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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
An amendment was filed on 05/12/2026. Claims 1 and 15 have been amended, and claims 2-3 have been canceled. Currently, claims 1 and 4-15 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to newly amended claims 1 and 15 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In this instance, newly cited Norris (US 20160101278) is utilized to teach the newly cited limitation of calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor.
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.
Claims 1, 7-8, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener (US 20180172685) in view of Li (US 20090076398), and further in view of Ng (US 200300788084777) and Norris (US 20160101278).
Regarding claim 1, Wegener discloses an apheresis system comprising (paragraph 0002):
an assembly for separating a component from a multi-component fluid
a processor (fig. 2, microprocessor 304), and
a memory storing data for processing by the processor (fig. 2, memory 306), the data, when processed, causes the processor to:
run a calibration test on one or more instruments of the assembly (paragraph 0048 describes the apparatus 200 conducting the self-calibration check, on instruments such as pumps, clamps, and sensors).
Wegener appears to disclose wherein the processor is caused to, based on failing the calibration test, calibrate the one or more instruments (paragraph 0048 describes the processor running self-calibration tests which appear to imply the system recalibrating itself in the event of dissatisfactory calibration), but does not teach a pump configured to generate a calibration pressure at a test port, and a pressure sensor configured to sense a pressure at the test port, the calibration test based on at least one of a calibration pressure or a calibration weight, wherein when the calibration test is based on the calibration pressure, the calibration test includes comparing the calibration pressure at a test port to a pressure sensed by a pressure sensor at the test port and calibrating the one or more instruments includes calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor.
However, if this is not clearly envisioned by the applicant, Li teaches wherein calibration is conducted automatically in response to failing a calibration test (paragraph 0011).
Li is considered pertinent prior art because it relates to the field of recalibration in medical systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the processor calibrates the system in response to failing a calibration test, as taught by Li, for the purpose of providing a suitable means of automatically recalibrating equipment in the event that the calibration is unsatisfactory (see Li, paragraph 0011).
Wegener, as modified by Li, does not teach the calibration test based on at least one of a calibration pressure or a calibration weight.
However, Ng teaches a weight sensor, and wherein calibrating a weight sensor using a calibration object with a known weight on the scale (paragraph 0103) and comparing the known weight with the weight sensed by the weight sensor (paragraph 0142) is a well-known practice in the art. Such a weight sensor is utilized for an instrument in a blood donation process (paragraph 0138)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the calibration test comprises placing a calibration object with a known weight on the holder and comparing the known weight with the weight sensed by the weight sensor, as taught by Ng, for the purpose of providing a suitable structure that sets a warning if the weight sensor isn’t calibrated (see Ng, paragraph 0142).
Wegner, as modified by Li, does not teach a calibration tested based on a calibration pressure, wherein when the calibration test is based on the calibration pressure, the calibration test includes comparing the calibration pressure at a test port to a pressure sensed by a pressure sensor at the test port, and calibrating the one or more instruments includes calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor.
However, Norris teaches a calibration means including a calibration port or test port (2684), wherein a pressure reference may be connected via the calibration port (fig. 95, calibration port 2684 to be connected to a pressure reference of a known pressure value, paragraph 0570. The calibration port or test port may also ), wherein pressure sensors therein are calibrated by comparing pressure readings of the pressure sensor with the known pressure of the pressure reference (paragraph 0570. The pressure sensors, due to being in fluid communication with the calibration port, are also configured to sense the pressure at the test port)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that it includes a pressure reference for generating a calibration pressure at a test port, the pressure sensor configured to sense the pressure at said test port, wherein the calibration test involves calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor, as taught by Norris, for the purpose of providing a suitable means of calibrating pressure sensors prior to use (see Norris, paragraph 0570).
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener in view of Norris such that the pressure reference is specifically a pump, as Wegener and Norris both establish that a pump is a well-known means of developing a pressure (see Norris, paragraph 0659)
Regarding claim 8, Wegener discloses wherein the processor is configured to execute the one or more tests in response to use of the apheresis system (paragraph 0048 describes the apparatus being switched on, at which point the apparatus conducts self-calibration checks).
Regarding claim 14, Wegener does not teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: automatically calibrate the one or more instruments based the one or more instruments failing the calibration test.
However, Li teaches wherein, in response to determining when it is necessary to perform a recalibration (i.e., when it fails a calibration test), the system initiates a recalibration (paragraph 0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the memory stores further data for processing by the processor that, when processed, causes the processor to: automatically calibrate the one or more instruments based the one or more instruments failing the calibration test, as taught by Li, for the purpose of providing a suitable means of automatically recalibrating equipment in the event that the calibration is unsatisfactory (see Li, paragraph 0011).
Regarding claim 15, Wegener discloses a method of calibrating an apheresis system (paragraph 0002 describes the apheresis system, paragraph 0048 describes the self-calibration check), comprising:
performing one or more calibration tests on one or more instruments of an assembly for separating a component from a multi-component fluid (paragraph 0048).
Wegener appears to discloses wherein, based on the one or more instruments failing the calibration test, to calibrate the one or more instruments (paragraph 0048 describes the processor running self-calibration tests which appear to imply the system recalibrating itself in the event of dissatisfactory calibration).
However, if this is not clearly envisioned by the applicant, Li teaches wherein calibration is conducted automatically in response to failing a calibration test (paragraph 0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wegener such that it comprises, based on the one or more instruments failing the calibration test, calibrating the one or more instruments, as taught by Li, for the purpose of providing a suitable means of automatically recalibrating equipment in the event that the calibration is unsatisfactory (see Li, paragraph 0011).
Wegener does not teach wherein the one or more calibration tests are based on at least one of a calibration pressure or a calibration weight, wherein when the one or more calibration tests are based on the calibration pressure, the one or more calibration tests include comparing the calibration pressure at a test port to a pressure sensed by a pressure sensor at the test port and wherein calibrating the one or more instruments includes calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor.
However, Ng teaches a weight sensor, and wherein calibrating a weight sensor using a calibration object with a known weight on the scale (paragraph 0103) and comparing the known weight with the weight sensed by the weight sensor (paragraph 0142) is a well-known practice in the art. Such a weight sensor is utilized for an instrument in a blood donation process (paragraph 0138)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wegener such that the calibration test comprises placing a calibration object with a known weight on the holder and comparing the known weight with the weight sensed by the weight sensor, as taught by Ng, for the purpose of providing a suitable structure that sets a warning if an instrument goes above a calibration weight (see Ng, paragraph 0142).
Wegner does not teach wherein when the one or more calibration tests are based on the calibration pressure, the one or more calibration tests include comparing the calibration pressure at a test port to a pressure sensed by a pressure sensor at the test port calibrating the one or more instruments includes calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor.
However, Norris teaches a calibration means including a calibration port or test port (2684), wherein a pressure reference may be connected via the calibration port (fig. 95, calibration port 2684 to be connected to a pressure reference, paragraph 0570), wherein pressure sensors therein are calibrated by comparing pressure readings of the pressure sensor with the known pressure of the pressure reference (paragraph 0570).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wegener such the one or more calibration tests include comparing the calibration pressure at a test port to a pressure sensed by a pressure sensor at the test port, and wherein calibrating the one or more instruments includes calibrating the pressure sensor based on a difference between the calibration pressure and the pressure sensed by the pressure sensor, as taught by Norris, for the purpose of providing a suitable means of calibrating pressure sensors prior to use (see Norris, paragraph 0570).
Regarding claim 16, Wegener discloses the method further comprising triggering the calibration test based on use of the apheresis system (paragraph 0048 describes the apparatus being switched on, at which point the apparatus conducts self-calibration checks)
Regarding claim 17, Wegener is silent to wherein the calibrating the one or more instruments comprises automatically calibrating the one or more instruments based on the one or more instruments failing the one or more calibration tests.
However, Li teaches wherein, in response to determining when it is necessary to perform a recalibration (i.e., when it fails a calibration test), the system initiates a recalibration (paragraph 0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wegener such that the calibrating the one or more instruments comprises automatically calibrating the one or more instruments based on the one or more instruments failing the one or more calibration tests, as taught by Li, for the purpose of providing a suitable means of automatically recalibrating equipment in the event that the calibration is unsatisfactory (see Li, paragraph 0011).
Regarding claim 18, Wegener is silent to wherein the method further comprises providing an alert that the one or more calibration tests have failed, wherein the calibrating the one or more instruments comprises manually triggering the calibrating of the one or more instruments by a user
However, Li teaches wherein alternatively, an alert is sent that recalibration should be initiated, and should be initiated manually rather than automatically (paragraph 0079).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Wegener such that the method further comprises providing an alert that the one or more calibration tests have failed, wherein the calibrating the one or more instruments comprises manually triggering the calibrating of the one or more instruments by a user, as taught by Li, for the purpose of providing a suitable method that alerts a user that recalibration should be done manually rather than automatically (see Li, paragraph 0079).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li and Ng and Norris, and further in view of Westberg (US 20050234384).
Regarding claim 4, Wegener discloses a holder and a weight sensor configured to sense a weight of an object placed on the holder (fig. 1, weight scales 240, 242, and 244 comprise the sensing portion and a portion holding respective containers), but is silent to wherein the one or more instruments [that the calibration test is run on as recited in claim 1] comprises the holder and weight sensor.
However, Westberg teaches wherein a weight sensing system being calibrated to ascertain an actual load applied to the hanger is well known in the art (paragraph 0163).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the weight sensor is part of the calibration tests recited in claim 1, as taught by Westberg, for the purpose of providing a suitable structure that ascertains an actual load applied to a respective hanger (see Westberg, paragraph 0163)
Regarding claim 5, Wegener, as modified by Westberg, does not teach wherein when the calibration test is based on the calibration weight, the calibration test comprises placing a calibration object with a known weight on the holder and comparing the known weight with the weight sensed by the weight sensor.
However, Ng teaches a weight sensor, and wherein calibrating a weight sensor using a calibration object with a known weight on the scale (paragraph 0103) and comparing the known weight with the weight sensed by the weight sensor (paragraph 0142) is a well-known practice in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the calibration test comprises placing a calibration object with a known weight on the holder and comparing the known weight with the weight sensed by the weight sensor, as taught by Ng, for the purpose of providing a suitable structure that sets a warning if the weight sensor isn’t calibrated (see Ng, paragraph 0142).
Regarding claim 6, Wegener does not teach wherein the processor is configured to: calibrate the weight sensor based on a difference between the known weight and the weight sensed by the weight sensor being greater than a threshold; and generate an alert based on the difference between the known weight and the weight sensed by the weight sensor being greater than a threshold.
However, Ng teaches wherein pre-defined calibration weights are used in the prior art of calibrating a scale (paragraph 0103), wherein if a calibration weight and a measured weight is more than a pre-defined variance, a warning is presented (paragraph 0142).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the processor is configured to calibrate the weight sensor based on a difference between the known weight and the weight sensed by the weight sensor being greater than a threshold, as taught by Ng, for the purpose of providing a suitable structure that sets a warning if the weight sensor isn’t calibrated (see Ng, paragraph 0142).
Regarding claim 7, Wegner discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
execute one or more tests (paragraph 0048 describes other self-calibration checks such as for clamps. The self-calibration checks for the clamps will be interpreted as a separate test than the self-calibration check for the peristaltic pumps and sensors)
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li, Ng, and Norris, and further in view of Prince (US 4657529).
Regarding claim 9, Wegener does not teach wherein:
the one or more tests comprises a fluid test;
the one or more instruments comprises one or more tubing; and
the fluid test comprises sending a fluid through the one or more tubing and detecting leaks in the one or more tubing.
However, Prince teaches a pump system (abstract) that comprises a fluid test that comprises pressurizing the tubing (i.e., sending a fluid to increase pressure) through the tubing and detecting leaks in the tubing (col. 11, lines 51-56)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the one or more tests comprises a fluid test, the fluid test comprising sending a fluid through the one or more tubing and detecting leaks in the one or more tubing, as taught by Prince, for the purpose of providing a suitable means of detecting leaks in the tubing during the initialization of the system (see Prince, col. 11, lines 51-56)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li, Ng, and Norris, and further in view of West (US 20170144172).
Regarding claim 10, Wegener does not teach wherein:
the one or more tests comprises a motor test;
the one or more instruments comprises a motor configured to cause a centrifuge to rotate; and
the motor test comprises causing the motor to rotate the centrifuge and measuring rotation of the centrifuge.
However, West teaches wherein if an electric drive of a centrifuge rotor is moving at an intermediate rotational speed (i.e., measuring the rotation of the centrifuge), then it shifts a counterweight response to the test (paragraph 0049)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the one or more tests comprises a motor test, the motor test comprises causing the motor to rotate the centrifuge and measuring rotation of the centrifuge, as taught by West, for the purpose of providing a suitable means of adjusting a counterweight to balance the centrifuge rotor (see West, paragraph 0049).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li, Ng, and Norris, and further in view of Muller (US 20020014462) and Jean-Marie (US 20030176813).
Regarding claim 11, Wegner discloses wherein the system comprises a wash medium of saline solution (paragraph 0048, bags 135a/135b of fig. 1)
wherein the saline moves through the tubing to a collection bag (paragraph 0054 describes a small amount of wash media to be transferred to collection bags 102, 122, 140 to ensure that they are connected)
wherein: the one or more tests comprises a saline test (paragraph 0054 describes a small amount of wash media to be transferred to collection bags 102, 122, 140 to ensure that they are connected) ;
the one or more instruments comprises one or more tubing (fig. 1, tubing connecting the bags and set through the pumps).
Wegener does not teach wherein the saline test comprises, moving saline from a saline bag through the one or more tubing to a collection bottle, and measuring a weight of the collection bottle with a weight sensor.
However, Muller teaches a system comprising a saline test (paragraph 0233), wherein the saline test comprises moving saline from the saline source (288) through the tubing to a collection bottle (312), and measuring a weight of the collection bottle with a weight sensor (paragraph 0233 discloses a pre-collection cycle where saline is expelled from a saline container 288 to in-process container 312, while paragraph 0234 describes in a further process the weight of the in-process container 312 is monitored).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the one or more tests comprises a saline test, wherein the saline test comprises, moving saline from a saline bag through the one or more tubing to a collection bag, and measuring a weight of the collection bag with a weight sensor, as taught by Muller, for the purpose of providing a suitable means that ensures that actions such as flushing have been executed correctly post-collection (see Mueller, paragraphs 0227 and 0236)
Wegener, as modified by Mueller, does not teach wherein the saline goes into a collection bottle.
However, Jean-Marie teaches wherein collection bottles for fluids are well known structures in the art of apheresis (paragraph 0011). While the collection bottle for Jean-Marie is for plasma, it demonstrates that the storage means has been considered in the art
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener in view of Mueller such that the saline goes into a collection bottle, as taught by Jean-Marie, since it appears the bags and bottles are equivalent means for collecting material in the art. It would have been obvious to one of ordinary skill in the art to substitute one known structure of another known structure of the same function.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li and Norris, and further in view of Thill (US 20160175514).
Regarding claim 12, Wegener does not teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: rerun the calibration test to test the one or more instruments after calibration.
However, Thill teaches wherein a calibration is carried out periodically (paragraph 0034), having a calibration happen after calibration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the memory stores further data for processing by the processor that, when processed, causes the processor to: rerun the calibration test to test the one or more instruments after calibration, as taught by Thill, for the purpose of providing a suitable structure that assists in maintaining the system over time (see Thill, paragraph 0034).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener in view of Li, Ng, and Norris, and further in view of Culbert (US 20190381223).
Regarding claim 13, Wegener does not teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: unlock the apheresis system based the one or more instruments passing the calibration test.
However, Culbert teaches wherein if a leak is detected in a line, the pump is disabled until the problem is corrected (paragraph 0186), thus suggesting that the pump is first disabled, then enabled after passing the test.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Wegener such that the memory stores further data for processing by the processor that, when processed, causes the processor to: unlock the system based the one or more instruments passing the calibration test, as taught by Culbert, for the purpose of providing a suitable means that ensures safe usage of the pump before the procedure (see Culbert, paragraph 0186).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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