DETAILED ACTION
Claims 1-23 are pending and hereby under examination.
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 23 is objected to because of the following informalities:
Claim 23, line 3, “the gastrointestinal tract” should read “a gastrointestinal tract”.
Claim 23, line 15, “a gastrointestinal tract” should read “the gastrointestinal tract”.
Appropriate correction is required.
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 1-22 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.
Regarding claim 1, the “revising step” is comprised of “revising” and “repeating the determining” step. Is this all one step, two or more distinct steps, or a step that is previously performed and stored for reference? It is also unclear if the “cross-sectional area” of line 9 is the area of the esophagus or “tubes of known diameter”. For examination purposes, the correction factor will be interpreted as a previously measured value that is used to revise a value of the cross-sectional area of the esophagus. Claims 2-22 are also rejected due to their dependence on claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-11, and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Mittal (WO 2016138541 – cited by Applicant) and Pandolfino (US 20220117542 – cited by Applicant).
Regarding claim 1, Mittal discloses a method for determining one or more parameters associated with an esophagus, comprising:
receiving data measured by an impedance and high-resolution manometry catheter in an esophagus, the data representative of an impedance or voltage associated with at least one swallowing event during which an amount of a bolus is consumed (Paragraph 0050);
determining, based on the received data and conductivity value of the bolus, a cross-sectional area of the esophagus (Paragraph 0055); and
revising a value of the cross-sectional area that is determined using a correction factor that is obtained in vitro by repeating the determining step to determine a cross-sectional area of tubes of known diameter (Paragraphs 0045-0046; Paragraph 0055, “The CSA value was updated using the correction factor estimated from the in-vitro study to calculate the final CSA estimate”).
Mittal fails to disclose receiving data associated with a baseline impedance obtained in an absence of a bolus being consumed.
However, Pandolfino teaches a system of four-dimensional manometry wherein impedance measurements are used to determine esophageal dimensions (Paragraph 0015) wherein impedance values are measured in the absence of a bolus being consumed (Paragraph 0024, wherein the data may include pre-swallow recordings; Paragraph 0041, wherein impedance analysis started three seconds before swallowing). Pandolfino discusses this is useful to retain enough baseline data.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mittal to incorporate the teachings of including pre-swallow recordings of impedance of Pandolfino to retain enough baseline data.
Regarding claim 2, Mittal further discloses wherein receiving the data recorded by the impedance and high-resolution manometry catheter includes receiving data representative of an impedance associated with a first swallowing event during which a known amount of a first bolus is consumed, and an impedance associated with a second swallowing event during which a known amount of a second bolus is consumed (Paragraph 0052), the first and second boluses having first and second conductivity values that are different from one another (Paragraphs 0050-0051); and
determining the cross-sectional area of the esophagus based on the received data and the first and second conductivity values (Paragraph 0055).
Regarding claim 3, Mittal further discloses wherein the determining accounts for conductance of perimeter tissues and organs surrounding the esophagus (Paragraphs 0034 and 0035, denoted by Gperim).
Regarding claim 5, Mittal further discloses wherein the recording is performed while a subject whose esophagus is being analyzed is lying down in the Trendelenburg position (Paragraph 0052).
Regarding claim 6, Mittal further discloses wherein the recording is performed while a subject whose esophagus is being analyzed is lying down in the Trendelenburg position (Paragraph 0052).
Regarding claim 7, Mittal further discloses wherein recording the data measured by the impedance and high-resolution manometry catheter includes recording data representative of pressure associated with the swallowing event (Paragraph 0015, “From the measured CSA and pressure, one can calculate various other parameters such as compliance of esophageal wall, pressure-CSA loops, as well as other parameters along the entire length of the esophagus”; Paragraph 0051, wherein the catheter includes pressure transducers).
Regarding claim 8, Mittal further discloses determining values of tension in walls of the esophagus based on the cross-sectional area of the esophagus and the pressure (Paragraph 0012, “The method may further include measuring a pressure in the esophagus, and calculating a value of esophageal compliance based on the estimated CSA and the measured pressure”).
Regarding claim 9, Mittal further discloses determining values of distensibility in walls of the esophagus based on the cross-sectional area of the esophagus and the pressure (“calculating a value of esophageal compliance based on the estimated CSA and the measured pressure”).
Regarding claim 10, while Mittal discloses determining tension and CSA as above, Mittal as modified does not explicitly disclose generating a display of cross sectional area and tension along the length of the esophagus. However, it would have been obvious to one of ordinary skill in the art to display measurements taken from the device to visualize different measurements and results of esophageal measurements.
Regarding claim 11, Pandolfino further discloses generating a display that simultaneously includes a heatmap of the pressure and the impedance along a length of the esophagus (Fig. 2A).
Regarding claim 17, Mittal further discloses generating a display that includes a cylindrical representation of distension and pressure at a plurality of points along a length of the esophagus at a plurality of different times during an entire swallow cycle (Fig. 7B).
Regarding claim 18, while Mittal discusses measuring distension, Mittal as modified does not explicitly disclose displaying distension and distensibility at a plurality of points along the esophagus. However, it would have been obvious to one of ordinary skill in the art to display measurements taken from the device to visualize different measurements and results of esophageal measurements.
