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 § 102
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 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.
Claims 1-6, 8, 9, 11-13, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seddon (WO-2008044057-A1).
Regarding claim 1, Seddon discloses a medical implant 10 (Fig. 15) for insertion at a treatment site, comprising:
an outer body 15c defining a longitudinal axis extending through a proximal end (left side of Fig. 15) of the outer body and a distal end of the outer body;
a screw 28 coupled to the outer body by assembly therewith;
one or more distal wings 16 operatively coupled to the screw 28; and
one or more proximal wings 19 operatively coupled to the screw 28,
wherein actuation of the screw 28 simultaneously pivots the one or more distal wings 16 and the one or more proximal wings 19 between a closed position (Fig. 16) and a deployed position (e.g., any position beyond closed),
wherein the actuation of the screw 28 further moves the one or more distal wings 16 and the one or more proximal wings 19 between the deployed position and a clamped position (Fig. 15, showing the wings clamped against lateral stops).
Regarding claim 2, the screw 28 comprises a first threaded portion (e.g., distal or right side of Fig. 15) and a second threaded portion (e.g., proximal or left side of Fig. 15), the first threaded portion being threaded in a first direction and the second threaded portion being threaded in a second opposite direction (Fig. 15; page 24, line 23 - page 25, line 6).
Regarding claim 3, the implant 10 further comprises:
a distal carrier 30 threadedly coupled to the first threaded portion (e.g., distal or right side of Fig. 15); and
a proximal carrier 30 threadedly coupled to the second threaded portion (e.g., proximal or right side of Fig. 15),
wherein the one or more distal wings 16 pivotally couple to the distal carrier 30 to thereby operatively couple the one or more distal wings 16 to the screw 28 and the one or more proximal wings 19 pivotally couple to the proximal carrier 30 to thereby operatively couple the one or more proximal wings 19 to the screw 28 (Fig. 15; page 24, line 23 - page 25, line 6).
Regarding claim 4, the outer body 15c comprises extensions (annotated Fig. 17, below; one side indicated but also including those on the opposite side) on an interior of the outer body 15c (id.),
wherein at least a portion of each of the one or more distal wings 16 and at least a portion of each of the one or more proximal wings 19 move along the extensions to move the one or more distal wings 16 and the one or more proximal wings 19 between the deployed position (e.g., any position beyond closed) and the clamped position (Fig. 15, showing the wings clamped against lateral stops).
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Regarding claim 5, the one or more distal wings 16 pivot proximally (e.g., portion 25 thereof; cf. Figs. 15 and 16) about the distal carrier 30 and the one or more proximal wings 19 pivot distally about the proximal carrier 30 to pivot the one or more distal wings 16 and the one or more proximal wings 19 from the closed position (Fig. 16) to the deployed position (e.g., any position beyond closed),
wherein the one or more distal wings 16 pivot distally about the distal carrier 30 and the one or more proximal wings 19 pivot proximally about the proximal carrier 30 to pivot the one or more distal wings 16 and the one or more proximal wings 19 from the deployed position to the closed position (i.e., they move in an opposite direction when closing).
Regarding claim 6, the outer body 15c defines distal apertures (second annotated Fig. 17, below) and proximal apertures (id.), the distal apertures and the proximal apertures each receiving pins 27 (id.),
wherein each of the one or more distal wings 16 and each of the one or more proximal wings 19 defines guiding surfaces (id.), and the actuation of the screw 28 moves the guiding surfaces (id.) on the one or more distal wings 16 along the pins 27 received in the distal apertures (id.) and moves the guiding surfaces (id.) on the one or more proximal wings 19 along the pins 27 received in the proximal apertures (id.) to thereby pivot the one or more distal wings 16 and the one or more proximal wings 19 between the closed position (Fig. 16) and the deployed position (e.g., any position beyond the closed position).
