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 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 19-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 19-20 are rejected for the recitation of “a plurality of helical flutes” in lines 1-2. This is indefinite since claim 14 from which they both depend recites a plurality of helical flutes in lines 6-7. Therefore, it is unclear if the flutes recited in claims 19-20 refer to new flutes or a further clarification of the same flutes. In the interest in compact prosecution the flutes will be interpreted as a further clarification.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 14-20, 26, 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huwais (WO2020/210442A1).
Huwais recites precision cutting tool for creating a large diameter burr hole in a patient. Specifically in regards to claim 14, Huwais recites a proximal end (end with 26) opposite a distal end (end with 46), with a body (24) extending between the proximal end and the distal end (Fig. 1-2); a cutting structure (structure on 24), the cutting structure including: a plurality of helical flutes (32) extending along at least a portion of the body (24) of the precision cutting tool (20) (fig. 5; and Para. [0031]-[0032]); a plurality of radial cutting edges (40) extending outwardly in a radial direction, each of the plurality of radial cutting edges (40) connected to one of the plurality of helical flutes (32) (Fig. 5 and Para. [0031]-[0032]); a plurality of nose cutting blades (48) extending outwardly in a distal direction at the distal end (end with 46) of the precision cutting tool (20), each of the plurality of nose cutting blades (48) connected to one of the plurality of helical flutes (32) (Fig. 5; and Para. [0042]). Wherein the plurality of radial cutting edges (40) and the plurality of nose cutting blades (48) are configured to remove an amount of material from a bone of the patient to create an implantation hole (Para. [0031], [0042], [0050], [0058]-[0061], Fig. 7a-7h).
In regards to claim 15 and 17-18, Huwais recites wherein the precision cutting tool (20) includes at least five radial cutting edges (40) and at least five helical flutes (32), wherein the plurality of radial cutting edges (40) includes five or more radial cutting edges (40), or wherein the plurality of nose cutting edges (48) includes five or more nose cutting edges (48) (Huwais recites wherein the burr is capable of having more than 4 spurs and flutes.) (Para. [0041],[0050]).
In regards to claim 16, Huwais recites a centrally recessed region (44) disposed in the distal end of the precision cutting tool (20) (Fig. 2).
In regards to claim 19-20, Huwais recites a plurality of helical flutes (32), each of the plurality of helical flutes (32) connected one of the plurality of radial cutting edges (40), and a plurality of helical flutes (32), each of the plurality of helical flutes (32) connected one of the plurality of nose cutting edges (48) (Fig. 5).
In regards to claim 26, Huwais recites a safety stop at a predetermined location from the distal end (end with 46) of the precision cutting tool (20) thereby establishing a maximum penetration depth of the precision cutting tool (20) (Fig. 1-2; and Para. [0026]).
In regards to claim 28, Huwais recites wherein the proximal end (end with 26) is secured to or attachable to a rotatable connection on a drill (Fig. 1-2; and Para. [0026]).
In regards to claim 29, Huwais recites a method of conditioning a large diameter burr hole in a patient. Specifically, Huwais recites the method comprising: conditioning an initial hole in the patient to create an implantation hole, wherein conditioning includes rotating a precision cutting tool within the initial hole (Fig. 7a-7h; and Para. [0058]-[0061]). The precision cutting tool (20) including: a proximal end (end with 26) opposite a distal end (end with 46), with a body (24) extending between the proximal end and the distal end (Fig. 1-2); a cutting structure (structure on 24), the cutting structure including: a plurality of helical flutes (32) extending along at least a portion of the body (24) (fig. 5; and Para. [0031]-[0032]); a plurality of radial cutting edges (40) extending outwardly in a radial direction, each of the plurality of radial cutting edges (40) connected to one of the plurality of helical flutes (32) (Fig. 5 and Para. [0031]-[0032]); a plurality of nose cutting blades (48) extending outwardly in a distal direction at the distal end (end with 46) of the precision cutting tool (20), each of the plurality of nose cutting blades (48) connected to one of the plurality of helical flutes (32) (Fig. 5; and Para. [0042]). Wherein the plurality of radial cutting edges (40) and the plurality of nose cutting blades (48) are configured to remove an amount of material from a bone of the patient to create an implantation hole (Para. [0031], [0042], [0050], [0058]-[0061], Fig. 7a-7h).
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.
Claim(s) 1-3, 5, 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huwais (WO2020/210442A1).
