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 Objections
Claims 18, 35 are objected to because of the following informalities:
Claim 18, line 2, “the direction” should be “the insertion direction” for clarity and consistency purposes.
Claim 35, line 2, remove “are” before “configured”.
Appropriate correction is required.
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.
Claim(s) 1-2, 5-9, 14-17, 20-29, 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eastlack et al. (US Publication No. 2015/0080973 A1).
Regarding Claim 17, Eastlack discloses a spinal implant delivery device (40, Fig. 4), the device comprising:
a first insertion member extending from a proximal end (47) in an insertion direction, wherein the first insertion member includes a first portion and a second portion extending substantially perpendicular to the first portion (see figure below); and
a second insertion member extending from the proximal end (47) in the insertion direction and spaced apart from the first insertion (spaced by slit 43), wherein the second insertion member includes a third portion and a fourth portion extending substantially perpendicular to the third portion (see figure below),
wherein the second and fourth portions extend toward each other, and wherein the first, second, third, and fourth portions at least partially define a channel through which a spinal implant can be delivered to a subject’s spine (see figure below) [0048].
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However, Eastlack is silent to the embodiment of device shown in Fig. 4 having a handle assembly at the proximal end (47).
Eastlack discloses other embodiments of delivery devices where the proximal end of the device has a handle assembly- finger loop 82 (Fig. 12A)– for the purpose of allowing a user to easily control the guide’s position [0056].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the proximal end of the device 40 shown in Fig. 4 of Eastlack with a handle assembly or finger loop as taught by Eastlack in order to provide a grip feature for easily controlling the device’s position.
Regarding Claim 20, Eastlack discloses the first and third portions are biased to extend parallel to one another (shown in Fig. 4), and wherein the first and second insertion members are fully capable of being pushed toward one another such that the first and third portions are no longer parallel to one another, thereby reducing a profile of the device (the slit 43 can be compressed such that the sides shown below are no longer parallel).
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Regarding Claim 21, the second and fourth portions define a protected side extending along lengths of the first and second insertion members, and wherein the handle assembly is oriented on the protected side (as modified by Eastlack, see figure below).
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Regarding Claim 22, the second and fourth portions are spaced apart to define a gap (43) therebetween (fig. 4) [0048].
Regarding Claim 23, each of the first and second insertion members is cantilevered (only attached at the proximal end 47, Fig. 4).
Regarding Claim 24, Eastlack discloses a spinal implant delivery system [0014], comprising: an implant delivery guide (40) coupled to a proximal end (47) (Fig. 4) and including: a slotted channel member (member containing slot 43, Fig. 4) having a compressed configuration for insertion into a disc space between vertebral bodies of a patient (shown in Fig. 4 and also the member is capable of being compressed further by reducing the size of slot 43) and an expanded configuration for distracting the vertebral bodies (slot allows for expansion in width, [0048]), and an implant delivery channel defined by the slotted channel member (space between rails 41) and configured to allow an implant to be delivered into the disc space when the slotted channel member is in the expanded configuration [0048].
However, Eastlack is silent to the embodiment of device shown in Fig. 4 having a handle assembly at the proximal end (47).
Eastlack discloses other embodiments of delivery devices where the proximal end of the device has a handle assembly- finger loop 82 (Fig. 12A)– for the purpose of allowing a user to easily control the guide’s position [0056].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the proximal end of the device 40 shown in Fig. 4 of Eastlack with a handle assembly or finger loop as taught by Eastlack in order to provide a grip feature for easily controlling the device’s position.
Regarding Claim 25, the implant delivery guide has a pair of cantilevered fingers each having a generally L-shaped cross section (fingers are cantilevered from proximal end 47, see below).
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Regarding Claim 26, the implant delivery guide has a longitudinal axis and a U-shaped cross-section taken perpendicular to the longitudinal axis (see below).
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Regarding Claim 27, further comprising an expandable intervertebral implant (“interbody implant” 104) having a collapsed state (Fig. 10D) for moving along the implant delivery channel and an expanded state for contacting the vertebral bodies (Fig. 10F), wherein the expandable intervertebral implant expands outwardly past sidewalls of the implant delivery guide when moved from the collapsed state to the expanded state (shown in Fig. 10F) [0054]].
Regarding Claim 28, the implant delivery guide includes first and second cantilevered insertion members each having tapered distal ends fully capable of laying flat against the vertebral bodies while a slotted region of the slotted channel member faces a midsagittal plane of the patient (see figure below).
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Regarding Claim 29, the implant delivery guide includes: a first insertion member extending from the handle assembly in an insertion direction (as modified in Claim 24 to include the handle at the proximal end 47), wherein the first insertion member includes a first portion and a second portion extending substantially perpendicular to the first portion; and a second insertion member extending from the handle assembly in the insertion direction and spaced apart from the first insertion, wherein the second insertion member includes a third portion and a fourth portion extending substantially perpendicular to the third portion, wherein the second and fourth portions extend toward each other, and wherein the first, second, third, and fourth portions at least partially define the implant delivery channel (see figure below).
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Regarding Claim 31, Eastlack discloses materials which the device could be made from include Radel ™ [0045]. As evidenced by WO 2023/141617 A1, Radel ™ is a material that is transparent under fluoroscopy [0045].
Regarding Claim 32, Eastlack discloses first and second sidewalls (rails 41) extending parallel to one another (shown in what could be considered an expanded configuration in Fig. 4), and fully capable of extending at a non-parallel orientation relative to one another when the slotted channel is in the compressed configuration. (the slit 43 can be compressed such that the sides shown below are no longer parallel).
