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 .
Election/Restrictions
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/2/2026.
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.
Claim(s) 1-3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geric (US 20250170320 A1) in view of Litzie (US 20040184953 A1).
Regarding claim 1, Geric discloses a heart-lung machine (HLM) system (100, fig. 1), comprising: a controller (110, para. [0032]); wherein upon activation of the HLM system, the controller is configured to suppress alarms associated with a sensor until blood is detected by the sensor (para. [0045]).
However, Geric fails to disclose a plurality of venous sensors disposed along a venous pathway, the plurality of venous sensors comprising a venous blood gas sensor.
Litzie teaches a similar system in the same field of endeavor with a plurality of venous sensors (25-27) disposed along a venous pathway (12, para. [0061]), the plurality of venous sensors comprising a venous blood gas sensor (26).
Firstly, Geric uses sensor data from a level sensor that is sent to a controller to suppress alarms and Litzie uses a different sensor to also send data to a controller. One having ordinary skill in the art at the time of invention would look at the invention disclosed by Geric, evaluate what sensors should be used to suppress alarms, and use a sensor known in the art to suppress alarms.
Regarding claim 2, the combination of Geric and Litzie discloses the system of claim 1. However, the combination fails to disclose a plurality of arterial sensors disposed along an arterial pathway.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to duplicate the sensors taught by Litzie and have sensors in the arterial line, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced, and more sensors leads to more beneficial data collection. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 3, the combination of Geric and Litzie discloses the system of claim 2. Geric further discloses wherein upon activation of the HLM system, the controller is configured to suppress alarms associated with the sensors until blood is detected by the sensor.
As explained in the rejection of claim 2, Litzie’s sensors were duplicated in the arterial line, and Geric uses sensor data from a level sensor that is sent to a controller to suppress alarms. Litzie also uses a different sensor to also send data to a controller; therefore, one having ordinary skill in the art at the time of invention would look at the invention disclosed by Geric, evaluate what sensors should be used to suppress alarms, and use a sensor known in the art to suppress alarms.
Regarding claim 15, Geric discloses a method of bypassing a patient's heart with a heart-lung machine (HLM) system (para. [0002, 0023]), comprising: activating the HLM system (para. [0038]), the HLM system comprising a controller (110), coupling a venous pathway of the HLM system to at least one venous portion of a patient's vasculature (para. [0027], fig. 1); coupling an arterial pathway of the HLM system to at least one arterial portion of the patient's vasculature (para. [0027], fig. 1); and suppressing alarms associated with a sensor until blood is detected by the sensor.
However, Geric fails to disclose a plurality of venous sensors disposed along a venous pathway, the plurality of venous sensors comprising a venous blood gas sensor.
Litzie teaches a similar system in the same field of endeavor with a plurality of venous sensors (25-27) disposed along a venous pathway (12, para. [0061]), the plurality of venous sensors comprising a venous blood gas sensor (26).
Firstly, Geric uses sensor data from a level sensor that is sent to a controller to suppress alarms and Litzie uses a different sensor to also send data to a controller. One having ordinary skill in the art at the time of invention would look at the invention disclosed by Geric, evaluate what sensors should be used to suppress alarms, and use a sensor known in the art to suppress alarms.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geric (US 20250170320 A1) in view of Litzie (US 20040184953 A1), Jones et al. (US 20180344919 A1), and Larsson et al. (WO 2023239283 A1).
The combination of Geric and Litzie discloses the system of claim 1. However, the combination fails to teach a capnograph sensor configured to detect an exhaled carbon dioxide content leaving the oxygenator, and a gas mixture flow sensor configured to detect a flow rate of a compressed air and oxygen gas mixture flowing into the oxygenator.
Jones teaches a capnograph sensor configured to detect an exhaled carbon dioxide content leaving the oxygenator (para. [0025]) and Larsson teaches a gas mixture flow sensor configured to detect a flow rate of a compressed air and oxygen gas mixture flowing into the oxygenator (page 17 lines 30-32, page 19 lines 4-12) both in the same field of endeavor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Geric and Litzie and incorporate the additional sensors of Jones and Larsson to provide more information/data gathering in the system and adding sensors commonly used in the art is an obvious modification.
Allowable Subject Matter
Claims 5-9 and 16-20 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. Claims 6-9, 18, and 20 are objected to by virtue of their dependence on an allowable claim.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the prior art alone or in combination does not disclose wherein the controller is configured to automatically activate the capnograph sensor without alarm limits when a case is started within the controller. Jones teaches a capnograph sensor but implementing the sensor into the system of Geric and further adding actions of the controller would be relying on hindsight. The controller of Geric suppresses alarms based on its sensors but the claim language requires more than just a controller using a capnograph sensor—the controller automatically activates the capnograph sensor without alarm limits when a case is started within the controller, and that is not taught by any of the references.
Claim 17 is objected to with substantially the same reasoning.
Claim 19 is objected to with substantially the same reasoning but for the flow rate sensor and adding an additional step of the controller to set a rate to zero liters per minute.
Regarding claim 16, the prior art alone or in combination does not disclose automatically starting a bypass timer configured to document an amount of time that blood flow bypasses the patient's heart while the HLM system is active upon detection of blood within the venous pathway by the venous blood gas sensor. No prior art could be found that would yield a reasonable modification with Geric without relying on hindsight or modifying the operation of Geric without the support to do so.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 20 March 2026