Patent Application 15395234 - IMPLANTABLE SOUND SENSOR FOR HEARING PROSTHESES

Title: IMPLANTABLE SOUND SENSOR FOR HEARING PROSTHESES
Application Information

Invention Title: IMPLANTABLE SOUND SENSOR FOR HEARING PROSTHESES
Application Number: 15395234
Submission Date: 2025-05-16T00:00:00.000Z
Effective Filing Date: 2016-12-30T00:00:00.000Z
Filing Date: 2016-12-30T00:00:00.000Z
National Class: 600
National Sub-Class: 025000
Examiner Employee Number: 86077
Art Unit: 3791
Tech Center: 3700
Rejection Summary

102 Rejections: 3
103 Rejections: 8
Cited Patents

The following patents were cited in the rejection:
Office Action Text



    DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application is being examined under the pre-AIA  first to invent provisions. 
Claim Objections
Claim 95 is objected to because of the following informalities: “implanted the recipient” should read --implanted in the recipient--.  Appropriate correction is required.
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 7, 65, 67, 73, and 75 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 7 recites “a defined gas layer” while parent claim 1 as amended recites a fluid medium contained in the cavity. It is unclear whether the gas layer of claim 6 is intended to be the same or different than the fluid medium of claim 1, and further whether applicant intends to claim both a defined gas layer as well as a separate fluid medium in the cavity.
Regarding claim 65, the limitation "an internal environment" renders the claim indefinite because it is unclear if the “internal environment” which is hermetically sealed inside the housing established at least in part by the membrane and the housing is the same as the cavity recited in claim 15, which is also hermetically sealed and defined by the housing and the membrane, or is intended to be an environment that is separate and distinct from the cavity defined in claim 15.
Regarding claim 67, the limitation "a hermetically sealed volume" renders the claim indefinite because it is unclear if the “hermetically sealed volume” which is inside the housing established at least in part by the membrane is the same as the cavity recited in claim 38 which is also hermetically sealed and defined by the housing and the membrane or is intended to be a volume that is separate and distinct from the cavity defined in claim 38.
Claim 73 recites “a component an apparatus” in line 2. It is unclear whether applicant intends to recite both a component and an apparatus.
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.  

Claims 42 and 70 are 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 42 recites “the sound sensor is implanted in a cochlea of the recipient” (emphasis added). Claim 70 recites “the entirety of the sound sensor is implanted in the recipient and located outside of the cochlea” (emphasis added). The broadest reasonable interpretation of each limitation encompasses a positively required human recipient and/or a relationship to the human recipient. Thus, each claim encompasses a human body, which is nonstatutory. The examiner suggests applicant amend these limitations to include --configured to-- or --adapted to-- to overcome these rejections. For example, the examiner suggests applicant amend claim 42 to read --the sound sensor is configured to be implanted in a cochlea of the recipient--.
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.

Claims 1, 6-8, 55, and 68 are rejected under pre-AIA  35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication No. 2007/0009132 (Miller, III et al., herein referred to as “Miller”).
Regarding claim 1, Miller teaches a sound sensor (10) (Figures 1 and 4a; [0031]), comprising:
a housing (20, 22) including a cavity (60) having an opening at a first end of the housing (membrane 30 extends over the opening at the first end of the housing; [0033], [0041], [0043]; Figure 4A); 
a membrane (30) attached to the housing so as to hermetically seal the opening, the membrane being configured to vibrate in response to vibration within a recipient (membrane 30 is positioned to receive acoustic signals through overlying tissue: [0029]; [0033]; [0043]);
an internal sensor (50), disposed in the housing, the internal sensor being configured to detect a physical phenomenon resulting from movement of the membrane ([0033]; Figure 4A), wherein
the sound sensor is implantable (abstract),
the sound sensor is configured to output signals representative of the detected physical phenomenon (sound sensor generates an output signal operative to actuate an actuator of a hearing instrument, claim 1; [0033]-[0034]), 
the housing has a tubular portion which establishes an outer boundary of the sound sensor (sound sensor includes a circular perimeter as shown in Figure 3, and a height as shown in Figure 4A, therefore the housing has a tubular portion that establishes the outer boundary of the sound sensor),
and at least one of:
the sound sensor is a tube microphone (Figures 3-4A show the sound sensor housing has a circular perimeter and a height, such that the housing of the sound sensor is tubular, thus the sound sensor is a “tube microphone”); or
the cavity contains a fluid medium (cavity 60 includes “gases”, [0033]; [0050]);
the fluid medium transfer vibrations from the membrane to the internal sensor; and
the physical phenomenon is vibrations of the membrane ([0033]-[0034]; [0043]; [0050]).
