DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 4 February 2026. Claims 1-6, 8, 11-13, 15-16, 19-20, 55-62 are now pending. The Examiner acknowledges the amendments to claims 1, 3, 4, 5, 8, 11, 12, 13, 19, 20, and newly added claims 55-62.
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 .
Claim Objections
Claims 8, 11, 13, 15, 16, 19, 56, 61, 62 objected to because of the following informalities:
-Claim 8 recites “the flat surface” in lines 4-5. Examiner recommends amending to –the at least one flat surface—
-Claim 11 recites “the abutment” in line 12 Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 13 recites “the abutment” in lines 2 and 3. Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 15 recites “the abutment” in line 2. Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 16 recites “the abutment” in line 2. Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 56 recites “the means for transferring torque and the means for receiving” in line 2. Examiner recommends amending to –the means for directly transferring torque and the means for directly receiving—
-Claim 61 recites “the abutment” in line 4. Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 62 recites “the abutment” in line 5. Examiner recommends amending to –the bone conduction hearing prosthesis abutment—
-Claim 62 recites “transfers toque to the abutment…direct contact wit” in lines 5-6. Examiner recommends amending to “transfers torque to the abutment…direct contact with”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claims 1 and 11 recites “bone conduction hearing prosthesis bone fixture implant insertion device” and “bone conduction hearing prosthesis abutment implantation device” which are generic placeholders. There is no sufficient
structure for this limitation provided in the claims. The function of this limitation is to interface with an interior of the bone fixture/abutment. For example, this device referenced could be a tool to insert a portion of a prosthesis, a portion of a prosthesis that is inserted, or a separate embodiment. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
-Claim 55 recites “a means for directly transferring torque”. According to the specification the means for directly transferring torque includes a torque transfer section [0091] and equivalents thereof.
-Claim 56 recites “a means for directly receiving torque”. According to the specification the means for directly receiving torque includes a torque receiver section [0091] and equivalents thereof.
-Claim 59 recites “a means for guiding the device into the bone conduction hearing prosthesis bone fixture implant”. According to the specification the means for guiding the device…implant includes a protrusion [0090] and equivalents thereof.
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.
Claims 1-6, 8, 11-13, 15-16, 19-20, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim limitation “bone conduction hearing prosthesis bone fixture implant insertion device” and “bone conduction hearing prosthesis abutment implantation device” (claims 1 and 11) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification provides reference to “a bone fixture insertion tool” in [0091], however, it is unclear what structure and corresponding portions are included in the recitation. Further clarification should provide detail on whether this structure requires sections of a prosthesis, sections of an abutment, sections of an implant, and/or sections of an insertion device. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
-Claim 1 recites “same class of materials” in line 7. It is unclear what constitutes “same class of materials” per this limitation. Further clarification should be provided.
-Claim 3 recites “sections of the device that interface with the bone fixture” in line 2. It is unclear whether this is the same or different from “sections that interface with the bone fixture” in claim 1, line 8.
-Claim 4 recites “sections of the device that interface with the bone fixture” in line 2. It is unclear whether this is the same or different from “sections that interface with the bone fixture” in claim 1, line 8.
-Claim 8 recites “sections of the device that interface with the bone fixture” in line 2. It is unclear whether this is the same or different from “sections that interface with the bone fixture” in claim 1, line 8.
-Claim 11 recites “like materials” in line 6. It is unclear what constitutes “like materials” per this limitation. Further clarification should be provided.
-Claim 13 recites “the interface created when interfacing with the bone conduction hearing prosthesis abutment” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “interfacing with the bone conduction hearing prosthesis abutment is completely male-female relationship” in lines 4-5. It’s unclear what this limitation requires structurally in terms of an interface defining a completely male-female relationship.
-Claim 13 recites “the male part” in line 5. There is insufficient antecedent basis for this limitation in the claim.
-Claim 15 recites “a combined lifting and counter torque adapter” in line 2. It is unclear what is required by the recitation combined lifting and counter torque in terms of the adapter described. Further clarification should be provided to define whether this includes an adapter that is able to impart these mechanisms on the abutment, a description of a positioning characteristics of the adapter in relation to the rotational force it applies or is applied to it or whether this includes a separate embodiment.
