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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 02 March 2026. As directed by the amendment: Claims 2, 3, 18, 19, 23, and 37 have been amended, claims 7, 12, 14, 15, 17, 21, 31, and 33-35 are cancelled, and claims 38-40 are newly added. Claims 1-6, 8-11, 13, 16, 18-20, 22-30, 32, and 36-40 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn.
The rejections under 35 U.S.C. 112(a) have not been addressed and are repeated below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are accordingly withdrawn. The current claim amendments have necessitated further rejections under 35 U.S.C. 112(b) which are provided below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by Meller (US 7,033,359) have been fully considered but they are not persuasive. Applicant contends that Meller fails to disclose a burr but rather discloses a drill bit 20, in which only the flutes at the tip form cutting edges on the bottom end. In other words, in Meller, the cutting edges are on the bottom end of the drill bit, not on the circumference of the drill bit, and therefore drilling occurs only at the bottom end of the drill bit and the drill bit can be used only along the axis of rotation. Examiner respectfully submits that, even if Meller is interpreted such that Meller’s tool head only has cutting edges on the bottom end, this bottom end comprises a conical tip so that any cutting edges on the bottom end/conical tip are also about the circumference at the conical tip. In other words, because the tip is conical, any cutting edges thereon would face outward and not just downward. Therefore, Meller meets the definition from the specification, where a burr has cutting edges on the circumference of the burr head.
Examiner notes that the burr head of the instant invention has a cutting flute/edges that extend around/across the bottom end of the burr head, FIGS. 1 and 3, and not only on the circumference. A burr head appears, then, to be defined by its use, e.g. moving laterally or radially, and not necessarily by the presence or absence of cutting edges on particular portions. Examiner also notes that the flutes along the cylindrical sides or circumference of Meller’s tool head are also capable of cutting a tissue of appropriate hardness, in any direction. Moving the tool head laterally or radially, while the tool head is extended out from the prevention means, would result in cutting of adjacent tissue. Laying the tool head on its side or angled off axis would also result in the side edges cutting tissue of appropriate hardness. While a “drill bit” can be used to remove material along the rotation axis, this is not the only use for a drill bit. Rotating the drill bit and advancing it in any direction or angling the drill bit relative to the tissue would result in other types of cuts, not just along the rotation axis.
Examiner also notes that claims 3 and 23 recite that the burr head processes hard tissue by drilling; therefore, a drill bit as disclosed by Meller, which performs drilling, would meet the claimed limitation of a burr head that performs drilling.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., multi-directional bone removal; a burr that cuts not only axially but also laterally and radially, allowing use in three dimensions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As above, the tool head in Meller is fully capable of such multi-directional bone removal and lateral/radial cutting, based on its various cutting edges and the capability of different tool positioning.
Applicant contends that in Meller, the container 12 is not rotatable because of the rod 42. In other words, the container 12 does not rotate with the drill bit 20, does not reach the cutting depth of the drill bit 20, and surrounds only the non-cutting flutes rather than the cutting edges on the bottom end of the drill bit. As a result, Applicant contends that there is no reason to use the container 12 of Meller with a surgical burr because doing so would render the burr unsatisfactory for its intended purpose because the container would prevent the burr from working in three dimensions. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the prevention means is rotatable; the prevention means rotates with the working means; the prevention means reaches the cutting depth of the working means) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner respectfully submits that claims 2 and 19 require only that the prevention means moves with the working means when the burr is in use. The burr is in use when it is being moved into position over the working site, as part of a positioning step, and the prevention means, as part of the assembled tool, moves with the working means into position. The prevention means being rotatable and rotating with the burr head are not claimed. The prevention means reaching the cutting depth of the burr head is also not claimed. As seen in Meller FIG. 2, the prevention means surrounds the cutting edges on the bottom end when the prevention means is extended. The prevention means can also be retracted to the position of FIG. 3 in which the cutting edges are exposed and the burr is not prevented from working in three dimensions. Examiner notes that even “drilling” along the longitudinal axis is “working in three dimensions” since Meller’s burr head is three-dimensional and would form a three-dimensional hole.
