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(b)
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 20-23 and 26-28 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 pre-AIA the applicant regards as the invention.
Claim 20 calls for “… wherein the processor is configured to selectively activate the plurality of indicators based on a trend in occurrences of changes in pressure of the fluid over time, the trend configured to correlate with the percentage of time that a patient is deemed to have an air leak from the patient's lung into the pleural cavity, and wherein the trend is derived from a number of respiratory cycles of the patient for which it is detected that a pressure differential exceeds a predetermined pressure differential threshold.”
This language is ambiguous because it appears to combine features from two incompatible embodiments. The specification describes several embodiments which display the patient’s data as either a waveform or a trio of discrete indicators:
Paragraphs and type of data
Type of display
¶ [0128], recorded air leak trend increment in terms of % from 0% to 100%
¶ [0132], [0135], [0136]-[0138], [0140], Figs. 6-7, display 3202 is configured to display changes in the pressure of the fluid in the collection device; graph 3204 may display a trend in occurrences of changes in pressure; a total amount of air leakage
Waveform or graph shows a trend over time
Waveform or graph in predetermined increments of time, e.g., 15-minute intervals
Fig. 6, display 3202 shows changes in the pressure of the fluid in the collection device
¶ [0129]-[0131], air leak magnitude under gravity
¶ [0156], the change in pressure decay and proportional correlation to air leak variation
¶ [0156], Progressive Red to Yellow to Green light indication
Trio of discrete red-yellow-green indicators displayed in real-time for a predetermined time interval, e.g., 60 seconds
Displays only a single light at any time and does not display a trend or history
¶ [0147] FIG. 8 pleural space pressure versus air leak magnitude
¶ [0155], FIG. 9, rate of pressure decay versus air leak magnitude
Neither Fig. 8 nor 9 represents a display on the drainage system. Instead, these graphs correlate pleural space pressure or pressure decay to an air leak magnitude.
Claim 20 appears to combine features from both the discrete indicator and waveform embodiments. Parent claim 16 describes discrete indicators and claim 20 adds the “trend” feature from the waveform embodiment.
The following instances likewise combine features from the two incompatible waveform and red-yellow-green LED embodiments.
Claim 21 calls for “…wherein the plurality of indicators is configured to show a trend in a magnitude of an air leak …”
Claim 22 calls for “…generating an indicator of the plurality of indicators showing the trend in the magnitude of the air leak …”
Claim 23 calls for “…wherein the trend is proportional to …”
Claim 26 calls for “…selectively activating the plurality of indicators based on a trend in occurrences of changes in pressure of the fluid over time …”
Claim 27 calls for “…show a trend in a magnitude of an air leak …”
Claim 28 calls for “…wherein the trend is proportional to …”
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Daly; Paul J. (US 20100130947 A1) with incorporation of Watson; Richard L. Jr. (WO 2007024230 A1) in view of Haggstrom; Kurt et al. (US 20070066946 A1).
Regarding claim 16, Daly discloses a pleural drainage system (¶ [0001], [0023], a mobile chest drainage unit connectable to a thoracic catheter; ¶ [0047], mobile chest drainage unit 1 is shown in FIG. 1; ¶ [0049] As shown in FIG. 1, the thoracic catheter 3 is inserted into the chest 100 of a patient … The lungs are provided within the pleural section or the pleural space 105);
comprising: a drainage catheter defining a drainage lumen and at least one drainage opening configured to draw fluid into the drainage lumen from a pleural cavity (¶ [0048], The thoracic catheter 3 includes holes 4 enabling to suction air and/or fluid from the patient's body);
a suction system configured to apply suction to the drainage lumen in order to draw fluid into the drainage lumen through the at least one drainage opening; a fluid collector configured to receive fluid from the drainage lumen of the drainage catheter (¶ [0006], The portable chest tube drainage system includes a vacuum chamber, a vacuum pump housing and a fluid reservoir; ¶ [0047], The mobile chest drainage unit 1 includes a collection chamber or fluid reservoir 5 and a vacuum chamber 8);
a pressure sensor coupled to the suction system and configured to be positioned for sensing a pressure in the pleural cavity (¶ [0051] FIG. 2 shows the distal end 3a of a thoracic catheter 3 … apart from the drainage holes 4 at least one sensor 5 is provided at the distal end 3a of the thoracic catheter 3 for measuring … temperature, pressure within the pleural space and/or other physiological parameters);
a processor (¶ [0007], WO 2007/024230 A1, the entire contents of which is hereby incorporated by reference; Watson discloses a processor (¶ [0039], These variations could be implemented as "hard wired" flow rates … or as variable flow rates through the use of variable electronic/electrical components in the motor controller circuitry; ¶ [0041], This increased electronic control complexity also allows the second embodiment described to lend itself to the greater use of sensors within the system that would monitor the various pressures, fluid content, and blood composition));
configured to receive a signal from the pressure sensor based on the sensed pressure in the pleural cavity (¶ [0033] Further, the at least one sensor may be adapted to acquire information regarding … temperature and/or pressure within the pleural cavity; ¶ [0051] FIG. 2 … at least one sensor 5 is provided at the distal end 3a of the thoracic catheter 3 for measuring or acquiring information regarding physiological parameters of the patient, such as … temperature, pressure within the pleural space and/or other physiological parameters); and
an indicator coupled to the processor and configured to visually indicate a status corresponding to the sensed pressure in the pleural cavity to an operator; wherein the processor is configured to selectively activate the indicator such that a first indicator is activated (¶ [0047], A display 6 is provided, where actual parameters, e.g. actual negative pressure applied to the patient's body, or other parameters or settings can be shown).
