DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office Action is responsive to the Amendment filed 04 May 2026. Claims 21-31, 33-37, 39, and 42-48 are currently under consideration. The Office acknowledges the amendments to claims 24, 29-31, and 34, as well as the cancellation of claims 32, 38, 40, and 41, and the addition of new claims 42-48.
Claim Objections
Claims 45 and 47 are objected to because of the following informalities:
In claim 45, line 4: “two noise sensor” should apparently read --two noise sensors--.
In claim 47, line 2: “the two noise sensors” should apparently read --the at least two noise sensors--.
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 31, 33-37, 39, 42, 43, 45-48 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 31 recites the limitation "the second output" in line 8. There is insufficient antecedent basis for this limitation in the claim; only a first output and an output from a second sensor have been previously recited.
Claims 33-37, 39, 42, and 43 are rejected by virtue of their dependence upon claim 31.
Claim 45 recites the limitation “the other of the two noise sensors” in line 4. The claim previously recites “at least two noise sensors” so it is not clear which sensor is being referred to here. Suggested language would be --a first noise sensor at least two noise sensors is located relatively close to the external sound sensor as compared to a second noise sensor at least two noise sensors, and the second first sensor
Claims 46 and 47 are rejected by virtue of their dependence upon claim 45.
Claim 48 recites the limitation “the system uses output from the third sensor and the first sensor improve the generated signal” in lines 2-3. There appears to be missing language from this limitation. This will be taken herein to recite --the system uses output from the third sensor and the first sensor to improve the generated signal--.
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 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 21-25, 31, 34, and 39 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dalton et al. (U.S. Pub. No. 2007/0161848 A1; hereinafter known as “Dalton”).
Regarding claim 21, Dalton discloses a system (Abstract; Figs. 2-4), comprising: a plurality of sensors, including at least a first implantable sensor 208A/402, operative to receive input and generate a first output signal in response thereto, and a second sensor 208B/408 operative to receive input and generate a second output signal in response thereto; an implantable processor 234/404, operatively in signal communication with said first sensor and said second sensor, configured to use said first output signal and said second output signal to generate a signal; and an implantable device 140, operatively interconnected to said processor, adapted to effect a recipient of the system in response to said generated signal ([0024]; [0027]; [0041]; [0044]-[0046]).
Regarding claim 22, Dalton discloses that the implantable processor is operatively wiredly interconnected to said first sensor (Figs. 2D, 4; [0033]; e.g., coupled by lead lines).
Regarding claim 23, Dalton discloses that said first sensor has a first predetermined minimum sensitivity, wherein said second sensor has a second predetermined minimum sensitivity different from the first predetermined minimum sensitivity ([0041]; [0044]-[0046]; sensitivities will be different where the vibrating surfaces are different in the embodiment of Fig. 2D, or in the embodiment of Fig. 4 where the interferometer is tuned to be sensitive to body noises, while the implanted microphone is of high sensitivity so as to detect airborne sound from beneath the skin).
Regarding claims 24 and 25, Dalton discloses that said first sensor has a first predetermined minimum sensitivity across a first predetermined range of a phenomena, wherein said second sensor has a second predetermined minimum sensitivity across a second range of the phenomena, wherein said first and second predetermined ranges are at least partially non-overlapping ([0041]; [0044]-[0046]; separate frequency ranges).
Regarding claim 31, Dalton discloses a method for use with a medical system including a device implanted in a recipient (Abstract), comprising: receiving with an implanted processor 234/404 a first signal based on a first output from a first sensor 208A/402 at a first implanted location of the recipient, wherein said first sensor is operative to receive input and generate the first output in response thereto; receiving with the implanted processor a second signal based on an output from a second sensor 208B/408 offset from said first implanted location, wherein said second sensor is operative to receive input and generate the second output in response thereto; generating by the implanted processor, based on at least one of the first signal or the second signal, a processor output signal, the processor output signal being a signal based upon which the implanted device can be operated ([0024]; [0027]; [0041]; [0044]-[0046]).
