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 § 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 13-15 and 29 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.
Claim 13 claims “a substantially non-circular cross-section” claim 12 has been amended to include this feature such that it is unclear if claim 13 is claiming a second non-circular cross section. Claim 13 should be amended to “wherein the substantially non-circular cross-section comprises…”
Claim 29 claims “wherein the threads of the first threaded portion are in reverse orientation to the threads of the second threaded portion.” Amended claim 12 includes this limitation now and the limitation should be removed from claim 29.
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(s) 12-20, 22, 24-27 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tontz (US Pub 2013/0090655) in view of Vega et al. (US Patent 9,433,449) and in view of Chirico et al. (US Pub 2009/0005782).
With respect to claim 12, Tontz discloses an orthopaedic system (see figures 2A, B and 3 below) comprising: an orthopaedic device (fig 2, 36) comprising: connecting means (Fig 2, 22a and b) comprising a shaft, wherein the shaft comprises at least one pair of threaded portions (fig 2, 26a, b) wherein the at least one pair of threaded portions comprises a first threaded portion and a second threaded portion (fig 2, 26a, b); at least two expandable sections (fig 2, 12a, b), wherein the at least two expandable sections comprise a first expandable section (fig 2, 12a) and a second expandable section (fig 2, 12b), each expandable section displaceable between a contracted position (fig 2A) and an expanded position (fig 2B); and expanding means in operable association with the connecting means and the expandable sections, wherein rotation of the connecting means causes the expanding means to apply a force to respective ends of the expandable sections (fig 2A to 2B rotation of 40), thereby causing displacement of the expandable sections between the contracted position and the expanded position; and an orthopaedic implant (fig 3, 10) comprising at least one transverse aperture (fig 3, 44) configured to receive the orthopaedic device, wherein the first and second expandable sections are configured to be located on either side of the orthopaedic implant (as seen in fig 3). With respect to claim 16, Tontz discloses wherein the at least one transverse aperture bisects a longitudinal axis (see fig 3 below) relative to the orthopaedic implant. With respect to claim 18, Tontz discloses wherein the orthopaedic implant further comprises a longitudinal aperture (See fig 3 below), wherein the longitudinal aperture is coaxial with a longitudinal axis (fig 3), and the longitudinal aperture comprises an inner threaded surface which is in mechanical communication with the transverse aperture (paragraph 27, inner threads allow for screw 48 to contact the outer surface of the device). With respect to claim 19, Tontz discloses further comprising locking means (fig 3, 48). With respect to claim 20, Tontz discloses wherein the orthopaedic device further comprises limiting means (length of the threads), wherein the limiting means limits displacement of at least one expandable section between the contracted position and the expanded position by preventing the respective ends of the expandable sections from moving sequentially into closer proximity relative to one another (can only rotate until the end of the threads). With respect to claim 22, Tontz discloses wherein the first expandable section comprises a first end (fig 2, 18a) and a second end (end of 12a by 38), and the second expandable section comprising a third end (fig 2, 18b) and a fourth end (end of 12b by 38). With respect to claim 24, Tontz discloses wherein the first and second expandable sections are reversibly expandable (from 2A to 2B and back depending on the rotation of 22). With respect to claim 25, Tontz discloses wherein the first threaded portion and the second threaded portion are located at or adjacent respective opposing ends of the shaft (fig 2A). With respect to claim 26, Tontz discloses wherein the expanding means comprises a first body (fig 2, 12a and 18a) threadably mountable to the first threaded portion and a second body (fig 2, 12a, 18a) threadably mountable to the second threaded portion to allow for simultaneous movement of the first body and the second body in opposite directions relative to each other (from fig 2A to 2B). With respect to claim 27, Tontz discloses wherein rotation of the shaft causes a first threadable body to advance along the first threaded portion of the shaft and a second threadable body to advance, in the opposite direction, along the second threaded portion of the shaft, thereby applying mechanical pressure to the first end of the first expandable section and fourth end of the second expandable section, wherein the first end of the first expandable section and fourth end of the second expandable section are bought sequentially into closer proximity relative to one another thereby displacing the first and second expandable sections between the contracted position and the expanded position (from fig 2A to fig 2B, 18a and 18b move in opposite directions to expand the sections). With respect to claim 30, Tontz discloses wherein at least one end of the shaft is dimensioned and arranged to receive a torque delivery device (fig 2, 40). With respect to claim 31, Tontz discloses wherein the orthopaedic implant includes an intramedullary nail (fig 3, 46) having a longitudinal axis (See fig 3 below), and wherein after reception of the orthopaedic device in the at least one transverse aperture, the first expandable section is positioned on one side of the longitudinal axis of the intramedullary nail and the second expandable section is positioned on the other side of the longitudinal axis of the intramedullary nail (fig 3). With respect to claim 33, Tontz, discloses wherein the first and second expandable sections are arranged contiguously (fig 2).
