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 .
Status of the Claims
The amendment filed 01/05/2026 has been entered. Claims 1-20 are pending and under consideration.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Applicant argues that the previously cited prior art reference Bosetto (US 5938938 A) and Levin ( US 4710164 A) in combination does not teaches the claim 1 because Bosetto emphasizes the “extreme variability” of a patient capacity to withstand treatment. Specifically, the applicant argues that Bosetto suggest automated means are insufficient for making relevant decisions regarding patient reaction, instead requiring a manual operator to response to alarm and determine adjustment. The applicant concludes that Bosetto relies on manual rather than automated control to minimize or prevent donor reactions.
This is not found persuasive. Contrary to applicant’s conclusion above, Bosetto explicitly discloses an “automated dialysis method and apparatus” (abstract) configured to regulate treatment session without constant operator intervention, namely the operation of the automatic dialysis apparatus. Specifically, Bosetto teaches an automatic dialysis apparats and its standard operation (figures 1-4 and col 7 lines 10-50) comprising sensors (figure 4, sensor for BV and WL) and control unit (figure 4, 21 and 22) comprising an estimator and a controller configured to b. monitoring at least one donor parameter during the blood draw by the automated blood draw device (monitoring patient parameter by sensors “the group of sensors 12 detects the first samples of the patient parameter BV and WL (items 5, 6)”); c. analyzing the at least one donor parameter by the automated blood draw device ( analyzing the patient parameter by control unit “and sends them, with the machine parameters CD, WLR and the blood sodium level calculated by the blood sodium level estimator 26, to the estimator 22 of the parameters of the dialysis-unit/patient model. The estimator 22 thus calculates the control coefficient values 21 which link the actual WLR and CD to the errors relating to BV and WL and (item 7)”); e. adjusting by the automated blood draw device at least one feature of the blood draw so that the reaction in the donor can be minimized or prevented if the reaction is determined to be probable (the control unit adjust machine parameter based on the calculation “communicates them to the controller 21 which corrects the machine parameters CD and WLR sent to the dialysis group 20 (item 8).”). Bosetto teaches the standard operation above is performed by the control unit, dialysis groups and sensors without involving operator input except when initial parameter values are needed to initiate the session or when measured patient parameter exceed the permitted intervals (col 7 lines 35-45). Applicants points to Bosetto’s alarms and manual override of the operator as evidence of manual control. However, the alarm triggers and operator’s involvement to decide to continue the automatic dialysis or interrupt the automatic treatment and manually terminate the session when the system determines the parameter exceed a “permitted interval” (col 7 lines 36-56) which does not negate the automated system during standard operation (the parameter within “permitted interval”) above, and 103 combination was made to modify the standard operation.
For the reasons above, applicant’s argument is not persuasive, but applicant's amendment necessitated the new ground(s) of rejection presented in this Office action
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 16, “at least one adjustment mechanism modifies the position of a blood collection container”, which will be interpreted as element illustrated in [0028] such as a telescoping member.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bosetto et al (US 5938938 A) in view of Levin et al (US 4710164 A)
Regarding claim 1, Bosetto substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A method (figures 1-4 and col 7 lines 10-50) for reducing donor reactions during a blood donation using an automated blood draw device (figure 4, apparatus 10), the device including a controller (figure 4, control unit), the method comprising:
a. initiating a blood draw (col 3 lines 10-30 and figure 1, the dialysis session start blood draw with step 5);
b. monitoring at least one donor parameter during the blood draw by the automated blood draw device (figures 1 and 4 and col 7 lines 10-50, monitoring patient parameter by sensors 12, for example measure WL and BV in step 5 and 6);
c. analyzing the at least one donor parameter by the automated blood draw device (figures 1 and 4 and col 7 lines 10-50, analyzing the patient parameter by control unit, for example calculate operating values of WLR and CD in step 7);
d. predicting the probability of a reaction in a donor by the automated blood draw device;
e. adjusting by the automated blood draw device at least one feature of the blood draw so that the reaction in the donor can be minimized or prevented if the reaction is determined to be probable (figures 1 and 4 and col 7 lines 10-50 adjusting machine parameter based on the calculation, for example correct WLR and CD in step 8); and
f. performing steps b-e until the blood draw is complete (col 3 lines 10-30).