Daly lacks first, second and third indicators that activate when the sensed pressure is within first, second and third predefined ranges. Haggstrom discloses a wound dressing apparatus (¶ [0003], [0008], [0012], [0026], FIGS. 1-3, the composite wound dressing 100);
comprising: a drainage tube defining a drainage lumen configured to draw fluid into the drainage lumen (¶ [0035], Typically, the top layer 108 includes a vacuum port or connector 114 in fluid communication with the vacuum reservoir 110 … A flexible tubing 118 is connected to the vacuum port 114 and the vacuum source 112);
a suction system configured to apply suction to the drainage lumen in order to draw fluid into the drainage lumen; a fluid collector configured to receive fluid from the drainage lumen (¶ [0035], Hence, the vacuum source 112 can draw wound fluid through the composite wound dressing 100 and tubing 118 into the canister 120);
a pressure sensor coupled to the suction system and configured for sensing a pressure (¶ [0040], FIG. 6, the visual indicator device 124 includes at least one, preferably, three position-sensitive switches 126a-126c, and a self-powered electronic signaling module 128 … The position-sensitive switches 126a-126c each may be a pressure sensor which electrically bridges contacts 140a, 140b of the visual indicator device 124);
a plurality of indicators configured to visually indicate a status corresponding to the sensed pressure to an operator (¶ [0040], FIG. 6, the visual indicator device 124 includes … a self-powered electronic signaling module 128 … at least one transducer including three light emitting diodes (LED) 134a-c and/or a loudspeaker 136 electrically connected 138 to the circuit board 130. The LEDs 134a-c are color coded red, yellow and green respectively. The position-sensitive switches 126a-126c each may be a pressure sensor which electrically bridges contacts 140a, 140b of the visual indicator device 124);
wherein the indicators are configured such that: a first indicator of the plurality of indicators is activated when the sensed pressure is within a first predefined range (¶ [0042], The green light of the LEDs 134c indicates a full vacuum condition of the vacuum reservoir 110);
a second indicator of the plurality of indicators is activated when the sensed pressure is within a second predefined range (¶ [0043] As vacuum pressure decreases … The yellow LED 134b represents a partial vacuum or marginal vacuum condition of the vacuum reservoir 110); and
a third indicator of the plurality of indicators is activated when the sensed pressure is within a third predefined range (¶ [0043], As the vacuum pressure further decreases … the red LED 134a is energized and visible to the clinician essentially providing a warning that the vacuum within the vacuum reservoir has dissipated or is nearly dissipated).
Haggstrom communicates a pressure level to a user or operator and warns the user when the drainage system’s pressure has approached zero. One would be motivated to modify Daly with Haggstrom’s trio of indicators to quickly inform a user since Daly calls for displaying negative pressure information (¶ [0047], A display 6 is provided, where actual parameters, e.g. actual negative pressure applied to the patient's body, or other parameters or settings can be shown). A skilled artisan would have been able to modify Daly with Haggstrom’s indicators by adding a trio of LEDs on Daly’s display. Therefore, it would have been obvious to modify Daly with Haggstrom’s indicators in order to quickly inform a user about the negative pressure level.