Regarding claim 34, Dalton discloses that the second sensor is implanted at a location offset from the first sensor ([0044]; located in a different housing).
Regarding claim 39, Dalton discloses executing combinative processing of the first and second signals to ultimately improve the processor output signal ([0041]; [0044]-[0046]; processor output signal is based on two frequency ranges or on ambient sound with body noises removed, which improves the output signal beyond that using a single signal).
Claims 21, 27-29, 31, 33, 35, 37, 42, and 48 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hlavka et al. (U.S. Pub. No. 2013/0345700 A1; hereinafter known as “Hlavka”).
Regarding claim 21, Hlavka discloses a system (Abstract), comprising: a plurality of sensors, including at least a first implantable sensor, operative to receive input and generate a first output signal in response thereto, and a second sensor operative to receive input and generate a second output signal in response thereto; an implantable processor 102/202, operatively in signal communication with said first sensor and said second sensor, configured to use said first output signal and said second output signal to generate a signal; and an implantable device, operatively interconnected to said processor, adapted to effect a recipient of the system in response to said generated signal ([0053]; [0057]-[0059]; [0065]; [0126]-[0130]; [0133]; [0142]-[0146]; e.g., implantable device is a nerve cuff/electrode, which effects its recipient based on the blocking signal; the blocking signal is based on various implantable/external sensors, including a physical activity sensor, a bronchial diameter sensor, a sleep/posture sensor, a cough sensor, and a mucus sensor).
Regarding claim 27, Hlavka discloses that the plurality of sensors includes at least a third sensor that is an external sensor operative to receive input directly from an ambient environment of the recipient and generate a third output signal in response thereto ([0065]; [0130]; e.g., the cough sensor may be an external microphone, which receives input sounds from the ambient environment).
Regarding claim 28, Hlavka discloses that the second sensor is an external sensor ([0130]; [0133]; external sensors).
Regarding claim 29, Hlavka discloses that the implantable processor is operatively wiredly interconnected to said first sensor ([0057]; [0065]; [0087]; [0126]; sensor/electrode coupled to implantable signal generator; coupling can be by electrical leads) and the second sensor is an external sensor ([0130]; [0133]; external sensors).
Regarding claim 31, Hlavka discloses a method for use with a medical system including a device implanted in a recipient (Abstract), comprising: receiving with an implanted processor 102/202 a first signal based on a first output from a first sensor at a first implanted location of the recipient, wherein said first sensor is operative to receive input and generate the first output in response thereto; receiving with the implanted processor a second signal based on an output from a second sensor offset from said first implanted location, wherein said second sensor is operative to receive input and generate the second output in response thereto; generating by the implanted processor, based on at least one of the first signal or the second signal, a processor output signal, the processor output signal being a signal based upon which the implanted device can be operated ([0053]; [0057]-[0059]; [0065]; [0126]-[0130]; [0133]; [0142]-[0146]; e.g., implantable device is a nerve cuff/electrode, which effects its recipient based on the blocking signal; the blocking signal is based on various implantable/external sensors, including a physical activity sensor, a bronchial diameter sensor, a sleep/posture sensor, a cough sensor, and a mucus sensor).
Regarding claim 33, Hlavka discloses that the second sensor is a sensor external to the recipient ([0130]; [0133]; external sensors).
Regarding claim 35, Hlavka discloses that the second signal is a signal from an external processor ([0067]; [0131]-[0132]).
Regarding claim 37, Hlavka discloses that the first sensor has a body interfacing architecture that is different from any such architecture of the second sensor (e.g., an implantable bronchial diameter sensor has a different body interfacing architecture than an external microphone or accelerometer).
Regarding claim 42, Hlavka discloses that the implantable processor is operatively wiredly interconnected to said first sensor ([0057]; [0065]; [0087]; [0126]; sensor/electrode coupled to implantable signal generator; coupling can be by electrical leads) and the second sensor is located external to the recipient ([0130]; [0133]; external sensors).