With respect to claim 32, Tontz discloses a method for fixation of bones having a fracture (paragraph 4), the method comprising: reducing the fracture (paragraph 4); providing a channel (fig 4, space for 10) across the fracture; inserting into the channel an orthopaedic implant (fig 4, 10) comprising a transverse aperture (fig 3, 44); inserting (fig 4) an orthopaedic device (fig 2A) into the transverse aperture of the orthopaedic implant, the orthopaedic device comprising: connecting means (fig 2, 22) comprising at least one pair of threaded portions (fig 2, 26a, b); at least two expandable sections (fig 2, 12a, 12b), wherein the at least two expandable sections comprise a first expandable section (fig 2, 12a) and a second expandable section (fig 2, 12b), each expandable section displaceable between a contracted position (fig 2A) and an expanded position (fig 2B); and expanding means in operable association with the connecting means and the expandable sections, wherein rotation of the connecting means causes the expanding means to apply a force to respective ends of the expandable sections, thereby causing displacement of the expandable sections between the contracted position and the expanded position (fig 2A to 2B and paragraph 26)); wherein the orthopaedic device is inserted into the transverse aperture of the orthopaedic implant such that the first expandable section is positioned on one side of the orthopaedic implant and the second expandable section is positioned on another side of the orthopaedic implant that is opposite said one side of the orthopaedic implant (fig 4).
With respect to claims 12 and 32, Tontz discloses the claimed invention except for specifically disclosing wherein the threads of the first threaded portion are of reverse orientation to the threads of the second threaded portion (Tontz is silent with regard to this feature although to cause the two ends to move towards each other on a common shaft the threads would necessarily be reversed) and Tontz does not disclose wherein at least part of the orthopaedic device has a substantially non-circular cross-section and the transverse aperture is substantially non-circular in shape to receive the orthopaedic device.
Chirico explicitly discloses the threads on a shaft having first threaded portion (paragraph 90, 57a) are of reverse orientation (paragraph 90) to the threads of the second threaded portion (paragraph 90, 57b) to pull the expandable members together (paragraph 90).
Vega discloses wherein at least part of the orthopaedic device has a substantially non-circular cross-section (flats in figure 2, 208) and the transverse aperture is substantially non-circular (bottom of 102 is in the aperture making for a corresponding flat surface) in shape to receive the orthopaedic device (fig 1) to prevent the rotation of the device in the implant to prevent the implant from hindering compression of a fracture (col. 10. ll. 9-22). With respect to claim 13, Vega discloses an orthopaedic device fig 1, 201) has a substantially non-circular cross-section comprising at least one linear section (fig 1, 208) and at least one curved section (fig 1 the exterior surface next to 208). With respect to claim 14, Vega discloses wherein the outer surface of the orthopaedic device comprises at least one planar section (fig 1, 208) and at least one curved section (outer surface next to 208). With respect to claim 15, Vega discloses wherein the at least one linear cross-section section corresponds to the at least one planar section on the outer surface of the orthopaedic device, and the at least one curved cross-section corresponds to the at least one curved section on the outer surface of the orthopaedic device (fig 1). With respect to claim 17, Vega discloses wherein the transverse aperture comprises a first part (fig 2, 72)and a second part (fig 2, 102), wherein the first part is circular to receive a curved outer section of the orthopaedic device (fig 4, 72), and the second part is non- circular (bottom of 102)to receive a flat outer section of the orthopaedic device (col. 10, 10-15).
it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Tontz to include wherein the threads of the first threaded portion are of reverse orientation to the threads of the second threaded portion in view Chirico in order to pull the expandable members together and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Tontz to include wherein the orthopaedic device has a substantially non-circular cross-section comprising at least one linear section and at least one curved section and wherein the transverse aperture comprises a first part and a second part, wherein the first part is circular to receive a curved outer section of the orthopaedic device, and the second part is non- circular to receive a flat outer section of the orthopaedic device in view of Vega in order to prevent the rotation of the device in the implant to prevent the implant from hindering compression of a fracture.
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Allowable Subject Matter
Claim 28 is 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.
Claim 29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12-20, 22, 24-27 and 30-33 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. It is noted that the applicant’s arguments regarding Vega states that it does not disclose reverse threads. The 103 rejection above relies on Chirico to explicitly teach reverse threads on a shaft.
Applicant’s arguments, see remarks, filed 12/9/2025, with respect to the 103 rejection of claims 28-29 have been fully considered and are persuasive. The 103 rejection of claims 28-29 has been withdrawn. Amending independent claims 12 and 32 to include the features of claim 28 would overcome the art of record.
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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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