DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1 and 14-16 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 10 and 11 of U.S. Patent No. 8357183. 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 many more elements and are thus much more specific as shown below (note that the underlined text and/or bolded sections contain comparable elements):
Invention 18/918730
US Patent 8357183
1. A spinal fixation device, comprising: a first anchor attached to a first vertebral body and a second anchor attached to a second vertebral body; a flexible member connecting the first anchor to the second anchor; a force directing member attached to a third vertebral body, wherein the force directing member is configured to guide movement of the first vertebral body relative to the second vertebral body; and an adjustment mechanism configured to increase or decrease a distance between the first vertebral body and the second vertebral body.
10. A system for correcting a spinal deformity, the system comprising: a rod adapted to extend along a spine of a patient; a first rod anchor adapted to be fixed to a first vertebra of the spine, the first rod anchor receiving the rod such that the rod is secured against substantial lateral translation relative to the first rod anchor and the rod is allowed to slide axially relative to the first rod anchor through a first pivot point and to change in at least two of pitch, yaw, and roll about the first pivot point; a second rod anchor adapted to be fixed to a second vertebra, the second rod anchor receiving the rod such that the rod is secured against substantial lateral translation relative to the second rod anchor and is allowed to change in at least pitch and yaw about a second pivot point; a first vertebral anchor adapted to be fixed to a third vertebra; a first adjustment mechanism; and a first force directing member coupled to the first vertebral anchor and the rod, the first force directing member defining an effective length between the first vertebral anchor and the rod, the first adjustment mechanism being adapted to modify the effective length of the force directing member; wherein the rod defines a central portion extending between the first and second rod anchors and further wherein the central portion is substantially non-linear.
* note that the rod is comparable to the flexible member
11. A system for correcting a spinal deformity, the system comprising: a rod adapted to extend along a spine of a patient; a first rod anchor adapted to be fixed to a first vertebra of the spine, the first rod anchor receiving the rod such that the rod is secured against substantial lateral translation relative to the first rod anchor and the rod is allowed to slide axially relative to the first rod anchor through a first pivot point and to change in at least two of pitch, yaw, and roll about the first pivot point; a second rod anchor adapted to be fixed to a second vertebra, the second rod anchor receiving the rod such that the rod is secured against substantial lateral translation relative to the second rod anchor and is allowed to change in at least pitch and yaw about a second pivot point; a first vertebral anchor adapted to be fixed to a third vertebra; a first adjustment mechanism; and a first force directing member coupled to the first vertebral anchor and the rod, the first force directing member defining an effective length between the first vertebral anchor and the rod, the first adjustment mechanism being adapted to modify the effective length of the force directing member; wherein the rod defines a central portion extending between the first and second rod anchors and further wherein the central portion includes a substantially curved section and a substantially straight section.
* note that the rod is comparable to the flexible member
14. The device of claim 1, wherein the force directing member is attached to a third anchor positioned on the third vertebral body.
Claims 10 and 11, see bolded section in claims 10 and 11 above and note that the first vertebral anchor is comparable to the third anchor
15. The device of claim 14, wherein the third anchor includes a mounting portion configured to secure the third anchor to the third vertebral body.
Claims 10 and 11, see bolded section in claims 10 and 11 above and note that the first vertebral anchor is comparable to the third anchor
16. The device of claim 1, wherein the force directing member is moveable relative to the first vertebral body and the second vertebral body.
Claims 10 and 11, see bolded section in claims 10 and 11 above and note that the because the effective length is able to be modified this limitation is met
Thus, the invention of US Patent 8357183, claims 10 and 11, respectively, are 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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4, 5 and 13-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790) in view of Holt (US 20080021469).