The arguments are substantially the same regarding claim 18, and are addressed as above.
As to claim 27, Applicant contends that the container 12 of Meller does not cover the tip of the drill bit 20, and therefore does not recite that when the prevention means is in the first position, the prevention means provides protection all around the burr head. Examiner respectfully submits that the prevention means in Meller provides protection all around the burr head because it is around all the sides of the burr head, i.e. all around a circumference of the burr head. In the first position of FIG. 2, the prevention means in Meller provides protection even at the distal tip of the burr head since the burr head does not extend past the prevention means. Even in the instant invention, the prevention means does not “cover” the cutting edges. The cutting edges are adjacent to the prevention means, just as in Meller.
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 3 and 23 are rejected under 35 U.S.C. 112(a) 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.
As to claims 3 and 23, the specification is silent as to a burr head (as required by claims 1 and 18) performing drilling or sawing. Rather, the specification recites that a burr can be suitable for cutting, milling, polishing, and/or grinding (originally filed specification, par. [0050]).
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 40 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 40, the limitations “the extended position” and “the retracted position” (line 3) render the claim indefinite because they lack proper antecedent basis in the claims. For examination purpose, the limitations will be interpreted as “the first position” and “the second position”.
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.
Claims 1-6, 8, 9, 11, 13, 16, 18-20, 22-28, 30, 32, and 36 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 7,033,359 to Meller.
As to claim 1, Meller discloses a method of protecting a soft tissue when using a surgical burr to process a hard tissue in a surgical procedure (because the prevention means, by its material properties, is designed to retract when pressed against hard tissue in order to allow the hard tissue to be processed, the prevention means also protects any tissue softer than the hard tissue by not retracting and not allowing its processing), the surgical burr comprising a shank (16), a burr head (20) attached to one end of the shank, and a movable prevention means (26, 28, 30) encircling the burr head (col. 5 / lines 25-29), FIGS. 2-3, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the soft tissue or the hard tissue when the surgical burr is in use, FIG. 2, and a separate, inner member (26) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2) and disposed between the burr head and the outer member (at 30), FIG. 2, the method comprising: selecting a threshold of a predetermined force for the prevention means (the movement of the prevention means is controlled by the spring 54, so that selecting the material of the spring 54, where the material has material properties such as spring constant, determines the threshold of a predetermined force required to deform the spring and move the prevention means); when the surgical burr reaches the hard tissue, a force from the hard tissue is greater than the threshold of the predetermined force (a force from the hard tissue is sufficient to overcome the threshold and deform the spring), which causes the prevention means to move from an extended position, FIG. 2, to a retracted position, FIG. 3, to allow the working means to process the hard tissue (col. 7 / lines 11-35); and when the surgical burr reaches the soft tissue, a force from the soft tissue is less than the threshold of the predetermined force, which causes the prevention means to move from the retracted position to the extended position to prevent the working means from processing the soft tissue (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue).
As to claim 2, Meller discloses the method of claim 1, wherein the prevention means moves with the working means (at least when being moved into position over the working site) when the surgical burr is in use (the surgical burr is in use when it is being moved into position over the working site, as part of a positioning step).
As to claim 3, Meller discloses the method of claim 1, wherein the processing of the hard tissue comprises one or more of cutting, grinding, milling, drilling (drill bit flutes 62), polishing, or sawing.
As to claim 4, Meller discloses the method of claim 1, wherein the hard tissue is selected from one or more of a bone (col. 7 / lines 11-35), a cartilage, a calcified tissue, a tooth, or a foreign object within a patient body.
As to claim 5, Meller discloses the method of claim 1, wherein when the prevention means is in the extended position, the prevention means at least reduces surface contact between the working means and the soft tissue, FIG. 2.
As to claim 6, Meller discloses the method of claim 5, wherein when the prevention means is in the extended position, the prevention means pushes the soft tissue away from the working means (due to the material property of the spring and the intervening physical position of the prevention means).
