Detailed Action
This is the final office action for US application number 17/929,924. Claims are evaluated as filed on January 26, 2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre- AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed January 26, 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 Meyer, Esser, and Orbay 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 new depended claim 8 is supported by Fig. 14C and paragraph 58 (Remarks p. 6), Examiner appreciates the identification of the intended support. However, as written, claim 8 provides at least two head portions where claim 1 already recites a plurality of head portions; thus claim 8 recites a total of at least four head portions, which is not supported by the disclosure. Examiner has provided amendment suggestions consistent with Applicant’s identified support for claim 8 with the corresponding rejections below.
With regards to Applicant’s argument that Forstein does not disclose at least one of the head portions being concave and at least one of the head portions being substantially flat (Remarks p. 9), Examiner notes that Esser has been provided in the below rejection in respect to this teaching.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 8, the specification appears to lack provide proper antecedent basis for “The fracture fixation plate of claim 1 further comprising at least two head portions, the at least two head portions having a gap therebetween sized to allow for movement of a flexor tendon without impingement of the at least two head portions when the fracture fixation plate is engaged with a volar surface of a distal radius.”. As claimed, there is a plurality of head portions of claim 1 line 5 and at least two head portions of claim 8 lines 1-4, i.e. a total of at least four head portions are claimed. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for four head portions. Thus, the specification fails to provide proper antecedent basis for “The fracture fixation plate of claim 1 further comprising at least two head portions, the at least two head portions having a gap therebetween sized to allow for movement of a flexor tendon without impingement of the at least two head portions when the fracture fixation plate is engaged with a volar surface of a distal radius.”. Examiner suggests amending to specify that the plurality of head portions comprise at least two head portions or amending claim 8 to further limit the plurality of head portions of claim 1 without introducing the ‘at least two head portions’ terminology.
As to claim 9, the specification appears to lack provide proper antecedent basis for “at least one head portion” that is in addition to the plurality of head portions of claim 1 line 5. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for three head portions. Thus, the specification fails to provide proper antecedent basis for the “at least one head portion” of claim 9. Examiner suggests amending as “at least one head portion of the plurality of head portions is substantially triangle shaped.”
As to claim 10, the specification appears to lack provide proper antecedent basis for “at least one head portion” that is in addition to the plurality of head portions of claim 1 line 5. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for three head portions. Thus, the specification fails to provide proper antecedent basis for the “at least one head portion” of claim 10. Examiner suggests amending as “at least one head portion of the plurality of head portions is substantially square shaped.”
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 fracture fixation plate of claim 1 further comprising at least two head portions, the at least two head portions having a gap therebetween sized to allow for movement of a flexor tendon without impingement of the at least two head portions when the fracture fixation plate is engaged with a volar surface of a distal radius” of claim 8, at least one head portion of claim 9 that is in addition to the plurality of head portions of claim 1 line 5, and at least one head portion of claim 10 that is in addition to the plurality of head portions of claim 1 line 5 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 8, “The fracture fixation plate of claim 1 further comprising at least two head portions, the at least two head portions having a gap therebetween sized to allow for movement of a flexor tendon without impingement of the at least two head portions when the fracture fixation plate is engaged with a volar surface of a distal radius.” appears to be new matter. As claimed, there is a plurality of head portions of claim 1 line 5 and at least two head portions of claim 8 lines 1-4, i.e. a total of at least four head portions are claimed. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for four head portions. Thus, “The fracture fixation plate of claim 1 further comprising at least two head portions, the at least two head portions having a gap therebetween sized to allow for movement of a flexor tendon without impingement of the at least two head portions when the fracture fixation plate is engaged with a volar surface of a distal radius.” constitutes new matter. Examiner suggests amending to specify that the plurality of head portions comprise at least two head portions or amending claim 8 to further limit the plurality of head portions of claim 1 without introducing the ‘at least two head portions’ terminology.
As to claim 9, “at least one head portion” that is in addition to the plurality of head portions of claim 1 line 5 appears to be new matter. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for three head portions. Thus, “at least one head portion” of claim 9 constitutes new matter. Examiner suggests amending as “at least one head portion of the plurality of head portions is substantially triangle shaped.”
