DETAILED ACTION
This action is a response to the filing on 3/23/2026. Examiner acknowledges the amendments made to claims 31, 35, 37, 45, 46, and 49; the cancellation of claim 41, and the addition of claims 50-52.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 3/23/2026, with respect to the 112 1st paragraph rejection of claim 34 and the 101 rejections of claims 34 and 49 have been fully considered and are persuasive. The 112 1st and 101 rejections of claims 34 have been withdrawn.
Applicant’s arguments, see pages 11-14, filed 3/23/20206, with respect to the rejection(s) of claim(s) 31 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s amendments to claim 37 have overcome the currently applied prior art rejection.
Applicant’s amendment to claim 49 has not fixed the 101 rejection.
Applicant has not address the double patenting rejections.
Applicant's arguments with regards to claims 21-30, filed 3/23/2026, have been fully considered but they are not persuasive. Applicant argues that Hakansson does not disclose the flexible component and relatively rigid subcomponent because they are both made of plastic and thus cannot meet the flexible and relatively rigid limitations due to them being made of the same material. Examiner disagrees. There are many different types of plastics with each type having various properties with some being more flexible than others. Hakansson clearly stated that the component labeled as 11 uses an elastic material citing plastic as an example. Without knowing the specific plastic type, the art would suggest two different plastic types are being used that has different properties with the component labeled 10 as more rigid and the component labeled 11 being explicitly labeled as an elastic component.
Note that this prior art rejection can be easily overcome by reciting material properties, the materials being used for these components or give specifics about how the coupling occurs such as the components forming a seal to eliminate or reduce micro-leakage of microbes into the gaps between the abutment, fixture, and screw or how element 242 elastically deforms during removal or installation.
It is also noted that while plastics are one of the examples noted in the art, the rigid and elastic materials do not necessarily have to be made of plastic.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 24, 26, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 8 of U.S. Patent No. 11,582,568. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 6, and 8 of U.S. Patent No. 11,582,568 disclose a species that anticipate the current genus claims.
The claims are mapped as follows in the table below:
Present Application
US 11,582,568
21. A prosthesis, comprising:
a body interfacing apparatus; and
an operationally removable component of a bone conduction device including a vibrator,
wherein
a coupling component is present between the body interfacing apparatus and the vibrator of the operationally removable component that includes a flexible sub-component and, relative to the flexible sub-component, a relatively rigid sub-component, both the flexible sub-component and the relatively rigid sub-component being in direct contact with the body interfacing apparatus.
1. A prosthesis, comprising:
an abutment; and
an operationally removable component of a bone conduction device including a vibrator, wherein
a coupling component is present between the abutment and the vibrator of the operationally removable component, wherein the coupling component includes a flexible sub-component and, relative to the flexible sub-component, a relatively rigid sub-component, both the flexible sub-component and the relatively rigid sub-component being in direct contact with the abutment, the flexible sub-component extending further in a direction of the abutment than the relatively rigid sub-component.
24. The prosthesis of claim 21, wherein:
the vibrator is in vibrational communication with the coupling component.
2. The prosthesis of claim 1, wherein: the vibrator is in vibrational communication with the coupling component.
26. The prosthesis of claim 21, wherein:
the coupling component is a composite assembly that includes a first material and a
second material both in direct contact with the body interfacing apparatus, the first material
establishing the flexible sub-component and the second material establishing the rigid sub-
component.
6.The prosthesis of claim 1, wherein:
the coupling component is a composite assembly that includes a first material and a second material both in direct contact with the abutment, the first material making up the flexible sub-component and the second material making up the relatively rigid sub-component.
28. The prosthesis of claim 21, wherein:
the coupling component includes a first portion and a second portion, the first portion
maintaining a spatial location of the removable component relative to the body interfacing apparatus and the second portion snap coupling to the body interfacing apparatus.
8. The prosthesis of claim 1, wherein:
the coupling component includes a first portion and a second portion, the first portion maintaining a spatial location of the removable component relative to the abutment and the second portion snap coupling to inside the abutment.
As noted in the table, claim 1 of US 11,582,568 and claim 21 of the present application cover similar limitations, with claim 1 reciting more specific limitations such as an abutment, which can be considered as a species/type of body interfacing apparatus. This makes US 11,582, 568 a species that anticipates the current genus claims. Claims 24, 26, and 28 are almost verbatim to the limitations specified in claims 2, 6, and 8 of US 11,582,568 with the only difference being the recited abutment in the patent and a body interfacing apparatus in the present application, which makes the present genus claims anticipated by the species claims in the patent.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 49 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 49 recites the limitation "screwed to bone of the recipient" in line 4. This is a positive recitation to a human organism. Amending to "configured to be screwed to bone of the recipient" fixes the issue.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21 and 23-30 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 5,935,170 (Hakansson et al., hereinafter Hakansson).
