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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-38 in the reply filed on 05/14/26 is acknowledged.
Claims 39-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/26.
Claim Objections
Claim 8 is objected to because of the following informalities: In Line 3, the word --the-- should be added before the second instance of the word “second”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: In Line 2, the word --the-- should be added before the word “implant”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 2, the word --the-- should be added before the word “second”, and a comma should be added immediately following the word “relationship”. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: In Line 5, the word --the-- should be added before the word “second”, and a comma should be added immediately following the word “relationship”. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: In Line 3, the word “on” should be replaced with the words --in the--. Furthermore, the limitation “the first and second bones” should be replaced with the limitation --the first bone and the second bone--. Appropriate correction is required.
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.
Claim 1 is 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 1 at Lines 11-12 recites two instances of the limitation “the intramedullary space of the second bone”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, each limitation is being interpreted as --an intramedullary space of the second bone--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 7-11, 13-16, & 18-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCormick et al. (US PG Pub No. 2015/0223849).
Regarding Claim 1 as best understood, McCormick et al. discloses a method of fusing first and second bones (proximal phalange C & middle phalange A, Figs. 5-7, 7B, 8B, 9D) at a joint (PIP joint, Figs. 5-7, 7B, 8B, 9D), the second bone having first and second ends, a first end of the first bone at the first end of the second bone where the joint is formed (See examiner annotated Fig. 7B below)(Paragraphs [0081-0087]), the method comprising the steps of: obtaining an implant (implant 2, Figs. 9B, 7B, 8B, 9C-9E, Paragraph [0081]) having a length (overall length of 2, Fig. 9B) between first and second ends (distal end 6 and proximal end 8, Fig. 9B-9C); directing the implant into an intramedullary space of the first bone (broached canal D of C, Figs. 5-7, Paragraph [0083]) so that a first length portion of the implant (front half of 2, Fig. 7B) resides within the intramedullary space of the first bone (Fig. 7B); exerting a force on the implant (moving k-wire 64 distally thereby pulling tail 62 and k-wire 61 causes 44 & 46 of end 6 and 24 & 26 of end 8 to spring outwardly, see arrows, Figs. 8B, 9D, Paragraph [0085]) through an opening at the second end of the second bone (See examiner annotated Fig. 7B below) as an incident of which: a) a part of the first length portion of the implant (barbs of end 6, Fig. 9C) within the intramedullary space of the first bone moves out of an intramedullary space of the first bone (barbs of end 6 spring outwardly to compressively engage the surface of the surrounding bone to bite into the bone, Fig. 9D, Paragraphs [0083-0085]); and b) the second end of the implant (8) is caused to move into the intramedullary space of the second bone (Fig. 8B, 9D, Paragraph [0084]).
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Regarding Claim 2, McCormick et al. discloses wherein the step of directing the implant comprises directing the first end of the implant (6) into the intramedullary space of the first bone (D of C, Fig. 7B) and the one of the first and second ends of the implant is the second end of the implant (8).
Regarding Claim 3, McCormick et al. discloses wherein the step of exerting a force on the implant comprises exerting a force through a component (flexible tail 62, Figs. 9B-9C, 7B, Paragraph [0081]) extending through the opening at the second end of the second bone (Fig. 8B) and engaged with the implant at or adjacent the second end of the implant (Figs. 8B, 9C).
Regarding Claim 4, McCormick et al. discloses wherein the step of exerting a force on the implant comprises exerting a force through a component (flexible tail 62, Figs. 9B-9C, 7B, Paragraph [0081]) extending through the opening at the second end of the second bone (Fig. 8B) and engaged with the implant at a location between the first and second ends of the implant (Figs. 8B, 9C).
Regarding Claim 7, McCormick et al. discloses the step of forming a receptacle for the implant in at least one of the first bone and the second bone (broached canal D in C, broached canal in D in A, Figs. 5-7)(“Using a broach or similar instrument (not shown) a canal D is defined through distal and proximal portions of the PIP joint.”, Paragraph [0082]).
