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 .
Election/Restriction
This application contains claims directed to the following patentably distinct species:
Species A1, drawn to an embodiment wherein extracting a loudness signal from a breathing sound signal comprises low-pass filtering a room mean square value of a window that slides over the breathing sound signal (section [0095] of the published specification);
Species A2, drawn to an embodiment wherein extracting the loudness signal from a breathing sound signal comprises summing magnitudes of Fourier transform values of the breathing sound signal within a portion of an audio frequency range (section [0096] of the published specification);
Species A3, drawn to an embodiment wherein extracting the loudness signal from a breathing sound signal comprises calculating a power in a resonant frequency range of a window that slides over the breathing sound signal (section [0127] of the published specification);
Species A4, drawn to an embodiment wherein extracting the loudness signal from a breathing signal comprises detecting frequency modulation around a basic resonant frequency (section [0128] of the published specification);
Species B1, drawn to an embodiment wherein identifying is based on a duration of a period between at least two successive peaks of a loudness signal (section [0108] of the published specification);
Species B2, drawn to an embodiment wherein identifying is based on a shape of peaks of a loudness signal, wherein an expiratory peak is more exponentially decaying than an inspiratory peak (section [0109] of the published specification); and
Species B3, drawn to an embodiment wherein identifying is based on frequency content of peaks of a loudness signal (section [0110] of the published specification).
The species are independent or distinct because claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1, 3, 7-9, and 15-20 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(c) the prior art applicable to one invention would not likely be applicable to another invention;
(d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a) or 112(b).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.During a telephone conversation with Mr. Raymond B. Churchill Jr. on 24 September 2026 a provisional election was made without traverse to prosecute the invention of Species A1 and Species B1, claims 1-3, 7-12, and 15-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4-6, 13, and 14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 3, 7, and 10-12 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.
Regarding claim 3, it is unclear what is meant by “to limit included frequencies to a portion of an audio frequency range”. (emphasis added) It is unclear to what “an audio frequency range” is referring in the claim. For this examination, the phrase is being interpreted as any frequency in which an audio signal can occur.
Regarding claim 7, the phrase “at two times an upper frequency limit of a human breathing frequency range” renders the claim indefinite. Different types of humans (e.g., infant, adolescent, young adult, elderly, healthy, unhealthy) have different breathing frequency ranges. As human breathing frequency ranges vary per human, the metes and bounds of “two times an upper frequency limit of a human breathing frequency range” is not clearly defined. For this examination, claim 7 is being interpreted such that the filtering of the loudness signal permits any upper frequency of any possible human breathing frequency range.
Regarding claim 10, it is unclear what is meant by identifying peaks based on a duration of a period between at least two successive peaks. If the duration between two successive peaks is used to identify peaks, then the two successive peaks would first need to be identified; it is unclear how peaks would be identified by using the peaks unless the peaks were already identified. Claims 11 and 12 are rejected due to their dependence on claim 10.
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.
Claims 1-3, 7-12, and 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including extracting a loudness signal from a breathing sound signal, and de-rectifying the loudness signal to estimate a respiratory flow rate signal. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of de-rectifying a loudness signal to estimate a respiratory flow rate signal sets forth a judicial exception. According to section [0107] of the published specification, “de-rectifying” a loudness signal is defined as “identifying which peaks of the loudness signal correspond to inspiratory portions and which peaks correspond to expiratory portions of a breathing cycle, and assigning a negative value to the expiratory portions”. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The de-rectified loudness signal does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the de-rectified loudness signal, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of extracting a loudness signal from a breathing sound signal generated by a microphone. The extracting step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 15, 17, and 18, the devices recited in the claims are generic devices comprising generic components configured to perform the abstract idea. The apparatus of claim 15 (comprising a microphone and a processor), the processor-readable medium of claim 17, and the portable computing device of claim 18 are generic computer systems configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. It is noted that the microphone of claims 15 and 18 is a generic transducer configured to perform routine insignificant presolution data gathering activity, and the display of claim 18 is a generic display with no recited function.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to routine data processing (filtering) or identifying peaks in acquired data (a mental process). The extracting and de-rectifying steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Further regarding claim 17, a claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. A processor-readable medium can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that Applicant amend the claim to recite a “non-transitory processor-readable medium”.
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.
Claims 1, 3, 7-9, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Alshear et al.’780 (US Pub No. 2014/0194780 – cited by Applicant) in view of Asai’777 (US Pub No. 2017/0325777 – cited by Applicant), or in the alternative, in view of Applicant Admitted Prior Art (AAPA).
Regarding claims 1, 8, and 9, Alshear et al.’780 discloses a method of one or more processors to estimate a respiratory flow rate signal from a breathing sound signal of a patient, the method comprising: extracting a loudness signal from the breathing sound signal, wherein the breathing sound signal is generated by a microphone (sections [0015], [0041], and [0074]); detecting sleep disordered breathing (SDB) events in the loudness signal (sections [0073-0083]); and computing a metric of severity of SDB of the patient from the detected SDB events (sections [0073], [0076], and [0141]). Alshaer et al.’780 discloses that the SDB events are detected based on detected inspiratory and expiratory portions of a breathing cycle (sections [0075], [0078-0079]), and also discloses that the method for detecting inspiratory and expiratory portions of a breathing cycle may differ from the one taught by Alshaer et al.’780 (section [0081]).
