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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-3 & 11-23 is rejected under 35 U.S.C 102(a)(2) as being anticipated by Lindsay (US 20220117543) herein referred to as Lindsay.
Regarding claim 1, Lindsay discloses a mucosal impedance measuring device for measuring a pressure-controlled impedance of mucosa (Figure 1 & 2), the device comprising: an endoscope (Figure 1, 10) having an elongated body extending to a scope end in which the scope end is articulable relative to the elongated body (Figure 1, 16); and a platform flexibly supported at the scope end (Figure 2, 14) with a plurality of impedance measuring electrodes on the platform (Figure 1, 28a-d).
Regarding claim 2, Lindsay discloses the mucosal impedance measuring device of claim 1, wherein, upon articulation of the scope end during an endoscopy using the endoscope, the platform flexibly supported at the scope end and the impedance measuring electrodes thereon are drawn into contact with the mucosa and the platform is able to flex to relative to the mucosa to equalize the pressure across the impedance measuring electrodes (Figure 2; Paragraph [0010]).
Regarding claim 3, Lindsay discloses the mucosal impedance measuring device of claim 1, wherein the platform is connected to a harness or sleeve that is secured to the endoscope (Paragraph [0032]).
Regarding claim 11, Lindsay discloses the mucosal impedance measuring device of claim 1, wherein the impedance measuring electrodes are part of a sensor subassembly (Paragraph [0040]; wherein the sensor subassembly consists of the impedance measuring electrodes and pressure-sensing elements).
Regarding claim 12, Lindsay discloses the mucosal impedance measuring device of claim 11, wherein the sensor subassembly is received in a recess of the platform (Paragraph [0040]; wherein the sensor subassembly consists of the impedance measuring electrodes and pressure-sensing elements attached to the electrodes which sit in a recess of the platform shown in Figure 2).
Regarding claim 13, Lindsay discloses the mucosal impedance measuring device of claim 1, wherein the plurality of impedance measuring electrodes include four impedance measuring electrodes (Figure 1, 28a-d).
Regarding claim 14, Lindsay discloses the mucosal impedance measuring device of claim 1, wherein the plurality of impedance measuring electrodes are arranged along a line parallel to an axial direction of the platform (See annotated Figure 1 below).
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Regarding claim 15, Lindsay discloses the mucosal impedance measuring device of claim 1, further comprising an impedance measuring system in electrical communication with the plurality of impedance measuring electrodes in which the impedance measuring system (Figure 5, 40) is configured to direct a current between the plurality of impedance measuring electrodes and through the mucosa and to measure the pressure-controlled impedance of the mucosa (Paragraph [0011]).
Regarding claim 16, Lindsay discloses the mucosal impedance measuring device of claim 15, wherein the impedance measuring system includes software configured to determine whether the pressure-controlled impedance of the mucosa is a stable impedance measurement indicative of consistent pressure-regulated contact between the plurality of impedance measuring electrodes and the mucosa (Paragraph [0011]).
Regarding claim 17, Lindsay discloses the mucosal impedance measuring device of claim 1, further comprising a plurality of conductors in which each of the conductors is in electrical communication with a corresponding one of the plurality of impedance measuring electrodes and in which the plurality of conductors extend from the impedance measuring electrodes (Paragraph [0014]).
Regarding claim 18, Lindsay discloses a method of measuring a pressure-controlled impedance of mucosa using the mucosal impedance measuring device of claim 1 (Paragraph [0016]), the method comprising: articulating the scope end of the endoscope relative to the elongated body of the endoscope to draw the impedance measuring electrodes on the platform flexibly supported at the scope end of the endoscope into contact with the mucosa under an applied pressure from the articulating (Paragraph [0016]); during contacting the impedance measuring electrodes with the mucosa, flexing the platform with the impedance measuring electrodes thereon to equalize the pressure across the impedance measuring electrodes (Paragraph [0016]); and conducting a current between the plurality of impedance measuring electrodes and through the mucosa and measuring the pressure-controlled impedance of the mucosa (Paragraph [0016]).
Regarding claim 19, Lindsay discloses the method of claim 18, wherein the step of measuring the pressure- controlled impedance involves using an impedance measuring system 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 (Paragraph [0011]).
Regarding claim 20, Lindsay discloses the method of claim 18, further comprising the step of attaching a support or a harness proximate the scope end in which the support or the harness has the platform flexibly attached thereto (Paragraph [0012]).
Regarding claim 21, Lindsay discloses the method of claim 20, wherein the support or the harness is compressively connected to the scope end of the endoscope (Paragraph [0012]; wherein the support might be tubular and/or compressively received around the scope end).
Regarding claim 22, Lindsay discloses the method of claim 18, wherein the step of measuring the pressure- controlled impedance of the mucosa includes determining a quality of a reading of the pressure-controlled impedance of the mucosa (Paragraph [0018]; wherein when a measurement is attempted, the system is capable of providing feedback regarding the quality of the measurement taken (e.g., whether the measurement taken a valid one based on contact and/or stabilization of the impedance measurement over time or not)).
