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 .
Response to Arguments
Applicant’s arguments, filed March 30, 2026, with respect to the rejection(s) of claim(s) 1-6, 8-10, 12-15, 21-23, and 25 under 35 U.S.C. 102 and claims 7, 11, 19, 24, and 26 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference McCormick regarding the amended limitations of wherein the central portion comprises four flat surfaces extending between the proximal portion and the distal portion.
Claims 11, 12, 13, 22, and 23 have been amended. 35 U.S.C. 112 rejection has been withdrawn.
Claim 15 has been amended. 35 U.S.C. 112 rejection has been withdrawn.
Claims 16-18 and 20 were directed to non-elected species, and are treated as withdrawn. Claims found to be drawn to nonelected inventions, including claims drawn to nonelected species or inventions that may be eligible for rejoinder, are treated as indicated in MPEP § 821.01 through § 821.04.
All claims that the examiner finds are not directed to the elected invention are withdrawn from further consideration by the examiner in accordance with 37 CFR 1.142(b). See MPEP § 821.01 through § 821.04.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-10, 12-15, 21-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0062868 to Casutt in view of U.S. Patent Pub. No. 2016/0081728 to McCormick.
As to Claim 1, Casutt discloses an implant (Fig. 4, [0105]). The implant comprises a proximal portion (11), a distal portion (21), and a central portion (17) disposed between the proximal portion and the distal portion (seen in Fig. 4). The central portion (17) comprises two flat surfaces (opposing surfaces of thin strip 27, Fig. 4 and [0105-0106]) and a depth (Fig. 4), wherein the implant further comprises a longitudinal axis (axis ‘C’, Fig. 4) and the proximal portion, the distal portion and the central portion are centered along the longitudinal axis (seen in Fig. 4).
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As to Claim 2, Casutt discloses an implant wherein the proximal portion (11), the distal portion (21) and the central portion (17) are integral to each other (one piece described in [0064]).
As to Claim 3, Casutt discloses an implant wherein the proximal portion (11), the distal portion (21) and the central portion (17) are couplable to each other (e.g. connected by joints described in [0067-0068]).
As to Claim 4, Casutt discloses an implant wherein the proximal portion (11) comprises a top surface (45) and a bottom surface (45) with the top surface and bottom surface being planar and parallel to each other (seen in Fig. 4, planar surfaces 45 described in [0085, 0106]).
As to Claim 5, Casutt discloses an implant wherein the proximal portion (11) further comprises an opening extending (seen in Fig. 4) from the top surface to the bottom surface, wherein the opening is sized to receive a bone fastener (coupling with connection device 64 described in [0084, 0142-0143]).
As to Claim 6, Casutt discloses an implant wherein the opening has a central axis (seen in Fig. 4), wherein the central axis is perpendicular to the longitudinal axis of the implant (Fig. 4).
As to Claim 8, Casutt discloses an implant wherein the proximal portion further comprises a lateral dimension and a longitudinal dimension, wherein the lateral dimension is greater than the longitudinal dimension (seen in Fig. 4, below).
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As to Claim 9, Casutt discloses an implant wherein the proximal portion wherein the proximal portion further comprises a lateral dimension and a longitudinal dimension, wherein the lateral dimension is less than the longitudinal dimension (seen in Fig. 4, below).
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As to Claim 10, Casutt discloses an implant wherein the proximal portion further comprises a lateral dimension and a longitudinal dimension, wherein the lateral dimension is equal to the longitudinal dimension (seen in Fig. 4, below).
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As to Claim 12, Casutt discloses an implant wherein the central portion has a longitudinal dimension, wherein the longitudinal dimension of the central portion is less than the longitudinal dimension of the proximal portion (seen in Fig. 4, below).
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As to Claim 13, Casutt discloses an implant wherein the central portion has a longitudinal dimension, wherein the longitudinal dimension of the central portion is greater than the longitudinal dimension of the proximal portion (seen in Fig. 4, below).
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As to Claim 14, Casutt discloses an implant wherein the central portion comprises a substantially rectanguloid section (27, [0105-0106]) and a cylindrical section (19, [0105]).
