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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 September 2025 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 23 September 2025 have been entered. Claims 24-26 are new. Claims 2 and 23 are cancelled. Claims 1, 3, 5, 7-9, 21-22, and 24-26 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 5, 7-9, 21-22, and 24-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “approximates” in claims 1 and 26 is a relative term which renders the claims indefinite. The term “approximate” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although “approximately” is defined in [0035] of the specification, it is unclear how that definition relates to “approximat[ing] a shape” as in claim 26, or “at least a portion of a shape” as in claim 1. Claims 3, 5, 7-9, 21-22, and 24-26 are rejected by dependency.
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.
Claim 1, 3, 5, 21, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nijenbanning et al. (US 2008/0362497 A1), “Nijenbanning” in view of Kaikkonen et al. (US 2011/0306975 A1), “Kaikkonen”.
Regarding claim 1, Nijenbanning teaches a condylar implant assembly (Fig. 1, implant used on broken femur [0029]), comprising: a tube (Fig. 4, outer tube 50) with a longitudinal length (Fig. 4, central axis of outer tube 50) having slots (Fig. 4, recesses 52 and 53) extending partially along the longitudinal length, the tube having a first end (Fig. 4, end having screw thread 51) having a first internal cross-sectional distance and a second end (Fig. 4, end having shoulder 54) having a second internal cross-sectional distance smaller than the first internal cross-sectional distance (Fig. 4, end having shoulder 54 is narrower than end having screw thread 51) such that an internal step is formed within the tube at the second end (Fig. 4, shoulder 54);
a driving device (Fig. 6, screw 57) positioned within the first end of the tube (Fig. 8, screw 57 is within end having screw thread 51); and a dilating member (Fig. 6, tube 55) positioned between the driving device and the internal step within the tube (Fig. 8, tube 55 is between screw 57 and shoulder 54), the dilating member (Fig. 6, tube 55) having a proximal end (Fig. 6, end closest to screw 57), a distal end (Fig. 6, end having end piece 56), a longitudinal axis parallel to the longitudinal length of the tube (Fig. 6, tube 55 has same central axis as outer tube 50), and a plurality of bands (Fig. 6, strips 52’ and 53’) extending along the longitudinal axis between the proximal end and the distal end (Fig. 6, strips 52’ and 53’ are between end closest to screw 57 and end with end piece 56), each of the plurality of bands (Fig. 6, strips 52’ and 53’) movable through a corresponding one of the slots of the tube (Fig. 9, strips 52’ and 53’ correspond with recesses 52 and 53) when the dilating member (Fig. 6, tube 55) is compressed between the driving device and the internal step of the tube (Fig. 9, [0044]); and
wherein the dilating member (Fig. 6, tube 55) is moveable between first (Fig. 8) and second positions (Fig. 9) between the driving device (Fig. 6, screw 57) and the internal step (Fig. 4, shoulder 54) within the tube (Fig. 4, outer tube 50), wherein in the first position (Fig. 8), the plurality of bands are unextended (Fig. 8, strips 52’ and 53’ are not bent (i.e., unextended)), and wherein in the second position (Fig. 9), the plurality of bands extend through the corresponding one of the four or more slots of the tube (Fig. 9, strips 52’ and 53’ extend through recesses 52 and 53) when the dilating member (Fig. 9, tube 55) is compressed between the driving device and the internal step of the tube (Fig. 9, [0044]), and wherein movement of the plurality of bands through the slots (Fig. 9, strips 52’ and 53’ extend through recesses 52 and 53) of the tube (Fig. 4, outer tube 50) positioned the plurality of bands symmetrically or asymmetrically (Fig. 9, strips 52’ and 53’ are symmetrical along the center axis of outer tube 50) around the longitudinal axis (Fig. 4, central axis of outer tube 50) of the dilating member (Fig. 9, tube 55) to form a preset three-dimensional shape (Fig. 9, strips 52’ and 53’ bend outwards under deformation to the shape shown [0044]), and wherein the dilating member is configured for insertion into a condylar head of a bone (Fig. 1, implant used on broken femur [0029]), but fails to teach four or more slots, and whereby the preset three-dimensional shape formed by the plurality of bands approximated at least a portion of a shape of the condylar head of the bone to facilitate support and stabilization of the condylar head of the bone.
Kaikkonen teaches an internal bone support comprising four or more slots (Fig. 1, support device 1 comprises 2 to 100 strips 4 (i.e., frame 2 comprises n-1 slits 5) [0046]), and whereby the preset three-dimensional shape formed by the plurality of bands approximated at least a portion of a shape of the condylar head of the bone to facilitate support and stabilization of the condylar head of the bone (Fig. 2, support device 1 comprises an oblong tube-like shape [0044] (i.e., rounded, similar to condylar head) and provides internal bone support [0009-0010]). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces.
Regarding claim 3, Nijenbanning teaches wherein the slots of the tube are positioned proximate to the second end of the tube (Fig. 4, recesses 52 and 53 are proximate to the end of tube 55 having end piece 56) but fails to teach that there are four or more slots.
Kaikkonen teaches an internal bone support comprising four or more slots (Fig. 1, support device 1 comprises 2 to 100 strips 4 (i.e., frame 2 comprises n-1 slits 5) [0046]). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces.
Regarding claim 5, Nijenbanning teaches wherein each of the plurality of bands in the second position (Fig. 9, strips 52’ and 53’ are in a compressed state) form one or more of an arc and a partial trapezoid (Fig. 9, strips 52’ and 53’ are bent at an angle (i.e., similar to an arc or a partial trapezoid)).
