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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-11 in the reply filed on 08/26/2026 is acknowledged.
Claims 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B and Species C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, in claim 8, wherein the plate includes one or more protrusions, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gil et al. (US Patent No. 5,665,088) in view of O’Connor et al. (US PG Pub No. 2018/0280066 A1).
Regarding claim 1, Gil discloses a prosthetic implant (Figs. 1-7) comprising: a body (Figs. 1-3, bone engaging member 10) comprising a first side (Figs. 1-3, inner surface J) and a second side (Figs. 1-3, outer surface I) opposite (see Fig. 2-3) the first side (J), wherein the first side (J) is configured to contact a tibia of a patient, and wherein the second side (I) is configured to be coupled to an articulation surface ; and at least one fixation component (Fig. 2, cable 50) extending away (Fig. 2) from the first side of the body (J), wherein the at least one fixation component (50) includes a first end (Fig. 2, cable 50 at T2) and a second end opposite (Fig. 2, cable 50 at T1) the first end (Fig. 2, cable 50 at T2), wherein the second end (Fig. 2, cable 50 at T1) of the at least one fixation component (50) is coupled to the body (Fig. 2, clamping screw 20, anchor for cable 50 on body 10).
The phrases “configured to contact a tibia of a patient” and “configured to be coupled to an articulation surface” are functional recitations that are not given full patentable weight. The prosthetic implant body is not positively recited here, but is instead merely recited as part of the intended use of the prosthetic implant. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used on a tibia and articulation surface in order to meet the claim requirements. In the case, Gils’s device discloses all the claimed structural features, such as a prosthetic implant comprising a body with a first side and a second side in contact with a femur and is considered to be capable of being used on a tibia and therefore an articulation surface.
Gil fails to disclose wherein the first end of the at least one fixation component includes a button configured to rotate from a first position while traveling through the tibia of the patient to a second position after exiting the tibia of the patient, and wherein a tension of the at least one fixation component is adjustable to thereby adjust a force applied by the body to the tibia of the patient.
O’Connor also discloses a prosthetic implant (Figs. 1-2 and 15A-15B, second bolster device 104) comprising a first side (see annotated Fig. 2 below), a second side (see annotated Fig. 2 below), and at least one fixation component (Figs. 1-2 and 15A-15B, suture 110). O’Connor teaches wherein the first end (Figs. 1-2, first end 112) of the at least one fixation component (110) includes a button (Figs. 1-2 and 15A-15B, bolster device 102) configured to rotate (Paragraph [0040], Figs. 15A-15B) from a first position (Fig. 15A) while traveling through the tibia of the patient to a second position (Fig 15B) after exiting the tibia of the patient, and wherein a tension (Paragraph [0037]) of the at least one fixation component (102) is adjustable to thereby adjust a force applied by the body to the tibia of the patient (Paragraph [0037]). The button (102) is configured to rotate as it is mounted to a flexible member (110) and is capable of traveling through bone from a first position (Fig 15A) to a second position (Fig. 15B) and “rotates” from a linear position traveling through the bore in the bone to a transverse position for anchoring to the bone after exiting (Paragraph [0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gil’s fixation component wherein the first end of the at least one fixation component includes a button configured to rotate from a first position while traveling through the tibia of the patient to a second position after exiting the tibia of the patient, as taught by O’Connor, in order to apply tension on the tibia from a button (Paragraph [0037]) and wherein a tension of the at least one fixation component is adjustable to thereby adjust a force applied by the body to the tibia of the patient, as taught by O’Connor, in order to compress the bone during healing (Paragraphs [0001 and 0038]).
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Regarding claim 2, Gil in view of O’Connor discloses wherein the at least one fixation component (Fig. 2, cable 50) comprises a suture (Col. 3, lines 64-65, “surgical cables”, wherein the cable is encompassed by the broadest reasonable interpretation of “suture”).
Regarding claim 3, Gil in view of O’Connor discloses the claimed invention except for wherein the at least one fixation component (Fig. 2, cable 50) comprises a Nitinol wire (Col. 5, lines 12-18, “other biocompatible materials” therefore, nitinol).
Regarding claim 4, Gil in view of O’Connor discloses further comprising: one or more pegs (Fig. 2-7, spikes 48) coupled to and extending away (see Fig. 3) from the first side of the body (J).
Regarding claim 5, Gil in view of O’Connor discloses wherein the at least one fixation component (Fig. 2, cable 50) comprises: a first fixation component (Fig. 2, cable 50); a second fixation component (Fig. 2, cable 52); a third fixation component (Fig. 2, cable 54); but fails to disclose a fourth fixation component.
Regarding a fourth fixation component, “the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the fixation components of Gil to include a fourth fixation component, as doing so would have yielded predictable results, namely improving fixation of the implant to a bone. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960): (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.)” MPEP § 2144.04-VI-B.
Regarding claim 9, Gil as modified by O’Connor discloses wherein a first end of the first fixation component (50) and a first end of the second fixation component (52) are positioned on an anterior side of the tibia of the patient, and wherein a first end of the third fixation component (54) and a first end of the fourth fixation component (see claim 5 above) are positioned on a posterior side of the tibia of the patient.
