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 .
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 1-4, 7, 15, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0194930 (Hess) in view of U.S. Patent Application Publication No. 2005/0182416 (Lim).
Regarding claim 1, Hess discloses a spinal implant (implants 10/100/200/300; embodiment 100 will be detailed below) comprising: a main body (112) defining a proximal end (end of body 112 with anchor collar 122), a distal end (end of body 112 with blades 116/118), and a longitudinal axis (axis along the length of body 112) between the proximal end and the distal end, wherein the main body defines a central bore (114) extending longitudinally through the main body and a window (apertures in which blades 116/118 are stowed and deployed from, see Figs. 6-9) extending laterally through an outer surface of the main body; a proximal anchor (122) defining a proximal side (side without blades 124/126), a distal side (side with blades 124/126), and an internal bore (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3), wherein the internal bore receives at least a portion of the main body (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3); a plunger (132) disposed within the central bore; a distal anchor (116/118) disposed at least partially with the window, the distal anchor comprising a plurality of wings (116/118) having a closed configuration (see Fig. 8) and an open configuration (see Fig. 9), wherein the distal anchor pivotably couples to the distal end of the main body at a first pivot point (20); wherein distal movement of the plunger along the longitudinal axis pivots the plurality of wings distally about the first pivot point to move the plurality of wings to the open configuration (see Figs. 8 and 9 and paragraph [0051])
Further regarding claim 1, Hess fails to disclose a plurality of linkages pivotably coupling the plurality of wings of the distal anchor to a distal region of the plunger at a second pivot point, and wherein proximal movement of the plunger along the longitudinal axis pivots the plurality of wings proximally about the first pivot point to move the plurality of wings to the closed configuration. However, Lim discloses a spinal implant (10) including a distal anchor with a plurality of wings (41/42) and a plunger (70), wherein a plurality of linkages (26/27) pivotably couples the wings to a distal region of the plunger at a second pivot point (31). Additionally, Lim discloses longitudinal movement of the internal plunger in opposing directions opens and folds the first anchor and the second anchor to transition between the open and closed configurations (see paragraphs [0033], [0034], and [0043]).
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the spinal implant of Hess to use a linkage to couple the plurality of wings to a distal region of the plunger as suggested by Lim in order to allow for movement of the plunger to control both opening and closing of the spinal implant (see paragraphs [0033], [0034], and [0043]), and because such a modification merely involves substituting one known spinal implant expansion mechanism (plunger + linkage of Lim) for another known spinal implant expansion mechanism (plunger + abutment surface of Hess) without any unpredictable results.
Regarding claim 2, Hess discloses wherein the window houses at least a portion of the plurality of wings when the distal anchor is in the closed configuration (see Fig. 8; apertures in which blades 116/118 are stowed).
Regarding claim 3, Lim discloses wherein the plurality of wings of the distal anchor defines slots (see marked-up Fig. 3 below), and wherein, in the closed configuration, each of the slots receives a portion of the plurality of linkages (see Figs. 1-3).
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Regarding claim 4, Hess discloses wherein the distal region of the plunger comprises at least one indentation (see marked-up Fig. 8 below), and wherein the closed configuration comprises the at least one indentation receiving a portion of the distal anchor (see marked-up Fig. 8 below).
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Regarding claim 7, Hess discloses wherein the proximal anchor comprises a nut (142/44, similar to 42/44, see paragraph [0050]), the nut forming a grip plate for gripping tissue and/or bone (via plates with spikes 40, see paragraph [0049]), wherein the nut comprises a hexagonal extension (50, see paragraph [0050]). Additionally, Hess suggests wherein an internal bore of a proximal anchor (260) comprises threading that cooperates with the threading on the outer surface of a corresponding main body (212) (see paragraph [0053]), and it would have been prima facie obvious to have the proximal anchor in all the embodiments threadedly cooperate with their corresponding main bodies in order to facilitate movement of the anchor along the main body (see Hess, paragraph [0053]).
Regarding claim 15, Hess discloses a method of placing a spinal implant (100) at a treatment site comprising: providing the spinal implant in a closed configuration (see Fig. 8), the spinal implant comprising: a main body (112) defining a proximal end (end of body 112 with anchor collar 122), a distal end (end of body 112 with blades 116/118), and a longitudinal axis (axis along the length of body 112) extending therebetween, the main body defining a central bore (114) extending longitudinally through the main body; a proximal anchor (122) defining a proximal side (side without blades 124/126), a distal side (side with blades 124/126), and an internal bore (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3), wherein the internal bore receives at least a portion of the main body (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3); a plunger (132) received by the central bore; and a distal anchor (116/118) comprising a plurality of wings (116/118) coupled to the distal end of the main body at a first pivot point (20); placing the spinal implant in a patient at a desired treatment site (see paragraphs [0009], [0010], and [0051]); and sliding the plunger distally along the longitudinal axis to thereby pivot the plurality of wings distally about the first pivot point to an open configuration (see Fig. 9 and paragraph [0051]), the open configuration comprising: at least a portion of each of the plurality of wings extending radially outward from the main body (see Fig. 9; free ends of each wing 116/118 extending radially outward from the main body 112).