Regarding claim 19, while Mittal discussing measuring distension and tension as above, Mittal as modified does not explicitly disclose displaying distension and tension at a plurality of points along the esophagus. However, it would have been obvious to one of ordinary skill in the art to display measurements taken from the device to visualize different measurements and results of esophageal measurements.
Regarding claim 20, Mittal further discloses wherein the determining employs esophageal impedance tomography (Paragraphs 0010-0011).
Regarding claim 21, Mittal further discloses wherein the bolus is a liquid bolus (Paragraph 0052, wherein the bolus is saline).
Regarding claim 22, Pandolfino further discloses comprising importing, visualizing, and analyzing esophageal or gastrointestinal extracted parameters on a handheld or wearable device (Paragraph 0059).
Regarding claim 23, Mittal discloses a non-transitory computer-readable medium, comprising instructions for causing a computing environment to perform a method for determining one or more parameters associated with a portion of the gastrointestinal tract, comprising:
receiving data measured by an impedance and high-resolution manometry catheter in a portion of a gastrointestinal tract, the data representative of an impedance associated with at least one swallowing event during which an amount of a bolus is consumed (Paragraph 0050),
wherein receiving the data measured by the impedance and high-resolution manometry catheter includes receiving data representative of an impedance associated with a first swallowing event during which an amount of a first bolus is consumed and an impedance associated with a second swallowing event during which an amount of a second bolus is consumed (Paragraph 0052), the first and second boluses having first and second conductivity values that are different from one another (Paragraphs 0050-0051); and
determining, based on the received data and conductivity value of the bolus, a cross-sectional area of the portion of a gastrointestinal tract (Paragraph 0055).
Mittal fails to disclose receiving data associated with a baseline impedance obtained in an absence of a bolus being consumed.
However, Pandolfino teaches a system of four-dimensional manometry wherein impedance measurements are used to determine esophageal dimensions (Paragraph 0015) wherein impedance values are measured in the absence of a bolus being consumed (Paragraph 0024, wherein the data may include pre-swallow recordings; Paragraph 0041, wherein impedance analysis started three seconds before swallowing). Pandolfino discusses this is useful to retain enough baseline data.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mittal and Pandolfino as applied to claim 7 above, and further in view of Bhargava (US 11143416 – cited by Applicant).
Regarding claim 12, while Mittal as modified discloses measuring impedance and pressure of the esophagus, Mittal as modified fails to explicitly disclose generating a display that simultaneously includes impedance gradient streamlines overlayed on a heatmap of the pressure along a length of the esophagus.
However, Bhargava teaches a method for characterizing a patient’s esophagus wherein a display of impedance and pressure along the length of the esophagus (Fig. 2A). It would have been obvious to one of ordinary skill in the art to have applied this known technique of generating a display of impedance and pressure along the length of the esophagus to the method of Mittal and Pandolfino that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mittal and Pandolfino to incorporate the teachings of Bhargava.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mittal and Pandolfino as applied to claim 7 above, and further in view of Zifan (“Topographical plots of esophageal distension and contraction: effects of posture on esophageal peristalsis and bolus transport”).
Regarding claim 13, while Mittal as modified discloses measuring distension (Paragraph 0014), Mittal as modified does not explicitly disclose displaying graphs such as distension and contraction during peristalsis.
However, Zifan teaches a novel way of visualizing esophageal peristalsis, wherein a display is shown that simultaneously includes esophageal distension and contraction during peristalsis at a plurality of points along a length of the esophagus and a plurality of different times (Fig. 4; Results section “Distension HRM Plots: Relationship Between Esophageal Distension and Contraction”, “Distension HRM plots reveal the temporal relationship between distension and esophageal contraction along the length of the esophagus”).
It would have been obvious to one of ordinary skill in the art to display measurements taken from the device to visualize different measurements and results of esophageal measurements. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mittal and Pandolfino to incorporate the teachings of Zifan.
Regarding claim 14, Zifan further discloses wherein the distension and contraction are displayed as waveforms (Fig. 4).
Regarding claim 15, Zifan further discloses wherein distension is displayed as a waveform and pressure as heatmap (Fig. 4).
Regarding claim 16, Zifan further discloses wherein distension is displayed as a heatmap and pressure as a waveform (Fig. 4).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mittal and Pandolfino as applied to claim 1 above, and further in view of Kassab (US 20040230131 – cited by Applicant).
Regarding claim 4, Mittal discloses wherein the determining assumes a constant conductance for perimeter tissues and organs surrounding the esophagus (Paragraph 0066), but Mittal fails to disclose wherein the conductance is zero.
However, Kassab teaches a catheter for measuring cross-sectional areas and pressure gradients in organs, including the esophagus (Paragraph ), wherein, when using the conductance method, the conductance through the vessel wall and surrounding tissue is neglected (Paragraph 0081-0082). It would have been obvious to one of ordinary skill in the art to apply the known technique of neglecting surrounding tissue to the known device of Mitta and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mittal and Pandolfino to incorporate the teachings of Kassab.
Conclusion
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/NOAH M HEALY/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791