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.
Claim(s) 19-25, 27-28 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-9 of U.S. Patent No. 11,998,221 B2.
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
19. A medical instrument for decorticating a vertebral endplate of a vertebra of a spine via a cannula during a surgical spine procedure, the medical instrument comprising: a handle; a controller connected to the handle; a first arm extending from the controller and defining a first arm distal end; a second arm extending from the controller opposite to the first arm and defining a second arm distal end; a control shaft defining a control shaft distal end, a control shaft proximal end, and a longitudinal axis, the control shaft disposed between the first and second opposing arms, the control shaft proximal end operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the first and second opposing arms; a decorticating head for decorticating a vertebral endplate of a vertebra, the decorticating head having an upper surface, a first blade extending along a first side of the upper surface and projecting laterally outward from the first side, and a second blade extending along a second side of the upper surface opposite the first side, the decorticating head pivotally coupled to the first arm and the second arm via a pivot for an angular articulation relative to the longitudinal axis of the control shaft; and a pivot mechanism disposed on and between the decorticating head and the control shaft distal end and configured to provide controlled articulation of the decorticating head through longitudinally axial movement of the control shaft.
1. A medical instrument for decorticating a vertebral endplate of a vertebra of a spine via a cannula during a surgical spine procedure comprising: a handle; a controller connected to the handle; a first arm extending from the controller and defining a first arm distal end; a second arm extending from the controller opposite to the first arm and defining a second arm distal end; a control shaft defining a control shaft distal end, a control shaft proximal end, and a longitudinal axis, the control shaft disposed between the first and second opposing arms, the control shaft proximal end operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the first and second opposing arms; a decorticating head for decorticating a vertebral endplate of a vertebra, the decorticating head having an end surface, an upper surface, a lower surface opposite the upper surface, a first lateral side surface between the upper surface and the lower surface, and a second lateral side surface between the upper surface and the lower surface and opposite to the first lateral side surface, a first single blade extending along a first side length of the upper surface and projecting laterally outward from the first lateral side surface, and a second single blade extending along a second side length of the upper surface opposite the first single blade and projecting laterally outward from the second lateral side surface, the decorticating head and pivotally connected to the first arm distal end and the second arm distal end via a single pivot for 90° articulation about the first arm and the second arm; and a pivot mechanism situated on and between the decorticating head and the control shaft distal end and configured to provide controlled articulation of the decorticating head through longitudinally axial movement of the control shaft.
20. The medical instrument of claim 19, wherein the first and second blades are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90°.
2. The medical instrument of claim 1, wherein the first single blade and the second single blade are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90°, relative to the longitudinal axis of the control shaft.
21. The medical instrument of claim 20, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end, and includes a hole at the decorticating head proximal end adjacent the first and second blades.
3. The medical instrument of claim 2, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end, and includes a hole at the decorticating head proximal end adjacent the first and second blades.
22. The medical instrument of claim 21, wherein the pivot mechanism includes a slot situated in the decorticating head distal end, and a post situated in the control shaft distal end and extending into the slot.
4. The medical instrument of claim 3, wherein the pivot mechanism includes a slot situated in the decorticating head distal end, and a post situated in the control shaft distal end and extending into the slot.
23. The medical instrument of claim 22, wherein the slot is angled relative to the longitudinal axis of the control shaft.
5. The medical instrument of claim 4, wherein the slot is angled relative to the longitudinal axis of the control shaft.
24. An articulating curette for decorticating a vertebral endplate of a vertebra of a spine during a surgical spine procedure, the articulating curette comprising: a handle; a controller connected to the handle; a shaft assembly including: two opposing arms extending from the controller; and a control shaft disposed between the two opposing arms and defining a longitudinal axis, the control shaft operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the two opposing arms; a decorticating head for decorticating a vertebral endplate of a vertebra, the decorticating head having an upper surface, a first blade extending along a first side of the longitudinal axis upper surface and projecting laterally outward from the first side, and a second blade extending along a second side of the longitudinal axis upper surface opposite the first side and projecting laterally outward from the second side, the decorticating head pivotally coupled to the two opposing arms for articulation via a pivot relative to the longitudinal axis of the control shaft; and a pivot mechanism disposed on and between the decorticating head and the control shaft for providing controlled articulation of the decorticating head through longitudinally axial movement of the control shaft.
