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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 & 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 2, 5, 6, & 9-14 of related U.S. Patent No. 11,737,890.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites an expandable intervertebral implant (See Line 1, Claim 1 of the patent) comprising: an upper body portion (See Line 2, Claim 1 of the patent); a lower body portion opposite the upper body portion (See Line 3, Claim 1 of the patent); a wedge member connecting the upper body portion to the lower body portion (See Lines 4-5, Claim 1 of the patent); a nose member having a tapered distal end and a proximal end opposite the distal end, the nose member slidably connected to the upper body portion and the lower body portion (See Lines 6-9, Claim 1 of the patent); and an actuator disposed along a longitudinal axis between a tip of the nose member and a back surface of the wedge member (See Lines 10-14, Claim 1 of the patent); the actuator at a distal end slidably connected the nose member and at a proximal end connecting to the wedge member, wherein translation of the wedge member along the longitudinal axis of the implant displaces the upper body portion and the lower body portion away from each other, thereby expanding the implant (See Lines 21-24, Claim 1 of the patent).
Regarding Claims 2 & 4-20: Claim 2 of the application is substantially similar to Claim 12 of the patent. The limitations of Claim 4 of the application are found in Claim 1 of the patent. Claims 5-6 of the application are substantially similar to Claims 4-5 of the patent. The limitations of Claims 7-8 of the application are found in Claim 9 of the patent. The limitations of Claim 9 of the application are found in Claim 1 of the patent. Claims 10-11 of the application are substantially similar to Claims 10-11 of the patent. Claims 13-14 of the application are substantially similar to Claims 13-14 of the patent. Claim 20 of the application is substantially similar to Claim 2 of the patent.
Claims 1-2 & 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-5, 7-16 & 18 of related U.S. Patent No. 11,173,044.
Claim 1 of the application recites an expandable intervertebral implant (See Line 1, Claims 1 & 18 of the patent) comprising: an upper body portion (See Line 2, Claims 1 & 18 of the patent); a lower body portion opposite the upper body portion (See Line 3, Claims 1 & 18 of the patent); a wedge member connecting the upper body portion to the lower body portion (See Lines 4-5, Claims 1 & 18 of the patent); a nose member having a tapered distal end and a proximal end opposite the distal end, the nose member slidably connected to the upper body portion and the lower body portion (See Lines 6-9, Claims 1 & 18 of the patent); and an actuator disposed along a longitudinal axis between a tip of the nose member and a back surface of the wedge member (See Lines 10-12, Claims 1 & 18 of the patent); the actuator at a distal end slidably connected the nose member and at a proximal end connecting to the wedge member, wherein translation of the wedge member along the longitudinal axis of the implant displaces the upper body portion and the lower body portion away from each other, thereby expanding the implant (See Lines 20-24, Claims 1 & 18 of the patent).
Regarding Claims 2 & 4-20: Claim 2 of the application is substantially similar to Claim 11 of the patent. The limitations of Claim 4 of the application are found in Claim 18 of the patent. Claims 5-6 of the application are substantially similar to Claims 4-5 of the patent. The limitations of Claims 7-8 of the application are found in Claim 7 of the patent. The limitations of Claim 9 of the application are found in Claims 1 & 18 of the patent. Claims 10-12 of the application are substantially similar to Claims 8-10 of the patent. Claims 13-14 of the application are substantially similar to Claims 12-13 of the patent. Claims 15-17 of the application are substantially similar to Claims 14-16 of the patent. The limitations of Claims 18-19 of the application are found in Claim 2 of the patent. Claim 20 of the application is substantially similar to Claim 3 of the patent.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker (US Patent No. 10,278,830).
Regarding Claim 1, Walker discloses an expandable intervertebral implant (implant 20, Figs. 1-7, Col. 5, Line 24- Col. 8, Line 59) comprising: an upper body portion (4, Fig. 4) portion; a lower body portion (6, Fig. 4) opposite the upper body portion; a wedge member (5, Fig. 4) connecting the upper body portion to the lower body portion (Figs. 1-2); a nose member (1, Fig. 4) having a tapered distal end (angled front portion of 1, Figs. 1-4) and a proximal end (dovetailed rear portion of 1, Figs. 1-4) opposite the distal end, the nose member slidably connected to the upper body portion and the lower body portion (via cooperating dovetails 24 on 1, 4 & 6, Fig. 5); and an actuator (3, Fig. 4) disposed along a longitudinal axis (axis running centrally through length of 20 between opposing ends, Fig. 6) between a tip of the nose member and a back surface of the wedge member (Fig. 6); the actuator at a distal end (leading end at head 3b, Fig. 4) slidably connected the nose member and at a proximal end (trailing end at 3a, Fig. 4) connecting to the wedge member (Fig. 2, Col. 6, Lines 1-18), wherein translation of the wedge member along the longitudinal axis of the implant displaces the upper body portion and the lower body portion away from each other, thereby expanding the implant (between an unexpanded configuration as seen in Fig. 1 and an expanded configuration as seen in Fig. 2, Col. 6, Lines 19-30).
