Detailed Action
This is the final office action for US application number 17/448,184. Claims are evaluated as filed on February 27, 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 February 27, 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, Huebner, Weil, Gauneau, and Mildner 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 IDS transmittal filed July 10, 2025 indicates that foreign and NPL references 1-5 and 7-17 are of record in 14/993,972 filed January 12, 2026 and therefore copies did not need to be submitted in the instant application but have nonetheless will be (and have now been) resubmitted on the IDS (no dated March 10, 2026) (Remarks p. 5-6), Examiner notes that review of the record in 14/993,97 shows that no IDS was filed in 14/993,972 on the asserted January 12, 2026 as shown in the below screenshot.
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Further, review of the IDS with the closest to asserted date, i.e. July 21, 2016, shows that the argued documents were not cited therein. Finally, review of the files show that no copies of references were filed on the asserted January 12, 2026.
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With regards to Applicant’s argument that the objected-to claim language has been deleted from the amended claims to address the drawing objections (Remarks p. 6-7), Examiner notes that “the at least one cutting flute of the first portion has a same height as a height of the first thread” of claim 52 lines 1-2 does not appear to be shown. On the contrary, Figs. 9 and 11 show 20, which paragraphs 23 and 25 disclose to be a flute; where Figs. 9 and 11 appear to show that the flute has a smaller diameter than what one would normally consider to be the root/inner diameter. Figs. 2 and 3 appear to show that the height of the first thread 10A is larger than the root/inner diameter. Instead, Applicant’s paragraph 27 discloses that “A cutting structure 20 is shown in FIGS. 3, 9, and 11 as positioned at the distal end of first section 12, and it preferably has the same height as threads 10A, or is formed in one or more threads 10A, and the portion of section 12 that includes cutting structure 20 as shown preferably has the same diameter as the rest of first section 12. The preferred configuration of cutting structure 20 is self-tapping features in one or more threads 10A, which are preferably indentations that basically make the thread serrated, as shown in FIG. 3.” (paragraph 27). Further, an alternate definition of a fluted does note appear to be provided, where the usage of flute in the disclosure is consistent with the ordinary definition that “a long, vertical, rounded groove in the shaft of a column” (https://www.collinsdictionary.com/dictionary/english/flute). Thus, the disclosure of paragraphs 23, 25, and 27 support the assertion that Applicant has disclosed such a cutting flute, but such is not shown nor is it clear how such can be achieved for an ordinarily defined cutting flute.
With regards to Applicant’s argument that paragraphs 11, 12, 27, and 28 provide written support along with Figs. 2, 4, 5, and 9 for the constant root diameters, heights, and diameter difference of 0.5-1.5 mm and that MPEP does not require the drawings to be in scale to show the features of a constant diameter and such is consistently shown across all the drawings a would be apparent to a skilled artisan (Remarks p. 7), Examiner notes that nothing has been identified from the noted paragraphs that Applicant is asserting supports the claim of constant root diameters. Instead, paragraphs 11, 12, 27, and 28 do not appear to mention a root diameter or any diameter being constant or the same over any particular length. Examiner agrees that Applicant is not required to provide a scale on drawings; however, in the absence of a scale or grid or lines or any indication of a particular value, diameter, etc. the viewer is provided with no tools to enable one to ascertain if a feature, such as a diameter, is constant or within a particular tolerance or a drawing artifact, etc. Further, MPEP 608.02 provides that drawings are to “supplement the original disclosure thereof for the purpose of interpretation of the scope of any claim”. Thus, it is not required that drawings show a scale to provide such a disclosure, as the drawings are a supplement to the specification. Thus, Examiner suggests Applicant identify how such support could be reasonably interpreted from description in the specification if Applicant amends claims to include such a limitation in the future.
With regards to Applicant’s argument that the teaching of Tara being capable of being implanted in an intramedullary canal teaches the opposite as col. 1 lines 30-37 disclose 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 Taras does not only not disclose intramedullary fixation of an alternative by criticizes and thus teaches away from intramedullary fixation of its fixation 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 15 of the non-final office action dated September 2, 2025 and in the below rejection, Taras discloses use in bone fracture fixation (col. 1 lines 7-9), known type II fracture repair with threaded pins in the intramedullary canal (col. 1 lines 30-36), and that an object of invention as a fixation device for type II fractures (col. 1 lines 49-51); thus the device of Taras is capable of intramedullary use as claimed.
