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 .
Claim Objections
Claim 29 is objected to because of the following informalities: there is no period at the end of claim 29. 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.
Claims 19-24 and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al (U.S. 2018/0078195) in view of Tal et al (U.S. 9,999,767). Sutaria discloses (Fig. 1A-B) (a) inserting a distal end of a tubing assembly into an orifice of the body, wherein the tubing assembly comprises: the catheter (par. 0322), wherein the catheter has a proximal end and a distal end and extends in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; a stimulation electrode assembly (par. 0302), wherein the stimulation electrode assembly is configured to deliver an electrical stimulation waveform to tissue and a noise signal over a frequency range (par. 0175), wherein the tissue comprises muscle or cartilage; and a recording electrode assembly; (b) electrically connecting the stimulation electrode assembly to a stimulator (par. 0405) and the recording electrode assembly to a processor (par. 0215-0217); (c) generating the stimulation waveform via the stimulator; (d) delivering the electrical stimulation waveform to tissue via the stimulation electrode assembly as the catheter is advanced inside the body in a direction away from the orifice; (e) activating the recording electrode assembly, wherein the recording electrode assembly monitors for electrical activity elicited by the tissue in response to the noise signal, further wherein the recording electrode assembly communicates the electrical activity elicited by the tissue to the processor in real-time (Fig. 25; par. 0321).
Sutaria discloses the claimed invention except for the delivered electrical waveform is at a voltage of from about 1.02 volts to about 100 volts. Tal discloses in a similar esophageal stimulation device delivering electrical stimulation to tissue at a voltage of from about 1.01 volts to about 100 volts (col. 13, lines 11-36: “Each electrical pulse has an amplitude; in exemplary embodiments, the amplitude is higher than a stimulating threshold. In some embodiments, the stimulating threshold is between 5V and 20V, optionally, between 8V and 10V or between 10V and 15V”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly of Sutaria to further include delivering electrical stimulation to tissue at a voltage of from about 1.01 volts to about 100 volts as is disclosed by Tal because doing so would help improve motility in patients (col. 3, lines 53-56).
Regarding claim 20, Sutaria discloses (par. 0216 and 0231) a memory device stores instructions which, when executed by the processor, cause the processor to (i) interpret the electrical activity elicited by the tissue and communicated by the recording electrode assembly and (ii) cause a display device to communicate whether or not the catheter is placed within the digestive tract of the patient based on the interpretation of the electrical activity elicited by the tissue.
Regarding claim 21, Sutaria discloses (par. 0321) if the electrical activity elicited by the tissue is in the form of one or more evoked potentials, then it is confirmed that the catheter is placed in the digestive tract, and if the electrical activity elicited by the tissue is not in the form of one or more evoked potentials, then the catheter is not placed in the digestive tract.
Regarding claim 22, Sutaria discloses (par. 0313-0315) the recording electrode assembly monitors for electrical activity elicited by the tissue by measuring an impedance level via one or more electrical contacts in the stimulation electrode assembly or the recording electrode assembly, wherein a first level of impedance indicates that the catheter is placed in the digestive tract and a second level of impedance indicates that the catheter is not placed in the digestive tract.
Regarding claim 23, Sutaria discloses (par. 0321) (f) observing a graph of the electrical activity on a display device coupled to the processor, wherein the display device alerts a user as to correct placement of the catheter in the digestive tract of the patient or alerts the user as to incorrect placement of the catheter in a respiratory tract of the patient.
Regarding claim 24, Sutaria discloses (Fig. 4) the display device is further configured to: output a reference image indicating a location and/or position of the catheter.
Regarding claim 26, Sutaria discloses (par. 0321) the processor is configured to: determine if the electrical activity elicited by the tissue is in the form of one or more evoked potentials or corresponds with an impedance signature for the tissue over the frequency range, determine whether the catheter is positioned in the esophagus based, at least in part, on the one or more evoked potentials or the determined impedance signature, and generate an alert in response to determining that the catheter is not positioned in the esophagus.
Regarding claim 27, Sutaria discloses (par. 0132) the alert comprises an auditory signal.
Regarding claim 28, Sutaria discloses (par. 0314) the stimulation electrode assembly comprises a first electrode disposed on an outer wall of the catheter and a second electrode configured for placement on a surface of skin.
Regarding claim 29, Sutaria discloses (par. 0314) the recording electrode assembly comprises an active recording electrode, an inactive recording electrode, and a reference electrode
Regarding claim 30, Sutaria discloses (par. 0302) the active recording electrode, the inactive recording electrode, and the reference electrode are disposed on an outer wall of the distal end of the catheter.
Regarding claim 31, Sutaria discloses (par. 0314) the active recording electrode, the inactive recording electrode, and the reference electrode are configured for placement on a surface of skin.
Regarding claim 32, Sutaria and Tal disclose the claimed invention but do not disclose expressly the electrical stimulation waveform is a square-wave pulsed waveform. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the unspecified waveform as taught by Sutaria and Tal, with the square-wave pulsed waveform, because the applicant has not disclosed the use of this particular waveform provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the stimulation pulse as taught by Tal and Sutaria, because Sutaria and Tal are able to sense the correct placement of the lead as in the claimed invention. Therefore, it would have been an obvious matter of design choice to modify Sutaria and Tal’s method to obtain the invention as specified in the claim.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al (U.S. 2018/0078195) in view of Tal et al (U.S. 9,999,767), in further view of Bulkes et al (U.S. 2008/0039904). Sutaria and Tal disclose the claimed invention except for the electrical activity passes through an amplifier to amplify one or more frequencies of interest, and a data acquisition system configured to digitize the recorded signals prior to presentation via the display device. Bulkes, however, discloses (par. 0131) an esophageal stimulator including an amplifier (par. 0325-0326) and means (par. 0329) for digitizing a sample. Tal, Sutaria and Bulkes all disclose systems for stimulating patient tissue including portions of the GI tract. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing data of the claimed invention in order to locate frequencies of interest for further processing and more efficient recording and reporting to medical personnel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. 10,058,669 to Razavi et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
Prosecution Insights