Further regarding claim 15, Hess fails to disclose a plurality of linkages pivotably coupling the plurality of wings to a distal region of the plunger at a second pivot point. Regarding claim 16, Hess discloses the closed configuration comprising at least a portion of each of the plurality of wings disposed within a window (apertures in which blades 116/118 are stowed and deployed from, see Figs. 6-9) extending laterally through an outer surface of the main body (see Fig. 8), but fails to disclose sliding the plunger proximally along the longitudinal axis to thereby pivot the plurality of wings proximally about the main body to the closed configuration. However, Lim discloses a spinal implant (10) including a distal anchor with a plurality of wings (41/42) and a plunger (70), wherein a plurality of linkages (26/27) pivotably couples the wings to a distal region of the plunger at a second pivot point (31). Additionally, Lim discloses longitudinal movement of the internal plunger in opposing directions opens and folds the first anchor and the second anchor to transition between the open and closed configurations (see paragraphs [0033], [0034], and [0043]).
Further regarding claims 15 and 16, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the spinal implant of Hess to use a linkage to couple the plurality of wings to a distal region of the plunger as suggested by Lim in order to allow for movement of the plunger to control both opening and closing of the spinal implant (see paragraphs [0033], [0034], and [0043]), and because such a modification merely involves substituting one known spinal implant expansion mechanism (plunger + linkage of Lim) for another known spinal implant expansion mechanism (plunger + abutment surface of Hess) without any unpredictable results.
Regarding claim 18, Hess discloses wherein, in the open configuration, each of the plurality of wings engage bone or tissue at the treatment site (see paragraph [0045]; positive engagement of spinous processes via spikes 15 on each wing).
Regarding claim 19, Hess discloses wherein the first pivot point corresponds to a first position on the longitudinal axis of the main body (see paragraphs [0045] and [0051] and Figs. 8 and 9; position of pin 20 used to mount wings 116/118 to main body 112). Hess as modified by Lim in claim 15 above results in a second pivot point corresponding to a position on the plunger, the plunger being proximal of the first pivot point in Hess (see Figs. 8 and 9 of Hess); thus, the second position is proximally located relative to the first position of the first pivot point when the spinal implant is in the closed configuration.
Regarding claim 20, Hess discloses moving the proximal anchor distally along the main body to engage the distal side of the proximal anchor with tissue or bone at the treatment site (see paragraphs [0046] and [0051]; engagement with tissue or bone via spikes 40 on distal side of the proximal anchor).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hess in view of Lim, and further in view of U.S. Patent Application Publication No. 2016/0166396 (McClintock).
Alternatively regarding claim 3, McClintock discloses a spinal implant (100) including anchors (110/130) and linkages (178/180), wherein an anchor (110) includes a first slot (between posts 122, see paragraphs [0063] and [0072] and Fig. 2) for receiving linkage (178) therein. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Hess in view of Lim to have the linkages received in slots on the wings as suggested by McClintock as such a modification merely involves a substitution of one known mechanism for attaching linkages to anchors for another known mechanism for attaching linkages to anchors with the predictable results of attaching the linkages to the anchors.
Regarding claim 4, Hess discloses wherein the distal region of the plunger comprises at least one indentation (see marked-up Fig. 8 above), and wherein the closed configuration comprises the at least one indentation receiving a portion of the distal anchor-region of the anchor (see marked-up Fig. 8 above).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hess in view of Lim, and further in view of U.S. Patent Application Publication No. 2007/0049934 (Edidin).
Regarding claim 8, Hess discloses wherein the plunger defines a recess (see paragraph [0048] and Figs. 8, 12, and 16, e.g.), but fails to disclose wherein the recess is a threaded bore for receiving a threaded portion of an inserter device. However, Edidin discloses a spinal implant (7100) which defines a threaded recess (7113 or 7155 or 7123) which is a threaded bore for receiving a threaded portion of an inserter device (7200) (see paragraphs [0042]-[0045]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the plunger recess to be a threaded bore for receiving a threaded portion of an inserter device in order to facilitate positioning and deployment of the spinal implant (see Edidin, paragraphs [0042]-[0045]).
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, 6, 9, 10, 14-17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 17, and 18 of U.S. Patent No. 11,534,310 (Frock ‘310).
Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include the subject matter of the application claims plus additional elements, and are thus more specific. Thus the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1, 5, 6, 9, 10, and 14 are anticipated by claim 1 of Frock ‘310.
Claims 15 and 17 are anticipated by claim 15 of Frock ‘310.