6. An articulating curette for decorticating a vertebral endplate of a vertebra of a spine during a surgical spine procedure comprising: a handle; a controller connected to the handle; a shaft assembly including: two opposing arms extending from the controller and defining two arm ends distal to the controller; and a control shaft defining a distal control shaft end and a proximal control shaft end and disposed between the two opposing arms, the control shaft proximal end operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the two opposing arms; a decorticating head for decorticating a vertebral endplate of a vertebra, the decorticating head having an end surface, an upper surface, a lower surface opposite the upper surface, a first lateral side surface between the upper surface and the lower surface, and a second lateral side surface between the upper surface and the lower surface and opposite to the first lateral side surface, a first single blade extending along a first side length of the upper surface and projecting laterally outward from the first lateral side surface, and a second single blade extending along a second side length of the upper surface opposite the first single blade and projecting laterally outward from the second lateral side surface, the decorticating head pivotally connected to the two arm ends of the two opposing arms via a single pivot for 90° articulation about the two opposing arms; and a pivot mechanism situated on and between the decorticating head and the control shaft distal end for providing controlled articulation of the decorticating head through longitudinally axial movement of the control shaft.
25. The articulating curette of claim 24, wherein the first and second blades are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90°.
7. The articulating curette of claim 6, wherein the first single blade and the second single blade are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90°, relative to the longitudinal axis of the control shaft.
27. The articulating curette of claim 26, wherein the pivot mechanism includes a slot and a post extending into the slot.
9. The articulating curette of claim 8, wherein the pivot mechanism includes a slot situated in the decorticating head distal end, and a post situated in the control shaft distal end and extending into the slot.
28. The articulating curette of claim 27, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end.
8. The articulating curette of claim 7, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end, and includes a hole at the decorticating head proximal end adjacent the first single blade and the second single blade.
As is evident from the table above, Patent claims 1 and 6 explicitly discloses all of the features of application claims 19 and 24, except Patent claims 1 and 6 use slightly different wording e.g. “connected” and “situated” instead of “coupled” and “disposed”, however it is clear that these words can be used interchangeably. In addition, since the first single blade in patent claim 1 extends along a first side, it is clear that patent claim 1 discloses, regarding claim 19, the second side being opposite the first side. And further, since the decorticating head is disclosed in patent claims 1 and 6 as being pivoted 90º about the first and second arm and the control shaft is disposed between the first and second opposing arms for longitudinal movement, it is clear that patent claims 1 and 6 discloses, regarding claims 19 and 24 that the decorticating head pivots for an angular articulation relative to the longitudinal axis of the control shaft.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sack et al. (U.S. Pub. No. 2015/0173808 A1, hereinafter “Sack”).
Sack discloses, regarding claim 19, a medical instrument (200, see Figs. 15.1-15.3) for decorticating a vertebral endplate of a vertebra of a spine via a cannula during a surgical spine procedure (see para. [0092]), the medical instrument comprising: a handle (14); a controller (6) connected to the handle (14); a first arm extending from the controller and defining a first arm distal end (see annotated Fig. 15.2 below); a second arm extending from the controller opposite to the first arm and defining a second arm distal end (see annotated Fig. 15.2 below); a control shaft (4) defining a control shaft distal end (e.g. end that attaches to 205), a control shaft proximal end (e.g. end that attaches to 6), and a longitudinal axis (e.g. long axis of 4), the control shaft disposed between the first and second opposing arms (see Fig. 15.2), the control shaft proximal end operably coupled to the controller (6) for longitudinally axial movement of the control shaft by the controller relative to the first and second opposing arms (see para. [0090]); a decorticating head (221) for decorticating a vertebral endplate of a vertebra (see para. [0092]), the decorticating head having an upper surface (see annotated Fig. 15.3 below), a first blade (236) extending along a first side of the upper surface and projecting laterally outward from the first side (see annotated Fig. 15.3 below), and a second blade (236) extending along a second side of the upper surface opposite the first side and projecting laterally outward from the second side (see annotated Fig. 15.3 below), the decorticating head pivotally coupled to the first arm and the second arm via a pivot (8) for an angular articulation relative to the longitudinal axis of the control shaft (see Figs. 15.2-15.3); and a pivot mechanism (205) disposed on and between the decorticating head and the control shaft distal end and configured to provide controlled articulation of the decorticating head through longitudinally axial movement of the control shaft (see Figs. 15.2-15.3 and para. [0090]).