-Claim 16 recites “a combined lifting and counter torque wrench” in line 2. It is unclear what is required by the recitation combined lifting and counter torque in terms of the wrench described. Further clarification should be provided to define whether this includes a wrench that is able to impart these mechanisms on the abutment, a description of a positioning characteristics of the wrench in relation to the rotational force it applies or is applied to it or whether this includes a separate embodiment.
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) 1-6, 8, 11-13, 15, 19, 20, 55, 56, 57, 58, 59, 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersson (U.S. 9596550)
Regarding Claim 1, Andersson teaches a device, comprising: a body including: a torque transfer section; and a torque receiver section [Fig. 3A, elements 340, (body), 352 (torque transfer section), and 342 (torque receiver section)] and [Col 9, lines 12-16]—describing component 352 as that of a male adapter which interfaces with female threads that would accept torque transferred from the male adapter as further described in reference to the torque applied to the adapter in [Col 9, lines 17-22] and [Col 10, lines 32-37]—describing another configuration where these components snap-couple to one another, wherein the device is a bone conduction hearing prosthesis bone fixture implant insertion device configured to interface with an interior of a bone fixture [Abstract]—description of the adapter and coupling apparatus and [Fig. 6C, element 612], and the device is made of a same class of materials at the torque transfer section and the torque receiver section and section(s) that interface with the bone fixture [Col 17, lines 32-34; “The adapter 450 can be in the form of a monolithic cylinder made of a ferromagnetic material having a bore therein.”]—where adapter 450 is considered equivalent of element 350 in above-described embodiment that includes components 340, 352, and 342.
Regarding Claim 2, Andersson teaches wherein: the torque transfer section and the torque receiver section and section(s) that interface with the bone fixture are integral sections of the body. See annotated Fig. 3A below.
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Regarding Claim 3, Andersson teaches wherein: section(s) of the device that interface with the bone fixture include the torque transfer section and a bone fixture interference section [Fig. 3A, elements 220 (interference section) and 210 (bone fixture)].
Regarding Claim 4, Andersson teaches wherein: section(s) of the device that interface with the bone fixture include the torque transfer section and a bone fixture interference section that includes three separate interference zones that contact the bone fixture during use. See annotated Fig. 3A below where interference zones are interpreted to be areas that interface between the bone fixture and the interference section where the interference section is also contacting the adapter.
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Regarding Claim 5, Andersson teaches Andersson teaches wherein: the section(s) that interface with the bone fixture include the torque transfer section and a bone fixture interference section that includes six separate interference surface portions that contact the bone fixture during use. See annotated Fig. 3A below:
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Regarding Claim 6, Andersson teaches wherein: the device is configured to lift and retain the bone fixture to the device during use [Col 5, lines 21-24; “Fixture 210 can further comprise a tool-engaging socket having an internal grip section for easy lifting and handling of fixture 210”] and [Col 40, lines 60-62; “which male portions react against an inside portion of the lip so as to retain the adapter to the abutment.”]
Regarding Claim 8, Andersson teaches wherein: section(s) of the device that interface with the bone fixture include the torque transfer section and a bone fixture interference section that includes at least one flat surface obliquely angled relative to a longitudinal direction of the body, See annotated Fig. 3A below
The flat surface creating a line interference contact, establishing boundaries of the flat surface, with the bone fixture during use. See annotated Fig. 3A below—where the line interference contact is considered to be the contact edges of element 220 contact the bone fixture, element 210, and create a boundary to hold the structure in place.
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Regarding Claim 11, Andersson teaches a device, comprising: a torque transfer section; and a torque receiver section, [Fig. 3A, element 352 (torque transfer section), and 342 (torque receiver section)] and [Col 9, lines 12-16]—describing component 352 as that of a male adapter which interfaces with female threads that would accept torque transferred from the male adapter as further described in reference to the torque applied to the adapter in [Col 9, lines 17-22] and [Col 10, lines 32-37]—describing another configuration where these components snap-couple to one another.
wherein the device is a bone conduction hearing prosthesis abutment implantation device configured to interface with an interior of a bone conduction hearing prosthesis abutment, [Abstract]—description of the adapter and coupling apparatus and [Fig. 6C, element 612] and at least one of: (i) the device is made of like materials at the torque transfer section and the torque receiver section and section(s) that interface with the bone conduction hearing prosthesis abutment; [Col 17, lines 32-34]—where adapter 450 is considered equivalent of element 350 in above-described embodiment that includes components 340, 352, and 342.
or (ii) the device is configured to retain the bone conduction hearing prosthesis abutment to the device and the device is configured such that torque transferred from the device is applied through a component that retains the device to the abutment. [Col 40, lines 60-62; “which male portions react against an inside portion of the lip so as to retain the adapter to the abutment.”]—where the adapter is interpreted as the component.
