Detailed Action
This is the final office action for US application number 18/628,192. Claims are evaluated as filed on May 4, 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 May 4, 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 Fischer and Oglaza 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 claimed invention is shown in the drawings in Figs. 6A-6E and ¶26 (Remarks p. 10), Examiner agrees that the limitations with drawing objections are supported in ¶26; however, the issue is that the claimed subject matter is not shown. Claims 1 and 8 include limitations that “the tip expander disposed to be moved in and out of the expansion tip” and the like in the locations identified in the drawing objections below. However, Figs. 6A-6C show an unexpanded state of the device and Figs. 6D and 6E shown the expanded device and yet none of Figs. 6A-6E show the tip expander 640 “moved out” of the expandable tip 615; thus, the shown tip expander is not shown to be capable of providing the claimed positioning for the claimed invention. Further, “a tip orientation knob … to rotatably orient the expandable tip without rotating the hollow tube” has not been shown as there is no detail shown as to how the tip orientation knob 625 is connected to or passes within the hollow tube 605 to enable one to ascertain if the claimed function is attainable with the shown structures.
With regards to Applicant’s argument that “a tip expander drawbar” and “a tip orientation knob” are defined by “tip expander” and “tip orientation” as well as what they are connected to and what they does as claimed and disclosed in ¶26 which has been amended to clarify (Remarks p. 11-12), Examiner notes that what a structure does defines the function of the structure, i.e. not what the structure is. That, Applicant’s asserted definitions detail the function that “drawbar” and “knob” is able to perform but do not define structures represent the claimed “drawbar” and “knob” to enable one to determine the broadest reasonable interpretation of the terms when the claims are read in light of the specification and no structures are shown that read on the ordinary definitions of “drawbar” and “knob”. Thus, Examiner suggests using a broad term such as “handle” that is consistent with what is shown in the drawings for the structures of 630 and 625 and consistent with the functions described in ¶26 and the claims. Alternately, one could file a continuation-in-part with drawings that show structures that enable a consistent interpretation of “drawbar” and “knob”.
With regards to Applicant’s argument that head 10 is not at the proximal end of the element 12 of Fischer as 10 is well inside of 12 and Oglaza does not supply what Fischer omits (Remarks p. 13-14), Examiner notes that a position of a part within another part does not prevent positioning within a proximal end. For example, Examiner has annotated the figure of Fischer below, which clearly shows 10 within the proximal end of 12 and thereby “at the proximal end”. Examiner further notes that this positioning will vary based upon the depth of insertion of 12. Further, such is also taught by Oglaza as detailed below and shown in Fig. 5.
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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 “a tip orientation knob … to rotatably orient the expandable tip without rotating the hollow tube” of claim 1 lines 4-6, “the tip expander disposed to be moved in and out of the expandable tip” of claim 1 lines 9-10, “a tip expander drawbar … to move the tip expander in and out of the expandable tip to expand the expandable tip in and out radially.” of claim 1 lines 10-12, “a tip orientation knob … to rotatably orient the expandable tip without rotating the hollow tube” of claim 8 lines 6-7, “the tip expander configured to be moved in and out of the expandable tip” of claim 8 lines 11-12, and “a tip expander drawbar … to move the tip expander in and out of the expandable tip to expand the expandable tip in and out radially.” of claim 8 lines 13-15 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 Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 line 6 should read “without rotating the hollow tube, wherein the expandable tip comprises a plurality of prongs”.
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) 1, 3, 6-8, 10, 13, and 14 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) 1 is/are unclear with regards to “a tip expander drawbar” in line 10 and the scope of “drawbar” or where such is supported in the specification as well as “a tip orientation knob” in lines 4-5 that is shown in Fig. 6A with a structure very similar to the asserted drawbar. Paragraph 26 identifies element 630 as the tip expander drawbar, but it does not appear that Applicant has chosen to act as their own lexicographer and define the term. However, the ordinary meaning is “a railroad coupler”; “a beam across the rear of a vehicle (such as a tractor) to which implements are hitched” (https://www.merriam-webster.com/dictionary/drawbar) or “coupler (sense a)”; “a bar at the rear of a tractor for attaching a plow, harrow, etc.” (https://www.collinsdictionary.com/dictionary/english/drawbar). Fig. 6A appears to show element 630 as having a very similar structure to element 625, which paragraph 26 identifies as “a tip orientation knob”; however a knob is “a small rounded ornament or handle” (https://www.merriam-webster.com/dictionary/knob) and Fig. 6A appears to show elements 630 and 625 as having a somewhat hexagonal shape and generally flat ends. Thus, it appears that elements 630 and 625 are neither a drawbar nor a knob under the ordinary meaning of the terms and instead represent an undescribed structure that functions as a handle. Examiner is interpreting this as referring to, and suggests amending as, “a tip orientation [[knob]]handle” in lines 4-5 and “a tip expander handle” in line 7.
