DETAILED ACTION
Note: 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
Claims 21-40 are pending and currently under consideration for patentability under 37 CFR 1.104
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (16/247716 filed on 15 January 2019; and 62/617877 filed on 16 January 2018) are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 1, 2023 has been considered by the examiner.
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 21-40 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 21 follows.
Regarding claim 21, the claim recites a system for monitoring gastrointestinal motility. Thus, the claim is directed to a machine/apparatus, 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 following limitations set forth a judicial exception:
“…analyzing a plurality of characteristics of the electrical signal relative to a plurality of respective thresholds indicative of (a) an imminence or an occurrence of a condition of the gastrointestinal tract and (b) a type of the condition; and based on the analyzing, determining that the type of the condition is imminent or occurring, the type of the condition determined as one of: at least a partial obstruction event, bradygastria associated with a trend toward an obstruction event, or tachygastria associated with a trend toward a cluster event.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“A system for monitoring gastrointestinal motility, the system comprising: a sensor configured to obtain an electrical signal including data associated with motility in a gastrointestinal tract of a patient; and at least one processor communicatively coupled to the sensor and configured to perform operations, the operations comprising: receiving the electrical signal from the sensor…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they are recited at a high level of generality. Moreover, Examiner takes official notice that “a sensor configured to obtain an electrical signal including data associated with motility in a gastrointestinal tract of a patient” is widely-understood, routine, and conventional.
Independent claims 36 and 40 are also not patent eligible for substantially similar reasons.
Dependent claims 22-35 and 37-39 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 21-40 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. (US PG Pub. No. 2018/0317800 A1) (hereinafter “Coleman”).
With respect to claim 21, Coleman teaches a system for monitoring gastrointestinal motility (title “characterizing gastrointestinal functions”), the system comprising: a sensor configured to obtain an electrical signal including data associated with motility in a gastrointestinal tract of a patient (electrode sensing module 110 in Fig. 1; par.0014 “obtain electrical signals representing GI activities of the subject”); and at least one processor communicatively coupled to the sensor and configured to perform operations (signal conditioning module 120, which includes GI monitoring signal DSP in Fig. 1A), the operations comprising: receiving the electrical signal from the sensor; (par.0014 “electrode sensing module 110…to obtain electrical signals representing GI activities of the subject under monitoring”) analyzing a plurality of characteristics of the electrical signal condition is imminent or occurring, the type of the condition determined as one of: at least a partial obstruction event, bradygastria associated with a trend toward an obstruction event, or tachygastria associated with a trend toward a cluster event (par.0104 “pyloric pseudo-obstruction… obtained by the physiological monitoring system”; see also par.0120-121 “obstruction had an abnormally high amplitude gastric slow wave occurring continuously throughout the recording period”; Note: “as one of” only requires that one of the subsequent conditions are taught by the prior art, i.e. Coleman’s teaching of at least a partial obstruction event, pyloric pseudo-obstruction, etc. meets the requirements of the currently recited claim).
Although Coleman does not explicitly teach a plurality of respective thresholds, further modification to incorporate this feature would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Coleman expressly teaches analysis of electrical signal data and indicating obstruction based on an “abnormally high amplitude gastric slow wave” (par.0121). Accordingly, it is understood that there would need to be an assessment of said electrical signal data and suggests a comparison with at least data that is indicative of being normal, i.e. in order to determine that said electric signal data is abnormally high. Therefore, utilizing a plurality of respective thresholds in place of Coleman’s implied comparison to normal reference data would have been prima facie obvious to PHOSITA as this would involve mere routine skill in the art.
With respect to claim 22, Coleman teaches wherein the plurality of characteristics of the electrical signal include at least one of a frequency, an amplitude, a measure of roughness, a fractal dimension, a minimum, a maximum, a segment endpoint, a short- time Fourier transform, or a discrete time Fourier transform (abstract “frequency and an amplitude”).
With respect to claim 23, Coleman teaches operations further comprising: filtering the electrical signal to identify the data associated with motility, wherein the plurality of characteristics analyzed are characteristics of the filtered electrical signal (par.0045, 48, 63).
