Detailed Action
This is the final office action for US application number 18/733,142. Claims are evaluated as filed on March 10, 2026.
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 10, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Taras, Champagne, and Weil teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that the term “headless” is a well-known term of art in the field of orthopedic screws and thus there is proper antecedent basis in the specification so that the meaning of “headless shaft” can be ascertained (Remarks p. 7), Examiner agrees that the term “headless” is a well-known term of art in the field of orthopedic screws; however, claim limitations are given their broadest reasonable interpretation in light of the disclosure. In the instant application, the disclosure uses the term “head” differently than in common in the art. That is, the specification is entirely silent to the term “headless” and instead specifically discloses “head 18” in at least paragraph 27 and Figs. 1-2. Thus, as the specification discloses a head and is silent to a headless shaft, it is unclear how one could reasonably conclude that the specification provides antecedent support for a “headless shaft”.
With regards to Applicant’s argument that Taras is not properly combinable with Champagne because there is no reason for a skilled artisan to modify the device of Taras to be an intramedullary implant for fixing fracture of a metacarpal as Tara instead supports the opposite in paragraph 6 which discloses that a drawback of many threaded pins in treating distal radius fractures is that the blunt tips will not always engage the cortex and will slide into the intramedullary canal and thereby limit the purchase of the pin which is a particular concern in older osteoporotic bone and thus the slipping of the threaded pins is a drawback that is criticized and therefore teaches away from intramedullary fixation of its device (Remarks p. 8-9), Examiner encourages Applicant to reread the quotation/citation they have provided and review the cited figures of Taras. Per the quotation provided by Applicant, the drawback of the pins is that the blunt tips do not engage bone and slide; however, review of Taras Figs. 1-3 show that the device of Taras does not have a blunt tip. Thus, the feature that Taras teaches away from is not a feature of the device of Taras. Instead, as detailed on at least page 14 of the non-final office action dated December 17, 2025 and in the below rejection, Taras discloses use in bone fracture fixation of distal radius fractures, olecranon fractures, malleolus fractures, and fractures of similar bones (¶s 2, 13, and 20), known type II fracture repair with threaded pins in the intramedullary canal (¶6), and that an object of invention as a fixation device for type II fractures (¶7); thus the device of Taras is capable of intramedullary use which Champagne teaches is beneficial to predicably repair a metacarpal bone (Champagne ¶8) by stabilizing the metacarpal bone while it heals (Champagne ¶2) after the fracture is aligned (Champagne ¶25, Taras ¶33) so that the reduction of the fracture provided by the physician is not disturbed or acted against by the implant, but rather maintained, and can even be used to maintain a reduced fracture in a distracted state (Taras ¶33).
With regards to Applicant’s argument that a distal radius fracture is a very different type of fracture compared to a metacarpal fracture and the standard of care for treating these two types of fractures are different and the Office has not shown why a skilled artisan would have modified a device for fixing distal radius fracture not via intramedullary fixation to be used for intramedullary fixation of a fractured bone (Remarks p. 9), Examiner notes that details regarding the fracture type and standards of care have not been claimed but nonetheless would appear to be addressed by the teaching of Champagne which specifically teaches intramedullary repair of a fractured metacarpal. With regards to the assertion that the Office has not shown why one would have modified a device for fixing distal radius fracture not via intramedullary fixation to be used for intramedullary fixation of a fractured bone, Examiner directs Applicant to the rejection below and pages 17-18 of the non-final office action dated December 17, 2025. In summary, Taras and Champagne disclose similarly structured implants for bone fracture fixation and Champagne teaches repairing a fracture via usage in an intramedullary canal of a metacarpal to predicably repair a metacarpal bone (Champagne ¶8) by stabilizing the metacarpal bone while it heals (Champagne ¶2) after the fracture is aligned (Champagne ¶25, Taras ¶33) so that the reduction of the fracture provided by the physician is not disturbed or acted against by the implant, but rather maintained, and can even be used to maintain a reduced fracture in a distracted state (Taras ¶33).
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 of this title, 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) 1-7 and 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taras et al. (US 2003/0158556, hereinafter “Taras”) in view of Champagne et al. (US 2014/0025124, hereinafter “Champagne”).
