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
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.
Claims 1-3, 7-8 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al., US20180263669 (hereinafter, Peterson) [[Fig. 58]] in view of Eekhoff et al., US20150327902 (hereinafter, Eekhoff).
Regarding claim 1, Peterson discloses a multi-part orthopedic bone fastener (see Figs. 55-59) comprising:
an inner core 5502 comprising a screw head 5506 and a shaft (see elongated shaft of central member 5502) extending along a central longitudinal axis (see Figs. 55-59) between a proximal end (end towards head of the central member) and a distal end (end towards tip of the central member 5502), the screw head 5606 defining a drive recess (see Fig. 55) and the shaft configured for engaging bone; and
an outer sleeve 5600 having a body (see extended body of sleeve in Figs. 56-59) with a through hole (see Figs. 57-58) extending from a proximal end to a distal end for receiving the inner core (see Figs. 57-58);
wherein the body of the outer sleeve being generally cylindrical, and tapered, and having an external thread (see threaded portion in distal portion 5608 of the sleeve 5600) helically wound around the shaft (see cylindrically extended body of sleeve 5600, also tapered having helical thread as disclosed in Figs. 56 & 59), each thread section having a crest, a root, and leading and following flanks connecting the crest to adjacent roots (see threaded section in distal portion 5608 having a crest, a root, leading flank facing tip and following flank facing head of the sleeve), wherein the leading flank faces toward the distal end and is configured to enter into bone first and the following flank faces toward the proximal end of the bone fastener (see Figs. 56-59), and wherein at least one of the leading and following flanks comprises an undercut (see annotated Figs. 57-58 below), thereby forming a hooked thread profile (see Figs. 57-58).
Peterson fails to teach an end cap configured to fit onto the distal end of the outer sleeve and configured to couple the outer sleeve to the inner core, the end cap having at least one cutting flute configured to cut bone during insertion and extending distally from the distal end of both the outer sleeve and the inner core; and
wherein the end cap is configured to permanently couple the sleeve to the core so that the multi-part orthopedic bone fastener acts as a single pedicle screw to be inserted into a pedicle of a vertebral body.
Eekhoff teaches a fastener assembly (see Fig. 4) having an end cap (28, see Fig. 4) configured to fit onto the distal end of the outer sleeve 24 and configured to couple the outer sleeve to the inner core (see Fig. 4) the end cap having at least one cutting flute 128 configured to cut bone during insertion and extending distally from the distal end of the both the outer sleeve and the inner core (see Fig. 4; and
Wherein the end cap 28 is configured to permanently couple the sleeve to the core (see Figs. 7-10 showing threaded connection between the sleeve and the core) so that the multi-part orthopedic bone fastener acts as a single pedicle screw to be inserted into a pedicle of a vertebral body (see Figs. 7-9).
It is the examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the fastener in Paterson to have cap as taught by Eekhoff so the assembly can be utilized to insert the fastener assembly in to the bones and control movement of the components of the fastener assembly (see para. [0038]), and such modification helps to rotate the fastener member 32 effectively and telescopically retract the distal fastener member 28.
PNG
media_image1.png
307
489
media_image1.png
Greyscale
Annotated Figs. 57-58
Regarding claim 2, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 1, wherein Peterson further teaches the undercut is a concave recessed surface (see annotated Fig. 57-58) with a radius of curvature extending between the crest and the root (see distal portion 5608 showing undercut with radius of curvature extending from crest to root of the thread).
Regarding claim 3, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 1, wherein the undercut is a radial undercut (see annotated Figs. 57-58).
Regarding claim 7, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 1, but fails to teach wherein the inner core comprises metallic material and the outer core comprises radiolucent carbon fiber.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner core comprises metallic material and outer core of Peterson to comprised of radiolucent carbon fiber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering design choice. It is also a common knowledge to choose a material that has sufficient strength, durability, flexibility, hardness, and potential aesthetics, etc., for the application, intended use, and design considerations for that material. MPEP 2144.07.
Regarding claim 8, A multi-part orthopedic bone fastener comprising:
an inner core comprising a screw head and a shaft extending along a central longitudinal axis between a proximal end and a distal end, the screw head defining a drive recess and the shaft configured for engaging bone; and
an outer sleeve having a body with a through hole extending from a proximal end to a distal end for receiving the inner core;
wherein the body of the outer sleeve being generally cylindrical, and tapered, and having an external thread helically wound around the shaft, each thread section having a crest, a root, and leading and following flanks connecting the crest to adjacent roots, wherein the leading flank faces toward the distal end and is configured to enter into bone first and the following flank faces toward the proximal end of the bone fastener, and wherein at least one of the leading and following flanks comprises an undercut, thereby forming a hooked thread profile; and
an end cap configured to fit onto the distal end of the outer sleeve and configured to couple the outer sleeve to the inner core, the end cap having at least one cutting flute configured to cut bone during insertion and extending distally from the distal end of both the outer sleeve and the inner core;
wherein the outer sleeve includes engagement surfaces configured to prevent rotation of the inner core; and
wherein the end cap is configured to permanently couple the sleeve to the core so that the multi-part orthopedic bone fastener acts as a single pedicle screw to be inserted into a pedicle of a vertebral body.