Regarding claim 48, Hlavka discloses a third sensor that is an implantable sensor and the system uses output from the third sensor and the first sensor to improve the generated signal ([0065]; [0133]; [0137]-[0146]; e.g., third sensor can be an additional cough sensor or mucus sensor; combination of sensors improves the generated signal by inhibiting nerve traffic/muscle contraction/cough and inhibiting mucus production or by temporarily ceasing the signal until mucus is cleared).
Claims 21, 22, 30, 31, 36, and 44 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lesinski et al. (U.S. No. 5,881,158; hereinafter known as “Lesinski”).
Regarding claim 21, Lesinski discloses a system (Abstract; Fig. 6), comprising: a plurality of sensors, including at least a first implantable sensor 50, operative to receive input and generate a first output signal in response thereto, and a second sensor 50 operative to receive input and generate a second output signal in response thereto; an implantable processor 30/100, operatively in signal communication with said first sensor and said second sensor, configured to use said first output signal and said second output signal to generate a signal; and an implantable device 32, operatively interconnected to said processor, adapted to effect a recipient of the system in response to said generated signal (col. 4, lines 20-26; col. 4, lines 39-55; col. 6, lines 22-29; col. 7, lines 19-37).
Regarding claim 22, Lesinski discloses that the implantable processor is operatively wiredly interconnected to said first sensor (col. 4, lines 23-27; col. 5, lines 52-56; col. 6, lines 29-35).
Regarding claim 30, Lesinski discloses that the implantable processor is configured to implement beamforming and/or directionality functionality based in the first output signal and the second output signal (col. 7, lines 29-37).
Regarding claim 31, Lesinski discloses a method for use with a medical system including a device implanted in a recipient (Abstract; Fig. 6), comprising: receiving with an implanted processor 30/100 a first signal based on first output from a first sensor 50 at a first implanted location of the recipient, wherein said first sensor is operative to receive input and generate the first output in response thereto; receiving with the implanted processor a second signal based on output from a second sensor 50 offset from said first implanted location, wherein said second sensor is operative to receive input and generate second output in response thereto; generating by the implanted processor, based on at least one of the first signal or the second signal, a processor output signal, the processor output signal being a signal based upon which the implanted device can be operated (col. 4, lines 20-26; col. 4, lines 39-55; col. 6, lines 22-29; col. 7, lines 19-37).
Regarding claim 36, Lesinski discloses using the first and second signal for beamforming and/or directionality purposes (col. 7, lines 29-37).
Regarding claim 44, Lesinski discloses that the first sensor includes a diaphragm 52 that receives vibrations (col. 5, lines 15-22).
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 21-25, 30-32, 34, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7 of U.S. Patent No. 8,771,166. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claim 1 of the issued patent includes each of the limitations of present claims 21 and 23-25. Claim 3 of the issued patent maps to present claim 22, while claim 7 of the issued patent maps to present claims 30 and 36. Claim 2 of the issued patent maps to present claims 31, 32, and 34.
Claims 21-25, 31, 32, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 9,635,472. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claim 1 of the issued patent includes each of the limitations of present claim 21. Claim 5 of the issued patent maps to present claim 22, while claim 2 of the issued patent maps to present claims 23-25. Claim 4 of the issued patent maps to present claims 31, 32, and 34. 14.
Claims 21-31, 33-37, 39, 42, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, 8, 10, 11, and 16-25 of U.S. Patent No. 10,516,953. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claims 1, 8, and 11 of the issued patent include each of the limitations of present claims 21 and 31. Claim 10 of the issued patent maps to present claim 22, while claim 2 of the issued patent maps to present claims 23-25. Claim 5 of the issued patent maps to present claims 26, 27, and 43, while claims 7, 10, and 16 of the issued patent map to present claims 28, 29, 33, and 42. Claims 19 and 25 of the issued patent map to present claims 30 and 36. Claim 17 of the issued patent maps to present claim 34, while claim 18 of the issued patent maps to present claim 35. Finally, claims 20 and 22 of the issued patent map to present claims 37 and 41, respectively.
