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 .
Election/Restrictions
Applicant’s election without traverse of Species C (Figs. 17A-D, 18A-D, 19A-C and 20) in the reply filed on March 14, 2026, is acknowledged.
Claim Objections
Claim 7 is objected to because of the following informalities:
In claim 7, line 4, “configured urge” should read ---configured to urge---.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-9, 11-12, 14-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Soo (US 2021/0052307 A1).
Regarding claim 1, Soo discloses a system (100; Fig. 1A; para. 0044) configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of adjacent vertebrae of a spine (see Figs. 5A-7), the system comprising:
a dynamic implant (100; Figs. 1A-D) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (shown in exemplary embodiment of implant 100 as implant 610/620/630/640 in Fig. 6; para. 0091-0092), the dynamic implant comprising:
an interconnecting member (124; Fig. 1A; para. 0046) comprising:
a proximal superior surface (140; Fig. 1B; para. 0052) comprising a superior concavity (146; Fig. 1D) shaped to receive the superior spinous process in the implanted position (see Figs. 1A-D and 6); and
a proximal inferior surface (150; Fig. 1B; para. 0053) comprising an inferior concavity (156; Fig. 1D) shaped to receive the inferior spinous process in the implanted position (see Figs. 1A-D and 6);
a superior member (120; Figs. 1A, 2A; para. 0046) comprising a distal superior surface (142; Fig. 1B; para. 0052), distal to the proximal superior surface (see Fig. 1B), that faces the superior lamina in the implanted position (see Figs. 1A-D, 6);
an inferior member (122; Figs. 1A, 2A; para. 0046) comprising a distal inferior surface (152; Fig. 1B; para. 0053), distal to the proximal inferior surface (see Fig. 1B), that faces the inferior lamina in the implanted position (see Figs. 1A-D, 6); and
a block (threaded block 132; Figs. 1A-2D; para. 0048) configured to move within a cavity between the superior member and the inferior member such that, with the dynamic implant in a deployed configuration, the block urges the superior member and the inferior member to move apart (threaded block 132 is operable to move distally, via threaded member 130, to move the implant from a retracted configuration shown in Figs. 1A-D to a deployed configuration shown in Figs. 2A-D, as described in at least para. 0052).
Soo further recites that the “implant 100 may be formed of any known biocompatible materials, including but not limited to […] biocompatible polymers such as Polyether ether ketone (PEEK)” and states that in some embodiments the implant “may be formed of a less rigid material so that the superior member 120 and the inferior member 122 can bend to spread apart from each other in order to allow the distal end 137 of the cavity 134 to widen as the threaded block 132 moves into the distal end 137” (recited in para. 0063, with reference to at least Figs. 1A-2D).
However, Soo does not explicitly disclose wherein the block is a resilient block.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Soo’s block of a resilient material such as PEEK, so as to provide the claimed resilient block, because, where Soo recognizes that the implant may generally be formed of a “less rigid material” such as PEEK (i.e., a resilient material) since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, and providing a resilient movable block would further enable dynamic movement of the implant to more appropriately mimic natural resilient movement between adjacent vertebrae of the patient’s spine. In re Leshin, 125 USPQ 416.
Regarding claim 2, Soo teaches the system of claim 1, wherein the dynamic implant further comprises: two superior wings (126; Fig. 1A; para. 0047), comprising superior tips (170; Fig. 1D; para. 0055), extending superiorly from the proximal superior surface such that, in the implanted position, the superior spinous process is received between the two superior wings (as shown; Figs. 6-7); and two inferior wings (128; Fig. 1A; para. 0047), comprising inferior tips (174; Fig. 1D; para. 0056), extending inferiorly from the proximal superior surface such that, in the implanted position, the inferior spinous process is received between the two inferior wings (as shown; Figs. 6-7); wherein the superior tips are displaced, along a proximal-distal direction, from the inferior tips (as shown in Figs. 1B, 2B).
Regarding claim 3, Soo teaches the system of claim 1, wherein the dynamic implant further comprises: a superior hinge (superior living hinge 200; Fig. 2B; para. 0064) configured to rotatably couple the superior member and the interconnecting member (see Figs. 1A-2D and para. 0064); and an inferior hinge (202; Fig. 2B; para. 0064) configured to rotatably couple the inferior member and the interconnecting member (see Figs. 1A-2D and para. 0064).
Regarding claim 6, Soo teaches the system of claim 1, wherein, the dynamic implant further comprises a threaded member (130; Figs. 1A-2D; para. 0048) configured to rotatably engage the resilient block such that rotation of the threaded member urges the resilient block to translate distally thereby urging the dynamic implant to move from a retracted configuration to the deployed configuration (as shown between Figs. 1A-2D for rotatably engaging block 132, i.e. the resilient block as described above, recited in at least para. 0048 and 0052-0053).
