Detailed Action
This is the first office action on the merits for US application number 18/628,192.
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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, the product of claims 1-14, in the reply filed on December 8, 2025 is acknowledged.
Accordingly, claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant's election with traverse of species c, Figs. 6A-8F, in the reply filed on December 8, 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden.
The argument that there is no search burden because the claims are generic is not found persuasive because, even though Applicant has not identified the claim asserted to be generic, the presence of a generic claim does not render the examination of distinct species unburdensome. That is, as provided by MPEP 806.04, “Where an application includes claims directed to different embodiments or species that could fall within the scope of a generic claim, restriction between the species may be proper if the species are independent or distinct”. Although there would be some overlap in searching fields, examination of multiple mutually exclusive features constitutes an undue search and examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election did not indicate which claims read on the elected species of Figs. 6A-8F.
As to claim 5, the limitation of “the tip expander is conical, with a conical base at a distal end of the tip expander and a conical point at a proximal end of the tip expander” does not read on the elected species with the tip expander best shown in Fig. 6C. Further, a conical tip expander is shown only in Fig. 3B and 3C, i.e. of non-elected species a of Figs. 3A-4D. Therefore, claim 5 does not read on the elected species.
As to claim 12, the limitation of “the tip expander is conical, with a conical base at a distal end of the tip expander and a conical point at a proximal end of the tip expander” does not read on the elected species with the tip expander best shown in Fig. 6C. Further, a conical tip expander is shown only in Fig. 3B and 3C, i.e. of non-elected species a of Figs. 3A-4D. Therefore, claim 5 does not read on the elected species.
Accordingly, claims 5 and 12 are withdrawn from further consideration along with claims 15-21.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "617a" and "167a have both been used to designate a prong. Examiner suggests amending paragraph 26 on page 7 line 10 as “the prongs [[167a]]617a, 617b.”.
The drawings are objected to because:
Fig. 6A includes a random arrow above “600” and a random line above “615”.
Fig. 6C includes a “615” with no line to identify a corresponding structure.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because currently provided Figs. 6A-6E do not constitute black and white line drawings as required by CFR 1.84 and the provided figures do not provide a clear indication of the intended structures, connections between structures, and portions of openings or bores that may or may not include a structure within or engaged therewith are not discernable. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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 expandable tip connected to a tip orientation knob” of claim 1 lines 4-5, “a tip orientation knob…to rotatably orient the expandable tip” of claim 1 lines 4-5; “the tip expander disposed to be moved in and out of the expansion tip” of claim 1 lines 6-7, “the tip expander …connected to a tip expander drawbar” of claim 1 lines 6-7, the “the expandable tip connected to a tip orientation knob” of claim 8 lines 5-6, “a tip orientation knob…to rotatably orient the expandable tip” of claim 8 lines 5-7; “the tip expander disposed to be moved in and out of the expansion tip” of claim 8 lines 8-9, “the tip expander …connected to a tip expander drawbar” of claim 8 lines 8-10, “one or more tools to manipulate the hollow tube, the expandable tip, the tip expander, or some combination” of claim 8 lines 11-12 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, 6, 8, and 13 is/are objected to because of the following informalities:
Claim 1 line 7 should read “the tip expander disposed to be moved in and out of the expansion tip[[,]] and connected to a”.
Claim 6 line 2 should read “a subc[[h]]ondylar bone”.
Claim 8 line 9 should read “the tip expander disposed to be moved in and out of the expansion tip[[,]] and connected to a”.
Claim 13 line 2 should read “a subc[[h]]ondylar 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) 1-4, 6-11, and 13 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 7 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 lines 9-10 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) 2-4, 6, 7, 9-11, and 13 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6-8, 11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oglaza et al. (US 2016/0317188, hereinafter “Oglaza”).
As to claim 1, Oglaza discloses a 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); 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 expansion 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).
As to claim 4, Oglaza discloses that the expandable tip can be rotated without rotating the hollow tube (¶s 97 and 102).
As to claim 6, Oglaza discloses 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 discloses 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).
As to claim 8, Oglaza discloses a bone reshaping tool kit (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); 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 expansion 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); and one or more tools (used to grip the left portion of 52 as shown in Fig. 5, Fig. 5, ¶97 discloses use for the operator to control the rotation of tip 1 independent of tube 2) capable of use to manipulate the expandable tip (¶97).
As to claim 11, Oglaza discloses that the expandable tip can be rotated without rotating the hollow tube (¶s 97 and 102).
As to claim 13, Oglaza discloses 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 discloses 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).
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 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (US 3,716,051) in view of Oglaza.
As to claim 1, 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); 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 expansion tip (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). As to claim 2, Fischer discloses that 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). As to claim 3, Fischer discloses that the plurality of prongs is beveled (Figure) capable of accommodating an anatomy of a femoral head (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 a 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); 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 expansion 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).
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 claim 8, 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); 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 expansion tip (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), and one or more tools (used to inserted into opening shown as dashed lines in 10 in the Figure, Figure, col. 4 lines 42-48 discloses used to cause rotation of 9) capable of use to manipulate the tip expander (Figure, col. 4 lines 42-48). As to claim 9, Fischer discloses that 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). As to claim 10, Fischer discloses that the plurality of prongs is beveled (Figure) capable of accommodating an anatomy of a femoral head (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 a 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); 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 expansion 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), and one or more tools (used to grip the left portion of 52 as shown in Fig. 5, Fig. 5, ¶97 discloses use for the operator to control the rotation of tip 1 independent of tube 2) capable of use to manipulate the expandable tip (¶97).
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
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