DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: Applicant is requested to amend the first paragraph of the specification to indicate that parent application 16/713,328 has now issued as U.S. Patent No. 11,577,078.
Appropriate correction is required.
Claim Objections
Claims 30-32 and 34 are objected to because of the following informalities:
In claim 30, line 3: “based on” should apparently read --based in--.
In claim 31, line 3: “based on first output” should apparently read --based on a first output--.
In claim 31, line 6: “based on output” should apparently read --based on an output--.
In claim 32, line 2: “e” should apparently be deleted between “includes” and “generating.”
In claim 34, line 1: “second sensor” should apparently read --the second sensor--.
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 24, 25, 29, and 31-41 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 24 recites the limitation “a phenomena” in lines 3-4. It is not clear if this is intended to be the same phenomena recited in line 2 or to be a separate phenomena.
Claim 25 is rejected by virtue of its dependence upon claim 24.
Claim 29 recites the limitation "the second microphone" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this is intended to implicitly recite a first microphone.
Claim 31 recites the limitation “second output” in line 8. It is not clear if this is intended to be the same output recited in line 6 or to be a separate output.
Claims 32-41 are rejected by virtue of their dependence upon claim 31.
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, 32, 34, and 38-41 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 a 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 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 output from a second sensor 208B/408 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 ([0024]; [0027]; [0041]; [0044]-[0046]).
Regarding claim 32, Dalton discloses that the action of generating the processor output signal includes generating the processor output signal based on the received first signal and the second signal ([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 38, Dalton discloses using the first and second signals to enhance the generation of the processor output signal beyond that which would be the case if only one of the first signal or second signal was available ([0041]; [0044]-[0046]; processor output signal is based on two frequency ranges or on ambient sound with body noises removed, which enhances the output signal beyond that using a single signal).
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).
Regarding claim 40, Dalton discloses executing combinative processing of the first and second signals to enhance the processor output signal, where the second sensor is implanted in the recipient ([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).
Regarding claim 41, Dalton discloses executing combinative processing of the first and second signals to generate the processor output signal ([0041]; [0044]-[0046]; processor output signal is based on two frequency ranges or on ambient sound with body noises removed).
Claims 21, 27, 28, 31, 33, 35, and 37 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 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 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 output from a second sensor 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 ([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).
Claims 21, 30, 31, and 36 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 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).
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.
Claims 21-41 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, 31, and 32. 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 and 27, while claims 7, 10, and 16 of the issued patent map to present claims 28, 29, and 33. 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 20-24 of the issued patent map to present claims 37-41, respectively.
Claims 21-41 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, 32, 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 and 27, while claims 8, 11, and 12 of the issued patent map to present claims 28, 29, and 33. 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 19-23 of the issued patent map to present claims 37-41, respectively.
Allowable Subject Matter
Claim 26 would be allowable if the double patent 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 29 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, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and if the double patent rejections set forth in this Office action are overcome.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 26, 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 generate the second output signal in response thereto, in combination with the other recited components. Regarding claim 29, none of the prior art of record teaches or reasonably suggests such a second microphone that is an external sensor, in combination with the other recited components. It is noted that this indication is premised upon the first implantable sensor being a first microphone, with the second sensor being an external sensor that is a second microphone. If claim 29 is merely reciting that the first implantable sensor is just a generic sensor, then claim 29 would be rejected over Hlavka.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Miller, III (U.S. Pub. No. 2007/0167671 A1) teaches a similar system including a first implantable sensor that is a microphone and a second implantable sensor that is a motion sensor, outputs of which are used to generate a signal to effect a recipient of an implantable device.
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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/THADDEUS B COX/Primary Examiner, Art Unit 3791