Regarding claim 17, Daly measures a pressure in the pleural cavity (¶ [0051], at least one sensor 5 … for measuring or acquiring information regarding … pressure within the pleural space).
Daly does not expressly describe the pressure as a pressure differential between the pressure in the pleural cavity and a pressure applied by the suction system. However, Daly measures both an applied pressure (¶ [0047], A display 6 is provided, where actual parameters, e.g. actual negative pressure applied to the patient's body, or other parameters or settings can be shown); and a pressure existing in the patient’s pleural cavity (¶ [0033] Further, the at least one sensor may be adapted to acquire information regarding … pressure within the pleural cavity; ¶ [0051], at least one sensor … for measuring … pressure within the pleural space). Here, Daly suggests that the system can measure and/or calculate a differential pressure between atmospheric pressure and the applied vacuum.
Daly lacks first, second, and third predefined ranges based on predefined pressure differentials. Haggstrom discloses a system comprising first, second, and third predefined ranges (¶ [0042], The green light of the LEDs 134c indicates a full vacuum condition of the vacuum reservoir 110; ¶ [0043] As vacuum pressure decreases … The yellow LED 134b represents a partial vacuum or marginal vacuum condition of the vacuum reservoir 110; ¶ [0043], As the vacuum pressure further decreases … the red LED 134a is energized and visible to the clinician essentially providing a warning that the vacuum within the vacuum reservoir has dissipated or is nearly dissipated).
Haggstrom quickly informs a user of the pressure’s approximate magnitude with a trio of differently colored LEDs or lights. Regarding the rationale and motivation to modify Daly with Haggstrom’s predefined ranges and visual scale, see the discussion of claim 16 above.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Daly and Haggstrom in view of Mas; Juan-Pablo et al. (US 20090270808 A1).
Regarding claims 18 and 19, Daly discloses a pump (¶ [0006], The portable chest tube drainage system includes a vacuum chamber, a vacuum pump housing and a fluid reservoir).
Daly and Haggstrom lack a fluid clearing device comprising a pump and an accumulator. Mas discloses an aspiration catheter comprising a lumen (¶ [0001], [0006], [0025], FIG. 1 … catheter 10);
further comprising a fluid-clearing device configured to clear fluid from the catheter; wherein the fluid clearing device comprises a pump (¶ [0034], One means of accumulating a lower pressure is to connect the proximal end of aspiration lumen 62 to a central or "wall" vacuum system provided by the hospital or other clinical infrastructure, and which is connected to a remote vacuum pump); and
an accumulator in fluid communication with the pump (¶ [0033], FIGS. 6 and 7 … lumen 12, can be evacuated to serve as a vacuum accumulator or reservoir within the aspiration catheter; ¶ [0034] It may be useful to accumulate a lower pressure in the reservoir than can be achieved with a single stroke of a syringe, which, for use with aspiration catheters, typically has a volume of 20 cc or larger … the repeated evacuation strokes of the syringe plunger can be used to "pump down" the pressure in the vacuum accumulator to lower and lower pressures; ¶ [0036] The embodiment of FIGS. 10 and 11 may be operated in an alternate mode … When in a sealing configuration, piston 58 seals the distal aspiration chamber 54 … and maintained at a desired level of negative pressure to function as a vacuum accumulator or suction reservoir, as described above with respect to FIGS. 6-9; ¶ [0037] Alternatively, sealing member 58 may be positioned at the distal tip of the aspiration lumen … the entire length of the aspiration lumen may be evacuated to generate a reduced pressure that may be accumulated until it is desired to perform the aspiration function. At that point, the valve element is rapidly collapsed to expose the distal port 25 to a sudden suction pulse to aspirate matter into the catheter).
Mas dislodges mature or resistant clots by applying a sudden negative pressure (¶ [0006], The sudden exposure of a clot or other intravascular matter to the reduced pressure may create a dislodging force that also draws the matter into the chamber and is believed to have increased dislodging force for adherent material, such as thrombus that may be attached to the vessel wall; ¶ [0033], piston 50 can open to port 60 to apply accumulated vacuum within lumen 62 to chamber 54). One would be motivated to modify Daly and Haggstrom with Mas’s fluid clearing device to remove any debris or clots that lodge inside the catheter. Therefore, it would have been obvious to modify Daly and Haggstrom with Mas’s fluid clearing device in order to more forcefully remove clots or debris.
