DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6, line 2, after “the at least one”, “the at least one” (typographically repeated) should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, line 25, “configured to attachment to the bone” is unclear.
In claim 13, line 2, “the seating surface cavity” lacks antecedent basis.
In claim 15, line 2, after “wherein the”, “closure” (by itself, as opposed to “closure top”) lacks antecedent basis.
In claim 16, line 25, “configured to attachment to the bone” is unclear.
Dependent claims include the limitations of their respective parent claim(s) and are therefore also rejected.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-10, 12, 13 and 15-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biedermann et al. (2002/0143341) in view of Peterson et al. (2008/0294202).
Regarding claim 1, Biedermann et al. disclose a pivotal bone anchor assembly (Figs. 1 and 2) for securing an elongate rod 19 to a bone of a patient via a closure top 22, 25, the pivotal bone anchor assembly comprising:
a receiver 1 comprising a base 3 defining a cavity portion of an axial bore 5 centered about a vertical centerline axis 4 and having a seating surface adjacent a bottom opening 6, and a pair of upright arms 8, 9 extending upward from the base to define a receiver channel 7 configured to receive the elongate rod 19, the receiver channel 7 opening upwardly onto top surfaces 2 on the upright arms 8, 9 and opening laterally onto front and back faces of the upright arms (Fig. 2), the axial bore 5 extending upwardly from the bottom opening 6 to the top surfaces 2 of the upright arms 8, 9, the pair of upright arms including:
opposed interior surfaces with a discontinuous helically wound guide and advancement structure 10 formed therein and configured to rotatably mate with the closure top 22, 25 to lock the elongate rod 10 within the channel 7;
side outer surfaces opposite the interior surfaces extending downward across the base toward a bottom of the receiver 1 (Fig. 1); and
a shank 12, 15 comprising a proximal capture portion 14 having an at least partially-spherical upper surface 15 joined therewith and a distal anchor portion 13 opposite the capture portion configured to attachment to the bone, the proximal capture portion 14 configured for uploading into the receiver through the bottom opening (Fig. 2 and para. 0027); and
a pressure insert 17 configured for positioning into the axial bore 5 of the receiver 1 at least partially above the capture portion 14 of the shank 12, 15, the pressure insert 17 comprising:
a substantially cylindrical body with a through-bore 20 centered about an insert longitudinal axis;
a downwardly-facing bottom surface surrounding the through-bore 20 (Fig. 1) and being sized and shaped to frictionally engage and mate with the partially-spherical upper surface 15 of the capture portion 14;
an upwardly open insert channel 18 formed into an upper portion of the pressure insert 17 and configured to receive the elongate rod 19; and
Thus, Biedermann et al. disclose the claimed invention except for:
the receiver including at least one inwardly-protruding structure above the seating surface that is integrally-formed with the receiver and projects inwardly into the axial bore;
at least one vertically-elongate depression formed into an outer side surface of the pressure insert, wherein the at least one depression formed into the outer side surface of the pressure insert is configured to receive and engage the at least one inwardly-protruding structure of the receiver when the pressure insert is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel; and
a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around the side outer surface of each upright arm to the front surface and the back surface of the receiver, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm.
Peterson et al. disclose a pivotal bone anchor assembly 100 (Figs. 1 and 7) and teach:
a receiver 104 including at least one inwardly-protruding structure, e.g., tabs 613a (cf. Fig. 7 and see para. 0038, teaching that “the tabs and slots may be reversed so that the tabs may be formed on the housing and the slots may be formed on the sleeve”), above a seating surface and projecting inwardly into the axial bore (id.);
at least one vertically-elongate depression, e.g., slot 715a (cf. Fig. 7 and see para. 0038, teaching that “the tabs and slots may be reversed so that the tabs may be formed on the housing and the slots may be formed on the sleeve”), formed into an outer side surface of the pressure insert, i.e., sleeve, 612, wherein the at least one depression, e.g., 715a (id.), formed into the outer side surface of the pressure insert, e.g., 612, is configured to receive and engage the at least one inwardly-protruding structure, e.g., 613a (id.) of the receiver 104 when the pressure insert 612 is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel (Fig. 7); and
a non-threaded tool engagement groove 118 (Fig. 1) extending horizontally and circumferentially at least partially around the side outer surface of each upright arm to the front surface and the back surface of the receiver 104, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm (Fig. 1). The groove facilitates securely grasping the receiver by a tool.
