Office Action 1: Non-Final Rejection (2024-01-04)
Rejection types: 102 - Lack of Novelty, 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
Applicant: VIVONICS, INC.

For: System and Method for Detecting and/or Monitoring the Presence of At Least One of Pneumothorax, Hemopneumothorax, or Hemothorax in a Living Subject Using One or More Light Sources and One or More Light Detectors CLAIMS I. A system for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using one or more light sources and one or more light detectors, the system comprising: one or more light sources adapted to be placed on skin of a living subject; one or more light detectors adapted to be placed on the skin of the living subject; and a processing subsystem coupled to the one or more light sources and the one or more light detectors configured to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

2\. The system of claim I in which the one or more light sources are configured to emit light which penetrates a thoracic cavity of the living subject at one or more predetermined penetration depths and the one or more light detectors are configured to detect at least one of reflected light from tissue between a lung of the living subject and the skin or reflected light from the lung of the living subject and generate output signals.
3\. The system of claim 2 in which the processing subsystem is responsive to I the output signals and is configured to detect and/or monitor the presence of pneumothorax, 2 hemopneumothorax, or hemothorax based on an amount of light reflected or not reflected from the thoracic cavity.
4\. The system of claim 2 in which the one or more light detectors are spaced from the one or more light sources by one or more predetermined separation distances such that the one or more light detectors detect at least one of the light reflected from tissue between the lung and the skin of the living subject or light reflected from the lung of the living subject and generate the output signals.

5\. The system of claim 4 in which the processing subsystem is configured to generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax, hemopneumothorax, or hemothorax based on the shape of the one or more tomography curves.

6\. The system of claim 1 in which the one or more light sources are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals.
7\. The system of claim 6 in which the processing subsystem is responsive to the one or more physiological output signals and is configured to determine at least one of a 3 respiration rate of the living subject, a tissue oxygen saturation of the living subject, blood 4 oxygenation of the living subject, or a heart rate of the living subject.

8\. The system of claim 7 in which the processing subsystem is configured to determine characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or
hemothorax in the living subject.
9\. The system of claim 7 in which the processing subsystem is configured to determine at least one of a characteristic change in the tissue oxygen saturation or blood oxygenation to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

10\. The system of claim 7 in which the processing subsystem is configured to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

11\. The system of claim 7 in which the processing subsystem is configured to determine at least one of a characteristic change in the respiration rate of the living subject, a characteristic change in the tissue oxygen saturation of the living subject, a characteristic change in blood oxygenation of the living subject, or a characteristic change in the heart rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.
1 12. The system of claim 7 in which the one or more light sources are 2 configured to emit light at two or more predetermined wavelengths and the one or more light detectors are configured to generate the physiological output signals responsive to each of the two or more wavelengths for the processing subsystem to determine at least one of the respiration rate of the living subject, the tissue oxygen saturation of the living subject, the blood oxygenation of the living subject, or a heart rate of the living subject.

13\. The system of claim 12 in which one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores.

14\. The system of claim 6 in which the one or more light sources include near infrared spectroscopy (NIRS) light sources.

15\. The system of claim I in which the one or more light sources are adapted to be placed above a rib of the living subject and configured to emit light into the rib of the living subject and the one or more light detectors are adapted to be placed over the rib and configured to detect reflected light from the rib and generate one or more physiological output signals.

16\. The system of claim 15 in which the processing subsystem is responsive to the one or more physiological output signals and is configured to determine a respiration rate of the living subject.
1 17. The system of claim 16 in which the processing subsystem is configured 2 to determine characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or
hemothorax in the living subject.

18\. The system of claim I in which the one or more light sources are placed over at least a portion of an intercostal space of the living subject and the one or more light detectors are adapted to be placed over at least a portion of the intercostal space and configured to detect reflected light from the intercostal space and generate one or more physiological output signals.

19\. The system of claim 18 in which the processing subsystem is responsive to the one or more physiological output signals and is configured to determine at least one of a respiration rate of the living subject, a tissue oxygen saturation of the living subject, blood oxygenation of the living subject, or a heart rate of the living subject.

20\. The system of claim 19 in which the processing subsystem is configured to determine characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or
hemothorax in the living subject.
21\. The system of claim 19 in which the processing subsystem is configured to determine characteristic change in the tissue oxygen saturation to detect and/or monitor I the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the 2 living subject.

22\. The system of claim 19 in which the processing subsystem is configured to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

23\. The system of claim 19 in which the processing subsystem is configured to determine at least one of a characteristic change in respiration rate of the living subject, a characteristic change in the tissue oxygen saturation of the living subject, and/or a characteristic change in the heart rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

24\. The system of claim t in which the one or more light sources, the one or more light detectors, and the processing subsystem are housed in an adhesive patch attachable to the living subject.

