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 with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner reinterpreted the Shoshtaev and Huang in view of the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "horizontal ramps of the rear plate" in line 8. There is insufficient antecedent basis for this limitation in the claim. Line 3 recites that the rear plate only has “a horizontal ramp.” The examiner will treat with art as best understood.
Claim 17 recites the limitation "horizontal ramps of the front plate" in line 10. There is insufficient antecedent basis for this limitation in the claim. Line 2 recites that the front plate only has “a horizontal ramp.” The examiner will treat with art as best understood.
Claim 17 recites the limitation "rear plate ramps" in the last line. There is insufficient antecedent basis for this limitation in the claim. It is not clear which ramps is applicant referring to the horizontal ramp(s) mentioned previously or different ramps of the rear plate. The examiner will treat with art as best understood.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shoshtaev US 2019/0269521 in view of Gray US 2021/0378836.
Regarding Claim 1, Shoshtaev discloses an expandable intervertebral implant (#1310, Fig 70-75, paragraph 251 where #1310 is similar to #10, shown in Figs 3-5) comprising:
a front plate (#1314) and a rear plate (#1316);
an central drive screw (#1312) rotationally coupled to and retained in the rear plate (#1316, Figs 70-75, paragraph 251);
a left side portion assembly (#1322a, #1322c) and a right side portion assembly (#1322b, #1322d) each of the left side portion assembly and the right side portion assembly including upper (#1322a, #1322b) and lower endplates (#1322c, #1322d),
an actuator (#1320a, #1320b, see also Figs 5, where they correspond to #20a, #20b respectively), and
a front ramp (#1318a, #1318b, see also Figs 5 where they correspond to #18am #18b); and
an endplate clip (#1340) positioned around the central drive screw (Figs 70-75) and comprising a plurality of posts (#1342, #1344), wherein the endplate clip is configured to prevent expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width (paragraph 253),
wherein the rear plate (#1316, which corresponds to #16 shown in Figs 5, 10-12) includes a plurality of ramps (#64a-d, #66a-d, see Fig 12, paragraph 153) that interface with corresponding ramps (#130a-d, #136a-d, Fig 17-20, paragraph 153) on the actuators (paragraph 153), and wherein a depth of one (see Fig below, which has a depth that extends along a “first” axis) of the plurality of ramps is different than a depth of another (see Fig below, which has a depth that extends along a “second” axis) of the plurality of ramps (see Fig below where the “one” ramp extends at a greater depth that the “another” ramp)(examiner notes that applicant is not claiming how the depths are different).
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Shoshtaev discloses the posts can come in a variety of shapes (paragraph 252 where the shape can be round like an ellipse) but does not disclose the central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve comprising a pair of keys on an outer surface configured to mate with a pair of keyways in a bore of the front plate to prevent the drive sleeve from rotating; and the endplate clip non-threadbly positioned around the drive sleeve.
Gray discloses a similar expandable intervertebral implant (Fig 75) comprising:
a front plate (#708) and a rear plate (#710) plates;
left (#702) and right (#704) side portion assemblies each including upper (#720) and lower (#722) endplates,
a central drive screw (#706) threadedly engaged with a drive sleeve (#728), where the drive sleeve has a smooth/ non-threaded out surface (Fig 77), the central drive screw retained in the rear plate (#710, Fig 74a-75) and the drive sleeve (#728) comprising a pair of keys (#756, Fig 77) on an outer surface (Fig 77) configured to mate with a pair of keyways (“pair of recesses or keyways in the bore 754” paragraph 210) in a bore (#754, paragraph 210) of the front plate to prevent the drive sleeve from rotating (Fig 77, end of paragraph 210), where the central drive screw and drive sleeve are configured to expand the implant in width and height (paragraph 207, 220). Gray also discloses posts (#792) that have a circular cross section (Fig 79-80) used to help guide expansion of the implant (paragraph 211).