With respect to claim 1, Carls teaches a spinal fixation device (500), comprising: a first anchor (e.g., see fig. 44a below) attached to a first vertebral body and a second anchor (e.g., see fig. 44a below) attached to a second vertebral body; a member (e.g., rod 536) directly connecting the first anchor to the second anchor (see fig. 44a below); a force directing member (e.g., 518) attached to a third vertebral body (see fig. 44a, 44b below), wherein the force directing member is configured to guide movement of the first vertebral body relative to the second vertebral body (see para. 192-194, 197); and an adjustment mechanism (telescopic mechanism of rod 536, see para. 192 and also fig. 44a-44b below) configured to increase or decrease a distance between the first vertebral body and the second vertebral body (see para. 191-192).
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Carls appears to be silent regarding the material of the member, specifically concerning wherein the member is a flexible member.
Holt, also drawn to spinal fixation devices, teaches a flexible member (spinal rod 10) composed of a composite material (see para. 9, 23), that directly connects two rod anchors (12, 12, see fig. 1 and para. 8) in order to provide a known spinal rod constructed to provide varying degrees of flexible stabilization of the vertebral segments based on the particular patient application, while maintaining a desired compression strength of the spinal rod (see para. 9, 23).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the member of Carls to be a flexible member, in view of Holt, as a matter of engineering design choice, in order to provide a known spinal rod constructed to provide varying degrees of flexible stabilization of the vertebral segments based on the particular patient application, while maintaining a desired compression strength of the spinal rod.
As for claim 2, Carls, as modified by Holt, further teaches the device of claim 1, wherein the flexible member extends in a straight line from the first anchor to the second anchor (see fig. 44a above).
As for claim 4, Carls, as modified by Holt, further teaches the device of claim 1, wherein the adjustment mechanism is attached to a vertebral body (note that the telescopic mechanism is part of rod 536 which is connected to the vertebral bodies via the rod anchors and via 531-535, 526-530, see fig. 44a, 44b above).
As for claim 5, Carls, as modified by Holt, further teaches the device of claim 1, wherein the adjustment mechanism is positioned independently of a vertebral body (see fig. 44a above, e.g., note that 536 does not contact 503 directly, thus, the telescopic mechanism does not directly contact 503).
As for claim 13, Carls, as modified by Holt, further teaches the device of claim 1, wherein the first and second anchors include a mounting portion configured to secure the first and second anchors to the first and second vertebral bodies (see fig. 44a above and para. 191).
As for claim 14, Carls, as modified by Holt, further teaches the device of claim 1, wherein the force directing member is attached to a third anchor positioned on the third vertebral body (see fig. 44a above).
As for claim 15, Carls, as modified by Holt, further teaches the device of claim 14, wherein the third anchor includes a mounting portion configured to secure the third anchor to the third vertebral body (see fig. 44a above and also para. 191).
As for claim 16, Carls, as modified by Holt, further teaches the device of claim 1, wherein the force directing member is moveable (tensioned) relative to the first vertebral body and the second vertebral body (see para. 192, 194).
Claim(s) 3 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790) and Holt (US 20080021469), as applied to claim 1 above, in view of Schaller (US 20080234687).
As for claims 3 and 6, Carls, as modified by Holt, teaches a ratcheted tensioning device (533) included with the adjustment member used with the flexible member (see para. 194) but does not teach wherein the flexible member is curved between the first anchor and the second anchor; and wherein the adjustment mechanism includes a reel.
Schaller, also drawn to spinal devices, teaches a variety of alternate equivalent wire/tether/cable (flexible member) tensioners including spools/spindles (reels) and ratchet mechanisms (see para. 192-193 and 195-196 below) in order to provide a known actuating mechanism (reel) that will perform the same function of providing the desired tension to a wire/tether/cable (flexible member) (see para. 192-193 and 195-196 below).
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It would have been obvious to one of ordinary skill in the art at the time the time the invention was made to modify Carls, as modified by Holt, wherein the flexible member is curved between the first anchor and the second anchor (e.g., curved because it is wound); and wherein the adjustment mechanism includes a reel, in view of Schaller, as a matter of engineering design choice to provide an alternate equivalent to the ratcheting mechanism, in order to provide a known actuating mechanism (reel) that will perform the same function of providing the desired tension to a wire/tether/cable (flexible member).