As to claim 10, “at least one head portion” that is in addition to the plurality of head portions of claim 1 line 5 appears to be new matter. There appears to be no description in the specification, no showing in the drawings, and no original claim limitations that provide for three head portions. Thus, “at least one head portion” of claim 10 constitutes new matter. Examiner suggests amending as “at least one head portion of the plurality of head portions is substantially square shaped.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1, 6-8, and 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Meyer et al. (US 2007/0123886, hereinafter “Meyer”) in view of Esser (US 6,096,040).
As to claim 1, Meyer discloses a fracture fixation plate (Figs. 2 and 3, ¶35; where ¶35 disclose that Fig. 3 has the longitudinal axes of the sections 11 approximately corresponding to an arc, i.e. not including the angle in Fig. 2) for use on a distal radius (¶24) comprising: a substantially rigid plate (Fig. 3) including an elongated body portion (1) having proximal and distal ends (upper and lower ends, respectively, as shown in Fig. 3, Fig. 3); said plate including a bone contacting surface (right-facing surface of Fig. 2 cross-section of portion 1, Fig. 2) and an opposite surface (left-facing surface of Fig. 2 cross-section of portion 1, Fig. 2); said plate including a plurality of head portions (11s) independently connected to the distal end of said body portion by a corresponding plurality of neck portions (10s, Fig. 3); each of said head portions including a plurality of threaded holes (9s, Figs. 2 and 3, ¶28) capable of receiving bone fasteners (Fig. 2, ¶19); each of said threaded holes defining a bone fastener axis (Figs. 2 and 3); said body portion including at least one anchoring hole (2s, 3, Fig. 3); wherein a bone contacting surface of said body portion is cylindrically concave (7, Fig. 2 cross-section of portion 1, Fig. 2, ¶26) in relation to a longitudinal axis of the body portion (Fig. 2, ¶26); wherein a bone contacting surface of at least one of the head portions (Fig. 2 cross-section of 11s, Fig. 2) and a bone contacting surface of at least one other of the head portions is substantially flat (Fig. 2 cross-section of 11s, Fig. 2). As to claim 8, Meyer discloses that the plurality of head portions having a gap (Fig. 2) therebetween sized capable of allowing movement of a flexor tendon without impingement of the plurality of head portions when the fracture fixation plate is engaged with a volar surface of a distal radius (Fig. 2). As to claim 10, Meyer discloses that at least one head portion of the plurality of head portions is substantially square shaped (Figs. 2 and 3).
Meyer is silent to the bone contacting surface of at least one of the head portions is concave.
Esser teaches a similar fracture fixation plate (Figs. 19-21, abstract, col. 11 lines 58-66; where col. 11 line 58 – col. 12 line 2 indicates that plate 180 of Figs. 19-21 is identical to plate 140 in Figs. 16-18 except for 180 is narrow, has an opposite orientation, and has a flange 182) for use on a distal radius (abstract) comprising: a substantially rigid plate (180, Figs. 19-21) including an elongated body portion (142) having proximal and distal ends (upper and lower ends, respectively, as shown in Fig. 19, Fig. 19); said plate including a bone contacting surface (150, Fig. 20, col. 11 lines 18-20) and an opposite surface (152, Fig. 20, col. 10 line 24); said plate including a plurality of head portions (164, 166/182, Figs. 19-21,col. 10 lines 51-59 and col. 11 line 66 – col. 12 line 1) connected to the distal end of said body portion (Fig. 19); each of said head portions includes at least one hole (172, Fig. 19, col. 10 line 62) capable of receiving bone fasteners (Fig. 19, col. 10 line 62); said body portion including at least one anchoring hole (158, Fig. 19, col. 11 lines 5-6); wherein a bone contacting surface of said body portion is cylindrically concave (col. 11 lines 18-20) in relation to a longitudinal axis of the body portion (col. 11 lines 18-20); wherein a bone contacting surface of at least one of the head portions is concave (surface of portion 182 as shown in Figs. 20 and 21, Figs. 20 and 21, col. 11 line 67 – col. 12 line 1, col. 12 lines 19-21; where col. 11 line 67 – col. 12 line 1 discloses that 182 facilitates matching the curvature of the distal radius, col. 12 lines 19-21 disclose that 182 gives more support to maintaining the reduction of the styloid process) and a bone contacting surface of at least one other of the head portions is substantially flat (surface of portion 164 as shown in Figs. 20 and 21, Figs. 20 and 21).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the bone contacting surface of at least one of the head portions as disclosed by Meyer to be concave as taught by Esser in order to provide a contoured surface for abutting the surface of the distal radius (Esser col. 12 lines 14-16) and matching the curvature of the distal radius (Esser col. 11 line 67 – col. 12 line 1) to support maintaining the reduction of the styloid process (Esser col. 12 lines 19-21), i.e. to match the portion of the bone surface that the bone contacting surface is configured to abut.