It would have been obvious to one having ordinary skill in the at a time before the effective filing date of the claimed invention to modify Shoshtaev and have the central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate via a pair of keys and corresponding keyways in view of Gray above because this provides a known alternative expansion configuration to house the drive screw and expand the implant in width and then in height. The examiner notes that with the modification, the drive screw is in the drive sleeve, and thus the endplate clip would be positioned around the drive sleeve. As discussed above, since the drive sleeve is smooth and non-threaded, it would also have been obvious that the endplate clip would also be non-threaded in order to fit about the smooth non-threaded drive sleeve. Examiner notes that Shostaev also contemplates other embodiments with non-threaded endplate clips (as seen in Fig 77).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the posts of Shoshtaev to be circular in cross section because this provides a known alternate shape in the art to help guide expansion of the implant. The examiner notes that a circle is a type of ellipse where the distance between two foci is 0.
Regarding Claim 2, Shoshtaev as modified discloses when the drive screw is rotated (paragraph 21-22, 253), the implant expands in width and once the upper and lower endplates are released from the endplate clip, then the implant expands in height (paragraph 253, Figs 70-75 in Shoshtaev).
Regarding Claim 3, Shoshtaev as modified discloses the endplate clip includes a ring (#1316, Fig 73 in Shoshtaev) with a plurality of posts (#1342, #1344, Fig 73 in Shoshtaev) configured to engage the upper and lower endplates (via openings #1350, paragraph 253, Fig 72-75 in Shoshtaev).
Regarding Claim 4, Shoshtaev as modified discloses the ring includes a full ring (Fig 73 in Shoshtaev) defining a central bore (Fig 73 in Shoshtaev) sized and dimensioned to snuggly fit around the drive sleeve (with the modification, it would fit around the drive sleeve as discussed above, where it would be obvious that it would be a snug fit since one would not want the posts to tilt after expanding in width).
Regarding Claim 5, Shoshtaev as modified discloses the posts extend from the ring and terminate at one or more free ends (as seen in Fig 73 in Shoshtaev).
Regarding Claim 6, Shoshtaev as modified discloses before the implant is fully expanded, the free ends of the posts are received in bores (#1350 in Shoshtaev ) through a side wall of the endplates (Figs 70-75 in Shoshtaev), thereby preventing any expansion in height (Figs 70-75, paragraph 253 in Shoshtaev).
Regarding Claim 7, Shoshtaev as modified discloses wherein once fully expanded in width, the endplates move outward and away from one another and the free ends of the posts are released from the bores (paragraph 253, Figs 70-75 in Shoshtaev), thereby allowing the upper and lower endplates to expand in height (Fig 72, 75 in Shoshtaev).
Regarding Claim 8, Shoshtaev as modified discloses wherein a first post (#1342 in Shoshtaev) is positioned above the ring (Fig 73 in Shoshtaev) with two opposed free ends extending into the upper endplates (paragraph 253, Fig 70-71, 74 in Shoshtaev), respectively, and a second post (#1344 in Shoshtaev) is positioned below the ring (Fig 73 in Shoshtaev) with two opposed free ends extending into the lower endplates, respectively (paragraph 253, Fig 70-71, 74 in Shoshtaev).
Regarding Claim 9, Shoshtaev as modified the two posts are aligned in parallel (paragraph 253, Fig 73-75 in Shoshtaev where they would be parallel to maintain horizontal expansion).
Claims 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shoshtaev US 2019/0269521 in view of Gray US 2021/0378836.