25\. The system of claim 24 in which the adhesive patch includes an outlined needle zone, the adhesive patch attachable to the living subject using a physiological reference point on the living subject to ensure the outlined needle zone is located at an intercostal space of the living subject for insertion of a needle to treat at least one of pneumothorax, hemopneumothorax, or hemothorax.
1 26. The system of claim 25 in which the physiological reference point 2 includes at least one of a second intercostal space-mid clavicula line, a fourth and a fifth intercostal space-mid axillary line, or the fourth and the fifth intercostal space-anterior axillary line.
1 27. A method for detecting and/or monitoring at least one of pneumothorax, 2 hemopneumothorax, or hemothorax using light;
emitting light into a human subject;
detecting light reflected from the human subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or
hemothorax in the living subject.

28\. The method of claim 27 including emitting light which penetrates a thoracic cavity of the living subject at one or more predetermined penetration depths and detecting at least one of reflected light from tissue between lung of the living subject and skin of the living subject or reflected light from the lung of the living subject and generating output signals.

29\. The method of claim 28 including responding to the output signals and detecting and/or monitoring the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax based on an amount of light reflected or not reflected from the thoracic cavity.

30\. The method of claim 28 in which the light emitted is spaced by one of more predetermined separation distances to detect at least one of light reflected from tissue between the lung and the skin of the living subject or light reflected from the lung of the living subject and generating output signals.
1 31. The method of claim 30 including generating one or more tomography 2 curves representative of an amount of reflected light from varying penetration depths to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax based on the shape of the one or more tomography curves.

32\. The method of claim 27 including emitting light into tissue of the living subject, detecting light from the tissue, and generating one or more physiological output signals.

33\. The method of claim 32 including responding to the one or more physiological output signals and determining at least one of the respiration rate of the living subject, a tissue oxygen saturation of the living subject, blood oxygenation of the living subject, or a heart rate of the living subject.

34\. The method of claim 33 including determining a characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax.

35\. The method of claim of 34 including determining at least one of a characteristic change in tissue oxygen saturation or blood oxygenation to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or
hemothorax in a living subject.
36\. The method of claim 33 including determining a characteristic change in 2 the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in a living subject.

37\. The method of claim 33 including determining at least one of a characteristic change in the respiration rate of a living subject, a characteristic change in the tissue oxygenation saturation of a living subject, a characteristic change in blood oxygenation of a living subject, or a characteristic change in the heart rate in a living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in a living subject.

38\. The method of claim 37 including emitting light at two or more predetermined wavelengths and detecting and generating the physiological output signals responsive to each of the two more wavelengths to determine at least one of the respiration rate of the living subject, the tissue oxygen saturation of the living subject, the blood oxygenation of the living subject, or the heart rate of the living subject.

39\. The method of claim 38 in which one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores.
40\. The method of claim 27 including emitting light into the rib of the living subject and detecting light from the rib and generating one or more physiological output 3 signals.
1 41. The method of claim 40 including responding to the one or more physiological signals and determining a respiration rate of the human subject.

42\. The method of claim 41 including determining a characteristic change in the respiration rate of the living subject and detecting and/or monitoring the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

43\. The method of claim 27 including emitting light over an intercostal space of the living subject and detecting light reflected from the intercostal space and generating one or more physiological output signals.

44\. The method of claim 43 including responding to the one or more physiological output signals and determining at least one of a respiration rate of the living subject, a tissue oxygenation of the living subject, blood oxygenation of the living subject, or a heart rate of the living subject.

45\. The method of claim 44 including determining a characteristic change in the respiration of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.
46\. The method of claim 44 including determining a characteristic change in 2 the tissue oxygen saturation to detect and/or monitor the presence of at least one of 3 pneumothorax, hemopneumothorax, or hemothorax in the living subject.

47\. The method of claim 44 including determining at least one of a characteristic change in respiration rate of the living subject, a characteristic change in tissue oxygen saturation of the living subject, or a characteristic change in the heart rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject. RJC/jmc48 RJC/jmc41 RJC/jmc43 RJC/jmc45 VIVO-175J RJC/jmc44 RJC/jmc46 RJC/jmc40 RJC/jmc38 RJC/jmc39 RJC/jmc42 RJC/jmc49 RJC/jme47 VIVO-175J VIVO-175J VIVO-1751 VIVO-175J VIVO-175J VIVO-175J VIVO-175J 1 1 1 1 2 2 2 3 3 3 4 5 6 7 8 9 l I I l