Regarding Claim 12, Andersson teaches wherein: the torque transfer section and the torque receiver section and any section(s) that interface with the bone conduction hearing prosthesis abutment are integral sections of the body. See annotated Fig. 3A below.
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Regarding Claim 13, Andersson teaches wherein: the device is configured such that when interfacing with the abutment, with respect to respective outermost profiles of the device and the abutment, the interface is completely male- female relationship with the device being the male part [Col 9, lines 12-16]—discloses male-female components of the adapter and describes these components which are shown in Fig. 3A to interface with one another in this mating relationship orientation by the portions of their outermost structures—interpreted to be in relation to the outermost edges of the structure that interface with corresponding components.
Regarding Claim 15, Andersson teaches wherein: the device is a combined lifting and torque adapter for the abutment [Col 31, lines 1-3]—includes reference to lifting the structure, and [Col 9, lines 17-22; “In some embodiments, the threads of the bore 354/screw head 270 have such direction that the torque applied to the adapter 350 to screw the adapter onto the screw head 270 is in the same direction 20 as the torque applied to the abutment screw 230 to tighten the abutment 220 to the fixture.”]
Regarding Claim 19, Andersson teaches wherein: the device is configured to retain the abutment to the device; [Col 40, lines 60-62] and the device is configured such that torque transferred from the device is applied through the component that retains the device to the abutment [Col 9, lines 17-19]—discusses the torque being applied to the adapter to tighten and retain the abutment to the fixture by means of a component (an abutment screw head).
Regarding Claim 20, Andersson teaches wherein: the device has a longitudinal axis; [Fig. 3A, element 219] and from a location of interface of the device with the component to a distal end of the device which fits into the component, [Col 6, lines 32-35]—describes an insertion tool cooperating with a screw head, a cross-sectional area lying normal to the longitudinal axis reduces or remains constant [Col 21, lines 62-64]—describes positive retention in the lateral direction normal to element 219.
Regarding Claim 55, Andersson teaches a device, comprising: a means for directly transferring torque to a bone conduction hearing prosthesis bone fixture implant; and a means for directly receiving torque [Fig. 3A, elements 352 (torque transfer section), and 342 (torque receiver section)] and [Col 9, lines 12-16]—describing component 352 as that of a male adapter which interfaces with female threads that would accept torque transferred from the male adapter as further described in reference to the torque applied to the adapter in [Col 9, lines 17-22] and [Col 10, lines 32-37]—describing another configuration where these components snap-couple to one another.
Regarding Claim 56, Andersson teaches wherein: the means for transferring torque and the means for receiving torque are parts of a single body [Fig. 3A, element 340, (body)].
Regarding Claim 57, Andersson teaches an assembly, comprising: the device of claim 55; and the bone conduction hearing prosthesis bone fixture implant [Abstract]—description of the adapter and coupling apparatus and [Fig. 6C, element 612], wherein the means for directly transferring torque is located inside the bone conduction hearing prosthesis bone fixture implant [Col 13, lines 25-27].
Regarding Claim 58, Andersson teaches wherein: the device is a metal body [Col 5, lines 8-14]—reference to the body made of titanium.
Regarding Claim 59, Andersson teaches further comprising: means for guiding the device into the bone conduction hearing prosthesis bone fixture implant [Fig. 2A, element 216 (flange)] and [Col 6, lines 9-15], wherein the means for guiding is separate from the means for directly transferring torque [Col 6, lines 15-24].
Regarding Claim 62, Andersson teaches wherein: the device is configured to retain the bone conduction hearing prosthesis abutment to the device by way of direct contact with the bone conduction hearing prosthesis abutment [Col 9, lines 17-26] and the device is configured such that torque transferred from the device is applied through the component that retains the device to the abutment [Col 9, lines 48-52], and the device transfers toque to the abutment by way of the direct contact with the abutment [Col 32, lines 29-35].
