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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation " a scope end" in line 3. It is unclear whether this is a distal end of the endoscope recited in the claim or a distal end of a different scope.
Claim 1 recites “a plurality of impedance measuring electrodes disposed on an axial-most face of the scope end” in line 5. It is unclear where the electrodes are disposed.
Claim 3 recites “a camera on a recessed axial face” in line 2. It is unclear where the electrodes are disposed.
Claims 2-15 are rejected for being dependent on a rejected base claim.
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 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.
Claim(s) 1-8, 10-11, is/are rejected under 35 U.S.C. 103 as being unpatentable over Mabary (US 20190254586) in view of Olds (US 20160143509).
Regarding claim 1, Mabary discloses mucosal impedance measuring device (abstract; FIG.2) for measuring a pressure-controlled impedance of mucosa, the device comprising:
a plurality of impedance measuring electrodes (mucosal Impedance sensor electrodes 40 on the catheter tube 12 into direct contact with the mucosa of the interior wall 84 of the esophagus E.; Para [0025]) disposed on an axial-most face (sensor electrodes 40 are on the scope end along the axial line; FIG. 5) of the device (Para [0050]).
Mabary does not expressly disclose an endoscope having an elongated body extending to a scope end in which the scope end is articulable relative to the elongated body.
Olds is directed to endoscopic imaging device (abstract) and teaches endoscope having an elongated body (endoscope body 618; FIG. 6) extending to a scope end in which the scope end is articulable relative to the elongated body (The endoscope body may be a flexible endoscope body. Para [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mabary’s measurement device to include an endoscope in accordance with the teaching of Olds so that visualization could be provided during the use of the impedance measuring device by allowing the measuring device pass through the working channel of the endoscope while measuring the mucosal Impedance.
Regarding claim 2, Mabary discloses wherein the impedance measuring electrodes are arranged to be placed in contact with mucosa during an endoscopy procedure (FIG. 5; para [0050]).
Regarding claim 3, Mabary as modified, teaches wherein the endoscope includes a camera on a recessed axial face on the scope end (Olds: camera 602; FIG. 6; Para [0030], [0050]).
Regarding claim 4, Mabary as modified, teaches wherein the camera is disposed to view an area in front of the axial-most face of the scope end, thereby providing a visual indication of the mucosa the impedance measuring electrodes specifically contacts (Olds: camera 602; FIG. 6; Para [0030]).
Regarding claim 5, Mabary discloses wherein the impedance measuring electrodes include linear surfaces (sensor electrodes 40 are on the scope end; FIG. 5) which are positioned for contact with the mucosa.
Regarding claim 6, Mabary discloses wherein an angular extent of the axial-most face having the impedance measuring electrodes disposed thereon exceeds 180 degrees (electrodes 1340; FIG. 13).
Regarding claim 7, Mabary discloses wherein the impedance measuring electrodes are each U-shaped (Impedance sensor electrodes 40; FIG. 4;) having an axially forwardmost central segment that constitutes a mucosa contact surface of the impedance measuring electrodes.
Regarding claim 8, Mabary discloses wherein the plurality of impedance measuring electrodes include four impedance measuring electrodes (sensor electrodes 40 are on the scope end; FIG. 5).
Regarding claim 10, Mabary discloses wherein an impedance measuring system (FIGS. 5-6) in electrical communication with the plurality of impedance measuring electrodes in which the impedance measuring system is configured to direct a current (abstract) between the plurality of impedance measuring electrodes and through the mucosa and to measure the pressure-controlled impedance of the mucosa (The impedance measuring system is adapted to measure a pressure-regulated impedance measurement of the mucosa; balloon provides pressure control; abstract; para [0042]-[0044], [0047]).
Regarding claim 11, Mabary discloses wherein the impedance measuring system includes software (computer 12) configured to determine whether the pressure-controlled impedance of the mucosa is a stable impedance measurement (Impedance data is displayed; FIG. 7 ) indicative of consistent pressure-regulated contact between the plurality of impedance measuring electrodes and the mucosa (balloon provides pressure control; para [0042]-[0044], [0047]).
Claim(s) 1, 9, is/are rejected under 35 U.S.C. 103 as being unpatentable over Franco (US 20080171950) in view of Olds (US 20190254586).
Regarding claim 1, Franco discloses mucosal impedance measuring device (impedance measuring device 10; FIG. 2B; Para [0027]) for measuring a pressure-controlled impedance of mucosa, the device comprising: and a plurality of impedance measuring electrodes (electrodes 12; FIG. 2B) disposed on an axial-most face of the scope end.
Franco does not expressly disclose an endoscope having an elongated body extending to a scope end in which the scope end is articulable relative to the elongated body.
Olds is directed to endoscopic imaging device (abstract) and teaches endoscope having an elongated body (endoscope body 618; FIG. 6) extending to a scope end in which the scope end is articulable relative to the elongated body (The endoscope body may be a flexible endoscope body. Para [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franco’s measurement device to include impedance measuring device (of Franco) on the distal end of the endoscope (of Olds) so that visualization could be provided during the use of impedance measuring device. For example, measuring device 10, FIGS. 1B, 2B, could be attached at the distal end of the endoscope body 618 during measurement while navigating inside the body.
Regarding claim 9, Franco as modified discloses wherein the plurality of impedance measuring electrodes are attached to the scope end via a cap secured in the axial end of the endoscope (Franco: FIGS. 1B, 2B; endoscope body 618; FIG. 6).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mabary (US 20190254586) in view of Olds (US 20160143509).
Regarding claim 12, Mabary as modified teaches a method of measuring a pressure-controlled impedance of mucosa using the mucosal impedance measuring device of claim 1 (Mabary: mucosal Impedance sensor electrodes 40 on the catheter tube 12 are into direct contact with the mucosa of the interior wall 84 of the esophagus E.; FIG. 5; Para [0025]; Olds: endoscope body 618; FIG. 6), the method comprising: advancing the scope end of the endoscope within a patient to draw the impedance measuring electrodes situated at the axial-most face of the scope end into contact with the mucosa (When the catheter tube 12 is inserted inside the body along with the endoscope for measuring mucosal Impedance. ); and
conducting a current between the plurality of impedance measuring electrodes and through the mucosa (the impedance sensing electrodes direct an electric current through mucosa; FIG. 1; abstract) and measuring the pressure-controlled impedance of the mucosa (Impedances measured with the electrodes 40; Para [0031], [0042]- [0044], [0047].).
Regarding claim 13, Mabary as modified teaches a camera on a recessed axial face on the scope end (Olds: camera 602; FIG. 6; Para [0030]) to view the mucosa and to direct the plurality of impedance measuring electrodes into contact with a region of the mucosa of interest for the measuring pressure-controlled impedance of the mucosa.
Regarding claim 14, Mabary as modified teaches wherein the step of measuring the pressure- controlled impedance involves using an impedance measuring system (FIGS. 5-6) in electrical communication with the plurality of impedance measuring electrodes in which the impedance measuring system directs the current between the plurality of impedance measuring electrodes and through the mucosa and measures the pressure-controlled impedance of the mucosa (balloon provides pressure control; Para [0031], [0034], [0042]-[0044], [0047]).
Regarding claim 15, Mabary as modified teaches wherein the mucosa at which the pressure- controlled impedance is measured is located in the duodenum or colon (Para [0035]; Intended use.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO – 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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, Anhtuan Nguyen can be reached on 571-272-4963. 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.
/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 6/25/26
Prosecution Insights