DETAILED ACTION
Applicant' s arguments, filed 06/30/2026 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 05/31/2024, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-12 are hereby the present claims under consideration.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 it appears that “accumulating an area under the curve of the pressure-time information” should recite “accumulating an area under a curve formed by the pressure-time information”
Claim 7 it appears that “accumulate an area under a curve of the pressure-time information” should recite “accumulate an area under a curve formed by the pressure-time information”
Appropriate correction is required.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Semler US Patent Application Publication Number US 2008/0287833 A1 hereinafter Semler in view of Burnett US Patent Application Publication Number US 2017/0136209 A1 hereinafter Burnett.
Regarding claim 1, Semler discloses a method for intra-abdominal pressure evaluation and warning executed by a control device (Abstract), comprising:
receiving a pressure value measured over time by a sensing device configured to be disposed inside an arrangement space of a living object (Paragraph 0036: the capsule is ingested and measurements taken through the gastrointestinal tract, or arrangement space; Paragraph 0037: pressure readings may be transmitted by the ingested capsule; Paragraph 0040: a data receiver worn by the patient receives the collected data);
recording pressure-time information based on the received pressure value (Paragraph 0011: pressure as a function of time; Fig. 3: pressure over time; Paragraph 0040: the capsule transmits measured data to a portable data receiver, or control device);
accumulating an area under the curve of the pressure-time information during a measuring duration (Paragraphs 0043-0045: Time intervals are determined and the total area under the curve of the pressure data is calculated; Paragraph 0060: the data point are cumulative area under the curve in given time intervals; Fig. 5); and
while the accumulated area meets a warning threshold, (Paragraphs 0009, 0013, 0043, 0045: the pressure pattern, including the area under the pressure curve, is compared to the reference pattern and if the deviation is more than a set threshold, such as 10% difference, the subject is determined to have gastroparesis; Paragraph 0049: the system may also utilize a requisite degree of similarity to a known disease pattern rather than a difference from a known healthy pattern).
Semler fails to further disclose the method wherein the area exceeds a threshold and outputting a warning signal
Burnett teaches devices and methods for draining and analyzing bodily fluids (Abstract) Burnett teaches a Foley catheter system capable of measuring intrabdominal pressures (Paragraphs 0126 and 0133). Thus, Burnett is reasonably pertinent to the problem at hand.
Burnett teaches that intra-abdominal pressure measurements may be used to detect conditions such as intra-abdominal hypertension (IAH), abdominal compartment syndrome (ACS), and other conditions. Burnett teaches that the absolute pressure measurements themselves and/or their trend data may be used for detecting these conditions (Paragraphs 0279-0280). Burnett further teaches a graphical indicator for displaying measured values and that the indicator may be set to generate alerts for when measured values or trends of values fall outside of a defined range (Paragraph 0155).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the teachings of Burnett to configure the method of Semler to detect other pressure related abdominal conditions such as IAH and/or ACS by comparing the already recorded pressure data and accumulated area under the curve of the pressure data to various thresholds that would indicate the other conditions and to produce an alert when these conditions are detected. Such a configuration would provide the benefit of allowing the method of Semler to be applied to a wider patient population since it would be configured to detect a wider range of conditions and the generated alert when certain conditions are detected, or value ranges exceeded, would provide the user with an easy to understand indication of whether the method detected a particular condition or not.
Regarding claim 7, Semler discloses a system for intra-abdominal pressure evaluation and warning (Abstract), comprising:
a sensing device configured to be disposed inside an arrangement space of a living object (Paragraph 0036: the capsule is ingested and measurements taken through the gastrointestinal tract, or arrangement space), the sensing device including a pressure sensing module configured to measure a pressure value of the arrangement space over time (Paragraph 0036: sensing pressure from the pressure sensor; Paragraph 0038: pressure sensor assembly; Paragraph 0011: pressure as a function of time; Fig. 3: pressure over time); and
a control device coupled to the sensing device, wherein the control device is configured to receive the pressure value and record pressure-time information (Paragraph 0011: pressure as a function of time; Fig. 3: pressure over time; Paragraph 0040: the capsule transmits measured data to a portable data receiver, or control device);
wherein the control device is further configured to accumulate an area under a curve of the pressure-time information during a measuring duration (Paragraphs 0043-0045: Time intervals are determined and the total area under the curve of the pressure data is calculated; Paragraph 0060: the data point are cumulative area under the curve in given time intervals; Fig. 5), and while the area meets a warning threshold (Paragraphs 0009, 0013, 0043, 0045: the pressure pattern, including the area under the pressure curve, is compared to the reference pattern and if the deviation is more than a set threshold, such as 10% difference, the subject is determined to have gastroparesis; Paragraph 0049: the system may also utilize a requisite degree of similarity to a known disease pattern rather than a difference from a known healthy pattern).