As to claim 7, the combination of Meyer and Esser discloses the invention of claim 1 and appears to show that each of said head portions is distally angled upwards between 10 and 30 degrees relative to the body portion (cross-sections of A-A and B-B of Fig. 2, Fig. 2).
The combination of Meyer and Esser is silent to an express disclosure of each of said head portions being distally angled upwards between 10 and 30 degrees relative to the body portion.
Esser further teaches that each of said head portions is distally angled upwards between 10 and 30 degrees relative to the body portion (Fig. 20, col. 12 lines 3-5; where col. 12 lines 3-5 disclose that the head portions preferably extend at an angle of about 160 degrees with respect to the plate of the body portion 142, i.e. that the head portion is angled about 20 degrees relative to the body portion).
One of ordinary skill in the art at the time of the invention would have been motivated to clarify/specify that each of said head portions as disclosed by the combination of Meyer and Esser is distally angled upwards between 10 and 30 degrees relative to the body portion as taught by Esser in order to raise the head portions to result in better conformity with the shape of the distal radius (Esser col. 12 lines 6-8) to provide a contoured surface for abutting the surface of the distal radius (Esser col. 12 lines 14-16) and matching the curvature of the distal radius (Esser col. 11 line 67 – col. 12 line 1), i.e. to match the portion of the bone surface that the bone contacting surfaces are configured to abut.
As to claim 6, Meyer discloses a fracture fixation plate (Figs. 2 and 3, ¶35; where ¶35 disclose that Fig. 3 has the longitudinal axes of the sections 11 approximately corresponding to an arc, i.e. not including the angle in Fig. 2) for use on a distal radius (¶24) comprising: a substantially rigid plate (Fig. 3) including an elongated body portion (1) having proximal and distal ends (upper and lower ends, respectively, as shown in Fig. 3, Fig. 3); said plate including a bone contacting surface (right-facing surface of Fig. 2 cross-section of portion 1, Fig. 2) and an opposite surface (left-facing surface of Fig. 2 cross-section of portion 1, Fig. 2); said plate including a plurality of head portions (11s) independently connected to the distal end of said body portion by a corresponding plurality of neck portions (10s, Fig. 3); each of said head portions including a plurality of threaded holes (9s, Figs. 2 and 3, ¶28) capable of receiving bone fasteners (Fig. 2, ¶19); each of said threaded holes defining a bone fastener axis (Figs. 2 and 3); said body portion including at least one anchoring hole (2s, 3, Fig. 3); wherein at least one of said neck portions has a lateral width different from a lateral width of at least one other neck portion (Fig. 3); wherein a bone contacting surface of at least one of the head portions (Fig. 2 cross-section of 11s, Fig. 2) and a bone contacting surface of at least one other of the head portions is substantially flat (Fig. 2 cross-section of 11s, Fig. 2).
Meyer is silent to the bone contacting surface of at least one of the head portions is concave.