	Regarding claim 6, Miller teaches the cavity contains the fluid medium; the fluid medium transfers vibrations of the membrane from the membrane (30) to the internal sensor (50); and the physical phenomenon is vibrations of the membrane (cavity 60 includes “gases”, [0033]-[0034]; [0043]; [0050]).
	Regarding claim 7, Miller teaches the internal sensor (50) is a microphone ([0009]; [0033]-[0034]); and a defined gas layer is positioned between a sensing element of the microphone and the membrane (30) (it is implicit that the microphone 50 includes a sensing element, and wherein there is a defined gas layer formed by the gases within the cavity 60 and tube 40 between the sensing element of the microphone and the membrane 30, [0033]-[0034]; Figure 4A).
	Regarding claim 8, Miller teaches the membrane (30) is only in contact with the walls of the housing (40) ([0033]-[0034]; [0041]; [0043]; Figure 4A).
	Regarding claim 55, Miller teaches the opening is immediately adjacent an ambient environment of the sound sensor (Figure 4A).
	Regarding claim 68, see discussion for claim 1.
Claims 1, 32, 42, 46, 55, 59, 60, 68, and 84 are rejected under pre-AIA  35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication No. 2004/0097785 (Schmid).
Regarding claim 1, Schmid teaches a sound sensor (10) (transducer can selectively be used as an actuator or a sensor to detect vibrations, [0006], [0028]; Figure 3), comprising:
a housing (11) including a cavity having an opening at a first end of the housing (housing 11 includes a cavity for accommodating the permanent magnetic arrangement 15, [0011]-[0012], [0032]-[0033], Figure 3; housing is open at a first housing wherein the membrane 13 is securely, hermetically, and tightly connected to the peripheral wall 12 of the housing, [0032]-[0033], Figure 3); 
a membrane (13) attached to the housing so as to hermetically seal the opening ([0011]-[0012]; [0032]; Figure 3), the membrane being configured to vibrate in response to vibration within a recipient (when configured as a sensor, the membrane 13 of the transducer 10 vibrates in response to vibration of the body part, [0006], [0028]); and
an internal sensor (15, 16), disposed in the housing, the internal sensor being configured to detect a physical phenomenon resulting from movement of the membrane (when configured as a sensor, the membrane 13 of the transducer 10 vibrates in response to vibration of the body part and the internal sensor 15,16 would be configured to detect movement of the membrane to generate vibration signals, [0006], [0028]), wherein 
the sound sensor is implantable ([0006]; [0009]; [0028]), 
the sound sensor is configured to output signals representative of the detected physical phenomenon (when configured as a sensor, the connections 17 are configured to transmit output signals generated by the sensor representative of the detected vibrations, [0006], [0028]; Figure 3),
the housing has a tubular portion which establishes an outer boundary of the sound sensor ([00012]; [0018]; [0032]; Figure 3), and
at least one of:
(a) the sound sensor is a tube microphone ([0012]; [0018]; [0032]; Figure 3); or 
(b) the cavity contains a fluid medium;
the fluid medium transfers vibrations from the membrane to the internal sensor; and
the physical phenomenon is vibrations of the membrane.
Regarding claim 32, Schmid teaches an implantable sound sensor (10) (transducer 10 can selectively be used as an actuator or a sensor to detect vibrations, [0006], [0028]; Figure 3) comprising:
a hermetically sealed enclosure (11) comprising a membrane (13), wherein the hermetically sealed enclosure is biocompatible ([0032]; Figure 3); 
a coupling mechanism (14, [0032]) configured to mechanically couple the membrane with one of:
the malleus, stapes, or incus of a recipient (when configured as a sensor, the coupling mechanism 14 is fully capable of mechanically coupling the membrane 13 to one of the malleus, incus, or stapes (i.e., middle ear ossicles), [0028], [0036]); 
wherein the coupling mechanism is thereby configured to relay to the membrane vibrations experienced by the coupled anatomical feature (when configured as a sensor, the coupling mechanism 14 is fully capable of relaying vibrations of the coupled anatomical feature to the membrane 13, [0028], [0036]); and 
a transducer (15, 16) configured to generate an electrical signal in response to vibrations experienced by the membrane, wherein the transducer is disposed within the hermetically sealed enclosure (when configured as a sensor, the membrane 13 of the transducer 10 vibrates in response to vibration of the body pat and the sensor 15,16 would be configured to detect movement of the membrane and generate vibration signals, [0006], [0028], [0032]).
