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 .
Status of Claims
Applicant's arguments, filed 11/14/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/14/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 9, 11, 20, and 21.
Applicants have left claims 2-8, 10, 12-19, and 22-27 as previously presented/originally filed.
Applicants have introduced new claim 28.
Claims 1-28 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2025 is being considered by the examiner.
Claim Objections - Withdrawn and Newly Applied
Claim 22 is objected to because of the following informalities:
Regarding claim 22, lines 1-2 recite “the number of identified predictive spectral events”, however it appears it should read along the lines of --a number of identified predictive spectral events-- (emphasis added).
Regarding claim 22, line 3 recites “the total number of identified predictive spectral events”, however it appears it should read along the lines of --a total number of identified predictive spectral events-- (emphasis added).
Response to Arguments
Applicant’s arguments, see page 4 of Remarks, filed 11/14/2025, with respect to the objection of claims 1, 11, 20, and 21 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 1, 11, 20, and 21 have been withdrawn. However, there are new claim objections.
Claim Interpretation - 35 USC § 112(f) - Maintained
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “primary audio collection device … collected audio data from at least one of the primary audio collection device” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “collected audio data from at least one of the primary audio collection device” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claim 1: The claim limitation “secondary audio collection device … collected audio data from … the second audio collection device” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “collected audio data from … the second audio collection device” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claim 17: The claim limitation “separable top portion and lower portion are secured using attachment means” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “means” coupled with functional language “secured” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “means”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“a microphone …”, or equivalents thereof, as described in para. [0036-0037] of the disclosure filed on 03/05/2024.
“second audio collection device can be a microphone”, or equivalents thereof, as described in para. [0031] and para. [0048] of the disclosure filed on 03/05/2024.
“attachment means can comprise screws, fasteners, pins, brackets, pegs, rivets, clips …”, or equivalents thereof, as described in para. [0035] of the disclosure filed on 03/05/2024.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicants have argued on page 5 of Remarks, filed 11/14/2025, that claims 1 and 17 have been amended, rendering the 112(f) interpretations moot.
Applicants did not amend claims 1 and 17 and did not present arguments towards the 112(f) claim interpretation. Therefore, the Examiner cannot find a reason to withdraw the 112(f) claim interpretations.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 11/14/2025, with respect to the 112(b) rejection of claim 9 have been fully considered and are persuasive. Applicants have amended the claim, rendering the rejection moot. The 112(b) rejection of claim 9 has been withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see pages 6-15 of Remarks, filed 11/14/2025, with respect to the rejection of claims 1-27 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejections moot. Further, Applicants arguments regarding Karthik are considered persuasive. The 103 rejection of claims 1-27 has been withdrawn.
Double Patenting - Maintained and Newly Applied Necessitated by Applicant’s Amendments
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 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 11918408 B2, hereinafter referred to as ‘408, in view of John Cromwell (US 20130035610 A1) (previously cited), hereinafter referred to as Cromwell.
Regarding claim 1 of the instant application, claim 1 of ‘408 recites an intestinal audio analysis device for predicting gastrointestinal impairment (line 1), the device comprising: a patient interface adapted to attach to a surface of a patient’s abdomen (lines 2-3); a diaphragm adapted to vibrate in response to intestinal sounds to create acoustic pressure waves which amplify the intestinal sounds made within the patient’s abdomen (lines 4-7); an acoustic chamber adapted to receive the acoustic pressure waves caused by diaphragm vibrations which amplify the intestinal sounds (lines 8-10); a primary audio collection device located in or near the acoustic chamber (lines 11-12); a secondary audio collection device (line 13); a user interface comprising a display (line 35); a housing comprising a computer including one or more processors configured to receive collected audio data from at least one of the primary audio collection device and the secondary audio collection device and one or more non-transitory computer-readable storage mediums storing instructions comprising one or more algorithms that when executed by the one or more processors cause the one or more processors to perform steps including (lines 14-18): analyzing the collected audio data from the acoustic pressure waves collected by the primary audio collection device for false signals due to ambient noise (lines 19-22); analyzing two or more spectral event values of the collected audio data over time (lines 23-25); after the analyzing the collected audio data for the false signals, producing a slope of a linear regression analysis of the two or more spectral event values of the collected audio data over time (lines 26-30); and comparing the slope of the linear regression analysis to a pre-determined slope threshold to predict a likelihood of gastrointestinal impairment occurring (lines 31-34).