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 § 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 27-47 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.
With respect to claim 27, the claim is considered indefinite due to the improper format since it lacks a transitional phrase to distinguish between the heading from the body of the claim. Therefore, the scope of the claim is undefined and unclear. See MPEP 2111.03 Transitional Phrases [R-07.2022]. For examination purposes the examiner will interpret the claim as follows:
“A method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using a light and comprising the steps of: emitting the light into a human subject; and detecting light reflected from the human subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.
The claims 28-47 are also rejected due to their dependency to claim 27 above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA  to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 15-18, 24, 27-30, 32, and 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manseur et al. (US 5,816,245 A).
With respect to claim 1, Manseur discloses a system (as seen on Figures 1 and 2, Figure 1 is provided herein) for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using one or more light sources and one or more light detectors, the system comprising (see abstract disclosing detection of pneumothorax): one or more light sources adapted to be placed on skin of a living subject (see LED patch assembly #1);
PNG
media_image1.png
335
446
media_image1.png
Greyscale
one or more light detectors adapted to be placed on the skin of the living subject (see photodetector #2); and a processing subsystem coupled to the one or more light sources and the one or more light detectors configured to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Column 2, lines 38-53, see also light sensor and detector circuit #6 for detection from photodetector patch #2).
With respect to claims 2 and 28, Manseur discloses the one or more light sources are configured to emit light (Column 3, lines 13-34) which penetrates a thoracic cavity of the living subject at one or more predetermined penetration depths and the one or more light detectors are configured to detect at least one of reflected light from tissue between a lung of the living subject and the skin or reflected light from the lung of the living subject and generate output signals (Column 3, lines 36-55; see Figure 3).
With respect to claims 3 and 29, Manseur discloses the processing subsystem is responsive to the output signals and is configured to detect and/or monitor the presence of pneumothorax, hemopneumothorax, or hemothorax based on an amount of light reflected or not reflected from the thoracic cavity (Column 3, lines 36-55; see Figure 3).
With respect to claims 4 and 30, Manseur discloses the one or more light detectors are spaced from the one or more light sources by one or more predetermined separation distances such that the one or more light detectors detect at least one of the light reflected from tissue between the lung and the skin of the living subject or light reflected from the lung of the living subject and generate the output signals (Column 3, lines 36-55; see Figure 2 showing space between light assembly #1 from sensor patch #2).
With respect to claims 6 and 32, Manseur discloses one or more light sources are configured to emit light into tissue of the living subject (Column 3, lines 13-34) and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals (Column 3, lines 36-55).
With respect to claims 15 and 40, Manseur discloses one or more light sources are adapted to be placed above a rib of the living subject and configured to emit light into the rib of the living subject (as seen on Figure 2, patches #1 and #2 located on the baby’s chest above the rib area) and the one or more light detectors are adapted to be placed over the rib and configured to detect reflected light from the rib and generate one or more physiological output signals (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claims 16 and 41, Manseur discloses the processing subsystem is responsive to the one or more physiological output signals and is configured to determine a respiration rate of the living subject (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claims 17 and 42, Manseur discloses the processing subsystem is configured to determine characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claim 18 and 43, Manseur discloses the one or more light sources are placed over at least a portion of an intercostal space of the living subject and the one or more light detectors are adapted to be placed over at least a portion of the intercostal space (as seen on Figure 2, patches #1 and #2 located on the baby’s chest above the intercostal space) and configured to detect reflected light from the intercostal space and generate one or more physiological output signals (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claim 24, Manseur discloses the one or more light sources, the one or more light detectors, and the processing subsystem are housed in an adhesive patch attachable to the living subject (Column 3, lines 13-35 disclosing said patches are attach interpreted as attached by adhesive).
With respect to claim 27, Manseur discloses a method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax (see abstract disclosing detection of pneumothorax) using light; emitting light into a human subject (see LED patch assembly #1); detecting light reflected from the human subject (see photodetector #2) to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Column 2, lines 38-53).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA  to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 5 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) in view of Saniye et al. (“How successful is “pleural sound sign” in the identification of pneumothorax?”).
With respect to claim 5 and 31, Manseur discloses the claimed invention as stated above except for specifying that the processing subsystem is configured to generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax, hemopneumothorax, or hemothorax based on the shape of the one or more tomography curves.  However, Saniye discloses generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax (see Abstract and page 275, “Statistical Analysis” section; see Figures 3 and 4). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax as taught by Saniye with Manseur’s detected signal for the purpose of determining the efficacy of the pneumothorax estimation according to Saniye.
Claims 7-12, 19-23, 33-38, 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) in view of McCoy (US 2013/0018240 A1).
With respect to claims 7-9, 11, 19-21, 23, 33-35, 37, and 44-47, Manseur discloses the system is responsive to the one or more physiological output signals (Abstract; Column 3, lines 36-55).
Furthermore, Manseur discloses the claimed invention as stated above except for specifying that the processing subsystem is configured to determine at least one of a respiration rate of the living subject, a tissue oxygen saturation of the living subject, blood oxygenation of the living subject, or a heart rate of the living subject. McCoy discloses determining tissue oxygen saturation of the living subject (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine tissue oxygen saturation of the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
With respect to claims 10, 22 and 36, Manseur discloses the claimed invention as stated above except for specifying the processing subsystem is configured to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject. However, McCoy discloses determining characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (see paragraph 0055). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
With respect to claims 12, 37 and 38, Manseur discloses the one or more light sources are configured to emit light at two or more predetermined wavelengths and the one or more light detectors are configured to generate the physiological output signals responsive to each of the two or more wavelengths for the processing subsystem (Columns 3 and 4, lines 43-58 and 1-28 respectively). Furthermore, Manseur discloses the claimed invention as stated above except for determining at least one of the respiration rate of the living subject, the tissue oxygen saturation of the living subject, the blood oxygenation of the living subject, or a heart rate of the living subject. However, McCoy discloses determining the tissue oxygen saturation of the living subject (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine tissue oxygen saturation of the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) in view of Kannan et al. (“A computational model to detect and quantify a primary blast lung injury using near-infrared optical tomography”).
With respect to claim 14, Manseur discloses the claimed invention as stated above except for specifying that one or more light sources include near infrared spectroscopy (NIRS) light sources.  However, Kannan discloses the use of NIRS (see Abstract). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was made to use of NIRS as taught by Kannan with Manseur ‘s infrared sensor for the purpose of specifying the infrared sensor used in order to obtain a measurement for detecting the presence of water, oxygenated and de-oxygenated blood in order to predict lung injury and the severity of said injury as taught by Kannan (see Abstract).
Allowable Subject Matter
Claims 13, 25, 26, and 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses different devices to monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