The inwardly protruding structure, i.e., tabs, e.g., 613a, and the depressions, e.g., 715a, can be configured to allow the pressure insert, i.e., sleeve, 612, to move up and down a small distance to facilitate tightening and to prevent rotation so as to align the channel of the sleeve with the channel of the receiver (para. 0038).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to configure the receiver 1 to include at least one inwardly-protruding structure above the seating surface that is integrally-formed with the receiver and projects inwardly into the axial bore 5, and
at least one vertically-elongate depression formed into an outer side surface of the pressure insert 17, wherein the at least one depression formed into the outer side surface of the pressure insert is configured to receive and engage the at least one inwardly-protruding structure of the receiver 1 when the pressure insert is 17 positioned within the axial bore 5 with the pressure insert channel co-aligned with the receiver channel 7, in view of Peterson et al., to allow the pressure insert 17 to move up and down a small distance to facilitate tightening and to prevent rotation so as to align the channel of the sleeve with the channel of the receiver.
It also would have been obvious to a person having ordinary skill in the art at the time of the invention to configure the receiver 1 to include a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around the side outer surface of each upright arm 8, 9 to the front surface and the back surface of the receiver 1, each tool engagement groove being isolated from the axial bore 5 and located below the top surface 2 of the respective upright arm 8, 9, in view of Peterson et al., to facilitate securely grasping the receiver 1 by a tool.
Regarding claim 2, the engagement between the at least one inwardly-protruding structure, e.g., tab 613a (supra) of the receiver 1 of the combination (supra) and the at least one depression, e.g., slot 715a (supra) formed into the outer side surface of the pressure insert (supra) is configured to hold the pressure insert in a desired alignment with respect to the receiver (para. 0038).
Regarding claim 3, the at least one inwardly-protruding structure, e.g., tab 613a (supra), of the receiver of the combination projects inwardly into the axial bore 5 prior to the uploading of the capture portion 14 of the shank 12, 15 and positioning the pressure insert 17 into the axial bore 5, because the inwardly-projecting structure is integrally formed with the receiver of the combination (supra).
Regarding claim 4, Peterson et al. do not explicitly characterize the inwardly-protruding structure, e.g., tab 613a, as a spring tab; however, they do describe that the tabs “snap” into the slots (para. 0038), which requires resiliency. Therefore, it would have been further obvious to a person having ordinary skill in the art at the time of the invention to have configured the inwardly-protruding structure, e.g., tab 613a, of the combination (supra) as a spring tab, so as to be resilient and facilitate the tab snapping into the slot.
Regarding claim 5, the engagement between the at least one inwardly-protruding structure, e.g., tabs 613a (supra), of the receiver 1 of the combination (supra) and the at least one depression, e.g., slot 715a (supra), of the pressure insert 17 of the combination is configured to inhibit rotation of the pressure insert 17 with respect to the receiver while allowing for vertical adjustment of the pressure insert within the axial bore (supra and para. 0038).
Regarding claim 6, the at least one the at least one inwardly-protruding structure, e.g., tab 613a (supra) of the axial bore further comprises a pair of opposing inwardly-protruding structures 613a and 613b, and wherein the at least one depression, e.g., slot 715a (supra) of the pressure insert further comprises a pair of opposite depressions, e.g., 715a and 715b configured to receive and engage with the pair of opposing inwardly-protruding structures 613a and 613b (supra).
Regarding claim 7, the pair of opposing inwardly-protruding structures, e.g., tabs 613a, 613b (supra), of the receiver 1 of the combination project resiliently into the axial bore to resiliently bias the pressure insert in a desired position within the axial bore 5 (para. 0038, the tabs “snap into respective slots” which requires resiliency. In addition, the tabs hold the pressure insert in a desired position within the axial bore (para. 0038).
Regarding claim 8, apart from the configuration described above (supra at claim 1), Peterson et al. disclose that various slots and tabs can be provided, including a configuration as shown in Figure 7 (para. 0038). This configuration can allow a flange, e.g., tab 613a, to be rotatably positioned under the at least one downwardly facing surface, e.g., the upper ceiling of depression, i.e., slot 715a (id., describing that “the slots can extend or be formed across the width or circumference of the interior housing wall so that the sleeve can rotate (spin) in the housing”), which prohibits upward movement of the pressure insert out of the receiver, e.g., until the other provided tabs, i.e., protruding structures, engage the slots, i.e., depressions (supra at claim 1) to restrict rotation and align the channels (id.).