Regarding claim 7, Soo teaches the system of claim 6, further comprising an inserter (400; Fig. 4; para. 0071) comprising:
a proximal end (430; Fig. 4; para. 0076) comprising a handle (not shown, described in para. 0083 as secured to proximal end 430);
a distal end (432; Fig. 4) configured to grip the dynamic implant (see Fig. 5A); and
a rotary element (406; Figs. 5A-B; para. 0072) configured urge the threaded member to rotate to move the resilient block in a proximal-distal direction and the dynamic implant from the retracted configuration to the deployed configuration (para. 0072 recites that “drive rod 406 may be a rotary element that rotates the threaded member” to move the block 132 from the retracted configuration in Figs. 1A-D to the deployed configuration in Figs. 2A-D).
Regarding claim 8, Soo teaches a system (100; Fig. 1A; para. 0044) configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of adjacent vertebrae of a spine (see Figs. 5A-7), the system comprising:
An implant (100; Figs. 1A-D) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (shown in exemplary embodiment of implant 100 as implant 610/620/630/640 in Fig. 6; para. 0091-0092), the implant comprising:
an interconnecting member (124; Fig. 1A; para. 0046) comprising:
a proximal superior surface (140; Fig. 1B; para. 0052) comprising a superior concavity (146; Fig. 1D) shaped to receive the superior spinous process in the implanted position (see Figs. 1A-D and 6); and
a proximal inferior surface (150; Fig. 1B; para. 0053) comprising an inferior concavity (156; Fig. 1D) shaped to receive the inferior spinous process in the implanted position (see Figs. 1A-D and 6);
a superior member (120; Figs. 1A, 2A; para. 0046) rotatably coupled to the interconnecting member (via superior living hinge 200; Fig. 2B; para. 0064) and comprising a distal superior surface (142; Fig. 1B; para. 0052), distal to the proximal superior surface (see Fig. 1B), that faces the superior lamina in the implanted position (see Figs. 1A-D, 6);
an inferior member (122; Figs. 1A, 2A; para. 0046) rotatably coupled to the interconnecting member (via inferior living hinge 202; Fig. 2B; para. 0064) and comprising a distal inferior surface (152; Fig. 1B; para. 0053), distal to the proximal inferior surface (see Fig. 1B), that faces the inferior lamina in the implanted position (see Figs. 1A-D, 6);
a threaded member (130; Figs. 1A-2D; para. 0048) extending along a proximal-distal direction and captive within the interconnecting member (as shown; Figs. 1A-2D); and
a block (threaded block 132; Figs. 1A-2D; para. 0048) configured to advance distally between the superior member and the inferior member to cause the superior member and the inferior member to rotate apart (threaded block 132 is operable to move distally, via threaded member 130, to move the implant from a retracted configuration shown in Figs. 1A-D to a deployed configuration shown in Figs. 2A-D, as described in at least para. 0052) and to maintain displacement between the superior member and the inferior member with the implant in a deployed configuration (as shown in Figs. 6 and/or 7).
Regarding claim 9, Soo teaches the system of claim 8, wherein the implant further comprises: a superior hinge (superior living hinge 200; Fig. 2B; para. 0064) configured to rotatably couple the superior member and the interconnecting member (see Figs. 1A-2D and para. 0064); and an inferior hinge (202; Fig. 2B; para. 0064) configured to rotatably couple the inferior member and the interconnecting member (see Figs. 1A-2D and para. 0064).
Regarding claim 11, Soo teaches the system of claim 8, wherein the implant further comprises: two superior wings (126; Fig. 1A; para. 0047), comprising superior tips (170; Fig. 1D; para. 0055), extending superiorly from the proximal superior surface such that, in the implanted position, the superior spinous process is received between the two superior wings (as shown; Figs. 6-7); and two inferior wings (128; Fig. 1A; para. 0047), comprising inferior tips (174; Fig. 1D; para. 0056), extending inferiorly from the proximal superior surface such that, in the implanted position, the inferior spinous process is received between the two inferior wings (as shown; Figs. 6-7); wherein the superior tips are displaced, along a proximal-distal direction, from the inferior tips (as shown in Figs. 1B, 2B).
Regarding claim 12, Soo teaches the system of claim 8, wherein the block (132; Figs. 1A-2D) is configured to move within a cavity between the superior member and the inferior member such that, with the implant in the deployed configuration, the resilient block urges the superior member and the inferior member to move apart (threaded block 132 is operable to move distally, via threaded member 130, to move the implant from a retracted configuration shown in Figs. 1A-D to a deployed configuration shown in Figs. 2A-D, as described in at least para. 0052).
Soo further recites that the “implant 100 may be formed of any known biocompatible materials, including but not limited to […] biocompatible polymers such as Polyether ether ketone (PEEK)” and states that in some embodiments the implant “may be formed of a less rigid material so that the superior member 120 and the inferior member 122 can bend to spread apart from each other in order to allow the distal end 137 of the cavity 134 to widen as the threaded block 132 moves into the distal end 137” (recited in para. 0063, with reference to at least Figs. 1A-2D).