APPLICANT REBUTTAL: REMARKS
The Applicant appreciates the Examiner's thorough examination of the subject application.
The Applicant appreciates and thanks the Examiner for indicating claims 13, 25, 26, and 39 would be allowable if rewritten in independent form including all the features of the base claim and any intervening claims.
In response, the Applicant has amended independent claim 1 to include the features of claims 13, 12, and 6 and corresponding independent method claim 27 to include the features of claims 39, 38, and 32. The Applicant believes intervening 7, 33, and 37 qualify as intended use and need not be included in independent claims 1 and 27.
Accordingly, the Applicant believes the application is now in condition for allowance.
CONCLUSION

NEXT 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 § 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 27-47 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.
With respect to claim 27, the claim is considered indefinite due to the improper format since it lacks a transitional phrase to distinguish between the heading from the body of the claim. Therefore, the scope of the claim is undefined and unclear. See MPEP 2111.03 Transitional Phrases [R-07.2022]. For examination purposes the examiner will interpret the claim as follows:
“A method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using a light and comprising the steps of: emitting the light into a human subject; and detecting light reflected from the human subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.
The claims 28-47 are also rejected due to their dependency to claim 27 above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA  to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-4, 15-18, 24, 27-30, and 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) in view of Stoddart et al. (US 2008/0269577 A1).
PNG
media_image1.png
335
446
media_image1.png
Greyscale
With respect to claim 1, Manseur discloses a system (as seen on Figures 1 and 2, Figure 1 is provided herein) for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using one or more light sources and one or more light detectors, the system comprising (see abstract disclosing detection of pneumothorax): one or more light sources adapted to be placed on skin of a living subject (see LED patch assembly #1); one or more light detectors adapted to be placed on the skin of the living subject (see photodetector #2); and a processing subsystem coupled to the one or more light sources and the one or more light detectors, the processing subsystem responsive to the one or more physiological output signals and configured to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Column 2, lines 38-53, see also light sensor and detector circuit #6 for detection from photodetector patch #2).
Furthermore, Manseur discloses the claimed invention as stated above except for the one or more light sources are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals, the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths, wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores. However, Stoddart discloses the one or more light sources are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals (see paragraphs 0028-0029; see Figure 2 showing near infrared light or NIR #9 as the light source to emit light into tissue of the living subject), the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths (see paragraph 0031), wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores (see paragraphs 0045-0046; see also claim 6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed wherein the one or more of the light sources disclosed by Manseur are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals, the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths, wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores as taught by Stoddart in combination with Manseur’s light source for the purpose of identifying tissue and blood components and their concentrations and more particularly to novel applications and methodology for determining the optical response, measurements and calculations relating to the concentrations of individual chromophores in the tissues as discussed by Stoddart (see paragraphs 0001) that can provide essential information for many aesthetic, therapeutic, and diagnostic applications such as monitoring of skin blood oxygenation.
With respect to claims 2 and 28, Manseur discloses the one or more light sources are configured to emit light (Column 3, lines 13-34) which penetrates a thoracic cavity of the living subject at one or more predetermined penetration depths and the one or more light detectors are configured to detect at least one of reflected light from tissue between a lung of the living subject and the skin or reflected light from the lung of the living subject and generate output signals (Column 3, lines 36-55; see Figure 3).
With respect to claims 3 and 29, Manseur discloses the processing subsystem is responsive to the output signals and is configured to detect and/or monitor the presence of pneumothorax, hemopneumothorax, or hemothorax based on an amount of light reflected or not reflected from the thoracic cavity (Column 3, lines 36-55; see Figure 3).
With respect to claims 4 and 30, Manseur discloses the one or more light detectors are spaced from the one or more light sources by one or more predetermined separation distances such that the one or more light detectors detect at least one of the light reflected from tissue between the lung and the skin of the living subject or light reflected from the lung of the living subject and generate the output signals (Column 3, lines 36-55; see Figure 2 showing space between light assembly #1 from sensor patch #2).
With respect to claims 15 and 40, Manseur discloses one or more light sources are adapted to be placed above a rib of the living subject and configured to emit light into the rib of the living subject (as seen on Figure 2, patches #1 and #2 located on the baby’s chest above the rib area) and the one or more light detectors are adapted to be placed over the rib and configured to detect reflected light from the rib and generate one or more physiological output signals (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claims 16 and 41, Manseur discloses the processing subsystem is responsive to the one or more physiological output signals and is configured to determine a respiration rate of the living subject (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claims 17 and 42, Manseur discloses the processing subsystem is configured to determine characteristic change in the respiration rate of the living subject to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claim 18 and 43, Manseur discloses the one or more light sources are placed over at least a portion of an intercostal space of the living subject and the one or more light detectors are adapted to be placed over at least a portion of the intercostal space (as seen on Figure 2, patches #1 and #2 located on the baby’s chest above the intercostal space) and configured to detect reflected light from the intercostal space and generate one or more physiological output signals (Columns 3 and 4, lines 43-58 and 1-28 respectively).