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Regarding claim 20, wherein the first and second blades are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90° (see Figs. 15.1-15.2, see para. [0092]).
Regarding claim 21, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end (see annotated Fig. 15.1 below), and includes a hole at the decorticating head proximal end adjacent the first and second blades (see annotated Fig. 15.1 below).
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Regarding claim 22, wherein the pivot mechanism includes a slot situated in the decorticating head distal end (see annotated Fig. 15.3 below), and a post situated in the control shaft distal end and extending into the slot (e.g. pivot pin, see para. [0090]).
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Regarding claim 23, wherein the slot is angled relative to the longitudinal axis of the control shaft (see Fig. 15.3).
Sack discloses, regarding claim 24, an articulating curette (200, see Figs. 15.1-15.3) for decorticating a vertebral endplate of a vertebra of a spine during a surgical spine procedure (see para. [0092]), the articulating curette comprising: a handle (14); a controller (6) connected to the handle (14); a shaft assembly including: two opposing arms extending from the controller (see annotated Fig. 15.2 above); and a control shaft (4) disposed between the two opposing arms and defining a longitudinal axis (e.g. long axis of 4), the control shaft operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the two opposing arms (see para. [0090]); a decorticating head (221) for decorticating a vertebral endplate of a vertebra, the decorticating head having an upper surface (see annotated Fig. 15.3 below), a first blade (236) extending along a first side of the surface and projecting laterally outward from the first side (see annotated Fig. 15.3 above), and a second blade (236) extending along a second side of the upper surface opposite the first side and projecting laterally outward from the second side (see annotated Fig. 15.3 below), the decorticating head pivotally coupled to the two opposing arms for articulation via a pivot relative to the longitudinal axis of the control shaft (8, see Figs. 15.2-15.3); and a pivot mechanism (205) disposed on and between the decorticating head and the control shaft for providing controlled articulation of the decorticating head through longitudinally axial movement of the control shaft (see Figs. 15.2-15.3 and para. [0090]).
Regarding claim 25, wherein the first and second blades are each configured to decorticate a vertebral endplate when the decorticating head is pivoted from 0° to 90° (see Figs. 15.1-15.2, see para. [0092]).
Regarding claim 26, wherein the control shaft further defines a control shaft distal end (e.g. end that attaches to 205) and a control shaft proximal end (e.g. end that attaches to 6), and wherein the control shaft proximal end is operably coupled to the controller (see para. [0090]).
Regarding claim 27, wherein the pivot mechanism includes a slot (see annotated Fig. 15.3 above) and a post extending into the slot (e.g. pivot pin, see para. [0090]).
Regarding claim 28, wherein the decorticating head defines a decorticating head proximal end and a decorticating head distal end (see annotated Fig. 15.1 above).
Regarding claim 29, wherein the slot is disposed on the decorticating head distal end, and the post is disposed on the control shaft distal end (see Fig. 15.3).
Regarding claim 30, wherein the slot is angled relative to the longitudinal axis of the control shaft (see Fig. 15.3).
Regarding claim 31, wherein the slot extends at an angle from the post relative to the longitudinal axis toward the proximal end of the control shaft (see Fig. 15.3).
Regarding claim 32, wherein the decorticating head includes an opening adjacent the first and second blades and configured to receive decorticated vertebral endplate material (see annotated Fig. 15.2 above).