As to Claim 15, Casutt discloses an implant wherein the substantially rectanguloid section extends between a distal end of the proximal portion (distal portion of 19) and a proximal end of the distal portion (proximal portion of 21, Fig. 4).
As to Claim 21, Casutt discloses an implant wherein the distal portion (21) comprises a threading (of 21) extending along at least a portion of the distal portion (seen in Fig. 4) and a tip positioned at a distal end of the distal portion (seen in Fig. 4, [0030]).
As to Claim 22, Casutt discloses an implant wherein a lateral dimension of the proximal portion is greater than an outermost dimension of the threading (of 21, seen in Fig. 4).
As to Claim 23, Casutt discloses an implant wherein the distal portion tapers from its proximal end to a distal end (taper of 21 to distal tip seen in Fig. 4).
As to Claim 25, Casutt discloses an implant wherein the threading is circumferential disposed spiral threads (Fig. 4, [0036]).
As to Claims 1-6, 8-10, 12-15, 21-23, and 25, Casutt discloses the claimed invention except for wherein the central portion comprises four flat surfaces extending between the proximal portion and the distal portion.
McCormick discloses an implant (2, [0031], Fig. 1) including wherein a central portion (6) comprises four flat surfaces (square cross section described in [0034], Fig. 1) extending between the proximal portion (8) and the distal portion (4) in order to allow provide a suitable cross-sectional shape for the implant [0034] to provide stable but provide adequate compression across a joint while being easily inserted with minimal damage to the surrounding tissue [0005].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt with the four flat surfaces modification of McCormick in order to allow provide a suitable cross-sectional shape for the implant to provide stable but provide adequate compression across a joint while being easily inserted with minimal damage to the surrounding tissue.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0062868 to Casutt in view of U.S. Patent Pub. No. 2016/0081728 to McCormick in view of U.S. Patent Pub. No. 2012/0197254 to Wolfe et al.
As to Claim 7, Casutt and McCormick disclose the claimed invention except for wherein the opening further comprises at least one of a tapered, a rounded or a gradient surface that extends from the top surface to an inside wall of the opening, and wherein the opening further comprises at least one of a tapered, a rounded or a gradient surface that extends from the bottom surface to the inside wall of the opening, wherein the at least one of the tapered, the rounded or the gradient surfaces extending from the top surface or the bottom surface facilitate polyaxial movement of the bone fastener when inserted into the opening of the implant.
Wolfe discloses a surgical implant (1400, Fig. 14, [0093]) wherein an opening (1630, seen in Fig. 16) further comprises a rounded surface (Fig. 16, [0097-0098]) that extends from the top surface to an inside wall of the opening (Fig. 16, [0098-0099]), and wherein the opening further comprises a rounded surface (Fig. 16, [0097-0098]) that extends from the bottom surface to the inside wall of the opening (Fig. 16, [0097-0098]), wherein the a surfaces extending from the top surface or the bottom surface facilitate polyaxial movement of a bone fastener (1415) when inserted into the opening of the implant [0093, 0098-0099] in order to allow for an angle of the bone fastener to be adjusted within the aperture to a desired angle [0093].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt and McCormick with the polyaxial opening modification of Wolfe in order to allow for an angle of the bone fastener to be adjusted within the aperture to a desired angle.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0062868 to Casutt in view of U.S. Patent Pub. No. 2016/0081728 to McCormick in view of U.S. Patent No. 5,443,482 to Stone et al.
As to Claim 11, Casutt and McCormick disclose the claimed invention except for wherein the proximal portion further comprises a tip section, wherein the tip section comprises a planar surface proximate to two tapered surfaces, wherein a length of the planar surface is less than a lateral dimension of the proximal portion proximate to an opening extending from a top surface to a bottom surface.
Stone discloses a surgical implant (10, Figs. 1-2, Col. 2, Lines 17-25) wherein a proximal portion further comprises a tip section (seen in Fig. 1, below), wherein the tip section comprises a planar surface proximate to two tapered surfaces (seen in Figs. 1-2, below), wherein a length of the planar surface is less than a lateral dimension of the proximal portion proximate to an opening extending from a top surface to a bottom surface (18, Figs. 1-2, below) in order to allow for coupling of the proximal portion of the implant with a driver (Col. 2, Lines 23-25).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt and McCormick with the proximal portion modification of Stone in order to allow for coupling of the proximal portion of the implant with a driver.