However, Soo does not explicitly disclose wherein the block is a resilient block.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Soo’s block of a resilient material such as PEEK, so as to provide the claimed resilient block, because, where Soo recognizes that the implant may generally be formed of a “less rigid material” such as PEEK (i.e., a resilient material) since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, and providing a resilient movable block would further enable dynamic movement of the implant to more appropriately mimic natural spinal movement. In re Leshin, 125 USPQ 416.
Regarding claim 14, Soo teaches the system of claim 6, further comprising an inserter (400; Fig. 4; para. 0071) comprising: a proximal end (430; Fig. 4; para. 0076) comprising a handle (not shown, described in para. 0083 as secured to proximal end 430); a distal end (432; Fig. 4) configured to grip the dynamic implant (see Fig. 5A); and a rotary element (406; Figs. 5A-B; para. 0072) configured urge the threaded member to rotate to move the block in a proximal-distal direction and the implant from the retracted configuration to the deployed configuration (para. 0072 recites that “drive rod 406 may be a rotary element that rotates the threaded member” to move the block 132 from the retracted configuration in Figs. 1A-D to the deployed configuration in Figs. 2A-D).
Regarding claim 15, Soo discloses a system (100; Fig. 1A; para. 0044) configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of adjacent vertebrae of a spine (see Figs. 5A-7), the system comprising:
a dynamic implant (100; Figs. 1A-D) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (shown in exemplary embodiment of implant 100 as implant 610/620/630/640 in Fig. 6; para. 0091-0092), the dynamic implant comprising:
an interconnecting member (124; Fig. 1A; para. 0046) comprising:
a proximal superior surface (140; Fig. 1B; para. 0052) comprising a superior concavity (146; Fig. 1D) shaped to receive the superior spinous process in the implanted position (see Figs. 1A-D and 6); and
a proximal inferior surface (150; Fig. 1B; para. 0053) comprising an inferior concavity (156; Fig. 1D) shaped to receive the inferior spinous process in the implanted position (see Figs. 1A-D and 6);
a superior member (120; Figs. 1A, 2A; para. 0046) comprising a distal superior surface (142; Fig. 1B; para. 0052), distal to the proximal superior surface (see Fig. 1B), that faces the superior lamina in the implanted position (see Figs. 1A-D, 6);
an inferior member (122; Figs. 1A, 2A; para. 0046) comprising a distal inferior surface (152; Fig. 1B; para. 0053), distal to the proximal inferior surface (see Fig. 1B), that faces the inferior lamina in the implanted position (see Figs. 1A-D, 6); and
a resilient block (threaded block 132; Figs. 1A-2D; para. 0048) configured to be positionable between the superior member and the inferior member and between the superior lamina and the inferior lamina (as shown, Figs. 1A-2D, 6-7).
Soo further recites that the “implant 100 may be formed of any known biocompatible materials, including but not limited to […] biocompatible polymers such as Polyether ether ketone (PEEK)” and states that in some embodiments the implant “may be formed of a less rigid material so that the superior member 120 and the inferior member 122 can bend to spread apart from each other in order to allow the distal end 137 of the cavity 134 to widen as the threaded block 132 moves into the distal end 137” (recited in para. 0063, with reference to at least Figs. 1A-2D).
However, Soo does not explicitly disclose wherein the block is a resilient block.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Soo’s block of a resilient material such as PEEK, so as to provide the claimed resilient block, because, where Soo recognizes that the implant may generally be formed of a “less rigid material” such as PEEK (i.e., a resilient material) since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, and providing a resilient movable block would further enable dynamic movement of the implant to more appropriately mimic natural spinal movement. In re Leshin, 125 USPQ 416.
Regarding claim 19, Soo teaches the system of claim 15, wherein the dynamic implant further comprises: a superior hinge (superior living hinge 200; Fig. 2B; para. 0064) configured to rotatably couple the superior member and the interconnecting member (see Figs. 1A-2D and para. 0064); and an inferior hinge (202; Fig. 2B; para. 0064) configured to rotatably couple the inferior member and the interconnecting member (see Figs. 1A-2D and para. 0064).
Allowable Subject Matter
Claims 4-5, 10, 13, 16-18 and 20 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:
Claims 4, 10 and 20 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in these claims. In particular, none of the cited references teach or suggest “wherein the superior hinge comprises a first hinge portion and a third hinge portion rotatably coupled with the first hinge portion using a superior hinge pin, and the inferior hinge comprises a second hinge portion and a fourth hinge portion rotatably coupled with the second hinge portion and a fourth hinge portion rotatably coupled with the second hinge portion using an inferior hinge pin” as required by claims.
Claims 5, 13 and 16 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in these claims. In particular, none of the cited references teach or suggest “wherein the resilient block comprises a plurality of flexible struts configured to expand and contract in a generally superior-inferior direction” as required by claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant prior art can be found in the attached PTO-892, including Salvermoser (US 2017/0252073 A1) and Ganter (US 2017/0027619 A1), each directed towards intervertebral implants engaging superior/inferior spinous processes, with Ganter disclosing a resilient block disposed between superior and inferior elements of the implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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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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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773