As to claim 8, Meller discloses the method of claim 1, wherein when the prevention means is in the extended position, the prevention means at least partially covers the working means, FIG. 2.
As to claim 9, Meller discloses the method of claim 1, wherein the prevention means (at distal face of 28) is tilted at an angle to an axis of rotation of the burr head to provide protection all around the burr head as the burr head rotates about the axis of rotation.
As to claim 11, Meller discloses the method of claim 1, wherein the outer member (28 and 30) comprises a rigid material (rigid enough to hold its structure and shape and be pushed against).
As to claim 13, Meller discloses the method of claim 1, wherein the outer member is a moving part, FIGS. 2-3.
As to claim 16, Meller discloses the method of claim 1, further comprising arranging the prevention means in intermediate positions between the extended and retracted positions based on a force applied to the burr head to allow for different processing depths of the hard tissue (intermediate positions up to the maximum compression of spring 54; col. 7 / lines 11-35).
As to claim 18, Meller discloses a method of using a burr to process a first material, the burr comprising a shank (16), a burr head (20) attached to one end of the shank, and a movable prevention means (26, 28, 30) encircling the burr head (col. 5 / lines 25-29), FIGS. 2-3, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the first material when the burr is in use, FIG. 2, and a separate, inner member (26) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2) and disposed between the burr head and the outer member (at 30), FIG. 2, the method comprising: when the burr reaches the first material, a force from the first material is greater than a predetermined force for the prevention means (a force from the hard tissue is sufficient to overcome the predetermined force based on the spring constant and deform the spring to move the prevention means), which causes the prevention means to move from a first position, FIG. 2, to a second position, FIG. 3, to allow the working means to process the first material (col. 7 / lines 11-35); and when the burr reaches a second material adjacent the first material, a force from the second material is less than the predetermined force, which causes the prevention means to move from the second position to the first position to prevent the working means from processing the second material (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue/second material would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue/second material).
As to claim 19, Meller discloses the method of claim 18, wherein the prevention means moves with the working means (at least when being moved into position over the working site) when the burr is in use (the burr is in use when it is being moved into position over the working site, as part of a positioning step).
As to claim 20, Meller discloses the method of claim 18, wherein when the prevention means is in the first position, the prevention means prevents the working means from contacting the first and second materials (before applying pressure to the working part and prevention means).
As to claim 22, Meller discloses the method of claim 18, further comprising arranging the prevention means in intermediate positions between the first and second positions based on a force applied to the burr head to allow for different processing depths of the first material (intermediate positions up to the maximum compression of spring 54; col. 7 / lines 11-35).
As to claim 23, Meller discloses the method of claim 18, wherein the processing of the first material comprises one or more of cutting, grinding, milling, drilling (drill bit flutes 62), polishing, or sawing.
As to claim 24, Meller discloses the method of claim 18, wherein the first material is selected from one or more of a bone (col. 7 / lines 11-35), a cartilage, a calcified tissue, a tooth, or a foreign object within a patient body.
As to claim 25, Meller discloses the method of claim 18, wherein when the prevention means is in the first position, the prevention means at least reduces surface contact between the working means and the second material (when adjacent the second softer material, the prevention means will take the extended first position that reduces surface contact between the working means and the second material because it intervenes between them).
As to claim 26, Meller discloses the method of claim 25, wherein when the prevention means at least reduces the surface contact between the working means and the second material, the prevention means pushes the second material away from the working means (since the second softer material does not meet the predetermined force, so the prevention means takes its extended position that pushes the second material away).
As to claim 27, Meller discloses the method of claim 18, wherein when the prevention means is in the first position, the prevention means provides protection all around the burr head, FIG. 2 (due to its encircling position).
As to claim 28, Meller discloses the method of claim 27, wherein the prevention means (at distal face of 28) is tilted at an angle to an axis of rotation of the burr head to provide the protection all around the burr head as the burr head rotates about the axis of rotation.
As to claim 30, Meller discloses the method of claim 18, wherein the outer member (28 and 30) comprises a rigid material (rigid enough to hold its structure and shape and be pushed against).