Claim(s) 7 and 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790), Holt (US 20080021469), and Schaller (US 20080234687), as applied to claim 6 above, in view of Pool (US 20090112263).
As for claims 7 and 8, Carls, as modified by Holt and Schaller, does not teach wherein the reel includes a gear; and wherein the real includes a plurality of gears.
Pool, also drawn to spinal devices, teaches a reel actuation mechanism (see fig. 41 below) wherein the reel (396) includes a gear (e.g., 392); and wherein the real includes a plurality of gears (390, 392) (see fig. 41 below) in order to provide a known mechanical mechanism that allows the user to control the tension on a flexible member (cable 345).
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It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls, as modified by Holt and Schaller, wherein the reel includes a gear; and wherein the real includes a plurality of gears, in view of Pool, in order to provide a known mechanical mechanism that allows the user to control the tension on a flexible member.
Claim(s) 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790) and Holt (US 20080021469), as applied to claim 1 above, in view of Kiester (US 20060009767).
As for claim 9, Carls, as modified by Holt, does not appear to teach further comprising a plurality of adjustment mechanisms.
Kiester, also drawn to spinal fixation devices (see abstract) teaches a kit including a plurality of expanding rods with multiple rods (e.g., telescopic rods with associated telescopic adjustment mechanisms) in order to provide the surgeon with a variety of rods, each associated with a different scoliotic curve or different curvature to provide the desired force to spine (see para. 16).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls, as modified by Holt, further comprising a plurality of adjustment mechanisms, in view of Kiester, in order to provide the surgeon with a variety of rods, each associated with a different scoliotic curve or different curvature to provide the desired force to spine.
Claim(s) 10 and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790) and Holt (US 20080021469), as applied to claim 1 above, in view of Drewry (US 6436099).
As for claims 10 and 11, Carls, as modified by Holt, appears to be silent regarding the cross-section of the flexible member, specifically, wherein the flexible member has a round cross section; and wherein the flexible member has a square cross section.
Drewry, also drawn to spinal devices teaches a flexible member (adjustable tether) has a round cross section (see col. 5 lines 5-25 below); and wherein the flexible member has a square cross section (see col. 5 lines 5-25 below) in order to provide a flexible member with the strength and elongation requirements depending on the application (see col. 5 lines 5-25 below).
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It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls, as modified by Holt, wherein the flexible member has a round cross section; and wherein the flexible member has a square cross section, in view of Drewry, in order to provide a flexible member with the strength and elongation requirements depending on the application.
Claim(s) 12, 17 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790) and Holt (US 20080021469), as applied to claim 1 above, in view of Carls (US 20060058790).
As for claim 12, the relied upon embodiment of Carls, as modified by Holt, does not appear to teach wherein the flexible member includes a surface coating.
However, Carls does teach the application of a coating in another embodiment (e.g., fig. 30) wherein a coating is applied to the device (see para. 182) in order to reduce tissue ingrowth on the device to permit movement prevent adhesions or to provide therapeutic agents to the site (see para. 182).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls (embodiment of 44a), as modified by Holt, wherein the flexible member includes a surface coating, in view of Carls (embodiment of fig. 30), in order to reduce tissue ingrowth on the device to permit movement prevent adhesions or to provide therapeutic agents to the site.
With respect to claim 17, Carls teaches a device (500) for correcting a spinal deformity, comprising: a first anchor (see fig. 44a above) attached to a first vertebral body and a second anchor (see fig. 44a above) attached to a second vertebral body; a member (rod 536) directly connecting the first anchor to the second anchor; a force directing member (518) attached to a third vertebral body (see fig. 44a above), wherein the force directing member is configured to guide movement of the first vertebral body relative to the second vertebral body and wherein the force directing member is moveable relative to the first vertebral body and the second vertebral body (see para. 191, 192, 194); and an adjustment mechanism (telescoping mechanism of rod 536) configured to increase or decrease a distance between the first vertebral body and the second vertebral body (note that 536 is telescopic, see para. 191-194).
Carls appears to be silent regarding the material of the member, specifically concerning wherein the member is a flexible member; and wherein the flexible member includes a coating.