Regarding claim 21, Nijenbanning teaches the dilating member (Fig. 9, tube 55), but fails to explicitly teach at least eight bands. However, Nijenbanning discloses that the number of deformable strips may be increased as required [0045]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to duplicate the number of bands on the dilating member in order to better fix bone parts.
Regarding claim 24, Nijenbanning fails to teach the limitations of claim 24. Kaikkonnen teaches an internal bone support wherein the preset three-dimensional shape has at least a partially spherical shape (Fig. 2, support device 1 comprises an oblong tube-like shape [0044]). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces.
Regarding claim 25, Nijenbanning fails to teach the limitations of claim 25. Kaikkonen teaches an internal bone support wherein the preset three-dimensional shape has at least a partially cylindrical shape (Fig. 2, support device 1 comprises an oblong tube-like shape [0044]). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces.
Regarding claim 26, Nijenbanning fails to teach the limitations of claim 26. Kaikkonnen teaches an internal bone support wherein the preset three-dimensional shape approximates a shape of a condylar head of a humerus or femur (Fig. 2, support device 1 comprises an oblong tube-like shape [0044] and is implanted in the femur head (Fig. 6)). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces.
Claims 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Nijenbanning et al. (US 2008/0362497 A1), “Nijenbanning” in view of Kaikkonen et al. (US 2011/0306975 A1), “Kaikkonen”, and further in view of Singh et al. (US 2020/0323571 A1).
Regarding claim 7, Nijenbanning teaches the implant assembly of claim 1, and a second end of the tube (Fig. 4, end having shoulder 54), but Nijenbanning in view of Kaikkonen fails to teach that the second end of the tube has external threads.
Singh teaches a tube (Fig. 7A, fixation device 300) that has a second end with external threads (Fig. 7A, end with compression screw 308). Singh discloses that the compression screw is used as a means for anchoring and expanding the anchoring members [0068]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the second end of the tube taught by Nijenbanning to include external threads for a better means for fixation to the afflicted bone.
Regarding claim 22, Nijenbanning teaches the plurality of bands (Fig. 9, strips 52’, 53’) of the dilating member (Fig. 9, tube 55), but Nijenbanning in view of Kaikkonen fails to teach they are formed of a shape memory nitinol. Singh teaches a locking system for femoral neck fractures comprising bands (Fig. 7B, anchoring members 316) that are formed of a shape memory nitinol (fingers (i.e., anchoring members) within housing comprise nitinol [0012]).
Singh discloses that the shape memory material is capable of transitioning between an inward and outward extension suited for preparing and deploying the device [0012]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the material of the bands taught by Nijenbanning to be formed of nitinol in order to allow for easy deferment of the bands during preparation and deployment.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nijenbanning et al. (US 2008/0362497 A1), “Nijenbanning” in view of Kaikkonen et al. (US 2011/0306975 A1), “Kaikkonen”, and further in view of Frei et al. (US 2003/0078581 A1), “Frei”.
Regarding claim 8, Nijenbanning teaches the implant assembly of claim 1, a driving device (Fig. 6, screw 57) and the distal end of the dilating member (Fig. 6, end of tube 55 having end piece 56), but Nijenbanning in view of Kaikkonen fails to teach a bushing positioned between the driving device and the distal end of the dilating member.
Frei teaches a bushing (Fig. 1, cylindrical portion 44) positioned between the driving device (Fig. 3, compression bone screw 30) and the distal end of the dilating member (Fig. 1, end of shaft portion 3 with plug member 24). Frei discloses that the cylindrical portion provides a coaxial prolongation of the external screw thread of the spindle (i.e., a guide for the internal movements of the device) [0019]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device taught by Nijenbanning to include a bushing to best guide the movement of the driving device and dilating member in order to avoid malfunction of the implant.
Regarding claim 9, Nijenbanning teaches wherein the plurality of bands (Fig. 9, strips 52’ and 53’) has a first position (Fig. 8) within the tube (Fig. 4, outer tube 50) when the dilating member (Fig. 9, tube 55) is unextended and have a second position (Fig. 9) wherein the plurality of bands (Fig. 9, strips 52’ and 53’) extends through corresponding ones of the slots (Fig. 4, recesses 52 and 53) of the tube (Fig. 6, tube 55) when the dilating member (Fig. 9, tube 55) is compressed between the internal step of the tube (Fig. 4, shoulder 54), but fails to teach a bushing, but fails to teach four or more slots, and when the dilating member is compressed between the bushing and the internal step of the tube.
Kaikkonen teaches an internal bone support comprising four or more slots (Fig. 1, support device 1 comprises 2 to 100 strips 4 (i.e., frame 2 comprises n-1 slits 5) [0046]). Kaikkonen discloses that the implant provides minimally invasive access for repositioning of the fractured bone without compromising its strengthened structural capabilities [0011-0013]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the tube taught by Nijenbanning to comprise four or more slots as taught by Kaikkonen in order to provide an implant with high tensional and torsional strength abilities that withstands higher impact forces. However, Nijenbanning in view of Kaikkonen fails to teach when the dilating member is compressed between the bushing and the internal step of the tube.
Frei teaches a bushing (Fig. 1, cylindrical portion 44) wherein the dilating member (Fig. 1, shaft portion 3) is compressed between the bushing and the internal step of the tube (Fig. 1, plug member 24). Frei discloses that the cylindrical portion provides a coaxial prolongation of the external screw thread of the spindle (i.e., a guide for the internal movements of the device) [0019]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device taught by Nijenbanning in view of Kaikkonen to include a bushing to best guide the movement of the driving device and dilating member in order to avoid malfunction of the implant.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774