The phrases “are positioned on an anterior side of the tibia of the patient” and “are positioned on a posterior side of the tibia of the patient” are functional recitations that are not given full patentable weight. The prosthetic implant is not positively recited here, but is instead merely recited as part of the intended use of the fixation component. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of positioning the fixation components in order to meet the claim requirements. In the case, Gils’s device discloses all the claimed structural features, such as having flexible fixation components (Cables 50, 52, and 54 can be nitinol (Col. 5, lines 12-18) which is a flexible material) which are considered to be capable of being positioned in the claimed manner.
Regarding claim 10, Gil as modified by O’Connor discloses wherein the first end of the first fixation component (50) and the first end of the third fixation component (54) are positioned on a medial side of the tibia of the patient, and wherein the first end of the second fixation component (52) and the first end of the fourth fixation component (see claim 5 above) are positioned on a lateral side of the patient.
The phrases “are positioned on a medial side of the tibia of the patient” and “are positioned on a lateral side of the tibia of the patient” are functional recitations that are not given full patentable weight. The prior art is not required to explicitly disclose the particular arrangement of the implant components relative to bones of a patient, but merely have the capability of positioning the fixation components according to the claims in order to meet the claim requirements. In the case, Gils’s device discloses all the claimed structural features, such as having flexible fixation components (Cables 50, 52, and 54 can be nitinol (Col. 5, lines 12-18) which is a flexible material) which are considered to be capable of being positioned in the claimed manner.
Regarding claim 11, Gil as modified by O’Connor discloses wherein an angle between the first fixation component (50) and the second fixation component (52) in a transverse plane is about 90 degrees, wherein an angle between the second fixation component (52) and the third fixation component (54) in the transverse plane is about 90 degrees, wherein an angle between the third fixation component (54) and the fourth fixation component (see claim 5 above) in the transverse plane is about 90 degrees, and wherein an angle between the fourth fixation component (see claim 5 above) and the first fixation component (50) in the transverse plane is about 90 degrees.
The phrases “an angle between the first, second, third, and fourth fixation components in a transverse plane is about 90 degrees” are functional recitations that are not given full patentable weight. The prior art is not required to explicitly disclose the particular arrangement of implant components relative to one another, but merely have the capability of positioning the fixation components in order to meet the claim requirements. In the case, Gils’s device discloses all the claimed structural features, such as having flexible fixation components (Cables 50, 52, and 54 can be nitinol (Col. 5, lines 12-18) which is a flexible material) which are considered to be capable of being positioned in the claimed manner.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gil et al. (US Patent No. 5,665,088) in view of O’Connor et al. (US PG Pub No. 2018/0280066 A1) as applied to claim 5 above, and further in view of Lyon (US PG Pub No. 2013/0123841 A1).
Regarding claim 6, Gil in view of O’Connor discloses further comprising: threaded fasteners (clamping screws 20) positioned adjacent the second side of the body (Figs. 1-3, outer surface I) and received in recesses (38, 54 and 66) to couple a second end (Fig. 2, cable 50 at T2) of the first fixation component (50), a second end (Fig. 2, cable 52 at T2) of the second fixation component (52), a second end (Fig. 2, cable 54 at T2) of the third fixation component (54), and a second end (see claim 5 above) of the fourth fixation component (see claim 5 above) to the implant body. Gil in view of O’Connor fails to disclose a plate positioned adjacent the second side of the body to which the second ends of the fixation components are coupled.
Lyon also discloses another prosthetic implant body (14) (Figs. 1-2 and 13-14) comprising a first side (40), a second side (42), at least one fixation component (sutures 18), and a threaded fastener (12) received in the recess (wall 52) of the opening (50) of the implant body for coupling fixation components (sutures 18) to the implant body. Lyon teaches that the threaded fastener (button 12) can include a plate shaped head (proximal rim 26 in Figure 2 [0042] or bar element (30) in Figures 6-8; [0057-0061]) that aids in securing the sutures (18) to the implant body. Lyons further teaches that multiple fixation components (sutures 18) can be coupled with one button suture clamping screw (12 and plate 30) [0070]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the suture clamping screws having a plate shaped element taught by Lyon for the suture clamping screws (20) of Gil, in order to aid in securing the fixation components to the implant body ([0042-0043]. The modification provides the capability of coupling second ends of multiple fixation components to one plate taught by Lyons, in order to accommodate for widely varying patient anatomy and trauma.
Regarding claim 7, Gil as modified by O’Connor, and Lyon further discloses wherein the second side of the body (Figs. 1-2, second side 42) includes a recess (Figs. 1-2, interior wall 52) configured to receive (Paragraphs [0042-0043]) the plate ( Figs. 1-2, proximal end portion 24 of the button 12).
Regarding claim 8, Gil as modified by O’Connor, and Lyon further discloses wherein the plate (24) includes one or more protrusions (Figs. 1-2, threads 36) configured to mate with one or more recesses (52) in the body (14) to prevent rotation of the plate in a transverse plane (Paragraph [0043], “locking mechanism”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kent et al. (US PG Pub No. 2023/0390068 A1) also discloses a prosthetic implant (Figs. 1-2, anchor 104) comprising a first side (Figs. 1-2, distal end 104b), a second side (Figs. 1-2, proximal end 104a), and at least one fixation component (Figs. 1-2, sutures 208).
Thornes (US PG Pub No. 2016/0051250 A1) also discloses a prosthetic implant (see Fig. 7) and at least one fixation component (Figs. 1-7, suture 18).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/K.L.C./ Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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