With regards to Applicant’s argument that Taras has a self-tapping tip 20 that facilitates initial insertion into bone per Taras 4:26-28 and adding a cutting flute to portion 14 would only make sense for an intramedullary device but would not be obvious given the teaching of Taras away from use in the intramedullary canal (Remarks p. 9), Examiner notes that this argument is unclear appears to be unsubstantiated by the prior art or Applicant’s own disclosure. That is, the argued criticism of Taras with regards to blunt tips in the intramedullary canal is a feature that the device of Taras specifically does not include. Further, adding a cutting flute to the tapered leading edge of an enlarged segment of a fixation device is commonly done in many environments beyond in intramedullary canal or even an orthopedic environment. Finally, the presence of cutting flutes on the leading tapered portion does not negate the benefit of providing cutting flutes on the tapered leading edge of an enlarged segment. While a review of the substantial number of art that provides multiple cutting flutes is beyond the time allotted by the office for review of the instant application, Examiner has provided Weil as a teaching reference that, as shown in Fig. 1 provides cutting flutes in each tapered portion and even teaches that such is beneficial 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).
With regards to Applicant’s argument that Weil has not been shown to teach that the first thread extends an entire length of the first portion and a cutting flute in a fluted section of the first portion as the flute in the first portion of Wiel is on a non-threaded portion (Remarks p. 9), Examiner notes that it has not been asserted that Weil teaches that the tapered portion of the first portion is threaded; thus, this argument is moot. Instead, as detailed below and on pages 15-21 of the non-final office action dated September 2, 2025, Taras teaches that the first portion includes a tapered portion and that the first thread extends an entire length of the first portion; Weil teaches that a tapered portion of a first portion includes a cutting flute to achieve the known benefit of self-tapping for self-boring as the device progresses into a borehole.
With regards to Applicant’s argument that Gauneau has not been shown to teaches “the at least one cutting flute of the first portion extending to an end of the first portion opposite the trailing end” and Mildner does not teach a cutting lute and so the cited art does not teach the amended claim limitation (Remarks p. 10), Examiner notes that such is shown in Gauneau Fig. 1 and is unclear how such could be reasonably construed to be unshown. In the interest of providing the utmost clarity, Examiner has annotated Fig. 1 immediately below with regards to the ends, cutting flutes, and threads and notes that the outer diameter of the thread has been interpreted as the extending from the upper limit of the thread to the lower limit of the thread as shown in Fig. 1, i.e. consistent with the manner used by Applicant in Applicant’s own disclosure.
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With regards to Applicant’s argument that the previous rejection relied on the teaching of 7.5 mm and 9 mm in Mildner paragraph 36 and 37 which does not teach the second outer diameter (Figs. 1 and 2) smaller than the first outer diameter by about 0.5 mm or the first outer diameter is greater than the second outer diameter by 7% to 15% (Remarks p. 10), Examiner agrees that Mildner paragraphs 36 and 37 do not teach the newly narrowed or added claim limitations; however, Mildner paragraph 18 does. Mildner paragraph 18 specifically discloses that that the second outer diameter is selected from a value range between 5.5 mm and 10 mm, in particular between 6 mm and 8 mm, and that the maximum first outer diameter is selected from a value range between 7 mm and 12 mm, in particular between 8 mm and 11 mm; thus, for values within the particular range, e.g. a second outer diameter of 7.5 mm and a first outer diameter of 8 mm the difference is about 0.5 mm as claimed or the first outer diameter is greater than the second outer diameter by 7.5+(8/7.5)= 8.57% which is well within the claimed range of 7-15%.
Information Disclosure Statement
The information disclosure statement filed March 10, 2026 has been considered. Examiner notes that it is unclear how documents such as US 2013/0130735 “Land Mobile Radio Dispatch Console”, US 2003/0014071 “Inflation device and Methods of use”, WO 2014/089522 “Ergonomic Surgical Glove”, etc. are relevant to the instant application as they appear to comprise no intramedullary implant or threaded structure or any kind.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the at least one cutting flute of the first portion has a same height as a height of the first thread” of claim 52 lines 1-2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) 32-35 and 50-53 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 32 recites/recite the limitation "the first root diameter" in line 11. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “includes a taper from [[the]]a first root diameter to a smaller second root diameter”.
