Detailed Action
This is the final office action for US application number 19/109,011. Claims are evaluated as filed on July 15, 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 July 15, 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 Blau, Prien, Yamazaki, and Watanabe teach all the newly-amended limitations and is capable of performing the functions as claimed.
With regards to Applicant’s argument that neither reference discloses the last paragraph of claim 16 (Remarks p. 10-11), Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
Claim Objections
Claim(s) 9 is/are objected to because of the following informalities:
Claim 9 lines 2-3 should read “intramedullary nail in a bone[[,]] to treat a fracture, wherein the positioning system”.
Claim 9 line 5 should read “an intramedullary canal of the bone[[:]]; wherein”.
Claim 9 lines 6-7 should read “a longitudinal axis of the intramedullary nail to accommodate a coupling device,”.
Claim 9 lines 9-10 should read “wherein the_coupling device can be secured on one end of the bone”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 12-15 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) 12-15 is/are unclear with regards to “A method” in claim 12 line 1, where the preamble ends and the body begins, the lack of a transitional phrase (see MPEP 2111.03) indicating what the method comprises/consists of, and the apparent absence of a recitation of a method step; where MPEP 2173.05(q) provides that “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness”. Further, claim 12 is unclear with regards to “a curved handle of the positioning device” in lines 5-6 that is claimed in addition to that of claim 16 line 3 from which claim 12 depends, “a target guide” in line 6 that is claimed in addition to that of claim 16 line 3 from which claim 12 depends, “an alignment sight” in lines 7-8 that is claimed in addition to that of claim 16 line 5 from which claim 12 depends, and similarly “a first indicator structure”, “a first X-ray image”, “a first alignment plane”, “a second X-ray image”, “a second line of sight”, “a second indicator structure”, “a plurality of walls”, “two tilt indicator gaps” and where support can be found in the original disclosure for having double the amount of some of the claim limitations relative to what is shown or, if some are intended to refer to the same structures, the intent of repeating limitations that appear to be the same scope. Examiner is interpreting this as referring to, and suggests amending as,
“A method for treating a bone fracture, the method comprising:
introducing an intramedullary nail
wherein the intramedullary nail is releasably connected to [[a]]the curved handle of the positioning device,
Claim(s) 13-15 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) 16, 2, 6, 7, 9, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blau (US 2009/0209851) in view of Yamazaki et al. (JP 2011115408 and corresponding English translation, hereinafter “Yamazaki”) and Prien et al. (US 2022/0296284, hereinafter “Prien”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 16, 2, 6, 7, 9, and 12-15, Blau discloses a positioning device (device shown in Fig. 16A, Fig. 16A) capable of positioning and/or securing a bone implant (1654, Fig. 16A) capable of treating a bone fracture (Fig. 16A, ¶94), wherein the positioning device comprises: a curved handle (see illustration of Fig. 16A, Fig. 16A) with a target guide (see illustration of Fig. 16A, Fig. 16A) capable of guiding a bone drill device (Fig. 16F), wherein the target guide defines a target axis (along a target aperture as labeled on the illustration of Fig. 16A, e.g. along the k-wire 1687 shown in Fig. 16D, Figs. 16A and 16D, ¶97) and wherein the curved handle comprises a connection element (see illustration of Fig. 16A, Fig. 16A) capable of releasably connecting the bone implant to the curved handle (¶94 discloses attachment to the nail as shown in Fig. 16A in a manner that appears to be releasable as Fig. 16H shows the intramedullary nail secured within the bone with a screw inserted therethrough as described in at least ¶98 where there appears to be no reason to keep the insertion tool/positioning connected to the implanted nail post-operatively) and an alignment sight (1660), wherein the alignment sight comprises a first indicator structure (see “First opening” as labeled on the illustration of Fig. 16A, Fig. 16A) capable of indicating a target path when viewed in a first X-ray image (relative to the longest sides of the indicator structure, Figs. 16C and 16E) and a second indicator structure (see “First opening” as labeled on the illustration of Fig. 16A, Fig. 16A) comprising an indicator gap (Figs. 16A, 16C, and 16E), wherein the tilt indicator gap is capable of being viewed in the first X-ray image of the alignment sight (Figs. 16C and 16E) capable of enabling determination of a direction of orthogonal tilting of a line of sight from a first alignment plane (Figs. 16C and 16E); wherein the tilt indicator gap is formed in the first X-ray image due to the presence of a first pair of substantially parallel walls (Figs. 16A, 16C, and 16E), wherein the first pair of parallel walls is located on the alignment sight and the second pair of parallel walls is located on an opposite side of the alignment sight (Figs. 16A, 16C, and 16E) and the tilt indicator gap is oriented to show different imaged gap widths in the first X-ray image depending on an orthogonal tilt (due