Office Action 1: Non-Final Rejection (2024-08-01)
Rejection types: 101 - Patent-Eligible Subject Matter, Double Patenting

CLAIMS:
CLAIMS

What is claimed is:

1\. A data acquisition module for a system for measuring a nasal valve collapse of a patient,
the data acquisition module being configured to:receive a plurality of images of a nasal valve from a camera of an endoscope positioned trough an endoscope port of a facial mask and a plurality of air flow measurements from an air flow sensor configured to measure an air flow across an opening in the facial mask;
determine (i) a first image of the plurality of images of the nasal valve taken during inhalation
and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is synchronized wit a zero flow measurement of the plurality of air flow measurements, wherein the first image is synchronized with a non-zero flow measurement of the plurality of air flow measurements; anddetermine, based on the first image and the second image, a size difference of the nasal valve
during inhalation and during the period between exhalation and inhalation.
2\. The data acquisition module of claim 1, wherein, to determine the size difference of the nasal valve, the data acquisition module is configured to:
determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation,
determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and determine the size difference by dividing the first distance by the second distance.

3\. The data acquisition module of claim 1, wherein the plurality of images are taken during a plurality of inhalation rates,

wherein the data acquisition module is further configured to, for each inhalation rate, determine a

4\. The data acquisition module of claim 3, wherein the data acquisition module is configured to communicate with an external computing device to cause display of a graph of (i) the relative distances between the septum and the lateral wall of the nasal valve at the plurality of inhalation
rates versus (ii) the air flow measurements at the plurality of inhalation rates.
5\. The data acquisition module of claim 1, wherein the data acquisition module is further configured to:
receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image;
determining a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation;
receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and
determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and
determine the size difference of the nasal valve based on the first distance and the second distance.
6\. The data acquisition module of claim 1, wherein the data acquisition module is configured to apply image analysis to the first image to automatically measure an area of space between a
septum and a lateral wall to automatically determine an area or a length of the septum and a lateral wall.
7\. The data acquisition module of claim 1, wherein the data acquisition module is configured to receive the plurality of images as video captured by the camera.

8\. A computer program product comprising program code portions that, when executed on a data acquisition module, cause the data acquisition module to:
receive a plurality of images of a nasal valve from a camera of an endoscope positioned through an endoscope port of a facial mask and a plurality of air flow measurements from an air flow sensor
configured to measure an air flow across an opening in the facial mask;determine (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is synchronized with a zero flow measurement of the plurality of air flow measurements, wherein the first image is synchronized with a non-zero flow
measurement of the plurality of air flow measurements; anddetermine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
9\. The computer program product of claim 8, wherein, to determine the size difference of
the nasal valve by, the program code portions, when executed on the data acquisition module, cause the data acquisition module to:determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation,
determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and
determine the size difference by dividing the first distance by the second distance.

10\. The computer program product of claim 8, wherein the plurality of images are taken during a plurality of inhalation rates,
wherein the data acquisition module is further configured to, for each inhalation rate, determine a

11\. The computer program product of claim 10, wherein the program code portions, when executed on the data acquisition module, cause the data acquisition module to communicate with an external computing device to cause display of a graph of (i) the relative distances between the septum and the lateral wall of the nasal valve at the plurality of inhalation rates versus (ii) the air flow measurements
at the plurality of inhalation rates.

12\. The computer program product of claim 8, wherein the program code portions, when executed on the data acquisition module, cause the data acquisition module to:
receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image;
determine a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation;
receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and
determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and
determine the size difference of the nasal valve based on the first distance and the second distance.

13\. The computer program product of claim 8, wherein the program code portions, when executed on the data acquisition module, cause the data acquisition module to apply image analysis to the
first image to automatically measure an area of space between a septum and a lateral wall to automatically determine an area or a length of the septum and a lateral wall.

14\. The computer program product of claim 8, wherein the program code portions, when executed on the data acquisition module, cause the data acquisition module to receive the plurality of
images as video captured by the camera.

