Office Action 2: Non-Final Rejection (2024-08-30)
Rejection types: 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
AMENDMENTS TO THE CLAIMS

This listing of claims will replace all prior versions and listings of claims in the application:

Listing of claims:

1\. (Currently Amended) 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;
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;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.

2\. (Original) The system of claim 1 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\. (Original) The system of claim 2 in which 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.

4\. (Original) 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\. (Original) 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\. (Cancelled)

7\. (Currently Amended) The system of claim 1 \[\[6\]\] 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 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.

8\. (Original) 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\. (Original) 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\. (Original) 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\. (Original) 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.

12\. (Cancelled).

13\. (Cancelled).

14\. (Currently Amended) The system of claim 1\_\[\[6\]\] in which the one or more light sources include near infrared spectroscopy (NIRS) light sources.

15\. (Original) The system of claim 1 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\. (Original) 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.

17\. (Original) The system of claim 16 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.

18\. (Original) The system of claim 1 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\. (Original) 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\. (Original) 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\. (Original) 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 the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

22\. (Original) 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\. (Original) 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\. (Original) The system of claim 1 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\. (Original) 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.

26\. (Original) The system of claim 25 in which the physiological reference point 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.

27\. (Currently Amended) A method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax, or hemothorax using light;emitting light into tissue of a human subject;
detecting light reflected from the tissue of the human subject;
generating one or more physiological output signals;
emitting light at two or more predetermined wavelengths and detecting and generating the physiological output signals responsive to each of the two 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; and
responding to the one or more physiological output signal to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

28\. (Original) 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\. (Original) 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\. (Original) 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.

31\. (Original) The method of claim 30 including generating one or more tomography 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\. (Cancelled).

33\. (Currently Amended) The method of claim 27 \[\[-32\]\] 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\. (Original) 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\. (Original) 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\. (Original) The method of claim 33 including determining a characteristic change in the heart rate to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in a living subject.

37\. (Original) 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\. (Cancelled).

39\. (Cancelled).

40\. (Original) 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 signals.

41\. (Original) The method of claim 40 including responding to the one or more physiological signals and determining a respiration rate of the human subject.

42\. (Original) 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\. (Original) 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\. (Original) 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\. (Original) 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\. (Original) The method of claim 44 including determining a characteristic change in the tissue oxygen saturation to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject.

47\. (Original) 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.

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).
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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.

APPLICANT REBUTTAL: REMARKS
The Applicant appreciates the Examiner's thorough examination of the subject application.
The Examiner rejects claims 27-47 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph as allegedly being indefinite.
As shown in the Amendments to the Claims above, the Applicant has amended claim 27 to traverse the Examiner's rejection.
Accordingly, claims 27-47 are definite and in accordance with 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph.
The Examiner rejects claims 1-4, 15-18, 24, 27-30 and 40-43 under 35 U.S.C. 103 as allegedly being unpatentable in view of Manseur et al. (U.S. Patent No. 5,816,245). The Examiner also rejects claims 5 and 31 under 35 U.S.C. 103 as allegedly being unpatentable in view of Manseur et al. and Stoddard et (U.S. Pub. No. 2008/0269577. The Examiner also rejects claims 7-11, 19-23, 33-37, and 44-47 under 35 U.S.C. 103 as allegedly being unpatentable in view of Manseur et al. and Stoddart et al in view of McCoy (U.S. Pub. No 2013/0018240). The Examiner also rejects claim 14 under 35 U.S.C. 103 as allegedly being unpatentable in view of Manseur et al. and Stoddart et al in view of Kannan et al. ("A computational model to detect and quantify a primary blast lung injury using near-infrared optical tomography").
The Applicant appreciates and thanks the Examiner for indicating claims 25 and 26
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 allowable claim 25 and intervening claim 24. The Applicant has also amended corresponding method claim 27 to include similar features.
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 .
Allowable Subject Matter
Claims 1-5, 7-11, 14-23, 26-31, 33-37, and 40-47 are allowed.
The following is an examiner’s statement of reasons for allowance:
With respect to claim 1, the claim has been found allowable over the prior art of record because the prior art of record fails to teach or fairly suggest 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: 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; and wherein 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 and 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 in combination with the remaining limitations of the claim.
With respect to claim 27, the claim has been found allowable over the prior art of record because the prior art of record fails to teach or fairly suggest a method for detecting and/or monitoring at least one of pneumothorax, hemopneumothorax or hemothorax using light, the method comprising: responding to the one or more physiological output signal to detect and/or monitor the presence of at least one of pneumothorax, hemopneumothorax, or hemothorax in the living subject and providing one or more light sources, one or more light detectors, and a processing subsystem housed in an adhesive patch attachable to the living subject and 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 in combination with the remaining limitations of the claim.
With respect to claims 2-5, 7-11, 14-26, 28-31, 33-37, and 40-47, the claims have been found allowable due to its dependency to claims 1 and 27 above.
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.”
Response to Arguments
Applicant’s arguments, see pages 13 and 14, filed 02/20/25, with respect to claims 1-5, 7-11, 14-31, 33-37, and 40-47 have been fully considered and are persuasive.  The 35 U.S.C 112 and 35 U.S.C 103 rejections of claims 1-5, 7-11, 14-31, 33-37, and 40-47 have been withdrawn.
Conclusion

