DETAILED ACTION
This action is in response to applicant’s amendment received on June 23rd, 2026.
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.
Claims 1, 5-8, 11, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Marnay (U.S. Patent 7,204,852) in view of Zucherman (U.S. Publication 2004/0138749) and in view of Bouchot (U.S. Publication 2014/0249636) and in view of Jodaitis (U.S. Patent 8,465,546).
Regarding claims 1 and 5-8:
Marnay discloses a device (for example see Figure 1) comprising:
(claim 1) a cervical spacer (10) including
(claim 1) an upper keel (16)
(claim 1) wherein the upper keel extends along a vertical plane
(claim 1) wherein the upper keel includes
(claim 1) an upper proximal opening (17)
(claim 1) wherein the upper opening is capable of receiving an arm of an implant inserter
(claim 1) a lower keel (40)
(claim 1) wherein the lower keel extends along the vertical plane
(claim 1) wherein the lower keel includes
(claim 1) a lower proximal opening (41)
(claim 1) wherein the lower opening is capable of receiving an arm of an implant inserter
Marnay fails to disclose the device wherein the upper keel includes a series of three spaced apart keel projections, the device further comprising a packaging insert, and the device further comprising a package.
Regarding the upper keel including a series of three spaced apart keel projections, Zucherman teaches a device comprising a spacer (100) comprising an upper keel (for example 116) and a lower keel (for example 126), wherein the upper keel includes a series of three spaced apart keel projections (for example see Figure 2A). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was to provide the device of Marnay wherein the upper keel includes a series of three spaced apart keel projections in view of Zucherman, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a keel on a spacer. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the device further comprising a packaging insert, Bouchot teaches a device comprising a spacer (2) and a packaging insert (1), wherein the packaging insert includes a main body in contact with the spacer and a latch (10) extending from the main body capable of being attached to an implant inserter such that the packaging insert remains attached to the implant inserter when separated from the spacer (paragraph 10) in order to hold the spacer in a stable configuration as a sterile packaged kit. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Marnay as modified by Zucherman further comprising a packaging insert in view of Bouchot in order to hold the spacer in a stable configuration as a sterile packaged kit.
Regarding claims 5-8, the device of Marnay as modified by Zucherman as further modified by Bouchot discloses a device wherein the latch includes a snap fit latch having a pair of legs extending proximally from the main body and a pair of hooks disposed at proximal ends of the legs to snap fit over a pair of mating tabs on the implant inserter, wherein the pair of legs are resiliently moveable radially outward relative to a central axis of the main body, wherein proximal portions of the legs form a curved shape complimentary to a shape of a distal portion of an implant inserter, and wherein the latch includes a pair of hooks lying along a plane lateral to the vertical plane and adapted to snap fit over a pair of mating tabs of the implant inserter (see Figure 1 of Bouchot; see paragraph 31 of Bouchot).
Regarding the device further comprising a package, Jodaitis teaches a device comprising a spacer (104) and a packaging insert (106), wherein the device further comprises a package (103) including a recess for receiving the spacer and the packaging insert in order to provide a sterile package for the device. It would have been obvious to one having ordinary skill in the art at the time the invention as filed to provide the device of Marnay as modified by Zucherman as further modified Bouchot wherein the device further comprises a package in view of Jodaitis in order to provide a sterile package for the device.
Regarding claims 11 and 15-18:
Marnay discloses a device (for example see Figure 1) comprising:
(claim 11) a cervical spacer including
(claim 11) an upper endplate (11) including
(claim 11) an upper proximal opening (17; the opening is in the keel which is part of the endplate)
(claim 11) an upper keel (16) extending along a vertical plane
(claim 11) a lower endplate (30) including
(claim 11) a lower proximal opening (41; the opening is in the keel which is part of the endplate)
(claim 11) a lower keel (40) extending along the vertical plane
Marnay fails to disclose the device wherein the upper keel includes a series of three spaced apart keel projections, the device further comprising a packaging insert, and the device further comprising a package.