Esser teaches a similar fracture fixation plate (Figs. 19-21, abstract, col. 11 lines 58-66; where col. 11 line 58 – col. 12 line 2 indicates that plate 180 of Figs. 19-21 is identical to plate 140 in Figs. 16-18 except for 180 is narrow, has an opposite orientation, and has a flange 182) for use on a distal radius (abstract) comprising: a substantially rigid plate (180, Figs. 19-21) including an elongated body portion (142) having proximal and distal ends (upper and lower ends, respectively, as shown in Fig. 19, Fig. 19); said plate including a bone contacting surface (150, Fig. 20, col. 11 lines 18-20) and an opposite surface (152, Fig. 20, col. 10 line 24); said plate including a plurality of head portions (164, 166/182, Figs. 19-21,col. 10 lines 51-59 and col. 11 line 66 – col. 12 line 1) connected to the distal end of said body portion (Fig. 19); each of said head portions includes at least one hole (172, Fig. 19, col. 10 line 62) capable of receiving bone fasteners (Fig. 19, col. 10 line 62); said body portion including at least one anchoring hole (158, Fig. 19, col. 11 lines 5-6); wherein a bone contacting surface of said body portion is cylindrically concave (col. 11 lines 18-20) in relation to a longitudinal axis of the body portion (col. 11 lines 18-20); wherein a bone contacting surface of at least one of the head portions is concave (surface of portion 182 as shown in Figs. 20 and 21, Figs. 20 and 21, col. 11 line 67 – col. 12 line 1, col. 12 lines 19-21; where col. 11 line 67 – col. 12 line 1 discloses that 182 facilitates matching the curvature of the distal radius, col. 12 lines 19-21 disclose that 182 gives more support to maintaining the reduction of the styloid process) and a bone contacting surface of at least one other of the head portions is substantially flat (surface of portion 164 as shown in Figs. 20 and 21, Figs. 20 and 21).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the bone contacting surface of at least one of the head portions as disclosed by Meyer to be concave as taught by Esser in order to provide a contoured surface for abutting the surface of the distal radius (Esser col. 12 lines 14-16) and matching the curvature of the distal radius (Esser col. 11 line 67 – col. 12 line 1) to support maintaining the reduction of the styloid process (Esser col. 12 lines 19-21), i.e. to match the portion of the bone surface that the bone contacting surface is configured to abut.
Claim(s) 11 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Meyer and Esser in view of Orbay et al. (US 2007/0233111, hereinafter “Orbay”).
As to claim 11, the combination of Meyer and Esser discloses the invention of claim 1 as well as wherein each of said head portions is capable of adjusting (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy) via adjustment of each corresponding neck portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy) with respect to a separation from another head portion of said head portions (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy), an elevation relative to the bone contacting surface of said body portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy), and rotationally around a longitudinal axis of the corresponding neck portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy). That is, Meyer discloses that the neck allows remodeling depending on a specific fracture/fragments as well as construction of 1-3mm thick implant steel, titanium, or titanium alloy (¶s 20, 36, and 40). Accordingly, such is capable of adjusting as claimed due to the bendability of the metals disclosed and would be done to allows remodeling depending on a specific fracture/fragments as disclosed.
The combination of Meyer and Esser is silent to does not expressly disclose a step of adjusting the separation of the heads, the elevation relative to the bone, or rotation around the neck, which is not claimed. Nonetheless, Examiner notes that such is well-known in the art and has provided an exemplary teaching as follows.
Orbay teaches a similar fracture fixation plate (500, Figs. 13, 14, and 16-19, ¶76 discloses that the plate may be Y-shaped) comprising: a substantially rigid plate (Figs. 13, 14, and 16-19) including an elongated body portion (left portion as shown in Fig. 14, Fig. 14) having proximal and distal ends (left and right ends, respectively, as shown in Fig. 14, Fig. 14); said plate including a bone contacting surface (lower-facing surface of Fig. 13, Fig. 13) and an opposite surface (upper-facing surface of Fig. 13, Fig. 13); said plate including at least one head portion (504, ¶76 discloses that the plate may be Y-shaped) independently connected to the distal end of said body portion by at least one corresponding neck portion (506, Figs. 13 and 14, ¶76 discloses that the plate may be Y-shaped); each of said head portion including a threaded hole (502, Figs. 13 and 14, ¶77) capable of receiving bone fasteners (“fixed angle fasteners” of ¶73, ¶73); each of said threaded holes defining a bone fastener axis (Figs. 13 and 14, ¶73); said body portion including at least one anchoring hole (502, Figs. 13 and 14, ¶77); wherein said head portion is capable of adjusting (Figs. 16-19, ¶s 76-84) via adjustment of each corresponding neck portion (Figs. 16-19, ¶s 76-84 with respect to a lateral separation (Figs. 17 and 18, ¶s 76-79 and 81), an elevation relative to the bone contacting surface of said body portion (Figs. 19, ¶s 76, 79, and 82), and rotationally around a longitudinal axis of the corresponding neck portion (Fig. 16, ¶s 76, 79, and 80).
