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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 November 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 28 October 2025. As directed by the amendment: claims 17 and 25 have been amended, claims 1-16, 18, 19, 23, and 32 are cancelled, claims 20-22, 24, 31, 33, and 34 are withdrawn, and claims 35-39 are newly added. Claims 17, 20-22, 24-31, and 33-39 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections, which are accordingly withdrawn.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) listed in the previous Office Action, which are accordingly withdrawn. However, a further rejection under 35 U.S.C. 112(b) has been necessitated by the current claim amendments.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) and 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 25 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 25, the limitation “between opposite surfaces of the cutter head” renders the claim indefinite because it is unclear if the opposite surfaces refer back to the first and second flat surfaces previously recited in claim 17, or to different opposite surfaces. For examination purposes, the limitation will be interpreted in the former instance, as between the first flat surface and the second flat surface.
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 17, 28-30, 35, 36, and 39 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 5,626,446 to Ching.
As to claim 17, Ching discloses a surgical milling cutter, FIGS. 1-3, comprising: a shaft (18) coupled to a drive unit (30) about a rotational axis, FIG. 1, the rotational axis extending in a longitudinal direction of the shaft; and a cutter head (12) arranged distally on the shaft, the cutter head comprising at least two teeth (left side and right side of 12), FIGS. 1-3, each of the at least two teeth comprising a cutting edge (44/56; 48/60) for rotationally removing tissue, the cutting edges each configured to remove tissue both in a distal direction and in a lateral direction (bottom and side cutting edges; col. 2 / lines 5-11; col. 3 / line 43 – col. 4 / line 49), the at least two teeth separated from one another by a chip space (negative space along back face 38) that forms a clearance in a circumferential direction, FIG. 2, the at least two teeth or cutting edges being non-helical and twist-free, FIG. 1, the chip space extending on a side of the rotational axis facing one of the cutting edges from the cutting edge into a region on a side of the rotational axis facing away from said one of the cutting edges, FIG. 2, the at least two teeth lying transversely to the rotational axis diametrically opposite each other without offset, FIG. 2, the at least two teeth being formed such that a front surface of one tooth (left half of 38 of left tooth) and a rear surface of the other tooth (right half of 38 of right tooth) together form a first flat surface (38; col. 3 / lines 31-33), FIG. 2, and a rear surface of the one tooth (left half of 36 of left tooth) and a front surface of the other tooth (right half of 36 of right tooth) together form a second flat surface (36), the cutting edges each being arcuate from distal-radial-inward to proximal-radial-outward to form a widest point of the cutter head and forming an arc (at sides of 22; the cutting edges are considered to extend along the sides of 22 to the shaft 18 because any outwardly facing edge is fully capable of cutting a relatively softer material) towards proximal-radial-inward in a proximal direction towards the shaft, FIG. 1, and the chip space being formed between the front surface of the one tooth and the rear surface of the other tooth comprises an angle of 180 degrees, FIG. 2.
As to claim 28, Ching discloses the surgical milling cutter according to claim 17, wherein each cutting edge has a rake angle of 0°, FIG. 2.
As to claim 29, Ching discloses the surgical milling cutter according to claim 17, wherein the cutter head has a tip (66) with a tip angle of 90° to 160° at its distal end (the tip angle relative to 38 is 135°), FIG. 3.
As to claim 30, Ching discloses the surgical milling cutter according to claim 17, wherein the surgical milling cutter is rotationally symmetrical to the rotational axis, FIG. 2.
As to claim 35, Ching discloses the surgical milling cutter according to claim 17, wherein a second chip space (negative space along back face 36) is formed between the front surface of the other tooth and the rear surface of the one tooth and the second chip space comprises an angle of 180 degrees, FIG. 2.
As to claim 36, Ching discloses the surgical milling cutter according to claim 17, wherein the first flat surface is spaced from the second flat surface by a cutter-head thickness, and the shaft has a shaft diameter about the rotational axis, the shaft diameter being greater than the cutter-head thickness, FIG. 3.