Claims 21-31, 33-37, 39, 42, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7-9, 11, 13, 15-24, and 28 of U.S. Patent No. 11,577,078. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claims 1 and 9 of the issued patent include each of the limitations of present claims 21, 31, and 34. Claims 11 and 12 of the issued patent map to present claim 22, while claim 5 of the issued patent maps to present claims 23-25. Claims 7 and 28 of the issued patent map to present claims 26, 27, and 43, while claims 8, 11, and 12 of the issued patent map to present claims 28, 29, 33, and 42. Claims 18 and 24 of the issued patent map to present claims 30 and 36. Claim 17 of the issued patent maps to present claim 35. Finally, claims 19 and 21 of the issued patent map to present claims 37 and 39, respectively.
Allowable Subject Matter
Claim 26 would be allowable if the double patenting rejections set forth in this Office action are overcome and if rewritten to include all of the limitations of the base claim and any intervening claims.
Claim 43 would be allowable if the double patenting rejections set forth in this Office action are overcome and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 45-47 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 26 and 43, as detailed previously, none of the prior art of record teaches or reasonably suggests such a third, external sensor that receives input directly from an ambient environment of the recipient and generates a third output signal in response thereto, while the second sensor transcutaneously receives the input indirectly from the ambient environment and generates the second output signal in response thereto, in combination with the other recited components. Regarding claims 45-47, none of the prior art of record teaches or reasonably suggests such an implantable auditory stimulation system that includes a first processing circuit with an external sound sensor, along with a second processing circuit with at least two noise sensors, one of the noise sensors being located closer to the external sound sensor than another one of the noise sensors, and wherein the two circuits cooperate to reduce body conduction noise received by the system.
Response to Arguments
Applicant’s arguments with respect to the objections to the specification and the claims, as well as the rejections under 35 U.S.C. 112(b), have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C. 102 have been fully considered but they are not persuasive. Applicant argues that Dalton fails to teach that implantable device 140 is presented in the background and is not operatively interconnected to the processor. The examiner disagrees. Dalton teaches, for example, that Fig. 2A is an exemplary embodiment of implant assembly 152, which includes 140. Implant 152 generates coded signals provided to a stimulator unit that applies the coded signal along 140, thus being operatively interconnected thereto. Electronic assembly 234 is taught to include integrated circuits that perform operations and functions such as signal processing and electrode stimulation.
Applicant next argues that Hlavka is not prior art. Applicant alleges that Hlavka may claim priority via provisional applications but the subject matter must have been claimed in the non-provisional. The effective priority date of the present application is 29 May 2009 (via, incidentally, its provisional application). Hlavka is a continuation of application 12/372,607, which was filed on 17 February 2009. Thus, Hlavka has an earlier effective priority date, without any reference to its provisional applications. Applicant also argues that the rejection of Hlavka does not properly or adequately inform Applicant why the claims were regarded as defective. This is apparently based upon a citation of Hlavka’s abstract. However, if Applicant scrolls down slightly farther in the rejection, there are numerous form paragraphs cited, along with a parenthetical explanation of how the various components are interpreted. The sensors are discussed in both the rejection of claim 21 and claim 31.
Applicant then turns to Lesinski. Applicant argues that the same element 50 is cited for both the first and second implantable sensors, which Applicant says cannot be anticipation. The examiner disagrees. The cited portions of Lesinski describe multiple implantable sensors (e.g., an array of individual implantable microphones), which are all given the same reference number 50.
Applicant argues claim 27 next, which allegedly does not teach a third sensor. As noted, Hlavka teaches numerous different sensors that may be included as part of its system; one of these sensors may be an external microphone and described as “third” while other, implantable, sensors may be “first” and “second.”
Applicant moves on to claim 37, arguing that there is no rationale for the finding asserted in the parenthetical. The examiner disagrees. The different types of sensors necessarily comprise different components and architecture and so meet the claim language.
Applicant argues that, regarding claim 35, there is no teaching of the second signal being a signal from an external processor. The cited paragraphs specifically recite an external device that can receive input from a user, such as a device programmer or other clinician operated device, that provide a signal. Such devices are asserted to comprise such a generic external processor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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