Regarding Claim 8, McCormick et al. discloses wherein the step of forming a receptacle comprises forming a receptacle in each of the first bone and the second bone (broached canal D in C, broached canal in D in A, Figs. 5-7)(“Using a broach or similar instrument (not shown) a canal D is defined through distal and proximal portions of the PIP joint.”, Paragraph [0082]), whereby with the first bone (C) and the second bone (A) in a fused relationship (Paragraph [0007]), one part of the implant (distal portion 6, Fig. 7B) is frictionally maintained within the receptacle formed in the first bone (Paragraph [0085]) and another part of the implant (proximal portion 8, Fig. 9C) is frictionally maintained within the receptacle formed in the second bone (Fig. 9D, Paragraph [0085]).
Regarding Claim 9, McCormick et al. discloses wherein the step of exerting a force comprises exerting a force through a component made up of a suture (flexible tail 62, Figs. 9B-9C, 7B, “Flexible tail 62 may be fashioned from woven, non-woven, knitted, braided or crocheted materials, any of which can included but not be limited to standard surgical sutures, polymer or fiberous cords, metal wire or tape, or the like, and may be formed from a single multiple strands of metals, polymers, or other bio compatible materials. Often, flexible tail 62 comprises a metal braid or cable.”, Paragraph [0081]) that is connected to the implant (Fig. 9C) and projects from the opening at the second end of the second bone (Figs. 7B, 8B).
Regarding Claim 10, McCormick et al. discloses wherein the suture connects to the implant at a location between the first and second ends of the implant (Fig. 9C).
Regarding Claim 11, McCormick et al. discloses the step of engaging the suture with the implant with the suture extending from the implant through the intramedullary space of the second bone (Fig. 7B, 8B, 9D) so that a graspable part of the suture (64, Fig. 8B) projects from the intramedullary space of the second bone through the opening at the second end of the second bone, and the step of exerting a force comprises exerting a force on the graspable part of the suture (Paragraph [0085]).
Regarding Claim 13, McCormick et al. discloses the steps of obtaining a suture engaging tool (64, Figs. 9B, 9C), engaging the suture engaging tool with the suture (Paragraph [0081]), and directing the suture engaging tool through an opening at the first end of the second bone (See examiner annotated Fig. 7B above) to thereby advance a part of the suture through the intramedullary space of the second bone (A) to cause the graspable part of the suture to project from the intramedullary space of the second bone at the second end of the second bone (Figs. 8B, 9D, Paragraph [0085]).
Regarding Claim 14, McCormick et al. discloses wherein the suture is connected to the implant by directing the suture through an opening in the implant (apertures 56a, 56b & 36A, 36b, Fig. 1) and doubling the suture against itself (Figs. 9B-9C) to create a bight portion (loop) that bears against the implant as the force is exerted through the suture (during alignment of bone A towards bone C when pulling the suture 62 through bone B, Fig. 7B).
Regarding Claim 15, McCormick et al. discloses wherein the step of exerting a force comprises exerting a force through a drawing component (64, Figs. 9B, 9C) that is extended through the opening at the second end of the second bone (Fig. 7B) and the intramedullary space of the second bone and connected to the implant at or adjacent to the second end of the implant (Fig. 9C).
Regarding Claim 16, McCormick et al. discloses wherein the drawing component is releasably connected to the implant through a connector (tail 62, Paragraph [0085]) on the drawing component that is releasably connected to a connector on the implant (apertures 56a, 56b, 36a, 36b, Fig. 1).
Regarding Claim 18, McCormick et al. discloses wherein the receptacle in the first bone is a bore in the first bone enlarging the intramedullary space of the first bone (broached canal D in C, Figs. 5-7, Paragraph [0082]) and the receptacle in the second bone is a bore in the second bone enlarging the intramedullary space of the second bone (broached canal D in A, Figs. 5-7).