Regarding claims 42, 46, 59, and 60, Schmid teaches the sound sensor is miniaturized since the space available for implantation is generally extremely limited ([0009]) and that the sound sensor is a circular cylindrical shape ([0018]; [0032]). Therefore, Schmid further teaches that the sound sensor is fully capable of being implanted in a cochlea of the recipient, wherein the recipient is a mammal, in a middle ear of the recipient, or implantable outside of the cochlea. A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
Regarding claim 55, Schmid teaches the opening is immediately adjacent an ambient environment of the sound sensor (the opening hermetically sealed by the membrane is immediately adjacent the ambient environment, Figure 3).
Regarding claim 68, see discussion for claim 1.
Regarding claim 84, Schmid teaches the sound sensor is configured so that when the sound sensor is implanted in a human recipient, the membrane of the sound sensor is located in one of a middle ear or an inner ear of the human recipient (implanted to be coupled to middle ear ossicle, perilymph, or the basilar membrane in the inner ear, [0028]).
Claims 1, 42, 46, 55, 68, and 84 are rejected under pre-AIA  35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication No. 2005/0177204 (Zhang et al., referred to as “Zhang”).
Regarding claim 1, Zhang et al. teaches a sound sensor (abstract; Figure 11), comprising: 
a housing (35) including a cavity having an opening at a first end of the housing (tube 47 attaches at the first end of the housing surrounding an opening in the first end of the housing, Figure 11); 
a membrane (48) attached to the housing so as to hermetically seal the opening ([0079]), the membrane being configured to vibrate in response to vibration within a recipient (Figure 11; [0078]); and
an internal sensor (49), disposed in the housing, the internal sensor being configured to detect a physical phenomenon resulting from movement of the membrane ([0078]-[0079]; Figure 11), wherein 
the sound sensor is implantable, 
the sound sensor is configured to output signals representative of the detected physical phenomenon ([0078]-[0079]),
the housing (35) has a tubular portion which establishes an outer boundary of the sound sensor (housing 35 has a clear diameter and length that defines a tubular portion and that defines an outer boundary of the sound sensor, Figures 10-11), and
at least one of:
(a) the sound sensor is a tube microphone (housing 35 has a clear diameter and length that defines a tubular portion and that defines an outer boundary of the sound sensor, Figures 10-11); or 
(b) the cavity contains a fluid medium;
the fluid medium transfers vibrations from the membrane to the internal sensor; and
the physical phenomenon is vibrations of the membrane.
Regarding claim 42, Zhang teaches the sound sensor is implanted in a cochlea of the recipient, wherein the recipient is a mammal ([0051]; [0056]; [0078]-[0079]; [0081]-[0082]).
Regarding claim 46, Zhang teaches the sound sensor is configured to be  implanted in a recipient such that the membrane is in a middle ear of the recipient ([0051]; [0056]; [0078]-[0079]; [0081]-[0082]).
Regarding claim 55, Zhang teaches the opening is immediately adjacent an ambient environment of the sound sensor (an exterior surface portion of the membrane is in direct contact with the fluid in the body and is only in contact with perilymph fluid from the ambient environment located within the tube 47 of the sound sensor, and wherein the opening is immediately adjacent the perilymph fluid from the ambient environment located within the tube 47: [0078]-[0079]; [0081]-[0082]; Figure 11).
Regarding claim 68, see discussion for claim 1.
Regarding claim 84, Zhang teaches the sound sensor is configured so that when the sound sensor is implanted in a human recipient, the membrane of the sound sensor is located in one of a middle ear or an inner ear of the human recipient (membrane 48 within housing 35, which is located in the cochlea wall, Figures 10-11).
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.

Claims 51 and 58 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid in view of Von Arx.
Regarding claim 51, Schmid teaches all the limitations of claim 32. Schmid further teaches a connection configured to provide the generated signals to one or more other components of the hearing device (when configured as a sensor, the connections 17 are configured to transmit output signals generated by the sensor representative of the detected vibrations to one or more other components of the hearing device, [0006], [0009], [0028]; Figure 3). Schmid does not explicitly teach a transmitter configured to transmit the generated electrical signal to a separate component external to the hermetically sealed enclosure, wherein the transmitter is disposed within the hermetically sealed enclosure.