to the offset/spacing between the openings as shown generally vertical in Fig. 16A, such will show as having a different imaged gap size depending on the axis the device is tilted about and the angle of the x-ray, Fig. 16A, 16C, and 16E). As to claim 2, Blau discloses the first indicator structure and/or the second indicator structure is formed with at least one elevation and/or at least one depression (openings are labeled as such in the illustration of Fig. 16A, which would cause a change in elevation relative to the surfaces of the walls shown on the right-facing surface of 1660 in Fig. 16A, Fig. 16A) in order to form a structure that can be identified in the first X-ray image (Fig. 16A, ¶s 94 and 96). As to claim 7, Blau discloses that opposite ends of the depression in the first indicator structure of the alignment sight (generally horizonal ends of the openings as shown in Fig. 16A, Fig. 16A) together form a third indicator structure (in as much as Applicant’s, Fig. 16A) an orthogonal tilting from a second alignment plane which is aligned at right angles to the first alignment plane (in as much as Applicant’s, Fig. 16A). As to claim 9, Blau discloses a positioning system (Figs. 16A-16H) capable of positioning and/or securing an intramedullary nail (1654, Fig. 16A) in a bone (Fig. 16A) to treat a fracture (Fig. 16A, ¶94), wherein the positioning system comprises the positioning device of claim 16 (as detailed herein), and an intramedullary nail (1654) that can be introduced into an intramedullary canal of the bone (Fig. 16A); wherein the intramedullary nail has a bore (see illustration of Fig. 16A, Fig. 16A) projecting transversely to a longitudinal axis of the intramedullary nail (Figs. 16A and 16E-16H) capable of accommodating a coupling device (shown as a bone screw in at least Fig. 16H, Fig. 16H, ¶98), wherein the coupling device projects beyond the bore on at least one side of the bore (Fig. 16H), wherein the coupling device can be secured on one end of the bone (Fig. 16H, ¶98). As to claim 12, Blau discloses a method (Figs. 16A-16H) capable of treating a bone fracture (Figs. 16A-16H, ¶94), the method comprising: introducing an intramedullary nail (1654, Fig. 16A) into an intramedullary canal of a bone using a positioning device according to Claim 16 (Figs. 16A-16H), wherein the intramedullary nail is releasably connected to the curved handle of the positioning device (Figs. 16A-16H, ¶94). As to claim 13, Blau discloses that a K-wire (Fig. 16E, ¶97) of a bone drill device (Figs. 16E and 16F, ¶s 97 and 98) is guided along the target axis into the bone using the target guide of the curved handle (Figs. 16E and 16F, ¶s 97 and 98), wherein the line of sight is adjusted on the basis of the second indicator structure before the bone drill device is visible in the second X-ray image for a comparison with the first indicator structure (Figs. 16A-16C, ¶s 94-96). As to claim 14, Blau discloses that the intramedullary nail comprises a bore (see illustration of Fig. 16A, Fig. 16A) extending transversely in relation to a longitudinal axis of the intramedullary nail (Figs. 16E-16H) capable of accommodating a coupling device (shown as a bone screw, Fig 16H, ¶98), wherein a K-wire of the bone drill device (Figs. 16E and 16F, ¶s 97 and 98) is guided with the target guide through the bore along the target axis (Figs. 16E and 16F, ¶s 97 and 98). As to claim 15, Blau discloses a K-wire (Fig. 16E, ¶97) of a bone drill device (Figs. 16E and 16F, ¶s 97 and 98) is a targeting wire (Figs. 16E and 16F, ¶s 97 and 98) and the bone drill device has a diameter smaller than the intermedullary nail (Figs. 16E-16H, ¶s 97 and 98), where the K-wire is guided along the target axis through a bore in a first step (Figs. 16E-16H, ¶s 97 and 98), after which a bone bore canal is introduced into the bone (Figs. 16E-16H, ¶s 97 and 98), after which the coupling device is introduced into the bore via the bone bore canal (Figs. 16E-16H, ¶s 97 and 98).
Blau is silent to an express disclosure of the connection element being capable of releasing the intramedullary nail and the curved handle arm, the first indicator structure formed as a depression in the alignment sight to indicate a target path when viewed in a first X-ray image, and the second indicator structure comprising two tilt indicator gaps spaced apart from one another, wherein the two tilt indicator gaps are configured to be viewed in the first X-ray image of the alignment sight to enable determination of a direction of orthogonal tilting of a line of sight from the first alignment plane by comparing relative gap widths of the two tilt indicator gaps; wherein the two tilt indicator gaps are formed in the first X-ray image due to the presence of a first pair of parallel walls and a second pair of parallel walls, wherein the first pair of parallel walls is located on one side of the alignment sight and the second pair of parallel walls is located on an opposite side of the alignment sight and the first pair of parallel walls and the second pair of parallel walls are parallel to each other and the two tilt indicator gaps are oriented to show different imaged gap widths in the first X-ray image depending on an orthogonal tilt; wherein the connection element comprises an opening (Fig. 16A) as an extension of that of the alignment sight (Fig. 16A). As to claim 6, Blau is silent to the depression of the first indicator structure is located between the two tilt indicator gaps.