Regarding Claim 2, Walker discloses wherein the wedge member (5) comprises a central opening (30, Figs. 4 & 7) on the longitudinal axis for reception of a driver for rotating the actuator (Col. 7, Lines 13-30).
Regarding Claim 3, Walker discloses wherein the wedge member (5) extends along the longitudinal axis, and the actuator (3) is disposed on the longitudinal axis (Figs. 3 & 6).
Regarding Claim 4, Walker discloses wherein the wedge member extends along the longitudinal axis (Fig. 6), and the actuator is disposed laterally offset from the longitudinal axis (the head portion 3b of the actuator 3 is disposed offset from the longitudinal axis of the implant as seen in Fig. 6).
Regarding Claim 5, Walker discloses wherein dovetails (24 of 5, Figs. 4-5) on the wedge member (5) hold and slidably connect the upper body portion and the lower body portion to the wedge member (Col. 6, Lines 31-61) (Figs. 1-2).
Regarding Claim 6, Walker discloses wherein dovetail grooves (24 of 1, Figs. 4-5) on the nose member (1) hold and slidably connect the upper body portion and the lower body portion to the nose member (Col. 6, Lines 31-61) (Figs. 1-2).
Regarding Claim 7, Walker discloses wherein the actuator by turning (via driver, Fig. 7) advances the wedge member toward the nose member to expand the implant (Col. 5, Lines 40-45, Col. 7, Lines 25-30).
Regarding Claim 8, Walker discloses wherein the actuator and the wedge member have threads to thereby advance the wedge member when the actuator is turned (Col. 6, Lines 1-18).
Regarding Claim 9, Walker discloses a pin (pin 2, Fig. 4) connected to the actuator for positioning the nose member relative to the actuator (Col. 5, Lines 27-36).
Regarding Claim 10, Walker discloses wherein the pin maintains a position of the nose member relative to the actuator once the implant has been assembled (Col. 5, Lines 30-36), the position being offset from a longitudinal axis of the wedge member (the pin 2 maintains flat front surface of the nose member 1 with respect to the actuator 3, where the flat front surface of 1 is offset from a longitudinal axis of the wedge member).
Regarding Claim 11, Walker discloses wherein, on a posterior side of the implant (at the tip/front side of implant 20), plural dovetail grooves in the nose member (inner grooves for 3b and outer grooves 24 for wedge member, Fig. 1-4) respectively hold and slidably connect the upper body portion and the lower body portion to the nose member (Figs. 1-2, Col. 6, Lines 31-61).
Regarding Claim 12, Walker discloses wherein, on an anterior side of the implant (at the back/rear side of implant 20), a dovetail groove in the wedge member (dovetails 24 in 5, Fig. 5) holds and slidably connects the upper body portion and the lower body portion to the nose member (Figs. 1-2, Col. 6, Lines 31-61).
Regarding Claim 20, Walker discloses a bone graft window opening (8, Figs. 5-6) in at least one of the upper body portion and the lower body portion (Col. 6, Lines 62-66).
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 13 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US Patent No. 10,278,830) in view of Seifert et al. (US Patent No. 10,350,081).
Regarding Claim 13, Walker et al. discloses the claimed invention as stated above in claim 1, including wherein the wedge member comprises a leading wedge (wedge member 5a, Fig. 4) and a trailing wedge (wedge member 5b, Fig. 4) connected together by a pair of rails (rails 5c, Fig. 4). Walker et al. does not disclose wherein the wedge member comprises an intermediate wedge comprising a pair of wedges with a gap in between.
Seifert et al. discloses the wedge member (carriage 156) of the implant (spacer 100) comprising 3 wedges, (leading, intermediate, and trailing ramps 168, Fig. 5), and further discloses in Col. 8, Lines 38-57 that “While three mating ramps 164, 168 are illustrated for each endplate 110, 112, it should be understood that one, two, or more than three sets of ramps 164, 168 may be provided. Mating ramps 164, 168 operate to enable a reduction or increase in height by sliding against each other as actuator screw 154 is rotated.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the wedge member of the implant of Walker et al. to add an intermediate third wedge as taught by Seifert et al. as an alternate and functionally equivalent means for enabling the reduction or expansion of the implant at various heights based on the particular needs of a patient and a surgeon’s preference.