Regarding Claim 19, McCormick et al. discloses wherein with the first bone and second bone in a fused relationship (Fig. 9D)(Paragraph [0007]), an axis of the bore in the first bone is aligned with an axis of the bore in the second bone (Fig. 9D).
Regarding Claim 20, McCormick et al. discloses wherein a diameter of the bore in the first bone (C) is different than a diameter of the bore in the second bone (A)(broached canal D through bone A ends at enlarged shoulder portion at 71 and then decreases in size to the distal end of A as seen in Figs. 5-7).
Regarding Claim 21, McCormick et al. discloses wherein the implant has a body (body defining 2, Figs. 9B-9C) with a non-uniform diameter between the first and second ends of the implant (diameter of 2 changes between opposing ends due to enlarged barbs, windows, and beam configurations, Fig. 9C).
Regarding Claim 22, McCormick et al. discloses wherein the diameter of the body tapers over a length of the body (diameter of 2 tapers between opposing ends due to enlarged barbs, windows, and beam configurations, Fig. 9D).
Regarding Claim 23, McCormick et al. discloses wherein the implant has a body (body defining 2, Figs. 9B-9C) with a lengthwise axis (longitudinal axis of 2, Fig. 9C) and an external surface (outer peripheral surface of 2, Fig. 9B) extending around the lengthwise axis, and the external surface has a non-circular shape as viewed along the lengthwise axis over at least a portion of the length of the implant (Fig. 9B), and with the first bone and second bone in a fused relationship (Paragraph [0007]), the non-circular shape causes the implant to be keyed against turning relative to at least one of the first bone and second bone around the lengthwise axis of the body (“Barbs 50a and 50b compressively engage the surface of the surrounding bone so as to "bite" into the bone, thus enhancing the retention of implant 2. This geometric effect applies an active compressive force to the articulating surfaces of the PIP joint while proximal pair of beams 8 maintain cortical fixation on either side of the joint. Advantageously, barbs 30a and barbs 30b are caused to bite into the bone that defines broached canal D by the outward force of superior beam 24 and inferior beam 26 moving into their partially biased state. The biting of barbs 30a and 30b into the bone greatly enhances the compressive load exerted by proximal pair of beams 8.”, Paragraphs [0075, 0085-0086]).
Regarding Claim 24, McCormick et al. discloses wherein the implant body has a first diameter (maximum diameter measured at barbed portion 6, Fig. 9C) over a first length portion of the body (barbed portion 6, when viewing Fig. 9C) and a second diameter (diameter measured at smooth central portion of 2, Fig. 9C), different than the first diameter, over a second length portion of the body (smooth central portion of 2, when viewing Fig. 9C).
Regarding Claim 25, McCormick et al. discloses wherein the first length portion of the body has a first axis portion (lengthwise axis running centrally through barbed portion 6, Fig. 9C), the second length portion of the body has a second axis portion (lengthwise axis running centrally through center of 2, Fig. 9C), and the first and second axes portions are coincident (when implant 2 is in the optimally biased configuration of Fig. 9C with 61 inserted therethrough).
Regarding Claim 26, McCormick et al. discloses wherein the first length portion of the body has a first axis portion (lengthwise axis running centrally through barbed portion 6, Fig. 9C), the second length portion of the body has a second axis portion (lengthwise axis running centrally through center of 2, Fig. 9C), and the first and second axes portions are non-coincident (when implant 2 is in the outwardly sprung configuration of Fig. 9D with 61 removed therefrom and beams 44 & 46 are in an expanded configuration).
Regarding Claim 27, McCormick et al. discloses wherein the first length portion of the body has a first axis portion (lengthwise axis running centrally through barbed portion 6, Fig. 9C), the second length portion of the body has a second axis portion (lengthwise axis running centrally through center of 2, Fig. 9C), and the first and second axes portions are non-parallel (when implant 2 is in the outwardly sprung configuration of Fig. 9D with 61 removed therefrom and beams 44 & 46 are in an expanded configuration).