	However, Von Arx teaches an implantable wireless sound sensor configured to communicate with an implantable medical device (abstract), the sound sensor comprising a tubular or cylindrical biocompatible housing (202) ([0009]; [0027]-[0028]; Figure 2); a membrane ([0029]); a vibrational sensor (206) disposed in the housing and configured to generate signals representative of acoustic waves in the body ([0028]-[0030]; Figure 2); and a transmitter (208) disposed inside the biocompatible housing and configured to provide the generated signals to one or more other components (108) implanted in the recipient ([0030]-[0031]; Figures 1-2). It would have been obvious to one of ordinary skill in the art before the invention was made to substitute the connector of the sound sensor of Schmid with a transmitter disposed in the housing like that which is taught by Von Arx in order to provide wireless transmission of the generated signals to the hearing device, thereby, reducing the number of wires needing to be implanted between components through tissue pathways to improve ease of implantation.
Regarding claim 58, Schmid teaches all the limitations of claim 1. Schmid teaches a connection configured to provide the generated signals to one or more other components of the hearing device (when configured as a sensor, the connections 17 are configured to transmit output signals generated by the sensor representative of the detected vibrations to one or more other components of the hearing device; Figure 3; [0006], [0009], [0028]); and 
the sound sensor is miniaturized since the space available for implantation is generally extremely limited ([0009]) and that the sound sensor is a circular cylindrical shape ([0018]; [0032]). Therefore, Schmid further teaches that the sounds sensor is fully capable of being implanted so as to be exposed to a middle ear cavity or a cochlea that is filled with a fluid. Schmid does not explicitly teach a transmitter configured to transmit a generated electrical signal generated by the internal sensor upon a detection of the physical phenomenon to a separate component external to the housing, wherein the transmitter is disposed within the hermetically sealed housing.
However, Von Arx teaches an implantable wireless sound sensor configured to communicate with an implantable medical device (abstract), the sound sensor comprising a tubular or cylindrical biocompatible housing (202) ([0009]; [0027]-[0028]; Figure 2); a membrane ([0029]); a vibrational sensor (206) disposed in the housing and configured to generate signals representative of acoustic waves in the body ([0028]-[0030]; Figure 2); and a transmitter (208) disposed inside the biocompatible housing and configured to provide the generated signals to one or more other components (108) implanted in the recipient ([0030]-[0031]; Figures 1-2). It would have been obvious to one of ordinary skill in the art before the invention was made to substitute the connector of the sound sensor of Schmid with a transmitter disposed in the housing like that which is taught by Von Arx in order to provide wireless transmission of the generated signals to the hearing device, thereby, reducing the number of wires needing to be implanted between components through tissue pathways to improve ease of implantation.
Claims 38, 79, and 80 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid in view of Von Arx and Miller.
Regarding claim 38, Schmid teaches a sound sensor (10) implantable in a recipient of a hearing device (transducer can selectively be used as an actuator or a sensor to detect vibrations, [0006], [0028]; Figure 3), the sound sensor comprising: 
a biocompatible housing (11) comprising a cavity having an opening at a first end of the housing (housing 11 includes a cavity for accommodating the permanent magnetic arrangement 15, [0011]-[0012], [0032]-[0033], Figure 3; housing is open at a first housing wherein the membrane 13 is securely, hermetically, and tightly connected to the peripheral wall 12 of the housing, [0032]-[0033], Figure 3); 
a membrane (13) attached to the housing so as to hermetically seal the opening ([0011]-[0012]; [0032]; Figure 3), the membrane being configured to vibrate in response to vibration of a structure of the recipient's middle or inner ear (when configured as a sensor, the membrane 13 of the transducer 10 vibrates in response to vibration of the body part, the coupling mechanism 14 is fully capable of relaying vibrations of the middle ear ossicles to the membrane 13; [0006]; [0028]; [0036]; Figure 3); 
the housing is configured to be implanted in rigid contact with a muscle or bone that has a large mass compared to the mass of the sensor ([0028]; [0036]); 
a second coupling mechanism (14) configured to mechanically couple the membrane to the structure of the recipient's middle or inner ear (when configured as a sensor, the coupling mechanism 14 is fully capable of mechanically coupling the membrane 13 to one of the middle ear ossicles, [0028]; [0032]; [0036]; Figure 3); 
a vibrational sensor (15, 16), disposed in the housing ([0032]-[0033]; Figure 3), the vibrational sensor being configured to: 
detect vibrations of the membrane; and 
generate signals representative of the detected vibrations (when configured as a sensor, the membrane 13 of the transducer 10 vibrates in response to vibration of the body part and the sensor 15, 16 would be configured to detect movement of the membrane and generate vibration signals, [0006], [0028]);
	a connection configured to provide the generated signals to one or more other components of the hearing device (when configured as a sensor, the connections 17 are configured to transmit output signals generated by the sensor representative of the detected vibrations to one or more other components of the hearing device, [0006], [0009], [0028]; Figure 3).