In regards to claim 21 Hakansson discloses a disconnection device for hearing aid implant coupling (title and abstract; figures 1 and 2; column 1, line 6-column 3, line 29). The device includes
a body interfacing apparatus (abutment: elements 5 and 6 interfaces with skull bone 14);
an operationally removable component of a bone conduction device (12 - bone conduction hearing aid) including a vibrator (bone conduction hearing aids generate vibrations and are transmitted through the coupling parts, which require the presence of a vibrator; see column 1, lines 6-50), wherein
a coupling component (11 and 10) is present between the body interfacing apparatus and the vibrator of the operationally removable component that includes a flexible sub-component (11- second coupling part is made of elastic material — column 3, lines 14-29) and, relative to the flexible component, a relatively rigid sub-component (10 — washer is made of plastic and can be considered relatively rigid to the second coupling; column 2, lines 37-49; column 3, lines 14-17), both the flexible sub-component and the rigid sub-component component being in direct contact with the body interfacing apparatus (figure 1; the coupling sub-components (11 and 10) are in contact with the abutment 6).
In regards to claim 23, Hakansson discloses the limitations of claim 21. Based on figure 1, sub-coupling components 11 and 10 can be considered as an adapter since it allows attachment to the flange.
In regards to claim 24, Hakansson discloses the limitations of claim 21. In addition, the vibrator is in vibrational communication with the coupling component because the coupling part is connected to the hearing device to transfer the vibration to the bone via the coupling component.
In regards to claim 25, Hakansson discloses the limitations of claim 21. In addition, it can be seen in figure 1 that the body interfacing apparatus has a male subcomponent (5 - screw) and the coupling component has a female subcomponent (10) where the male sub-component is received into the female sub-component of the coupling component.
In regards to claim 26, 28, and 30 Hakansson discloses the limitation of claim 21. In addition, as shown in figure 1 and column 2, line 7-column 3, line 29, the coupling component is made of a first and second portion (10 and 11) made of a first and second material in direct contact with the body interfacing apparatus, where the first material establishes the flexible sub-component that extends into a female portion of the body interfacing apparatus (11 extends into 6 -female portion of body interfacing apparatus) and the rigid sub-component directly contacts the uppermost surface of the body interfacing apparatus (10 contacts an upper surface of 6). It can be seen in the figure that the first portion (10) maintains a spatial location of the removable component relative to the abutment and the second portion snap couples to the inside of the body interfacing apparatus (11 snaps into 6).
In regards to claims 27 and 29, Hakansson discloses the limitations of claim 21. In addition, it can be seen in column 3, lines 10-29 that the coupling component is part of a quick release and quick connect assembly for the operationally removable component (simple snap-in mechanism).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,935,170 (Hakansson et al., hereinafter Hakansson) as applied to claim 21 above, and further in view of US 2006/0050913 (Westerkull).
In regards to claim 22, Hakansson discloses the limitations of claim 21. Hakansson shows in figure 1 that the body interfacing apparatus includes an abutment (elements 5 and 6) and a flange fixture (2) that engages a bone. Hakansson does not state that the flange fixture is a bone screw assembly. In a related area, Westerkull discloses a hearing aid interconnection system anchored to a skill bone (title and abstract). Westerkull states that screw fixtures are common mechanisms used with external hearing aids involving vibration that are anchored to the skull (paragraphs 2-3). Paragraphs 34-43 and figures 1-8 show several screw embodiments and state that the anchoring system is mounted to the skull bone. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Hakansson to substitute a bone screw assembly, as taught by Westerkull, in place of the flange because it is one of several known skull attachment methods for attaching a vibrational hearing aid to the skull when using an abutment.
Allowable Subject Matter
Claims 31-40, 42-48, 50, and 52 are allowed.
Claims 49 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and/or 35 U.S.C. 101 set forth in this Office action.
Claim 51 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 31, the prior art of record does not teach or suggest a device, as claimed by Applicant, where the prosthesis includes a body interface assembly interface that interfaces with the body interface assembly on a side of the body interface assembly opposite from a side of the body interface assembly that interfaces with the body, wherein the body interface assembly interface is an assembly of at least two separate elements.
Claims 32-36 are dependent on allowed matter from claim 31 and are allowed.
In regards to claim 37, the prior art of record does not teach or suggest a method with the combination of steps, as claimed by Applicant, where the attaching step is performed by placing the male half of the male-female coupling into the female half of the male-female coupling, wherein the male half is part of the body interfacing assembly and extends towards the removable component.
Claims 38-40 and 42 are dependent on allowed matter from claim 37 and are allowed.
In regards to claim 43, the prior art of record does not teach or suggest an adapter as claimed by Applicant where the adapter comprises:
a first end at a first side having a male portion with a generally circular outer periphery, the male portion being configured with chamfered edges to facilitate snap coupling with a female portion of a coupling apparatus of an operationally removable component of a bone conduction device including a vibrator; and
a second end including a magnet,
wherein the second end includes a flat outer surface, which surface represents a second side of the adapter opposite the first side of the adapter.
Claims 44-49 are dependent on allowed matter from claim 43 and would be allowable once the 101 rejections are overcome.
In regards to claim 51, the prior art of record does not teach or suggest a prosthesis, as claimed by Applicant, where the relatively rigid sub-component is a female portion of a male-female coupling.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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