DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive.
Regarding the 112 rejections: Most of the rejections were addressed due to the amendment. A few remaining 112b rejections remain.
Regarding the 101 rejection:
Applicant argues: “The identification of spectral events requires digital signal processing algorithms applied to audio recordings, where each type of spectral event is "defined by unique target signal parameters (minimum and maximum frequency, minimum and maximum duration, and minimum separation), signal-to-noise ratio parameters (minimum occupancy, signal-to-noise threshold), and noise power estimation parameters (block size, hop size, percentile)."” Examiner notes this is not claimed. No algorithm is claimed. Merely identifying spectral events is claimed. A human can look at data and identify arbitrary spectral events. Nothing specific is being claimed.
Applicant argues: “Detecting these subtle acoustic differences in the 900-20,000 Hz frequency range cannot practically be performed in the human mind. The MH4 spectral event, for example, requires detection of signals with minimum frequency of 900 Hz, maximum frequency of 20,000 Hz, minimum duration of 5.8 ms, maximum duration of 600 ms, minimum separation of 20 ms, minimum occupancy of 70%, and SNR threshold of 10.0 dB. A human cannot mentally process audio data to identify events meeting all of these precise parameters simultaneously.” Again, this is not claimed. This being done simultaneously is not claimed. Also given a data set with labeled data such as a graph or table one of ordinary skill in the art could use those parameters to sort through the data mentally.
Applicant argues that the claims are similar to SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Circ. 2019) and not similar to Electric Power Group, LLC v. Alstom, S.A. Examiner notes from MPEP 2106.04(a)(2) III A: In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include: • a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). The claimed invention recites data analysis steps at a high level of generality. It is not clear to the examiner where any particular analysis is claimed.
Applicant then argues: “Turning to the present application, the specification discloses that the analysis requires "a digital signal processor and appropriate software/firmware" and "a central processing unit (CPU) or other processing device, such as a microprocessor or digital signal processor." See, e.g., p. 5, line 5- 8; p. 8, 1. 7-10. This is not merely using a computer as a tool to perform what could otherwise be done mentally. Instead, the spectral analysis itself requires computational processing that is beyond human mental capability.” Applicant is clearly pointing out the additional elements are conventional computer equipment used to perform the abstract idea. No specific algorithm or analysis is being claimed. No specific or particular hardware is being claimed.
Any alleged improvement must be reflected in the claims. Per MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception” There are no additional elements recited in the claimed that provide significantly more. No clear improvement is reflected in the claims.
Response to Amendment
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.
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:
-‘an external patient interface’ with the function of ‘obtaining the intestinal sounds’ in claim 24 interpreted to be “In some embodiments, the patient interface 14 comprises, or is similar in design and function to, a stethoscope head. Stethoscope heads comprise a diaphragm that is placed in contact with the patient and that vibrates in response sounds generated within the body.” per the specification
-‘a patient interface’ with the function of ‘obtaining the intestinal sounds’ in claim 24 interpreted to be “In some embodiments, the patient interface 14 comprises, or is similar in design and function to, a stethoscope head. Stethoscope heads comprise a diaphragm that is placed in contact with the patient and that vibrates in response sounds generated within the body.” per the specification
-‘a separate data collection device that collects the intestinal sounds’ in claim 35 interpreted to be “The data collection device 12 can comprise any device that is capable of collecting audio data that is generated within a patient's intestinal tract. In some embodiments, the data collection device 12 comprises a portable (e.g., handheld) digital audio recorder. In such a case, the data collection device 12 can comprise an integral microphone (not shown) that is used to capture the intestinal sounds.” per the specification.
-‘a data collection device that collects the intestinal sounds’ in claim 36 interpreted to be “The data collection device 12 can comprise any device that is capable of collecting audio data that is generated within a patient's intestinal tract. In some embodiments, the data collection device 12 comprises a portable (e.g., handheld) digital audio recorder. In such a case, the data collection device 12 can comprise an integral microphone (not shown) that is used to capture the intestinal sounds.” per the specification.
-‘a data collection device that…collects the intestinal sounds’ in claim 38 interpreted to be “The data collection device 12 can comprise any device that is capable of collecting audio data that is generated within a patient's intestinal tract. In some embodiments, the data collection device 12 comprises a portable (e.g., handheld) digital audio recorder. In such a case, the data collection device 12 can comprise an integral microphone (not shown) that is used to capture the intestinal sounds.” per the specification.
-‘an external patient interface configured for…obtaining the intestinal sounds’ in claim 40 interpreted to be “In some embodiments, the patient interface 14 comprises, or is similar in design and function to, a stethoscope head. Stethoscope heads comprise a diaphragm that is placed in contact with the patient and that vibrates in response sounds generated within the body.” per the specification
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.