Semler fails to further disclose the system wherein the area exceeds a threshold and outputting a warning signal by the control device
Burnett teaches that intra-abdominal pressure measurements may be used to detect conditions such as intra-abdominal hypertension (IAH), abdominal compartment syndrome (ACS), and other conditions. Burnett teaches that the absolute pressure measurements themselves and/or their trend data may be used for detecting these conditions (Paragraphs 0279-0280). Burnett further teaches a graphical indicator for displaying measured values and that the indicator may be set to generate alerts for when measured values or trends of values fall outside of a defined range (Paragraph 0155).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the teachings of Burnett to configure the system of Semler to detect other pressure related abdominal conditions such as IAH and/or ACS by comparing the already recorded pressure data and accumulated area under the curve of the pressure data to various thresholds that would indicate the other conditions and to produce an alert when these conditions are detected. Such a configuration would provide the benefit of allowing the system of Semler to be applied to a wider patient population since it would be configured to detect a wider range of conditions and the generated alert when certain conditions are detected, or value ranges exceeded, would provide the user with an easy to understand indication of whether the method detected a particular condition or not.
Regarding claims 2 and 8, Semler in view of Burnett teaches the method and system of claims 1 and 7 respectively. Modified Semler further teaches the method and system wherein a Y-axis of the pressure-time information is represented (Fig. 3: the y axis is pressure information; the x axis is time).
Modified Semler further teaches the display of normalized values with respect to a baseline (Paragraphs 0011, 0027, and 0060; Fig. 5: the normalized motility index)
An obvious variation of modified Semler would be to represent the y-axis as a ratio of the pressure value to a critical pressure value. Such a variation would be obvious because Semler already teaches the display of normalized data with respect to a certain value (Paragraphs 0011, 0027, and 0060). While Semler does not explicitly teach the display of normalized pressure data with respect to a critical value, such a display is an obvious variation of displaying absolute pressure values and/or normalized pressure values with respect to a baseline. The value to which the recorded data is normalized with respect to is a matter of routine optimization and experimentation to best suit the display to a desired use case. The normalization of the display data serves to better illustrate the recorded data with respect to a desired parameter. The desired parameter used to normalize the data is subject to routine optimization and experimentation to best adapt the system and display to the particular use case based on what condition, value, or relationship is being monitored. The normalization of the display data to a particular value does not produce a surprising technical effect.
Regarding claims 3 and 9, Semler in view of Burnett teaches the method and system of claims 1 and 7 respectively. Modified Semler further teaches the method and system wherein the sensing device is configured to be delivered to the arrangement space via an esophagus of the living object (Paragraph 0036: the capsule is ingested and thus passes through the esophagus).
Regarding claims 4 and 10, Semler in view of Burnett teaches the method and system of claims 3 and 9 respectively. Modified Semler further teaches the method and system wherein sensing device is configured to be located at any location in a digestive system of the living object (Paragraph 0036: the capsule is ingested and measurements taken through the gastrointestinal tract, or arrangement space).
Regarding claims 5 and 11, Semler in view of Burnett teaches the method and system of claims 1 and 7 respectively. Modified Semler further teaches the method and system wherein the sensing device is communicatively coupled to the control device via a wireless communication (Paragraph 0040: the capsule transmits data wirelessly to the portable data receiver).
Regarding claims 6 and 12, Semler in view of Burnett teaches the method and system of claims 1 and 7 respectively. Modified Semler further teaches the method and system wherein the sensing device includes a pressure sensor with a piezoelectric, a piezoresistive, a capacitive, an inductive, an electromagnetic piezoelectric, or a thin-film pressure sensing mechanism (paragraph 0038: the pressure sensors senses pressure in a space surrounded by flexible sleeve; Fig. 7 references 26, 28, and 29. This arrangement is considered a “thin-film pressure sensing mechanism” since the flexible sleeve deflects with pressure and changes the pressure in the space which is sensed by the pressure sensor).