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Regarding claim 8, the distal carrier 30 moves along the first threaded portion (Fig. 17, right side of 28) and the proximal carrier 30 moves along the second threaded portion (Fig. 17, left side of 28) during the actuation of the screw 28 to thereby cause the one or more distal wings 16 and the one or more proximal wings 19 to pivot between the closed position (Fig. 16) and the deployed position (e.g., any position beyond closed) and move between the deployed position and the clamped position (Fig. 15, showing the wings clamped against lateral stops).
Regarding claim 9, the outer body 15c defines a central bore (second annotated Fig. 17, above) at a center of the outer body and circumferentially extending about the longitudinal axis (note also the central widthwise bore; i.e., the semicylindrical bore),
wherein the central bore receives at least a portion of the screw 28 (id.).
Regarding claim 11, Seddon discloses a system configured to insert a medical implant 10 (Fig. 15) into a treatment site, the system comprising:
the medical implant 10, comprising:
an outer body 15c;
a screw 28 coupled to the outer body by assembly therewith;
a distal anchor 16 operatively coupled to the screw 28;
a proximal anchor 19 operatively coupled to the screw, and an insertion tool (Fig. 12), comprising:
an outer shaft 28 coupled to a handle (page 23, lines 25-27); and
an inner rod 30 having a distal end (at the end of driver 31) and a proximal end,
wherein the outer shaft 28 receives at least a portion of the inner rod 30,
wherein the distal end 31 of the inner rod 30 comprises a driver 31 and the proximal end of the inner rod comprises a control (e.g., the surface portion rotated by the surgeon; page 23, line 33),
wherein the screw 28 is configured to receive the driver thereabout (page 23, lines 27-28),
wherein rotation of the control rotates the driver 31 to actuate the screw 28 (page 23, lines 25-33),
wherein actuation of the screw 28 transitions the distal anchor 16 and the proximal anchor 19 between a closed position (Fig. 16) and a deployed position (e.g., any position beyond closed),
wherein the actuation of the screw 28 further translates the distal anchor 16 and the proximal anchor 19 between the deployed position and a clamped position (Fig. 15, showing the wings clamped against lateral stops).
Regarding claim 12, the insertion tool (Fig. 12) further comprising:
an attachment member 32 coupled to the outer shaft 28,
wherein the attachment member 32 comprises a plurality of arms 33 configured to attach the medical implant 10 to the insertion tool (Fig. 13).
Regarding claim 13, the medical implant further comprising:
openings (annotated Fig. 16, below; page 10, lines 1-2) defined by the outer body 15c (Fig. 15),
wherein the openings receive at least a portion of each of the plurality of arms (id. and cf. Fig. 14) to thereby attach the medical implant 10 to the insertion tool and maintain the medical implant on the insertion tool.
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Regarding claim 18, Seddon discloses a method of inserting a medical implant 10 (Figs. 15 and 16) into a treatment site, the method comprising:
providing the medical implant 10, the medical implant comprising:
an outer body 15c defining a longitudinal axis extending through a proximal end (Fig. 15, left side) of the outer body and a distal end of the outer body;
a screw 28 coupled to the outer body by assembly therewith;
one or more distal wings 16 operatively coupled to the screw 28;
one or more proximal wings 19 operatively coupled to the screw 28,
wherein the medical implant is in a closed configuration (Fig. 16);
providing instructions comprising:
attaching an insertion tool (Fig. 12; page 23, line 25 - page 26, line 2; page 25, line 16 - page 26, line 2) to the medical implant 10 (id.; cf. Fig. 13);
inserting the medical implant into the treatment site (id. and Fig. 19); and
actuating the insertion tool (id.) in a first direction to transition the medical implant 10 from the closed configuration (Fig. 16) to a deployed configuration (e.g., any position beyond closed) and from the deployed configuration to a clamped configuration (Figs. 16 and 19; page 23, line 25 - page 26, line 2; page 25, line 16 - page 26, line 2),
wherein actuating the insertion tool in the first direction comprises rotating a portion of the insertion tool in the first direction to pivot the one or more distal wings 16 and the one or more proximal wings 19 from the closed configuration to the deployed configuration (supra),
wherein rotating the portion of the insertion tool in the first direction also translates the one or more distal wings 16 and the one or more proximal wings 19 from the deployed configuration to the clamped configuration (supra).