Claim(s) 8 is/are unclear with regards to “a tip expander drawbar” in line 13 and the scope of “drawbar” or where such is supported in the specification as well as “a tip orientation knob” in line 6 that is shown in Fig. 6A with a structure very similar to the asserted drawbar. Paragraph 26 identifies element 630 as the tip expander drawbar, but it does not appear that Applicant has chosen to act as their own lexicographer and define the term. However, the ordinary meaning is “a railroad coupler”; “a beam across the rear of a vehicle (such as a tractor) to which implements are hitched” (https://www.merriam-webster.com/dictionary/drawbar) or “coupler (sense a)”; “a bar at the rear of a tractor for attaching a plow, harrow, etc.” (https://www.collinsdictionary.com/dictionary/english/drawbar). Fig. 6A appears to show element 630 as having a very similar structure to element 625, which paragraph 26 identifies as “a tip orientation knob”; however a knob is “a small rounded ornament or handle” (https://www.merriam-webster.com/dictionary/knob) and Fig. 6A appears to show elements 630 and 625 as having a somewhat hexagonal shape and generally flat ends. Thus, it appears that elements 630 and 625 are neither a drawbar nor a knob under the ordinary meaning of the terms and instead represent an undescribed structure that functions as a handle. Examiner is interpreting this as referring to, and suggests amending as, “a tip orientation [[knob]]handle” in line 6 and “a tip expander handle” in lines 9-10.
Claim(s) 3, 6, 7, 10, 13, and 14 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) 1, 3, 6-8, 10, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 3,716,051) in view of Oglaza et al. (US 2016/0317188, hereinafter “Oglaza”).
As to claims 1, 3, 6, and 7, Fischer discloses a bone reshaping tool (Figure, col. 3 lines 42-47 discloses reuniting fractured bone portion) comprising: a hollow tube (12, Figure) comprising an exterior surface of the hollow tube (Figure); an expandable tip (2) at a distal end of the hollow tube (Figure), the expandable tip connected to a proximal end of the hollow tube (Figure) and capable of being rotatably oriented without rotating the hollow tube (col. 4 lines 35-38 and 52-56), wherein the expandable tip comprises a plurality of prongs (4s, Figure, col. 4 lines 16-19), each prong fixed at a proximal end of the expandable tip (Figure, col. 4 lines 16-19) and free to be moved in and out radially by the tip expander at a distal end of the expandable tip (Figure, col. 4 lines 16-19); and a tip expander (7) disposed at a distal end of the expandable tip (Figure), the tip expander disposed to be moved in and out of the expandable (in as much as Applicant’s, Figure, col. 4 lines 49-50, col. 3 lines 48-52) and connected to a tip expander handle (10, col. 4 lines 46-50) at the proximal end of the hollow tube (Figure) capable of moving the tip expander in and out of the expandable tip (in as much as Applicant’s, Figure, col. 4 lines 49-50, col. 3 lines 48-52) capable of expanding the expandable tip in and out radially (Figure, col. 4 lines 50-52). As to claim 3, Fischer discloses that the plurality of prongs is beveled (Figure) capable of accommodating an anatomy of a femoral head (Figure). As to claim 6, Fischer discloses that the expandable tip is capable of elevating a subcondylar bone to near anatomical geometry (Figure). As to claim 7, Fischer discloses that the bone reshaping tool is capable of being driven within a femoral head (Figure) capable of pushing a condyle (Figure).
Fischer is silent to the hollow tube comprising bone-engaging drive threads on at least a portion of the exterior surface of the hollow tube, the expandable tip connected to a tip orientation handle at the proximal end of the hollow tube to rotatably orient the expandable tip.