One of ordinary skill in the art at the time of the invention would have been motivated to clarify that the thin, metal neck portions that appear to be adjustable as disclosed by the combination of Meyer and Esser are expressly adjustable laterally, elevationally, and rotationally as taught by Orbay in order to maintain structural integrity and desired stiffness while facilitating bendability to match the plate with a preselected region of bone and/or to a particular injury to the bone (Orbay ¶76) by contouring the plate (Orbay ¶78), i.e. to allow remodeling depending on a specific fracture/fragments (Meyer ¶s 20, 36, and 40).
As to claim 12, the combination of Meyer and Esser discloses the invention of claim 6 as well as wherein each of said head portions is capable of adjusting (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy) via adjustment of each corresponding neck portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy) with respect to a separation from another head portion of said head portions (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy), an elevation relative to the bone contacting surface of said body portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy), and rotationally around a longitudinal axis of the corresponding neck portion (if one so chooses to apply sufficient force, ¶s 20, 36, and 40; where ¶20 discloses construction of implant steel or titanium, ¶36 discloses that the shape of the Y-plate neck 10 allows minor remodeling performance depending on the type of fracture or fragments, and ¶40 discloses construction of 1-3mm thick implant steel, titanium, or titanium alloy). That is, Meyer discloses that the neck allows remodeling depending on a specific fracture/fragments as well as construction of 1-3mm thick implant steel, titanium, or titanium alloy (¶s 20, 36, and 40). Accordingly, such is capable of adjusting as claimed due to the bendability of the metals disclosed and would be done to allows remodeling depending on a specific fracture/fragments as disclosed.
The combination of Meyer and Esser is silent to does not expressly disclose a step of adjusting the separation of the heads, the elevation relative to the bone, or rotation around the neck, which is not claimed. Nonetheless, Examiner notes that such is well-known in the art and has provided an exemplary teaching as follows.
Orbay teaches a similar fracture fixation plate (500, Figs. 13, 14, and 16-19, ¶76 discloses that the plate may be Y-shaped) comprising: a substantially rigid plate (Figs. 13, 14, and 16-19) including an elongated body portion (left portion as shown in Fig. 14, Fig. 14) having proximal and distal ends (left and right ends, respectively, as shown in Fig. 14, Fig. 14); said plate including a bone contacting surface (lower-facing surface of Fig. 13, Fig. 13) and an opposite surface (upper-facing surface of Fig. 13, Fig. 13); said plate including at least one head portion (504, ¶76 discloses that the plate may be Y-shaped) independently connected to the distal end of said body portion by at least one corresponding neck portion (506, Figs. 13 and 14, ¶76 discloses that the plate may be Y-shaped); each of said head portion including a threaded hole (502, Figs. 13 and 14, ¶77) capable of receiving bone fasteners (“fixed angle fasteners” of ¶73, ¶73); each of said threaded holes defining a bone fastener axis (Figs. 13 and 14, ¶73); said body portion including at least one anchoring hole (502, Figs. 13 and 14, ¶77); wherein said head portion is capable of adjusting (Figs. 16-19, ¶s 76-84) via adjustment of each corresponding neck portion (Figs. 16-19, ¶s 76-84 with respect to a lateral separation (Figs. 17 and 18, ¶s 76-79 and 81), an elevation relative to the bone contacting surface of said body portion (Figs. 19, ¶s 76, 79, and 82), and rotationally around a longitudinal axis of the corresponding neck portion (Fig. 16, ¶s 76, 79, and 80).
One of ordinary skill in the art at the time of the invention would have been motivated to clarify that the thin, metal neck portions that appear to be adjustable as disclosed by the combination of Meyer and Esser are expressly adjustable laterally, elevationally, and rotationally as taught by Orbay in order to maintain structural integrity and desired stiffness while facilitating bendability to match the plate with a preselected region of bone and/or to a particular injury to the bone (Orbay ¶76) by contouring the plate (Orbay ¶78), i.e. to allow remodeling depending on a specific fracture/fragments (Meyer ¶s 20, 36, and 40).
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 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