Claims 24, 25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Daly and Haggstrom in view of Karpowicz; John R. et al. (WO 2008039223 A1).
Regarding claim 25, Daly and Haggstrom teach a pleural drainage system including a pressure sensor and indicators as discussed for claim 16 above. Daly and Haggstrom do not determine, based on a sensed pressure, a rate of pressure decay; and do not correlate the rate of pressure decay to an air leak. Karpowicz discloses a system and method for applying suction to a wound (¶ [0002], [0013], [0039] Figure 1 shows an embodiment of a system (10) for suction wound therapy; ¶ [0067] In a portable pump embodiment (100) of the suction system as shown in Figures 5A; ¶ [0078] As shown in Fig 6A, a fault detection system (108));
a drainage device (¶ [0040] The typical wound dressing (12) includes a wound cover (22) and wound packing material (24), and may include a special wound contact layer (26). It will have a suction tube (14));
a fluid collector configured to receive fluid from the drainage device (¶ [0039], waste collection canister (16));
a pressure sensor coupled configured to sense a pressure in the drainage device (¶ [0072], A pressure transducer (not shown) monitors the negative pressure produced at the pump, and is preferably located in the conduit between the waste collection canister (16) and the pump (102));
a processor configured to receive a signal from the pressure sensor (¶ [0071], Figure 6B, the fault detection and alarm system includes a microprocessor (200)); and
an indicator coupled to the processor (¶ [0096], In the microprocessor embodiment of Fig 6B, a visual error indicator display (216) that is separate from the flow rate annunciator (214) provides additional trouble shooting assistance. These errors are detected by signals from sensors to the microprocessor);
the method comprising: determining, based on the sensed pressure over time, a rate of pressure decay; correlating, via the processor, the rate of pressure decay to an associated air leak; and selectively activating, via the processor, the indicator (¶ [0081] Where the pump is independently turned On and Off by the pressure control circuit to maintain set point pressure, the pressure sensed by the transducer will oscillate between the upper and lower control limits. The period of this oscillation is related to the leakage in the wound dressing. The higher the leakage, the shorter the period. Thus, the time intervals between the pump turning On or Off could be detected by the microprocessor and used as a rough measure of air flow rate; ¶ [0085], As the On time increases to equate to a flow of approximately 3 liters per minute, an indicator will light on the flow annunciator display (214) of the unit to alert the caregiver to the fact that the dressing system has a leak).
Karpowicz monitors a wound evacuation system for leakage, and alerts a caregiver in order to more effectively drain a wound or to conserve the system’s battery power (¶ [0096] warning or caution lights (116, 118, 120) indicating … low battery charge). One would be motivated to modify Daly and Haggstrom by detecting a leak with a pressure decay rate according to Karpowicz since Daly’s portable system relies on batteries (¶ [0006], one or more removable, replaceable and/or rechargeable batteries). Therefore, it would have been obvious to modify Daly and Haggstrom with Karpowicz’s pressure decay rate leak detection in order to conserve Daly’s batteries.
Regarding claims 24 and 29, Daly lacks a plurality of indicators. Haggstrom discloses plural indicators as discussed for claim 16 above.
Daly and Haggstrom do not detect an air leak. Karpowicz discloses a system that detects an air leak by sensing pressure and also measuring a pump’s duty cycle (¶ [0081], [0085]).
Karpowicz further discloses a microprocessor that monitors and controls the system including its sensors and vacuum pump (¶ [0078], [0081], [0083], [0090], [0092], [0096]); and
an indicator comprising multiple lights arranged in a row (¶ [0095] The system status annunciator may be in the form of a bar meter (114) color coded and graduated to provide a visual indication that the flow through the pump is within a range … that the pump is running faster than required … indicating air leakage in the system, or is running slower than required … indicating air blockage in the system); and
further examples of indicator lights (¶ [0096] The pump may also have warning or caution lights (116, 118, 120) indicating pump operating parameters, or errors other than those that are detected from reference airflow such as low battery charge. Electronic controls provide the ability to enable numerous combinations of visual and audible indications of flow detection faults and other errors).
A skilled artisan would have been able to combine the teachings of Daly, Haggstrom and Karpowicz by sensing a pressure decay in Daly’s catheter, then correlating the decay with an air leak and displaying the leak according to Karpowicz. Updating the indicator’s state constitutes a change in indicators, since the indicator changes its state depending on the severity of the leak. One would have been motivated to detect and display the leak since Daly relies on batteries to power a portable system, and Karpowicz’s leak detection conserves battery power.