CITED REFERENCE SUMMARIES: Ref US8073517B1: Claims:
A system for determining constituents of blood in a vascular region comprising: a small diameter catheter adapted to be introduced to the vascular region using an introduction needle over which the catheter is mounted, the catheter including a distal shaft defining a lumen and a hub; a light emitter and a photodetector constructed and arranged to pass light through blood from the emitter to the photodetector when the blood is drawn through the lumen and into the hub from the vascular region; and a processor operatively connected to at least one of the light emitter and the photodetector that measures and indicates a level of blood constituents of the blood drawn from the vascular region; wherein the light emitter and photodetector are both positioned on a surface of the lumen, such that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, to allow measurement of light absorbed by the blood moving between the light emitter and the photodetector as blood is drawn through the lumen.
a small diameter catheter adapted to be introduced to the vascular region using an introduction needle over which the catheter is mounted, the catheter including a distal shaft defining a lumen and a hub;
a light emitter and a photodetector constructed and arranged to pass light through blood from the emitter to the photodetector when the blood is drawn through the lumen and into the hub from the vascular region; and
a processor operatively connected to at least one of the light emitter and the photodetector that measures and indicates a level of blood constituents of the blood drawn from the vascular region;
wherein the light emitter and photodetector are both positioned on a surface of the lumen, such that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, to allow measurement of light absorbed by the blood moving between the light emitter and the photodetector as blood is drawn through the lumen.
The system as set forth in claim 1 wherein the lumen is adapted to receive a guide wire and is in a range of approximately 1 mm in diameter.
The system as set forth in claim 2 wherein further comprising leads embedded in the shaft and extending to a cable and connector that extends remotely from a location proximate to the hub.
The system as set forth in claim 2 wherein the light emitter comprises a micro LED assembly located within the lumen proximate to the distal tip of the catheter and the photodetector comprises a miniature photodetector located within the lumen diametrically opposed to the LED assembly.
The system as set forth in claim 4 wherein the LED assembly comprises LEDs that emit light in at least two discrete ranges of wavelengths at predetermined times.
The system as set forth in claim 5 wherein the discrete ranges of wavelengths comprise the infra red band and the visible red light band.
The system as set forth in claim 2 wherein the processor is constructed and arranged to receive a signal from a co-oximeter and to compare a value for oxygen saturation from the co-oximeter to a measured value based upon the light emitter and the photodetector.
The system as set forth in claim 2 wherein the light emitter and the photodetector are located at a position in fluid communication with the lumen that is external to a vascular region.
The system as set forth in claim 8 wherein the light emitter and the photo detector are located in a structure proximate to the hub.
The system as set forth in claim 1 wherein the level of blood constituents is determined for at least one of solutes, electrolytes, complex molecules, and pharmacologic agents.
A method for introducing a central venous catheter (CVC) to a vascular region comprising the steps of: introducing a small diameter catheter that is mounted on an introducer needle, through tissue and into the vascular region; removing the needle so as to place a light emitter and a photodetector in communication with a lumen of the catheter, a distal tip of the lumen being located within the vascular region; aspirating blood through the lumen so as to pass between the light emitter and photodetector; measuring absorption of light by the blood passing between the light emitter and the photodetector such that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, so as to determine a level of blood constituents of the blood moving within the lumen, between the light emitter and the photodetector; and when venous blood is detected, free of arterial blood, directing a guidewire through the lumen, removing the catheter and guiding a CVC over the guide wire into the vascular region.
introducing a small diameter catheter that is mounted on an introducer needle, through tissue and into the vascular region;
removing the needle so as to place a light emitter and a photodetector in communication with a lumen of the catheter, a distal tip of the lumen being located within the vascular region;