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.
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 29-41 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 29 recites ‘the predefined spectral event’ after reciting ‘predefined spectral events’ making it unclear if ‘the predefined spectral event’ (singular) is part of ‘predefined spectral events’ (plural) or not. For examination purposes the singular will be treated as part of the plural.
Claim 32 recites the limitation "the identified predefined spectral events" in Line 14. There is insufficient antecedent basis for this limitation in the claim.
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 23-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claimed invention in claims 23-41 are directed to statutory subject matter as the claims recite a system (claims 29-41) and a method (claims 23-28).
Step 2A, Prong One
Regarding claims 23, 29, 32, the recited steps are directed mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Specifically from claim 23:
obtaining intestinal sounds of a patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop to generate audio data;
identifying predefined spectral events in the audio data that are predictive of subsequent gastrointestinal impairment, the predefined spectral events being defined by predefined parameters, wherein the predefined parameters include frequency of the predefined spectral events and the frequency is in a range of approximately 900 to 20,000 Hertz; and
predicting a likelihood of subsequent gastrointestinal impairment relative to the predefined spectral events.
Specifically from claim 29:
identifying predefined spectral events in audio data obtained from intestinal sounds of a patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop, the predefined spectral events being defined by predefined parameters and predictive of subsequent gastrointestinal impairment, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in a range of approximately 900 to 20,000 Hertz; and
predicting a likelihood of subsequent gastrointestinal impairment relative to the predefined spectral events.
Specifically from claim 32:
receive audio data obtained from intestinal sounds of a patient
identifying predefined spectral events in the audio data obtained from the intestinal sounds of the patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop, the predefined spectral events being defined by predefined parameters and predictive of subsequent gastrointestinal impairment, wherein the predefined parameters include frequency of the predefined spectral events and the frequency is in a range of approximately 900 to 20,000 Hertz; and
predicting the likelihood of subsequent gastrointestinal impairment relative to the identified predefined spectral events.
These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps. A human can receive audio data and identify spectral events. A human can make predictions with any arbitrary algorithm given the claimed invention does not require any particular algorithm for the predictions.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Step 2A, Prong Two
This judicial exceptions (abstract ideas) in claims 23-41 are not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for obtaining, identifying, predicting, receive merely invoke a computer as a tool.
•The data-gathering step (obtaining and receive) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for obtaining, identifying, predicting, and receive.
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for obtaining, identifying, predicting, and to receive. The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Step 2B
The additional elements are identified as follows:
‘an external patient interface’ in claim 24, ‘a patient interface’ in claims 24 and 25, ‘wireless transmitter’ in claim 25, ‘a non-transitory computer-readable medium’, ‘algorithm’, ‘processor’ in claim 29, ‘a device’, ‘a processor’, ‘a non-transitory computer-readable storage medium’, ‘algorithm’ in claim 32, ‘a computer’ in claim 35, ‘a separate data collection device’ in claim 35, ‘a data collection device’ in claim 36, ‘a microphone’ in claim 37, ‘a patient monitoring system’ in claim 38, ‘a data collection device’ in claim 38, ‘a wireless receiver’ in claim 39, ‘a patient interface’ in claim 39, ‘a wireless transmitter’ in claim 39, ‘an external patient interface’ in claims 40 and 41.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant's specification (Page 4, Line 23-Page 5, Line 8) which discloses that the processor and memory comprise generic computer components that are configured to perform the generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose each of the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 24, 25, 35, 36, 37, 38, 39, 40, 41 recites additional elements at a high level of generality which are conventional in the art
Claims 26, 27, 28, 30, 31, 33, 34 are steps that are also abstract as a mental process through additional data gathering or analysis (or further limiting the type of data gathered/analyzed)
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-9 of U.S. Patent No. 9179887 and claims 1-19 of U.S. Patent No. 10603006.
Instant Application 18/385,490
Conflicting US Patent No. 9179887
Conflicting US Patent No. 10603006
23. (New) A method for predicting gastrointestinal impairment, the method comprising:
obtaining intestinal sounds of a patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop to generate audio data;
identifying predefined spectral events in the audio data that are predictive of subsequent gastrointestinal impairment, the predefined spectral events being defined by predefined parameters, wherein the predefined parameters include frequency of the predefined spectral events and the frequency is in a range of approximately 900 to 20,000 Hertz; and
predicting a likelihood of subsequent gastrointestinal impairment relative to the predefined spectral events.
