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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 07, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
The application has been amended as follows:
Regarding claims 22-27, line 1 all this claims should be depended on claim 21.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite the steps that direct towards an abstract idea can be done by a human without a practical application or significantly more. For example, a human can obtain a bone interface, pushing the bone interface into a hole, nothing in the claim precludes the above steps from being practically performed by a human, See MPEP 2106.04.
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) 21, 23-27 and 36-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Westerkull (US 2006/0126874 A1).
As to claim 21, Westerkull discloses a method [§0002], comprising:
obtaining a bone interface [An abutment 102 on FIG. 1 ] of a transcutaneous bone conduction [Fixture 104 on FIG. 1] assembly [“The abutment with a fixture to convert sound into vibrations.” §0056]; and
pushing the bone interface into a hole [106 on FIG.1] in a skull of a human [“The fixture is screwed into a skull bone of a user (human).” §0056].
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As to claim 23, Westerkull discloses the method of claim 21, wherein: the bone interface extends from an implantable transcutaneous bone conduction device [“The fixture is screwed into a skull bone of a user (human).” §0056].
As to claim 24, Westerkull discloses the method of claim 21, further comprising: attaching the bone interface to an implantable transcutaneous bone [102 on FIG. 1] conduction device [“The fixture is screwed into a skull bone of a user (human), therefore the fixture is attached to the abutment device.” §0056].
As to claim 25, Westerkull discloses the method of claim 24, wherein: the action of attaching the bone interface to the implantable transcutaneous bone conduction device is executed prior to putting the bone interface into the hole [“The action of attaching is prepared by drilling a hole into the skull.” §0061].
As to claim 26, Westerkull discloses the method of claim 21, wherein: a depth of insertion of the bone interface into the hole is limited by a component attached to the bone interface [“The direct bone conduction hearing-aid fixture provided has a thread depth.” §0061].
As to claim 27, Westerkull discloses the method of claim 21, further comprising: turning the bone interface in the hole [“The fixture is screwed, therefore turning into the hole in the skull bone.” §0061].
As to claim 36, Westerkull discloses an apparatus [100 on FIG. 1], comprising:
an implantable component [102 on FIG.1], wherein the implantable component is a component of a bone conduction device [108 on FIG. 1], and the component includes a skull facing side [104 on FIG. 1] and a skin facing side [102 on FIG. 1], the skull facing side including half of a male-female interface arrangement configured to interface with the other half of a male-female interface arrangement of a bone implant [“A connection screw (male-female interface) is usually placed through the abutment and then screwed into the a threaded hole in the fixture.” §0017 and §0018].
As to claim 37, Westerkull discloses the apparatus of claim 36, wherein: the implantable component is part of a transcutaneous bone conduction device [102 on FIG. 1 and §0056].
As to claim 38, Westerkull discloses the apparatus of claim 36, wherein: the half of the male-female interface arrangement includes a circular groove [“The grove is circular.” §0040].
As to claim 39, Westerkull discloses the apparatus of claim 38, wherein: the bone implant is attached to the implantable component, and a circular wall of the bone implant is located in the circular groove [“The grove is circular.” §0040].
As to claim 40, Westerkull discloses the apparatus of claim 36, wherein: male-female interface arrangement establishes alignment between the component and the bone implant when the implant is attached to the component [“The embodiment showed along a line view of the fixture, therefore there is an alignment between the component.” §0060].
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull in view of Kashiwabara et al. (US 2013/0017511 A1).
As to claim 22, Westerkull discloses the method of claim 21, but fails to disclose the bone interface is a pedestal.
However, Kashiwabara teaches wherein the bone interface is a pedestal [23 on FIG.2 and “The pedestal is to receive the model in close contact with inner surface of the outer model.” §0041].
Westerkull and Kashiwabara are analogous because they are all directed to implant fixture system. One of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to modify Westerkull reference with the teaching of Kashiwabara, so that the pedestal would include the implant fixture of Westerkull, would have been combined into an implant, for the obvious purpose of providing the pedestal in close contact with an inner surface, by combining prior art elements according to known methods to yield predictable results.
Claim(s) 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull in view of Gibson (US 7,937,156 B2) .
As to claim 28, Westerkull discloses an apparatus [100 on FIG.1], comprising:
an osseointegrating lateral stability device configured for removable attachment to an implantable medical component [“The fixture is fully osseointegrated with the skull bone.” §0061], but fails to disclose a pocket on a side of the device.
However, Gibson teaches the device including at least one pocket on a side of the device [“The surface of the patient’s skull on placement of housing in a periosteal pocket formed in bone.” Column 6, lines 21-26].
Westerkull and Gibson are analogous because they are all directed to implant fixture system. One of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to modify Westerkull reference with the teaching of Gibson, so that the pocket would include in the implant fixture of Westerkull, would have been combined into an implant, for the obvious purpose of providing the pocket loops gradually sink into the bone, by combining prior art elements according to known methods to yield predictable results.
As to claim 29, Westerkull discloses the apparatus of claim 28, but fails to disclose a distal end of the device.
However, Gibson teaches wherein: the at least one pocket extends from a distal end of the device towards a proximal end of the device [“The distal end of each screw is positioned so as to abut the bony surface.” Column 7, lines 30-37].
Westerkull and Gibson are analogous because they are all directed to implant fixture system. One of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to modify Westerkull reference with the teaching of Gibson, so that the distal end would include in the implant fixture of Westerkull, would have been combined into an implant, for the obvious purpose of providing the abutting the bony surface under pressure, by combining prior art elements according to known methods to yield predictable results.
As to claim 30, Westerkull discloses the apparatus of claim 28, wherein: the pocket is configured for at least one of bone anchoring, rotational stability [“The anchoring system provides an effective solution for attaching direct bone conduction. The examiner choosing the anchoring system because of a simple or.” §0038].
As to claim 31, Westerkull discloses the apparatus of claim 28, but fails to disclose the at least one pocket includes at least three pockets.
However, Gibson (US 7937156 B2) teaches the device including the at least one pocket includes at least three pockets [“The surface of the patient’s skull on placement of housing in a periosteal pocket formed in bone.” Column 6, lines 21-26].
Westerkull and Gibson are analogous because they are all directed to implant fixture system. One of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to modify Westerkull reference with the teaching of Gibson, so that the pocket would include in the implant fixture of Westerkull, would have been combined into an implant, for the obvious purpose of providing the pocket loops gradually sink into the bone, by combining prior art elements according to known methods to yield predictable results.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull in view of Dunn (US 2009/0029316 A1).
As to claim 41, Westerkull discloses the apparatus of claim 36, but fails to disclose a magnet.
However, Dunn teaches wherein: the component includes a magnet [“Implants comprise a magnetic material to form a magnetic field.” §0038].
Westerkull and Dunn are analogous because they are all directed to implant fixture system. One of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to modify Westerkull reference with the teaching of Dunn, so that the magnetic material would include in the implant fixture of Westerkull, would have been combined into an implant, for the obvious purpose of providing a bipolar magnetic environment, by combining prior art elements according to known methods to yield predictable results.
Allowable Subject Matter
Claims 32-35 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Petric et al. (US 2021/0228361 A1) discloses a bone implant comprising at least one means for providing at least one bone stimulation dynamic interaction to at least one area of a bone-implant interface formed when the implant is inserted into bone.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD GAUTHIER whose telephone number is (571)272-7539. The examiner can normally be reached 8:00 AM to 4:30 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, CAROLYN R EDWARDS can be reached at (571) 270-7136. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GERALD GAUTHIER/Primary Examiner, Art Unit 2692
July 10, 2026
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