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 .
Status of the Claims
This Office Action is responsive to the amendment filed April 23, 2026. As directed by the amendment: Claims 1, 5, 8, 10, and 13 have been amended. Claims 2-4, 15, and 16 have been cancelled. Claims 17-21 are newly added. Claims 1, 5-14, and 17-21 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1, 5-14, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Billeter (US 2,454,372).
Regarding claim 1, Billeter discloses a drill guide (figure 1) for an implantable medical device (considered as intended use) comprising a template (element “c”) comprising a turntable (35+60) having a drill guide opening (figure 1), and a drill clip (20) connected to the turntable (35+60) (figure 1), and a bearing (element “d”) at least partially seated in a template recess (figure 1), the bearing (element “d”) having a bearing opening (element “b”), wherein the turntable (35+60) is at least partially seated in the bearing opening (element “b”) (col. 6, ll. 44-50), wherein the bearing opening (element “b”) is aligned with the drill guide opening (figure 1), and wherein a bottom surface (considered as a side surface of element 60) of the turntable (35+60) slides along a top surface (considered as a side surface of element “c”) of the template (element “c”).
Regarding claim 5, Billeter discloses wherein the template recess (figure 1) comprises a template recess opening (figure 1) coaxially aligned with the drill guide opening (figure 1) and the bearing opening (element “b”) (figure 1).
Regarding claim 6, Billeter discloses wherein the drill clip (20) is connected to the turntable (35+60) by a support element (36) extending above the turntable (35+60) (figure 1).
Regarding claim 7, Billeter discloses wherein the drill clip (20) is slidably connected (figure 1) to the support element (36).
Regarding claim 8, Billeter discloses wherein the support element (36) is configured to (i.e. capable of) restrict slidable drill movement perpendicular to a target site when a drill (16) is attached to the drill clip (20).
Regarding claim 9, Billeter discloses wherein the support element (36) comprises a plurality of separate support elements (elements 36) (figure 1).
Regarding claim 10, Billeter discloses wherein the support element (36) extends from an offset position above the turntable (35+60) (figure 1).
Regarding claim 11, Billeter is capable of having wherein the template is an implantable hearing device template as this is considered functional.
Regarding claim 12, Billeter is capable of having wherein the implantable medical device is an implantable hearing device as this is considered functional.
Regarding claim 13, Billeter discloses a drill guide (figure 1) for an implantable medical device (considered as intended use) comprising a template (element “c’) comprising a template opening (figure 1) and a turntable (35+60) having a drill guide opening (figure 1) coaxially aligned with the template opening (figure 1), a bearing (element “d’) at least partially seated in a template recess (figure 1), the bearing (element “d’) having a bearing opening (element “b”), a drill interface (20) connected to the turntable (35+60) (figure 1), and a support element (36) connected to the drill interface (20) extending from the turntable (35+60) and offset from the drill guide opening (figure 1), wherein the turntable (35+60) is at least partially seated in the bearing opening (element “b”) (col. 6, ll. 44-50), wherein the bearing opening (element “b”) is aligned with the drill guide opening (figure 1), and wherein a bottom surface (considered as a side surface of element 60) of the turntable (35+60) slides along a top surface (considered as a side surface of element “c”) of the template (element “c”).
Regarding claim 14, Billeter discloses wherein the support element (36) is slidably connected to the drill interface (20) (figure 1).
Regarding claim 17, Billeter discloses wherein an axis (considered as an arbitrary horizontal axis) intersecting the plurality of separate support elements (elements 36) does not intersect the drill guide opening (figure 1).
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) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Billeter (US 2,454,372) in view of Le Picq (US 6,860,682).
Regarding claim 18, Billeter’s drill guide discloses all the features/elements as claimed but lacks a detailed description on at least a portion of the template is flexible.
However, Le Picq teaches at least a portion of a template (30) (figure 2) is flexible (col. 6, ll. 59-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Billeter’s drill guide with at least a portion of the template is flexible as taught by Le Picq, since such a modification would provide an optimum material (col. 6, ll. 59-67).
Regarding claims 19, 20, 21, Billeter’s drill guide discloses all the features/elements as claimed but lacks wherein the template comprises a first portion, a second portion, and a neck portion connecting the first portion and the second portion, wherein the neck portion is more flexible than the first portion and the second portion, wherein a thickness of the first portion and the second portion is greater than a thickness of the neck portion.
However, Le Picq teaches a template (30) (figure 2) comprises a first portion (one side of element 30), a second portion (another side of element 30), and a neck portion (considered as a middle portion of element 30) connecting the first portion (one side of element 30) and the second portion (another side of element 30), wherein the neck portion (considered as a middle portion of element 30) (figure 2) is more flexible (due to different thicknesses) than the first portion (one side of element 30) and the second portion (another side of element 30), wherein a thickness of the first portion and the second portion is greater (due to different thicknesses) than a thickness of the neck portion (considered as a middle portion of element 30) (figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Billeter’s template with the template comprises a first portion, a second portion, and a neck portion connecting the first portion and the second portion, wherein the neck portion is more flexible than the first portion and the second portion, wherein a thickness of the first portion and the second portion is greater than a thickness of the neck portion as taught by Le Picq, since such a modification would provide an alternative template shape, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 6-9, under 35 U.S.C. 102(a)(1), of the Remarks are directed to the amended claims and the reference Billeter. Applicant argues that “Billeter nowhere suggests that its structure could or would be modified to achieve a flush, gapless arrangement”. 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 bearing and turntable are arranged so that the bottom surface of the turntable sits flush against the top surface of the template, forming a gapless configuration”) 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.
Applicant further argues that “Billeter fails to anticipate or suggest the limitations of claim 17”. However, the Examiner respectfully disagrees because as generally claimed, Billeter discloses wherein an axis (considered as an arbitrary horizontal axis) intersecting the plurality of separate support elements (elements 36) does not intersect the drill guide opening (figure 1).
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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