Regarding claim 20, actuating the insertion tool in a second direction transitions the medical implant 10 from the clamped configuration (supra) back to the deployed configuration or the closed configuration (Fig. 16) because of the threaded connection between the screw 28 and the carriers 30.
Claims 1, 2, 4, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flower et al. (2014/0257484).
Regarding claim 1, Flower et al. disclose a medical implant 200 (Figs. 2 and 7) for insertion at a treatment site (Fig. 2), comprising:
an outer body 202, 204 (Fig. 4) defining a longitudinal axis extending through a proximal end of the outer body and a distal end of the outer body (id.);
a screw 210 (Fig. 6) coupled to the outer body 202, 204 by assembly;
one or more distal wings 208 operatively coupled to the screw 210 (id.); and
one or more proximal wings 206 operatively coupled to the screw 210 (id.),
wherein actuation of the screw simultaneously pivots (relative to the screw 210) the one or more distal wings 208 and the one or more proximal wings 206 between a closed position (Figs. 1 and 3) and a deployed position (e.g., any position beyond closed),
wherein the actuation of the screw further moves the one or more distal wings 208 and the one or more proximal wings 206 between the deployed position and a clamped position (Figs. 2 and 4).
Regarding claim 2, the screw 210 comprises a first threaded portion and a second threaded portion (Fig. 14; para. 0094), the first threaded portion being threaded in a first direction and the second threaded portion being threaded in a second opposite direction (id. and see Fig. 5).
Regarding claim 4, the outer body 202, 204 comprises extensions (annotated Fig. 4, below; visible extensions labeled but including similar extensions that are obscured) on an interior of the outer body 202, 204,
wherein at least a portion of each of the one or more distal wings 208 and at least a portion of each of the one or more proximal wings 206 move along the extensions (Figs. 3 and 4) to move the one or more distal wings and the one or more proximal wings between the deployed position (e.g., any position beyond closed) and the clamped position (Figs. 2 and 4).
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Regarding claim 7, the medical implant 200 defines a first length when in the closed position (Fig. 3),
wherein the medical implant defines a second length when in the deployed position (Fig. 4), the second length less than the first length (cf. Figs. 3 and 4).
Regarding claim 9, the outer body 202, 204 defines a central bore at a center of the outer body and circumferentially extending about the longitudinal axis (Fig. 6),
wherein the central bore receives at least a portion of the screw 210 (id.).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Seddon (WO-2008044057-A1) in view of Michelson (2004/0102848).
Seddon discloses the claimed invention except for threading on an exterior surface. Michelson discloses an expandable spinal implant 300 (Fig. 11) and teaches that threading (id.) can be provided on exterior surface (para. 0053). The threads facilitate secure engagement with bone.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the implant of Seddon with threading on an exterior surface, in view of Michelson, to facilitate secure engagement with bone.
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 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18894556. (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The substantive difference between the application claims and the reference application claims is that the claims of the reference application include more elements and are more specific (e.g., further reciting an inner body, a carrier and ramps). 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding application claim 1, claim 1 of the reference application sets forth a medical implant for insertion at a treatment site, comprising:
an outer body defining a longitudinal axis extending through a proximal end of the outer body and a distal end of the outer body;
a screw coupled to the outer body;
one or more distal wings operatively coupled to the screw (“actuation of the threaded screw simultaneously pivots . . . the one or more distal wings between a closed position and a deployed position”); and
one or more proximal wings operatively coupled to the screw (via the carrier), wherein actuation of the screw simultaneously pivots the one or more distal wings and the one or more proximal wings between a closed position and a deployed position, wherein the actuation of the screw further moves the one or more distal wings and the one or more proximal wings between the deployed position and a clamped position.
Regarding application claim 2, claim 1 of the reference application sets forth wherein the screw comprises a first threaded portion and a second threaded portion, the first threaded portion being threaded in a first direction and the second threaded portion being threaded in a second opposite direction.
Allowable Subject Matter
Claims 14-17 and 19 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.
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
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