15\. A method of measuring a nasal valve collapse by a data acquisition module, the method comprising:
receiving a plurality of images of a nasal valve from a camera of an endoscope positioned
through an endoscope port of a facial mask and a plurality of air flow measurements from an air flow sensor configured to measure an air flow across an opening in the facial mask,determining (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is synchronized with a zero flow measurement of the
plurality of air flow measurements, wherein the first image is synchronized with a non-zero flow measurement of the plurality of air flow measurements, anddetermining, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.

16\. The method of claim 15, wherein, determining the size difference of the nasal valve comprises:
determining, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation,
determining, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and determining the size difference by dividing the first distance by the second distance.

17\. The method of claim 15, wherein the plurality of images are taken during a plurality of
inhalation rates,
wherein the method further comprises, for each inhalation rate, determining a relative distance

18\. The method of claim 17, further comprising communicating with an external computing device to cause display of a graph of (i) the relative distances between the septum and the lateral wall of the nasal valve at the plurality of inhalation rates versus (ii) the air flow measurements at the plurality of inhalation rates.

19\. The method of claim 15, further comprising:
receiving an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in
the first image;determining a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation;
receiving an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the
septum and the lateral wall of the nasal valve in the second image; anddetermining a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and
determining the size difference of the nasal valve based on the first distance and the second distance.

20\. The method of claim 15, further comprising applying image analysis to the first image to automatically measure an area of space between a septum and a lateral wall to automatically determine an area or a length of the septum and a lateral wall.5 10 15 20 25 30