Therefore, it would have been further obvious to a person having ordinary skill in the art at the time of the invention to also provide at least one downwardly facing surface formed into the axial bore 5 below the discontinuous helically wound guide and advancement structure 10; and
at least one flange, i.e., tab, projecting radially outward from the outer side surface of the pressure insert 17, wherein the at least one flange is rotatably positionable under the at least one downwardly facing surface, e.g., the upper ceiling of depression, i.e., slot 715a, in view of Peterson et al., to prohibit upward movement of the pressure insert 17 out of the receiver 1 until the other provided tabs, i.e., protruding structures, engage the slots, i.e., depressions, to restrict rotation and align the channels.
Regarding claim 9, the upper portion of the pressure insert 17 further comprises a pair of upstanding arms extending upward from a cylindrical base portion (Fig. 2) to define the upwardly-open insert channel therebetween, and wherein the at least one flange of the combination (e.g., tab 613a in Fig. 7 of Peterson; supra at claim 8) would project radially outward from a top end (e.g., above the halfway point) of one of the pair of upstanding arms as shown by Peterson et al. (id.)
Regarding claim 10, the assembly of the combination discloses the claimed invention except for explicitly reciting a particular location of the depression being below the flange. However, it would have been further obvious to have formed the at least one depression into an outer side surface of one of the pair of upstanding arms (supra at claim 1) below the at least one flange (supra at claims 8 and 9), e.g., so that the flange can retain the pressure insert in the receiver until the inwardly-protruding structure is rotated into engagement with the depression to restrict rotation (supra at claims 1 and 8).
Regarding claim 12, the bone anchor assembly of Biedermann et al. comprises a retainer, i.e., bush 26 (Fig. 1; para. 0027), configured to engage and hold the bone anchor assembly as a whole, including the capture portion 14 of the shank 12, 15 within the cavity of the receiver of the combination (id.). It is noted that the retainer, i.e., bush, exerts additional pressure on the partially-spherical upper surface 15, i.e., the head, of the capture portion 14 (id.), and thus also exerts additional pressure on the capture portion 14 of the shank to engage and hold the capture portion 14 within the cavity of the receiver.
Regarding claim 13, the capture portion 14 of the shank 12, 15 is spaced from the seating surface within the cavity of the receiver 1 upon engagement with the retainer 26 (i.e., in a fully assembled configuration; Fig. 1 and para. 0024 of Biedermann et al. and supra at claim 12).
Regarding claim 15, the bone anchor assembly comprises the elongate rod 19 and the closure top 22, 25 (Figs. 1 and 2 of Biedermann et al.), wherein the closure top 22, 25 is configured for positioning entirely within the axial bore 5 of the receiver 1 above the elongate rod 19 and in engagement with the discontinuous guide and advancement structure 10 to apply a downward pressure to a top of the elongate rod 19, so as to lock the pivotal bone anchor assembly and secure the elongate rod 19 to the bone of the patient (id.).
Regarding claim 16, Biedermann et al. disclose a pivotal bone anchor assembly (Figs. 1 and 2) for securing an elongate rod 19 to a bone of a patient via a closure top 22, 25, the pivotal bone anchor assembly comprising:
a receiver 1 comprising a base 3 defining a cavity portion of an axial bore 5 centered about a vertical centerline axis 4 and having a seating surface adjacent a bottom opening 6, and a pair of upright arms 8, 9 extending upward from the base to define a receiver channel 7 configured to receive the elongate rod 19, the receiver channel opening upwardly onto top surfaces 2 on the upright arms 8, 9 and opening laterally onto front and back faces of the upright arms (Fig. 2), the axial bore 5 extending upwardly from the bottom opening 6 to the top surfaces 2 of the upright arms, the pair of upright arms 8, 9 including:
opposed interior surfaces with a discontinuous helically wound guide and advancement structure 10 formed therein and configured to rotatably mate with the closure top 22, 25 to lock the elongate rod 19 within the channel 7;
side outer surfaces opposite the interior surfaces extending downward across the base toward a bottom of the receiver 1 (Fig. 1); and
a shank 12, 15 comprising a proximal capture portion 14 having an at least partially-spherical upper surface 15 joined therewith and a distal anchor portion 13 opposite the capture portion configured to attachment to the bone, the proximal capture portion 14 configured for uploading into the receiver 1 through the bottom opening (Fig. 2 and para. 0027); and
a pressure insert 17 configured for positioning into the axial bore 5 of the receiver 1 at least partially above the capture portion 14 of the shank 12, 15, the pressure insert 17 comprising:
a substantially cylindrical body with a through-bore 20 centered about an insert longitudinal axis;
a downwardly-facing bottom surface surrounding the through-bore 20 (Fig. 1) and being sized and shaped to frictionally engage and mate with the partially-spherical upper surface 15 of the capture portion 14; and
an upwardly open insert channel 18 formed into an upper portion of the pressure insert 17 and configured to receive the elongate rod 19.