As to claim 32, Meller discloses the method of claim 18, wherein the outer member is a moving part, FIGS. 2-3.
As to claim 36, Meller discloses the method of claim 18, wherein the second material is softer than the first material.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 10, 18, and 29 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by Meller, or in the alternative, under 35 U.S.C. 103 as being unpatentable over Meller in view of U.S. Patent No. US 8,794,963 to Lancieux et al. (hereinafter, “Lancieux”).
As to claim 1, Meller discloses a method of protecting a soft tissue when using a surgical burr to process a hard tissue in a surgical procedure (because the prevention means, by its material properties, is designed to retract when pressed against hard tissue in order to allow the hard tissue to be processed, the prevention means also protects any tissue softer than the hard tissue by not retracting and not allowing its processing), the surgical burr comprising a shank (18), a burr head (14) attached to one end of the shank, and a movable prevention means (28, 30, 26, and 54) encircling the burr head, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the soft tissue or the hard tissue when the surgical burr is in use, FIG. 2, and a separate, inner member (26 and 54) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2, and 54 is directly supported by 26 and thus by the burr head via 26) and disposed between the burr head and the outer member, FIG. 2, the method comprising: selecting a threshold of a predetermined force for the prevention means (the movement of the prevention means is controlled by the spring 54, so that selecting the material of prevention means including the spring 54, where the material has material properties such as spring constant, determines the threshold of a predetermined force required to deform the spring and move the prevention means); when the surgical burr reaches the hard tissue, a force from the hard tissue is greater than the threshold of the predetermined force (a force from the hard tissue is sufficient to overcome the threshold and deform the spring), which causes the prevention means to move from an extended position, FIG. 2, to a retracted position, FIG. 3, to allow the working means to process the hard tissue (col. 7 / lines 11-35); and when the surgical burr reaches the soft tissue, a force from the soft tissue is less than the threshold of the predetermined force, which causes the prevention means to move from the retracted position to the extended position to prevent the working means from processing the soft tissue (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue).
As to claim 10, Meller discloses the method of claim 1, wherein the inner member (26 and 54) comprises a resilient material (at 54) and is attached to a surface of the burr head (the portion 26 of the inner member is frictionally attached to a surface at the shoulder of the burr head), FIG. 2.
Assuming arguendo, Meller discloses part of the inner member (at 26) is directly supported by the burr head, but does not disclose that the other part of the inner member (at 54) is directly supported by the burr head.
Lancieux teaches a spring (25) that is directly supported by a rod (5c) that is concentrically disposed within the spring, since the spring and rod are complementarily sized such that they contact each other and the spring is thus frictionally attached to an outer surface of the rod.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to size the spring (inner member 54) of Meller and the concentrically received burr head (14) of Meller such that they are complementarily sized and contact each other with the spring sliding along the outer surface of the burr head, since the burr head would provide directional guidance to the spring during compression and relaxation of the spring to prevent kinking and off-axis compression of the spring that may occur with the spring radially spaced from the burr head. In this interpretation, the inner member may be interpreted as comprising the spring (54) alone, which, as modified in view of Lancieux, is directly supported by the burr head due to their concentric contact and is frictionally attached to an outer surface of the burr head, and which comprises a resilient material.
As to claim 18, Meller discloses a method of using a burr to process a first material, the burr comprising a shank (18), a burr head (14) attached to one end of the shank, and a movable prevention means (28, 30, 26, and 54) encircling the burr head, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the first material when the burr is in use, FIG. 2, and a separate, inner member (26 and 54) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2, and 54 is directly supported by 26 and thus by the burr head via 26) and disposed between the burr head and the outer member, FIG. 2, the method comprising: when the burr reaches the first material, a force from the first material is greater than a predetermined force for the prevention means (a force from the hard tissue is sufficient to overcome the predetermined force based on the spring constant and deform the spring to move the prevention means), which causes the prevention means to move from a first position, FIG. 2, to a second position, FIG. 3, to allow the working means to process the first material (col. 7 / lines 11-35); and when the burr reaches a second material adjacent the first material, a force from the second material is less than the predetermined force, which causes the prevention means to move from the second position to the first position to prevent the working means from processing the second material (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue/second material would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue/second material).
