DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed January 16, 2026.
Status of Claims
1. Claims 1-6, 8-14, 16-32, 34-40 and 42-50 are pending and currently under consideration for patentability.
Response to Arguments
2. Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
While examiner agrees with applicant’s assertion that Grziwa fails to disclose a display which provides a pleural assessment indicating a presence or lack of presence of pressure oscillations, as required by the amended independent claims 1 and 27, examiner respectfully disagrees with applicant’s argument that Luxon fails to cure the deficiencies of Grziwa. Applicant fails to provide any specific evidentiary support to back this argument other than a general allegation that the claims define a patentable invention. Nonetheless, examiner points to at least paragraphs [0105], [0110], [0138-0139], [0213], claim 41 and Figures 35-40, 63 and 64 of Luxon, which clearly suggest a display (controller monitor/screen, 6302) in communication with the controller (108; [0075-0076]; [0081]), wherein the controller is configured to monitor tidal oscillations and detect when the magnitude of tidal oscillations has diminished, indicative of blockage forming in the chest tube, and, to aid in diagnosis, results from sensors monitored by the controller may be displayed on the display. Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date to have modified the controller configuration disclosed by Grziwa to monitor and indicate a presence or lack of presence of pressure oscillations relating to breathing by the subject, similar to that disclosed by Luxon, in order to aid in diagnosis and indicate on the monitor that additional suction is being pulled by the controller based on the presence of tidal oscillations being no longer detected in the drainage system by the controller, indicative of blockage forming in the chest tube, as suggested by Luxon in at least paragraphs [0105] and [0110]. Accordingly, the presently amended claims remain rejected under 35 U.S.C. 103 as being unpatentable over Grziwa et al. (US PGPUB 2019/0134363) in view of Luxon et al. (US PGPUB 2018/0104391), as outlined below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claim(s) 1-6, 8-14, 16-32, 34-40 and 42-50 are rejected under 35 U.S.C. 103 as being unpatentable over Grziwa et al. (US PGPUB 2019/0134363) in view of Luxon et al. (US PGPUB 2018/0104391).
5. With regard to claim 1, Grziwa discloses a drainage system (chest drainage system, Fig. 1, para. [0015]), comprising: a chest tube configured for insertion at least partially within a body of a subject (chest tube 18...is inserted into the patient 12, Fig. 1, para. [0016]); 'a drainage tube fluidly coupled with the chest tube (tubing circuit 14, Fig. 1; chest tube 18...attached to the tubing circuit 14 at a juncture, para. [0016]); a reservoir fluidly coupled with the drainage tube (fluid collection vessel 16, Fig. 1, para. [0016]); a pump (selective flow device 24, of circulation assembly 20) in communication with the reservoir (circulation assembly intakes and exhausts canister 16) configured to separate fluid from the pump (para. [0017]; Fig. 1; para. [0020]; para. [0044]); a controller (control unit 32) in communication with the reservoir (Fig. 1; in communication with reservoir, para. [0041]), wherein the controller (32) is configured to determine a readiness for removal of the chest tube from the body based upon removal parameters including a combination of a chest/thoracic air leak rate from the chest tube or drainage tube (determine when the patient 12 can be safely be removed from the system, para. [0024]; based on leak in patient’s lung, para. [0024]; CPU may monitor change in gas concentration over time to track healing status of leak over time, para. [0043]) and a liquid drainage volume (V.sub.circuit, V.sub.canister, V.sub.chest tube) from the chest tube or drainage tube (monitoring/measuring fluid volume within chest tube, fluid circuit and canister, para. [0041-0043]) where the chest/thoracic air leak rate and the liquid drainage volume are each obtained over a period of time via the controller (control unit tracks healing status of leak over time, para. [0040-0043]); and a display (display unit, 36) in communication with the controller (32; [0024]; [0032]).
However, Grziwa is silent in regard to the controller being further configured to provide a pleural assessment upon the display indicating a presence or a lack of presence of pressure oscillations relating to breathing by the subject.