Bosetto does not expressly teach the method comprising
d. predicting the probability of a reaction in a donor by the automated blood draw device;
In the same field of endeavor, namely automated hemodialysis control, Levin teaches a method comprising predicting the probability of a reaction in a donor (col 2 lines 1-25, monitoring and comparing patient blood pressure with first systolic and/or diastolic alarm limit).
Therefore, 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 Bosetto, to incorporate the teachings of Levin, and provides the claimed method for the purpose of reducing risk of potential complications during a dialysis procedure, such as a hypotensive episode as taught by Levin (col 1 lines 5-10).
Regarding claim 2, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination further teaches wherein at least one baseline donor parameter is inputted into the automated blood draw device (Bosetto; col 7 lines 15-35, operator inputting variation intervals permitted during the treatment (item 1) for weight loss and weight loss rate).
Regarding claim 3, Bosetto, as modified by Levin, teaches the method of claim 2.
The combination further teaches wherein the at least one baseline donor parameter is a range that includes minimum and maximum values (Bosetto; col 3 lines 10-15 “the permitted variation intervals for the few controlled variables during the treatment, with the minimum permitted value and the maximum permitted value. In particular, the permitted variation intervals are stored for the reduction in the blood volume BV (item 1), for the weight loss WL (item 2), for the weight loss rate WLR (item 3) and for the conductivity CD of the dialysis fluid (item 4).”).
Regarding claim 4, Bosetto, as modified by Levin, teaches the method of claim 2.
The combination further teaches wherein the analyzing the at least one parameter includes comparing the measured at least one parameter to the at least one baseline donor parameter (Bosetto; figure 1 col 3 lines 10-30 col 7 lines 10-15, compare measured values of BV and WL with allowed value intervals).
Regarding claim 5, Bosetto, as modified by Levin, teaches the method of claim 3.
The combination further teaches wherein the predicting the probability of the reaction includes determining if the at least one parameter is outside of the at least one baseline donor parameter range (Levin; col 2 lines 1-25, determine if the patient blood pressure goes below first systolic and/or diastolic alarm limit).
Regarding Claim 9, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination does not teach wherein the at least one donor parameter includes at least one of pulse, temperature, blood pressure, heart rate, sweat, facial expression, and nerve conduction
In the same field of endeavor, namely automated hemodialysis control, Levin teaches wherein the at least one donor parameter includes at least one of pulse, temperature, blood pressure, heart rate, sweat, facial expression, and nerve conduction (col 1 lines 55-67, heart rate).
Therefore, 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 Bosetto, as modified by Levin, to incorporate the teachings of Levin and provide the at least one donor parameter as claimed for the purpose of reducing risk of potential complications during a dialysis procedure, such as a hypotensive episode as taught by Levin (col 1 lines 5-10).
Regarding Claim 10, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination further teaches wherein the monitoring at least one patient parameter including using at least one sensors (Bosetto; figure 4 and col 3 lines 45-65, sensors 12 for measuring patient parameters BV and WL).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bosetto et al (US 5938938 A) in view of Levin et al (US 4710164 A), and in further view of Granzow et al (US 4560472 A).
Regarding Claim 6, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination does not teach the wherein the adjusting at least one feature of the blood draw includes modifying the position of a blood collection container.