With respect to claim 24, Manseur discloses the one or more light sources, the one or more light detectors, and the processing subsystem are housed in an adhesive patch attachable to the living subject (Column 3, lines 13-35 disclosing said patches are attach interpreted as attached by adhesive).
With respect to claim 27, Manseur discloses a method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax (see abstract disclosing detection of pneumothorax) using light; emitting light into tissue of a human subject (see LED patch assembly #1); detecting light reflected from the tissue of the human subject; (see photodetector #2; Column 3, lines 13-34) generating one or more physiological output signals; and responding to the one or more physiological output signal (Column 3, lines 36-55) to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (Column 2, lines 38-53).
Furthermore, Manseur discloses the claimed invention as stated above except for the one or more light sources are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals, the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths, wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores. However, Stoddart discloses the one or more light sources are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals (see paragraphs 0028-0029; see Figure 2 showing near infrared light or NIR #9 as the light source to emit light into tissue of the living subject), the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths (see paragraph 0031), wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores (see paragraphs 0045-0046; see also claim 6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed wherein the one or more of the light sources disclosed by Manseur are configured to emit light into tissue of the living subject and the one or more light detectors are configured to detect light from the tissue and generate one or more physiological output signals, the one or more light sources configured to emit light at two or more predetermined wavelengths and the one or more light detectors configured to generate the physiological output signals responsive to the two or more wavelengths, wherein one of the predetermined wavelengths is configured to target oxyhemoglobin chromophores and another of the predetermined wavelengths is configured to target deoxyhemoglobin chromophores as taught by Stoddart in combination with Manseur’s light source for the purpose of identifying tissue and blood components and their concentrations and more particularly to novel applications and methodology for determining the optical response, measurements and calculations relating to the concentrations of individual chromophores in the tissues as discussed by Stoddart (see paragraphs 0001) that can provide essential information for many aesthetic, therapeutic, and diagnostic applications such as monitoring of skin blood oxygenation.
Claims 5 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) and Stoddart et al. (US 2008/0269577 A1) in view of Saniye et al. (“How successful is “pleural sound sign” in the identification of pneumothorax?”).
With respect to claim 5 and 31, Manseur discloses the claimed invention as stated above except for specifying that the processing subsystem is configured to generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax, hemopneumothorax, or hemothorax based on the shape of the one or more tomography curves.  However, Saniye discloses generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax (see Abstract and page 275, “Statistical Analysis” section; see Figures 3 and 4). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to generate one or more tomography curves representative of the amount of reflected light from varying penetration depths and to detect and/or monitor the presence of pneumothorax as taught by Saniye with Manseur’s detected signal for the purpose of determining the efficacy of the pneumothorax estimation according to Saniye.
Claims 7-11, 19-23, 33-37, 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) and Stoddart et al. (US 2008/0269577 A1) in view of McCoy (US 2013/0018240 A1).
With respect to claims 7-9, 11, 19-21, 23, 33-35, 37, and 44-47, Manseur discloses the system is responsive to the one or more physiological output signals (Abstract; Column 3, lines 36-55).
Furthermore, Manseur discloses the claimed invention as stated above except for specifying that the processing subsystem is configured to determine at least one of a respiration rate of the living subject, a tissue oxygen saturation of the living subject, blood oxygenation of the living subject, or a heart rate of the living subject. McCoy discloses determining tissue oxygen saturation of the living subject (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine tissue oxygen saturation of the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
With respect to claims 10, 22 and 36, Manseur discloses the claimed invention as stated above except for specifying the processing subsystem is configured to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject. However, McCoy discloses determining characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject (see paragraph 0055). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
With respect to claims 37 and 38, Manseur discloses the one or more light sources are configured to emit light at two or more predetermined wavelengths and the one or more light detectors are configured to generate the physiological output signals responsive to each of the two or more wavelengths for the processing subsystem (Columns 3 and 4, lines 43-58 and 1-28 respectively). Furthermore, Manseur discloses the claimed invention as stated above except for determining at least one of the respiration rate of the living subject, the tissue oxygen saturation of the living subject, the blood oxygenation of the living subject, or a heart rate of the living subject. However, McCoy discloses determining the tissue oxygen saturation of the living subject (see paragraph 0034). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to determine tissue oxygen saturation of the living subject as taught by McCoy with Manseur’s signal for the purpose of providing spectral information for diagnosis (see Abstract) including diagnose of pneumothorax (see paragraph 0074) similarly to Manseur’s device (Abstract).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Manseur et al. (US 5,816,245 A) and Stoddart et al. (US 2008/0269577 A1) in view of Kannan et al. (“A computational model to detect and quantify a primary blast lung injury using near-infrared optical tomography”).
With respect to claim 14, Manseur discloses the claimed invention as stated above except for specifying that one or more light sources include near infrared spectroscopy (NIRS) light sources.  However, Kannan discloses the use of NIRS (see Abstract). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was made to use of NIRS as taught by Kannan with Manseur ‘s infrared sensor for the purpose of specifying the infrared sensor used in order to obtain a measurement for detecting the presence of water, oxygenated and de-oxygenated blood in order to predict lung injury and the severity of said injury as taught by Kannan (see Abstract).
Allowable Subject Matter
Claims 25 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses chromophore properties of human skin in vivo and measuring said oxygen parameters.