Claims 19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0062868 to Casutt in view of U.S. Patent Pub. No. 2016/0081728 to McCormick in view of U.S. Patent No. 10,631,994 to Fallin et al.
As to Claims 19 and 24, Casutt and McCormick disclose the claimed invention except for wherein the cylindrical section of the central portion extends distally from the substantially rectanguloid section and tapers into a proximal end of the distal portion of the implant, and wherein the tip comprises at least one of a self- tapping mechanism or at least one cutting flute.
Fallin discloses a surgical implant wherein a cylindrical section (126) of the central portion extends distally from a substantially rectanguloid section (formed by 122, Fig. 2) and tapers into a proximal end of the distal portion of the implant (102, Fig. 2, Col. 3, Lines 56-67 – Col. 4, Lines 1-17), and wherein the tip comprises a self- tapping mechanism (114, Col. 3, Lines 59-63) in order to allow the implant to cut threads to aid its insertion into bone (Col. 3, Lines 59-66).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt and McCormick with the central portion and tip modification of Fallin in order to allow the implant to cut threads to aid its insertion into bone.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0062868 to Casutt in view of U.S. Patent Pub. No. 2016/0081728 to McCormick in view of U.S. Patent No. 10,631,994 to Fallin et al. in view of U.S. Patent Pub. No. 2012/0197254 to Wolfe et al.
As to Claim 26, Casutt discloses an implant system (Fig. 4, [0105]). The system comprises an implant for insertion into a first bone [0010] that comprises a proximal portion (11) comprising an opening extending through the proximal portion of the implant (Fig. 4, below), a distal portion (21) comprising a threading (of 21) extending along at least a portion of the distal portion (seen in Fig. 4, [0030]), a tip positioned at an end of the distal portion opposite the proximal portion (seen in Fig. 4, [0030]), and a central portion (17) disposed between the proximal portion and the distal portion (seen in Fig. 4) and comprising comprises two flat surfaces (opposing surfaces of thin strip 27, Fig. 4 and [0105-0106]) and a depth (Fig. 4) disposed about an outer surface thereof [0105-0106], and a fastener (64).
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As to Claim 26, Casutt discloses the claimed invention except for wherein the central portion comprises four flat surfaces extending between the proximal portion and the distal portion, wherein the tip comprises at least one of a self- tapping mechanism or at least one cutting flute, and wherein the fastener is sized to be inserted into and through the opening and into a second bone.
McCormick discloses an implant (2, [0031], Fig. 1) including wherein a central portion (6) comprises four flat surfaces (square cross section described in [0034], Fig. 1) extending between the proximal portion (8) and the distal portion (4) in order to allow provide a suitable cross-sectional shape for the implant [0034] to provide stable but provide adequate compression across a joint while being easily inserted with minimal damage to the surrounding tissue [0005].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt with the four flat surfaces modification of McCormick in order to allow provide a suitable cross-sectional shape for the implant to provide stable but provide adequate compression across a joint while being easily inserted with minimal damage to the surrounding tissue.
Fallin discloses a surgical implant wherein the tip comprises a self- tapping mechanism (114, Col. 3, Lines 59-63) in order to allow the implant to cut threads to aid its insertion into bone (Col. 3, Lines 59-66).
Wolfe discloses a surgical implant (1400, Fig. 14, [0093]) a fastener (1415) is sized to be inserted into and through the opening (1630, seen in Fig. 16) and into a second bone [0093, 0098-0099] in order to allow for an angle of the bone fastener to be adjusted within the aperture to a desired angle [0093].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical implant of Casutt and McCormick with the tip modification of Fallin in order to allow the implant to cut threads to aid its insertion into bone, and with the fastener modification of Wolfe in order to allow for an angle of the bone fastener to be adjusted within the aperture to a desired angle.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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