Oglaza teaches a similar bone reshaping tool (Figs. 1-7B, ¶s 9 and 13; where ¶9 discloses the ability to reconstruct vertebral fractures and ¶13 discloses vertebral correction) comprising: a hollow tube (2, Figs. 3A and 3B) comprising bone-engaging drive threads (21, Figs. 3A, 3B, 6, and 6B, ¶89) on at least a portion of an exterior surface of the hollow tube (Figs. 3A and 3B); an expandable tip (1, Figs. 1, 2, and 5-7B) at a distal end of the hollow tube (Figs. 6A-7B), the expandable tip connected to a tip orientation handle (left portion of 52 as shown in Fig. 5, Fig. 5, ¶s 97 and 102) at a proximal end of the hollow tube (Fig. 5) capable of rotatably orienting the expandable tip (¶97) without rotating the hollow tube (¶s 97 and 102, where ¶97 discloses rotatably positioning 1 regardless of the screwing angle obtained during the insertion of 2), wherein the expandable tip comprises a plurality of prongs (portions of 11 as shown in Fig. 7B, Fig. 7B); and a tip expander (13) disposed at a distal end of the expandable tip (Figs. 7A and 7B), the tip expander disposed capable of being moved in and out of the expandable tip (Fig. 7B, ¶99) and connected to a tip expander handle (left portion of 51 as shown in Fig. 5, Fig. 5, ¶s 97 and 99; where ¶97 discloses that 52 is connected to 12 and 13, and ¶99 discloses pulling on 13 via 52 to cause expansion, i.e. by pulling 52 relative to 51) at the proximal end of the hollow tube (Fig. 5) capable of moving the tip expander in and out of the expandable tip (7A and 7B) capable of expanding the expandable tip in and out radially (Figs. 7A and 7B). As to claim 6, Oglaza teaches that the expandable tip is capable of elevating a subcondylar bone to near anatomical geometry (Figs. 6A-7B, ¶s 9 and 13). As to claim 7, Oglaza teaches that the bone reshaping tool is capable of being driven within a femoral head (Figs. 6A-7B, ¶s 9 and 13 disclose use in bone reconstruction and fracture correction) capable of pushing a condyle (Figs. 6A-7B, ¶s 9 and 13 disclose use in bone reconstruction and fracture correction).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the exterior surface of the hollow tube as disclosed by Fischer by adding bone-engaging drive threads on at least a portion of the exterior surface of the hollow tube as taught by Oglaza in order to provide bone anchoring (Oglaza ¶89) to aid in tightening/drawing together of the bone fragments so that the fracture can heal (Fischer col. 4 lines 54-60). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the expandable tip as disclosed by Fischer to include a tip orientation handle at a proximal end of the hollow tube to rotatably orient the expandable tip as taught by Oglaza in order to enable the operator to be able to control the axial rotation of the expandable tip independently of the tube (Oglaza ¶97) to provide expansion in a desired direction regardless of the screwing angle of the hollow tube (Oglaza ¶97) and predictably aid in stabilization of the expandable tip position during rotation of the tip expander handle to cause expansion prior to insertion of the hollow tube into bone (Fischer col. 4 lines 42-55).
As to claims 8, 10, 13, and 14, Fischer discloses a bone reshaping tool (Figure, col. 3 lines 42-47 discloses reuniting fractured bone portion) kit/components comprising: a hollow tube (12, Figure) comprising an exterior surface of the hollow tube (Figure); an expandable tip (2) at a distal end of the hollow tube (Figure), the expandable tip capable of being connected to a proximal end of the hollow tube (Figure) and capable of being rotatably oriented without rotating the hollow tube (col. 4 lines 35-38 and 52-56), wherein the expandable tip comprises a plurality of prongs (4s, Figure, col. 4 lines 16-19), each prong fixed at a proximal end of the expandable tip (Figure, col. 4 lines 16-19) and free to be moved in and out radially by the tip expander at a distal end of the expandable tip (Figure, col. 4 lines 16-19); and a tip expander (7) disposed at a distal end of the expandable tip (Figure), the tip expander capable of being moved in and out of the expandable (in as much as Applicant’s, Figure, col. 4 lines 49-50, col. 3 lines 48-52) and capable of being connected to a tip expander handle (10, col. 4 lines 46-50) at the proximal end of the hollow tube (Figure) capable of moving the tip expander in and out of the expandable tip (in as much as Applicant’s, Figure, col. 4 lines 49-50, col. 3 lines 48-52) capable of expanding the expandable tip in and out radially (Figure, col. 4 lines 50-52). As to claim 10, Fischer discloses that the plurality of prongs is beveled (Figure) capable of accommodating an anatomy of a femoral head (Figure). As to claim 13, Fischer discloses that the expandable tip is capable of elevating a subcondylar bone to near anatomical geometry (Figure). As to claim 14, Fischer discloses that the bone reshaping tool is capable of being driven within a femoral head (Figure) capable of pushing a condyle (Figure).