CITED REFERENCE SUMMARIES: Ref US20220096796A1: Claims:
A medical instrument system for inserting a medical instrument within a patient body, the system comprising: the medical instrument comprising an optical fiber having one or more of core fibers; and a console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including: providing an incident light signal to the optical fiber, receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from one or more of red blood cells or tissue within the patient body, and processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber.
the medical instrument comprising an optical fiber having one or more of core fibers; and
a console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including: providing an incident light signal to the optical fiber, receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from one or more of red blood cells or tissue within the patient body, and processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber.
providing an incident light signal to the optical fiber,
receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from one or more of red blood cells or tissue within the patient body, and
processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber.
The system of claim 1 , wherein each of the one or more core fibers includes a plurality of sensors distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of the optical fiber.
The system of claim 1 , wherein the optical fiber is a single-core optical fiber, and wherein the incident light is provided in pulses.
The system of claim 1 , wherein the optical fiber is a multi-core optical fiber including a plurality of core fibers, and wherein the incident light propagates along a first core fiber and the reflect light signal propagates along a second core fiber.
The system of claim 1 , wherein determining the location of the distal tip of the optical fiber within the patient body is based on the oxygen level and an entry site of the medical instrument.
The system of claim 1 , wherein the logic, when executed by the one or more processors, causes further operations including generating a display indicating the location of the distal tip of the optical fiber within the patient body.
The system of claim 1 , wherein the medical instrument is one of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle or a catheter with the optical fiber inlayed into one or more walls of the catheter.
The system of claim 1 , wherein the reflected light signal indicates pneumothorax.
The system of claim 1 , wherein the medical instrument is located within a vessel of the patient body, and wherein the reflected light signal indicates a direction of blood flow.
The system of claim 1 , wherein the medical instrument is located within a vessel of the patient body, and wherein the reflected light signal indicates a juncture of the vessel with a second vessel based on an increase in the oxygen level.
The system of claim 1 , wherein the medical instrument is located within the patient body, and wherein the reflected light signal indicates a change in volume of blood between a first location within the patient body and a second location within the patient body.
The system of claim 1 , wherein the medical instrument is a needle and has been inserted into a vessel of the patient body, and wherein the reflected light signal indicates the needle has punctured a posterior wall of the vessel based on a decrease in the oxygen level.
The system of claim 1 , wherein the logic, when executed by the one or more processors, causes further operations including determining whether the optical fiber is located within an artery or a vein of the patient body based on the oxygen level.
The system of claim 1 , wherein the logic, when executed by the one or more processors, causes further operations including determining a location of the distal tip of the optical fiber within the patient body at least based on the oxygen level.
A method for placing a medical instrument into a body of a patient, the method comprising: providing an incident light signal to an optical fiber disposed within the medical instrument, the optical fiber having one or more core fibers; receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from at least one or red blood cells or tissue within the patient body; and processing the reflected light signal to determine an oxygen level within the patient body near a distal tip of the optical fiber.
providing an incident light signal to an optical fiber disposed within the medical instrument, the optical fiber having one or more core fibers;
receiving a reflected light signal of the incident light, wherein the reflected light signal is reflected from at least one or red blood cells or tissue within the patient body; and
The method of claim 15 , wherein each of the one or more core fibers includes a plurality of sensors distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of the optical fiber.
The method of claim 15 , wherein the optical fiber is a single-core optical fiber, and wherein the incident light is provided in pulses.
The method of claim 15 , wherein the optical fiber is a multi-core optical fiber including a plurality of core fibers, and wherein the incident light propagates along a first core fiber and the reflect light signal propagates along a second core fiber.
The method of claim 15 , wherein determining the location of the distal tip of the optical fiber within the patient body is based on the oxygen level and an entry site of the medical instrument.
The method of claim 15 , further comprising generating a display indicating the location of the distal tip of the optical fiber within the patient body.
The method of claim 15 , wherein the medical instrument is one of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle or a catheter with the optical fiber inlayed into one or more walls of the catheter.
The method of claim 15 , wherein the reflected light signal indicates pneumothorax.
The method of claim 15 , wherein the medical instrument is located within a vessel of the patient body, and wherein the reflected light signal indicates a direction of blood flow.