Cromwell teaches wherein one spectral event value of the two or more spectral event values includes predefined signal parameters comprising a frequency in a range of 900 to 20,000 Hertz (Table 2, para. [0032], para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor recited in ‘408 to evaluate one spectral event value of the two or more spectral event values includes predefined signal parameters comprising a frequency in a range of 900 to 20,000 Hertz. Cromwell teaches spectral events, specifically within a frequency range of 900 to 20,000 Hertz allows for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 2 of the instant application, ‘408 recites the device of claim 1.
Cromwell teaches wherein the predefined signal parameters comprise: a duration in a range of 5 to 600 milliseconds (Table 2, para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predefined signal parameters of ‘408 to additionally include a duration in a range of 5 to 600 milliseconds. Cromwell teaches different signal parameters allow for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 3 of the instant application, ‘408 recites the device of claim 2.
Cromwell teaches wherein the predefined signal parameters comprise: a minimum separation in time of the one spectral event value from other spectral event values, wherein the minimum separation in time is 20 milliseconds (Table 2, para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predefined signal parameters of ‘408 to additionally include a minimum separation in time of the one spectral event value from other spectral event values, wherein the minimum separation in time is 20 milliseconds. Cromwell teaches different signal parameters allow for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 4 of the instant application, ‘408 recites the device of claim 3.
Cromwell teaches wherein the predefined signal parameters comprise: a signal-to-noise ratio of 70% (Table 2, para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predefined signal parameters of ‘408 to additionally include a signal-to-noise ratio of 70%. Cromwell teaches different signal parameters allow for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 5 of the instant application, ‘408 recites the device of claim 4.
Cromwell teaches wherein the predefined signal parameters comprise: a signal-to-noise ratio threshold is 10 decibels (Table 2, para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify predefined signal parameters of ‘408 to additionally include a signal-to-noise ratio threshold is 10 decibels. Cromwell teaches different signal parameters allow for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 6 of the instant application, claim 1 of ‘408 recites the device of claim 1, wherein the steps further comprise: making a binary prediction regarding gastrointestinal impairment based on the comparing the slope of the linear regression analysis to the pre-determined slope threshold (lines 31-34).
Regarding claim 7 of the instant application, claim 12 of ‘408 recites the device of claim 6, wherein the steps further comprise: displaying, on the display, the binary prediction regarding gastrointestinal impairment (lines 22-23).
Regarding claim 8 of the instant application, claim 12 of ‘408 recites the device of claim 1, wherein the steps further comprise: providing a user with a risk level regarding gastrointestinal impairment based on the comparing the slope of the linear regression analysis to the pre-determined slope threshold (lines 20-23).
Regarding claim 9 of the instant application, claim 12 of ‘408 recites the device of claim 8, wherein the steps further comprise: displaying, on the display, the risk level (lines 22-23).
Regarding claim 10 of the instant application, claim 2 of ‘408 recites the device of claim 1, wherein the display comprises a graphical user interface (lines 1-2).
Regarding claim 11 of the instant application, claim 3 of ‘408 recites the device of claim 1, wherein the device is configured to collect and analyze the audio signals from the patient to predict the likelihood of the gastrointestinal impairment occurring before clinical signs of the gastrointestinal impairment occur (lines 1-4).
Regarding claim 12 of the instant application, claim 1 of ‘408 recites the device of claim 1, wherein the computer, the primary audio collection device, and the secondary audio collection device are contained within the housing (lines 15-17).
Regarding claim 13 of the instant application, claim 4 of ‘408 recites the device of claim 1, wherein the secondary audio collection device comprises an outward-pointing microphone on the housing and configured to collect the ambient noise (lines 1-4).
Regarding claim 14 of the instant application, claim 5 of ‘408 recites the device of claim 1, wherein the secondary audio collection device is configured to collect the ambient noise (lines 1-2).
Regarding claim 15 of the instant application, claim 6 of ‘408 recites the device of claim 1, wherein the patient interface collects acoustic sound waves and at least one of the primary audio collection device and the secondary audio collection device collects the acoustic pressure waves caused by the diaphragm vibrations resulting from the acoustic sound waves vibrating the diaphragm (lines 1-6).
Regarding claim 16 of the instant application, claim 7 of ‘408 recites the device of claim 1, wherein the secondary audio collection device further comprises a second diaphragm (lines 1-2).
Regarding claim 17 of the instant application, claim 8 and claim 9 of ‘408 recites the device of claim 1, wherein the housing further comprises a separable top portion and lower portion (claim 8, lines 1-2), and wherein the separable top portion and lower portion are secured using attachment means (claim 9, lines 1-3).
Regarding claim 18 of the instant application, claim 10 of ‘408 recites the device of claim 1, wherein the device comprises a warning indicator for the false signals due to the ambient noise (lines 1-3).