Regarding Claim 28, McCormick et al. discloses wherein the implant is made from metal such as titanium, stainless steel, or Nitinol (Paragraph [0080]).
Regarding Claim 29, McCormick et al. discloses the step of separating the suture from the implant after exerting the force through the component (Fig. 9D).
Regarding Claim 30, McCormick et al. discloses wherein the implant is a first implant and further comprising the steps of obtaining a second implant (kwire 61, Figs. 9B, 9C, 7B, Paragraph [0081]) and engaging the second implant (through implant 2) with the first and second bones (Figs. 7B, 9B).
Regarding Claim 31, McCormick et al. discloses wherein the step of engaging the second implant comprises engaging the second implant with the first and second bones (Paragraph [0085]) so that parts of the first and second bones are urged towards each other (Figs. 7B, 8B, 9D).
Regarding Claim 32, McCormick et al. discloses wherein the second implant is made up of a suture (Paragraph [0081]).
Regarding Claim 33, McCormick et al. discloses wherein the step of engaging the second implant with the first and second bones comprises forming the suture into a loop (Fig 7B) acting against parts of the first and second bones (during alignment of bone A towards bone C when pulling the suture 62 through bone B, Fig. 7B).
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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (US PG Pub No. 2015/0223849) in view of Fallin et al. (US PG Pub No. 2014/0107712).
Regarding Claims 5-6, McCormick et al. discloses the claimed invention as stated above in Claim 2, except the step of modifying at least one of the first end of the first bone and the first end of the second bone to define cooperating surfaces at the first end of the first bone and the first end of the second bone that are brought together with the first bone and second bone in a fused relationship; wherein the step of modifying comprises causing the cooperating surfaces at the first end of the first bone and the first end of the second bone to have substantially flat apposed surface configurations with the first bone and second bone in the fused relationship. McCormick et al. does depict in Figs. 5-7 the mating first ends of bones C & A being planar and further shows them in an adjacent cooperating relationship after alignment and stabilization in Figs. 8-9 but does not specifically disclose the step of modifying the first ends to define substantially flat apposed surfaces that are brought together with the bones in a fused relationship.
Fallin et al. discloses implants, instruments and methods for fixing adjacent bone portions to promote fusion thereof (Abstract), wherein the method comprising inserting an implant across a joint between first and second bones of the foot or hand (Paragraph [0002] such as a proximal and intermediate phalanx (960 & 962, Figs. 24-34), wherein “In FIG. 24, articulating ends of the proximal phalanx 960 and intermediate phalanx 962 have been cut to provide flat fusion surfaces 964, 966.” (Paragraph [0060]), and wherein the flat fusion surfaces of the bones are brought together in a fused relationship after completing insertion of the implant into each of the first and second bones (Figs. 24-34) to fuse a PIP joint (Paragraphs [0060-0070]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of McCormick et al. with the step of modifying each first end of the first and second bones to have flat fusion surfaces to be brought together in a fused relationship after completing insertion of the implant into the bones as taught by Fallin et al. in order to allow the bones to heal together in a stable, correctly-aligned configuration.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (US PG Pub No. 2015/0223849) in view of O’Donald et al. (US PG Pub No. 2020/0030011).
Regarding Claim 12, McCormick et al. discloses the claimed invention as stated above in Claim 11, and further discloses wherein the graspable part of the suture projects from the intramedullary space of the second bone through the opening at the second end of the second bone (Fig. 8B, 9D), but does not disclose the steps of obtaining a suture engaging tool, directing a part of the suture engaging tool in a first direction through the opening at the second end of the second bone and the intramedullary space of the second bone and engaging the part of the suture engaging tool with the suture, and with the part of the suture engaging tool engaged with the suture, moving the part of the suture engaging tool oppositely to the first direction to cause the graspable part of the suture to project from the intramedullary space of the second bone through the opening at the second end of the second bone.