OFFICE ACTION:
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.  The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims, claim “a data acquisition module…”. A data acquisition module is not defined within the Specification and thus can be considered to be software or a signal per se, which is not statutory subject matter. Appropriate correction is required.
Claims 8-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.  The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims, claim “a computer program product comprising program code…”. A computer program product is not defined within the Specification and thus can be considered to be software or a signal per se, which is not statutory subject matter. Appropriate correction is required.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.  The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims, claim a method for “a data acquisition module…”. A data acquisition module is not defined within the Specification and thus can be considered to be software or a signal per se, which is not statutory subject matter. Appropriate correction is required.
Double Patenting
Non-Statutory Obviousness-Type Double Patenting: Rejection Based on Anticipation Analysis
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159.  See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 14, and 15 (respectfully) of U.S. Patent No. 11,642,043 B2. It is clear that all the elements of the application claims 1-7 are to be found in patent claims 1-4, 7, 14, and 15 (respectfully) (as the application claims 1-7 fully encompasses patent claims 1-4, 7, 14, and 15 (respectfully)).  The difference between the application claims 1-7 and the patent claims 1-4, 7, 14, and 15 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 14, and 15 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 1-7.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 1-7 is anticipated by claims 1-4, 7, 14, and 15 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 14, and 15 (respectfully) of the patent.
Claims 8-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 14, and 15 (respectfully) of U.S. Patent No. 11,642,043 B2. It is clear that all the elements of the application claims 8-14 are to be found in patent claims 1-4, 7, 14, and 15 (respectfully) (as the application claims 8-14 fully encompasses patent claims 1-4, 7, 14, and 15 (respectfully)).  The difference between the application claims 8-14 and the patent claims 1-4, 7, 14, and 15 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 14, and 15 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 8-14.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 8-14 is anticipated by claims 1-4, 7, 14, and 15 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 14, and 15 (respectfully) of the patent.
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 14, and 15 (respectfully) of U.S. Patent No. 11,642,043 B2. It is clear that all the elements of the application claims 15-20 are to be found in patent claims 1-4, 7, 14, and 15 (respectfully) (as the application claims 15-20 fully encompasses patent claims 1-4, 7, 14, and 15 (respectfully)).  The difference between the application claims 15-20 and the patent claims 1-4, 7, 14, and 15 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 14, and 15 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 15-20.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 15-20 is anticipated by claims 1-4, 7, 14, and 15 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 14, and 15 (respectfully) of the patent.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 13, and 14 (respectfully) of U.S. Patent No. 11,957,448 B2. It is clear that all the elements of the application claims 1-7 are to be found in patent claims 1-4, 7, 13, and 14 (respectfully) (as the application claims 1-7 fully encompasses patent claims 1-4, 7, 13, and 14 (respectfully)).  The difference between the application claims 1-7 and the patent claims 1-4, 7, 13, and 14 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 13, and 14 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 1-7.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 1-7 is anticipated by claims 1-4, 7, 13, and 14 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 13, and 14 (respectfully) of the patent.
Claims 8-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 13, and 14 (respectfully) of U.S. Patent No. 11,957,448 B2. It is clear that all the elements of the application claims 8-14 are to be found in patent claims 1-4, 7, 13, and 14 (respectfully) (as the application claims 8-14 fully encompasses patent claims 1-4, 7, 13, and 14 (respectfully)).  The difference between the application claims 8-14 and the patent claims 1-4, 7, 13, and 14 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 13, and 14 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 8-14.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 8-14 is anticipated by claims 1-4, 7, 13, and 14 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 13, and 14 (respectfully) of the patent.