Regarding claim 23, Lindsay discloses the method of claim 22, wherein determining the quality of the reading of the pressure-controlled impedance of the mucosa involves assessing the stability of the reading over a time of measurement (Paragraph [0018]; wherein when a measurement is attempted, the system is capable of providing feedback regarding the quality of the measurement taken (e.g., whether the measurement taken a valid one based on contact and/or stabilization of the impedance measurement over time or not)).
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.
Claims 4-6 & 10 are rejected under 35 U.S.C 103 as being unpatentable over Lindsay in view of Misener et al. (US 20230285085) herein referred to as Misener.
Regarding Claim 4, Lindsay discloses the mucosal impedance measuring device of claim 1. However, Lindsay does not explicitly disclose wherein the platform is flexibly supported by a living hinge that permits angular flexure of the platform and the impedance measuring electrodes received thereon relative to the scope end.
Misener discloses a measuring device (Figure 5) wherein a platform is flexibly supported by a living hinge that permits angular flexure of the platform and the impedance measuring electrodes received thereon relative to the scope end (Figure 5, 522; Paragraph [0088]; wherein section 522 contains slits that’s allow for the flexibility therefore making it a living hinge). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay to include a living hinge as taught by Misener. The motivation being to allow for greater flexibility in bending without causing tissue damage or trauma (Misener, Paragraph [0086]).
Regarding claim 5, Lindsay in view of Misener disclose the mucosal impedance measuring device of claim 4. Misener also discloses wherein the living hinge connects the platform to a harness or sleeve that is secured to the endoscope (Figure 5, 560). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay to include the living hinge as taught by Misener. The motivation being to allow for greater flexibility in bending without causing tissue damage or trauma (Misener, Paragraph [0086]).
Regarding claim 6, Lindsay in view of Misener disclose the mucosal impedance measuring device of claim 4. Misener also discloses wherein the living hinge connects to a central portion of the platform (Figure 5, 560; wherein the living hinge is connected to the entire bottom portion of the platform 560 in which includes the central portion). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay to include the living hinge and platform as taught by Misener. The motivation being to allow for greater flexibility in bending without causing tissue damage or trauma (Misener, Paragraph [0086]).
Regarding claim 10, Lindsay in view of Misener disclose the mucosal impedance measuring device of claim 6. Misener also discloses wherein the living hinge includes an opening therein through (Figure 5, 522; Paragraph [0088]; wherein section 522 contains slits that’s allow for the flexibility therefore making it a living hinge). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay to include the living hinge as taught by Misener. The motivation being to allow for greater flexibility in bending without causing tissue damage or trauma (Misener, Paragraph [0086]).
Claims 7-9 are rejected under 35 U.S.C 103 as being unpatentable over Lindsay and Misener in view of Mitsuda et al. (US 6013024) herein referred to as Mitsuda.
Regarding Claim 7, Lindsay in view of Misener disclose the mucosal impedance measuring device of claim 6. However, Lindsay in view of Misener does not explicitly disclose wherein the living hinge connects to the central portion of the platform at a position such that a smaller first length of the platform extends forward from the living hinge in the direction of a distal tip of the platform and a larger second length of the platform extends backward from the living hinge on the side of the living hinge away from the distal tip.
Mitsuda discloses a measuring system (Figure 1) wherein the living hinge connects to the central portion of the platform at a position such that a smaller first length of the platform extends forward from the living hinge in the direction of a distal tip of the platform and a larger second length of the platform extends backward from the living hinge on the side of the living hinge away from the distal tip (See annotated Figure 7A below). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay in view of Misener to include the structure taught by Mitsuda. The motivation being allow each member comprising the tip of probe to bend together and allow the direction in which probe 3 bends to change flexibly (Mitsuda, Column 9, lines 37-45).
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Regarding claim 8, Lindsay and Misener in further view of Mitsuda discloses the mucosal impedance measuring device of claim 7. Mitsuda also discloses wherein the larger second length of the platform that extends backward from the living hinge connects to an elastic strip or tether that elongates upon angular flexure of the platform in which the second larger length of the platform is angled further upward (Figure 7A, G; Figure 7B). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay in view of Misener to include the tethers taught by Mitsuda. The motivation being by applying tension to any one of these tethers G, the probe will bend to the side of the operation wire G to which the tension was applied (Mitsuda, Column 9, lines 4-6).
Regarding claim 9, Lindsay and Misener in further view of Mitsuda discloses the mucosal impedance measuring device of claim 8. Mitsuda also discloses wherein the elastic strip or tether avoids a possibility of an otherwise exposed terminal rear end of the platform fish-hooking or snagging on mucosa during an extubation of the endoscope (Figure 7A, G; wherein tether G does not extend down to an exposed terminal rear end of the platform such that it would not snag or fish-hook on mucosa during an extubation of the endoscope). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the platform taught by Lindsay in view of Misener to include the tethers taught by Mitsuda. The motivation being by applying tension to any one of these tethers G, the probe will bend to the side of the operation wire G to which the tension was applied (Mitsuda, Column 9, lines 4-6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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