Holt, also drawn to spinal fixation devices, teaches a flexible member (spinal rod 10) composed of a composite material (see para. 9, 23), that directly connects two rod anchors (12, 12, see fig. 1 and para. 8) in order to provide a known spinal rod constructed to provide varying degrees of flexible stabilization of the vertebral segments based on the particular patient application, while maintaining a desired compression strength of the spinal rod (see para. 9, 23).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the member of Carls to be a flexible member, in view of Holt, as a matter of engineering design choice, in order to provide a known spinal rod constructed to provide varying degrees of flexible stabilization of the vertebral segments based on the particular patient application, while maintaining a desired compression strength of the spinal rod.
While the relied upon embodiment of Carls does not teach the flexible member includes a coating, Carls does teach the application of a coating in another embodiment (e.g., fig. 30) wherein a coating is applied to the device (see para. 182) in order to reduce tissue ingrowth on the device to permit movement prevent adhesions or to provide therapeutic agents to the site (see para. 182).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls (embodiment of 44a), as modified by Holt, wherein the flexible member includes a surface coating, in view of Carls (embodiment of fig. 30), in order to reduce tissue ingrowth on the device to permit movement prevent adhesions or to provide therapeutic agents to the site.
As for claim 20, Carls (embodiment of fig. 44a), as modified by Holt and Carls (embodiment of fig. 30) further teaches device of claim 17, wherein the force directing member is attached to a third anchor positioned on the third vertebral body (see fig. 44a above).
Claim(s) 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790), Holt (US 20080021469) and Carls (US 20060058790), as applied to claim 17 above, in view of Schaller (US 20080234687).
As for claim 18, Carls (embodiment of fig. 44a), as modified by Holt and Carls (embodiment of fig. 30), teaches a ratcheted tensioning device (533) included with the adjustment member used with the flexible member (see para. 194) but does not teach wherein the adjustment mechanism includes a reel.
Schaller, also drawn to spinal devices, teaches a variety of alternate equivalent wire/tether/cable (flexible member) tensioners including spools/spindles (reels) and ratchet mechanisms (see para. 192-193 and 195-196) in order to provide a known actuating mechanism (reel) that will perform the same function of providing the desired tension to a wire/tether/cable (flexible member) (see para. 192-193 and 195-196).
It would have been obvious to one of ordinary skill in the art at the time the time the invention was made to modify Carls (embodiment of fig. 44a), as modified by Holt and Carls (embodiment of fig. 30), wherein the adjustment mechanism includes a reel, in view of Schaller, as a matter of engineering design choice to provide an alternate equivalent to the ratcheting mechanism, in order to provide a known actuating mechanism (reel) that will perform the same function of providing the desired tension to a wire/tether/cable (flexible member).
Claim(s) 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carls (US 20060058790), Holt (US 20080021469) and Carls (US 20060058790), as applied to claim 17 above, in view of Mehdian (US 4998936).
As for claim 19, Carls (embodiment of fig. 44a), as modified by Holt and Carls (embodiment of fig. 30) is silent regarding the structure of the adjustment mechanism and does not appear to teach further comprising a plurality of adjustment mechanisms positioned colinearly along an axis.
Mehdian, also drawn to devices for correcting a spinal deformity (see abstract), teaches a telescopic rod comprising a plurality of adjustment mechanisms (e.g., ratchets at 37) positioned colinearly along an axis (e.g., longitudinal axis, see fig. 9-10) in order to provide known structure to controllably adjust the length of the spinal rod (see col. 5 lines 1-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Carls (embodiment of fig. 44a), as modified by Holt and Carls (embodiment of fig. 30), in view of Mehdian, as a matter of engineering design choice, in order to provide known structure to controllably adjust the length of the spinal rod.
Response to Arguments
The Double Patenting rejection has been updated to include the subject matter included in the amendment to the claims entered on 3/17/2026.
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection relies on a new combination of references (the addition of Holt) that has been applied in response to the amendment entered on 3/17/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 5413576.
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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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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