Claim(s) 33-35 and 50-53 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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) 32-35 and 50-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taras et al. (US 6,875,215, hereinafter “Taras”) in view of Huebner (US 6,030,162) and Weil et al. (US 2003/0028193, hereinafter “Weil”).
As to claims 32-35 and 50-53, Taras discloses an implant (Figs. 1-5) capable of intramedullary use (col. 1 lines 7-9 disclose use in bone fracture fixation, col. 1 lines 30-36 discloses known type II fracture repair with threaded pins in the intramedullary canal, col. 1 lines 49-51 disclose an object of invention as a fixation device for type II fractures) capable of being implanted within an intramedullary canal of a metacarpal capable of use for fixation of a fracture (col. 1 lines 7-9 disclose use in bone fracture fixation, col. 1 lines 30-36 discloses known type II fracture repair with threaded pins in the intramedullary canal, col. 1 lines 49-51 disclose an object of invention as a fixation device for type II fractures), the intramedullary 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), wherein the shaft comprises: a driver (26) at the trailing end (Figs. 1-3) and capable of driving the implant into bone (col. 3 lines 51-56 and 63-66) and separating from the implant thereafter (col. 3 line 63-col. 4 line 10); a first portion (14) extending from the trailing end (as defined, Figs. 1-5) and including a connection to the driver (Figs. 1-3), the first portion comprising a first thread (18), wherein the first thread extends an entire length of the first portion (Fig. 1, col. 3 lines 24-30) and comprises a tapered section of the first portion (at the left end of 14 as shown in Figs. 1-5, at the right end of 14 as shown in Figs. 1-5, Figs. 1-5), wherein the tapered section of the first portion includes a taper from a first root diameter to a smaller second root diameter (Figs. 1-5); and a second portion (12) extending from the leading end (as defined, Figs. 1-3) to the tapered section of the first portion (as defined, Figs. 1-3), the second portion comprising a second thread (16), the second thread having a root diameter (in as much as Applicant’s, Figs. 1-3) that is the same as the smaller second root diameter (as defined, in as much as Applicant’s, Figs. 1-3), the second thread comprising at least one cutting flute (24, Figs. 1-3, col. 3 lines 47-48), wherein the first thread and the second thread have the same pitch (Figs. 1-5, col. 3 lines 38-41), wherein the first portion extends about 25% of the length of the shaft (col 3 lines 33-38 disclose for radius fractures, 12 is ~2.55 inches and 14 is ~0.6 inches long; therefore, (0.6/(0.6+2.55))*100 = 19%, which is about 25%). As to claim 34, Taras discloses that the first thread has a first major diameter (Figs. 2 and 3, col 3 lines 33-38) so that the first thread is capable of engaging a larger distal portion of the metacarpal (Figs. 2 and 3, col. 1 lines 7-9 disclose use in bone fracture fixation). As to claim 35, Taras discloses that the second portion has a smaller second major diameter Figs. 2 and 3, col 3 lines 33-38) so that the second thread is capable of engaging a narrower proximal or mid portion of the metacarpal (Figs. 2 and 3, col. 1 lines 7-9 disclose use in bone fracture fixation). As to claim 50, Taras discloses that the second thread extends along an entire length of the second portion (as defined, Fig. 1). As to claim 51, Taras discloses that the tapered section of the first portion is immediately adjacent to the second section (as defined, Fig. 1). As to claim 52, Taras discloses that the at least one cutting flute has a same height as a height of the second thread (Figs. 1-3) and that the first thread along the tapered portion of the first portion a same height as a height of the second thread (Figs. 1-3). As to claim 53, Taras discloses that the first thread has a same height as the second thread (Fig. 3, col. 3 lines 38-41).
Taras is silent to a driving recess at the trailing end and configured to receive a driver; the first thread comprises at least one cutting flute defining a fluted section of the first portion, wherein the shaft is cannulated throughout an entire length of the shaft, and the first portion extends about 25% to 45% of the length of the shaft. As to claim 33, Taras is silent to the driving recess is shaped to receive a flat screwdriver, a Phillips screwdriver, a hex head, or an Allen wrench. As to claim 52, Taras is silent to the at least one cutting flute of the first portion has a same height as a height of the second thread.