aspirating blood through the lumen so as to pass between the light emitter and photodetector;
measuring absorption of light by the blood passing between the light emitter and the photodetector such that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, so as to determine a level of blood constituents of the blood moving within the lumen, between the light emitter and the photodetector; and
when venous blood is detected, free of arterial blood, directing a guidewire through the lumen, removing the catheter and guiding a CVC over the guide wire into the vascular region.
The method as set forth in claim 11 further comprising analyzing a signal from a non-invasive co-oximeter to provide a comparison for the step of determining.
The method as set forth in claim 11 wherein the step of aspirating includes drawing blood with a syringe attached to a proximal hub of the catheter.
The method as set forth in claim 11 wherein the step of measuring includes emitting light from at least two discrete LED units that emit light at each of infra red range and a visible red range at predetermined times.
The method as set forth in claim 11 wherein the step of measuring absorption of light includes emitting light from at least two discrete LED units at two discrete wavelengths and measuring absorption of light by the blood passing between the light emitter and the photodetector and determining a level of blood constituents, including at least one of solutes, electrolytes, complex molecules, and pharmacologic agents.
The system as set forth in claim 1 wherein the light emitter and photodetector are disposed in opposed positions about the lumen.
The system as set forth in claim 1 wherein the light emitter and photodetector are disposed in diametrically opposed positions about the lumen.
The system as set forth in claim 1 wherein the light emitter comprises an LED assembly located within the lumen proximate to a distal tip of the catheter and the photodetector comprises a miniature photodetector located within the lumen diametrically opposed to the LED assembly.
The system as set forth in claim 18 wherein the LED assembly comprises LEDs that emit light in at least two discrete ranges of wavelengths at predetermined times.
The system as set forth in claim 19 wherein the discrete ranges of wavelengths comprise the infra red band and the visible red light band.
The system as set forth in claim 1 wherein the light emitter and the photodetector are located at a position in fluid communication with the lumen that is external to a vascular region.
The system as set forth in claim 21 including a separate sealed bulb in communication with the hub with the light emitters and photodetector provided at the sealed bulb.
The system as set forth in claim 22 wherein the photodetector is diametrically opposed to the light emitter, and the light emitter includes an LED array.
A system for measuring blood constituents in a vascular region comprising: a small diameter catheter adapted to be introduced to the vascular region using an introduction needle over which the catheter is mounted, the catheter including a distal shaft defining a lumen and a hub; a light emitter and a photodetector disposed proximate the hub of the catheter, the light emitter and the photodetector being constructed and arranged to pass light through blood from the emitter to the photodetector when the blood is drawn through the lumen and into the hub from the vascular region; and a processor operatively connected to at least one of the light emitter and the photodetector that measures and indicates a level of blood constituents of the blood drawn from the vascular region; wherein the light emitter and photodetector are positioned so that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, to allow measurement of light absorbed by the blood moving between the light emitter and the photodetector as blood is drawn through the lumen.
a light emitter and a photodetector disposed proximate the hub of the catheter, the light emitter and the photodetector being constructed and arranged to pass light through blood from the emitter to the photodetector when the blood is drawn through the lumen and into the hub from the vascular region; and
wherein the light emitter and photodetector are positioned so that when the blood is drawn through the lumen, the light passes from the light emitter through the blood in the lumen to the photodetector, to allow measurement of light absorbed by the blood moving between the light emitter and the photodetector as blood is drawn through the lumen.
The system as set forth in claim 24 wherein the light emitter and photodetector are disposed proximate the hub of the catheter by means of a separate sealed bulb in communication with the hub.
The system as set forth in claim 25 wherein the light emitters and photodetector are provided at the sealed bulb.