Peterson in view of Eekhoff teaches and/or make obvious of the limitations in italic above. Please refer to the rejection and rationale set forth above in claim 1.
wherein Eekhoff further discloses the outer sleeve 24 includes engagement surfaces 88 configured to prevent rotation of the inner core 32 when the distal end portion 164 is threadingly engaged with the internal thread 142 of the cap 28.
Regarding claim 15, A multi-part orthopedic bone fastener comprising:
an inner core comprising a screw head and a shaft extending along a central longitudinal axis between a proximal end and a distal end, the screw head defining a drive recess and the shaft configured for engaging bone; the inner core having a through lumen (see Figs. 56-59) and
an outer sleeve having a body with a through hole extending from a proximal end to a distal end for receiving the inner core;
wherein the body of the outer sleeve being generally cylindrical, and tapered,
an end cap configured to fit onto the distal end of the outer sleeve and configured to couple the outer sleeve to the inner core, the end cap having at least one cutting flute configured to cut bone during insertion and extending distally from the distal end of both the outer sleeve and the inner core; and
wherein the end cap is configured to permanently couple the sleeve to the core so that the multi-part orthopedic bone fastener acts as a single pedicle screw to be inserted into a pedicle of a vertebral body.
Limitations of claim 15 is already being met/made obvious by Peterson in view of Eekhoff. Please refer to the rejection and rationale set forth above in claim 1.
Regarding claim 16, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 15, wherein Peterson further teaches the shaft 5502 of the inner core includes engagement surfaces 5504 configured to prevent rotation of the sleeve.
Regarding claim 17, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 16, wherein the engagement surfaces 5504 may be provided at opposite ends of the shaft to capture the proximal and distal ends of the shaft (see Figs. 55 and 57-58).
Regarding claim 18, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 15, wherein the distal end of the shaft is configured to be secured to the end cap.
However, Peterson combined/modified by the end cap of Eekhoff is capable of being configured to be secured to the distal end of the shaft. See rejection established in claim 1 above.
Regarding claim 19, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 15, Eekhoff further teaches wherein the outer surface of the end cap includes cutting flutes 128 configured to cute bone during insertion (see rejection set forth in claim 1 above).
Regarding claim 20, Peterson in view of Eekhoff teaches the fastener of claim 15, wherein Peterson further teaches screw head 5610 is configured to receive a tulip 5506 for capturing a rod (see Figs. 57-58).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Eekhoff, in further view of Mesiwala et al., US20200268525 (hereinafter, Mesiwala).
Regarding claim 4, Peterson in view of Eekhoff teaches and/or make obvious of the fastener of claim 1, but fails to teach wherein the hooked thread profile extends along an entire length of the shaft.
However, Mesiwala teaches the hooked thread profile (see hook shape thread profile of composite implant 4400 in Fig. 44B) extends along an entire length of the shaft (shaft of the central element 4410).
The Examiner interprets the disclosure, in para. [0084], does not provide any evidence of the criticality of the length of the thread profile. Therefore, it would have been obvious matter of design choice to one having ordinary skill in the art before the effective filing date of claimed invention to modify the shape and/or size of the threaded profile in Peterson as an obvious change in shape and/or size.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to have modified the sleeve of Peterson to have hooked thread profile extending along an entire length of the shaft as taught by Mesiwala so the sleeve may be made of single component to be a single, integral unit, and have a constant pitch along its length (see para. [0196] & [0199]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 7-8 and 15-20 have been fully considered. Rejection based on existing and/or newly found prior art has been set forth above.
Applicant argues the end cap of Patel is designed to rotate relatively to the catheter housing.
The Examiner notes that the rejection and rationale set forth above is based on newly found teaching reference, Eekhoff.
Applicant argues the screw of Peterson teaches away from any combination that requires an end cap.
The Examiner respectfully disagrees.
In general, screws are modified to have cap for several advantages like protection against soft tissue and/or modular cutting assembly for robust system. Advantage of using the cap 28 in Eekhoff is for suitable retraction and compression of the fastener assembly 14. See Figs. 7-9 in Eekhoff.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20190167326 (Greenhalgh et al.), in Figs. 28A-28F, discloses sleeve 10 having helical thread and muffler 138 having head and tip configured to be inserted into the sleeve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIL K MAGAR whose telephone number is (571)272-8180. The examiner can normally be reached M-F 7:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christine Mills can be reached at (571) 272-8322. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DIL K. MAGAR/Examiner, Art Unit 3675
/CHRISTINE M MILLS/Supervisory Patent Examiner, Art Unit 3675
Prosecution Insights