Response to Arguments
The objection to claim 16 for minor informalities and the rejection of claim 16 under 35 USC § 101 are withdrawn in view of the amendments filed 04 March 2026.
Applicant’s arguments filed 04 March 2026 regarding the rejection of claims 16-19 as amended, under 35 USC § 103 over Daly, Haggstrom and Mas, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
New claims 24, 25 and 29 are rejected over Daly, Haggstrom and Karpowicz.
Applicant submits that the Examiner has not pointed to anything in Daly that shows a processor that is configured to receive a signal from the sensor 5 based on the sensed pressure in the pleural cavity; nor has the Examiner pointed to anything in Daly that shows a plurality of indicators coupled to a processor and configured to visually indicate a status corresponding to the sensed pressure in the pleural cavity to an operator (remarks p. 7). Applicant asserts that the circuitry in Watson is not "configured to receive a signal from the pressure sensor based on the sensed pressure in the pleural cavity" (remarks p. 9).
Examiner notes that Daly calls for electronic elements that require a computerized electronic controller (¶ [0035] In one embodiment, the transmitting means may be a fixed transmitter adapted to wirelessly transmit the acquired information via radiofrequency RF, Bluetooth or infrared IR; ¶ [0061] The electric CDU connector 17 and/or the electric catheter connector 15 can be any type of connection adapted to electronically connect the thoracic catheter 3 and the mobile chest drainage unit 1. Specifically, an USB port or any similar electric connection can be provided; ¶ [0067], radiofrequency (RF), Bluetooth, infrared (IR)). Bluetooth and USB communication each requires more than a simple electrical connection and requires a digital controller to send, receive and interpret digital signals. This implies that Daly’s system includes a microcontroller. Watson further demonstrates that Daly’s system includes a microcontroller. Daly explicitly discloses that the CDU receives information from the sensor (¶ [0071], Thereby, an electronic connection is established between the sensors 5 and the receiving means 14, more generally an electronic connection is provided between the thoracic catheter 3 and the mobile chest drainage unit 1). Therefore, Daly’s microcontroller receives sensor information including the pressure signal.
Applicant contends that since Daly is directed to a chest drainage unit and Haggstrom is directed to a "wound dressing apparatus," which are different types of systems, the Examiner has failed to provide a rational basis for why one of ordinary skill in the art would combine Haggstrom with Daly (remarks p. 9).
Examiner replies that both Daly and Haggstrom remove fluid from a patient’s wound. Daly removes fluid from an internally-positioned catheter and Haggstrom withdraws fluid from an external dressing. Both systems generate vacuum pressure and finely regulate the pressure within safe limits. Therefore, Haggstrom’s teachings are relevant to Daly.
Applicant asserts that as an initial matter, contrary to the assertion on page 7 of the Office Action, Haggstrom does not warn the user when the drainage system's pressure has approached zero (remarks p. 9). Applicant reasons that since Haggstrom does not warn the user when the drainage system's pressure has approached zero, but instead provides an indication that vacuum pressure within the vacuum reservoir is decreasing, the stated rationale to combine Haggstrom with Daly is based on a faulty assumption and is thus improper (remarks p. 10).
Examiner responds that Haggstrom explicitly designates the red LED as a warning that vacuum pressure has approached zero (¶ [0043], As the vacuum pressure further decreases and the top layer 108 moves towards its fully expanded or normal condition of FIG. 1 … In this condition, the red LED 134a is energized and visible to the clinician essentially providing a warning that the vacuum within the vacuum reservoir has dissipated or is nearly dissipated (i.e., subatmospheric pressure is close to or no longer present)).
Applicant submits that even if Haggstrom was properly combined with Daly, the Examiner has provided no showing that the resultant system would disclose "a plurality of indicators … to an operator," as disclosed in claim 16 (remarks p. 11). Applicant reasons that instead, Daly simply discloses a sensor that may measure or acquire information relating to pressure within the pleural space (remarks p. 11).
Examiner responds that Daly and Watson are cited as teaching a system that measures pleural pressure and conveys the sensor’s information to a processor. Haggstrom is cited as teaching a triple-LED display configured to show pressure information. This rejection modifies Daly with Haggstrom’s triple-LED display by substituting or augmenting Daly’s generic display with Haggstrom’s triple-LED display. Haggstrom more clearly indicates pressure levels and rapidly communicates the pressure level to a caregiver, similarly to a traffic stoplight.