	Schmid is silent to a first coupling mechanism configured to mechanically couple the housing to the stationary bony structure of the recipient; and a transmitter disposed inside the biocompatible housing and configured to provide the generated signals to one or more other components implanted in the recipient.
However, Von Arx teaches an implantable wireless sound sensor configured to communicate with an implantable medical device (abstract), the sound sensor comprising a tubular or cylindrical biocompatible housing (202) ([0009]; [0027]-[0028]; Figure 2); a membrane ([0029]); a vibrational sensor (206) disposed in the housing and configured to generate signals representative of acoustic waves in the body ([0028]-[0030]; Figure 2); and a transmitter (208) disposed inside the biocompatible housing and configured to provide the generated signals to one or more other components (108) implanted in the recipient ([0030]-[0031]; Figures 1-2). It would have been obvious to one of ordinary skill in the art before the invention was made to substitute the connector of the sound sensor of Schmid with a transmitter disposed in the housing like that which is taught by Von Arx in order to provide wireless transmission of the generated signals to the hearing device, thereby, reducing the number of wires needing to be implanted between components through tissue pathways to improve ease of implantation. As noted above, Schmid teaches the housing being configured to be implanted in rigid contact with a muscle or bone that has a large mass compared to the mass of the sensor ([0028]; [0036]). However, Schmid as modified by Von Arx does not explicitly teach a first coupling mechanism configured to mechanically couple the housing to a stationary bony structure of the recipient.
However, Miller teaches a transducer (108) (Figure 1) implantable in a recipient of a hearing device (Figures 1 and 4A; claim 1), a transducer (108) (Figure 1); a first coupling mechanism (110, 116) configured to mechanically couple the housing of the transducer to a stationary bony structure of the recipient (Figure 1; [0030]); and a second coupling mechanism (112) configured to mechanically coupled to transducer to a structure of the recipient’s middle ear (120) ([0030]; Figure 1). It would have been obvious to one of ordinary skill in the art before the invention was made to provide the housing of Schmid, as modified by Von Arx, with a first coupling mechanism for mechanically coupling the housing to the stationary bone of the recipient like taught by Miller in order to yield predictable results in maintaining rigid contact with the bone (Schmid: [0028]; Miller: [0030]).
Regarding claims 79 and 80, Schmid in view of Von Arx and Miller teaches all the limitations of claim 38. Schmid teaches the vibrational sensor (15, 16) is a microphone or a pressure sensitive transducer configured to generate an electrical signal in response to detected pressure waves (sensor detects vibrations which may be caused by sound and outputs electrical signals representative of the vibrations, thus may function as a microphone or pressure sensitive transducer, [0028], [0046]; Figure 3).
Claims 34, 44, 50, and 86 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid.
Regarding claims 34, 44, and 86, Schmid teaches all the limitations of claim 1 or 32. Schmid teaches the sound sensor is miniaturized since the space available for implantation is generally extremely limited ([0009]) and that the sound sensor is a circular cylindrical shape ([0018]; [0032]). However, Schmid is silent to an aspect ratio of less than or equal to 0.75. However, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the device of Schmid to have an aspect ratio of less than or equal to 0.75 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Schmid would not operate differently with the claimed aspect ratio since modifying the aspect ratio of the sound sensor (i.e., modifying the relative dimensions of the housing 12) would not affect the way signals are generated based on vibrations of the membrane or the ability for the sensor to be implanted into the generally limited space required for implantation, as recognized by Schmid ([0009]).
Regarding claim 50, Schmid teaches all the limitations of claim 1. Schmid teaches the sound sensor is miniaturized since the space available for implantation is generally extremely limited ([0009]) and that the sound sensor is a circular cylindrical shape ([0018]; [0032]). However, Schmid is silent to an aspect ratio of less than or equal to 0.4. However, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the device of Schmid to have an aspect ratio of less than or equal to 0.4 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Schmid would not operate differently with the claimed aspect ratio since modifying the aspect ratio of the sound sensor (i.e., modifying the relative dimensions of the housing 12) would not affect the way signals are generated based on vibrations of the membrane or the ability for the sensor to be implanted into the generally limited space required for implantation, as recognized by Schmid ([0009]).
