DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 08/25/2026 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated "Validation of body surface colonic mapping (BSCM) against high resolution colonic manometry for evaluation of colonic motility" by Seo, et al. (hereinafter "Seo"-Cited by the Applicant).
Regarding claim 1, Seo discloses a system for mapping colonic and rectal activity of a patient (high resolution fiber-optic colonic manometer and body surface mapping array system; figure 1; page 2), the system comprising: an electrode array patch having a plurality of electrodes (body surface mapping array comprises an 8x8 stretchable electronics adhesive array (electrode array patch) with pre-gelled electrodes (plurality of electrodes); figure l; pages 2 and 3) configured to noninvasively measure electrical signals associated with colonic and rectal activity of the patient (the array (electrode array patch) is adhesively affixed to the abdominal skin (noninvasive) to capture electrical activity (electrical signals) arising from the rectosigmoid junction (rectal activity) and the left colon (colonic activity); figure l; pages 2 and 3) over a predetermined time period (the array is capable of measuring data over a predetermined time period as shown in the x-axis of the data graphically represented in figure 2; page 5); and a processor configured to: receive the measured electrical signals from the electrode array patch over the predetermined time period (the high resolution fiber-optic colonic manometer and body surface mapping array (electrode array patch) necessarily requires the use of a processor for the purposes of data monitoring, gathering, and reporting; figures 1 and 2; pages 2 and 3); determine one or more abnormal cyclic motor patterns "CMPs" based at least in part on the received measured electrical signals (the colonic manometer and body surface mapping array (electrode array patch) is designed to measure cyclic motor patterns based on the captured electrical activity ( electrical signals) arising from the rectosigmoid junction and the left colon of a patient and would be capable of measuring one or more abnormal cyclic motor patterns; figure 1; pages 2 and 3); and generate a report comprising at least the determination of the one or more abnormal CMPs ( data gathered by the colonic manometer and body surface mapping array (electrode array patch) is processed and displayed in various graphical formats depending on CMP levels as shown in Figure 2, and would be capable or determining one or more abnormal CMPs; figure 2; page 5).
Regarding claim 2, Seo discloses the system of claim 1, the processor being further configured to process the measured electrical signals using a continuous wavelet transform analysis to characterize the measured electrical signals within a predetermined frequency bandwidth (the high resolution fiber-optic colonic manometer and body surface mapping array system uses Continuous Wavelet Transform (CWT) analysis to characterize the electrical activities (electrical signals) occurring within a set frequency bandwidth; page 3).
Regarding claim 3, Seo discloses the system of claim 2, wherein the predetermined frequency bandwidth is between 4 and 10 cycles per minute (as shown in figure 3, each frequency range contains a frequency within the 4 and 10 cycles per minute bandwidth limit; page 3).
Regarding claim 4, Seo discloses the system of claim 2, the processor being further configured to compute a body surface colonic mapping "BSCM" motility index "MI" based on the CWT analysis (the BSCM MI was derived from Continuous Wavelet Transform (CWT) analysis in a 3-step process which necessarily requires the use of a processor for the purposes of data gathering, computing, and reporting; page 4).
Regarding claim 5, Seo discloses the system of claim 4, wherein the BSCM MI comprises a CWT max val, wherein the CWT max val is a mean of a top 10% of wavelet coefficient values at one or more time points during the predetermined time period (BSCM MI was computed as the mean of the top 10% wavelet coefficient values at each time point (one or more time points). This was termed the 'CWT max val' method. Because the preprocessing stage accurately rejects artifacts and noise components, CWT max val is a robust metric quantifying the colonic motility over time (predetermined time period); page 4).
Regarding claim 6, Seo discloses the system of claim 1, wherein the electrode array patch is disposed on the lower abdomen for measuring electrical signals arising from a rectosigmoid junction, an infraumbilical region, or a left colon (the array (electrode array patch) is adhesively affixed to the abdominal skin (lower abdomen) to capture electrical activity (electrical signals) arising from the rectosigmoid junction and the left colon; figure 1; pages 2 and 3).
Regarding claim 7, Seo discloses the system of claim 1, wherein the determination of one or more abnormal CMPs correlates to a colonic motility disorder (the body surface colonic mapping system is designed to measure, process, and report colonic motor patterns (CMPs). This data is used when evaluating colonic motility. CMP hypoactivity or hyperactivity has been associated with the development of low anterior resection syndrome, fecal incontinence, postoperative ileus, and irritable bowel syndrome (colonic motility disorders); pages 1, 3, and 13).
Regarding claim 8, Seo discloses the system of claim 7, wherein the colonic motility disorder comprises fecal incontinence, constipation, irritable bowel syndrome, or low anterior resection syndrome (CMP hypoactivity or hyperactivity has been associated with the development of low anterior resection syndrome, fecal incontinence, postoperative ileus, and irritable bowel syndrome (colonic motility disorders); page 13).
Regarding claim 9, Seo discloses the system of claim 1, wherein the predetermined time period comprises a meal response duration between 30 minutes and 180 minutes (the body surface colonic mapping system uses a meal response duration as a time measurement. The meal response duration is determined through the calculation of meal response end time-start time. As shown, in Figure 4b the meal response duration can range anywhere from 30-150 minutes; figure 4b; pages 8 and 9).
Regarding claim 10, Seo discloses the system of claim 1, the processor being further configured to generate spatio-temporal mapping of the colonic and rectal activity (high resolution colonic manometry spatiotemporal activity maps (spatio-temporal mapping) were generated in each temporal epoch using a two-step process, which included receiving and processing sensor data from the sensors monitoring the rectosigmoid junction (rectal activity) and the left colon ( colonic activity) of a patient; figures 5 and 6; pages 3, 4, 10, and 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