Yamazaki teaches a similar positioning device (Figs. 1-11) capable of use for positioning and/or securing a bone implant (Fig. 11) capable of treating a bone fracture (title), wherein the positioning device comprises: a curved handle (3) with a target guide (2) capable of guiding a bone drill device (Fig. 2), wherein the target guide defines a target axis (along a target aperture 6, e.g. along the pin P as shown in Figs. 1 and 2, Figs. 1 and 2) and wherein the curved handle comprises a connection element (left portion of 4 as shown in Fig. 2, i.e. the portion of 4 that extends along the same axis as 8 as shown in Fig. 2, Fig. 2) capable of releasably connecting the bone implant to the curved handle (¶s 25 and 32) and an alignment sight (right portion of 4 as shown in Fig. 2, i.e. the portion of 4 that extends along the same axis as 8 as shown in Fig. 2, 17, Fig. 2), wherein the alignment sight comprises a first indicator structure (9, 10) formed as a depression in the alignment sight (Figs. 2, 3, and 6) capable of indicating a target path (Fig. 6) when viewed in a first X-ray image (Fig. 6) and a second indicator structure (20s) comprising a tilt indicator gap (between 20s, Figs. 4 and 6, ¶22 discloses that when imaged, 20s become 2 walls) spaced apart from one another (¶22), wherein the tilt indicator gap is capable of being viewed in the first X-ray image of the alignment sight (Fig. 6) capable of enabling determination of a direction of orthogonal tilting of a line of sight from a first alignment plane (Fig. 6, ¶s 27-30); wherein the tilt indicator gap is formed in the first X-ray image due to the presence of a first pair of parallel walls (Figs. 4 and 6, ¶22 discloses that when imaged, 20s become 2 walls), wherein the first pair of parallel walls is located on the alignment sight (as defined) and the first pair of parallel walls and the two tilt indicator structures are oriented to show different imaged gap widths in the first X-ray image depending on an orthogonal tilt (Fig. 6); wherein the connection element comprises a depression (9, 10) as an extension of that of the alignment sight (Fig. 2). As to claim 6, Yamazaki teaches that the depression of the first indicator structure is located between the tilt indicator gap (Fig. 6). As to claim 12, Yamazaki teaches a method (Figs. 1-11) capable of treating a bone fracture (Figs. 1-11, title), the method comprising: introducing an intramedullary nail (8/B, Figs. 1-11) into an intramedullary canal of a bone using a positioning device according to Claim 16 (Figs. 1-11), wherein the intramedullary nail is releasably connected to the curved handle of the positioning device (Figs. 1-11, ¶s 25 and 32).
Prien teaches a similar positioning device (Figs. 1A-3A and 8, ¶51) capable of positioning and/or securing an bone implant (108, Fig. 1B) capable of treating a bone fracture (¶4), wherein the positioning device comprises: a curved handle (104, 106) with a target guide (210) capable of guiding a bone drill device (Figs. 1A and 1B, ¶s 30, 33, and 35), the target guide defining a target axis (along 112A and 112B as shown in Figs. 1A and 1B, Figs. 1A and 1B) and wherein the curved handle comprises a connection element (114, 122) capable of releasably connecting the bone implant to the curved handle (Fig. 1B, ¶s 37, 57, and 64; where ¶s 37 and 57 discloses that 122 in a bolt threadably connected to the nail, ¶64 discloses decoupling the device from the nail by removing bolt 122) and an alignment sight (800), wherein the alignment sight comprises a first indicator structure (808, 810, Fig. 8) and a second indicator structure (¶51 discloses more than one straight line on a fluoroscopy image caused by k-wires inserted in recesses 804, 805) comprising two tilt indicator gaps (Fig. 8) spaced apart from one another (Fig. 8), wherein the two tilt indicator gaps are capable of being viewed in the first X-ray image of the alignment sight (Fig. 8, ¶51) capable of enabling determination of a direction of orthogonal tilting of a line of sight from a first alignment plane by comparing relative gap widths of the two tilt indicator gaps (due to the disclosed structures, Fig. 8, ¶51); wherein the two tilt indicator gaps are formed in the first X-ray image due to the presence of a first pair of parallel walls and a second pair of parallel walls (Fig. 8, claims 12 and 20), wherein the first pair of parallel walls is located on one side of the alignment sight (Fig. 8) and the second pair of parallel walls is located on an opposite side of the alignment sight (Fig. 8) and the first pair of parallel walls and the second pair of parallel walls are parallel to each other (Fig. 8, claims 12 and 20) and the two tilt indicator gaps are oriented to show different imaged gap widths in the first X-ray image depending on an orthogonal tilt (due to the offset/spacing between the openings as shown generally horizontal in Fig. 8, such will show as having a different imaged gap size depending on the axis the device is tilted about and the angle of the x-ray, Fig. 8, ¶51 and claims 12 and 20). As to claim 6, Prien teaches that the first indicator structure is located between the two tilt indicator gaps (Fig. 8 shows that there are recesses between gaps due to the number of recesses and walls provided, Fig. 8). As to claim 12, Prien teaches a method (Figs. 13 and 14) capable of treating a bone fracture (Figs. 13 and 14, ¶4), the method comprising: introducing an intramedullary nail (“nail” of ¶34, Figs. 13 and 14, ¶34) into an intramedullary canal of a bone using a positioning device according to Claim 16 (Figs. 13 and 14), wherein the intramedullary nail is releasably connected to the curved handle of the positioning device (via 114, Figs. 13 and 14, ¶34).