Regarding Claim 10, Shoshtaev an expandable intervertebral implant (#10, Figs 3-5, end of paragraph 251 and paragraph 252, where embodiment #10 can include clip #1340 where embodiment #1310 is similar to #10 with like components with a prefix of “13” in front of it compared to #10) comprising:
a front plate having at least two ramps (see Fig below) and
a rear plate (#16) having at least two ramps (see Fig below);
a central drive screw (#12);
a left side portion assembly (#22a, #22c) and a right (#22b, #22d) side portion assembly, wherein the left and right side portion assemblies each include an upper endplate (#22a, #22b), a lower endplate (#22c, #22d),
an actuator (#20a, #20b), and
a front ramp (#18a, #18b),
wherein the actuator of each of the left side portion assembly and the right side assembly portion includes a ramp slidably engaged with one of the ramps of the rear plate (see Fig below, ramped along a horizontal plane, paragraph 153), and
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the front ramp includes a ramp slidably engaged with one of the ramps of the rear plate (see Fig below, ramped along a horizontal plane, paragraph 157); and
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an endplate clip (#1340, Fig 73, paragraph 253) positioned between central drive screw and the upper and lower endplates (Fig 74-75) and comprising a plurality of posts (#1342, #1344), wherein rotation of the drive screw moves the front plate toward the rear plate and the ramp of the actuator slides across the ramp of the rear plate, the ramp of the front ramp slides across the ramp of the front plate, thereby expanding a width of the implant (paragraph 21-22, 253, Fig 3-4, 70-75), and
the endplate clip prevents expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width (paragraph 253),
wherein a depth of one of the at least two ramps (see Fig below, where the “one” ramp has a depth that extends along a first axis) of the rear plate is different than a depth of another of the at least two ramps of the rear plate (see Fig below, the “another” ramp has a depth that extends a second axis, where the “one” ramp extends at a greater depth that the “another” ramp)(examiner notes that applicant is not claiming how the depths are different).
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Shoshtaev discloses the posts can come in a variety of shapes (paragraph 252 where the shape can be round like an ellipse) but does not disclose the central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve comprising a pair of keys of an outer surface configured to mate with a pair of keyways in a bore of the front plate to prevent the drive sleeve from rotating, the endplate clip non-threadably positioned between the drive sleeve and the upper and lower endplates.
Gray discloses a similar expandable intervertebral implant (Fig 75) comprising:
a front plate (#708) and a rear plate (#710) plates;
left (#702) and right (#704) side portion assemblies each including upper (#720) and lower (#722) endplates,
a central drive screw (#706) threadedly engaged with a drive sleeve (#728), where the drive sleeve has a smooth/ non-threaded out surface (Fig 77), the central drive screw retained in the rear plate (#710, Fig 74a-75) and the drive sleeve (#728) comprising a pair of keys (#756, Fig 77) on an outer surface (Fig 77) configured to mate with a pair of keyways (“pair of recesses or keyways in the bore 754” paragraph 210) in a bore (#754, paragraph 210) of the front plate to prevent the drive sleeve from rotating (Fig 77, end of paragraph 210), where the central drive screw and drive sleeve are configured to expand the implant in width and height (paragraph 207, 220). Gray also discloses posts (#792) that have a circular cross section (Fig 79-80) used to help guide expansion of the implant (paragraph 211)
It would have been obvious to one having ordinary skill in the at a time before the effective filing date of the claimed invention to modify Shoshtaev and have the central drive screw threadedly engaged with a drive sleeve, the central drive screw retained in the rear plate and the drive sleeve retained in the front plate via a pair of keys and corresponding keyways in view of Gray above because this provides a known alternative expansion configuration to house the drive screw and expand the implant in width and then in height. The examiner notes that with the modification, the drive screw is in the drive sleeve, and thus the endplate clip would be positioned around the drive sleeve. As discussed above, since the drive sleeve is smooth and non-threaded, it would also have been obvious that the endplate clip would also be non-threaded in order to fit about the smooth non-threaded drive sleeve. Examiner notes that Shostaev also contemplates other embodiments with non-threaded endplate clips (as seen in Fig 77).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the posts of Shoshtaev to be circular in cross section because this provides a known alternate shape in the art to help guide expansion of the implant. The examiner notes that a circle is a type of ellipse where the distance between two foci is 0.
