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 10 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Remington et al. (2018/0200078).
Regarding claim 10, Remington et al. disclose a system (Figs. 2, 3, 4A, 4B, 9C) configured to insert a medical implant 100 into a treatment site, the system comprising:
the medical implant 100, comprising:
an outer body 114 (Fig. 2) defining a longitudinal axis (e.g., coaxial with a central longitudinal axis of the screw 108 (Fig. 3)) extending through a proximal end (visible in Fig. 2) of the outer body 114 and an opposite distal end of the outer body;
a threaded screw 108 (id.) operatively coupled to the outer body (Figs. 4A and 4B) and having a first threading 102 and a second threading 104 (id.), wherein the first threading threads in an opposite direction relative to the second threading (id. and para. 0053);
one proximal wing 110; and
one distal wing 112;
an insertion tool 802 (Fig. 9C, paras. 0071-0074), comprising:
an outer shaft 906 coupled to an outer grip 908;
a handle (916 and enlarged proximal portion of 906; Fig. 9C) operatively coupled to the outer grip 908 such that the outer shaft 906 couples to the handle;
an inner shaft 905, the outer shaft 906 receiving at least a portion of the inner shaft 905;
an attachment member 902 integrally coupled to the inner shaft 905, wherein the attachment member 902 removably couples to the outer body 114 of the medical implant 100 (via clamping arms, i.e., “fingers” 903 that engage gripping apertures 128; Figs. 2 and 9C) to attach the implant 100 to the insertion tool 802 (id. and para. 0057); and
an inner rod, i.e., a screw driver rod (para. 0074), having a distal end and a proximal end, wherein the inner shaft 905 receives at least a portion of the inner rod (para. 0074, via a central hollow channel), wherein the distal end of the inner rod comprises a driver head, i.e., the drive/engaging mechanism that engages positioning aperture 134 of the threaded screw 108 (Figs. 2 and 3; paras. 0053-0054) and the proximal end of the inner rod comprises a control (para. 0053), wherein the threaded screw 108 is configured to receive the driver head (at positioning aperture 134), wherein operation of the control rotates the driver head (para. 0053) to actuate the threaded screw (paras. 0053-0054), wherein rotation of the driver head rotates the threaded screw 108 to transition the proximal wing 110 and the distal wing 112 between a closed position (Fig. 4A) and a deployed position (Fig. 4B).
Regarding claim 12, the insertion tool 802 comprises an attachment member 902 integrally coupled to the inner shaft 905 (Fig. 9C), wherein the attachment member 902 comprises a plurality of arms 903 (id.) configured to attach the medical implant 100 to the insertion tool (Figs. 2 and 9C; para. 0057).
Regarding claim 13, openings 128 are defined by the outer body 114 (Fig. 2), wherein the openings receive at least a portion of each arm of the plurality of arms 903 to thereby attach the medical implant 100 to the insertion tool 802 and maintain the medical implant on the insertion tool (para. 0057).
Regarding claim 14, rotation of the outer grip 908 translates the plurality of arms 903 of the attachment member 902 such that the openings 128 receive the plurality of arms 903 to thereby maintain the medical implant on the insertion tool (paras. 0057 and 0073).
Regarding claim 15, a connector 912 operatively couples the handle (916 and enlarged proximal portion of 906; Fig. 9C) to the outer grip 908 and the outer shaft 905 to the handle (para. 0073).
Regarding claim 16, the handle (916 and enlarged proximal portion of 906; Fig. 9C) defines a tunnel, i.e., “a central hollow channel”, configured to receive at least a portion of the inner rod (para. 0074).
Claims 1, 3, 4, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quadrant Medical “Quadrant” (WO 2008/044057 A1).
Regarding claim 1, Quadrant discloses a medical implant (Fig. 15) for insertion at a treatment site, comprising:
an outer body 15c defining a longitudinal axis extending through a proximal end of the outer body and a distal end of the outer body;
a threaded screw 28 operatively coupled to the outer body and having a first threading and a second threading, wherein the first threading threads in an opposite direction relative to the second threading (Fig. 15);
a carrier 30 coupled to the threaded screw 28;
ramps, e.g., sloped portion (near reference number 32 in Fig. 15), defined by the medical implant;
one or more proximal wings 19 operatively coupled to the carrier 30; and
one or more distal wings 16, wherein actuation of the threaded screw 28 simultaneously pivots the one or more proximal wings between a closed position and a deployed position and pivots the one or more distal wings between a closed position and a deployed position, wherein continued actuation of the threaded screw distally translates the proximal wings from the deployed position to a clamped position to engage the proximal wings with bone or tissue at the treatment site.
Regarding claim 3, the outer body comprises a first outer body piece 12 and a second outer body piece 32, and wherein the first outer body piece and the second outer body piece define openings, e.g., the semi-cylindrical openings at the proximal end (Fig. 15).
Regarding claim 4, the openings of the first outer body piece and the second outer body piece (supra) are configured to receive at least a portion of an insertion tool 28 (Fig. 14) to attach and maintain the medical implant to the insertion tool 28.
Regarding claim 7, the carrier 30 defines a carrier bore and the carrier bore receives the threaded screw 28 to thereby couple the carrier to the threaded screw (Fig. 15).
Regarding claim 8, the distal wings comprise one or more arms (e.g., the rectangular lower portion), and wherein the one or more distal wings comprise one or more clamps 25 extending from the one or more arms (Fig. 15).
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Remington et al. (2018/0200078) in view of Crall et al. (2009/0005787).
Remington et al. disclose a threaded screw 108 comprising a screw head (defined as the end portion having the positioning aperture 134) and the screw head receives the driver head (para. 0053) of the inner rod, i.e., screw driver rod (supra; para. 0074). It is further noted that the positioning aperture 134 is small relative to the screw head and the threaded screw 108 (Fig. 2).
However, Remington et al. do not explicitly recite the inner rod comprising a taper proximate the distal end of the inner rod such that a size of the distal end of the inner rod is smaller than a size of the proximal end of the inner rod.
Crall et al. is also concerned with medical implants (para. 0001) and teaches that a tool engaging portion of an inner rod 231 of a driver tool (Fig. 18) can have a tapered section (id. and para. 0094) and be smaller than a proximal end 259 of the inner rod 231 of the driver tool (id.). The taper allows the inner rod to arrive at the size of the relatively smaller driving portion and fit therein.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide a taper at the distal end of the inner rod of Remington et al., in view of Crall et al., to arrive at the size of the small positioning aperture 134 of the driver head and enable the driver head to fit therein.
Allowable Subject Matter
Claims 17-20 are allowable over the prior art of record.
Claims 2, 5, 6 and 9 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claims 17-20 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in independent claim 17. In particular, none of the cited references teach or suggest the rotation of the screw causing at least a portion of each proximal wing of the one or more proximal wings to contact the ramps to thereby pivot the one or more proximal wings from the closed configuration to the deployed configuration, as required by independent claim 17.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
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, 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.
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.
DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773