Regarding the upper keel including a series of three spaced apart keel projections, Zucherman teaches a device comprising a spacer (100) comprising an upper keel (for example 116) and a lower keel (for example 126), wherein the upper keel includes a series of three spaced apart keel projections (for example see Figure 2A). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was to provide the device of Marnay wherein the upper keel includes a series of three spaced apart keel projections in view of Zucherman, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a keel on a spacer. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding the device further comprising a packaging insert, Bouchot teaches a device comprising a spacer (2) and a packaging insert (1), wherein the packaging insert includes a main body in contact with the spacer and a snap fit latch (10) extending from the main body capable of being attached to an implant inserter such that the packaging insert remains attached to the implant inserter when separated from the spacer (paragraph 10) in order to hold the spacer in a stable configuration as a sterile packaged kit. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Marnay as modified by Zucherman further comprising a packaging insert in view of Bouchot in order to hold the spacer in a stable configuration as a sterile packaged kit.
Regarding claims 15-18, the device of Marnay as modified by Zucherman as further modified by Bouchot discloses a device wherein the snap fit latch includes a pair of legs extending proximally from the main body and a pair of hooks disposed at proximal ends of the legs to snap fit over a pair of mating tabs on the implant inserter, wherein the pair of legs are resiliently moveable radially outward relative to a central axis of the main body, wherein proximal portions of the legs form a curved shape complimentary to a shape of a distal portion of an implant inserter, and wherein the latch includes a pair of hooks lying along a plane lateral to the vertical plane and adapted to snap fit over a pair of mating tabs of the implant inserter (see Figure 1 of Bouchot; see paragraph 31 of Bouchot).
Regarding the device further comprising a package, Jodaitis teaches a device comprising a spacer (104) and a packaging insert (106), wherein the device further comprises a package (103) including a recess for receiving the spacer and the packaging insert in order to provide a sterile package for the device. It would have been obvious to one having ordinary skill in the art at the time the invention as filed to provide the device of Marnay as modified by Zucherman as further modified by Bouchot wherein the device further comprises a package in view of Jodaitis in order to provide a sterile package for the device.
Claims 2-4, 9, 10, 12-14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Marnay (U.S. Patent 7,204,852) in view of Zucherman (U.S. Publication 2004/0138749) further in view of Bouchot (U.S. Publication 2014/0249636) further in view of Jodaitis (U.S. Patent 8,465,546) further in view of Fuhrer (U.S. Patent 9,937,060).
The device of Marnay as modified by Zucherman as further modified by Bouchot as further modified by Jodaitis discloses the invention as claimed except for the packaging insert including at least one spacing element. Fuhrer teaches a device comprising a spacer (2) and a packaging insert (3) having a main body (5), wherein the packaging insert further includes a spacer element (6) having a first laterally spaced extension, a second laterally spaced extension, a first vertically spaced spacing element (upper element 7), and a second vertically spaced spacing element (lower element 7) that include the laterally spaced extensions (6) such that each extend distally from the main body between the upper and lower endplates of the spacer along a plane lateral to a vertical plane of the device in order to hold the elements of the spacer in a predetermined configuration during packaging. It would have been obvious to one having ordinary skill in the art at the time the invention as filed to provide the device of Marnay as modified by Zucherman as further modified by Bouchot as further modified by Jodaitis wherein the spacer includes vertically spaced spacing elements and laterally spaced extensions in view of Fuhrer in order to hold the elements of the space in a predetermined configuration during packaging.
The device of Marnay as modified by Zucherman as further modified by Bouchot as further modified by Jodaitis as further modified by Fuhrer discloses a device wherein the vertically spaced spacing elements and the laterally spaced extensions would be located between the upper and lower keels and the upper and lower endplates.
Response to Arguments
Applicant's arguments filed June 23rd, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the new limitations added to the claims which are discussed in the new grounds of rejection provided above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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