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Regarding Claim 33, the slotted channel member is fully capable of moving spaced apart distal tapered ends (shown below) of the slotted channel member towards one another when a proximal end of the slotted channel member is compressed (slot 43 can be compressed).
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Regarding Claim 34, the slotted channel member includes a pair of tapered distal sidewalls spaced apart from one another (distal ends shown above are sidewalls).
Regarding Claim 35, the slotted channel member includes first and second insertion members (members on each side of slot 43) fully capable of being pushed toward one another to reduce a width of a slot between the first and second insertion members.
Regarding Claim 36, the implant delivery guide includes a pair of members (see below) at a bottom of the implant delivery channel (space between rails 41), wherein the pair of members defines a slot (43).
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Regarding Claim 1, Eastlack discloses the delivery device as modified in the rejections of claims 17 and 24 above. Further, Eastlack discloses using the delivery device to deliver an implant to a subject’s spine, the method comprising: inserting the implant delivery device in a subject [0053]; and delivering a spinal implant to the subject’s spine along the delivery channel toward the implantation site while the first and second insertion members keep the spinal implant within the channel [0048, 0054] (Fig. 10A-F).
Regarding Claim 2, the first insertion member extends from the handle assembly (as modified on the proximal end 47) and includes a first bottom and a first sidewall extending substantially perpendicular to the first bottom, the second insertion member extends from the handle assembly and spaced apart from the first insertion member, the second insertion member includes a second bottom and a second sidewall extending substantially perpendicular to the second bottom and substantially parallel to the first sidewall, and the first and second bottoms extend toward each other and define the slot (43) (see figure below).
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Regarding Claim 5, comprising moving the spinal implant along the elongated split delivery guide while a distal portion of the elongated split delivery guide is positioned directly between vertebral bodies of the subject’s spine [0053].
Regarding Claim 6, positioning a distal portion, in a compressed configuration, of the elongated split delivery guide between vertebral bodies of the subject’s spine; and allowing expansion of the distal portion toward an expanded configuration to distract the subject’s spine. (Eastlack describes that the delivery plates are first put into the vertebral space (shown in Fig. 10A) then the implant is moved through the delivery plates (shown in Fig. 10B) which expands and distracts the vertebral bodies. Further, in [0048], the slit 43 is described as accommodating a wider implant so that the plate may expand. If using a wider implant, the slot would also expand upon positioning of the implant along the insertion path.)
Regarding Claim 7, Eastlack discloses the delivery device as modified and described in the rejections of claims 17, 20-29 and 31-36 above. Further, Eastlack discloses using the delivery device to deliver an implant to a subject’s spine, the method comprising: inserting the implant delivery device in a subject [0053]; and passing a surgical device (implant) along the delivery channel of the elongated split delivery guide and toward an intervertebral space of the subject [0048, 0054] (Fig. 10A-F).
Regarding Claim 8, the elongated split delivery guide includes (i) a protected face defined by the bottom portions of the first and second insertion members and (ii) an open side opposite the protected face, and wherein inserting the delivery device comprises orienting the delivery device such that the protected face faces the intervertebral space of the subject when the delivery device is inserted in the subject (see figures below).
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Regarding Claim 9, the elongated split delivery guide includes (i) a protected face defined by the bottom portions of the first and second insertion members and (ii) an open side opposite the protected face (shown in figure above), and wherein inserting the delivery device comprises orienting the delivery device such that the open side faces the intervertebral space of the subject when the delivery device is inserted in the subject (shown below).
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Regarding Claim 14, inserting the delivery device comprises inserting the delivery device until a distal tip of the elongated split delivery guide is positioned in the intervertebral space of the subject [0053] (Fig 10A).
Regarding Claim 15, inserting the delivery device comprises inserting the delivery device until the proximal portion of the elongated split delivery guide abuts against a skin of the subject (shown for example in Fig. 14, the extent that the delivery device is inserted into the patient would require the proximal portion of the device to abut the skin, because the proximal portion can be an length of portion between the proximal terminal end and the midpoint of the delivery device and the device inherently abuts the skin as it is passed through an incision).
Regarding Claim 16, passing the surgical device comprises passing a spinal implant along the delivery channel of the elongated split delivery guide and to the intervertebral space of the subject (Fig. 10B-10F) [0054].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eastlack et al. (US Publication No. 2015/0080973 A1) in view of Milella, Jr. et al. (US Publication No. 2022/0039969 A1)
Regarding Claim 19, Eastlack discloses the device as described in the rejection of claim 17 above. Eastlack discloses materials which the device could be made from include Radel ™ [0045]. As evidenced by WO 2023/141617 A1, Radel ™ is a material that is transparent under fluoroscopy [0045]. However, Eastlack is silent to the first portion including distance indicators along the insertion direction.
Milella discloses a vertebral implant delivery system, wherein the wall of the implant delivery device includes a plurality of distance (29) indicators along the insertion direction in order to determine the depth of the distal end of the delivery tube in the surgical site [0149].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the side wall of any of the portions, including the first portion, of the device of Eastlack with distance indicators along the insertion direction as taught by Milella in order to allow the practitioner to determine the depth of the distal end of the delivery tube in the surgical site.
Allowable Subject Matter
Claims 3, 4, 10-13, 18, 30 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. The following is a statement of reasons for the indication of allowable subject matter: Prior art could not be found which taught or suggested an implant delivery device which further includes distance indicators and a plurality of apertures arranged along the distance indicators as required by claims 4, 12-13, 18 and 30. Prior art could not be found which taught or suggested a method as required by claims 3 and 10 comprising compressing, prior to inserting the delivery device in the subject, rather the prior art cited (including Eastlack) teaches delivery devices which are in a biased closed state and are expandable through the passage of an implant.
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