1. A method for predicting gastrointestinal impairment, the method comprising:
obtaining intestinal sounds of a patient with a data collection device to generate audio data, wherein the intestinal sounds are obtained after surgery, but before clinical signs and symptoms of a gastrointestinal impairment develop;
identifying, by a processor, predefined spectral events in the audio data that are predictive of subsequent gastrointestinal impairment, the predefined spectral events being defined by predefined parameters; and
predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events.
4. The method of claim 1, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
14. A computer-readable medium including program instructions that when executed by a processor are configured to cause the processor to perform the following actions: identifying predefined spectral events in audio data obtained with a data collection device from intestinal sounds of a patient, wherein the patient does not currently have gastrointestinal impairment, wherein gastrointestinal impairment comprises one or more of: presence of emesis, need for nasogastric intubation, and reversal of diet, and wherein the predefined spectral events are defined by predefined parameters and predictive of subsequent gastrointestinal impairment; predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events; and outputting an indication of level of risk for development of subsequent gastrointestinal impairment.
15. The computer-readable medium of claim 14, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
29. (New) A non-transitory computer-readable medium storing program instructions comprising one or more algorithms that when executed by a processor cause the processor to perform steps including: identifying predefined spectral events in audio data obtained from intestinal sounds of a patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop, the predefined spectral events being defined by predefined parameters and predictive of subsequent gastrointestinal impairment, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of approximately 900 to 20,000 Hertz; and predicting a likelihood of subsequent gastrointestinal impairment relative to the predefined spectral events.
1. A method for predicting gastrointestinal impairment, the method comprising:
obtaining intestinal sounds of a patient with a data collection device to generate audio data, wherein the intestinal sounds are obtained after surgery, but before clinical signs and symptoms of a gastrointestinal impairment develop;
identifying, by a processor, predefined spectral events in the audio data that are predictive of subsequent gastrointestinal impairment, the predefined spectral events being defined by predefined parameters; and
predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events.
4. The method of claim 1, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
14. A computer-readable medium including program instructions that when executed by a processor are configured to cause the processor to perform the following actions: identifying predefined spectral events in audio data obtained with a data collection device from intestinal sounds of a patient, wherein the patient does not currently have gastrointestinal impairment, wherein gastrointestinal impairment comprises one or more of: presence of emesis, need for nasogastric intubation, and reversal of diet, and wherein the predefined spectral events are defined by predefined parameters and predictive of subsequent gastrointestinal impairment; predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events; and outputting an indication of level of risk for development of subsequent gastrointestinal impairment.
15. The computer-readable medium of claim 14, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
32. (New) A system for predicting gastrointestinal impairment, the system comprising:
a device including a processor configured to receive audio data obtained from intestinal sounds of a patient and a non-transitory computer-readable storage medium storing instructions comprising one or more algorithms that when executed by the processor cause the processor to perform steps including:
identifying predefined spectral events in the audio data obtained from the intestinal sounds of the patient after surgery and before clinical signs and symptoms of gastrointestinal impairment develop, the predefined spectral events being defined by predefined parameters and predictive of subsequent gastrointestinal impairment, wherein the predefined parameters include frequency of the predefined spectral events and the frequency is in a range of approximately 900 to 20,000 Hertz; and predicting a likelihood of subsequent gastrointestinal impairment relative to the predefined spectral events.
1. A method for predicting gastrointestinal impairment, the method comprising:
obtaining intestinal sounds of a patient with a data collection device to generate audio data, wherein the intestinal sounds are obtained after surgery, but before clinical signs and symptoms of a gastrointestinal impairment develop;
identifying, by a processor, predefined spectral events in the audio data that are predictive of subsequent gastrointestinal impairment, the predefined spectral events being defined by predefined parameters; and
predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events.
4. The method of claim 1, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
1. A system comprising: a patient interface configured for detecting intestinal sounds obtained before clinical signs and symptoms of a gastrointestinal impairment develop in a patient, wherein the patient interface comprises a microphone; a data collection device configured for processing audio data from the patient interface; a predicting device configured for receiving the audio data from the data collection device, identifying predefined spectral events in the audio data, the predefined spectral events being defined by predefined parameters and predictive of subsequent gastrointestinal impairment, and predicting a likelihood of subsequent gastrointestinal impairment based on the predefined spectral events.
2. The system of claim 1, wherein the predefined parameters include frequency of the predefined spectral event and the frequency is in the range of 900 to 20,000 Hertz.
The difference between the rejected claims of the instant application and patented claims of the patents lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Further the computer readable medium claims are not distinguishable from the method and/or system claims. Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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