Thus, Biedermann et al. disclose the claimed invention except for:
the receiver including a pair of opposing inwardly-protruding structures above the seating surface that are integrally-formed with the receiver and project inwardly into the axial bore;
a pair of opposite depressions formed into outer side surfaces of the pressure insert, wherein the pair of opposite depressions of the pressure insert are configured to receive and engage the pair of opposing inwardly-protruding structures of the receiver when the pressure insert is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel; and
a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around the side outer surface of each upright arm to the front surface and the back surface of the receiver, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm.
Peterson et al. disclose a pivotal bone anchor assembly 100 (Figs. 1 and 7) and teach:
a receiver 104 including a pair of opposing inwardly-protruding structures, e.g., tabs 613a, 613b (cf. Fig. 7 and see para. 0038, teaching that “the tabs and slots may be reversed so that the tabs may be formed on the housing and the slots may be formed on the sleeve”), above a seating surface and projecting inwardly into the axial bore (id.);
a pair of opposite depressions, e.g., slot 715a (cf. Fig. 7 and see para. 0038, teaching that “the tabs and slots may be reversed so that the tabs may be formed on the housing and the slots may be formed on the sleeve”), formed into an outer side surface of the pressure insert, i.e., sleeve, 612, wherein the pair of opposite depressions, e.g., 715a, 715b (id.), formed into the outer side surface of the pressure insert, e.g., 612, are configured to receive and engage the pair of opposing inwardly-protruding structures, e.g., 613a, 613b (id.) of the receiver 104 when the pressure insert 612 is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel (Fig. 7); and
a non-threaded tool engagement groove 118 (Fig. 1) extending horizontally and circumferentially at least partially around the side outer surface of each upright arm to the front surface and the back surface of the receiver 104, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm (Fig. 1). The groove facilitates securely grasping the receiver by a tool.
The pair of opposing inwardly protruding structures, i.e., tabs, e.g., 613a, 613b and the pair of opposite depressions, e.g., 715a, 715b can be configured to allow the pressure insert, i.e., sleeve, 612, to move up and down a small distance to facilitate tightening and to prevent rotation so as to align the channel of the sleeve with the channel of the receiver (para. 0038).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to configure the receiver 1 to include a pair of opposing inwardly-protruding structures above the seating surface that are integrally-formed with the receiver and project inwardly into the axial bore 5, and
a pair of opposite depressions formed into an outer side surface of the pressure insert 17, wherein the pair of opposite depressions formed into the outer side surface of the pressure insert are configured to receive and engage the pair of opposing inwardly-protruding structures of the receiver 1 when the pressure insert is 17 positioned within the axial bore 5 with the pressure insert channel co-aligned with the receiver channel 7, in view of Peterson et al., to allow the pressure insert 17 to move up and down a small distance to facilitate tightening and to prevent rotation so as to align the channel of the sleeve with the channel of the receiver.
It also would have been obvious to a person having ordinary skill in the art at the time of the invention to configure the receiver 1 to include a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around the side outer surface of each upright arm 8, 9 to the front surface and the back surface of the receiver 1, each tool engagement groove being isolated from the axial bore 5 and located below the top surface 2 of the respective upright arm 8, 9, in view of Peterson et al., to facilitate securely grasping the receiver 1 by a tool.
Regarding claim 17, the pair of opposing inwardly-protruding structures, e.g., tabs 613a, 613b (supra) of the receiver of the combination project inwardly into the axial bore 5 prior to the uploading of the capture portion 14 of the shank 12, 15 and positioning the pressure insert 17 into the axial bore 5, because the inwardly-projecting structures are integrally formed with the receiver of the combination (supra).
Regarding claim 18, the engagement between the pair of opposing inwardly-protruding structures, e.g., tabs 613a, 613b (supra), of the receiver 1 of the combination (supra) and the pair of opposite depressions, e.g., slots 715a, 715b (supra), are configured to inhibit rotation of the pressure insert 17 with respect to the receiver while allowing for vertical adjustment of the pressure insert within the axial bore (supra and para. 0038).