As to claims 1-7, 9, and 10, Taras discloses a method (¶s 18, 20, and 33) of implanting an intramedullary implant (Figs. 1-5, ¶s 2, 6, 7, 13, and 20; where ¶s 2, 13, and 20 disclose use in bone fracture fixation of distal radius fractures, olecranon fractures, malleolus fractures, and fractures of similar bones, ¶6 discloses known type II fracture repair with threaded pins in the intramedullary canal, ¶7 discloses an object of invention as a fixation device for type II fractures) capable of fixation of a fracture (Figs. 1-5, ¶s 2, 6, 7, 13, 20), the method comprising: aligning a fracture (¶33); rotatably driving the intramedullary implant (¶18), the implant comprising a shaft (14, 12, 20) having a trailing end (right end of 14 as shown in Figs. 1-5, Figs. 1-5) and a leading end (left end of 12 as shown in Figs. 1-3, Figs. 1-3), the shaft comprising a thread (16, 18) of a constant pitch (Figs. 1 and 3, ¶29) along an entire length of the shaft (Figs. 1 and 3, ¶28), wherein a first portion of the thread has a greater major diameter (Fig. 3, ¶28) that appears to be constant (Fig. 3) and a second portion of the thread has a smaller major diameter (Fig. 3, ¶28) that appears to be constant (Fig. 3), the first portion of the thread being continuous with the second portion of the thread (Figs. 1-3, ¶28), and wherein the first portion of the thread engages bone material in a larger distal portion (¶33 discloses that the wider threads 18 provide superior purchase on the distal fragment of bone) and the second portion of the thread engages bone material in a narrower proximal and mid portion (¶33 discloses that threads 16 provide a stable engagement with the shaft of the radial shaft bone proximal of the fracture) such that the intramedullary implant is anchored in the bone (¶33); wherein the trailing end comprises a guide pin (26, Figs. 1-3, ¶33) that is capable of use in driving the implant into bone (¶30); and removing the guide pin (¶s 31 and 33). As to claim 2, Taras discloses that the intramedullary implant is inserted with the leading end entering the opening into the intramedullary canal first (Figs. 1-3, ¶29), the second portion of the thread being closer to the leading end than to the trailing end (as defined, Figs. 1-3). As to claim 3, Taras discloses that the first portion of the threads engages the bone (¶33). As to claim 4, Taras discloses that a first root diameter of the shaft at the first portion of the thread is greater than a second root diameter of the shaft at the second portion of the thread (Fig. 3). As to claim 5, Taras discloses that the first portion and the second portion of the thread are of the same thread height (Fig. 3, abstract and ¶29 discloses the same thread depth, i.e. height).
As to claim 6, Taras discloses that the shaft further comprises a transition region (see illustration of Fig. 3, Fig. 3), a root diameter of the transition region transitions from the first root diameter to the second root diameter (Fig. 3). As to claim 7, Taras discloses that the shaft comprises a driving surface at the trailing end (surfaces of 26, Figs. 1-3, ¶s 30 and 33), the driving surface capable of receiving a driver (“chuck of a drill” of ¶30, ¶s 30 and 33) that applies a torque to rotatably drive the intramedullary implant into the intramedullary canal (¶s 30 and 33). As to claim 9, Taras discloses that the implant comprises a driving surface (surfaces of 26, Figs. 1-3, ¶s 30 and 33) at the trailing end (as defined, Figs. 1-3), wherein the driving surface is capable of receiving a driver (“chuck of a drill” of ¶30, Figs. 1-3, ¶s 30 and 33). As to claim 10, Taras discloses that the driving surface is a hex head (¶30).
Taras is silent to the intramedullary implant being cannulated, implanting the intramedullary implant within an intramedullary canal of a metacarpal, inserting a guidewire into the intramedullary canal of the metacarpal; drilling an opening into the metacarpal past a location of the fracture guided by the guidewire; the rotatably driving of the intramedullary implant being into the intramedullary canal guided by the guidewire; the larger distal portion being of the metacarpal; the narrower proximal and mid portion is of the metacarpal, each of the thread portions engage the metacarpal from inside the metacarpal, the anchoring being in the metacarpal, removing the guidewire. As to claim 3, Taras is silent to the first portion engages a metacarpal head. As to claim 10, Taras is silent to the driving surface is configured to accept a hex head.