Claims 14-15 is rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US Patent No. 10,278,830) in view of Seifert et al. (US Patent No. 10,350,081) as applied to claim 13 above, and further in view of Weiman et al. (US PG Pub No. 2016/0151168).
Regarding Claims 14-15, the combination of Walker et al. and Seifert et al. discloses the claimed invention as stated above in claim 13, except wherein a posterior wedge of the pair of wedges is shorter in height than an anterior wedge of the pair of wedges, relative heights of the posterior wedge and the anterior wedge defining a lordotic angle tapering downward toward a posterior side of the implant, wherein the anterior wedge has a) an upper half with a superior dovetail disposed outside a bone graft window and b) a lower half with an inferior dovetail disposed outside the bone graft window. Walker et al. does disclose wherein upper halves of the wedges comprise superior dovetails (upper grooves 24 in the wedges of 5) disposed outside a bone graft window (window formed between 5c & 5c, Figs. 5-6) and wherein lower halves of the wedges comprise inferior dovetails (lower grooves 24 in the wedges of 5) disposed outside the bone graft window (Figs. 4-5).
Weiman et al. discloses an expandable intervertebral implant (10, Figs. 59-64, Paragraphs [0155-0156]) comprising an upper endplate, a lower endplate, and a ramped wedge member therebetween, wherein the implant may have a lordotic angle (theta sub LA) of approximately 0 degrees when in the unexpanded position and wherein in an expanded position, lordotic expansion may be achieved by use of different ramp angles with respect to a longitudinal axis (512). Weiman et al. teaches that the angles may each individually be selected from about 5 degrees to about 85 degrees (Paragraphs [0155-0156]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the angles of the ramped wedges of the implant of the combination such that a posterior wedge of the pair of wedges is shorter in height than an anterior wedge of the pair of wedges, and relative heights of the posterior wedge and the anterior wedge defining a lordotic angle tapering downward toward a posterior side of the implant, wherein the anterior wedge has an upper half with a superior dovetail disposed outside the bone graft window and a lower half with an inferior dovetail disposed outside the bone graft window, as taught by Weiman et al. in order to provide the implant with a lordotic angle between the upper and lower body portions when in an expanded position as needed based on a particular patient’s needs.
Claims 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US Patent No. 10,278,830) in view of Gray et al. (US PG Pub No. 2014/0277471).
Regarding Claims 18-19, Walker et al. discloses the claimed invention as stated above in claim 1, except wherein the actuator comprises a washer disposed on a flange of the actuator, wherein the washer comprises a compressible frictional bearing held in a compressed state between the actuator and the nose member, thereby providing a frictional force retarding movement of the upper body portion relative to the lower body portion.
Gray et al. discloses an expandable intervertebral implant (100, Figs. 1 & 8) comprising an upper body portion (110), a lower body portion (112), a wedge member (156, Fig. 4), a nose member (set screw 178), and an actuator (154, Figs. 4 & 8) disposed between the nose member and the wedge member (Paragraph [0072]), wherein a PEEK thrust washer (184, Fig. 8) is disposed on a distal flange of the actuator (distal most tip of 172, Figs. 4, 9-10, Paragraph [0082]) and used between the actuator and the wedge member to minimize friction during expansion of implant 100.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the implant of Walker et al. to add a PEEK thrust washer to the distal-most end of the actuator as taught by Gray et al. in order to provide the implant with a wear surface between the actuator and the nose which would provide an added means for absorbing friction between the rotating actuator and the nose member during expansion of the implant.
Allowable Subject Matter
Claims 16-17 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: Walker et al. discloses the claimed invention as stated above, except wherein the posterior wedge has a) an upper half with a superior dovetail disposed inside a bone graft window and b) a lower half with an inferior dovetail groove disposed outside the bone graft window, wherein, in a collapsed state on a posterior side of the implant, an upper ramp extending downward from the upper body portion overlaps a lower ramp extending upward from the lower body portion, and an upper dovetail groove in the upper ramp on the posterior side engages the superior dovetail inside the bone graft window and a lower dovetail groove in the lower ramp on the posterior side engages the inferior dovetail that is disposed outside the bone graft window. Furthermore, no art was found which could have been used to reasonably modify Walker et al. as claimed without destroying the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/ Primary Examiner, Art Unit 3775