DETAILED ACTION
Notice of 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/25/2026 has been entered.
Response to Arguments
Applicant's arguments filed 03/25/2026 have been fully considered but they are moot in view of the new grounds of rejection in view of the teachings of Weitzner (US 10993606) as described below.
Claim Rejections - 35 USC § 103
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1-13, 15, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sogade (US 2008/0009732, of record) in view of “Transurethral light delivery for prostate photoacoustic imaging” by M.A. Bell et al. J Biomed Optics. 20(3) 2015 (Bell, of record) in view of Meduri (US 2020/0337683, of record) in view of Weitzner (US 10993606).
Regarding claims 1 and 8, Sogade discloses a system and method for monitoring progression of labor ([0001]: “measuring dilation of the human cervix and the descent of the presenting part of the fetus during labor”), the system comprising: a) a urinary catheter that is inserted into a urethra of a pregnant female during labor for obtaining physiological measurements of a cervical region and a uterus region of the pregnant female, and performing real-time 3D imaging in an intra-urinary bladder catheter to image a cervical/uterus region to monitor progression of labor through the use of ultrasound imaging ([0013]: “measuring the dilation of cervix…descent of the fetal presenting part…intra-urinary bladder catheter ultrasound applications”). Sogade does not explicitly disclose, b) a working channel attached to the urinary catheter, the working channel having a lumen, a proximal end, and a distal end; and c) an ultrasound transceiver device, disposed in the lumen of the working channel. However, Bell teaches a working channel attached to a urinary catheter, the working channel having a lumen, proximal and distal end, and an ultrasound transceiver disposed in the lumen of the working channel (Fig. 1a). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the urinary catheter of Bell to the ultrasound monitoring of Sogade, as to provide a photoacoustic means of monitoring labor. Neither Sogade nor Bell explicitly disclose a cap attached to the distal end of the working channel that is configured to maintain sterility of the ultrasound transceiver device within the lumen of the working channel. Meduri teaches a plug that maintains the sterility of a catheter lumen ([0033]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the plug of Meduri to the catheter system of Sogade and Bell, as to provide robust sterility for the lumen of a catheter. Neither Sogade, Bell, nor Meduri explicitly disclose that there’s a working channel that’s attached to and extending along a portion of a catheter. However, Weitzner teaches peripheral channels attached to a main body of a catheter system (Figs. 3A, 3B, 4A, 4B). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the working channel of Weitzner to the urinary catheter of Sogade, Bell, and Meduri, as to provide robust catheter functionality and tool access.
Regarding claim 2, Sogade discloses that the working channel is temporarily or permanently attached to the urinary catheter (temporary and permanently cover all forms of attachment, thus the catheter of Sogade would satisfy the claim limitation).
Regarding claim 3, while Sogade does not explicitly disclose that the working channel is detachable from the urinary catheter, if it were considered desirable for any reason to obtain access to the end of a device (in the instant case, accessing the working channel for maintenance or storage) which an enclosing structure is applied, it would be obvious to make the enclosing structure removable for such a purpose (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)).
Regarding claim 4, while Sogade does not explicitly disclose a detachable cap, if it were considered desirable for any reason to obtain access to the end of a device (in the instant case, accessing the working channel for maintenance or storage) which an enclosing structure is applied, it would be obvious to make the enclosing structure removable for such a purpose (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)).
Regarding claims 5 and 9, Sogade does not explicitly disclose that an ultrasound transceiver control module operably connected to the ultrasound transceiver device, however Bell teaches this very limitation (Fig. 1: “X-ducers” would have a control module connected). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the urinary catheter of Bell to the monitoring of Sogade, as to provide a photoacoustic means of monitoring labor.
Regarding claim 6, Sogade does not explicitly disclose that an end of the ultrasound transceiver device is at or near a distal end of the working channel, however Bell teaches this very limitation (Fig. 1). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the urinary catheter of Bell to the monitoring of Sogade, as to provide a photoacoustic means of monitoring labor.
Regarding claim 7, Sogade does not explicitly disclose that the ultrasound transceiver device is configured to be inserted into the working channel (Fig. 1).
Regarding claims 10 and 11, while neither Sogade nor Bell explicitly disclose that the ultrasound transceiver transmits ultrasound signals between 7-25 MHZ at a depth of 9cm, it would have been obvious to one of ordinary skill in the art of photoacoustic imaging that the frequency of ultrasound waves and the depth of penetration of said ultrasound are conventional, well-known, and well-controlled parameters of acoustic imaging.
Regarding claim 12, while Sogade does not explicitly disclose creating a 3D ultrasound image using the ultrasound transceiver device (130), Sogade does teach real-time 3D imaging in an intra-urinary bladder catheter with ultrasound applications ([0010]: “three-dimensional ultrasound imaging device using a catheter”; [0013]: “three-dimensional imaging). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply 3D ultrasound imaging, as to provide robust visualization.
Regarding claims 13, 15, and 16, Sogade does not explicitly disclose that the light source inserted into the lumen of the working channel is a light emitting optical fiber carrying photoacoustic excitation light and that the ultrasound transceiver device receives photoacoustic signals generated by the excitation light, wherein the excitation light is absorbed by tissue chromophores (oxyhemoglobin, deoxyhemoglobin, or both) upon irradiation. However, Bell teaches a photoacoustic imaging catheter with fiber optics (Fig. 1a: “Optical fiber”, “X-ducers”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the photoacoustic catheter of Bell to the monitoring of Sogade, as to provide a photoacoustic means of monitoring labor.
Regarding claim 20, Sogade discloses that physiological measurements comprise cervical dilation ([0013]: “measuring dilation of the cervix”).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sogade (US 2008/0009732, of record) in view of “Transurethral light delivery for prostate photoacoustic imaging” by M.A. Bell et al. J Biomed Optics. 20(3) 2015 (Bell, of record) in view of Meduri (US 2020/0337683, of record) in view of Weitzner (US 10993606), as applied to claim 1 above, in view of Sulek (US 5487740, of record).
Regarding claim 4, neither Sogade, Bell, Meduri, nor Weitzner, explicitly disclose a cap attached to a distal end of the working channel wherein the cap is detachable. However, Sulek teaches a catheter with a detachable cap (7:26-48). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the detachable cap of Sulek to the catheter of Sogade, Bell, Meduri, and Weitzner, as to provide a modular end section.
Conclusion
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/JASON M IP/
Primary Examiner, Art Unit 3793