Office Action 3: Notice of Allowance (2025-05-08)

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;
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; 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.

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\. (Previously Presented) The system of claim 1 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\. (Previously Presented) The system of claim 1 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.- 25. (Cancelled).

26\. (Currently Amended) The system of claim 1\[\[25\]\] 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, the method comprising: \[\[;\]\] 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;
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.

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\. (Previously Presented) The method of claim 27 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 .
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

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