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify that the first indicator structure as disclosed by Blau to include a depression in the alignment sight as an extension of that of the connection element as taught by Yamazaki in order to provide an overlap when viewed from the ML surface (Yamazaki ¶24) to confirm that the alignment for insertion of pin P is correct (Yamazaki ¶31). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to expressly specify that the connection element as disclosed by Blau is removable as taught by Prien in order to predictably couple the handle arm to the nail (Prien ¶s 37 and 57) while permitting selected removal of the device from the installed nail (Prien ¶64). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the alignment sight as disclosed by Blau by adding the second indicator structure as taught by Prien in order to permit k-wires to be snapped into surgeon selected recesses to best assess the equidistant alignment between the k-wire and an installed nail on a fluoroscopy image (Prien ¶51), e.g. for a particular target axis of a particular target aperture (Blau Fig. 16A; Prien Fig. 3A).
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Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blau, Yamazaki, and Prien in view of Watanabe et al. (WO 2007/109302, hereinafter “Watanabe” as provided with the PTO-892 dated April 10, 2026).
As to claim 10, the combination of Blau, Yamazaki, and Prien discloses the invention of claim 9 as well as the target guide comprises a guide device (Fig. 16A).
The combination of Blau, Yamazaki, and Prien is silent to a drill device guide, wherein the drill device guide comprises a drill device canal for guiding the bone drill device, wherein the drill device guide is releasably connected to the guide device in an interlocking manner such that the drill device guide can be guided displaceably along the target axis relative to the guide device to guide the drill device canal to a bone surface of the bone or to the intramedullary nail when the intramedullary nail is introduced into the bone. As to claim 11, the combination of Blau, Yamazaki, and Prien is silent to the target guide comprises a tissue protection jacket that moves relative to the guide device in order to at least partially envelop the drill device guide in a deployed position, wherein the drill device guide is guided in the direction of bone or intramedullary nail in order to separate the drill device guide from a body part tissue surrounding the bone.
Watanabe teaches a similar positioning device (device of Figs. 50-53, Figs. 50-53) capable of positioning and/or securing a bone implant (2002. Figs 45-60, ¶142), wherein the positioning device comprises: a curved handle (2030) with a target guide (2034) capable of guiding a bone drill device (¶158), wherein the target guide defines a target axis (along the aperture 2036, Fig. 50, ¶155) and wherein the curved handle comprises a connection element (Fig. 50) capable of connecting the bone implant to the curved handle (Fig. 50), wherein the target guide comprises a guide device (Fig. 50) and a drill device guide (2048), wherein the drill device guide comprises a drill device canal (Fig. 53, ¶158) capable of guiding the bone drill device (¶158), wherein the drill device guide is releasably connected to the guide device in an interlocking manner such that the drill device guide can be guided displaceably along the target axis relative to the guide device (Fig. 53, ¶158) capable of guiding the drill device canal to a bone surface of the bone or to the bone implant when the bone implant is introduced into the bone (Fig. 53, ¶158). As to claim 11, the Watanabe teaches that the target guide comprises a tissue protection jacket (2044, 2042, 2038) that moves relative to the guide device in order to at least partially envelop the drill device guide in a deployed position (Fig. 50, ¶155), wherein the drill device guide is guided in the direction of bone or intramedullary nail (Figs. 50-53, ¶s 155-158) in order to separate the drill device guide from a body part tissue surrounding the bone (Figs. 50-53, ¶s 155-158).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the system as disclosed by the combination of Blau, Yamazaki, and Prien by adding a drill device guide and a tissue protection jacket as taught by Watanabe in order to guide insertion of a guide pin (Blau Fig. 16E, ¶97; Watanabe ¶157) and a drill (Blau Fig. 16F; Watanabe ¶158) that will prepare a cavity in the bone (Watanabe ¶158).
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.
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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