Luxon disclose devices and methods for managing chest drainage, providing objective and accurate measures of drained fluid volume and chest air leak (abstract; Fig. 3), comprising a chest tube (104); a drainage tube (208) fluidly coupled with the chest tube; a reservoir (306) fluidly coupled with the drainage tube (208); a pump (316) in communication with the reservoir (306) configured to separate fluid from the pump ([0210]); and a display (controller monitor/screen, 6302) in communication with a controller (108; [0075-0076]; [0081]), wherein the controller (108) is configured to monitor tidal oscillations and detect when the magnitude of tidal oscillations has diminished, indicative of a pleural assessment that a blockage forming in the chest tube ([0105]; [0110]), and, to aid in diagnosis, results from sensors monitored by the controller may be displayed on the display (6302; [0138-0139], [0213], claim 41 and Figures 35-40, 63 and 64).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date to have modified the controller configuration disclosed by Grziwa to monitor and indicate a presence or lack of presence of pressure oscillations relating to breathing by the subject, similar to that disclosed by Luxon, in order to aid in diagnosis and indicate on the monitor that additional suction is being pulled by the controller based on the presence of tidal oscillations being no longer detected in the drainage system by the controller, indicative of blockage forming in the chest tube, as suggested by Luxon in at least paragraphs [0105] and [0110].
6. With regard to claim 2, Grziwa discloses that the controller is further configured to provide an indication of the readiness for removal (CPU 34 of control unit causes display unit 36 to display a blue color if a leak exists, a green color if a leak doesn't exist, and a white or grey color if a leak exists but is healing, para. [0033]).
7. With regard to claim 3, Grziwa discloses wherein the controller is further configured to provide the indication of the readiness for removal upon the display (display unit 36 to display a blue color if a leak exists, a green color if a leak doesn't exist, and a white or grey color if a leak exists but is healing, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], green would indicate readiness for removal while blue/white/grey would indicate non-readiness).
8. With regard to claim 4, Grziwa discloses that the indication of the readiness for removal further comprises an indication of subject progress over the period of time (display unit 36 to display a white or grey color if a leak exists but is healing, para. [0033]).
9. With regard to claim 5, Grziwa discloses that the indication of the readiness for removal further comprises an indication that the chest tube is ready for removal from the body (display unit 36 to display a green color if a leak doesn't exist, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], green would indicate readiness for removal).
10. With regard to claim 6, Grziwa discloses that the indication of the readiness for removal further comprises an indication that the chest tube is not ready for removal from the body (display unit 36 to display a blue color if a leak exists, or a white/grey color if a leak exists but is healing, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], blue/white/grey would indicate non-readiness for removal).
11. With regard to claim 8, Grziwa discloses that the air leak rate is obtained over a 6 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
12. With regard to claim 9, Grziwa discloses that the air leak rate is obtained over a 8 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
13. With regard to claim 10, Grziwa discloses that wherein the air leak rate is obtained over a 12 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
14. With regard to claim 11, Grziwa discloses that the air leak rate is obtained over a 24 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
15. With regard to claim 12, Grziwa discloses that the air leak rate is obtained over a 48 hour period of time (circulation ‘assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
16. With regard to claim 13, Grziwa discloses that the removal parameters comprise a mean and/or median of the air leak rate over the period of time (using average of most recent concentrations for determining rate of healing of leak, para. [0048]).
17. With regard to claim 14, Grziwa discloses that the removal parameters comprise a maximum value of the air leak rate over the period of time (using magnitude of maximum of gas concentration for determining rate of healing of leak, para. [0048)).
18. With regard to claim 16, Grziwa discloses that the liquid drainage volume is obtained ([0041]) over a 6 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. (0042]).
19. With regard to claim 17, Grziwa discloses that the liquid drainage volume is obtained ([0041]) over a 8 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [(0042)).
20. With regard to claim 18, Grziwa discloses that the liquid drainage volume is obtained ([0041]) over a 12 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
21. With regard to claim 19, Grziwa discloses that the liquid drainage volume is obtained ([0041]) over a 24 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. {0040}; control unit calculation after every cycle, para. [0042]).
22. With regard to claim 20, Grziwa discloses that the liquid drainage volume is obtained ([0041]) over a 48 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
23. With regard to claim 21, Grziwa discloses the system of claim 1 (see rejection above), but fails to teach wherein the removal parameters comprise an indication of patency of the chest tube based upon a confirmation of dynamic pressure within the system.
Luxon teaches a chest drainage system (Abstract) wherein the removal parameters comprise an indication of patency of the chest tube based upon a confirmation of dynamic pressure within the system (pressure may be monitored for tidal oscillations, which are indicative of tube patency, para. {0138]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the removal parameters disclosed by Grziwa, to include an indication of patency of the chest tube, similar to that disclosed by Luxon, in order to ensure patency of the implanted chest tube, as suggested by Luxon in paragraph [0138].
24. With regard to claim 22, Grziwa discloses that the controller (32) is further configured to compare the one or more removal parameters against a threshold value in determining readiness for removal (CPU comparing the calculation to a threshold value to evaluate presence, severity, and healing of a leak, para. [0045]; [0041]).