In the same field of endeavor, namely peritoneal dialysis apparatus, Granzow teaches the wherein adjusting at least one feature of the blood draw includes modifying the position of a blood collection container (col 13 lines 34-40 “support column 58 may be raised or lowered relative to housing 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 have modified Bosetto, as modified by Levin, to incorporate the teachings of Granzow and provide the claimed method for the purpose of adjust the pressure inside the collection container, as taught by Granzow (col 13 lines 34-40), which adjust blood withdrawal rate. For example, increasing the vertical position of the blood-collection container to approximate the donor’s position reduces the pressure differential between the donor and the container, thereby reducing the blood-withdrawal rate.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bosetto et al (US 5938938 A) in view of Levin et al (US 4710164 A), and in further view of Tamari (US 5215450 A).
Regarding Claim 7, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination does not teach wherein the adjusting at least one feature of the blood draw includes tightening a clamp on a flow line of the blood draw device.
In the same field of endeavor, namely Innovative Pumping System For Peristaltic Pumps, Tamari teaches wherein the adjusting at least one feature of the blood draw includes tightening a clamp on a flow line of the blood draw device (col 25 line 25- col 26 line 25 and figure 1a, clamp 16 occlude reciprocating line 14 in order to provide direct control of pressure and flow rate to the patient).
Therefore, 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 Bosetto, as modified by Levin, to incorporate the teachings of Tamari and provide the claimed clamp in order to control blood withdrawal rate as taught by Tamari (col 25 line 25- col 26 line 25).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bosetto et al (US 5938938 A) in view of Levin et al (US 4710164 A), and in further view of Case et al (US 20130190674 A1).
Regarding claim 8, Bosetto, as modified by Levin, teaches the method of claim 1.
The combination does not teach wherein the adjusting at least one feature of the blood draw includes decreasing the amount of citrate returned to the donor.
In the same field of endeavor, namely using physiological data in a medical device, Case teaches wherein the adjusting at least one feature of the blood draw includes decreasing the amount of citrate returned to the donor ([0049] medical device adjust a citrate infusion rate).
Therefore, 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 Bosetto, as modified by Levin, to incorporate the teachings of Case and provide the claimed method for the purpose of reducing risk of an adverse reaction as citrate-based anticoagulant may result in an increased pulse rate and/or a decreased blood pressure as taught by Case ([0019]).
Claims 11-15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Behague (US 7879000 B2 A) in view of Bosetto et al (US 5938938 A) and Levin et al (US 4710164 A).
Regarding claim 11, Behague teaches a system for performing a blood draw procedure comprising:
i. a vein access device (figure 2 and col 3 lines 27-31, collection device 3 needle 42 allowing access to the vein);
ii. a fluid circuit (figures 1 and 2, bag system 2 including flexible tubes 6, 8 and connector 7 and the tubes connected to needle 42) comprising tubing connected to the vein access device and at least one blood collection container (figure 1, collection bag 5) for collecting blood and/or blood components;
iii. at least one donor parameter monitoring device (figures 3 and col 5 lines 10-25, sensor 24 and 25 configured to detect the presence of blood within fluid circuit and checks presence of anticoagulant);
iv. at least one adjusting mechanism (figure 3 and col 4 lines 55-67, peristatic pump 22 with control electronics 23 adjust speed of rotation of peristaltic pump 22 in order to supply the appropriate flow of solution);
v. a programmable user interface;
vi. a controller configured to communicate with the at least one donor parameter monitoring device, the at least one adjusting mechanism, and the programmable user interface; wherein the controller is configured to:
a. initiate the blood draw;
b. monitor at least one donor parameter during the blood draw;
c. analyze at least one donor parameter;
d. predict the probability of a reaction in a donor;
e. adjust at least one feature of the blood draw so that a donor reaction can be minimized or prevented if a reaction is determined to be probable; and
f. perform steps b-e until the blood draw is complete.
v. a programmable user interface;
Behague does not teach the system comprising:
v. a programmable user interface
vi. a controller configured to communicate with the at least one donor parameter monitoring device, the at least one adjusting mechanism, and the programmable user interface; wherein the controller is configured to:
a. initiate the blood draw;
b. monitor at least one donor parameter during the blood draw;
c. analyze at least one donor parameter;
d. predict the probability of a reaction in a donor;
e. adjust at least one feature of the blood draw so that a donor reaction can be minimized or prevented if a reaction is determined to be probable; and
f. perform steps b-e until the blood draw is complete.