Claims 44, 50, 75, 78, and 86 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Miller.
Regarding claim 44, Miller teaches all the limitations of claim 1. Miller teaches the dimensions and shape of the sound sensor may be adjusted to “effect the frequency response of the diaphragm”, as needed ([0048]). Miller is silent to an aspect ratio that is less than or equal to 0.75. However, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the device of Miller to have an aspect ratio less than or equal to 0.75 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Miller would not operate differently with the claimed aspect ratio since modifying the aspect ratio of the sound sensor (i.e., modifying the relative dimensions of the housing) would not negatively affect the way signals are generated based on vibrations of the membrane or the ability for the sensor to be implanted into the generally limited space required for implantation, since Miller recognizes the shape and dimensions of the sound sensor are adjustable to achieve a desired acoustic response ([0048]).
Regarding claim 50, Miller teaches all the limitations of claim 1. Miller teaches the dimensions and shape of the sound sensor may be adjusted to “effect the frequency response of the diaphragm”, as needed ([0048]). Miller is silent to an aspect ratio that is less than or equal to 0.4. However, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the device of Miller to have an aspect ratio less than or equal to 0.4 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Miller would not operate differently with the claimed aspect ratio since modifying the aspect ratio of the sound sensor (i.e., modifying the relative dimensions of the housing) would not negatively affect the way signals are generated based on vibrations of the membrane or the ability for the sensor to be implanted into the generally limited space required for implantation, since Miller recognizes the shape and dimensions of the sound sensor are adjustable to achieve a desired acoustic response ([0048]).
Regarding claim 75, 78, and 86, Miller teaches all the limitations of claims 1 and 7. Miller teaches the dimensions and shape of the sound sensor may be adjusted to “effect the frequency response of the diaphragm”, as needed ([0048]). Miller is silent to an aspect ratio that is smaller than 1. However, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the device of Miller to have an aspect ratio smaller than 1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. Tec Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Miller would not operate differently with the claimed aspect ratio since modifying the aspect ratio of the sound sensor (i.e., modifying the relative dimensions of the housing) would not negatively affect the way signals are generated based on vibrations of the membrane or the ability for the sensor to be implanted into the generally limited space required for implantation, since Miller recognizes the shape and dimensions of the sound sensor are adjustable to achieve a desired acoustic response ([0048]).
Claim 81 is rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid in view of U.S. Patent No. 5,814,095 (Müller et al., herein referred to as “Müller”).
Regarding claim 81, Schmid teaches all the limitations of claim 32. Schmid does not teach the transducer is an electret microphone.
However, Müller teaches an implantable sound sensor of an implantable hearing aid (abstract), comprising: a hermetically sealed enclosure comprising a membrane (5) , wherein the hermetically sealed enclosure is biocompatible; a transducer (15) configured to generate an electrical signal in response to vibrations experienced by the membrane, wherein the transducer is disposed within the hermetically sealed enclosure; and wherein the transducer is an electret microphone (col. 8, lines 24-35; col. 9, lines 29-57; Figure 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electret microphone of Müller for the electromagnetic transducer of Schmid, because Müller teaches electromagnetic and electret microphones are substitutable alternative microphone types for converting vibration into electrical signals in an implantable hearing aid (claim 12; col. 8, lines 30-33). 
Claim 82 and 83 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid in view of U.S. Patent Application Publication No. 2005/0197524 (Miller, III et al., herein referred to as “Miller ‘524”).
Regarding claims 82 and 83, Schmid teaches all the limitations of claim 32. Schmid does not specify the vibrational sensor is vibrationally isolated from a remainder of the sound sensor and its motion.
However, Miller ‘524 teaches an implantable sound sensor for a hearing aid (abstract), comprising: a vibrational sensor (10) that is vibrationally isolated from motion of the sound sensor, and from a remainder of the sound sensor (100) ([0020]; microphone 10 vibrationally isolated from housing 100, [0058]; [0078]; Figures 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sound sensor of Schmid such that the vibrational sensor is vibrationally isolated from motion of the sound sensor as taught by Miller ‘524, because Miller ‘524 teaches providing such vibration isolation “preserves the microphone’s sensitivity to ambient sound vibrations” while isolating the microphone from non-ambient vibrations received by the sensor housing ([0020]). 