Huebner teaches a similar implant (110, Figs. 10-14) capable of intramedullary use (Figs. 11-14) capable of being implanted within an intramedullary canal of a metacarpal capable of use for fixation of a fracture (Figs. 11-14, col. 6 lines 44-66, application and materials are disclosed for alternate embodiment in col. 5 lines 9-17), the intramedullary implant comprising: a shaft (110, Fig. 10) having a trailing end (right end of 110 as shown in Figs. 10-14, Figs. 10-14) and a leading end (right end of 110 as shown in Figs. 10-14, Figs. 10-14), wherein the shaft comprises: a driving recess (130) at the trailing end (shown in dashed lines in Fig. 10, Fig. 10) and capable of receiving a driver (“driver” of col. 6 line 53, Figs. 11-14, col. 6 lines 19-20 and 45-65); a first portion (126) extending from the trailing end (as defined, Fig. 10) and including the driving recess (Fig. 10), the first portion comprising a first thread (122 in 126, Fig. 10), wherein the first thread extends an entire length of the first portion (as defined, Fig. 10) and comprises, wherein the first portion includes a first root diameter (Fig. 10); and a second portion (124) extending from the leading end (as defined, Fig. 10), the second portion comprising a second thread (124 in 126, Fig. 10), the second thread having a root diameter (Fig. 10), the second thread comprising at least one cutting flute (at 132, Fig. 10), wherein the first thread and the second thread have the same pitch (col. 6 lines 23-24), wherein the shaft is cannulated (134) throughout an entire length of the shaft (shown with dashed lines in Fig. 10, Fig. 10, col. 6 lines 25-27) capable of use for insertion over a guide wire (72, Figs. 5 and 11-14, col. 6 lines 21-22 discloses that 132 is similar to 32 on implant 10, col. 5 lines 66-67, col. 6 lines 7, 44-46, and 63-65). As to claim 33, Huebner teaches that the driving recess is shaped to receive a flat screwdriver, a Phillips screwdriver, a hex head, or an Allen wrench (if one is sized to fit in the shown socket, Fig. 10).
Weil teaches a similar implant (Figs. 1-12) 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), wherein the shaft comprises: a driving recess (20, Fig. 2, ¶31) at the trailing end and capable of receiving a driver (“screwing tool” of ¶31, Fig. 2, ¶31); a first portion (left portion of 2 as shown in Figs. 1 and 2 including 2a, 12, 13, 14, and 15, Figs. 1-2) extending from the trailing end (as defined, Figs. 1 and 2) and including the driving recess (Fig. 2, ¶31), the first portion comprising a first thread (2a), wherein the first thread extends an entire length of the first portion (as defined, Fig. 1) and comprises at least one cutting flute (12, 13, 14, 15, Figs. 1, 2, and 8, ¶s 42 and 43) defining a fluted section of the first portion (section of the first portion that includes 12, 13, 14, 15, Figs. 1, 2, and 8), wherein the fluted section of the first portion includes a taper (Figs 1 and 2) from a first root diameter to a smaller second root diameter (Figs 1 and 2, ¶31); and a second portion (3) extending from the leading end (as defined, Figs. 1 and 2), the second portion comprising a second thread (3a), the second thread having a constant root diameter (in as much as Applicant’s, Figs 1 and 2) that is the same as the smaller second root diameter (in as much as Applicant’s, Figs 1 and 2), the second thread comprising at least one cutting flute (5, 6, Figs. 1-5, ¶38), wherein the shaft is cannulated (4) throughout an entire length of the shaft (Fig. 2, ¶31). As to claim 52, Weil teaches that the at least one cutting flute of the first portion has a same height as a height of the second thread (in as much as Applicant’s, Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the separable driver and corresponding connection to the first portion as disclosed by Taras to be a distinct driver that engages a driving recess at the trailing end of the first portion as taught by Huebner in order to drive the implant into the member to be secured (Huebner col. 6 lines 45-65) using a known alternative structure (Huebner Figs. 11-14), since constructing a formerly integral structure in various elements involves only routine skill in the art. Further, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tip and shaft as disclosed by Taras such that the shaft is cannulated throughout an entire length of the shaft and the tip is provided by a distinct guide wire as taught by Huebner in order to enable checking positioning and depth in the bone through x-ray (Huebner col. 5 line 66 – col. 6 line 5) to enable selection of an appropriately sized implant (Huebner col. 6 line 3-4) using a known alternative structure (Huebner Figs. 11-14), since constructing a formerly integral structure in various elements involves only routine skill in the art. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the first thread and the tapered portion as disclosed by Taras by adding at least one cutting flute defining a fluted section of the first portion 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the first portion of Taras to extend about 25% to 45% of the length of the shaft since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the first portion of Taras would not operate differently when sized to extend about 25% to 45% of the length of the shaft and, since the exemplary sizing for radius fractures is about 19%, the implant would function appropriately with the claimed values. Further, Applicant places no criticality on the range claimed, indicating simply that the first section preferably extends between about 25% to 45% of the length of device 10 and in one preferred embodiment is about 40% of the length (paragraph 27).