25. With regard to claim 23, Grziwa discloses that the threshold value is stored within the controller (threshold value may be stored by data storage medium device 38 of control unit 32, Fig. 1, para. [0045]; [0041]).
26. With regard to claim 24, Grziwa discloses that the threshold value is entered within the controller for storage via a user (threshold value may be entered by a user of the system 10, para. [0046]; stored by storage medium device 38, Fig. 1, para. [0045]; [0041]).
27. With regard to claim 25, Grziwa discloses that the threshold value is selected within the controller via a user (threshold value entered by a user via a selector dial coupled to control unit 32, para. [0046]; [0041]).
28. With regard to claim 26, Grziwa discloses that the one or more removal parameters are entered or selected within the controller via a user (sensing one or more parameters pressure, pressure differential, reference fluid concentration, para. [0059]; threshold values being entered by a user, para. [0046]; by setting a threshold, user is consequently setting a value to be monitored).
29. With regard to claim 27, Grziwa discloses a method for removing a drainage system (removal of a patient from a chest drainage system 10, Fig. 1, para. [0024]), comprising: receiving a liquid from a body of a subject through a drainage tube and into a reservoir (16) configured to separate fluid from a pump (selective flow device 24, of circulation assembly 20; para. [0017]; Fig. 1; para. [0020]; para. [0044]), where the drainage tube is fluidly coupled with a chest tube inserted at least partially within the body (chest tube 18 facilitates flow of fluid into tubing circuit 14 from patient 12, para. [0016]); monitoring the drainage system via a controller for removal parameters including a chest/thoracic air leak rate from the chest tube or drainage tube (determine when the patient 12 can be safely be removed from the system, para. [0024]; based on leak in patient’s lung, para. [0024]; CPU may monitor change in gas concentration over time to track healing status of leak over time, para. [0043]) and a liquid drainage volume (V.sub.circuit, V.sub.canister, V.sub.chest tube) from the chest tube or drainage tube (monitoring/measuring fluid volume within chest tube, fluid circuit and canister, para. [0041]) where the chest/thoracic air leak rate and the liquid drainage volume are each obtained over a period of time (control unit tracks healing status of leak over time, para. [0040-0043]; control unit monitors data measured by sensor 30, para. [0033]); determining a readiness for removal of the chest tube from the body via the controller based upon the removal parameters (determine when the patient 12 can be safely be removed from the system, para. [0024]; based on leak in patient’s lung, para. [0024]; control unit tracks healing status of leak over time, para. [0043]); and displaying indications on a display (display unit, 36) in communication with the controller (32; [0024]; [0032]).
However, Grziwa is silent in regard to displaying a pleural assessment upon the display indicating a presence or a lack of presence of pressure oscillations relating to breathing by the subject.
Luxon disclose devices and methods for managing chest drainage, providing objective and accurate measures of drained fluid volume and chest air leak (abstract; Fig. 3), comprising a chest tube (104); a drainage tube (208) fluidly coupled with the chest tube; a reservoir (306) fluidly coupled with the drainage tube (208); a pump (316) in communication with the reservoir (306) configured to separate fluid from the pump ([0210]); and a display (controller monitor/screen, 6302) in communication with a controller (108; [0075-0076]; [0081]), wherein the controller (108) is configured to monitor tidal oscillations and detect when the magnitude of tidal oscillations has diminished, indicative of a pleural assessment that a blockage forming in the chest tube ([0105]; [0110]), and, to aid in diagnosis, results from sensors monitored by the controller may be displayed on the display (6302; [0138-0139], [0213], claim 41 and Figures 35-40, 63 and 64).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date to have modified the controller/display configuration disclosed by Grziwa to monitor and indicate a presence or lack of presence of pressure oscillations relating to breathing by the subject, similar to that disclosed by Luxon, in order to aid in diagnosis and indicate on the monitor that additional suction is being pulled by the controller based on the presence of tidal oscillations being no longer detected in the drainage system by the controller, indicative of blockage forming in the chest tube, as suggested by Luxon in at least paragraphs [0105] and [0110].
30. With regard to claim 28, Grziwa discloses providing an indication of the readiness for removal to a user (CPU 34 of control unit causes display unit 36 to display a blue color if a leak exists, a green color if a leak doesn't exist, and a white or grey color if a leak exists but is healing, para. [0033]).
31. With regard to claim 29, Grziwa discloses wherein the controller (32) is further configured to display the indication of the readiness for removal upon the display to the user (display unit 36 to display a blue color if a leak exists, a green color if a leak doesn't exist, and a white or grey color if a leak exists but is healing, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], green would indicate readiness for removal while blue/white/grey would indicate non-readiness).