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 13, and 14 (respectfully) of U.S. Patent No. 11,957,448 B2. It is clear that all the elements of the application claims 15-20 are to be found in patent claims 1-4, 7, 13, and 14 (respectfully) (as the application claims 15-20 fully encompasses patent claims 1-4, 7, 13, and 14 (respectfully)).  The difference between the application claims 15-20 and the patent claims 1-4, 7, 13, and 14 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1-4, 7, 13, and 14 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 15-20.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 15-20 is anticipated by claims 1-4, 7, 13, and 14 (respectfully) of the patent, it is not patentably distinct from claims 1-4, 7, 13, and 14 (respectfully) of the patent.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 (respectfully) of U.S. Patent No. 10,987,024 B2. It is clear that all the elements of the application claims 1-3 are to be found in patent claims 1, 2, and 4 (respectfully) (as the application claims 1-3 fully encompasses patent claims 1, 2, and 4 (respectfully)).  The difference between the application claims 1-3 and the patent claims 1, 2, and 4 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1, 2, and 4 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 1-3.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 1-3 is anticipated by claims 1, 2, and 4 (respectfully) of the patent, it is not patentably distinct from claims 1, 2, and 4 (respectfully) of the patent.
Claims 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 (respectfully) of U.S. Patent No. 10,987,024 B2. It is clear that all the elements of the application claims 8-10 are to be found in patent claims 1, 2, and 4 (respectfully) (as the application claims 8-10 fully encompasses patent claims 1, 2, and 4 (respectfully)).  The difference between the application claims 8-10 and the patent claims 1, 2, and 4 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1, 2, and 4 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 8-10.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 8-10 is anticipated by claims 1, 2, and 4 (respectfully) of the patent, it is not patentably distinct from claims 1, 2, and 4 (respectfully) of the patent.
Claims 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 (respectfully) of U.S. Patent No. 10,987,024 B2. It is clear that all the elements of the application claims 15-17 are to be found in patent claims 1, 2, and 4 (respectfully) (as the application claims 15-17 fully encompasses patent claims 1, 2, and 4 (respectfully)).  The difference between the application claims 15-17 and the patent claims 1, 2, and 4 (respectfully) lies in the fact that the patent claim includes many more elements and is thus much more specific.  Thus, the invention of claims 1, 2, and 4 (respectfully) of the patent is in effect a “species” of the “generic” invention of the application claims 15-17.  It has been held that the generic invention is “anticipated” by the “species”.  See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).  Since application claims 15-17 is anticipated by claims 1, 2, and 4 (respectfully) of the patent, it is not patentably distinct from claims 1, 2, and 4 (respectfully) of the patent.
Allowable Subject Matter
Claims 1-20 would be allowable if the 35 USC 101 and Double Patenting Rejections were overcome, since the prior art does not teach each and every limitation within the claim language.  The best prior art Qui (Qui, US 2015/0051449 A1) teaches systems, methods and devices for diagnosing sleep apnea (Abstract); wherein end imaging sensor 104 may be configured for continuous or intermittent video (e.g., 1 frame/second) recording during sleep cycles ([0042]). As such, dynamic images of the anatomic changes of the upper airway can be viewed to assess an obstruction or degree of obstruction compared to a baseline profile collected when the subject is awake (Fig. 1; [0042]); wherein the airflow data undulates with larger amplitudes in response to inhalation and exhalation events during the breathing cycle ([0054-0055]); since the data and images are continuously taken through time, the data and images are thus taken when the patient is inhaling and the time between exhaling and inhaling (Figs. 6A-6D and 7; [0054-0055]); and taking images with imaging sensor 104, which can be camera (Fig. 2A; [0021]). However, Qui does not teach wherein images are taken of a “nasal valve” to determine “nasal valve collapse”, “an endoscope”, or a size difference between the “nasal valve” during inhalation and during a period between exhalation and inhalation. Qui also teaches away from using an endoscope since Qui teaches that endoscopic techniques are known that are aimed at monitoring breathing and snoring during the sleep cycle ([0003]). However, such techniques may still require cumbersome equipment to monitor airflows within the upper airway and further lack a means for detecting a sleep position, especially in a remote environment where a trained professional is not present to observe the sleep cycles ([0003]); and wherein the inventor has recognized disadvantages with the approaches above and herein discloses a wearable hollow nasal tube ([0004]).
Contact