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson (U.S. 9596550) in view of Bjorn (U.S. 20130090518).
Regarding Claim 16, Andersson is silent on wherein: the device is a combined lifting and counter torque wrench for the abutment. Bjorn teaches wherein: the device is a combined lifting and counter torque wrench for the abutment [0072; “As detailed herein, abutment 720 may include wrench flats or the like to provide a counter torque to the abutment 720 to react against the torque of the magnetic implant abutment coupling 760.”] and [0032; “Fixture 210 may further comprise a tool-engaging socket having an internal grip section for easy lifting and handling of fixture 210,”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize counter-torque wrench as taught by Bjorn to provide torque by means of an insertion or adapter tool as suggested by Andersson, as Andersson discusses the importance of applying continued torque to tighten the connection between the adapter and the abutment [Col 9, lines 48-51] with Bjorn because Bjorn teaches creating a suitable connection between the fixture and abutment include an axially well-defined fit and ease of disassembly [0057].
Claim(s) 60, 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson (U.S. 9596550) in view of Hough (U.S. 4774933).
Regarding Claim 60, Andersson is silent on wherein: the bone conduction hearing prosthesis bone fixture implant has a hollow portion that has three separate and distinct female portions into which respective three separate and distinct male portions of the device are fitted. Hough teaches wherein: the bone conduction hearing prosthesis bone fixture implant has a hollow portion that has three separate and distinct female portions [Fig. 6, element 21 (seats)], into which respective three separate and distinct male portions of the device are fitted [Fig. 1, element 18 (bearings)] and [Col 4, lines 29-33]—reference to seats and bearings fitting within the seats.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize this configuration with three distinct segments as taught by Hough to provide torque by means of an insertion or adapter tool as suggested by Andersson, as Andersson discusses the use of through holes to enable the abutment screws to be accessed by a removal tool [Col 15, lines 43-48] with Hough because Hough teaches providing a stable operating characteristic and small torque requirement to effect slippage between the handle and shank portion of the tool [Col 4, lines 24-28] and [Col 4, lines 38-45].
Regarding Claim 61, Andersson is silent on wherein: the device is configured to retain the bone conduction hearing prosthesis abutment to the device and the device is configured such that torque transferred from the device is applied through the component that retains the device to the abutment, wherein the torque transferred from the device imparts a moment about a longitudinal axis of the bone conduction hearing prosthesis abutment. Hough teaches wherein: the device is configured to retain the bone conduction hearing prosthesis abutment to the device [Col 4, lines 45-52]—references holding and locking together components of the device, and the device is configured such that torque transferred from the device is applied through the component that retains the device to the abutment [Col 4, lines 45-52; “requiring greater and greater torque to cause slippage”], wherein the torque transferred from the device imparts a moment about a longitudinal axis of the bone conduction hearing prosthesis abutment [Col 4, lines 38-45]—where the moment is interpreted to be the slippage caused by the rotation of the of handle based on the torque imparted on the device where the longitudinal axis is considered to be that of [Fig. 1, element 26 (bore)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize identify the forces applied by the device as taught by Hough to provide torque by means of an insertion or adapter tool as suggested by Andersson, as Andersson discusses components that hold the abutment to the bone fixture [Col 4, lines 57-63] with Hough because Hough teaches adjustment of the device to provide the desired slip/torque between the handle and shank portion [Col 7, lines 29-31].
Response to Arguments
Applicant’s arguments filed 4 February 2026 with respect to the Unity of Invention Restriction Requirement have been fully considered but are not persuasive. The finality given in the previous office action is maintained given the previous reasoning provided.
Applicant's arguments filed 4 February 2026 with respect to the specification, drawing and abstract objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 4 February 2026 with respect to the claim objections have been fully considered and are persuasive in light of the amendments, however, new objections are presented in light of the amendments.
Applicant's arguments filed 4 February 2026 with respect to the claim interpretation have been fully considered and are not persuasive. Applicant contends that a prima facie case has not been established. The examiner has revisited the entire disclosure and outside of the recitation of the generic placeholder, there is no further structure recited in relation to this element. In view of the foregoing, this claim interpretation has been maintained.