Applicant asserts that since the indicators in Haggstrom are for providing an indication that vacuum pressure within the vacuum reservoir is decreasing, not an indication of the sensed pressure in a pleural cavity, the Examiner has not shown that Haggstrom discloses "a plurality of indicators … to an operator," as disclosed in claim 16 (remarks p. 11). Examiner reiterates that Haggstrom explicitly designates the red LED as a warning that vacuum pressure has approached zero (¶ [0043], providing a warning that the vacuum within the vacuum reservoir has dissipated or is nearly dissipated (i.e., subatmospheric pressure is close to or no longer present)).
Applicant respectfully submits that the Office Action has not shown that the cited references teach or suggest "first, second, and third predefined ranges are based on predefined pressure differentials … by the suction system," as recited in claim 17 (remarks p. 12). Applicant notes that the Examiner provides no basis for the allegation that the system can measure or calculate a differential pressure between atmospheric pressure and the applied vacuum … and has not pointed to anything in Daly that suggests measuring or calculating a differential pressure between atmospheric pressure and the applied vacuum (remarks p. 12).
Examiner notes that Daly measures an applied pressure (¶ [0047], A display 6 is provided, where actual parameters, e.g. actual negative pressure applied to the patient's body); and also measures a pressure existing in the patient’s pleural cavity (¶ [0033] Further, the at least one sensor may be adapted to acquire information regarding … pressure within the pleural cavity; ¶ [0051], at least one sensor … for measuring … pressure within the pleural space).
Daly also includes an electronic microcontroller and display as discussed above. Since Daly measures both applied and intra-pleural pressures and also includes a microcontroller, Daly’s system is capable of displaying any of these pressures, or calculated derivatives, on the display. Calculating the differential pressure requires only a single arithmetical step of subtracting the applied pressure from the intra-pleural pressure, which is within the capability of any microcontroller.
Applicant submits that decreasing pressure within a vacuum reservoir is not the same as "predefined pressure differentials between the pressure in the pleural cavity and a pressure applied by the suction system," as recited in claim 17 (remarks p. 13). Applicant reasons that Haggstrom is silent as pressure in the pleural cavity and thus cannot show that first, second, and third predefined ranges … as recited in claim 17 (remarks p. 13).
Examiner acknowledges that Haggstrom does not measure intra-pleural pressure and instead measures pressures in a vacuum reservoir or wound dressing. Daly is cited as measuring intra-pleural pressure. Haggstrom is instead cited as teaching a display that indicates three pressure ranges. Haggstrom’s wound treatment system applies therapeutic vacuum and extracts fluids from a patient similarly to Daly. Both systems regulate negative pressure within safe boundaries, and transmit information to a user.
Applicant asserts that paragraph 0001 of Mas discloses aspiration catheters for removal of "thrombotic, atherosclerotic or particulate matter" from a blood vessel. Thus, instead of clearing fluid from a drainage catheter, as recited in claim 18, Mas discloses removing matter from a blood vessel (remarks p. 13). Examiner responds that Mas removes occlusive biological material from a suction conduit. Mas is relative to Daly’s problem of aspirating fluid from a pleural cavity since Daly removes fluid from a patient after surgery, which is likely to contain blood (¶ [0002], The need also arises following heart surgery to prevent the accumulation of fluid around the heart; ¶ [0004], Mediastinal tubes placed to drain the pericardium after open-heart surgery are positioned directly under the sternum; ¶ [0049] As shown in FIG. 1, the thoracic catheter 3 is inserted into the chest 100 of a patient).
Applicant respectfully submits that claims 20-24 depend from claim 16 and are patentable based on their dependency from claim 16. In addition, claims 25-29 contain additional limitations not taught or suggested by the cited references (remarks p. 14). Examiner responds that new claims 20-23 and 26-28 are rejected under 112(b) for contradictory language that combines two incompatible embodiments. New claims 24 and 29 are rejected over Daly, Haggstrom and Karpowicz.
Allowable Subject Matter
Claims 20-23 and 26-28 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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.
Polaschegg; Hans-Dietrich US 5580460 A
Kellam, Benjamin et al. US 20040016700 A1
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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781