Fischer is silent to the hollow tube comprising bone-engaging drive threads on at least a portion of the exterior surface of the hollow tube, the expandable tip connected to a tip orientation handle at the proximal end of the hollow tube to rotatably orient the expandable tip.
Oglaza teaches a similar bone reshaping tool (Figs. 1-7B, ¶s 9 and 13; where ¶9 discloses the ability to reconstruct vertebral fractures and ¶13 discloses vertebral correction) comprising: a hollow tube (2, Figs. 3A and 3B) comprising bone-engaging drive threads (21, Figs. 3A, 3B, 6, and 6B, ¶89) on at least a portion of an exterior surface of the hollow tube (Figs. 3A and 3B); an expandable tip (1, Figs. 1, 2, and 5-7B) at a distal end of the hollow tube (Figs. 6A-7B), the expandable tip capable of being connected to a tip orientation handle (left portion of 52 as shown in Fig. 5, Fig. 5, ¶s 97 and 102) at a proximal end of the hollow tube (Fig. 5) capable of rotatably orienting the expandable tip (¶97) without rotating the hollow tube (¶s 97 and 102, where ¶97 discloses rotatably positioning 1 regardless of the screwing angle obtained during the insertion of 2), wherein the expandable tip comprises a plurality of prongs (portions of 11 as shown in Fig. 7B, Fig. 7B); and a tip expander (13) disposed at a distal end of the expandable tip (Figs. 7A and 7B), the tip expander capable of being moved in and out of the expandable tip (Fig. 7B, ¶99) and capable of being connected to a tip expander handle (left portion of 51 as shown in Fig. 5, Fig. 5, ¶s 97 and 99; where ¶97 discloses that 52 is connected to 12 and 13, and ¶99 discloses pulling on 13 via 52 to cause expansion, i.e. by pulling 52 relative to 51) at the proximal end of the hollow tube (Fig. 5) capable of moving the tip expander in and out of the expandable tip (7A and 7B) capable of expanding the expandable tip in and out radially (Figs. 7A and 7B)). As to claim 13, Oglaza teaches that the expandable tip is capable of elevating a subcondylar bone to near anatomical geometry (Figs. 6A-7B, ¶s 9 and 13). As to claim 14, Oglaza teaches that the bone reshaping tool is capable of being driven within a femoral head (Figs. 6A-7B, ¶s 9 and 13 disclose use in bone reconstruction and fracture correction) capable of pushing a condyle (Figs. 6A-7B, ¶s 9 and 13 disclose use in bone reconstruction and fracture correction).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the exterior surface of the hollow tube as disclosed by Fischer by adding bone-engaging drive threads on at least a portion of the exterior surface of the hollow tube as taught by Oglaza in order to provide bone anchoring (Oglaza ¶89) to aid in tightening/drawing together of the bone fragments so that the fracture can heal (Fischer col. 4 lines 54-60). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the expandable tip as disclosed by Fischer to include a tip orientation handle at a proximal end of the hollow tube to rotatably orient the expandable tip as taught by Oglaza in order to enable the operator to be able to control the axial rotation of the expandable tip independently of the tube (Oglaza ¶97) to provide expansion in a desired direction regardless of the screwing angle of the hollow tube (Oglaza ¶97) and predictably aid in stabilization of the expandable tip position during rotation of the tip expander handle to cause expansion prior to insertion of the hollow tube into bone (Fischer col. 4 lines 42-55).
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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