Regarding Claim 11, Shoshtaev as modified discloses the claimed invention as discussed above where Huang further teaches the drive sleeve includes a tubular body (Fig 15-16 in Huang) with an internally threaded bore (#22), and the central drive screw includes an externally threaded shaft (#41) allowing for threaded engagement with the internally threaded bore of the drive sleeve (paragraph 40).
Regarding Claim 12, Shoshtaev as modified discloses the endplate clip includes a ring (#1346, Fig 73 in Shoshtaev) in fitted over the tubular body of the drive sleeve (as discussed in the modification above in view of Gray) with the plurality posts (#1342, #1344 in Shoshtaev) configured to engage the upper and lower endplates (via openings #1350, paragraph 253, Fig 74-75 in Shoshtaev).
Regarding Claim 13, Shoshtaev as modified discloses the endplate clip includes a first post (#1342, Fig 73 in Shoshtaev) affixed to a top of the ring and a second post affixed to a bottom of the ring (#1344, Fig 73 in Shoshtaev).
Regarding Claim 14, Shoshtaev as modified discloses the first post terminates at first and second free ends (as seen in Fig 73 in Shoshtaev) configured to engage the upper endplates(via openings #1350, paragraph 253, Fig 74-75 in Shoshtaev) and the second post terminates at third and fourth free ends (as seen in Fig 73 in Shoshtaev) configured to engage the lower endplates (via openings #1350, paragraph 253, Fig 74-75 in Shoshtaev).
Regarding Claim 15, Shoshtaev as modified discloses, wherein the first and second posts are horizontally aligned with the upper and lower endplates (paragraph 253, Fig 74-75 in Shoshtaev), respectively.
Regarding Claim 16, Shoshtaev as modified discloses before the implant is fully expanded, the free ends of the posts are received in bores (#1350 in Shoshtaev ) through a side wall of the endplates (Figs 70-75 in Shoshtaev), thereby preventing any expansion in height (Figs 70-75, paragraph 253 in Shoshtaev).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huang US 2021/0137695 in view of Shoshtaev US 2019/0269521.
Regarding Claim 17, Huang discloses an expandable intervertebral implant (Fig 1-14) comprising:
front plate (#30) having a horizontal ramp (front plate #30 has horizontal ramps #32, #33);
and rear plate (#20) having a horizontal ramp (rear plate #20 has horizontal ramps #23, paragraph 51 Fig 1-2);
a central drive screw (#40) for moving the front plate relative to the rear plate (paragraph 40-41, Fig 10-14), the central drive screw rotationally coupled to the rear plate (paragraph 38, via screw hole #22);
an expandable assembly including an upper endplate (#13 and/or #11), a lower endplate (#14 and/or #12), an actuator (#17 and/or #15), and a front ramp (#18 and/or #16),
wherein the upper endplate and lower endplate each include a vertical ramp (see Fig below, upper endplate has vertical ramps #130, and/or #111)(lower endplate has vertical ramps #140 and/or #120),
wherein each the actuator includes horizontal ramps (#174 and/or #154) engaged with the horizontal ramps of the rear plate (paragraph 47, 51, Fig 3-4, 9) and
vertical ramps (#170, #171 and/or #150, #151) engaged with the vertical ramps of the upper and lower endplates (paragraph 49, Fig 3-12), and
the front ramp has horizontal ramps (#184 and/or #164) engaged with the horizontal ramps of the front plate (paragraph 48, 50, 52, Figs 3-4, 9) and
vertical ramps (#180, #181 and/or #160, #161) interfacing with the vertical ramps of the upper and lower endplates (paragraph 50, Figs 3-12),
wherein the depths of the rear plate ramps differ (see Fig below, Fig 1 paragraph 51 where the ramps #23 are made of inclined planes and dovetail in shape, where the ramps #23 each have a depth measured vertically, where a depth of one of the ramps measured vertically and closest to the central vertical axis is different than a depth of another ramp #23 measured vertically and away from the central vertical axis)(examiner notes that applicant is not claiming how the depths are measured).