Champagne teaches a method (Figs. 1-3) of implanting a cannulated intramedullary implant (Figs. 1-3) within an intramedullary canal of a metacarpal (Figs. 2-3, ¶25) capable of fixation of a fracture (Figs. 2-3, ¶25), the method comprising: aligning a fracture (¶25); inserting a guidewire (“K-wire” of ¶25, Fig. 2, ¶25) into the intramedullary canal of the metacarpal (Fig. 2, ¶25); drilling an opening into the metacarpal past a location of the fracture guided by the guidewire (Fig. 2A, ¶26); rotatably driving the cannulated intramedullary implant into the intramedullary canal guided by the guidewire (Fig. 2B, ¶27), the implant comprising a shaft (16) having a trailing end (upper end of 16 as shown in Fig. 1, Fig. 1) and a leading end (lower end of 16 as shown in Fig. 1, Fig. 1), the shaft comprising a thread (28), wherein a first portion of the shaft (18) has a greater major diameter (Fig. 1) and a second portion of the shaft (portion below 18 as shown in Fig. 1, Fig. 1) has a smaller major diameter (Fig. 1), and wherein the first portion of the shaft engages bone material in a larger distal portion of the metacarpal (Figs. 2B-3) and the second portion of the shaft engages bone material in a narrower proximal and mid portion of the metacarpal (Figs. 2B-3) from inside the intramedullary canal (Figs. 2B-3) such that the cannulated intramedullary implant is anchored in the metacarpal (Fig. 3, ¶29); and removing the guidewire (Figs. 2C and 3, ¶29); wherein the trailing end comprises a driving surface (20, Figs. 1 and 2B, ¶s 17 and 18) that is capable of use in driving the implant into bone (¶s 17 and 18). As to claim 2, Champagne teaches that the cannulated intramedullary implant is inserted with the leading end entering the opening into the intramedullary canal first (Figs. 2B-3), the second portion of the thread being closer to the leading end than to the trailing end (as defined, Fig. 1). As to claim 3, Champagne teaches the first portion engages a metacarpal head (Fig. 3). As to claim 7, Champagne teaches the shaft comprises a driving surface (20) at the trailing end (Fig. 1, ¶17), the driving surface capable of receiving a driver that applies a torque to rotatably drive the cannulated intramedullary implant into the intramedullary canal (¶s 17 and 18). As to claim 9, Champagne teaches that rotatably driving the cannulated intramedullary implant is performed using a driver (¶s 17 and 18), the implant comprising a driving surface (20) at the trailing end (Fig. 1, ¶17), wherein the driving surface is capable of receiving the driver (¶s 17 and 18). As to claim 10, Champagne teaches that the driving surface is capable of accepting a hex head (¶18).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of bone fracture fixation in distal radius fractures and fractures of similar bones and the implant as disclosed by Taras to be performed in an intramedullary canal of a metacarpal from inside the intramedullary canal and the implant being correspondingly sized for such insertion as taught by Champagne in order to predicably repair a metacarpal bone (Champagne ¶8) by stabilizing the metacarpal bone while it heals (Champagne ¶2) after the fracture is aligned (Champagne ¶25, Taras ¶33) so that the reduction of the fracture provided by the physician is not disturbed or acted against by the implant, but rather maintained, and can even be used to maintain a reduced fracture in a distracted state (Taras ¶33). Further, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method and the implant with an integral guide pin that is used in driving the implant and is removed following anchorage of the implant within the bone as disclosed by Taras to be performed over a distinct guidewire that is removed following anchorage of the implant within the bone and the implant comprising a corresponding cannulation for use with the distinct guidewire and a driving surface for use in driving the implant as taught by Champagne in order to use a known alternative structure to aid in insertion into bone (Champagne Figs. 2-3, ¶25-29), since constructing a formerly integral structure in various elements involves only routine skill in the art and would provide a known benefit of enable checking positioning and depth in the bone through x-ray (as evidenced by Huebner US 6,030,162 col. 5 line 66 – col. 6 line 5) to enable selection of an appropriately sized implant (as evidenced by Huebner US 6,030,162 col. 6 line 3-4) followed by driving the implant into the member to be secured (as evidenced by Huebner US 6,030,162 col. 6 lines 45-65).
