DETAILED ACTION
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 .
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.
Claims 16-21 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 16 and 21 described the details of the cutting windows 5 as the width of the window being equal or substantially equal to a distance between consecutive teeth, windows separated by three teeth lengths, windows arranged in rows circumferentially on the blade, and the proximal wall of the window is thicker than the distal wall, and wherein the length of the windows is less than the step length. However, in the specification as originally file the following details are provided regarding the windows: “a number of windows 5 are cut through the full thickness of the saw blade” (Para. [0039]); and “[w]indows 205 facilitate bone debris removal produced by the leading edge teeth 203” (para. [0048]). As can be seen from the paragraphs provided in the specification, there is minimal details as to the specifics of the window construction in relation to size and shape, instead applicant appears to be relying solely on Fig. 4-5 as evidentiary support for the new limitations. However, it is well established that patent drawings alone cannot define the precise proportions of specific elements and may not be relied on to show particular sizes unless the specification recites that the drawings are to scale. Therefore, based on these arguments the claims are deemed new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 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, 5-7, 11-12, 17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidebotham et al (US Patent Pub. 20180125503A1) in view of Anderson (US Patent 8939981B1) and Souza et al (US Patent Pub. 20090044679A1).
Sidebotham discloses an oscillating saw blade adapted for bone surgery. Specifically in regards to claim 1 and 19-20, Sidebotham recites a saw blade (100) wherein a thickness of the saw blade (100) increases from a saw blade leading edge (110) at a lower end of the saw blade (100) towards an upper end of the saw blade (100), wherein the blade (100) is of curved shape (Fig. 14a; and Para. [0069],[0076]). However, the reference is silent as to the thickness changing in steps or each step having cutting teeth, or wherein the blade has windows with cutting teeth therein.
Anderson discloses an oscillating saw blade adapted for bone surgery. Specifically in regards to claim 1 and 19-20, Anderson recites a saw blade (12) wherein its thickness increases from the leading edge (14) at its lower end towards its upper end, and wherein its thickness increases stepwise with cutting teeth at leading edges of each step (Fig. 1-8; and Col. 2 line 40 to 67, Col. 3 lines 1-11). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the wedge shape of the blade (100) of Sidebotham adding steps with cutting teeth as taught in Anderson in order to create precise, reproducible, and predictable wedge osteotomies (Col. 1 lines 33-34). However, the reference is silent as the blade having windows with cutting teeth therein.
Souza recites a saw blade capable of being used for surgery. Specifically in regards to claim 1, Souza recites a saw blade (70) having a leading edge (74) with teeth therein and wherein the saw blade (70) further comprises windows (windows with 76) along the leading edge for facilitating bone debris removal; and wherein the windows (windows with 76) are at least partially defined by cutting teeth (76), and a proximal portion of each window is bordered by cutting teeth (76) (Fig. 7’ and Para. [0031]). In regards to claim 19, Souza recites wherein the windows (window with 76) are arranged in rows, and rows are circumferentially offset from each other on the saw blade (Fig. 7). In regards to claim 20, Souza recites wherein each window comprises proximal and distal walls, and a thickness of the proximal is greater than the distal wall (If the blade is modified to have the windows as recited in Souza the windows would have the same increasing thickness shape as described above.). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the leading edge and each step edge of the blade (100) of Sidebotham by adding windows with cutting teeth as taught in Souza in order to obtain a smoother cutting surface to make a finer and more finished cut (Para. [0022]).
In regards to claim 5 and 11, Sidebotham recites wherein the curved shape is adapted for use in a Tibial Plateau Leveling Osteotomy TPLO procedure, and recites cutting a bone with the saw blade of claim 1 (The recitation of a osteotomy procedures is being interpreted as an intended use recitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case the blade of Sidebotham is capable of being used in the osteotomy procedures.) (Fig 14a).
In regards to claim 6, Sidebotham recites wherein the blade (100) thickness at the saw blade leading edge (110) is uniform while the blade thickness increases in steps away from the leading edge but not along its longitudinal edges (112/114) (Fig. 14a).
In regards to claim 7, Sidebotham recites where the shape of the cross-section at a trailing end (108) of the blade (100) is of biradial, Slocum type, and wherein the blade further comprises a concave and convex surfaces with the radius of curvature of the concave surface equal to the radius of curvature of the convex surface (As seen in Fig. 14a the blade has concave/convex surfaces (Fig. 14a; and Para. [0070],[0076]).
In regards to claim 12, Sidebotham recites wherein the curved shape is adapted for cutting a bone with the saw blade of claim 7 (The recitation of a osteotomy procedures is being interpreted as an intended use recitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case the blade of Sidebotham is capable of being used in the osteotomy procedures.) (Fig. 14a).
