DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
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.
Claim(s) 29-43 is/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 pre-AIA the applicant regards as the invention.
Amended claim(s) 29 recites
‘said acoustic sensor is placed in an area of the system for monitoring’
Which is a method step in an apparatus claim(s).
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim(s) 30-43 is/are rejected due to its/their dependence on claim(s) 29.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 29-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Munyard (research publication: A New Device for Ambulatory Cough Recording – cited in IDS).
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation/embodiment/passage within a reference.
For claim(s) 29, 35-38, and 40-41, Munyard teaches a system for monitoring, characterization and evaluation of a user's cough, [entire disclosure – see at least abstract] characterised by comprising a sensory instrumentation unit,
wherein the sensory instrumentation unit includes:
at least one abdominal contraction sensor, adapted to be in contact with the body of a user; [EMG in Fig. 3]
and at least one acoustic sensor [microphone in Fig. 3] wherein said acoustic sensor is placed in an area of the system for monitoring, characterisation and evaluation of a user's cough that does not come into contact with the user's skin; [see § 112b rejection; since the microphone of Munyard is capable of being placed in an area that does not come into contact with the skin, then the limitation is taught by Munyard]
wherein said abdominal contraction sensor and said acoustic sensor collect and transmit raw sensory signals to the sensory instrumentation unit; [recorder at end of p. 182 and onto p. 184 l. col.]
wherein the sensory instrumentation unit performs the conditioning of said signals of said abdominal contraction sensor and said acoustic sensor; [preprocessing in p. 179]
and by comprising a microcontroller,
wherein the microcontroller includes:
a data acquisition unit obtained by the sensory instrumentation unit; [DAQ functionality shown in p. 181 detailed in p. 184]
and an acoustic sensor activation unit, which activates said acoustic sensor only when an abdominal contraction on the signal obtained from said abdominal contraction sensor is detected, [p. 184 l. col.]
wherein said acoustic sensor only collects and transmits raw sensory signals to the sensory instrumentation unit when it is activated; [p. 184 l. col.]
wherein said acquisition unit of the data obtained by the sensory instrumentation unit and said acoustic sensor activation unit of the microcontroller are interrelated; [p. 184 l. col.]
and by comprising at least one data flow unit, selected from the group consisting of a data transmission and reception unit and of a data storage unit, [computing units shown in p. 181]
wherein the data flow unit is controlled by the microcontroller; [CPU in p. 181 (microcomputer)]
and by comprising a data processing and analysis unit for cough assessment configured to process and analyse the data resulting from the microcontroller's action and to monitor, characterize and evaluate the user's cough [CPU in p. 181 (microcomputer) in view of p. 184 l. col.]
wherein the data processing and analysis unit for cough assessment is configured to outcome results comprising:
the frequency of the cough, specifically the number of times the user coughs and the distribution of cough events over time; and the type of cough; and cough patterns, involving the frequency and type of cough. [Fig(s). 4 and p. 182 showing cough peak layouts which are output from a processor per p. 184 l. col.]
For claim 30, Munyard teaches The system for monitoring, characterization and evaluation of a user's cough, according to claim 29,
characterised by the abdominal contraction sensor is a surface electromyography sensor, with a configuration of at least 2 electrodes. [p. 181]
For claim 31, Munyard teaches The system for monitoring, characterization and evaluation of a user's cough, according to claim 29,
characterised by the sensory instrumentation unit comprises at least one body positioning and motion characterization sensor, adapted to collect and send raw sensory signals to the sensory instrumentation unit. [Fig. 3 p. 181]
For claim 32, Munyard teaches The system for monitoring, characterization and evaluation of a user's cough, according to claim 29,
characterised by the sensory instrumentation unit comprises the connection to one or more external sensory instrumentation units. [p. 181]
For claim(s) 33 and 34, Munyard teaches central module including a microcontroller and
at least one energy source; [p. 181, p. 184 l. col.]
and at least one data transmission and reception unit, adapted to transmit the data resulting from the microcontroller's operation, [comms link and preprocessor in p. 181]
wherein the microcontroller controls the data transmitted by a data transmission and reception unit, [computer and comms link in p. 181]
wherein the data is transmitted via a wired communication or via a wireless communication protocol; [p. 181]
and at least one data storage unit, adapted to store the data resulting from the microcontroller's operation, [memory in p. 181]
wherein the microcontroller controls the data stored by the data storage unit; [p. 181]
and by a data processing and analysis unit for cough assessment process and analyse the data transmitted by the data transmission and reception unit and the data stored in the data storage unit. [p. 184 l. col. in view of p. 181]
and analysis unit for cough assessment. [p. 181]
For claim 39, Munyard teaches The method for monitoring, characterization and evaluation of a user's cough, according to claim 35, characterised by the abdominal contraction sensor is an EMG sensor, with a configuration of at least two electrodes,
wherein the step of contacting the EMG sensor with the user's body comprises the following steps:
i. Contact an upper electrode of the surface electromyography sensor with the user's body below the sternum xiphoid process, over the linea alba; [Fig. 2]
ii. Contact a lower electrode of the surface electromyography sensor with the user's body on an imaginary line that includes the upper electrode of the surface electromyography sensor, parallel to the costal margin, in the epigastric region and over the rectus abdominis muscle; [Fig. 2]
iii. Optionally, contact an additional electrode in contact with the user's body on a bone dominant region, namely the iliac crest. [Fig. 2]
For claim 40, Munyard teaches A portable device for monitoring, characterization and evaluation of a user's cough characterised by comprising the system as defined in claim 29, and a means for attachment to the user's body. [p. 181]
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
In consideration of Examiner’s interpretation and citation for the amended data processing unit outputting results of (specifically) cough frequency and patterns, and in earnest and good faith advancement of prosecution, claim(s) 29, 35-37, and 40-43 is/are alternately rejected under 35 U.S.C. 103 as being unpatentable over Munyard in view of Coyle (US 20060074334 A1).
If (arguendo) Munyard fails to teach the amended feature of the processing unit outputting (specifically) a number of coughs and its distribution over time along with type and corresponding patterns, then:
Coyle teaches a cough analysis system [abstract] utilizing a microphone [¶45] for which a processor outputs a cough pattern analysis that determines (inter alia) a number, type, and distribution of cough signals [cough index from cough sound frequency, count, and distribution in ¶¶64-69 and at length throughout at least ¶¶80-110]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the processor of Munyard to incorporate the cough pattern analyses and output(s) of Coyle in order to improve objectivity of cough determination and subsequent data utilization. As motivated by Coyle ¶¶5-21.
Response to Arguments
Applicant's 9/15/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 11-12 that Munyard fails to teach the amended claim(s) especially amended claim(s) 29. Examiner respectfully disagrees. The processor of Munyard outputs a filtered peak result of cough data as in Munyard Fig(s). 4 detailed on Munyard p. 184 l. col. Munyard thus teaches at least some form of cough pattern analysis including number, distribution, and pattern therefrom (under BRI) as a result. In any event, such an argument is moot in view of the alternate § 103 rejection provided in earnest advancement of prosecution.
Applicant argues in remarks p. 12-16 that Munyard in view of Vatanparvar does not make the claim(s) obvious (e.g., amended claim(s) 29). However, such arguments are moot as claim(s) 29 is rejected under § 102 and then alternately under § 103 with a new reference (Coyle). Applicant generally discusses alleged distinctions between Munyard and the present application. However, such arguments do not specify what the supposed distinctions between the claim language and Munyard are — only that there may be a difference in design intent. Accordingly, such arguments are unpersuasive to show either of non-anticipation or nonobviousness.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
Prosecution Insights