Regarding claim 19 of the instant application, claim 11 of ‘408 recites the device of claim 1, further comprising: a buffer, wherein the at least one of the one or more algorithms analyzes the two or more spectral event values of the collected audio data and provides a time stamp and a total number of identified spectral events to the buffer, and wherein the at least one of the one or more algorithms serves to produce the slope of the linear regression analysis using the buffered data (lines 1-10).
Regarding claim 20 of the instant application, claim 12 of ‘408 recites a method of predicting a likelihood of gastrointestinal impairment occurring (lines 1-2), the method comprising: recording, with the device of claim 1, the intestinal sounds made within the patient’s abdomen to collect the audio data from the acoustic pressure waves collected by the primary audio collection device (lines 3-6); analyzing, with the computer, the collected audio data for the false signals due to the ambient noise (lines 7-8); mitigating, with the computer, for the false signals if the analyzing the collected audio data for the false signals indicates mitigation is necessary (lines 9-11); processing, with the computer, the collected audio data to identify the two or more spectral event values (lines 12-13); acquiring, with the computer, a total number of the identified two or more spectral event values (lines 14-15); performing, with the computer, the linear regression analysis on the processed audio data resulting in the slope of the two or more spectral event values over time (lines 16-19); correlating, with the computer, the slope with a likelihood of gastrointestinal impairment occurring (lines 20-21); and providing, with the display, a user with a risk level based on the likelihood (lines 22-23).
Regarding claim 21 of the instant application, ‘408 recites the method of claim 20.
Cromwell teaches wherein one spectral event value of the two or more spectral event values includes predefined signal parameters further comprising: a duration in a range of 5 to 600 milliseconds; and a minimum separation in time of the one spectral event value from other spectral event values, wherein the minimum separation in time is 20 milliseconds; and wherein the one spectral even value of the two or more spectral event values includes signal-to-noise ratio parameters comprising: a signal-to-noise ratio of 70%; and a signal-to-noise ratio threshold is 10 decibels (Table 2, para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in ‘408 to additionally include one spectral event value of the two or more spectral event values includes predefined signal parameters further comprising: a duration in a range of 5 to 600 milliseconds; and a minimum separation in time of the one spectral event value from other spectral event values, wherein the minimum separation in time is 20 milliseconds; a signal-to-noise ratio of 70%; and a signal-to-noise ratio threshold is 10 decibels. Cromwell teaches different signal parameters allow for the analysis of certain spectral events to predict gastrointestinal impairment (Table 2, para. [0032], para. [0034], para. [0041]).
Regarding claim 22 of the instant application, claim 13 of ‘408 recites the method of claim 20, wherein the mitigating step comprises adjusting the number of identified predictive spectral events by accounting for the false signals due to ambient noise, resulting in the total number of identified predictive spectral events (lines 1-5).
Regarding claim 23 of the instant application, claim 14 and claim 15 of ‘408 recites the method of claim 20, wherein the performing step comprises providing a time stamp and writing the total number of identified spectral events to a buffer of the device, and wherein the linear regression analysis is performed using the buffered data (claim 14, lines 1-3; claim 15, lines 1-2).
Regarding claim 24 of the instant application, claim 16 of ‘408 recites the method of claim 20, wherein the correlating step is performed by comparing the slope with data correlating the slope with the likelihood of a later occurring gastrointestinal impairment (lines 1-4).
Regarding claim 25 of the instant application, claim 17 of ‘408 recites the method of claim 20, wherein the method further comprises a step of warning the user if the analyzing for the false signals indicates that the mitigation is necessary (lines 1-3).
Regarding claim 26 of the instant application, claim 18 of ‘408 recites the method of claim 25, wherein the warning is provided with a warning indicator as part of the device, wherein the warning indicator is selected from a list comprising a light, a noise, a graphic on the display of the user interface, or combinations thereof (lines 1-5).
Regarding claim 27 of the instant application, claim 19 of ‘408 recites the method of claim 25, wherein the warning step is activated by: 1) a preset ambient noise decibel level from the secondary audio collection device; 2) analysis of a signal-to-noise ratio from the primary audio collection device versus the secondary audio collection device; and 3) processing the ambient noise received by the secondary audio collection device for false-triggering of a spectral event above a preset threshold (lines 1-10).
Regarding claim 28 of the instant application, claim 12 of ‘408 recites the device of claim 1, wherein the one or more processors perform steps further comprising: after the analyzing the collected audio data for the false signals, mitigating the collected audio data for the false signals before the step of producing the slope of the linear regression analysis and the step of comparing the slope of the linear regression analysis to the pre-determined slope threshold to predict the likelihood of gastrointestinal impairment occurring (lines 9-11).