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As to claims 11-18, Taras discloses a method (¶s 18, 20, and 33) of implanting an intramedullary implant (Figs. 1-5, ¶s 2, 6, 7, 13, and 20; where ¶s 2, 13, and 20 disclose use in bone fracture fixation of distal radius fractures, olecranon fractures, malleolus fractures, and fractures of similar bones, ¶6 discloses known type II fracture repair with threaded pins in the intramedullary canal, ¶7 discloses an object of invention as a fixation device for type II fractures) capable of fixation of a fracture (Figs. 1-5, ¶s 2, 6, 7, 13, 20), the method comprising: aligning a fracture (¶33); rotatably driving the intramedullary implant (¶18), the implant comprising a shaft (14, 12, 20) having a trailing end (right end of 14 as shown in Figs. 1-5, Figs. 1-5) and a leading end (left end of 12 as shown in Figs. 1-3, Figs. 1-3), the shaft comprising a thread (16, 18) of a constant pitch (Figs. 1 and 3, ¶s 28 and 29), wherein a first portion of the shaft closer to the trailing end has a greater outer diameter (Fig. 3, ¶28) and a second portion of the shaft closer to the leading end has a smaller outer diameter (Fig. 3, ¶28), the thread extending along the first portion and the second portion (Figs. 1-3), and wherein the thread on the first portion engages bone material in a larger distal portion (¶33 discloses that the wider threads 18 provide superior purchase on the distal fragment of bone) and the thread on the second portion engages bone material in a narrower proximal and mid portion (¶33 discloses that threads 16 provide a stable engagement with the shaft of the radial shaft bone proximal of the fracture) such that the intramedullary implant is anchored in the bone (¶33); wherein the trailing end comprises a guide pin (26, Figs. 1-3, ¶33) that is capable of use in driving the implant into bone (¶30); and removing the guide pin (¶s 31 and 33). As to claim 12, Taras discloses that the intramedullary implant is inserted with the leading end entering the opening into the intramedullary canal first (Figs. 1-3, ¶29). As to claim 13, Taras discloses that the threads on the first portion engage the bone (¶33). As to claim 14, Taras discloses that the implant is strong enough to be rotatably driven into the metacarpal by a torque without being deformed (Figs. 1-3, ¶33). As to claim 15, Taras discloses that the threads on the first portion and the threads on the second portion are of the same thread height (Fig. 3, abstract and ¶29 discloses the same thread depth, i.e. height). As to claim 16, Taras discloses that the implant comprises a driving surface (surfaces of 26, Figs. 1-3, ¶s 30 and 33) at the trailing end (as defined, Figs. 1-3), wherein the driving surface is capable of receiving a driver (“chuck of a drill” of ¶30 ,Figs. 1-3, ¶s 30 and 33). As to claim 17, Taras discloses that the driver is a hex head (¶30). As to claim 18, Taras discloses that the shaft further comprises a transition region (see illustration of Fig. 3, Fig. 3), a root diameter of the transition region transitions from the greater outer diameter to the smaller outer diameter (Fig. 3).
Taras is silent to the intramedullary implant being cannulated, implanting the intramedullary implant within an intramedullary canal of a metacarpal, inserting a guidewire into the intramedullary canal of the metacarpal; drilling an opening into the metacarpal past a location of the fracture guided by the guidewire; the rotatably driving of the intramedullary implant being into the intramedullary canal guided by the guidewire; the larger distal portion being of the metacarpal; the narrower proximal and mid portion is of the metacarpal, each of the thread portions engage the metacarpal from inside the metacarpal, the anchoring being in the metacarpal, removing the guidewire. As to claim 13, Taras is silent to the first portion engages a metacarpal head. As to claim 17, Taras is silent to the driving surface is configured to accept a hex head.