With respect to claim 24, Coleman renders obvious wherein analyzing the plurality of characteristics of the electrical signal relative to the plurality of respective thresholds comprises: analyzing a first set of one or more of the plurality of characteristics of the electrical signal relative to a first threshold value indicative of the imminence or the occurrence of the condition of the gastrointestinal tract to determine that the condition is imminent or is occurring (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 25, Coleman renders obvious wherein the analyzing of the first set comprises: comparing a fractal dimension of the electrical signal to the first threshold value, wherein the fractal dimension being below the first threshold value indicates that the condition is imminent or is occurring (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 26, Coleman renders obvious wherein analyzing the plurality of characteristics of the electrical signal relative to the plurality of respective thresholds comprises: analyzing a second set of one or more of the plurality of characteristics of the electrical signal relative to a second threshold value indicative of the type of the condition to determine the type of the condition (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 27, Coleman renders obvious wherein the analyzing of the second set comprises: comparing a reduction in an amplitude of the electrical signal to the second threshold value; wherein, in response to determining that the amplitude has been reduced by at least the second threshold value, the operations further comprise evaluating whether the type of the condition that is imminent or is occurring is the at least partial obstruction; and wherein, in response to determining that the at least partial obstruction is not the type of the condition, the operations further comprise analyzing a frequency of the electrical signal to determine the type of the condition as one of the bradygastria or the tachygastria based on measured shifts in the frequency (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 28, Coleman suggests wherein analyzing the frequency of the electrical signal comprises: calculating one or more of a short-time Fourier transform or a discrete time Fourier transform of the electrical signal; and analyzing the one or more of the short-time Fourier transform or the discrete time Fourier transform for a change in frequency of the electrical signal (par.0024, 74, 109-110).
With respect to claim 29, Coleman teaches wherein the type of the condition is determined as the bradygastria if the change in frequency of the electrical signal is to a lower frequency, or as the tachygastria if the change in frequency of the electrical signal is to a higher frequency (Note: it is widely known that bradygastria corresponds to lower frequency with respect to electrical activity, while tachygastrica corresponds to higher frequency with respect to electrical activity. Examiner also cites additional references at the end of the office action that further demonstrate this known concept).
With respect to claim 30, Coleman renders obvious wherein the analyzing of the second set comprises: comparing a reduction in an amplitude of the electrical signal to the second threshold value; in response to determining that the amplitude has not been reduced by at least the second threshold value, comparing a fractal dimension of the electrical signal to a third threshold value; and in response to the fractal dimension of the electrical signal being higher than the third threshold value, determining that a resting or fasting period is not occurring, and analyzing a frequency of the electrical signal to determine the type of the condition as one of the bradygastria or the tachygastria based on measured shifts in the frequency (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 31, Coleman renders obvious wherein the second set is analyzed to determine the type of the condition in response to a determination that the condition is imminent or is occurring, based on an analyzing of a first set of one or more of the plurality of characteristics of the electrical signal relative to a first threshold value indicative of the imminence or the occurrence of the condition of the gastrointestinal tract, wherein the second threshold value is different from the first threshold value (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 1 above).
With respect to claim 32, Coleman teaches wherein the operations further comprise: at least one of generating an alert or causing administration of a treatment in response to determining the type of the condition is imminent or occurring (par.0050).
With respect to claim 33, Coleman does not teach wherein the sensor is located in the gastrointestinal tract of the patient (Coleman teaches non-invasive surface electrodes). However, further modification to utilize implantable sensors/device in place of Coleman’s non-invasive electrodes would have been obvious to PHOSITA when the invention was filed as a simple substitution. See also prior art cited at the end of the current office action for further evidence of the known nature of utilizing an implantable sensor for monitoring at a location in the GI tract of the patient.
With respect to claim 34, Coleman does not teach further comprising; an implantable device, wherein one or more of the sensor or the at least one processor is a component of the implantable device. However, further modification to utilize implantable sensors/device in place of Coleman’s non-invasive electrodes would have been obvious to PHOSITA when the invention was filed as a simple substitution. See also prior art cited at the end of the current office action for further evidence of the known nature of utilizing an implantable sensor for monitoring at a location in the GI tract of the patient.
With respect to claim 35, Coleman teaches further comprising: a therapy delivery system communicatively coupled to the at least one processor and configured to administer a treatment for the type of the condition that is imminent or occurring based on data received from the at least one processor (par.0101+).
With respect to claim 36, Coleman teaches a system for monitoring gastrointestinal motility (title “characterizing gastrointestinal functions”), the system comprising: monitoring system”; see also par.0120-121 “obstruction had an abnormally high amplitude gastric slow wave occurring continuously throughout the recording period”; Note: “as one of” only requires that one of the subsequent conditions are taught by the prior art, i.e. Coleman’s teaching of at least a partial obstruction event, pyloric pseudo-obstruction, etc. meets the requirements of the currently recited claim).