As to claim 29, Meller discloses the method of claim 18, wherein the inner member (26 and 54) comprises a resilient material (at 54) and is attached to a surface of the burr head (the portion 26 of the inner member is frictionally attached to a surface at the shoulder of the burr head), FIG. 2.
Assuming arguendo, Meller discloses part of the inner member (at 26) is directly supported by the burr head, but does not disclose that the other part of the inner member (at 54) is directly supported by the burr head.
Lancieux teaches a spring (25) that is directly supported by a rod (5c) that is concentrically disposed within the spring, since the spring and rod are complementarily sized such that they contact each other and the spring is thus frictionally attached to an outer surface of the rod.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to size the spring (inner member 54) of Meller and the concentrically received burr head (14) of Meller such that they are complementarily sized and contact each other with the spring sliding along the outer surface of the burr head, since the burr head would provide directional guidance to the spring during compression and relaxation of the spring to prevent kinking and off-axis compression of the spring that may occur with the spring radially spaced from the burr head. In this interpretation, the inner member may be interpreted as comprising the spring (54) alone, which, as modified in view of Lancieux, is directly supported by the burr head due to their concentric contact and is frictionally attached to an outer surface of the burr head, and which comprises a resilient material.
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Meller in view of U.S. Patent No. US 4,834,655 to Kyotani et al. (hereinafter, “Kyotani”).
As to claim 1, Meller discloses a method of protecting a soft tissue when using a surgical burr to process a hard tissue in a surgical procedure (because the prevention means, by its material properties, is designed to retract when pressed against hard tissue in order to allow the hard tissue to be processed, the prevention means also protects any tissue softer than the hard tissue by not retracting and not allowing its processing), the surgical burr comprising a shank (18), a burr head (14) attached to one end of the shank, and a movable prevention means (28, 30, 26, and 54) encircling the burr head, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the soft tissue or the hard tissue when the surgical burr is in use, FIG. 2, and a separate, inner member (26 and 54) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2, and 54 is directly supported by 26 and thus by the burr head via 26) and disposed between the burr head and the outer member, FIG. 2, the method comprising: selecting a threshold of a predetermined force for the prevention means (the movement of the prevention means is controlled by the spring 54, so that selecting the material of prevention means including the spring 54, where the material has material properties such as spring constant, determines the threshold of a predetermined force required to deform the spring and move the prevention means); when the surgical burr reaches the hard tissue, a force from the hard tissue is greater than the threshold of the predetermined force (a force from the hard tissue is sufficient to overcome the threshold and deform the spring), which causes the prevention means to move from an extended position, FIG. 2, to a retracted position, FIG. 3, to allow the working means to process the hard tissue (col. 7 / lines 11-35); and when the surgical burr reaches the soft tissue, a force from the soft tissue is less than the threshold of the predetermined force, which causes the prevention means to move from the retracted position to the extended position to prevent the working means from processing the soft tissue (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue).
As to claim 37, Meller discloses the method of claim 1, wherein the inner member (at 26) is disposed in an indentation of the burr head (the proximal end of the inner member at 26 is disposed in an indentation of the burr head 14 at the smaller diameter portion of 14 proximal to 20, which is an indentation between 20 and 56), FIG. 2.
Meller is silent as to the burr head is spherically shaped.
In another embodiment, shown in FIG. 5, Meller teaches a surgical burr (78) with blades on its bottom and side surfaces to enable milling in a direction perpendicular to the surface of the bone or in a direction parallel to the surface of the bone (par. [0025], [0053]).