The method of claim 15 , wherein the medical instrument is located within a vessel of the patient body, and wherein the reflected light signal indicates a juncture of the vessel with a second vessel based on an increase in the oxygen level.
The method of claim 15 , wherein the medical instrument is located within the patient body, and wherein the reflected light signal indicates a change in volume of blood between a first location within the patient body and a second location within the patient body.
The method of claim 15 , wherein the medical instrument is a needle and has been inserted into a vessel of the patient body, and wherein the reflected light signal indicates the needle has punctured a posterior wall of the vessel based on a decrease in the oxygen level.
The method of claim 15 , wherein the logic, when executed by the one or more processors, causes further operations including determining whether the optical fiber is located within an artery or a vein of the patient body based on the oxygen level.
The method of claim 15 , further comprising determining a location of the distal tip of the optical fiber within the patient body at least based on the oxygen level.
- 41 . (canceled)
Ref US20220241474A1: Claims:
A computing system comprising a processor configured to at least: determine a first threshold associated with a first patient biomarker, obtain a first measurement data associated with the first patient biomarker; monitor the first measurement data in real-time by comparing the first measurement data against the first threshold. predict a thoracic post-surgical complication based on the monitoring of the first measurement data; and generate a real-time notification indicating the predicted thoracic post-surgical complication when the first measurement data crosses the first threshold.
determine a first threshold associated with a first patient biomarker,
obtain a first measurement data associated with the first patient biomarker;
monitor the first measurement data in real-time by comparing the first measurement data against the first threshold.
predict a thoracic post-surgical complication based on the monitoring of the first measurement data; and
generate a real-time notification indicating the predicted thoracic post-surgical complication when the first measurement data crosses the first threshold.
The computing system of claim 1 , wherein the processor is further configured to: determine a severity level associated with the thoracic post-surgical complication based on the first measurement data; and determine, based on the determined severity level, a notification type associated with the real-time notification.
determine a severity level associated with the thoracic post-surgical complication based on the first measurement data; and
determine, based on the determined severity level, a notification type associated with the real-time notification.
The computing system of claim 2 , wherein on a condition that the determined severity level is low, the processor is configured to send the real-time notification and the severity level to a display for displaying to a patient; and on a condition that the determined severity level is high, the processor is configured to send the real-time notification and the severity level to a display for displaying to an HCP.
on a condition that the determined severity level is low, the processor is configured to send the real-time notification and the severity level to a display for displaying to a patient; and
on a condition that the determined severity level is high, the processor is configured to send the real-time notification and the severity level to a display for displaying to an HCP.
The computing system of claim 1 , wherein the processor is further configured to: obtain a context based on at least one of a thoracic surgery recovery timeline, at least one situational attribute, or at least one environmental attribute; and adjust the first threshold based on the obtained context.
obtain a context based on at least one of a thoracic surgery recovery timeline, at least one situational attribute, or at least one environmental attribute; and
adjust the first threshold based on the obtained context.
The computing system of claim 1 , wherein the processor is further configured to: obtain second measurement data associated with a second patient biomarker; determine a second threshold associated with the second patient biomarker; monitor the second measurement data in real-time by comparing the second measurement data against the second threshold; and generate a real-time notification indicating the predicted thoracic post-surgical complication based on the monitoring of the first measurement data and the second measurement data.
obtain second measurement data associated with a second patient biomarker;
determine a second threshold associated with the second patient biomarker;
monitor the second measurement data in real-time by comparing the second measurement data against the second threshold; and
generate a real-time notification indicating the predicted thoracic post-surgical complication based on the monitoring of the first measurement data and the second measurement data.
The computing system of claim 5 , wherein the thoracic post-surgical complication is a lung collapse, wherein one of the first patient biomarker or the second patient biomarker is a rate of change in patient's Oxygen saturation, a rate of change in patient's blood pressure, or a rate of change in patient's heart rate.
The computing system of claim 5 , wherein comparing each of the first measurement data and the second measurement data against the first threshold and the second threshold respectively is based on a context.
The computing system of claim 7 , wherein the monitoring of the second measurement data is based on a condition that the first measurement data crosses the first threshold for a predetermined amount of time.
The computing system of claim 1 , wherein the thoracic post-surgical complication is a prolonged air leak (PAL), a lung collapse, an indication of limited lung volume, or an indication of irregular respiration, wherein the thoracic post-surgical complication is a prolonged air leak (PAL), wherein the PAL is determined by measuring at least one of the following: an air volume, a respiratory rate, or a phase of respiration.