32. With regard to claim 30, Grziwa discloses indicating a progress of the subject over the period of time (display unit 36 to display a white or grey color if a leak exists but is healing, para. [0033]).
33. With regard to claim 31, Grziwa discloses indicating that the chest tube is ready for removal from the body (display unit 36 to display a green color if a leak doesn't exist, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], green would indicate readiness for removal).
34. With regard to claim 32, Grziwa discloses indicating that the chest tube is not ready for removal from the body (display unit 36 to display a blue color if a leak exists, or a white/grey color if a leak exists but is healing, para. [0033]; thus, as readiness for removal is determined based on leak, para. [0024], blue/white/grey would indicate non-readiness for removal).
35. With regard to claim 34, Grziwa discloses that monitoring the drainage system comprises monitoring the air leak rate over a 6 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042)).
36. With regard to claim 35, Grziwa discloses that monitoring the drainage system comprises monitoring the air leak rate over a 8 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. {0042}).
37. With regard to claim 36, Grziwa discloses that monitoring the drainage system comprises monitoring the air leak rate over a 12 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
38. With regard to claim 37, Grziwa discloses that monitoring the drainage system comprises monitoring the air leak rate over a 24 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
39. With regard to claim 38, Grziwa discloses that monitoring the drainage system comprises monitoring the air leak rate over a 48 hour period of time (circulation assembly is cycled every five to thirty minutes, and healing may include hundreds or thousands of cycles, para. [0040]; control unit calculation after every cycle, para. [0042]).
40. With regard to claim 39, Grziwa discloses that monitoring the drainage system further comprises determining a mean and/or median of the air leak rate over the period of time (using average of most recent concentrations for determining rate of healing of leak, para. [0048]).
41. With regard to claim 40, Grziwa discloses that monitoring the drainage system further comprises determining a maximum value of the air leak rate over the period of time (using magnitude of maximum of gas concentration for determining rate of healing of leak, para. [0048)).
42. With regard to claim 42, Grziwa discloses that monitoring the drainage system comprises monitoring the liquid drainage volume over a 6 hour period of time (determine when the patient 12 can be safely be removed from the system, para. [0024]; based on leak in patient’s lung, para. [0024]; CPU may monitor change in gas concentration over time to track healing status of leak over time, para. [0043]).
43. With regard to claim 43, Grziwa discloses that monitoring the drainage system comprises monitoring the liquid drainage volume over a 24 hour period of time (determine when the patient 12 can be safely be removed from the system, para. [0024]; based on leak in patients lung, para. [0024]; CPU may monitor change in gas concentration over time to track healing status of leak over time, para. [0043]).
44. With regard to claim 44, Grziwa discloses the method of claim 27, but fails to teach further comprising determining an indication of patency of the chest tube based upon a confirmation of dynamic pressure within the system.
Luxon teaches a chest drainage system (Abstract) wherein the one or more removal parameters comprise an indication of patency of the chest tube based upon a confirmation of dynamic pressure within the system (pressure may be monitored for tidal oscillations, which are indicative of tube patency, para. (0138)]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the removal parameters disclosed by Grziwa, to include an indication of patency of the chest tube, similar to that disclosed by Luxon, in order to ensure patency of the implanted chest tube, as suggested by Luxon in paragraph [0138].
45. With regard to claim 45, Grziwa discloses comparing the removal parameters against a threshold value in determining readiness for removal (CPU comparing the calculation to a threshold value to evaluate presence, severity, and healing of a leak, para. [0045]).
46. With regard to claim 46, Grziwa discloses that the threshold value is stored within the controller (threshold value may be stored by data storage medium device 38 of control unit 32, Fig. 1, para. [0045]).
47. With regard to claim 47, Grziwa discloses that the threshold value is entered within the controller for storage via a user (threshold value may be entered by a user of the system 10, para. [0046]; stored by storage medium device 38, Fig. 1, para. [0045]).
48. With regard to claim 48, Grziwa discloses that the threshold value is selected within the controller via a user (threshold value entered by a user via a selector dial coupled to control unit 32, para. [0046]).
49. With regard to claim 49, Grziwa discloses receiving the removal parameters within the controller (control unit monitors data measured by sensor 30, para. [0033]).
50. With regard to claim 50, Grziwa discloses that receiving the fluid from the body comprises receiving the liquid within a reservoir fluidly coupled with the drainage tube (canister 16 to catch fluids, Fig. 1, para. [0034]).
Conclusion
51. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
52. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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