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.
Claim(s) 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sack et al. (U.S. Pub. No. 2015/0173808 A1, hereinafter “Sack”) in view of Phillips et al. (U.S. Pub. No. 2005/0113838 A1, hereinafter “Phillips”).
Sack discloses, regarding 33, a method of decorticating a vertebral endplate of a vertebra of a spine (see para. [0092]), the method comprising: and an articulating curette (200, see Figs. 15.1-15.3), the articulating curette comprising: a handle (14); a controller (6) connected to the handle (14); a shaft assembly including: two opposing arms extending from the controller and defining two arm ends distal to the controller (see annotated Fig. 15.2 above); and a control shaft (4) disposed between the two opposing arms and defining a longitudinal axis (e.g. long axis of 4), the control shaft operably coupled to the controller for longitudinally axial movement of the control shaft by the controller relative to the two opposing arms (see para. [0090]); a decorticating head (221) for decorticating a vertebral endplate of a vertebra (see para. [0092]), the decorticating head having an upper surface (see annotated Fig. 15.2 above), a first blade (236) extending along a first side of the upper surface and projecting laterally outward from the first side (see annotated Fig. 15.2 above), and a second blade (236) extending along a second side of the longitudinal axis upper surface opposite the first side and projecting laterally outward from the second side (see annotated Fig. 15.2 above), the decorticating head pivotally coupled to the two arm ends of the two opposing arms for articulation via a pivot relative to the longitudinal axis of the control shaft (8, see Figs. 15.2-15.3); and a pivot mechanism (205) disposed on and between the decorticating head and the control shaft distal end for providing controlled articulation of the decorticating head through longitudinally axial movement of the control shaft (see Figs. 15.2-15.3 and para. [0090]); making an incision in a body of a patient adjacent desired vertebrae (see para. [0089] “annulotomy”); inserting the articulating curette (see paras. [0089] and [0093]); operating the articulating curette to decorticate the vertebral endplate by the decorticating head when the decorticating head is pivoted from about 0° to about 90° (see Fig. 15.2, see para. [0092]).
Regarding claim 34, wherein the first and second blades of the articulating curette are each configured to decorticate the vertebral endplate when the decorticating head is pivoted from 0° to 90° (see Fig. 15.2, see para. [0092]).
Regarding claim 35, wherein the decorticating head of the articulating head defines a decorticating head proximal end and a decorticating head distal end (see annotated Fig. 15.1 above), and includes a hole at the decorticating head proximal end adjacent the first and second blades (see annotated Fig. 15.2 above).
Regarding claim 36, wherein the pivot mechanism of the articulating curette includes a slot situated in the decorticating head distal end (see annotated Fig. 15.3 above), and a post situated in the control shaft distal end and extending into the slot (e.g. pivot pin, see para. [0090]).
Regarding claim 37, wherein the slot of the pivot mechanism of the articulating curette is angled relative to the longitudinal axis of the control shaft (see Fig. 15.3).
Sacks fails to disclose, regarding claim 33, the method comprising providing a cannula; inserting the cannula in the incision; and inserting and removing the articulating curette from the cannula.
Phillips discloses a method of decorticating a vertebral endplate of a vertebra of a spine (see para. [0070]) with an articulating curette (10 and 20), wherein the method includes inserting a cannula (23) in the incision (see para. [0074]), and inserting and removing the articulating curette from the cannula (see paras. [0074] and [0124]) in order to enable the tool to be introduced in a minimally invasive procedure (see para. [0074]) and into a desired treatment region (see para. [0098]) and enable the surgeon to complete the procedure (see para. [0124]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Sacks to include providing a cannula and inserting the cannula in the incision, and inserting and removing the articulating curette in the cannula in view of Phillips in order to enable the tool to be introduced in a minimally invasive procedure and into a desired treatment region and enable the surgeon to complete the procedure.
Response to Arguments
Applicant’s arguments with respect to claim(s) 19-37 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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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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