The system as set forth in claim 26 wherein the photodetector is diametrically opposed to the light emitter, and the light emitter includes an LED array.
The system as set forth in claim 24 wherein the level of blood constituents is determined for at least one of solutes, electrolytes, complex molecules, and pharmacologic agents.
The method as set forth in claim 11 wherein the step of introducing a small diameter catheter that is mounted on an introducer needle includes providing the needle having a diameter of approximately 20 gauge.
The method as set forth in claim 11 wherein the step of determining the level of blood constituents includes determining for at least one of solutes, electrolytes, complex molecules, and pharmacologic agents.
Ref US7831298B1: Claims:
A method for optically measuring blood in lung, comprising: directing to a target area of a lung light in two spectral bands centered at two different wavelengths at which oxygenated blood and the de-oxygenated blood in the target area possess distinctively different absorption characteristics, wherein the two different wavelengths are selected to be located respectively at a lower side and upper side of a light wavelength at which absorption of light by the oxygenated blood equals absorption of light by the de-oxygenated blood; measuring reflection of the light from the target area of the lung in the two spectral bands centered at the two different wavelengths to obtain optical images of the target area of the lung at different depths from a surface of the target area; and processing the obtained optical images to extract information on an oxygen exchange state in blood present at the target area of the lung to produce a map of the oxygen exchange state in blood at different depths at each location where the light enters the target area.
directing to a target area of a lung light in two spectral bands centered at two different wavelengths at which oxygenated blood and the de-oxygenated blood in the target area possess distinctively different absorption characteristics, wherein the two different wavelengths are selected to be located respectively at a lower side and upper side of a light wavelength at which absorption of light by the oxygenated blood equals absorption of light by the de-oxygenated blood;
measuring reflection of the light from the target area of the lung in the two spectral bands centered at the two different wavelengths to obtain optical images of the target area of the lung at different depths from a surface of the target area; and
processing the obtained optical images to extract information on an oxygen exchange state in blood present at the target area of the lung to produce a map of the oxygen exchange state in blood at different depths at each location where the light enters the target area.
The method as in claim 1 , comprising: scanning the light in the two spectral bands centered at two different wavelengths along a scanning line to obtain an optical image of a slice of the tissue defined by the scanning line and a depth of penetration of the light into the lung; and obtaining the information on the oxygen exchange state in blood at different regions in the slice of the tissue from the optical images to form a two dimensional map of the oxygen exchange state of the slice of the tissue.
scanning the light in the two spectral bands centered at two different wavelengths along a scanning line to obtain an optical image of a slice of the tissue defined by the scanning line and a depth of penetration of the light into the lung; and
obtaining the information on the oxygen exchange state in blood at different regions in the slice of the tissue from the optical images to form a two dimensional map of the oxygen exchange state of the slice of the tissue.
The method as in claim 1 , comprising: scanning the light in the two spectral bands centered at two different wavelengths along a plurality of parallel scanning lines to obtain an optical image of each slice of the tissue defined by a respective scanning line and a depth of penetration of the light into the lung; and obtaining the information on the oxygen exchange state in blood at different regions in each of the slices of the tissue to form a three dimensional map of the oxygen exchange state of the lung.
scanning the light in the two spectral bands centered at two different wavelengths along a plurality of parallel scanning lines to obtain an optical image of each slice of the tissue defined by a respective scanning line and a depth of penetration of the light into the lung; and
obtaining the information on the oxygen exchange state in blood at different regions in each of the slices of the tissue to form a three dimensional map of the oxygen exchange state of the lung.
The method as in claim 1 , wherein: one of the two spectral bands ranges from 650 nm to 800 nm and the other of the two spectral bands ranges from 850 nm to 1000 nm.