Regarding claim 19, apart from the configuration described above (supra at claim 16), Peterson et al. disclose that various slots and tabs can be provided, including a configuration as shown in Figure 7 (para. 0038). This configuration can allow a pair of flanges, e.g., tabs 613a, 613b, to be rotatably positioned under a pair of downwardly facing surfaces, e.g., the upper ceilings of depressions, i.e., slots 715a, 715b (id., describing that “the slots can extend or be formed across the width or circumference of the interior housing wall so that the sleeve can rotate (spin) in the housing”), which prohibits upward movement of the pressure insert out of the receiver, e.g., until the other provided tabs, i.e., protruding structures, engage the slots, i.e., depressions (supra at claim 16), to restrict rotation and align the channels (id.).
Therefore, it would have been further obvious to a person having ordinary skill in the art at the time of the invention to also provide a pair of downwardly facing surfaces formed into the axial bore 5 below the discontinuous helically wound guide and advancement structure 10; and
a pair of flanges, i.e., tabs, projecting radially outward from the outer side surface of the pressure insert 17, wherein the pair of flanges are rotatably positionable under the pair of downwardly facings surfaces, e.g., the upper ceilings of depressions, i.e., slots 715a, 715b) in view of Peterson et al., to prohibit upward movement of the pressure insert 17 out of the receiver 1 until the other provided tabs, i.e., protruding structures, engage the slots, i.e., depressions, to restrict rotation and align the channels.
Regarding claim 20, the upper portion of the pressure insert 17 further comprises a pair of upstanding arms extending upward from a cylindrical base portion (Fig. 2) to define the upwardly-open insert channel therebetween, and wherein the pair of flanges of the combination (e.g., tabs 613a, 613b in Fig. 7 of Peterson; supra at claim 19) would project radially outward from top ends (e.g., above the halfway point) of the pair of upstanding arms as shown by Peterson et al. (id.).
Regarding claim 21, the assembly of the combination discloses the claimed invention except for explicitly reciting a particular location of the depressions being below the flanges. However, it would have been further obvious to have formed the opposite depressions into outer side surfaces of the pair of upstanding arms (supra at claim 16) below the pair of flanges (supra at claims 19 and 20), e.g., so that the flanges can retain the pressure insert in the receiver until the inwardly-protruding structures are rotated into engagement with the depressions to restrict rotation (supra at claims 16 and 19).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biedermann et al. (2002/0143341) in view of Peterson et al. (2008/0294202), as applied to claim 1 above, further in view of Hawkes et al. (2006/0161153; cited by Applicant).
The bone anchor assembly of the combination of Biedermann et al. and Peterson et al. discloses the claimed invention (supra) except for explicitly reciting the shank being cannulated with a central bore extending an entire length of the shank.
Hawkes et al. teach that a bone screw 108 (Fig. 2) can be cannulated with an axial bore 130 extending an entire length of the shank to allow the screw to be maneuvered over a guide wire thereby facilitating an accurate procedure (para. 0037).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to have configured the shank of the bone anchor assembly of the combination of Biedermann et al. and Peterson et al., with an axial bore extending an entire length of the shank, in view of Hawkes et al., to allow the shank to be maneuvered over a guide wire thereby facilitating an accurate procedure.
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, 12, 13 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 and 15-18 of U.S. Patent No. 11,051,856. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement and phraseology of the claim limitations.
