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 .
Status of the Claims
This Office Action is responsive to the amendment filed May 11, 2026. As directed by the amendment: Claims 1, 8, 10, 12, and 18 have been amended. Claims 6, 7, 16, 17, 19, and 20 were withdrawn. Claims 1-20 are presently pending in this application.
Examiner’s Note
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.
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 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allard et al. (US 7,766,918), herein referred to as Allard.
Regarding claim 1, Allard discloses a cervical disc instrument (10) (figure 1), comprising a handle (100, 200, 300) that defines a cavity therein (figure 1), a trial head (110, 210) removably coupled to the handle (100, 200, 300) and configured for (i.e. capable of) insertion into a disc space (col. 4, ll. 20-21), a depth stop (400) including a depth stop drive shaft (420) and a depth stop post (410) driven by the depth stop drive shaft (420) (col. 5, ll. 12-39), the depth stop post (410) coupled to the depth stop drive shaft (420) by a pair of opposing depth stop pins (elements 412) (figure 5), and a blade (500) disposed in the cavity of the handle (100, 200, 300) (figure 1) and configured to (i.e. capable of) cut a surface that at least partially defines the disc space when the trial head is located in the disc space (col. 6, ll. 52-67).
Regarding claim 8, Allard discloses wherein the depth stop (410) is configured to (i.e. capable of) define a cutting depth of the blade (500) with respect to the surface.
Regarding claim 9, Allard discloses wherein the blade (500) extends along a longitudinal axis (figure 5) of the cervical disc instrument (10) and the depth stop (400) is offset from the longitudinal axis (figures 1 and 5).
Regarding claim 10, Allard discloses wherein the depth stop post (410) is configured to (i.e. capable of) contact the surface, and the drive shaft (420) coupled to the depth stop post (410) is engaged with a track (figures 1, 4, 5) disposed in the handle (100, 200, 300), wherein rotation of the drive shaft (420) about an axis of rotation of the drive shaft moves the depth stop post (410) axially along the axis of rotation (col. 5, ll. 40-57).
Regarding claim 11, Allard discloses wherein the blade (500) is configured to (i.e. capable of) extend through a groove (122) of the trial head (110, 210) to cut the surface.
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) 2, 12-14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard (US 7,766,918) in view of Fischer et al. (US 7,749,271), herein referred to as Fischer.
Regarding claim 2, Allard’s cervical disc instrument discloses all the features/elements as claimed but lacks wherein the trial head is removably coupled to the handle by a trial head shaft extending therebetween.
However, Fischer teaches a trial head (24) is removably coupled (col. 8, ll. 18-43) to a handle (14+16) by a trial head shaft (34) extending therebetween (figures 1 and 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allard’s cervical disc instrument with wherein the trial head is removably coupled to the handle by a trial head shaft extending therebetween as taught by Fischer, since such a modification would result in a removable trial head.
Regarding claim 12, Allard discloses a cervical disc instrument (10) (figure 1), comprising a handle (100, 200, 300), a trial head (110, 210) that is configured for (i.e. capable of) insertion into a disc space (col. 4, ll. 20-21), a depth stop (400) including a depth stop drive shaft (420) and a depth stop post (410) driven by the depth stop drive shaft (420) (col. 5, ll. 12-39), the depth stop post (410) coupled to the depth stop drive shaft (420) by a pair of opposing depth stop pins (elements 412) (figure 5), and a blade (500) configured to (i.e. capable of) cut a surface that at least partially defines the disc space when the trial head is located in the disc space (col. 6, ll. 52-67).
Yet, Allard lacks the trial head that includes a trial head shaft and that is configured for insertion into a disc space, wherein the trial head is removably coupled to the handle by the trial head shaft, a blade disposed in a groove of the trial head shaft and configured to cut a surface that at least partially defines the disc space when the trial head is located in the disc space.
However, Fischer teaches a trial head (24) that includes a trial head shaft (34) and that is configured for (i.e. capable of) insertion into a disc space, wherein the trial head (24) is removably coupled (col. 8, ll. 18-43) to the handle (14+16) by the trial head shaft (34), a blade (112) disposed in a groove (110) of the trial head shaft (34) (figure 1) and configured to (i.e. capable of) cut a surface that at least partially defines the disc space when the trial head (24) is located in the disc space (figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allard’s cervical disc instrument with the trial head that includes a trial head shaft and that is configured for insertion into a disc space, wherein the trial head is removably coupled to the handle by the trial head shaft, a blade disposed in a groove of the trial head shaft and configured to cut a surface that at least partially defines the disc space when the trial head is located in the disc space as taught by Fischer, since such a modification would result in a removable trial head and further guide the blade along the handle.
Regarding claim 13, the modified Allard’s cervical disc instrument has wherein the groove (110 of Fischer) extends along a longitudinal axis of the cervical disc instrument (the modified Allard’s cervical disc instrument) and the blade (figure 1 of Fischer) is configured to (i.e. capable of) move along the groove.
Regarding claim 14, the modified Allard’s cervical disc instrument has wherein the handle (100, 200, 300 of Allard) defines a cavity therein (figures 6 and 7 of Allard) and the cervical disc instrument (the modified Allard’s cervical disc instrument) further includes a rod (figures 6 and 7 of Allard) that extends through the cavity to contact (has been interpreted as indirect contact) the blade (500 of Allard).
Regarding claim 18, the modified Allard’s cervical disc instrument has wherein the depth stop (400 of Allard) is configured to (i.e. capable of) define a cutting depth of the blade with respect to the surface, wherein the depth stop (400 of Allard), the handle (100, 200, 300 of Allard), the trial head (110, 210 of Allard), and the blade (500 of Allard) are coaxial along a longitudinal axis of the cervical disc instrument (figure 5 of Allard).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard and Fischer as applied to claims above, and further in view of Grinberg et al. (US 2006/0084986), herein referred to as Grinberg.
Regarding claim 3, the modified Allard’s cervical disc instrument discloses all the features/elements as claimed but lacks wherein the trial head shaft engages a latch mechanism disposed in the handle to removably couple the trial head to the handle.
However, Grinberg teaches a trial head shaft (114) engages a latch mechanism (figure 3) disposed in a handle (318) to removably couple a trial head (112) to the handle (figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the modified Allard’s cervical disc instrument with wherein the trial head shaft engages a latch mechanism disposed in the handle to removably couple the trial head to the handle as taught by Grinberg, since such a modification is a mere substitution of one known coupling mechanism for another to yield predictable results.
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 1-5, 8-15, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/788,478 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. For example, claim 1 of the co-pending application ‘478 states the features of “a blade component movably coupled to the handle, wherein a groove of the handle is configured to guide the blade along the groove of the handle” wherein it appears the terms “groove” and “cavity” are used interchangeably. Claim 9 of the co-pending application ‘478 discloses all the features/elements as claims 1 and 12 of the instant application except for a depth stop. However, claims 8-10 and 18 of the instant application clearly contemplates a depth stop. Claim 14 of the co-pending application ‘478 discloses all the features/elements as claim 1 of the instant application such as a handle, a trial head, a blade except for a latch mechanism. However, claims 3 and 4 of the instant application clearly contemplates a latch mechanism.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed May 11, 2026 have been fully considered. Applicant’s arguments with respect to the references Arramon and Glerum 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.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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