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicants did not present arguments towards the non-statutory obviousness-type double patenting rejection of claims 1-27 (see page 4 of Remarks). The Examiner cannot find a reason to withdraw the rejection.
Prior Art Analysis
Claims 1-28 are objected to and/or rejected to as recited above. However, claims 1-28 are not rejected in view of prior art under 35 USC 102 or 35 USC 103. The closest prior art made of record includes: Hsu et al. (US 20190216420 A1) (previously cited), hereinafter referred to as Hsu, John Cromwell (US 20130035610 A1) (previously cited), hereinafter referred to as Cromwell, Mansy et al. (US 6840913 B2), hereinafter referred to as Mansy, and Karthik et al. (US 20120163622 A1) (previously cited), hereinafter referred to as Karthik.
Hsu discloses an intestinal audio analysis device for predicting gastrointestinal impairment (Fig. 2B, Abstract, para. [0050]), the device comprising: a patient interface adapted to attach to a surface of a patient’s abdomen (Fig. 1, element 100, Fig. 2A, Fig. 2B, para. [0031], para. [0050]); a diaphragm (Fig. 2B, element 212) adapted to vibrate in response to intestinal sounds to create acoustic pressure waves which amplify the intestinal sounds made within the patient’s abdomen (para. [0032], para. [0034], para. [0050]); an acoustic chamber (Fig. 2B, element 204, Fig. 3A-3B) adapted to receive the acoustic pressure waves caused by diaphragm vibrations which amplify the intestinal sounds (para. [0024], para. [0034], para. [0041]); a primary audio collection device (Fig. 2B, element 206) located in or near the acoustic chamber (para. [0034]); a secondary audio collection device (Fig. 2B, elements 208, para. [0035]); a user interface comprising a display (Fig. 7, element 750, 752, 758, para. [0061]); a housing (Fig. 2B, element 202, Fig. 7, element 702) comprising a computer including one or more processors configured to receive collected audio data from at least one of the primary audio collection device and the secondary audio collection device and one or more non-transitory computer-readable storage mediums storing instructions comprising one or more algorithms (Fig. 7, element 704, element 712, para. [0056-0057], para. [0074]) that when executed by the one or more processors cause the one or more processors to perform steps including: analyzing the collected audio data from the acoustic pressure waves collected by the primary audio collection device for the false signals due to ambient noise (para. [0037], para. [0057]).
Cromwell teaches a system and method for predicting gastrointestinal impairment using intestinal sounds (Abstract, Fig. 1, Fig. 2, Fig. 6, para. [0014]). Cromwell teaches analyzing two or more spectral event values of the collected audio data over time (Fig. 6, element 102, 104, para. [0031-0033], para. [0041]). Cromwell teaches one spectral event value of the two or more spectral event values includes predefined signal parameters comprising a frequency in a range of 900 to 20,000 Hertz (Table 2, para. [0032], para. [0041]).
Mansy teaches of a method for detecting gastric motility dysfunction by calculating the spectral content of acoustic data (col. 8, lines 15-26) and determining the presence of gastric motility based on the spectral content (col. 8, line 46 - col. 9, line 12).
Karthik teaches of a method and apparatus for noise detection and reduction (Abstract, Fig. 3, para. [0001]). Karthik teaches analyzing two or more spectral event values of the collected audio data over time (para. [0036-0037], “wind noise spectral content … acquired audio signals may be segregated into blocks having discrete block numbers … transformed signals may be arranged into an array”). Karthik teaches producing a slope of a linear regression analysis of the two or more spectral event values of the collected audio data over time (para. [0037], “a linear regression on the array elements may be performed … to generate a slope value …”).
Using spectral analysis to make determinations, specifically for gastrointestinal impairment and/or determining events is known within the art. However, the prior art made of record does not disclose, teach, or reasonably suggest producing a slope of a linear regression analysis of two or more spectral event values of the collected audio data over time, and comparing the slope of the linear regression analysis to a pre-determined slope threshold to predict a likelihood of gastrointestinal impairment occurring, in combination with the other elements of the independent claim. Further, while Karthik does teach using a slope of a linear regression to compare values to different thresholds, one of ordinary skill in the art would not have been motivated in view of Karthik to apply the linear regression analysis of wind noise to the device of modified Hsu, and would further not have been motivated to compare the slope of the linear regression analysis to predict a likelihood of gastrointestinal impairment occurring.
Conclusion
THIS ACTION IS MADE FINAL. 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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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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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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791