Claims 87 and 88 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid in view of Von Arx and Miller as applied to claim 38 above, and further in view of Miller ‘524.
Regarding claims 87 and 88, Schmid in view of Von Arx and Miller teaches all the limitations of claim 38. Schmid as modified does not specify the vibrational sensor is vibrationally isolated from a remainder of the sound sensor and its motion.
However, Miller ‘524 teaches an implantable sound sensor for a hearing aid (abstract), comprising: a vibrational sensor (10) that is vibrationally isolated from motion of the sound sensor, and from a remainder of the sound sensor (100) ([0020]; microphone 10 vibrationally isolated from housing 100, [0058]; [0078]; Figures 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the sound sensor of Schmid, Von Arx, and Miller such that the vibrational sensor is vibrationally isolated from motion of the sound sensor as taught by Miller ‘524, because Miller ‘524 teaches providing such vibration isolation “preserves the microphone’s sensitivity to ambient sound vibrations” while isolating the microphone from non-ambient vibrations received by the sensor housing ([0020]). 
Claim 95 is rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Schmid as applied to claim 32 above, and further in view of Miller.
Regarding claim 95, Schmid teaches all the limitations of claim 32. Schmid teaches the sound sensor is a means for sensing sound while implanted in the recipient as part of a hearing aid ([0006]; [0028]). Schmid does not disclose the additional components of an implantable hearing prosthesis, comprising an implantable sound processor, and an implantable stimulator unit configured to generate stimulation signals for delivery to the recipient.
However, Miller teaches an implantable hearing prosthesis, comprising: (Miller: Figure 1), comprising: a sound sensor (10) ([0033]-[0034]; Figure 1); and an implantable sound processor (Figure 1; “signal processor”, [0029], [0031]); and an implantable stimulator unit (108) configured to generate stimulation signals for delivery to the recipient, wherein the implantable sound processor and/or the implantable stimulator unit is in signal communication with the sound sensor (10), and the implantable sound sensor is a means for sensing sound while implanted in the recipient (Miller: [0029]-[0031]; Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the sound sensor of Schmid in an implantable hearing prosthesis comprising the sound sensor for sensing sound while implanted in the recipient, an implantable sound processor, and an implantable stimulator unit configured to generate stimulation signals for delivery to the recipient, wherein the processor and/or the stimulation unit is in signal communication with the sound processor, as taught by Miller, in order to provide an implantable hearing prosthesis for improving hearing for the recipient (Miller: [0028]-[0029]), as desired by Schmid (“implantable hearing aid”, [0002], [0006], [0028]).
Response to Arguments
Applicant's arguments filed 13 February 2025 have been fully considered but they are not persuasive. 
Applicant contends the rejections under 35 U.S.C. 101 are improper as there is allegedly no basis for dependent claims to remain rejected because a mammal encompasses a human (arguments, pages 13, 14, 17, and 18). The examiner does not find these arguments to be persuasive. Claims 42 and 70 positively recite a human, thus are nonstatutory. See remarks in previous Office action, and pages 6-8 of the Board decision mailed 22 December 2023. Applicant remains invited to amend claims 42 and 70 to include “configured to”, or as noted by the Board, “implantable” or “placeable”, in order to overcome these rejections.
Applicant contends the rejections of claims 7, 65, and 67 under 35 U.S.C. 112, 2nd paragraph, are improper as the claim limitations are merely broad, rather than indefinite (arguments, pages 15-17). The examiner does not find these arguments to be persuasive. As detailed in the rejections above, these claims are indefinite as they each raise the question of whether applicant intends to reference a same or different element than is previously claimed. This lack of clarity in scope renders the claims indefinite, rather than merely broad. Applicant asserts the rejections of claims 65 and 67 in the prior Office action are due to a personnel change, and are simply “the preference of the new Examiner” (arguments, pages 16-17). The examiner notes claims 65 and 67 were similarly rejected in the non-final Office action of 19 March 2024, written by the previous examiner.
Applicant generally contends the rejections under 35 U.S.C. 102 citing Miller have been overcome by amendment (arguments, page 19). Applicant’s remarks merely asserting the reference fails to meet the claim without a substantive evidenced rebuttal are unpersuasive. See detailed rejections citing Miller above.