APPLICANT REBUTTAL: REMARKS
I.
of the Office Action
In the Office Action dated August 1, 2024, the Examiner:
(i)   rejected claims 1-20 under 35 U.S.C. § 101 as allegedly being directed to non- statutory subject matter;
(ii)  rejected claims 1-20 on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-4, 7, 14, and 15 of U.S. Pat. No. 11,642,043; (iii) rejected claims 1-20 on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-4, 7, 13, and 14 of U.S. Pat. No. 11,957,448;
-17 on the ground of nonstatutory doublepatenting as allegedly being unpatentable over claims 1, 2, and 4 of U.S. Pat. No. 10,987,024; and
(v)   indicated that claims 1-20 would be allowable if the 35 U.S.C. § 101 and Double Patenting rejections were overcome.
of Claims
Claims 1-20 are pending. In this response, Applicant has (a) amended claims 1-2, 4-7, and 15, (b) canceled claims 8-14, and (c) added claims 21-27. After entry of this amendment,
-27 will be pending.
III. Examiner Interview
Applicant's representative would like to thank Examiner Vanchy for the telephonic interview on January 30, 2025. During the interview, the participants discussed proposed
MCDONNELL BOEHNEN
amendments to independent claims 1, 8, and 15 in view of the rejections under 35 U.S.C. § 101.
The Examiner agreed that the proposed amendments to claims 1 and 15 would overcome the current rejections. No agreement was reached with respect to the proposed amendment to
independent claim 8.
IV.   Response to the Rejections Under 35 U.S.C. § 101
As indicated above, the Office rejected claims 1-20 under 35 U.S.C. § 101 as allegedly being directed to non-statutory subject matter.
In this response, Applicant has amended independent claims 1 and 15 as discussed during the interview, and canceled independent claim 8. Accordingly, as agreed during the interview,
amended claims 1-7 and 15-20 are directed to statutory subject matter.
V.    Response to the Double Patenting Rejection
As indicated above, the Office (i) rejected claims 1-20 on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-4, 7, 14, and 15 of U.S. Pat. No.
11,642,043, (ii) rejected claims 1-20 on the ground of nonstatutory double patenting as allegedly being unpatentable over claims 1-4, 7, 13, and 14 of U.S. Pat. No. 11,957,448, and (iii) rejected claims 1-3, 8-10, and 15-17 on the ground of nonstatutory double patenting as allegedly being
unpatentable over claims 1, 2, and 4 of U.S. Pat. No. 10,987,024.
To overcome this rejection, a Terminal Disclaimer is submitted herewith. This Terminal Disclaimer should not be construed as an admission to the merits of the nonstatutory double
MCDONNELL BOEHNEN
patenting rejections pursuant to Quad Environmental Technologies Corp. v. Union Sanitary
District, 946 F.2d 870 (Fed. Cir. 1991); see also MPEP § 804.02.
In view of the Terminal Disclaimer, Applicant respectfully requests withdrawal of the rejection of claims 1-3, 5, 11-13, and 15-17 on the ground of nonstatutory double patenting.
VI.    Allowable Subject Matter
As indicated above, the Office indicated that claims 1-20 would be allowable if the 35 U.S.C. § 101 and Double Patenting rejections were overcome. Applicant thanks the Examiner
for the indication of allowable subject matter.
VII. Conclusion