In the same field of endeavor, namely an automated dialysis method and apparatus, Bosetto teaches an automatic dialysis machine and method (figures 1-4 and col 7 lines 10-50, apparatus 10) comprising
v. a programmable user interface (figure 4, I/O device 32, system operator interface 14 and memory 15)
vi. a controller (figure 4, control unit 13 is configured to communicate with the at least one sensor 12, dialysis unit, and the user interface) configured to communicate with the at least one donor parameter monitoring device, the at least one adjusting mechanism, and the programmable user interface; wherein the controller is configured to:
a. initiate the blood draw (col 3 lines 10-30 and figure 1, dialysis session start blood draw with step 5);
b. monitor at least one donor parameter during the blood draw (figures 1 and 4 and col 7 lines 10-50, monitoring patient parameter by sensors 12, for example measure WL and BV in step 5 and 6);
c. analyze at least one donor parameter (figures 1 and 4 and col 7 lines 10-50, analyzing the patient parameter by control unit, for example calculate operating values of WLR and CD in step 7);
e. adjust at least one feature of the blood draw so that a donor reaction can be minimized or prevented if a reaction is determined to be probable (figures 1 and 4 and col 7 lines 10-50 adjusting machine parameter based on the calculation, for example correct WLR and CD in step 8); and
f. perform steps b-e until the blood draw is complete (col 3 lines 10-30).
Therefore, 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 Behague to incorporate the teachings of Bosetto and provides the controller and monitoring device as claimed for the purpose of providing automated tailored procedure for individual patient and to reduce risk of potential complication during blood withdrawal including hypotension phenomena as taught by Bosetto (abstract and col 1 lines 10-25).
The combination is still silent as to the controller is configured to: d. predict the probability of a reaction in a donor;
In the same field of endeavor, namely automated hemodialysis control, Levin teaches a method comprising predicting the probability of a reaction in a donor (col 2 lines 1-25, monitoring and comparing patient if measured blood pressure goes below first systolic and/or diastolic alarm limit).
Therefore, 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 Behague, as modified by Bosetto, to incorporate the teachings of Levin, and provides the claimed method for the purpose of reducing risk of potential complications during a dialysis procedure, such as a hypotensive episode as taught by Levin (col 1 lines 5-10).
Regarding Claim 12, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination does not teach wherein at least one baseline donor parameter is inputted into the system.
In the same field of endeavor, namely automated hemodialysis control, Bosetto wherein at least one baseline donor parameter is inputted into the blood draw device (Bosetto; col 7 lines 15-35, operator inputting variation intervals permitted during the treatment (item 1) for weight loss and weight loss rate)
Therefore, 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 Behague, as modified by Bosetto and Levin, to incorporate the teachings of Bosetto and provides the controller as claimed for the purpose of providing automated tailored procedure for individual patient and to reduce risk of potential complication including hypotension phenomena as taught by Bosetto (abstract and col 1 lines 10-25).
Regarding Claim 13, Behague, as modified by Bosetto and Levin, teaches the system of claim 12.
The combination further teaches wherein the at least one baseline donor parameter is a range that includes minimum and maximum values (Bosetto; col 3 lines 10-15 “the permitted variation intervals for the few controlled variables during the treatment, with the minimum permitted value and the maximum permitted value”).
Regarding Claim 14, Behague, as modified by Bosetto and Levin, teaches the system of claim 12.
The combination further teaches wherein the controller is configured to analyze at least one parameter by comparing a measured at least one parameter to the at least one baseline donor parameter (Bosetto; figure 1 col 3 lines 10-30 and col 7 lines 10-15, compare measured values of BV and WL with allowed value intervals)
Regarding Claim 15, Behague, as modified by Bosetto and Levin, teaches the system of claim 13.
