Detailed Action
This office action is for US application number 18/733,142 evaluates the claims as filed on August 24, 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 24, 2026 has been entered.
Response to Arguments
Applicant's arguments filed August 24, 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 and Champagne teach all the 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 combination of Taras and Champagne constitutes impermissible hindsight as Champagne discloses structurally different implants from Taras contrary to the assertion in the office action that “Taras and Champagne disclose similarly structured implants but Champagne discloses that their implant is only threaded along a small portion of the implant (¶8) but Taras discloses that threads are substantially uninterrupted along the length of the pin (¶28) (Remarks p. 7), Examiner notes that, as detailed in the rejection below and that on pages 5-9 and 10-13 of the final office action dated March 27, 2026, Examiner has identified many aspects in which the structures of Taras and Champagne are structurally similar as is also apparent by a cursory review of Taras Fig. 1 and Champagne Fig. 1. Identification of a structural difference does not render the implants completely dissimilar as appears to be argued. That is, it has not been asserted that the implants of Taras and Champagne are structurally identical as appears to be argued. Instead, as detailed in the rejection below and that on pages 5-13 of the final office action dated March 27, 2026, the rejection is Taras in view of Champagne, where Taras discloses a method with an implant and Champagne teaches conducting the method in a metacarpal and using a distinct guidewire inserted therein and later removed.
With regards to Applicant’s argument that the combination of Taras and Champagne constitutes impermissible hindsight as Taras fails to teach that the second portion of the thread engage bone material in a narrower portion of the metacarpal and Champagne does not teach these features as Champagne teaches threading over only a small portion (¶8) (Remarks p. 7), Examiner notes the implant of Champagne having threading over only a small portion is irrelevant to the rejection and it has not been asserted otherwise. Instead, as detailed in the rejection below and that on pages 5-13 of the final office action dated March 27, 2026, the rejection is Taras in view of Champagne, where Taras discloses that the implant “is percutaneously introduced to the bone and rotationally drilled through the distal fragment, across the fracture, and into the radial shaft cortex. The self-tapping tip 20 facilitates initial insertion into the bone and as well as purchase of the tip in the radial shaft cortex. The threads 16 on the first portion 12, with their particular depth and pitch, provide a stable engagement with the shaft of the radial shaft bone proximal of the fracture. As the pin is inserted further, the second portion 16 enters the distal fragment and the wider threads 18 provide superior purchase on the distal fragment of bone. The pin 10 is inserted until the intersection of the second portion 16 and the shaft portion 26 lies flush with, or more preferably slightly recessed relative to, the surface of the distal fragment.” (¶33) and Champagne very clearly shows in Figs. 2B-3 that the first portion of the shaft engages bone material in a larger distal portion of the metacarpal and the second portion of the shaft engages bone material in a narrower proximal and mid portion of the metacarpal from inside the intramedullary canal such that the cannulated intramedullary implant is anchored in the metacarpal (¶29). As something about this appears to have been unclear, Examiner additionally notes that that Taras ¶s 2 and 7 disclose use in treatment of type I and type II distal radial fractures and an NPL image from the University of Washington has been provided as evidentiary support regarding such anatomy, i.e. that shows that the distal fragment of bone in such repairs is larger/wider than the proximal region of bone. For convenience:
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(https://faculty.washington.edu/jeff8rob/trauma-radiology-reference-resource/9-upper-extremity/frykman-classification-of-distal-radial-fractures/).
With regards to Applicant’s argument that the combination of Taras and Champagne constitutes impermissible hindsight as the only place teaching using threads to engage bone material in a narrower portion of the metacarpal can be found is in the instant application (Remarks p. 8), Examiner notes that it has not been asserted that such is anticipated by a single reference as appears to be argued. Instead, as explained above and detailed in the rejection below and that on pages 5-13 of the final office action dated March 27, 2026, the rejection is Taras in view of Champagne where Taras discloses a threaded first portion and a threaded second portion for engaging bone as disclosed in ¶33 for type I and II distal radial fractures (¶s 2 and 7) which the above provided image of such fractures shows comprise a distal bone fragment is includes an enlarged end portion of the radius and Champagne very clearly teaches that the first portion of the shaft engages bone material in a larger distal portion of the metacarpal and the second portion of the shaft engages bone material in a narrower proximal and mid portion of the metacarpal from inside the intramedullary canal such that the cannulated intramedullary implant is anchored in the metacarpal (Figs. 2B-3, ¶29).
