatment of the L5-S1 level of a spine (see ABSTRACT) to stabilize and reduce pain between the fifth lumbar vertebra (L5) and sacral bone (S1) (see para. [0006]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Abdou in view of Dietze to be performed on the L5-S1 level of the spine in further view of Schell in order to provide treatment of the L5-S1 level of a spine to stabilize and reduce pain between the fifth lumbar vertebra (L5) and sacral bone (S1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose methods of implanting interspinous / interlaminar implants:
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The following reference discloses a method of performing anterior and posterior fusion:
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773