The combination further teaches wherein the controller is configured to predict the probability of a reaction includes determining if the at least one parameter is outside of the at least one baseline donor parameter range (Levin; col 2 lines 1-25, determine if the patient blood pressure goes below first systolic and/or diastolic alarm limit).
Regarding Claim 18, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination further teaches wherein the at least one adjustment mechanism includes a pump on an anticoagulant line (Behague; figure 3 and col 4 lines 55-67, peristatic pump 22 on tubing 8 that supplies anticoagulant from bag 4)
Regarding Claim 19, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination does not teach wherein the at least one donor parameter includes at least one of pulse, temperature, blood pressure, heart rate, sweat, facial expression, and nerve conduction.
In the same field of endeavor, namely automated hemodialysis control, Levin teaches at least one donor parameter includes at least one of pulse, temperature, blood pressure, heart rate, sweat, facial expression, and nerve conduction (Levin; col 1 lines 55-67, heart rate).
Therefore, 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 Behague, as modified by Bosetto and Levin, to incorporate the teachings of Levin and provide the at least one donor parameter for the purpose of reducing risk of potential complications during a dialysis procedure, such as a hypotensive episode as taught by Levin (col 1 lines 5-10).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Behague (US 7879000 B2 A) in view of Bosetto et al (US 5938938 A) and Levin et al (US 4710164 A), and in further view of Granzow et al (US 4560472 A).
Regarding Claim 16, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination does not teach the at least one adjust mechanism modified the position of a blood collection container.
In the same field of endeavor, namely peritoneal dialysis apparatus, Granzow teaches the at least one adjust mechanism modified the position of a blood collection container (figure 4, col 13 lines 34-40 column 58 is consist of two fixed length shafts, which can be raised or lowered relative to the housing 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 have modified Behague, as modified by Bosetto and Levin, to incorporate the teachings of Granzow and provide the claimed adjustment mechanism for the purpose of adjust the pressure inside the collection container, as taught by Granzow (col 13 lines 34-40), thereby adjusting blood withdrawal rate. For example, increasing the vertical position of the blood-collection container to approximate the donor’s position reduces the pressure differential between the donor and the container, thereby reducing the blood-withdrawal rate.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Behague (US 7879000 B2) in view of Bosetto et al (US 5938938 A) and Levin et al (US 4710164 A), and in further view of Tamari (US 5215450 A).
Regarding Claim 17, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination does not teach wherein the at least one adjustment mechanism includes a clamp on a flow line of the blood draw device.
In the same field of endeavor, namely Innovative Pumping System For Peristaltic Pumps, Tamari teaches wherein the at least one adjustment mechanism includes a clamp on a flow line of the blood draw device (col 25 line 25- col 26 line 25 and figure 1a, clamp 16 occlude reciprocating line 14 in order to provide direct control of pressure and flow rate to the patient).
Therefore, 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 Bosetto, as modified by Levin, to incorporate the teachings of Tamari and provide the claimed clamp in order to control blood withdrawal rate as taught
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Behague (US 7879000 B2) in view of Bosetto et al (US 5938938 A) and Levin et al (US 4710164 A), and in further view of Case et al (US 20130190674 A1).
Regarding Claim 20, Behague, as modified by Bosetto and Levin, teaches the system of claim 11.
The combination does not teach wherein the at least one donor parameter monitoring device includes at least one of a blood pressure cuff, a pulse oximeter, an electrocardiogram, and a thermometer.
In the same field of endeavor, namely using physiological data in a medical device, Case teaches wherein the at least one donor parameter monitoring device includes at least one of a blood pressure cuff, a pulse oximeter, an electrocardiogram, and a thermometer ([0027] measurement device 114 may include a blood pressure cuff).
Therefore, 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 Behague, as modified by Bosetto and Levin, to incorporate the teachings of Case and provide the at least one donor parameter monitoring device as claimed for the purpose of accurately measures the blood pressure of patient during procedure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781