one of the two spectral bands ranges from 650 nm to 800 nm and the other of the two spectral bands ranges from 850 nm to 1000 nm.
The method as in claim 1 , wherein: combining and guiding optical radiation from two light sources that emit light at the two different spectral bands, respectively, towards the target area through a common optical waveguide; reflecting a first portion of the combined radiation away from the target area at a location near the target area away from the target area before the first portion reaches the target area while directing a second portion of the combined radiation to reach the target area; using a reflection of the second portion from the target area to produce a reflected second portion that spatially overlaps and co-propagates with the first portion at the location where the first portion is reflected; collecting and guiding at least part of the reflected first portion and at least part of the reflected second portion from the target area towards a detection module through the common optical waveguide; separating the light into the two beams in two paths in the two spectral bands, respectively, before sending the two beams to the detection module; and detecting the two beams at the detection module to obtain the optical images.
combining and guiding optical radiation from two light sources that emit light at the two different spectral bands, respectively, towards the target area through a common optical waveguide;
reflecting a first portion of the combined radiation away from the target area at a location near the target area away from the target area before the first portion reaches the target area while directing a second portion of the combined radiation to reach the target area;
using a reflection of the second portion from the target area to produce a reflected second portion that spatially overlaps and co-propagates with the first portion at the location where the first portion is reflected;
collecting and guiding at least part of the reflected first portion and at least part of the reflected second portion from the target area towards a detection module through the common optical waveguide;
separating the light into the two beams in two paths in the two spectral bands, respectively, before sending the two beams to the detection module; and
detecting the two beams at the detection module to obtain the optical images.
The method as in claim 5 , comprising: controlling the reflected first portion to propagate inside the common waveguide in a first propagation mode and the reflected second portion to propagate inside the common waveguide in a second propagation mode that is different from the first propagation mode.
controlling the reflected first portion to propagate inside the common waveguide in a first propagation mode and the reflected second portion to propagate inside the common waveguide in a second propagation mode that is different from the first propagation mode.
The method as in claim 6 , wherein the first propagation mode is a first polarization mode of the common waveguide and the second propagation mode is the second polarization mode different from the first polarization mode of the common waveguide.
The method as in claim 5 , comprising: controlling the reflected first portion and the reflected second portion to propagate inside the common waveguide in a common propagation mode.
controlling the reflected first portion and the reflected second portion to propagate inside the common waveguide in a common propagation mode.
The method as in claim 5 , comprising: producing a delay between the reflected first and second portions; and modulating the relative delay between the reflected first portion and the reflected second portion to measure a variation in power of light.
producing a delay between the reflected first and second portions; and
modulating the relative delay between the reflected first portion and the reflected second portion to measure a variation in power of light.
A method for optically measuring blood in lung, comprising: combining and guiding optical radiation from two light sources, that emit light at two different spectral bands centered at two different wavelengths at which oxygenated blood and de-oxygenated blood in a target area of a lung possess distinctively different absorption characteristics, towards the target area through a common optical waveguide wherein selecting the two wavelengths to be respectively at a lower side and upper side of a light wavelength at which absorption of light by the oxygenated blood equals absorption of light by the de-oxygenated blood; reflecting a first portion of the combined radiation away from the target area at a location near the target area away from the target area before the first portion reaches the target area while dir
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