Regarding independent application claim 1, patent claim 11 (11/1) discloses a pivotal bone anchor assembly for securing an elongate rod to a bone of a patient via a closure top, the pivotal bone anchor assembly comprising:
a receiver comprising a base defining a cavity portion of an axial bore centered about a vertical centerline axis (i.e., “about a receiver longitudinal axis”) and having a seating surface adjacent a bottom opening, and a pair of upright arms extending upward from the base to define a receiver channel configured to receive the elongate rod, the receiver channel opening upwardly onto top surfaces on the upright arms and opening laterally onto front and back faces of the upright arms, the axial bore extending upwardly from the bottom opening to the top surfaces of the upright arms, the receiver including at least one inwardly-protruding structure above the seating surface that is integrally-formed with the receiver and projects inwardly into the axial bore, the pair of upright arms including:
opposed interior surfaces with a discontinuous helically wound guide and advancement structure formed therein and configured to rotatably mate with the closure top to lock the elongate rod within the channel;
side outer surfaces opposite the interior surfaces extending downward across the base toward a bottom of the receiver; and
a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around (“entirely around” includes at least partially around) the side outer surface of each upright arm to the front surface and the back surface of the receiver, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm;
a shank comprising a proximal capture portion having an at least partially-spherical upper surface and a distal anchor portion opposite the capture portion configured for attachment to the bone, the proximal capture portion configured for uploading into the receiver through the bottom opening (patent claim 11); and
a pressure insert configured for positioning into the axial bore of the receiver at least partially above (“above” includes at least partially above) the capture portion of the shank, the pressure insert comprising:
a substantially cylindrical body with a through-bore centered about an insert longitudinal axis;
a downwardly-facing bottom surface surrounding the through-bore and being sized and shaped to frictionally engage and mate with the partially- spherical upper surface of the capture portion;
an upwardly open insert channel formed into an upper portion of the pressure insert and configured to receive the elongate rod; and
at least one vertically-elongate depression (a “groove or notch” is a depression) formed into an outer side surface of the pressure insert, wherein the at least one depression formed into the outer side surface of the pressure insert is configured to receive and engage the at least one inwardly-protruding structure of the receiver when the pressure insert is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel.
Regarding independent application claim 16, patent claim 15 discloses a pivotal bone anchor assembly for securing an elongate rod to a bone of a patient via a closure top, the pivotal bone anchor assembly comprising:
a receiver comprising a base defining a cavity portion of an axial bore centered about a vertical centerline axis (i.e., “a lower portion with . . . an axial bore centered about a receiver longitudinal axis”) and having a seating surface adjacent a bottom opening, and a pair of upright arms extending upward from the base to define a receiver channel configured to receive the elongate rod, the receiver channel opening upwardly onto top surfaces on the upright arms and opening laterally onto front and back faces of the upright arms, the axial bore extending upwardly from the bottom opening to the top surfaces of the upright arms, the receiver including a pair of opposing inwardly-protruding structures above the seating surface that are integrally-formed with the receiver and project inwardly into the axial bore, the pair of upright arms including:
opposed interior surfaces with a discontinuous helically wound guide and advancement structure formed therein and configured to rotatably mate with the closure top to lock the elongate rod within the channel;
side outer surfaces opposite the interior surfaces extending downward across the base toward a bottom of the receiver; and
a non-threaded tool engagement groove extending horizontally and circumferentially at least partially around (“entirely around” includes at least partially around) the side outer surface of each upright arm to the front surface and the back surface of the receiver, each tool engagement groove being isolated from the axial bore and located below the top surface of the respective upright arm;
a shank comprising a proximal capture portion having an at least partially-spherical upper surface and a distal anchor portion opposite the capture portion configured for attachment to the bone, the proximal capture portion configured for uploading into the receiver through the bottom opening; and
a pressure insert configured for positioning into the axial bore of the receiver at least partially above the capture portion of the shank, the pressure insert comprising:
a substantially cylindrical body with a through-bore centered about an insert longitudinal axis;
a downwardly-facing bottom surface surrounding the through-bore and being sized and shaped to frictionally engage and mate with the partially- spherical upper surface of the capture portion;
an upwardly open insert channel formed into an upper portion of the pressure insert and configured to receive the elongate rod; and
a pair of opposite depressions (“opposing grooves or notches”) formed into outer side surfaces of the pressure insert,
wherein the pair of opposite depressions of the pressure insert are configured to receive and engage the pair of opposing inwardly-protruding structures of the receiver when the pressure insert is positioned within the axial bore with the pressure insert channel co-aligned with the receiver channel.
The claims of the present application and the issued patent are mapped as follows:
Appl. 19/082,093
Pat. 11,051,856
1
11 (11/1)
2
N/A
3
N/A
4
N/A
5
N/A
6
N/A
7
N/A
8
N/A
9
N/A
10
N/A
11
N/A
12
12 (12/11/1)
13
13 (13/12/11/1)
14
N/A
15
N/A
16
15
17
16 (16/15)
18
17 (17/15)
19
18 (18/15)
20
N/A
21
N/A
Allowable Subject Matter
No claims are currently allowed. However, if the rejection under 35 U.S.C. 112 above is overcome, claim 14 would be objected to as being dependent upon a rejected base claim, but would be allowable over the prior art of record if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773