Alshaer et al.’780 discloses all of the elements of the current invention, as discussed above, except for de-rectifying the loudness signal to estimate the respiratory flow rate signal of the patient. It is noted that according to section [0107] of the published specification, “de-rectifying” the loudness signal is defined as “identifying which peaks of the loudness signal correspond to inspiratory portions and which peaks correspond to expiratory portions of a breathing cycle, and assigning a negative value to the expiratory portions”. Asai’777 teaches identifying inspiratory and expiratory portions of a breathing cycle by de-rectifying a loudness signal (sections [0131-0134]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Alshaer et al.’780 to include detecting SDB events in a de-rectified loudness signal as Alshaer et al.’780 teaches that that its method for detecting inspiratory and expiratory portions of a breathing cycle may differ from the one taught by Alshaer et al.’780, and Asai’777 teaches that inspiratory and expiratory portions of a breathing cycle can be identified by de-rectifying a loudness signal. The modification to Alshaer et al.’780 would merely be the simple substitution of one known inspiratory/expiratory phase detection method (that of Asai’777) for another (that of Alshaer et al.’780) to obtain predictable results.
It is noted that section [0111] of the published specification teaches that “The result of such ‘de-rectification’ is an approximation to the respiratory flow rate signal”. Therefore, the result of the de-rectification of the loudness signal of Alshaer et al.’780 in view of Asai’777 is an estimate of the respiratory flow rate signal of the patient.
Furthermore, according to section [0111] of the published specification, it is already known in the art to de-rectify a loudness signal to estimate the respiratory flow rate signal of a patient (“The process of inverting this transfer function, and thereby estimating respiratory flow rate from breathing sound loudness, is known as phonospirometry.”). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Alshaer et al.’780 to include de-rectifying the loudness signal to estimate the respiratory flow rate signal of the patient as this is a known method in the art. The modification to Alshaer et al.’780 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 3, Alshaer et al.’780 discloses extracting the loudness signal from the breathing sound signal by filtering the breathing sound signal to limit included frequencies to a portion of an audio frequency range (sections [0056-0057]).
Regarding claim 7, Alshaer et al.’780 discloses filtering the loudness signal to permit an upper frequency of a human breathing frequency range (sections [0056-0057]). Alshaer et al.’780 discloses fails to explicitly disclose that the upper frequency is at two times an upper frequency limit of a human breathing frequency range. However, Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particular upper frequency limit recited in the claim. As such, it would have been obvious, through routine experimentation, to determine the optimal frequency limit of the filtering step of Alshaer et al.’780. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 15 and 16, Figures 4-5 of Alshaer et al.’780, as modified by Asai’777, disclose an apparatus comprising means for extracting a loudness signal from a breathing sound signal of a patient (section [0046], microphone 302); means for de-rectifying the loudness signal to estimate a respiratory flow rate signal of the patient (section [0062], one or more processors 506,512); and means for conducting breathing sounds from nares of the patient to a microphone of a portable computing device (sections [0046-0049], support structure 306).
Regarding claim 17, the sections of Alshaer et al.’780 cited above, as modified by Asai’777, disclose a processor-readable medium, having stored thereon processor-executable instructions which, when executed by a processor of a portable computing device, cause the processor estimate a respiratory flow rate signal from a breathing sound signal of a patient, the processor-executable instructions comprising the steps recited in the claim.
Regarding claim 18, Figures 4-5 and sections [0061-0062] of Alshaer et al.’780, as modified by Asai’777, disclose a portable computing device comprising the processor-readable medium of claim 17, a microphone, a display, and one or more processors configured to access the processor-readable medium to estimate a respiratory flow rate signal from a breathing sound signal of a patient.
Regarding claim 19, Official notice is being taken that it is well known in the art to download processor-executable instructions to a portable computing device over a network, the download request being received by a server with access to a processor-readable medium storing the instructions (see section [0041] of Margolis et al.’271 – US Pub No. 2012/0130271).
Regarding claim 20, Official notice is being taken that it is well known in the art to download processor-executable instructions to a portable computing device over a network, the download request being received by a server with access to a processor-readable medium storing the instructions (see section [0041] of Margolis et al.’271 – US Pub No. 2012/0130271).
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-23, 25-27, 31-36, 40, 41 of copending Application No. 18/337756 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending Application are narrower in scope than claims 1-20 of the current application, encompassing the subject matter of the current claims. Any reference meeting the limitations set forth in claims 21-23, 25-27, 31-36, 40, 41 of the copending Application would also meet the limitations set forth in claims 1-20 of the current invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Note
Regarding claim 2, none of the prior art discloses or suggests, either alone or in combination, a method comprising extracting a loudness signal from a breathing sound signal by low-pass filtering a root mean square of a window that slides over the breathing sound signal, in combination with the other claimed steps.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