The computing system of claim 1 , wherein the processor is further configured to send a control program configured to modulate suction level of a chest tube system, wherein the suction level is modulated based at least one or more of a phase of respiration or a diaphragmatic muscle tone.
The computing system of claim 1 , wherein the comparing is performed by accounting for an amount of lung volume reduction.
The computing system of claim 1 , wherein the processor is further configured to: generate an actionable notification associated with the prediction of the thoracic post-surgical complication, wherein the actionable notification enables a patient or a healthcare provider (HCP) to perform at least one recommended action.
generate an actionable notification associated with the prediction of the thoracic post-surgical complication, wherein the actionable notification enables a patient or a healthcare provider (HCP) to perform at least one recommended action.
A computing system comprising a processor configured to at least: receive measurement data from at least one sensing system, wherein the measurement data is associated with a set of patient biomarkers; predict an occurrence of a prolonged air leak (PAL) based at least on the measurement data associated with the set of patient biomarkers; and
receive measurement data from at least one sensing system, wherein the measurement data is associated with a set of patient biomarkers;
predict an occurrence of a prolonged air leak (PAL) based at least on the measurement data associated with the set of patient biomarkers; and
generate a set of recommendations for preventing the PAL.
The computing system of claim 13 , wherein the set of recommendations for preventing the PAL comprises at least one of the following: one or more stapling recommendations or settings, one or more post-stapling recommendations, or one or more surgical procedural recommendations, or one or more post-surgical recommendations.
The computing system of claim 14 , wherein the one or more stapling recommendations or settings comprise at least one of: applying a buttressed staple line, avoiding overlapping parenchymal staple lines, or stapling using a cautious mode on a powered stapling device.
The computing system of claim 15 , wherein using the cautious mode on the powered stapling device comprises using at least one of: a modified speed setting or a modified force setting.
The computing system of claim 14 , wherein the one or more post-stapling recommendations comprise at least one of: using a low inspiratory pressure when inflating a lung or using a sealant.
The computing system of claim 14 , wherein the one or more surgical procedural recommendations comprise at least one of: controlling a number of dissections, creating an apical tent, or creating a pneumoperitoneum.
The computing system of claim 14 , wherein the one or more post-surgical recommendations comprise at least one of: whether or not to use a water seal, or whether or not to use suction, wherein whether or not to use a water seal is based on a degree of likelihood of a patient experiencing pneumothorax.
The computing system of claim 13 , wherein the set of patient biomarkers is a set of pre-surgical patient biomarkers.
The computing system of claim 13 , wherein the processor is further configured to generate a set of thresholds for monitoring an in-surgical PAL or a post-surgical PAL, if an occurrence of the PAL is predicted, wherein the processor is further configured to send the set of thresholds for monitoring an in-surgical PAL or a post-surgical PAL to a healthcare provider (HCP).
A sensing system comprising a processor configured to at least: obtain a first threshold associated with a first patient biomarker; obtain first measurement data associated with the first patient biomarker; monitor the first measurement data in real-time by comparing the first measurement data against the first threshold; predict a thoracic post-surgical complication based on the monitoring; and generate a real-time notification indicating the predicted thoracic post-surgical complication.
obtain a first threshold associated with a first patient biomarker;
obtain first measurement data associated with the first patient biomarker;
monitor the first measurement data in real-time by comparing the first measurement data against the first threshold;
predict a thoracic post-surgical complication based on the monitoring; and
generate a real-time notification indicating the predicted thoracic post-surgical complication.
The sensing system of claim 22 , wherein the processor is further configured to: receive a request for predicting a thoracic post-surgical complication based on a first measurement data associated with the first patient biomarker crossing a first threshold for a predetermined amount of time; and generate a real-time notification indicating the predicted thoracic post-surgical complication when the first measurement data crosses the first threshold for a predetermined amount of time.
receive a request for predicting a thoracic post-surgical complication based on a first measurement data associated with the first patient biomarker crossing a first threshold for a predetermined amount of time; and
generate a real-time notification indicating the predicted thoracic post-surgical complication when the first measurement data crosses the first threshold for a predetermined amount of time.
The sensing system of claim 22 , wherein the processor is further configured to: obtain a second threshold associated with a second patient biomarker; obtain second measurement data associated with the second patient biomarker; monitor the second measurement data in real-time by comparing the second measurement data against the second threshold; and generate a real-time notification indicating the predicted thoracic post-surgical complication based on the monitoring of the first measurement data and the second measurement data.
obtain a second threshold associated with a second patient biomarker;
obtain second measurement data associated with the second 
[Truncated to input limit]