Applicant's arguments filed 4 February 2026 with respect to 35 U.S.C. 112(b) rejections of claims 3, 4, 5, 8, 12, 13, 19, 20 have been fully considered and are persuasive. Applicant’s arguments filed 4 February 2026 with respect to 35 U.S.C. 112(b) rejections of claims 1, 11, 15 and 16 have been fully considered but are not persuasive. Regarding claims 1 and 11, applicant contends that one of ordinary skill in the art would understand that “bone conduction hearing prosthesis bone fixture implant insertion device” and “bone conduction prosthesis abutment implant device” is referencing a “bone fixture insertion tool”. The examiner understands that an insertion tool is involved in the structure of this recitation, however, the recitation contains other structural components that may or may not be part of the recited device. For example, the insertion tool could include the prosthetic, an implant, and/or an abutment in combination with the insertion and implant device. Because of this reason, the recitation was interpreted under 35 U.S.C.112(f) and rejected under 35 U.S.C. 112(b). In view of the foregoing, the rejection is maintained.
Regarding Claim 11, applicant contends that one of ordinary skill in the art would understand what “like materials” constitutes and that this limitation is clear. The Examiner maintains this rejection since it is unclear what the claim requires in the art of prosthetic implants and tools used to deploy such devices. The specification does provide example as to what like material constitutes in [00118] and [00133] however, these statements are somewhat contradictory and further add to the indefiniteness because these examples include combinations of titanium and stainless steel, stainless steel (only) and a statement of “like material and/or the same material.” This does not provide clarity especially considering materials used in manufacturing processes of medical implants. Implantable devices include materials across multiple classes of materials (e.g. metals, ceramics, polymers, composites, etc.). The Examiner maintains that the limitation is indefinite since it is unclear whether any of these materials could be included under the characterization of “like materials” since they share similarities in biocompatibility and presence in manufactured medical devices.
Regarding Claim 13, Applicant contends that one of ordinary skill in the art would not question the limitation regarding “interfacing with the bone conduction hearing prosthesis abutment is completely male-female relationship”. The examiner maintains that this limitation is still unclear as to what it required structurally by the recited structures to constitute a “completely male-female relationship”.
Applicant’s arguments filed 4 February 2026 with respect to the rejection of
claims 1 and 11 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive. Regarding claim 1, applicant contends that:
(1) the annotated copies of figures provided are not legible,
(2) the reference numerals 352 and 342 do not indicate that they are torque related, and
(3) the OA does not provide justification or explanation for “wherein the device is a bone conduction hearing prosthesis bone fixture implant insertion device configured to interface with an interior of the bone fixture”.
In response to the argument regarding the annotated figures (1), the examiner has provided revised legible copies of all of the annotated figures. However, the annotated copy of the figure was not relied upon for the claim 1 rejection and was only provided to clearly show that the elements cited were integral as required by claim 2.
In response to the argument that the reference numbers 352 and 342 are not indicated as torque related (2), the examiner has provided additional reference in the body of the rejection.
In response to the argument regarding the OA not providing justification or explanation for the recited limitation “wherein…the bone fixture,” it is noted that the limitation involved in the teaching includes indefinite aspects and is construed as best possible as outlined in the rejection above. The abstract of the cited reference describes a prosthesis, an abutment and removable components (insertion device). These are interpreted to fulfill the requirement of “a bone conduction hearing prosthesis bone fixture implant insertion device.” In view of the foregoing, the rejection citing Andersson is maintained.
Regarding claim 11, the applicant contends that the reference fails to teach “a bone conduction hearing prosthesis abutment implantation device.” In response to applicant’s argument that the references fail to teach certain features of the invention, it is noted that the limitation involved in the teaching includes indefinite aspects and is construed as best possible as outlined in the rejection above. The abstract of the cited reference describes a prosthesis, an abutment and removable components (implantation device). In view of the foregoing, the rejection citing Andersson is maintained.
Applicant’s arguments filed 4 February 2026 with respect to the rejection of
Claim 16 under 35 U.S.C.103 have been fully considered but they are not persuasive. Applicant contends that because of the dependency of claim 16 on claim 11, the argument previously presented in regards to claim 11 in the previous paragraph warrants withdrawal of claim 16. In view of the 35 U.S.C. 102 rejection of claim 11 citing Anderson being maintained, the 35 U.S.C. 103 rejection of claim 16 citing Andersson in view of Bjorn is also maintained.
Conclusion
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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