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 of the species restriction in the reply filed on January 12, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has elected Species IV: Figures 14-17, wherein applicant states claims 1-20 are directed to the elected species.
However, the Examiner notes that claims 6, 7, 16, 17, 19, and 20 are directed to non-elected species. For example, features of the trial head shaft is offset from the longitudinal axis and an alignment post stated in claims 6 and 7 are directed to non-elected species Figures 6-9 (¶77, ¶78). Features of a bayonet and a bayonet sleeve stated in claims 16 and 17 are directed to non-elected species Figures 10A-13B (¶100, ¶101). Features of a keyed opening, a retention feature, a plunger stated in claims 19 and 20 are directed to non-elected species Figures 10A-13B (¶107, ¶109). Thus, claims 6, 7, 16, 17, 19, and 20 are withdrawn from consideration.
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 § 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) 1, 2, 8-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arramon (US 11,666,460) in view Glerum et al. (US 9,597,200), herein referred to as Glerum.
Regarding claim 1, Arramon discloses a cervical disc instrument (10) (figures 1-6), comprising a handle (see figure 6 below) that defines a cavity therein (see figure 6 below), a trial head (14) coupled to the handle (see figure 6 below) and configured for (i.e. capable of) insertion into a disc space (col. 3, ll. 66-67 and col. 4, ll. 1), and a blade (16) disposed in the cavity of the handle (see figure 6 below) and configured to (i.e. capable of) cut a surface that at least partially defines the disc space when the trial head (14) is located in the disc space (col. 4, ll. 26-29).
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Yet, Arramon lacks the trial head removably coupled to the handle.
However, Glerum teaches a trial head (500) removably coupled (col. 21, ll. 10-12) to a handle (582).
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 Arramon’s trial head and handle to be removably coupled as taught by Glerum, since such a modification would help facilitate easier cleaning of the trial head (col. 21, ll. 10-12).
Regarding claim 2, the modified Arramon’s cervical disc instrument has wherein the trial head (14 of Arramon) is removably coupled (col. 21, ll. 10-12 of Glerum) to the handle (see figure 6 of Arramon above) by a trial head shaft (portion of element 14 of Arramon) extending therebetween (figures 1-6 of Arramon).
Regarding claim 8, the modified Arramon’s cervical disc instrument further comprising a depth stop (50 of Arramon) (figure 7 of Arramon) configured to (i.e. capable of) define a cutting depth of the blade with respect to the surface (col. 4, ll. 50-65 of Arramon).
Regarding claim 9, the modified Arramon’s cervical disc instrument has wherein the blade (16 of Arramon) extends along a longitudinal axis of the cervical disc instrument (10 of Arramon) (figures 1-7 of Arramon) and the depth stop (50 of Arramon) is offset from the longitudinal axis (figures 1-7 of Arramon).
Regarding claim 10, the modified Arramon’s cervical disc instrument has wherein the depth stop (50 of Arramon) includes a depth stop post (54 of Arramon) configured to (i.e. capable of) contact the surface, and a drive shaft (52 of Arramon) coupled to the depth stop post (54 of Arramon) and engaged with a track (figure 7 of Arramon) disposed in the handle (figures 1-7 of Arramon), wherein rotation of the drive shaft (52 of Arramon) about an axis of rotation of the drive shaft moves the depth stop post (54 of Arramon) axially along the axis of rotation (col. 4, ll. 50-65 of Arramon).
Regarding claim 11, the modified Arramon’s cervical disc instrument has wherein the blade (16 of Arramon) is configured to (i.e. capable of) extend through a groove (20 of Arramon) of the trial head (14 of Arramon) to cut the surface (figures 1-6 of Arramon).
Regarding claim 12, Arramon discloses a cervical disc instrument (10) (figures 1-6), comprising a handle (see figure 6 above), a trial head (14) that includes a trial head shaft (24) and that is configured for (i.e. capable of) insertion into a disc space (col. 3, ll. 66-67 and col. 4, ll. 1), wherein the trial head (14) is coupled to the handle (see figure 6 above) by the trial head shaft (portion of element 14), and a blade (16) disposed in a groove (20) of the trial head shaft (portion of element 14) (figures 1-6) and configured to (i.e. capable of) cut a surface that at least partially defines the disc space when the trial head (14) is located in the disc space (col. 4, ll. 26-29).
Yet, Arramon lacks the trial head removably coupled to the handle.
However, Glerum teaches a trial head (500) removably coupled (col. 21, ll. 10-12) to a handle (582).
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 Arramon’s trial head and handle to be removably coupled as taught by Glerum, since such a modification would help facilitate easier cleaning of the trial head (col. 21, ll. 10-12).
Regarding claim 13, the modified Arramon’s cervical disc instrument has wherein the groove (20 of Arramon) extends along a longitudinal axis of the cervical disc instrument (10 of Arramon) (figures 1-6 of Arramon) and the blade (16 of Arramon) is configured to (i.e. capable of) move along the groove (20 of Arramon) (figures 1-6 of Arramon).
Regarding claim 14, the modified Arramon’s cervical disc instrument has wherein the handle defines a cavity (see figure 6 of Arramon above) therein and the cervical disc instrument (the modified Arramon’s cervical disc instrument) further includes a rod (24 of Arramon) that extends through the cavity (see figure 6 of Arramon above) to contact the blade (16 of Arramon).
Regarding claim 15, the modified Arramon’s cervical disc instrument has wherein the rod (24 of Arramon) is configured to (i.e. capable of) move the blade (16 of Arramon) along the groove (20 of Arramon).
Regarding claim 18, the modified Arramon’s cervical disc instrument further comprising a depth stop (50 of Arramon) (figure 7 of Arramon) configured to (i.e. capable of) define a cutting depth of the blade with respect to the surface (col. 4, ll. 50-65 of Arramon), wherein the depth stop (50 of Arramon), the handle (see figure 6 of Arramon above), the trial head (14 of Arramon), and the blade (16 of Arramon) are coaxial along a longitudinal axis of the cervical disc instrument (10 of Arramon) (figure 7 of Arramon).
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.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775