Applicant contends the rejections under 35 U.S.C. 102 citing Schmid are overcome as “Schmid is not our claim”, generally asserting Schmid operates differently than applicant’s invention (arguments, pages 19-20). Appellant’s remarks merely asserting the reference fails to meet the claim without a substantive evidenced rebuttal are unpersuasive. See detailed rejections citing Schmid above.
Applicant contends Zhang does not anticipate the claims, generally stating “[t]he PTAB determined that the rejections in view of Zhang were bad” (arguments, page 20). The examiner does not find this argument to be persuasive. The Board decision of 22 December 2023 states their decision to not sustain the examiner’s rejections citing Zhang is “based solely on the indefiniteness of the claimed subject matter” and “does not reflect on the adequacy of the prior art evidence applied in support of the rejection” (Board decision, page 15). See rejections citing Zhang above.
Applicant contends the rejections under 35 U.S.C. 103 citing at least Von Arx are improper as there is insufficient motivation for the proposed combinations. Particularly, applicant contends the rejections citing Von Arx do not set forth a prima facie case of obviousness because a reduction of wires as a rationale is “nebulous”, without reasoning, and would result in increased power consumption among other purported disadvantages (arguments, pages 21-23). The examiner does not find these arguments to be persuasive. Von Arx is relied upon to teach the benefit of wireless transmission in order to reduce the number of wires extending between implanted components through tissue pathways, in order to improve the ease of implantation. The proposed combination does not address assumptions in power consumption, structural redundancy, etc. as asserted by applicant, but rather is based on the benefit of easing implantation.
Applicant’s arguments, see pages 14-15, filed 13 February 2025, with respect to the rejection of claim 74 under 35 U.S.C. 112, second paragraph, have been fully considered and are persuasive upon reconsideration of the claim language.  The rejection of 13 November 2024 has been withdrawn. 
Applicant’s arguments, see page 20, filed 13 February 2025, with respect to the rejection of claim 21 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the amendments to the claims.  The rejection of 13 November 2024 has been withdrawn. 
Allowable Subject Matter
Claims 20-23, 47, 49, 61, 62, 71, and 77 are allowed for the reasons noted in the prior Office action with respect to claim 76.
Claim 52, 53, 74, 85, and 89-94 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.
Claim 70 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, or 35 U.S.C. 101, respectively, set forth in this Office action and to include 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:  
No prior art of record teach and/or fairly suggest the implantable sound sensor of claim 52, wherein the sound sensor is configured to mechanically couple the membrane with one of the malleus, stapes, incus, oval window, or round window of the recipient, within the context of all of parent claims 1 and 6.
No prior art of record teach and/or fairly suggest the implantable sound sensor of claim 53, wherein a hermetically sealed enclosure established by the housing and the membrane corresponding to the cavity includes the fluid medium, which is separate and distinct from body fluid of the recipient, which fluid medium transmits vibrations of the membrane that travel through the fluid in the body to the internal sensor, within the context of all of parent claims 1, 46, and 59.
No prior art of record teach and/or fairly suggest the sound sensor of claim 70, wherein the entirety of the sound sensor is implantable in the recipient to be located outside of the cochlear, wherein the recipient is a mammal, within the context of all of parent claims 1 and 46.
No prior art of record teach and/or fairly suggest the implantable sound sensor of claim 74, wherein electrical wires lead from the transmitter, which electrical wire conduct the transmitted signal to the exterior of the sound sensor, within the context of all of parent claims 32 and 51.
No prior art of record teach and/or fairly suggest the sound sensor of claim 85, wherein the sound sensor is configured so that when the sound sensor is implanted in a human recipient, the membrane of the sound sensor is located in one of a middle ear or in an inner ear of the human recipient, within the context of all of parent claims 1 and 8.
No prior art of record teach and/or fairly suggest the sound sensor of claim 89 or 92, wherein the membrane is in vibrational communication with the vibrational sensor or transducer by fluid communication, within the context of al of parent claim 32 or 38, as applicable.
No prior art of record teach and/or fairly suggest the sound sensor of claim 90 or 93, wherein the vibrational sensor or transducer detects vibrations of the membrane by way of a gas medium between the membrane and the vibration sensor or transducer, within the context of all of parent claim 32 or 38, as applicable.
No prior art of record teach and/or fairly suggest the sound sensor of claim 91 or 94, wherein the only moving parts of the sound sensor are the membrane and the second coupling mechanism when the membrane vibrates, within the context of all of parent claim 32 or 38, as applicable.
Conclusion
The examiner notes that, though no art has been applied against claims 65, 67, 73 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous clarity issues noted above.
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 Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791