Claim(s) 54-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gauneau et al. (US 2015/0150613, hereinafter “Gauneau”) in view of Mildner et al. (US 2016/0030097, hereinafter “Mildner”).
As to claims 54-59, Gauneau discloses an implant (1, ¶s 1 and 27) capable of intramedullary use (¶s 1 and 27 disclose use in bone fixation) capable of being implanted within an intramedullary canal of a metacarpal capable of use for fixation of a fracture (¶s 1 and 27 disclose use in bone fixation), the intramedullary implant comprising: a shaft (Fig. 1) having a trailing end (right end surface as shown in Fig. 1, Fig. 1) and a leading end (left end surface as shown in Fig. 1, Fig. 1), wherein the shaft comprises: a driving engagement structure that appears to be a recess at the trailing end (Fig. 4; ¶63 discloses a screw driver instrument inserted in head 6) and capable of receiving a driver (¶63); a first portion (right portion as shown in Fig. 1, Fig. 1) extending from the trailing end (as defined, Fig. 1) and including the driving engagement structure (as defined, Figs. 1 and 4, ¶63), the first portion comprising a first thread (portion of 3 in the first portion, Fig. 1, ¶34) and at least one cutting flute (20/12, Figs. 1-4, ¶s 57-59), the at least one cutting flute of the first portion extending to an end of the first portion opposite the trailing end (as defined, Fig. 1), wherein the first portion includes a first outer diameter (Fig. 1); and a second portion (left portion as shown in Fig. 1, Fig. 1) extending from the leading end (as defined, Fig. 1), the second portion comprising a second thread (portion of 3 in the second portion, Fig. 1, ¶34) and at least one cutting flute (7, Fig. 1, ¶35), the second thread having a second outer diameter smaller than the first outer diameter (Fig. 1); wherein the first thread and the second thread have the same pitch (Fig. 1, ¶34 discloses that the pitch is constant), wherein the shaft is cannulated (Figs. 1 and 4, ¶32) and the cannulation appears to be along an entire length of the shaft (Figs. 1 and 4, ¶32). As to claim 33, Gauneau discloses that the driving engagement structure that appears to be a recess is shaped to receive a flat screwdriver, a Phillips screwdriver, a hex head, or an Allen wrench (if one is sized accordingly to fit within the driving engagement structure of Fig. 4 that appears to be a recess). As to claim 56, Gauneau discloses that the first outer diameter is sized so that the first thread is capable of engaging a larger distal portion of the metacarpal (¶s 1 and 27 disclose use in bone fixation). As to claim 57, Gauneau discloses that the second outer diameter is sized so that the second thread is capable of engaging a narrower proximal or mid portion of the metacarpal (¶s 1 and 27 disclose use in bone fixation). As to claim 58, Gauneau discloses that the second thread extends along an entire length of the second portion (as defined, Fig. 1). As to claim 59, Gauneau discloses that the first thread extends along an entire length of the first portion (as defined, Fig. 1).
Gauneau is silent to an explicit disclosure of the driving engagement structure that appears to be a recess that the screw driving tool is inserted in being a driving recess, the second outer diameter being smaller than the first outer diameter by about 0.5 mm, and the cannula of the shaft shown at each end of the implant being along the entire length of the shaft. As to claim 55, Gauneau is silent to the driving recess is shaped to receive a flat screwdriver, a Phillips screwdriver, a hex head, or an Allen wrench.