Huwais recites a surgical instrument for conditioning a large diameter burr hole in a patient. Specifically in regards to claim 1, Huwais recites a surgical instrument (20) comprising: a proximal end (end with 26) opposite a distal end (end with 46), with a body (24) extending between the proximal end and the distal end (Fig. 1-2); a cutting structure (structure on 24) proximate the distal end (end with 46), the cutting structure including: a plurality of radial cutting edges (40), each of the plurality of radial cutting edges (40) extending outwardly in a radial direction (fig. 5; and Para. [0031]-[0032]); a plurality of nose cutting edges (48), each of the plurality of nose cutting edges (48) extending outwardly in a distal direction at the distal end (end with 46) of the surgical instrument (20) (Fig. 5; and Para. [0042]). However, the reference is silent as to an outer diameter greater than or equal to approximately 7 mm. It would have been obvious to one having ordinay skill in the art at the time of the invention was filed to modify the diameter of the tool to be 7mm; since it has been held that discovering an optimum value of a result effective variable involves, only routine skill in the art. Huwais also recites that diameter of the tool can be incrementally expanded as the osteotomy is progressively made wider until a final intended diameter is achieved thereby allowing for the tool to be modified to be 7mm (Para. [0055]).
In regards to claim 2, Huwais recites a centrally recessed (44) region disposed in the distal end of the surgical instrument (20) (Fig. 2).
In regards to claim 3, Huwais wherein the plurality of radial cutting edges (40) and plurality of nose cutting edges (48) includes five or more radial cutting edges (Huwais recites wherein the burr is capable of having more than 4 spurs and flutes.) (Para. [0041],[0050]).
In regards to claim 5, Huwais recites a plurality of helical flutes (32), each of the plurality of helical flutes connected to one of the plurality of radial cutting edges (40) or one of the plurality of nose cutting edges (48) (Fig. 5).
In regards to claim 7, Huwais recites wherein each of the radial cutting edges (40) includes a rake angle between approximately -20° and approximately 20° ( Huwais recites that the pitch of the rake angle fluctuates along the length of each flute 32 with a variance of less than 30 degrees with a regressive pitch that become flatter.) (Para. [0033]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the range of rake angle between approximately -20° and approximately 20° 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.
In regards to claim 8, Huwais recites wherein each of the radial cutting edges (40) includes a relief angle between approximately 3° and approximately 30° (Huwais recites that the cutting flutes 32 taper along the length in the range of 1-5 degrees, more preferably at 2-3 degrees, or 2 degree 36’.) (Para. [0028]).
In regards to claim 9, Huwais recites wherein each of the nose cutting edges (48) includes a rake angle between approximately -20° and approximately 20°( Huwais recites that the angle between the leading and trailing flanks (B+C) shown in fig. 6 at the grinding edge 48 is between 90-100 degrees and is generally equally set so that each flank angle 30,32 away from a normal plane about the same degree.) (Para. [0043]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the range of rake angle between approximately -20° and approximately 20° 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.
In regards to claim 10, Huwais recites wherein each of the nose cutting edges (48) includes at least one relief surface having a relief angle between approximately 3° and approximately 45°( Huwais recites that the angle between the leading and trailing flanks (B+C) shown in fig. 6 at the grinding edge 48 is between 90-100 degrees and is generally equally set so that each flank angle 30,32 away from a normal plane about the same degree.) (Para. [0043]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the range of relief angle between approximately 3° and approximately 45°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.
In regards to claim 11, Huwais recites a safety stop at a predetermined location from the distal end (end with 46) of the precision cutting tool (20) thereby establishing a maximum penetration depth of the precision cutting tool (20) (Fig. 1-2; and Para. [0026]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huwais (WO2020/210442A1) in view of Huwais (WO2018/071863A1, referred herein as Huwais2).
Huwais recites a precision cutting tool having proximal end opposite a distal end, with a body extending from between the proximal end and the distal end; a cutting structure, the cutting structure including: a plurality of helical flutes; a plurality of radial cutting edges; and a plurality of nose cutting blades; wherein the plurality of radial cutting edges and the plurality of nose cutting blades are configured to remove an amount of material from a bone of the patient to create an implantation hole.
Huwais2 recites precision cutting tool for creating a large diameter burr hole in a patient. Specifically in regards to claim 27, Huwais2 recites a precision cutting tool (36) further including a safety stop (54), wherein the safety stop (54) is a distal end of a removable cover when the removable cover is securely attached to the precision cutting tool (36) (Fig. 6-8; and Para. [0049]-[0052]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the tool (20) of Huwais by adding a stop as taught in Huwais2 in order to have an improved stop element that prohibits insertion of a surgical drilling tool or bur into the bone tissue beyond a predetermined depth, and which can be used conveniently in combination with a jig for guided surgery (Para. [0013]).
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 . SHIRSAT
Primary Examiner
Art Unit 3775
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