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Huang discloses the central drive screw (#40) is received in a drive sleeve (#21, Fig 11) that is smooth and non-threaded (Fig 11) and where the implant expands in width first then in height (Figs 3, 9-14, paragraph 41)but does not disclose an endplate clip non-threadably attached the drive sleeve the endplate clip comprising a plurality of posts having a circular cross-section and configure to prevent expansion of the upper and lower endplates in height until the expandable assembly is fully expanded in width.
Shoshtaev discloses a similar expandable intervertebral implant (#1310 , Fig 70-75, paragraph 251 where #1310 is similar to #10, shown in Figs 3-5) comprising:
front (#1314) and rear (#1316) plates;
an central drive screw (#1312) retained in the rear plate (#1316, Figs 70-75, paragraph 251);
upper (#1322a, #1322b) and lower endplates (#1322c, #1322d),
an actuator (#1320a, #1320b, see also Figs 5, where they correspond to #20a, #20b respectively), and
a front ramp (#1318a, #1318b, see also Figs 5 where they correspond to #18am #18b); and
an endplate clip (#1340) positioned around the central drive screw (Figs 70-75), the endplate clip comprising a plurality of posts (#1342, #1344) that can come in a variety of shapes (paragraph 252 where the shape can be round like an ellipse) and configured to prevent expansion of the upper and lower endplates in height until the left and right side portion assemblies are fully expanded in width (paragraph 253, where posts #1342, #1344 of the clip are inserted into corresponding bores #1350 in the upper and lower endplates) to stabilize expansion in width prior to expansion in height (paragraph 253), where the posts ensures the upper and lower endplates remain generally parallel to one another during width expansion (paragraph 252).
Regarding Claim 18, Shoshtaev discloses, wherein the plurality of posts (#1342, #1344) receivable in corresponding bores (#1350) in the upper and lower endplates (Figs 70-75, paragraph 253).
Regarding Claim 19, Shoshtaev discloses, wherein the endplate clip only permits lateral expansion of the expandable assembly until the posts disengage from the bores in the upper and lower endplates (paragraph 253).
Regarding Claim 20, Shoshtaev discloses wherein a first post (#1342) is receivable in the bore (#1350) in the upper endplate (Figs 70-75, paragraph 253) and a second post (#1344) is receivable in the bore (#1350) in the lower endplate (Figs 70-75, paragraph 253), and the first and second posts are aligned in parallel (Fig 73-75, paragraph 253, parallel to allow a stabile width expansion).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Huang to include an endplate clip and for the upper and lower endplates to include corresponding holes to accept posts of the endplate clip in view of Shoshtaev above because this helps stabilize width expansion and prevents horizontal expansion until width expansion is complete. The examiner notes that with the modification, the drive screw is in the drive sleeve since the central drive screw is placed in the drive sleeve, and thus the endplate clip would be positioned around the drive sleeve. As discussed above, since the drive sleeve of Huang is smooth and non-threaded, it would also have been obvious that the endplate clip would also be non-threaded in order to fit about the smooth non-threaded drive sleeve. Examiner notes that Shostaev also contemplates other embodiments with non-threaded endplate clips (as seen in Fig 77).
Huang further discloses another embodiment (Fig 15) with a plurality of posts (#820) comprising a plurality of posts having a circular cross-section (as seen in Fig 15-16) that are inserted into corresponding bores (#81) in the upper and lower endplates (#11, #13, #14, #12) (Figs 22), where the circular shape is a known shape to help guide lateral/width expansion of the endplates of the implant and maintain the upper and lower endplates to be generally parallel during lateral/width expansion (paragraph 60, Fig 22).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Huang as modified by Shoshtaev to have the posts have a circular cross section in view of another embodiment of Huang because this provides a known alternate shape for posts to help guide lateral/width expansion of the endplates and to maintain the endplates to be generally parallel during lateral/width expansion. The examiner notes that a circle is a type of ellipse where the distance between two foci is 0.
Conclusion
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773