Champagne teaches a method (Figs. 1-3) of implanting a cannulated intramedullary implant (Figs. 1-3) within an intramedullary canal of a metacarpal (Figs. 2-3, ¶25) capable of fixation of a fracture (Figs. 2-3, ¶25), the method comprising: aligning a fracture (¶25); inserting a guidewire (“K-wire” of ¶25, Fig. 2, ¶25) into the intramedullary canal of the metacarpal (Fig. 2, ¶25); drilling an opening into the metacarpal past a location of the fracture guided by the guidewire (Fig. 2A, ¶26); rotatably driving the cannulated intramedullary implant into the intramedullary canal guided by the guidewire (Fig. 2B, ¶27), the implant comprising a shaft (16) having a trailing end (upper end of 16 as shown in Fig. 1, Fig. 1) and a leading end (lower end of 16 as shown in Fig. 1, Fig. 1), the shaft comprising a thread (28), wherein a first portion of the shaft (18) has a greater outer diameter (Fig. 1) and a second portion of the shaft (portion below 18 as shown in Fig. 1, Fig. 1) has a smaller outer diameter (Fig. 1), and wherein the first portion of the shaft engages bone material in a larger distal portion of the metacarpal (Figs. 2B-3) and the second portion of the shaft engages bone material in a narrower proximal and mid portion of the metacarpal (Figs. 2B-3) from inside the intramedullary canal (Figs. 2B-3) such that the cannulated intramedullary implant is anchored in the metacarpal (Fig. 3, ¶29); and removing the guidewire (Figs. 2C and 3, ¶29); wherein the trailing end comprises a driving surface (20, Figs. 1 and 2B, ¶s 17 and 18) that is capable of use in driving the implant into bone (¶s 17 and 18). As to claim 12, Champagne teaches that the cannulated intramedullary implant is inserted with the leading end entering the opening into the intramedullary canal first (Figs. 2B-3). As to claim 13, Champagne teaches that the first portion engages a metacarpal head (Fig. 3). As to claim 14, Champagne teaches that the implant is strong enough to be rotatably driven into the metacarpal by a torque without being deformed (in as much as Applicant’s, Fig. 3). As to claim 16, Champagne teaches that the implant comprises a driving surface (20) at the trailing end (Fig. 1, ¶17), wherein the driving surface is capable of receiving a driver (¶s 17 and 18). As to claim 17, Champagne teaches that the driving surface is capable of receiving a hex head (¶18).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of bone fracture fixation in distal radius fractures and fractures of similar bones and the implant as disclosed by Taras to be performed in an intramedullary canal of a metacarpal from inside the intramedullary canal and the implant being correspondingly sized for such insertion as taught by Champagne in order to predicably repair a metacarpal bone (Champagne ¶8) by stabilizing the metacarpal bone while it heals (Champagne ¶2) after the fracture is aligned (Champagne ¶25, Taras ¶33) so that the reduction of the fracture provided by the physician is not disturbed or acted against by the implant, but rather maintained, and can even be used to maintain a reduced fracture in a distracted state (Taras ¶33). Further, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method and the implant with an integral guide pin that is used in driving the implant and is removed following anchorage of the implant within the bone as disclosed by Taras to be performed over a distinct guidewire that is removed following anchorage of the implant within the bone and the implant comprising a corresponding cannulation for use with the distinct guidewire and a driving surface for use in driving the implant as taught by Champagne in order to use a known alternative structure to aid in insertion into bone (Champagne Figs. 2-3, ¶25-29), since constructing a formerly integral structure in various elements involves only routine skill in the art and would provide a known benefit of enable checking positioning and depth in the bone through x-ray (as evidenced by Huebner US 6,030,162 col. 5 line 66 – col. 6 line 5) to enable selection of an appropriately sized implant (as evidenced by Huebner US 6,030,162 col. 6 line 3-4) followed by driving the implant into the member to be secured (as evidenced by Huebner US 6,030,162 col. 6 lines 45-65).
Claim(s) 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taras and Champagne in view of Weil et al. (US 2003/0028193, hereinafter “Weil”).