Claim 16 is anticipated by claim 18 of Frock ‘310.
Claims 20 is anticipated by claim 17 of frock ‘310.
Claim 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 12, 15, and 18-20 of U.S. Patent No. 12,263,095 (Frock ‘095) in view of Hess.
Regarding claim 1, claim 1 of Frock ‘095 discloses all of the subject matter of claim 1 except for a proximal anchor defining a proximal side, a distal side, and an internal bore, wherein the internal bore receives at least a portion of the main body. However, Hess discloses a spinal implant (implants 10/100/200/300; embodiment 100 will be detailed below) comprising: a main body (112); a distal anchor (116/118); and a proximal anchor (122) defining a proximal side (side without blades 124/126), a distal side (side with blades 124/126), and an internal bore (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3), wherein the internal bore receives at least a portion of the main body (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the spinal implant of claim 1 of Frock ‘095 to include a proximal anchor in order to facilitate secure attachment of the spinal implant between adjacent spinal processes by allow the spinal implant to grip opposite sides of the spinal processes via proximal and distal anchors of the spinal implant.
Claim 2 is disclosed by claim 1 of Frock ‘095.
Claim 3 is disclosed by claim 3 of Frock ‘095.
Claim 4 is disclosed by claim 4 of Frock ‘095.
Claim 5 is disclosed by claim 1 of Frock ‘095.
Claim 6 is disclosed by claim 1 of Frock ‘095.
Claim 7 is disclosed by claim 15 of Frock ‘095.
Claim 8 is disclosed by claim 12 of Frock ‘095.
Regarding claim 9, claim 1 of Frock ‘095 discloses all of the subject matter of claim 9 except for a proximal anchor comprising a proximal side, a distal side, and an internal bore. However, Hess discloses a spinal implant (implants 10/100/200/300; embodiment 100 will be detailed below) comprising: a main body (112); a distal anchor (116/118); and a proximal anchor (122) defining a proximal side (side without blades 124/126), a distal side (side with blades 124/126), and an internal bore (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3), wherein the internal bore receives at least a portion of the main body (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the spinal implant of claim 1 of Frock ‘095 to include a proximal anchor in order to facilitate secure attachment of the spinal implant between adjacent spinal processes by allow the spinal implant to grip opposite sides of the spinal processes via proximal and distal anchors of the spinal implant.
Claim 10 is disclosed by claim 1 of Frock ‘095.
Claim 11 is disclosed by claim 3 of Frock ‘095.
Claim 12 is disclosed by claim 18 of Frock ‘095.
Claim 13 is disclosed by claim 19 of Frock ‘095.
Claim 14 is disclosed by claim 20 of Frock ’095.
Regarding claim 15, claim 1 of Frock ‘095 discloses all of the subject matter of claim 9 except for a proximal anchor comprising a proximal side, a distal side, and an internal bore, and the placing and sliding steps of the method. However, Hess discloses a spinal implant (implants 10/100/200/300; embodiment 100 will be detailed below) comprising: a main body (112); a distal anchor (116/118); and a proximal anchor (122) defining a proximal side (side without blades 124/126), a distal side (side with blades 124/126), and an internal bore (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3), wherein the internal bore receives at least a portion of the main body (122 is a collar with an internal bore for receiving main body 112; see Figs. 6-9 and paragraph [0051]; see also corresponding collar 22 in a previous embodiment in Fig. 3). Additionally Hess discloses placing the spinal implant in a patient at a desired treatment site (see paragraphs [0009], [0010], and [0051]); and sliding the plunger distally along the longitudinal axis to thereby pivot the plurality of wings distally about the first pivot point to an open configuration (see Fig. 9 and paragraph [0051]), the open configuration comprising: at least a portion of each of the plurality of wings extending radially outward from the main body (see Fig. 9; free ends of each wing 116/118 extending radially outward from the main body 112).
Regarding claims 16 and 18-20, see the disclosure of Hess regarding these method steps in the rejections of claims 16 and 18-20 above.
Regarding claim 17, this subject matter is disclosed by claim 1 of Frock ’095.
Regarding claims 15-20, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the spinal implant of claim 1 of Frock ‘095 to include a proximal anchor in order to facilitate secure attachment of the spinal implant between adjacent spinal processes by allow the spinal implant to grip opposite sides of the spinal processes via proximal and distal anchors of the spinal implant. Additionally, it would have been obvious to place the spinal implant at the treatment site according to the method disclosed by Hess in order to properly use and deploy the implant to facilitate treatment of a patient.
Allowable Subject Matter
Claims 9-14 would be allowable if a terminal disclaimer is filed to overcome the double patenting rejections set forth in this Office action.
Claims 5, 6, and 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 and if a terminal disclaimer is filed to overcome the double patenting rejections set forth in this Office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for prior art of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773