NEXT OFFICE ACTION: Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: the amendments filed on 02/03/2025 have overcome the rejections within the previous Office Action. Specifically, claims 1-7 have been amended and overcome the 35 USC 101 rejection; claims 8-14 were canceled and thus there is no 35 USC 101 rejection to be made; and claims 15-20 have been amended to overcome the 35 USC 101 rejection. The filing and Approval of a Terminal Disclaimer, on 02/03/2025, for US PATs 11,642,043 B2, 11,957,448 B2, and 10,987,024 B2 overcomes the Double Patenting Rejections made within the previous Office Action. Since the only rejections made in the previous Office Action were 35 USC 101 rejections and Double Patenting rejections, and this issues have been resolved, the claims are allowable. None of the prior art, either alone or in combination, teaches each and every limitation within the claim language and thus the claims are allowable.
Claims 1-7 and 15-27 are allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

CITED REFERENCE SUMMARIES: Ref US11957448B2: Claims:
A system for measuring a nasal valve collapse of a patient comprising: a facial mask adapted to form a seal with a facial structure of the patient, the facial mask including an endoscope port and an opening to allow air flow; an air flow sensor in fluid communication with the opening of the facial mask configured to measure an air flow across the opening; an endoscope with a camera adapted to pass through the endoscope port in the facial mask and image a nasal valve; and a data acquisition module configured to: receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor, determine (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is determined based on a zero flow measurement of the plurality of air flow measurements, wherein the first image is determined based on a non-zero flow measurement of the plurality of air flow measurements, and determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
a facial mask adapted to form a seal with a facial structure of the patient, the facial mask including an endoscope port and an opening to allow air flow;
an air flow sensor in fluid communication with the opening of the facial mask configured to measure an air flow across the opening;
an endoscope with a camera adapted to pass through the endoscope port in the facial mask and image a nasal valve; and a data acquisition module configured to: receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor, determine (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is determined based on a zero flow measurement of the plurality of air flow measurements, wherein the first image is determined based on a non-zero flow measurement of the plurality of air flow measurements, and determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
a data acquisition module configured to:
receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor,
determine (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, wherein the second image is determined based on a zero flow measurement of the plurality of air flow measurements, wherein the first image is determined based on a non-zero flow measurement of the plurality of air flow measurements, and
determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
The system of claim 1 , wherein, to determine the size difference of the nasal valve, the data acquisition module is configured to: determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation, determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and determine the size difference by dividing the first distance by the second distance.
determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation,
determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and
determine the size difference by dividing the first distance by the second distance.
The system of claim 1 , wherein the plurality of images are taken during a plurality of inhalation rates, wherein the plurality of inhalation rates are different from each other, and wherein the data acquisition module is further configured to, for each inhalation rate, determine a relative distance between a septum and a lateral wall of the nasal valve.
wherein the plurality of inhalation rates are different from each other, and
wherein the data acquisition module is further configured to, for each inhalation rate, determine a relative distance between a septum and a lateral wall of the nasal valve.
The system of claim 3 , further comprising a display device that is configured to display a graph of (i) the relative distances between the septum and the lateral wall of the nasal valve at the plurality of inhalation rates versus (ii) the air flow measurements at the plurality of inhalation rates.
The system of claim 1 , further comprising a display device configured to display a graphical user interface, GUI.
The system of claim 5 , wherein the graphical user interface, GUI, is configured to display (i) an image of the plurality of images taken at a first time and (ii) an air flow measurement measured at the first time.
The system of claim 5 , wherein the data acquisition module is further configured to: receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image; determine a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation; receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and determine the size difference of the nasal valve based on the first distance and the second distance.
receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image;
determine a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation;
receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and
determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and
determine the size difference of the nasal valve based on the first distance and the second distance.
The system of claim 7 , wherein the graphical user interface, GUI, is configured to display the annotation of the first image and the annotation of the second image.
The system of claim 7 , wherein the annotation of the first image comprises a line across the nasal valve between the lateral wall and the septum in the first image, and the annotation of the second image comprises a line across the nasal valve between the lateral wall and the septum in the second image.
The system of claim 7 , wherein the annotation of the first image comprises a tracing of a perimeter of the nasal valve in the first image, and the annotation of the second image comprises a tracing of the perimeter of the nasal valve in the second image.
The system of claim 5 , wherein the graphical user interface, GUI, is configured to display a graph including the air flow measurements versus time.
The system of claim 11 , wherein the graphical user interface, GUI, is configured to: receive an input from a user indicating a time of interest on the graph; and display an image of the plurality of images of the nasal valve that was taken at the time of interest.
receive an input from a user indicating a time of interest on the graph; and
display an image of the plurality of images of the nasal valve that was taken at the time of interest.
The system of claim 1 , wherein the data acquisition module is configured to apply image analysis to the first image to automatically measure an area of space between a septum and a lateral wall to automatically determine an area or a length of the septum and a lateral wall.
The system of claim 1 , wherein the camera is configured to capture the plurality of images as a video of the nasal valve.
The system of claim 1 , wherein the data acquisition module is configured to synchronize the plurality of images from the camera and the plurality of air flow measurements from the air flow sensor using a plurality of time stamps associated with the plurality of images and the plurality of air flow measurements.
The system of claim 1 , wherein the facial mask is adapted to engage with the facial structure of the patient without changing a nasal anatomy of the patient.
The system of claim 1 , wherein the data acquisition module is configured to determine the size difference of the nasal valve during inhalation and during the period between exhalation and inhalation by calculating, based on the first image and the second image, a percentage difference in an area or one or more dimensions of the nasal valve between the image of the nasal valve taken during inhalation and the image of the nasal valve during zero flow.