O’Donald et al. discloses a system and method for bone fixation between phalanxes of a toe (Fig. 7-8, Paragraph [0046]), wherein a guide wire (118) is inserted through a medullary portion of the phalanxes, and wherein an implant (102) is inserted over the guide wire and into engagement with and anchored to one of the phalanxes (Paragraph [0047]), wherein the implant is moved along the wire until a desired level of compression is reached between the middle phalanx and the proximal phalanx so that osseous union can occur therebetween (Paragraphs [0047, 0049]), and wherein when the implant and guidewire are to be removed or repositioned, they may be grasped by hand or by a suitable gripping tool such as a set of pliers and withdrawn from the phalanxes and skin and tissue (Paragraph [0052], “Other methods may be used during removal including, but not limited to, removal of the entire locking cap 102 from the wire and skin before removal of the wire 118 or repositioning of the locking cap 102 to aid in removal of the wire 118. In another method of removal, the locking cap 102 may be grasped and employed as a handle to unscrew the threads 123 of the wire 118 from the cortical bone in which it is embedded. This may be done without loosening the set screw 122, or alternatively, by loosening the set screw 122, moving the locking cap 102 proximally on the wire 118 so that the locking cap 102 is easier to grip, and then re-tightening the set screw 122 so that torque is transmitted from the locking cap 102 to the wire 118. The locking cap 102 may then be rotated, for example, by hand, to withdraw the threads of the threaded second end 120 from engagement with the interior bone of the proximal phalanx 18. Then, the system 100 may be distracted by grasping the locking cap 102 (for example, by hand or with a suitable gripping tool such as a set of pliers) and withdrawing the system 100 from the proximal phalanx 18, the middle phalanx 16, the distal phalanx 14, and finally, the skin 8 and subcutaneous tissue 12. Once the system 100 has been removed with any method, the incision may be closed, for example, with sutures, staples, and/or sterile tape.” (Paragraph [0052])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of McCormick et al. with the step of obtaining a gripping tool and directing it in a first direction toward the second bone through the opening at the second end of the second bone and the intramedullary space of the second bone, engaging the suture and moving the gripping tool away from the bones to cause the graspable part of the suture to project from the intramedullary space of the second bone through the opening at the second end of the second bone to reposition or remove the guidewire 61 from the patient as taught by O’Donald et al. in order to provide the surgeon with a tool for adjusting the position of the guide wire/suture.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (US PG Pub No. 2015/0223849) in view of Chang et al. (US PG Pub No. 2009/0171358).
Regarding Claim 38, McCormick et al. discloses the claimed invention as stated above in Claim 7, except the steps of obtaining a sound and directing a part of the sound into the formed receptacle on at least one of the first and second bones to check for at least one of: a) a desired depth; b) desired shape; and c) desired effective diameter of the formed receptacle.
Chang et al. discloses an internal bone fixation sizing device for use during a procedure for repairing a weakened or fractured bone (Abstract, Paragraph [0007, 0017]), wherein the device can be used prior to inserting an implant within the medullary cavity space to predict the size of the medullary cavity (Paragraph [0006]), wherein the sizing device (100, Figs. 1A-5, Paragraph [0018]) comprises a flexible elongate shaft (101) which may accommodate bends in the shape and geometry of a bone, allowing a distal end (104 of the device to reach a desired location inside a bone, wherein “The outside surface of the elongated shaft 101 is marked with radiopaque markers 130, displaying depth indicators and numbers in millimeter dimensions. These radiopaque markers 130 allow a user to gauge the depth of a cleared-out medullary cavity of a fractured bone. The radiopaque markers 130, using radiopaque materials such as barium sulfate, tantalum, or other materials known to increase radiopacity, allow the user to view the device 100 using fluoroscopy techniques. A typical readout for the length of the medullary cavity may range from about 10 mm to about 70 mm or greater. In an embodiment, the sizing arms 105 are coated with a radiopaque material or contain radiopaque materials that are known to increase radiopacity, which will allow the user to view the sizing arms 105 using fluoroscopy techniques. [0020] A handle 140 engages the proximal end 102 of the device 100 and