As to claim 8, the combination Taras and Champagne discloses the invention of claim 1 as well as at least another cutting structure (24, Figs. 1-3, ¶29) extending through part of the second portion of the thread (Figs. 1-3).
The combination Taras and Champagne is silent to the shaft comprises at least one cutting structure extending through part of the first portion of the thread.
Weil teaches a similar cannulated implant (Figs. 1-2, ¶31 discloses cannulation 4) capable of intramedullary use (abstract discloses use in small-bone surgery, ¶44 discloses use on bone fragments with an example of the metatarsus) capable of being implanted within an intramedullary canal of a metacarpal capable of use for fixation of a fracture (¶44 discloses use on bone fragments with an example of the metatarsus), the intramedullary implant comprising: a shaft (Figs. 1 and 2) having a trailing end (left end of 2 as shown in Figs. 1-2, Figs. 1-2) and a leading end (right end of 3 as shown in Figs. 1-2, Figs. 1-2), the shaft comprising a thread (2a, 3a), wherein a first portion of the thread (2a) has a greater major diameter (Fig. 2) and a second portion of the thread (3a) has a smaller major diameter (Fig. 2), wherein the shaft comprises at least one cutting structure (12, 13, 14, 15, Figs. 1, 2, and 8, ¶s 42 and 43) extending through part of the first portion of the thread (Figs. 1, 2, and 8) and a transition region (Fig. 2) and at least another cutting structure (5, 6, Figs. 1-5, ¶38) extending through part of the second portion of the thread (Figs. 1-5).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the first portion of the thread and transition region as disclosed by the combination Taras and Champagne by adding at least one cutting structure as taught by Weil in order to achieve self-tapping and a certain amount of self-boring into the bone tissue as the screw progresses to be able to dispense with the prior borehole, particularly for implants of the smallest diameters (Weil ¶41), i.e. to produce an implant which has improved qualities in terms of self-tapping, self-boring and screwing, then in terms of compressively holding the two bits of bone fragments, for example of metatarsus, together (Weil ¶44).
As to claim 19, the combination Taras and Champagne discloses the invention of claim 11 as well as at least another cutting structure (24, Figs. 1-3, ¶29) extending through part of the second portion (Figs. 1-3).
The combination Taras and Champagne is silent to the shaft comprises at least one cutting structure extending through part of the first portion.
Weil teaches a similar cannulated implant (Figs. 1-2, ¶31 discloses cannulation 4) capable of intramedullary use (abstract discloses use in small-bone surgery, ¶44 discloses use on bone fragments with an example of the metatarsus) capable of being implanted within an intramedullary canal of a metacarpal capable of use for fixation of a fracture (¶44 discloses use on bone fragments with an example of the metatarsus), the intramedullary implant comprising: a shaft (Figs. 1 and 2) having a trailing end (left end of 2 as shown in Figs. 1-2, Figs. 1-2) and a leading end (right end of 3 as shown in Figs. 1-2, Figs. 1-2), the shaft comprising a thread (2a, 3a), wherein a first portion of the shaft (portion shown comprising 2a in Fig. 2, Fig. 2) has a greater outer diameter (Fig. 2) and a second portion of the shaft (portion shown comprising 3a in Fig. 2, Fig. 2) has a smaller outer diameter (Fig. 2), wherein the shaft comprises at least one cutting structure (12, 13, 14, 15, Figs. 1, 2, and 8, ¶s 42 and 43) extending through part of the first portion (Figs. 1, 2, and 8) and a transition region (Fig. 2) and at least another cutting structure (5, 6, Figs. 1-5, ¶38) extending through part of the second portion of (Figs. 1-5).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the first portion of the thread and transition region as disclosed by the combination Taras and Champagne by adding at least one cutting structure as taught by Weil in order to achieve self-tapping and a certain amount of self-boring into the bone tissue as the screw progresses to be able to dispense with the prior borehole, particularly for implants of the smallest diameters (Weil ¶41), i.e. to produce an implant which has improved qualities in terms of self-tapping, self-boring and screwing, then in terms of compressively holding the two bits of bone fragments, for example of metatarsus, together (Weil ¶44).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892, Notice of References Cited.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 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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/AMY R SIPP/Primary Examiner, Art Unit 3775
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