The system of claim 1 , further comprising an external computing device communicating with the data acquisition module, wherein the external computing device comprises a display having a graphical user interface (GUI) for display of patient data.
The system of claim 18 , wherein the graphical user interface (GUI) is configured to display a degree of nasal valve collapse simultaneously with air flow passing through the nasal valve.
The system of claim 1 , wherein the endoscope port is located at a bottom of the facial mask and comprises a sealed port.
Ref US11642043B2: Claims:
A system for measuring a nasal valve collapse of a patient comprising: a facial mask adapted to form a seal with a facial structure of the patient, the facial mask including an endoscope port and an opening to allow air flow; an air flow sensor in fluid communication with the opening of the facial mask configured to measure an air flow across the opening; an endoscope with a camera adapted to pass through the endoscope port in the facial mask and image a nasal valve; and a data acquisition module configured to: receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor, determine, based on the air flow measurements, (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, and determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
a facial mask adapted to form a seal with a facial structure of the patient, the facial mask including an endoscope port and an opening to allow air flow;
an air flow sensor in fluid communication with the opening of the facial mask configured to measure an air flow across the opening;
an endoscope with a camera adapted to pass through the endoscope port in the facial mask and image a nasal valve; and
a data acquisition module configured to: receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor, determine, based on the air flow measurements, (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, and determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
receive a plurality of images from the camera and a plurality of air flow measurements from the air flow sensor,
determine, based on the air flow measurements, (i) a first image of the plurality of images of the nasal valve taken during inhalation and (ii) a second image of the plurality of images of the nasal valve taken during a period between exhalation and inhalation, and
determine, based on the first image and the second image, a size difference of the nasal valve during inhalation and during the period between exhalation and inhalation.
The system of claim 1 , wherein, to determine the size difference of the nasal valve, the data acquisition module is configured to: determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation, determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and determine the size difference by dividing the first distance by the second distance.
determine, based on the first image, a first distance between a septum and a lateral wall of the nasal valve during inhalation,
determine, based on the second image, a second distance between the septum and the lateral wall of the nasal valve during the period between exhalation and inhalation, and
determine the size difference by dividing the first distance by the second distance.
The system of claim 1 , wherein the plurality of images are taken during a plurality of inhalation rates, wherein the plurality of inhalation rates are different from each other, and wherein the data acquisition module is further configured to, for each inhalation rate, determine a relative distance between a septum and a lateral wall of the nasal valve.
wherein the plurality of inhalation rates are different from each other, and
wherein the data acquisition module is further configured to, for each inhalation rate, determine a relative distance between a septum and a lateral wall of the nasal valve.
The system of claim 3 , further comprising a display device that is configured to display a graph of (i) the relative distances between the septum and the lateral wall of the nasal valve at the plurality of inhalation rates versus (ii) the air flow measurements at the plurality of inhalation rates.
The system of claim 1 , further comprising a display device configured to display a graphical user interface (GUI).
The system of claim 5 , wherein the graphical user interface (GUI) is configured to display (i) an image of the plurality of images taken at a first time and (ii) an air flow measurement measured at the first time.
The system of claim 5 , wherein the data acquisition module is further configured to: receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image; determining a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation; receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and determine the size difference of the nasal valve based on the first distance and the second distance.
receive an annotation of the first image of the nasal valve during inhalation, wherein the annotation of the first image indicates a distance between a septum and a lateral wall of the nasal valve in the first image;
determining a first distance between the septum and the lateral wall based on the annotation of the first image of the nasal valve during inhalation;
receive an annotation of the second image of the nasal valve during the period between exhalation and inhalation, wherein the annotation of the second image indicates a distance between the septum and the lateral wall of the nasal valve in the second image; and
determine a second distance between the septum and the lateral wall based on the annotation of the second image of the nasal valve during the period between exhalation and inhalation; and
determine the size difference of the nasal valve based on the first distance and the second distance.
The system of claim 7 , wherein the graphical user interface (GUI) is configured to display the annotation of the first image and the annotation of the second image.
The system of claim 7 , wherein the annotation of the first image comprises a line across the nasal valve between the lateral wall and the septum in the first image, and the annotation of the second image comprises a line across the nasal valve between the lateral wall and the septum in the second image.
The system of claim 7 , wherein the annotation of the first image comprises a tracing of a perimeter of the nasal valve in the first image, and the annotation of the second image comprises a tracing of the perimeter of the nasal valve in the second image.
The system of claim 5 , wherein the graphical user interface (GUI) is configured to display a graph including the air flow measurements versus time.
The system of claim 11 , wherein the graphical user interface (GUI) is configured to: receive an input from a user indicating a time of interest on the graph; and display an image of the plurality of images of the nasal valve that was taken at the time of interest.
receive an input from a user indicating a time of interest on the graph; and
display an image of the plurality of images of the nasal valve that was taken at the time of interest.
The system of claim 5 , wherein the graphical user interface is configured to display a graph of a quantification of the nasal valve collapse at a plurality of inhalation rates versus air flow rate.
The system of claim 1 , wherein the data acquisition module is configured to apply image analysis to the first image to automatically measure an area of space between a septum and a lateral wall to automatically determine an area or a length of the septum and a lateral wall.
The system of claim 1 , wherein the camera is configured to capture the plurality of images as a video of the nasal valve.
The system of claim 1 , wherein the data acquisition module is configured to synchronize the plurality of images from the camera and the plurality of air flow measurements from the air flow sensor using a plurality of time stamps associated with the plurality of images and the plurality of air flow measurements.
The system of claim 1 , wherein the data acquisition module is configured to determine the size difference of the nasal valve during inhalation and during the period between exhalation and inhalation by calculating a percentage difference in an area or one or more dimensions of the nasal valve during inhalation and the period between exhalation and inhalation.
The system of claim 17 , wherein the data acquisition module is configured to determine the size difference of the nasal valve during inhalation and during the period be
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