Mildner teaches a similar intramedullary implant (1, Figs. 1-5) capable of being implanted within an intramedullary canal of a metacarpal (¶s 1 and 38 discloses use for fixing bone fractures in a human heel) capable of use for fixation of a fracture (¶s 1 and 38), the intramedullary implant comprising: a shaft (Figs. 1-5) having a trailing end (right end surface as shown in Fig. 1, Fig. 1) and a leading end (left end surface as shown in Fig. 1, Fig. 1), wherein the shaft comprises: a driving recess (4, “appendage” of ¶24, Figs. 2 and 4, ¶s 24 and 41, abstract) at the trailing end (Figs. 2 and 4) and capable of receiving a driver (Figs. 2 and 4, ¶24); a first portion (right portion as shown in Fig. 1, Fig. 1) extending from the trailing end (as defined, Fig. 1), the first portion comprising a first thread (Figs. 1 and 3) and including the driving recess (as defined, Figs. 2 and 4), the first portion comprising a first thread (portion of 2 in the first portion, Fig. 1, ¶35), wherein the first portion includes a first outer diameter (Figs. 1 and 2); and a second portion (left portion as shown in Fig. 1, Fig. 1) extending from the leading end (as defined, Fig. 1), the second portion comprising a second thread (portion of 2 in the second portion, Fig. 1, ¶35) and at least one cutting flute (7, Figs. 1, 2, and 5, ¶43), the second thread having a second outer diameter (Figs. 1 and 2) smaller than the first outer diameter by about 0.5 mm (¶18 discloses that the second outer diameter is selected from a value range between 5.5 mm and 10 mm, in particular between 6 mm and 8 mm, and that the maximum first outer diameter is selected from a value range between 7 mm and 12 mm, in particular between 8 mm and 11 mm, for good handling capability of the screw, a good fitting capability in the bones with a small weakening of the bone material, a sufficiently large strength of the screw as well as a good friction-induced inhibition of the thread turns in the end position of the implanted screw result with these dimensions; thus, for values within the particular range, e.g. a second outer diameter of 7.5 mm and a first outer diameter of 8 mm, the difference is about 0.5 mm as claimed) or the first outer diameter is greater than the second outer diameter by 7% to 15% (¶18 discloses that the second outer diameter is selected from a value range between 5.5 mm and 10 mm, in particular between 6 mm and 8 mm, and that the maximum first outer diameter is selected from a value range between 7 mm and 12 mm, in particular between 8 mm and 11 mm; thus, for values within the particular range, e.g. a second outer diameter of 7.5 mm and a first outer diameter of 8 mm, the first outer diameter is greater than the second outer diameter by 8.57%); wherein the first thread and the second thread have the same pitch (¶40, abstract); and wherein the shaft is cannulated (5, Figs. 2, 4, and 5, ¶42) along the entire length of the shaft (Figs. 2, 4, and 5, ¶42). As to claim 55, Mildner teaches that the driving recess is shaped to receive a hex head (Figs. 2 and 4, ¶24).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify/specify that the driving engagement structure that the screw driving tool is inserted in as disclosed by Gauneau is a driving recess as taught by Mildner in order to drive the implant (Mildner ¶s 24 and 41, abstract) via a driving tool (Mildner ¶24; Gauneau ¶63) to impart perform screw-tightening in a conventional manner (Gauneau ¶63) to counter any movement of the bone elements to stabilize the bone elements that the surgeon has put into compression (Gauneau ¶62). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify that the second outer diameter that is smaller than the first outer diameter as disclosed by Gauneau is smaller by about 0.5 mm or the first outer diameter is greater than the second outer diameter by 7% to 15% as taught by Mildner in order to provide good handling capability of the implant, a good fitting capability in the bones with a small weakening of the bone material, a sufficiently large strength of the implant as well as a good friction-induced inhibition of the thread turns in the end position of the implanted implant result with these dimensions (Mildner ¶18). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify/specify the cannula of the shaft shown at each end of the implant as disclosed by Gauneau is along the entire length of the shaft as taught by Mildner in order to receive a Kirschner wire (Mildner ¶s 10 and 42) for guiding the implant (Mildner ¶s 23 and 27) to ensure an optimum, targeted introducibility of the surgical locking implant into the human bone (Mildner ¶11).
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 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.
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/AMY R SIPP/Primary Examiner, Art Unit 3775