Although Coleman does not explicitly teach an implantable device positionable in a gastrointestinal tract of a patient and a plurality of respective thresholds, further modification to incorporate these feature would have been obvious to PHOSITA when the invention was filed for the following reasons. First, modification to utilize implantable sensors/device in place of Coleman’s non-invasive electrodes would have been obvious to PHOSITA when the invention was filed as a simple substitution. See also prior art cited at the end of the current office action for further evidence of the known nature of utilizing an implantable sensor for monitoring at a location in the GI tract of the patient. Second, Coleman expressly teaches analysis of electrical signal data and indicating obstruction based on an “abnormally high amplitude gastric slow wave” (par.0121). Accordingly, it is understood that there would need to be an assessment of said electrical signal data and suggests a comparison with at least data that is indicative of being normal, i.e. in order to determine that said electric signal data is abnormally high. Therefore, utilizing a plurality of respective thresholds in place of Coleman’s implied comparison to normal reference data would have been prima facie obvious to PHOSITA as this would involve mere routine skill in the art.
With respect to claim 37, Coleman renders obvious wherein analyzing the plurality of characteristics of the electrical signal relative to the plurality of respective thresholds comprises: determining a fractal dimension of the electrical signal is below a first threshold value indicative of the imminence or the occurrence of the condition; and in response to the determination, comparing a reduction in an amplitude of the electrical signal to a second threshold value indicative of the type of the condition to determine the type of the condition (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 36 above).
With respect to claim 38, Coleman renders obvious wherein, in response to determining that the amplitude has been reduced by at least the second threshold value, the operations comprise: evaluating whether the at least partial obstruction, the bradygastria, or the tachygastria is the type of the condition that is imminent or is occurring (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 36 above).
With respect to claim 39, Coleman renders obvious wherein, in response to determining that the amplitude has not been reduced by at least the second threshold value, the operations further comprise: comparing a fractal dimension of the electrical signal to a third threshold value; and in response to the fractal dimension of the electrical signal being lower than the third threshold value, determining that the resting or fasting period is imminent or occurring; or in response to the fractal dimension of the electrical signal being higher than the third threshold value, evaluating whether the bradygastria or the tachygastria is the type of the condition that is imminent or is occurring (Note: PHOSITA would have had predictable success utilizing plurality of respective thresholds in the manner recited, see obviousness rationale of claim 36 above).
With respect to claim 40, Coleman teaches a system for monitoring gastrointestinal motility (title “characterizing gastrointestinal functions”), the system comprising: a sensor configured to obtain an electrical signal including data associated with motility in a gastrointestinal tract of a patient (electrode sensing module 110 in Fig. 1; par.0014 “obtain electrical signals representing GI activities of the subject”); and at least one processor communicatively coupled to the sensor and configured to perform operations (signal conditioning module 120, which includes GI monitoring signal DSP in Fig. 1A), the operations comprising: receiving the electrical signal (par.0014 “electrode sensing module 110…to obtain electrical signals representing GI activities of the subject under monitoring”); determining an imminence or an occurrence of a condition of the gastrointestinal tract based on an analysis of a first set of one or more of a plurality of characteristics of the electrical signal obtained by the physiological monitoring system”; see also par.0120-121 “obstruction had an abnormally high amplitude gastric slow wave occurring continuously throughout the recording period”; Note: “as one of” only requires that one of the subsequent conditions are taught by the prior art, i.e. Coleman’s teaching of at least a partial obstruction event, pyloric pseudo-obstruction, etc. meets the requirements of the currently recited claim)
Although Coleman does not explicitly teach a first threshold and one or more additional thresholds, further modification to incorporate this feature would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Coleman expressly teaches analysis of electrical signal data and indicating obstruction based on an “abnormally high amplitude gastric slow wave” (par.0121). Accordingly, it is understood that there would need to be an assessment of said electrical signal data and suggests a comparison with at least data that is indicative of being normal, i.e. in order to determine that said electric signal data is abnormally high. Therefore, utilizing respective thresholds in place of Coleman’s implied comparison to normal reference data would have been prima facie obvious to PHOSITA as this would involve mere routine skill in the art.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PG Pub. No. 2014/0058282 A1, see abstract; par.0005
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791