In regards to claim 17, Sidebotham in view of Anderson and Souza recite an oscillating saw blade adapted for bone surgery having a curved shape and windows in the blade whose thickness increases in a stepped manner with teeth at every leading edge. However, the references are silent as to three teeth separating each window. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the blade of Sidebotham to have the windows spaced by three teeth since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Souza.
Anderson discloses an oscillating saw blade adapted for bone surgery. Specifically in regards to claim 8, Anderson recites wherein the blade is planar, wherein a thickness of the blade (Fig. 8) increases from a leading edge at (14) a lower end of the blade towards an upper end of the blade, wherein the leading edge (14) is of a radius (R) around an axis and provided with cutting teeth, and wherein the thickness of the blade increases in a step-wise manner (Fig. 5) from the leading edge (14) (Fig. 5 and 8; and Col. 2 lines 40-61). However, the reference is silent as the blade having windows with cutting teeth therein.
Souza recites a saw blade capable of being used for surgery. Specifically in regards to claim 8, Souza recites a saw blade (70) having a leading edge (74) with teeth therein and wherein the saw blade (70) further comprises windows (windows with 76) along the leading edge for facilitating bone debris removal; and wherein the windows (windows with 76) are at least partially defined by cutting teeth (76), and a proximal portion of each window is bordered by cutting teeth (76) (Fig. 7’ and Para. [0031]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the leading edge and each step edge of the blade of Anderson by adding windows with cutting teeth as taught in Souza in order to obtain a smoother cutting surface to make a finer and more finished cut (Para. [0022]).
Claim(s) 9 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidebotham in view of Anderson and Souza as applied to claims 1 and 2 above, and further in view of in view of Oakes (US Patent 3758222).
Sidebotham in view of Anderson and Souza recites an oscillating saw blade adapted for bone surgery having a curved shape and windows in the blade whose thickness increases in a stepped manner with teeth at every leading edge. However, the reference is silent as to the incremental step height.
Oakes discloses a blade. Specifically in regards to claims 9, Oakes recites a blade (10) whose thickness increases step-wise, and wherein the steps are in the range of 0.1 to 1.0 mm (Oaks recites wherein each of the steps 13-24 increase by increments of 1/32in, 0.79375mm.) (Fig. 1, and Col. 2 line 7-13). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the steps of Sidebotham to have an incremental height increase in the range of .1-1mm as taught in Oakes in order to have a device that a is continuous and uninterrupted and thus gives maximum bearing surface for each formation in the cutting being formed and also during the beginning entry of the next formation into the work (Col. 1 lines 29-38).
In regards to claims 13-14, Sidebotham in view of Anderson and Oakes disclose an oscillating saw blade adapted for bone surgery having a curved shape and windows in the blade whose thickness increases in a stepped manner with teeth at every leading edge. However, the reference is silent as to the incremental step height being in the range of 0.3-0.5mm or 0.04mm. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by making the height increase of the blade (100) of Sidebotham be in steps in the range of 0.3-0.5mm, or in the range is of 0.04mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art.
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sidebotham in view of Anderson and Souza and further in view of Cundiff et al (US Patent Pub. 20210000486A1).
Sidebotham in view of Anderson and Souza discloses disclose an oscillating saw blade adapted for bone surgery having a curved shape and windows in the blade as recited above. However, the reference is silent as to the angle corresponding to the thickness increase.
Cundiff discloses a saw blade. Specifically in regards to claim 10 and 15, Cundiff recites a saw blade (100) whose thickness increases from leading to trailing edge, and wherein the angle (θ) corresponding to the increase in thickness is in the range of 2 to 10 degrees, or an angle of 5 degrees (Cundiff recites the slope 118 includes a grade in the range of about zero degrees (0° or flat) to about fifteen degrees (15°) defined between the top surface 106 and the bottom surface 104 beginning at the distal end 108 and extending upward and toward the proximate end 110, as shown in FIGS. 1C and 1D. In some embodiments, the slope 118 includes a grade of about seven (7°) degrees (e.g., the angle θ=7° or (e.g., the angle θ=0°, 1°, 2°, 3°, 4°, 5°, 6°, 7° 8°, 9° 10°, 11°, 12°, 13°, 14°, or 15° among other suitable grades and/or slopes that are possible and contemplated herein.) (Fig. 1c-1d; and Para. [0026]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the angle of the blade of Sidebotham to have an incremental height increase in the range of 2-10 degrees, or 5 degrees as taught in Cundiff in order to have a blade with a suitable grade (e.g., rise over run) that can facilitate and/or assist the surgical instrument in performing an osteotomy and particularly, a wedge-shaped osteotomy in one cut and/or one pass (Para. [0025]).
Response to Arguments
Applicant’s arguments filed on 1/7/26 with respect to the claims have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775