allows for activation of an activation mechanism 145. In an embodiment, the activation mechanism 145 is a thumb press. The thumb press 145 activates a spring 148 located at a proximal end of the arm shaft 115, within the handle 140 housing, which pushes the arm shaft 115 forward. A spring pin 170 keeps the arm shaft 115, the spring 148, and the thumb press 145 housed within the handle 140 and controls the distance traveled by the spring 148. A window 160 machined into the handle 140 provides millimeter dimension readouts that reflect the inner diameter dimensions of the medullary cavity of the fractured bone. A typical readout for the diameter of the medullary cavity may range from about 4 mm to about 9 mm or greater. As seen in FIG. 2A, the readout in the window 160 is 6 mm. Alternately, other suitable activation mechanisms 145 can be used that are known in the art including, but not limited to, a trigger device, a threaded knob which translates rotational motion to linear motion, and mating gears. [0021] FIG. 3A and FIG. 3B show close-up perspective views of the distal end 104 of the internal bone fixation sizing device. The head portion 103 is rounded, allowing for smooth entry into a fractured bone void, i.e., a medullary cavity of a fractured bone. The head portion 103 has a gradual increase in diameter. The openings 116 at the head portion 103 allow for the sizing arms 105 to extend and retract. As shown in FIG. 3A, the sizing arms 105 are in a retracted position, also referred to as a "bone sound" position. In this retracted position, the sizing arms 105 rest about 4 mm apart along the inclined surfaces 125. When the sizing arms 105 are in the bone sound position, the rounded head portion 105 is able to clear away any residual medullary material that remains within the medullary cavity of the fractured bone. As the thumb press 145 is pushed, the arm shaft 115 moves forward within the interior of the elongated shaft 101, thus moving the sizing arms 105 up along the inclined surfaces 125. The sizing arms 105 extend through the openings 116 of the head portion 103 extending beyond the outer shaft 101, as shown in FIG. 3B. When the sizing arms 105 contact interior surfaces of the fractured bone void, the corresponding diameter dimensions are displayed within the window 160 of the handle 140. In an embodiment, the diameter dimensions are displayed in units of millimeters. Once the readout is determined or a desired measurement is achieved, the thumb press 145 is released, causing the sizing arms 105 to retract into the head portion 103 and return to the retracted position. At this time, the sizing device 100 may be removed from the void or re-positioned within the void in order to obtain another diameter dimension readout. For example, the sizing device 100 may be re-positioned within the void so that the sizing arms 105 are about perpendicular to a longitudinal axis of the void. After re-positioning, the thumb press 145 is pushed, the arm shaft 115 moves forward within the interior of the elongated shaft 101, and the sizing arms 105 are moved up along the inclined surfaces 125. The sizing arms 105 extend through the openings 116 of the head portion 103 and extend beyond the outer shaft 101. The sizing arms 105 contact the interior surfaces of the fractured bone void, and a corresponding diameter dimension is displayed within the window 160 of the handle 140. In this way, the sizing device 100 will be able to provide an overall picture of the internal geometry of the void.” (Paragraphs [0019-0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of McCormick et al. with the step of obtaining a sizing device and directing a shaft thereof into the formed receptacle on at least one of the first and second bones to check the depth and diameter of the formed receptacle as taught by Chang et al. in order to provide the surgeon with a means for verifying the diameter and depth of the broached canal in order to ensure subsequent proper implant sizing and orientation.
Allowable Subject Matter
Claims 17 & 34-37 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.
The following is a statement of reasons for the indication of allowable subject matter: McCormick et al. discloses the claimed invention as stated above, except wherein the loop of the suture is a continuous loop, in the form of a box, in the form of a figure eight, or in the form of a box and additionally in the form of a figure eight, and wherein the connectors on the drawing component and implant are releasably threadably engaged. Furthermore, there is no reasonable motivation to modify McCormick et al. to provide the loop in the claimed forms, and modify the connectors on the drawing component and implant to be threadably engaged with each other without destroying the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775