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant’s arguments and amendments are sufficient to overcome the previously presented rejections presented under 35 USC 101 and 112.
In regards to the rejections presented under 35 USC 103. Applicant’s arguments are not found to be persuasive.
In particular, Applicant argues that Semler and Burnett are physically and algorithmically exclusive and that one of ordinary skill in the art would have no motivation to modify Semler’s ingestible capsule with Burnett’s IAP monitoring because Burnett is drawn towards a stationary measurement catheter while Semler is drawn towards an ingestible capsule that moves through the GI tract.
Applicant’s arguments are not found to be persuasive because the structure of Burnett is not being combined with the structure of Semler, only portions of its functionality. Semler and Burnett both monitor pressure values inside the abdomen and thus one of ordinary skill in the art would have a reasonable expectation of success for incorporating the data processing methods of Burnett into the method and device of Semler. This is further evidenced by Liao “An Ingestible Electronics for Continuous and Real-Time Intraabdominal Pressure Monitoring” published by MDPI on December 24th 2020 pages 1-10 hereinafter Liao which teaches that ingestible pressure sensors may be used in IAH and ACS detection because they record IAP pressure values. One of ordinary skill in the art, would have a reasonable expectation of success when incorporating the IAH and ACS detection of Burnett into the method and device of Semler because both inventions are directed towards processing pressure values in the abdominal cavity.
Applicant further argues that the core algorithms of Semler and Burnett are mutually exclusive and that combining them would destroy the operative function of Semler’s system. Applicant argues that the baseline compensation of Semler is incompatible with IAH and ACS detection because it removes the required absolute values utilized by Burnett.
Applicant’s arguments are not found to be persuasive because they mischaracterize the combination of references. In particular, Semler teaches the acquisition, storage, and processing of raw pressure values (Semler paragraph 0040: the capsule transmits sensed data , or raw data values, which are received and stored for analysis on the portable data receiver; Fig. 3). There is no requirement for Semler to utilize the baseline compensation in the IAH and ACS detection algorithm imported from Burnett. The algorithms may be run in parallel using their own processing techniques and both access the raw data. Additionally, it is noted that IAH is defined by a sustained IAP of greater than 12mmHg. Semler recites that the baseline compensation may be 3 mmHg (Semler: paragraph 0011) with the minimum threshold of about 9mmHg (Semler: paragraph 0044). Thus, even if Semler in view of Burnett were limited to the compensation and conditioning methods described in Semler, the resultant data includes all values above 12mmHg in absolute pressure and below an artifact peak of 200mmHg. Thus the filtered data includes any pressure readings indicative of IAH and would still be suitable for the detection of IAH since the conditioning would only filter out values in the normal pressure range while any value in the IAH range is preserved to add to the AUC.
Applicant further argues that Burnett focuses on analyzing the slope or variability of pressure values over time which is a fundamentally different concept than the claimed AUC accumulation and Burnett does not contemplate using such a metric.
Applicant’s arguments are not found to be persuasive because they do not address the combination of references. One cannot show non-obviousness by attacking references individually where the based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In particular, the analysis of IAH and ACS of Burnett is integrated into Semler but is in view of the AUC analysis operations performed by Semler. Thus, Burnett teaches the detection of IAH and ACS, while Semler teaches that AUC is a useful metric for monitoring pressure conditions in the abdomen and that pressure patterns in the AUC can be used in the identification of gastric conditions relating to pressure. See Fig. 10 of Semler which illustrates how the AUC of healthy versus diseased subjects shows a significant difference. One of ordinary skill in the art in light of the teachings of Semler and Burnett would have been motivated to use the AUC measures taught by Semler to perform the detection of IAH and/or ACS as taught by Burnett because such a detection would improve the usefulness of the device by allowing it to detect a wider range of conditions and one of ordinary skill in the art would have a reasonable expectations of success in detecting IAH using the AUC values since IAH is known to be characterized by a sustained increase in IAP and thus would clearly be reflected in greater AUC than a healthy patient since the pressure readings will be higher on average than a healthy individual. Applicant does not describe why one of ordinary skill in the art would not have a reasonable expectation of success of detecting IAH and/or ACS using AUC metrics.
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 MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights