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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04MAR2026 has been entered.
Response to Arguments
Applicant's arguments filed 04MAR2026 have been fully considered but they are not persuasive.
Regarding data entry by an operator using the data entry device, Applicant’s arguments are not persuasive. Case teaches that data entry device (52) is used by the operator to control the procedure [0051], further teaching a desire for the operator to gather status information and handle error conditions. While Applicant cited [0013] recognizes the potential dangers of manual entry, the device of Case is intended to address these concerns. Therefore, Case does not teach away from this feature of manual entry and Applicant’s arguments are not convincing.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7, 9-12, 24, 26, and 27 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210043316 A1 (Case et al.).
Regarding Claims 1, 2, 5, 7, 9-12, and 24 Case teaches blood separation system (10) (Fig. 2) (an automated system for separating plasma from whole blood [0025] comprising:
a data entry device (at least 52) configured to receive entered data from an operator (via the GUI) using the data entry device [0051] regarding a blood source [0051], with the entered data comprising one or more numbers characterizing one or more physical dimensions of the blood source and/or composition of the blood of the blood source (height, weight, age) [0051];
a blood separator (14) [0048] configured to separate blood into two or more separated blood components (via at least the cell line 40 and plasma line 44 [0050]);
a pump system (anticoagulant pump 54, blood pump 56, and cell pump 58 [0052]) configured to convey blood to the blood separator and to convey at least a portion of at least one separated blood component out of the blood separator (the cell pump delivering components to a reservoir [0052]); and
a controller (118) configured to control the blood separator and the pump system to execute a blood separation procedure ([0026] discussing scenarios which are executed by the controller), wherein the controller is further configured to
compare at least a portion of the entered data received by the data entry device or a calculated value derived from said at least a portion of the entered data received by the data entry device to a target range, a minimum value, and/or a maximum value (the controller comparing patient information to that entered through the data entry device [0140]) ([0118] noting that parameters vary based on numerous factors, thereby teaching a range of acceptable values),
request reentry by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device or request confirmation by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device when said at least a portion of the entered data or said calculated value is outside of said target range, less than said minimum value, and/or greater than said maximum value (the controller generating a message to re-measure the value [0140]), and
proceed with said blood separation procedure when said at least a portion of the entered data or said calculated value is not outside of said target range, less than said minimum value, and/or greater than said maximum value ([0127] describing that the entered data is verified before proceeding with the medical procedure), wherein
said at least a portion of the entered data includes at least one of an entered height of the blood source and an entered weight of the blood source (height and weight being parameters [0132]), wherein
said calculated value comprises a body mass index (BMI) of the blood source derived from the entered height of the blood source and the entered weight of the blood source (through use of additional image processing [0140]),
said target range comprises a range of body mass indices, said minimum value comprises a minimum body mass index, and said maximum value comprises a maximum body mass index ([0074-0075] detailing that the calculated BMI takes other variables into account, such as age [0076], and therefore would necessarily comprise a range), and
the controller is configured to compare the body mass index of the blood source to said range of body mass indices, said minimum body mass index, and/or said maximum body mass index ([0074 setting out a plurality of means for calculations based on BMI), wherein
said at least a portion of the entered data includes a hematocrit level of the blood of the blood source, said target range comprises a range of hematocrit levels, said minimum value comprises a minimum hematocrit level, and said maximum value comprises a maximum hematocrit level, and the controller is configured to compare the entered hematocrit level to said range of hematocrit levels, said minimum hematocrit level, and/or said maximum hematocrit level ([0132] and Figs. 7-9), wherein
said calculated value comprises a target collection volume [0132], said target range comprises a range of collection volumes, said minimum value comprises a minimum collection volume, and said maximum value comprises a maximum collection volume, and the controller is configured to compare the target collection volume to said range of collection volumes, said minimum collection volume, and/or said maximum collection volume (Figs. 7-9 showing ranges based on at least volume), wherein
said target collection volume comprises a volume of collected plasma or a combined volume of collected plasma and anticoagulant (volume of raw plasma and plasma plus anticoagulant [0132]), wherein
said calculated value comprises a total blood volume of the blood source [0132], said target range comprises a range of total blood volumes, said minimum value comprises a minimum total blood volume, and said maximum value comprises a maximum total blood volume, and the controller is configured to compare the total blood volume of the blood source to said range of total blood volumes, said minimum total blood volume, and/or said maximum total blood volume (Figs. 7-9 showing ranges based on blood product volumes), wherein
said calculated value comprises a total plasma volume of the blood source [0132], said target range comprises a range of total plasma volumes, said minimum value comprises a minimum total plasma volume, and said maximum value comprises a maximum total plasma volume, and the controller is configured to compare the total plasma volume of the blood source to said range of total plasma volumes, said minimum total plasma volume, and/or said maximum total plasma volume (Figs. 7-9 showing ranges based on blood product volumes), wherein
the controller is configured to request reentry of said at least a portion of the entered data when said at least a portion of the entered data or said calculated value is outside of said target range ([0140] discussing reentry of data based on entered weight and calculated BMI), less than said minimum value, and/or greater than said maximum value, and when the reentered data is different from said at least a portion of the entered value, request reentry of said different portion of the entered data.
Regarding Claim 26, Case teaches blood separation system (10) (Fig. 2) (an automated system for separating plasma from whole blood [0025] comprising:
a data entry device (at least 52) configured to receive entered data from an operator (via the GUI) using the data entry device [0051] regarding a blood source [0051],
a blood separator (14) [0048] configured to separate blood into two or more separated blood components (via at least the cell line 40 and plasma line 44 [0050]);
a pump system (anticoagulant pump 54, blood pump 56, and cell pump 58 [0052]) configured to convey blood to the blood separator and to convey at least a portion of at least one separated blood component out of the blood separator (the cell pump delivering components to a reservoir [0052]); and
a controller (118) configured to control the blood separator and the pump system to execute a blood separation procedure ([0026] discussing scenarios which are executed by the controller), wherein the controller is further configured to
compare at least a portion of the entered data received by the data entry device or a calculated value derived from said at least a portion of the entered data received by the data entry device to a target range, a minimum value, and/or a maximum value (the controller comparing patient information to that entered through the data entry device [0140]) ([0118] noting that parameters vary based on numerous factors, thereby teaching a range of acceptable values),
for each entered datum and each calculated value, request reentry by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device or request confirmation by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device when said at least a portion of the entered data or said calculated value is outside of said target range, less than said minimum value, and/or greater than said maximum value (the controller generating a message to re-measure the value [0140, 0141]), and
proceed with said blood separation procedure when said at least a portion of the entered data or said calculated value is not outside of said target range, less than said minimum value, and/or greater than said maximum value ([0127] describing that the entered data is verified before proceeding with the medical procedure), wherein each entered datum or calculated value is selected from at least one of an entered height of the blood source and an entered weight of the blood source (height and weight being parameters [0132]), wherein said calculated value comprises a body mass index (BMI) of the blood source derived from the entered height of the blood source and the entered weight of the blood source (through use of additional image processing [0140]),
said target range comprises a range of body mass indices, said minimum value comprises a minimum body mass index, and said maximum value comprises a maximum body mass index ([0074-0075] detailing that the calculated BMI takes other variables into account, such as age [0076], and therefore would necessarily comprise a range), and
the controller is configured to compare the body mass index of the blood source to said range of body mass indices, said minimum body mass index, and/or said maximum body mass index ([0074 setting out a plurality of means for calculations based on BMI), wherein
said at least a portion of the entered data includes a hematocrit level of the blood of the blood source, said target range comprises a range of hematocrit levels, said minimum value comprises a minimum hematocrit level, and said maximum value comprises a maximum hematocrit level, and the controller is configured to compare the entered hematocrit level to said range of hematocrit levels, said minimum hematocrit level, and/or said maximum hematocrit level ([0132] and Figs. 7-9), wherein
said calculated value comprises a target collection volume [0132], said target range comprises a range of collection volumes, said minimum value comprises a minimum collection volume, and said maximum value comprises a maximum collection volume, and the controller is configured to compare the target collection volume to said range of collection volumes, said minimum collection volume, and/or said maximum collection volume (Figs. 7-9 showing ranges based on at least volume), wherein
said target collection volume comprises a volume of collected plasma or a combined volume of collected plasma and anticoagulant (volume of raw plasma and plasma plus anticoagulant [0132]), wherein
said calculated value comprises a total blood volume of the blood source [0132], said target range comprises a range of total blood volumes, said minimum value comprises a minimum total blood volume, and said maximum value comprises a maximum total blood volume, and the controller is configured to compare the total blood volume of the blood source to said range of total blood volumes, said minimum total blood volume, and/or said maximum total blood volume (Figs. 7-9 showing ranges based on blood product volumes), wherein
said calculated value comprises a total plasma volume of the blood source [0132], said target range comprises a range of total plasma volumes, said minimum value comprises a minimum total plasma volume, and said maximum value comprises a maximum total plasma volume, and the controller is configured to compare the total plasma volume of the blood source to said range of total plasma volumes, said minimum total plasma volume, and/or said maximum total plasma volume (Figs. 7-9 showing ranges based on blood product volumes).
Regarding Claim 27, Case teaches blood separation system (10) (Fig. 2) (an automated system for separating plasma from whole blood [0025] comprising:
a data entry device (at least 52) configured to receive entered data from an operator (via the GUI) using the data entry device [0051] regarding a blood source [0051],
a blood separator (14) [0048] configured to separate blood into two or more separated blood components (via at least the cell line 40 and plasma line 44 [0050]);
a pump system (anticoagulant pump 54, blood pump 56, and cell pump 58 [0052]) configured to convey blood to the blood separator and to convey at least a portion of at least one separated blood component out of the blood separator (the cell pump delivering components to a reservoir [0052]); and
a controller (118) configured to control the blood separator and the pump system to execute a blood separation procedure ([0026] discussing scenarios which are executed by the controller), wherein the controller is further configured to
compare at least a portion of the entered data received by the data entry device or a calculated value derived from said at least a portion of the entered data received by the data entry device to a target range, a minimum value, and/or a maximum value (the controller comparing patient information to that entered through the data entry device [0140]) ([0118] noting that parameters vary based on numerous factors, thereby teaching a range of acceptable values),
for each entered datum and each calculated value, request reentry by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device or request confirmation by the operator of said at least a portion of the entered data and/or a different portion of the entered data using the data entry device when said at least a portion of the entered data or said calculated value is outside of said target range, less than said minimum value, and/or greater than said maximum value (the controller generating a message to re-measure the value [0140, 0141]), and
proceed with said blood separation procedure when said at least a portion of the entered data or said calculated value is not outside of said target range, less than said minimum value, and/or greater than said maximum value ([0127] describing that the entered data is verified before proceeding with the medical procedure), wherein each entered datum or calculated value is selected from at least one of an entered height of the blood source and an entered weight of the blood source (height and weight being parameters [0132]), wherein said calculated value comprises a body mass index (BMI) of the blood source derived from the entered height of the blood source and the entered weight of the blood source (through use of additional image processing [0140]),
said target range comprises a range of body mass indices, said minimum value comprises a minimum body mass index, and said maximum value comprises a maximum body mass index ([0074-0075] detailing that the calculated BMI takes other variables into account, such as age [0076], and therefore would necessarily comprise a range), and
the controller is configured to compare the body mass index of the blood source to said range of body mass indices, said minimum body mass index, and/or said maximum body mass index ([0074 setting out a plurality of means for calculations based on BMI), wherein
said at least a portion of the entered data includes a hematocrit level of the blood of the blood source, said target range comprises a range of hematocrit levels, said minimum value comprises a minimum hematocrit level, and said maximum value comprises a maximum hematocrit level, and the controller is configured to compare the entered hematocrit level to said range of hematocrit levels, said minimum hematocrit level, and/or said maximum hematocrit level ([0132] and Figs. 7-9), wherein
said calculated value comprises a target collection volume [0132], said target range comprises a range of collection volumes, said minimum value comprises a minimum collection volume, and said maximum value comprises a maximum collection volume, and the controller is configured to compare the target collection volume to said range of collection volumes, said minimum collection volume, and/or said maximum collection volume (Figs. 7-9 showing ranges based on at least volume), wherein
said target collection volume comprises a volume of collected plasma or a combined volume of collected plasma and anticoagulant (volume of raw plasma and plasma plus anticoagulant [0132]), wherein
said calculated value comprises a total blood volume of the blood source [0132], said target range comprises a range of total blood volumes, said minimum value comprises a minimum total blood volume, and said maximum value comprises a maximum total blood volume, and the controller is configured to compare the total blood volume of the blood source to said range of total blood volumes, said minimum total blood volume, and/or said maximum total blood volume (Figs. 7-9 showing ranges based on blood product volumes), wherein
said calculated value comprises a total plasma volume of the blood source [0132], said target range comprises a range of total plasma volumes, said minimum value comprises a minimum total plasma volume, and said maximum value comprises a maximum total plasma volume, and the controller is configured to compare the total plasma volume of the blood source to said range of total plasma volumes, said minimum total plasma volume, and/or said maximum total plasma volume (Figs. 7-9 showing ranges based on blood product volumes).
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.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case, in view of US 20160022952 A1 (Brown).
Regarding claims 16-18, Case teaches the use of a data management system (a server [0116]), but fails to explicitly teach the ability of an operator to adjust the target range, the minimum value, and/or the maximum value.
Brown teaches an automated system for affecting blood parameters [Abstract] and is therefore considered relevant prior art. Brown further teaches an operator (a care provider) may adjust the target range [0024], wherein said adjustments are limited (example ranges being 0-100% and 21-100% [0027].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Case to allow for range and parameter adjustments as taught by Brown in order for a care provider to customize the treatment based on institution guidelines or medical standards as necessary [Brown 0024].
The combined device is therefore considered to fulfill the claim requirements of claims 16-18.
Regarding claim 19, Case teaches the ranges of donor weights are divided into categories [0073], these weights being characteristics of a blood source not previously having blood separated by the system, and as these categories result in placement of the source into specific categories (see Figs. 7-9), the device is considered to fulfill the claim requirements wherein the data transmitted to the controller from the data management system is based at least in part on one or more characteristics of a blood source not previously having blood separated by the blood separation system.
Claim(s) 20-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case.
Regarding claim 20, Case teaches the ranges of donor weights are divided into categories [0073], these weights being characteristics of a blood source not previously having blood separated by the system, and as these categories result in placement of the source into specific categories (see Figs. 7-9), the device is considered to fulfill the claim requirements wherein the controller is configured to automatically adjust the target range, the minimum value, and/or the maximum value based at least in part on one or more characteristics retained by the controller of a plurality of blood sources previously having blood separated by the blood separation system. Furthermore, since the device already performs characterizations of data it would have been obvious to a person of ordinary skill in the art to automatically adjust values as claimed.
Regarding claims 21 and 22, Case teaches the ranges of donor weights are divided into categories [0073], these weights being characteristics of a blood source not previously having blood separated by the system, and as these categories result in placement of the source into specific categories (see Figs. 7-9), the device is considered to fulfill the claim requirements wherein the data transmitted to the controller from the data management system is based at least in part on one or more characteristics of a blood source not previously having blood separated by the blood separation system. Furthermore, since the device already performs characterizations of data it would have been obvious to a person of ordinary skill in the art to automatically adjust values as claimed.
Regarding claim 23, Case fails to teach the controller is configured to request reentry of all of the entered data when said at least a portion of the entered data or said calculated value is outside of said target range, less than said minimum value, and/or greater than said maximum value.
As Case teaches re-entry of individual values [0140] as well as the system being configured to re-measure or re-enter certain values [0140], it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Case to request re-entry of all data upon receipt of errant data to ensure proper care is administered to the patient.
Regarding claim 25, Case teaches the system is configured to require a combination of correct subject-specific information before proceeding with the medical procedure [0127]. As the system prompts re-entry of data outside anticipated ranges [0104], confirming settings and identity [0013, 0123, 0124, 0133], displaying error messages [0122] the system is considered capable of being configured to determine whether an entered datum and/or calculated value outside of said target range, less than said minimum value, and/or greater than said maximum value is acceptable, and proceed with said blood separation procedure when all entered data and/or calculated values outside of said target range, less than said minimum value, and/or greater than said maximum value are determined to be acceptable, wherein the controller is configured to determine that an entered datum and/or calculated value outside of said target range, less than said minimum value, and/or greater than said maximum value is acceptable when the same entered datum and/or calculated value has been reentered and/or confirmed to be correct at least once.
Claim(s) 6, 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case in view of US 12079993 B1 (Lochner et al.).
Regarding claims 6, 8, and 13, Case fails to teach at least a portion of the entered data includes a hemoglobin level, a platelet pre-count, or an extracellular fluid volume of the blood.
Lochner teaches a system for analysis of health parameters [Abstract] wherein a complete blood test includes red blood cells, white blood cells, hemoglobin, hematocrit, and platelets (Col. 26: ll. 28-38).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Case to incorporate the complete blood test of Lochner as an evaluation of health and in use of disorder detection (Lechner Col. 26: ll. 24-26).
By measuring all individual elements of blood, the combined device is considered capable of fulfilling the requirement wherein said at least a portion of the entered data includes a hemoglobin level of the blood of the blood source, said target range comprises a range of hemoglobin levels, said minimum value comprises a minimum hemoglobin level, and said maximum value comprises a maximum hemoglobin level, and the controller is configured to compare the entered hemoglobin level to said range of hemoglobin levels, said minimum hemoglobin level, and/or said maximum hemoglobin level, said at least a portion of the entered data includes a platelet pre-count of the blood of the blood source, said target range comprises a range of platelet pre-counts, said minimum value comprises a minimum platelet pre-count, and said maximum value comprises a maximum platelet pre-count, and the controller is configured to compare the entered platelet pre-count to said range of platelet pre-counts, said minimum platelet pre-count, and/or said maximum platelet pre-count, said calculated value comprises an extracellular fluid volume of the blood source, said target range comprises a range of extracellular fluid volumes, said minimum value comprises a minimum extracellular fluid volume, and said maximum value comprises a maximum extracellular fluid volume, and the controller is configured to compare the extracellular fluid volume of the blood source to said range of extracellular fluid volumes, said minimum extracellular fluid volume, and/or said maximum extracellular fluid volume.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bene US 20130317850 A1 discloses a system for monitoring a blood separation procedure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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