Kyotani teaches that a milling cutter can have a burr head comprising a cylindrical or spherical shape (col. 2 / line 68 – col. 3 / line 2), FIGS. 1-6.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the burr head in the embodiment of FIG. 2 in Meller to be a milling cutter as taught in the second embodiment in Meller, to enable milling in a direction perpendicular to the surface of the bone or in a direction parallel to the surface of the bone, therefore providing flexibility to the apparatus and allowing its use in various circumstances. The burr head would be provided with blades on the bottom and side surfaces. The rest of the apparatus including the movable prevention means would remain as disclosed in the first embodiment, with force applied to press the movable prevention means against the tissue to compress the spring and allow the working means to be exposed and process the tissue, with subsequent movement in either a perpendicular or parallel direction to the tissue.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the burr head to be spherically shaped, since Kyotani teaches that a milling cutter can have a burr head comprising a cylindrical or spherical shape, and a spherical shape would provide smoother edges of the cut tissue while preventing tissue damage that could occur with the edge of a cylindrical burr head.
As to claim 18, Meller discloses a method of using a burr to process a first material, the burr comprising a shank (18), a burr head (14) attached to one end of the shank, and a movable prevention means (28, 30, 26, and 54) encircling the burr head, the burr head comprising a working means (flutes, 62), FIG. 2, the prevention means comprising an outer member (28 and 30) configured to contact (at 28) the first material when the burr is in use, FIG. 2, and a separate, inner member (26 and 54) directly supported by the burr head (proximal end of 26 is directly supported by a shoulder of the burr head, col. 6 / lines 40-46, FIG. 2, and 54 is directly supported by 26 and thus by the burr head via 26) and disposed between the burr head and the outer member, FIG. 2, the method comprising: when the burr reaches the first material, a force from the first material is greater than a predetermined force for the prevention means (a force from the hard tissue is sufficient to overcome the predetermined force based on the spring constant and deform the spring to move the prevention means), which causes the prevention means to move from a first position, FIG. 2, to a second position, FIG. 3, to allow the working means to process the first material (col. 7 / lines 11-35); and when the burr reaches a second material adjacent the first material, a force from the second material is less than the predetermined force, which causes the prevention means to move from the second position to the first position to prevent the working means from processing the second material (these limitations are not positively recited method steps, but rather describe a property of the surgical burr and how it would interact with different tissues based on its material properties; accordingly, because soft tissue is softer than the hard tissue, soft tissue/second material would exert a lesser force and would not compress the spring which would push the prevention means to return to the extended non-compressed position to prevent the working means from processing the soft tissue/second material).
As to claim 39, Meller discloses the method of claim 1, wherein the inner member (at 26) is disposed in an indentation of the burr head (the proximal end of the inner member at 26 is disposed in an indentation of the burr head 14 at the smaller diameter portion of 14 proximal to 20, which is an indentation between 20 and 56), FIG. 2.
Meller is silent as to the burr head is spherically shaped.
In another embodiment, shown in FIG. 5, Meller teaches a surgical burr (78) with blades on its bottom and side surfaces to enable milling in a direction perpendicular to the surface of the bone or in a direction parallel to the surface of the bone (par. [0025], [0053]).
Kyotani teaches that a milling cutter can have a burr head comprising a cylindrical or spherical shape (col. 2 / line 68 – col. 3 / line 2), FIGS. 1-6.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the burr head in the embodiment of FIG. 2 in Meller to be a milling cutter as taught in the second embodiment in Meller, to enable milling in a direction perpendicular to the surface of the bone or in a direction parallel to the surface of the bone, therefore providing flexibility to the apparatus and allowing its use in various circumstances. The burr head would be provided with blades on the bottom and side surfaces. The rest of the apparatus including the movable prevention means would remain as disclosed in the first embodiment, with force applied to press the movable prevention means against the tissue to compress the spring and allow the working means to be exposed and process the tissue, with subsequent movement in either a perpendicular or parallel direction to the tissue.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the burr head to be spherically shaped, since Kyotani teaches that a milling cutter can have a burr head comprising a cylindrical or spherical shape, and a spherical shape would provide smoother edges of the cut tissue while preventing tissue damage that could occur with the edge of a cylindrical burr head.
Allowable Subject Matter
Claim 38 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 40 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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