With regards to Applicant’s argument that the combination of Taras and Champagne constitutes impermissible hindsight as there is no teaching of the dimensions of the thread in the second portion of Taras would be suitable for engaging bone material in the narrower portions of the metacarpal (Remarks p. 8), Examiner notes that it appears this argument is making assumptions regarding unclaimed size or satisfaction requirements that are simply not claimed. Instead, as claimed Taras discloses a method of distal radius repair with a threaded implant and Champagne teaches a similar repair in a metacarpal to stabilized the fracture after the fracture is aligned (Champagne ¶25, Taras ¶33). That is, in modifying the method and implant to be used on the metacarpal, it would be exceedingly clear to one of ordinary skill in the art that, on a given patient, a metacarpal is smaller than a radius, i.e. that a patient’s hand bone is smaller than their forearm, and thus the implant structure would be resized to be appropriate for the needed location for a given patient.
With regards to Applicant’s argument that the combination of Taras and Champagne does not teach metacarpal fixation as “metacarpal” does not appear even once in the disclosure of Taras (Remarks p. 8), Examiner notes that such has not been asserted and is therefore moot.
With regards to Applicant’s argument that the combination of Taras and Champagne does not teach metacarpal fixation as Champagne teaches that current screws are not designed for intramedullary placement (¶7) (Remarks p. 8), Examiner notes that Taras specifically discloses intramedullary placement (¶s 2, 7, and 33) and Champagne teaches using a similar implant in a metacarpal. It has not been asserted that such was known prior to the Champagne publication. As the Champagne publication is prior art, this appears to have been known prior to the effectively filed dated of the instant application.
With regards to Applicant’s argument that the combination of Taras and Champagne does not teach metacarpal fixation as Champagne teaches that metacarpal fractures are different and one would not have simply used an implant for a distal radius fracture to fix metacarpal fractures (Remarks p. 8-9), Examiner agrees that one would not merely take an implant for a distal radius and implant it in a metacarpal and notes that such has not been asserted. Instead, as detailed in the below rejection and that of pages 5-13 of the final office action dated March 27, 2026, Champagne teaches that it is known how to use similarly structured implants in the metacarpal. As the Champagne publication is prior art, this appears to have been known prior to the effectively filed dated of the instant application.
With regards to Applicant’s argument that one of ordinary skill in the art would not have been motivated to modify Taras for intramedullary fracture fixation (Remarks p. 9), Examiner notes that one need not modify Taras for intramedullary fracture fixation as such is specifically disclosed for such use as explained above in view of ¶s 2, 7, and 33 and in the rejection below and that on pages 5-13 of the final office action dated March 27, 2026.
With regards to Applicant’s argument that one of ordinary skill in the art would not have been motivated to modify Taras for intramedullary fracture fixation as paragraph 6 clearly discourages intramedullary fixation of the device taught by Taras due to reasons such as blunt tips and only mentions “intramedullary” ONCE under “State of the Art” and nowhere in its description does did Taras describe any of its features as suitable for intramedullary use or mention changing the design of blunt tips to pointed tips (Remarks p. 9), Examiner notes that there appears to be a significant disconnect between this argument and the disclosure of Taras. For example, there is no mention changing the design of blunt tips to pointed tips because Tara does NOT disclose a device having a blunt tip. The “State of the Art” section is just what the title implies, i.e. a summary of what Taras knew to be the state of the art that provides the background information for the disclosed invention, and should not be construed to be a disclosure of an invention of Taras. Further, one need not use a specific term, e.g. “intramedullary”, in the description in order to provide a disclosure of such use. That is, one of ordinary skill in orthopedics knows basic bone properties such as that the medullary canal/cavity/bone is within the outer cortical layer, general properties of type I and II distal radius fractures, relative properties of a distal radius compared to a metacarpal, etc. Thus, when Taras discloses that they’re using their device that is shown with a pointed tip for repairing a type I or type II distal radius fracture (¶s 2, 7, and 33) one would readily know that it is physically impossible to perform the disclosed method without inserting the disclosed device into the medullary canal/cavity/bone.
Claim Objections
Claim 19 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 11-13, 15, 16, 18, and 22 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 11-13, 15, 16, and 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, ¶s 2 and 7 disclose use in treatment of type I and type II distal radial fractures, NPL Washington shows that the distal fragment of bone is larger than the proximal region 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, ¶s 2 and 7 disclose use in treatment of type I and type II distal radial fractures, NPL Washington shows that the distal fragment of bone is larger than the proximal region of bone) 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 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 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.
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 (portion above 26 as shown in Fig. 1, Fig. 1) has a greater outer diameter (Fig. 1) and a second portion of the shaft (portion below 26 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 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).
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 claim 22, 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, ¶s 2 and 7 disclose use in treatment of type I and type II distal radial fractures, NPL Washington shows that the distal fragment of bone is larger than the proximal region 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, ¶s 2 and 7 disclose use in treatment of type I and type II distal radial fractures, NPL Washington shows that the distal fragment of bone is larger than the proximal region of bone) 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).
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.
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 (portion above 26 as shown in Fig. 1, Fig. 1) has a greater major diameter (Fig. 1) and a second portion of the shaft (portion below 26 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).
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).
Allowable Subject Matter
Claims 1-9, 20, and 21 are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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