As to claim 39, Ching discloses the surgical milling cutter according to claim 17, wherein the at least two teeth are formed such that the entire front surface of the one tooth and the entire rear surface of the other tooth together form the first flat surface, and the entire rear surface of the one tooth and the entire front surface of the other tooth together form the second flat surface (col. 3 / lines 31-33).
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 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ching.
As to claim 26, Ching discloses a distal thickness of each of the at least two teeth is a fraction of a diameter of the cutter head in a radial direction, FIGS. 1-3, but is silent as to wherein the fraction is between 1/20 and 1/10.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the distal thickness as between 1/20 and 1/10 of a diameter of the cutter head in a radial direction, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and since Ching appears to show approximately this ratio. Even if the dimensions would have to be adjusted to meet the ratio, a slightly thinner cutter head would save material costs and provide precise cutting.
As to claim 27, Ching appears to disclose that each cutting edge has a relief angle of 0° to 30° (relief angle of 40/42 with respect to a surface of the workpiece, i.e. the superior-inferior axis in FIG. 2, is about 30°) along the cutting edge.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the relief angle as between 0° to 30° (e.g. about or slightly less than 30°) since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and since Ching appears to show an angle at the end of this range.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ching in view of U.S. Patent No. US 9,848,894 to Burley et al. (hereinafter, “Burley”).
As to claim 25, Ching is silent as to wherein a thickness of each of the at least two teeth increases with a tooth thickness angle of between 0° to 20° between opposite surfaces of the cutter head from distal to proximal.
Burley teaches a surgical cutter comprising a cutter head comprising two teeth (on either side of the head), FIG. 32, wherein a thickness of each of the at least two teeth increases with a tooth thickness angle of between 0° to 20° between opposite surfaces of the cutter head from distal to proximal.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to increase a thickness of each of the teeth in Ching from distal to proximal, as taught by Burley, to facilitate entry of the cutter into the tissue without damaging the tissue by virtue of the relatively thinner distal tip, while still achieving the desired size of the removed tissue area based on, at least, the diameter of the cutter head and the largest thickness.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a tooth thickness angle of between 0° to 20° between opposite surfaces of the cutter head from distal to proximal since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and since Burley appears to show an angle within this range (slightly less than 20°).
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Ching in view of U.S. Patent Application Publication No. US 2019/0183521 to Li et al. (hereinafter, “Li”).
As to claim 37, Ching discloses wherein each of the first flat surface and the second flat surface transitions into the shaft along a respective transition surface (since the shaft has a greater diameter, there is a transition surface to connect each flat surface to the shaft, along upper portion 22).
As to claim 38, Ching discloses wherein the at least two teeth comprise two teeth defining a circular profile (circular at least at the distal portions) as viewed perpendicular to the rotational axis, FIG. 1.
Ching is silent as to the respective transition surface being concave and having a respective radius as viewed perpendicular to the rotational axis (claim 37); and the respective radius of each respective transition surface corresponds to one half of a diameter of the circular profile (claim 38).
Li teaches a cutter head with a flat surface that transitions into a shaft (2) along a concave transition surface having a respective radius as viewed perpendicular to a longitudinal axis of the tool, FIG. 4.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to transition each of Ching’s flat surfaces into the shaft along a respective concave transition surface to provide a smooth transition from a smaller dimension component (the thickness of the cutter head) to a larger dimension component (the shaft), as taught by Li, to reduce sharp angles between the components that may damage tissue or be subject to mechanical stress and failure. Although Ching does not show a side view of the cutter, the tapered shape of the upper portion (22) appears to provide transition surfaces into the shaft, which transition surfaces must at least not be convex in order to transition from small to large (FIG. 3). In view of Li, these transition surfaces would be made concave for the above reasons. Each concave transition surface would then have a respective radius as viewed perpendicular to the rotational axis (as viewed from the side of the cutter in the perspective of FIG. 4 in Li).
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the respective radius of each respective transition surface correspond to one half of a diameter of the circular profile, i.e. for the curvatures of the transition surfaces and the circular profile to be the same, to provide ease of manufacture and since discovering an optimum value of a result effective variable involves only routine skill in the art.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775