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 29 October 2025. As directed by the amendment: claim 1 has been amended, claims 3 and 5 are cancelled, and claims 10-20 stand withdrawn. Claims 1, 2, 4, and 6-20 currently stand pending in the application.
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive. As to the rejections under 35 U.S.C. 103, Applicant contends that Sommers et al. (US 2019/0105060) discloses recesses that are helical flutes 72 which wrap around stop 190, and that the inner wall of a helical flute is not a planar surface parallel to the drill axis but rather a continuously twisted surface. Applicant contends that the wall that defines cutting edge 80 is not a planar surface but also part of the same spiral. Examiner respectfully submits that Sommers does not disclose the embodiment of FIGS. 26-30 as comprising helical flutes. Sommers discloses that flutes may be helical (as in previous embodiments) or axial (par. [0040]). As is shown in FIGS. 26-30, the flutes are not helical. For comparison, see the helical flutes in FIGS. 1-4. Therefore, as shown in Sommers FIGS. 26-29, the recess is formed by a first planar surface (internal face of 72, shown opposite 80 in FIGS. 26-28, at least and including at its distal edge, where at least the distal edge is planar as shown in FIGS. 28-29 and at least as planar as the instant invention) and a second planar surface (internal face of 80, planar as shown in FIGS. 26-29, and at least as planar as the instant invention).
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., two intersecting planar faces oriented orthogonally, see page 7 of the arguments) 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). These features are not only not recited in the claims, but not supported by the specification as originally filed (see rejections under 35 U.S.C. 112 below).
Examiner also notes that the instant invention does not disclose the recess comprising first and second planar surfaces (see rejections under 35 U.S.C. 112 below). Therefore, Sommers discloses the recess comprising first and second planar surfaces at least as much as the instant invention does.
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 1, 2, 4, and 6-9 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 claim 1, the limitations that the recess comprises a first planar surface and a second planar surface are not supported by the specification as originally filed. The specification does not recite that the recess has any planar surfaces. Although there appears to be a first planar surface (the bottom of the recess, furthest from the cutting edges 24) extending in a plane substantially parallel to the central longitudinal axis (not conceding this point, since the specification does not make clear that this is a planar surface, but only for illustrative purposes), there is no second planar surface connected to the first planar surface, where the second planar surface extends a first distance from a first end of the second planar surface to a most proximal position of the second planar surface, and a second distance from the most proximal position to a second end of the second planar surface. Even if, although also not conceding this point, there is a planar portion on the left of the interior wave-shaped wall of the recess, this extends from one end (distal end on the left) to the most proximal position but does not extend a second distance to a second end, since the right portion of the interior wall of the recess is curved and not planar and thus cannot be included in the second planar surface.
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, 2, 4, and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2019/0105060 to Sommers et al. (hereinafter, “Sommers”).
As to claim 1, Sommers discloses a drill bit, FIGS. 26-28, comprising: a shaft extending along a central longitudinal axis and from a proximal end to a distal end (shaft 66 shown in another embodiment in FIGS. 1-6), the distal end having a drill tip (proximal portion of 192) (par. [0071]-[0073]), FIG. 27; a sharp point (tapering distal portion of 192) extending distally from the drill tip; a stop (190) at the drill tip (where the stop is a stop because it has a larger diameter and is fully capable of abutting against tissue and providing at least some resistance), FIG. 27, the stop having a proximal end surface and a distal end surface (the distal end surface shown in FIG. 27 and the proximal end surface shown in the other embodiment in FIG. 2), one or more cutting edges (edge 80) and a diameter that is greater than a diameter of the shaft (shown in the other embodiment in FIGS. 1-6); and a recess (recesses forming flutes 72 between edges 80) extending through an outer surface of the stop, FIGS. 26-28, wherein the recess comprises a first planar surface (internal face of 72, shown opposite 80 in FIGS. 26-28, at least and including at its distal edge, where at least the distal edge is planar as shown in FIGS. 28-29 and at least as planar as the instant invention) extending in a plane substantially parallel to the central longitudinal axis, FIG. 28, and a second planar surface (internal face of 80, planar as shown in FIGS. 26-29, and at least as planar as the instant invention) connected to the first planar surface, FIGS. 26-28, wherein: the second planar surface extends along an axis from the first planar surface, wherein the axis of the second planar surface is substantially perpendicular to the central longitudinal axis, FIGS. 26 and 28; and a first distance from a first end of the second planar surface toward the proximal end of the shaft to a most proximal position of the second planar surface, and a second distance from the most proximal position of the second planar surface toward the distal end of the shaft to a second end of the second planar surface, shown in the annotated figures below; the most proximal position of the second planar surface is positioned distally to the proximal end surface of the stop, FIGS. 2 and 27.
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Sommers, FIGS. 26 and 27, annotated
As to claim 2, Sommers discloses the drill bit of claim 1, wherein the stop is cylindrical (at least at the unfluted portion), FIG. 26.
As to claim 4, Sommers discloses the drill bit of claim 1, wherein the recess extends to the one or more cutting edges (the recess extends from a root of the flute to the cutting edges at the crest of the flute, and also extends from a proximal end of the recess to the distal portion of cutting edges 80).
As to claim 6, Sommers discloses the drill bit of claim 1, wherein the outer surface of the stop is smooth (at least at the unfluted portion).
As to claim 7, Sommers discloses the drill bit of claim 1, wherein the drill tip comprises one or more flat faces (194) (par. [0073]), FIG. 27.
As to claim 8, Sommers discloses the drill bit of claim 7, wherein two of the one or more flat faces oppose each other (any two of the flat faces oppose each other, where oppose means to be opposite or across from each other) and converge at the sharp point, FIGS. 26-28.
As to claim 9, Sommers discloses the drill bit of claim 1, wherein the sharp point is substantially triangular (the sharp point is substantially triangular pyramid, and has triangular faces), FIGS. 27 and 30, and increases in width in a proximal direction, FIG. 26.
Sommers is silent as to the stop extending around the shaft, wherein the stop is a collar.
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 stop as a separate collar that extends around and is secured to the smaller diameter shaft, since constructing a formerly integral structure in various elements involves only routine skill in the art, and the different diameters of the stop and shaft lend themselves to this modularity. At least a proximal end of the stop would be a female cylindrical collar that receives a distal end of the shaft, to provide modularity so that different diameter or length stops can be used with the same shaft, therefore providing flexibility to the practitioner. The stop and shaft would be secured to each other so that rotational force as required by Sommers would not dislodge their connection.
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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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.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775