!DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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) 35-41,43-48 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Case US 2020/0222617, hereafter Case, provided in the IDS.
Regarding claim 35, Case discloses a blood circuit (fig. 1) including a withdrawal line (para. 0024 where an apheresis procedure is detailed and a needle inserted into the user. Thus the blood being removed through the needle during apheresis is interpreted to be the withdrawal line), the withdrawal line configured to transmit blood from vasculature of a patient (para. 0024, for the reasons detailed directly above)); an adjustable cuff (cuff 12, inflated by pump (per para. 0014)) configured to receive a portion of a limb of a patient (para. 0012), wherein: the cuff is configured to selectively engage with the limb to apply an external force to the limb and correspondingly inhibit flow of blood within the vasculature of the limb (para. 0006-0008). The examiner notes that per these paragraph citations, the cuff is controlled to be inflated and/or deflated based on data from sensors, where said sensors may include a sensor for measuring blood pressure (per para. 0006 and 0008). Also per paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. Per paragraph 0025, the same sensor is able to determine “flow/pressure of the vein”.
As detailed above under the same rejection in view of paragraphs 0006-0008 and 0016, Case further discloses the cuff is adjustable to change the force applied to the limb and correspondingly change flow of blood from the vasculature the blood circuit. Case discloses and a controller in communication with the cuff and configured to operate the cuff to adjust the force applied to the limb of the patient (para. 0016, 0025), wherein: the controller is configured to monitor venous flow rate using one or more physiological sensors (abstract, para. 0025, sensors 28 and 30); and the controller is configured to operate the cuff to adjust the force applied to the limb based on changes in the monitored venous flow rate (para. 0025), including: the controller is configured to operate the cuff and increase the force applied to the limb based on a decrease in the monitored venous flow rate; or the controller is configured to operate the cuff and decrease the force applied to the limb based on an increase in the monitored venous flow rate (para. 0025). The examiner notes that as detailed under para. 0025 and figure 3, the controller monitors the flow pressure/rate of the vein and checks the sensor values. If the value is good nothing is changed, however if the value is bad, the cuff is adjusted. In the case of para. 0025 if the flow is lower than an acceptable value the cuff is inflated (thus increasing force on the user) to raise the flow and as such Case reads to the claimed limitation.
Regarding claim 36, Case discloses, the blood filtration system of claim 35, wherein the cuff is configured to inhibit distal blood flow in the vasculature and correspondingly redirect the blood flow into the withdrawal line. The examiner notes that as detailed under the rejection of claim 35, the cuff of Case inhibits blood flow and blood is removed from a patient through a withdraw line. As such it is interpreted that the device of Case reads to the claimed limitation. Should applicant disagree the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature and further discloses a withdrawal line through which blood is removed, Case is understood to teach the required structure and thus reads to the claimed function of “inhibit distal blood flow in the vasculature and correspondingly redirect the blood flow into the withdrawal line”. As such Case reads to the claimed limitation.
Regarding claim 37, Case discloses The blood filtration system of claim 35, wherein the cuff is configured to inhibit venous return within the limb. Per paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb”. As such Case reads to the claimed limitation.
Regarding claim 38, Case discloses the blood filtration system of claim 35, wherein: the cuff is configured to inhibit venous return within the limb; and the cuff is configured to permit arterial inflow into the limb. Per paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb” and “permit arterial inflow”. As such Case reads to the claimed limitation.
Regarding claim 39, Case discloses the blood filtration system of claim 35, wherein: the controller is configured to compare the monitored venous flow rate with a venous flow rate threshold; and the controller is configured to operate the cuff to adjust the force applied to the limb based on the comparison of the monitored venous flow rate with the venous flow rate threshold (para. 0025, figure 3). Per paragraph 0025, the controller monitors the flow rate/pressure and then adjusts the cuff, as needed, to keep the rate/pressure at an acceptable level.
Regarding claim 40, Case discloses the blood filtration system of claim 35, wherein the withdrawal line is configured for communication with a first portion of the vasculature and the physiological sensors are configured to determine the venous flow rate of a second portion of the vasculature. The examiner notes that sensor (30) can be seen in figures 1 and 2 as being incorporated or within the cuff (see para. 0015,0017 disclosing various location in which sensor can be located). The examiner notes that as the needle is separate from the cuff and is positioned, preferably, in the crook of the elbow, the withdraw line and sensor would be located at different locations within the vasculature and thus it is interpreted that the withdraw line is in communication with a first portion and the sensor is at a second portion of the vasculature.
Regarding claim 41, Case discloses the blood filtration system of claim 35, further comprising the one or more physiological sensors. The examiner notes that as detailed under the rejection of claim 35, the device may comprise sensors (28 and 30).
Regarding claim 43, Case discloses the blood filtration system of claim 35, wherein: the one or more physiological sensors are configured to determine a venous pressure of the patient (para. 0017); the controller is in communication with the one or more physiological sensors (para. 0025); and the controller is configured to operate the cuff to adjust the force applied to the limb in correspondence with the determined venous pressure (para. 0025).
Regarding claim 44, Case discloses the blood filtration system of claim 43, wherein the controller is configured to adjust a cuff pressure corresponding to the force applied to the limb such that the cuff pressure is greater than or equal to the venous pressure (para. 0025, where the cuff pressure (inflation of the cuff) is adjusted based on the sensor parameters as compared to an acceptable level). In the example given, when the flow rate/pressure falls below a desired level the cuff is inflated such that the flow rate/pressure is increased back to the desired level. As such Case reads to the claimed limitation. Should applicant argue that the interpretation provided above is incorrect, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Case disclose a blood collection device including a cuff that increases or decreases in pressure by use of a controller, such that the corresponding flow rate/pressure returns to a desired value, Case is understood to teach the required structure and thus reads to the claimed function of “adjusting the cuff pressure such that the cuff pressure is greater than or equal to the venous pressure”. As such Case reads to the claimed limitation.
Regarding claim 45, Case discloses the blood filtration system of claim 35, wherein the controller is configured to operate the cuff to allow arterial inflow into the limb in correspondence with inhibiting venous return from the limb. Per paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb” and “permit arterial inflow”. As such Case reads to the claimed limitation.
Regarding claim 46, Case discloses the blood filtration system of claim 45, wherein the one or more physiological sensors are configured to determine one or more of a venous pressure or an arterial pressure of the patient (para. 0017), wherein the controller is configured to adjust the force applied to the limb to correspondingly apply a pressure that is greater than or equal to the venous pressure (para. 0025, where the cuff pressure (inflation of the cuff) is adjusted based on the sensor parameters as compared to an acceptable level). In the example given, when the flow rate/pressure falls below a desired level the cuff is inflated such that the flow rate/pressure is increased back to the desired level. As such Case reads to the claimed limitation.
Regarding claim 47, Case discloses the blood filtration system of claim 46, wherein the controller is configured to adjust the force applied to the limb to correspondingly apply a pressure that is less than or equal to one or more of systolic arterial pressure or diastolic arterial pressure (para. 0016). Per para. 0016 Case discloses that the cuff is initially inflated to a level that stops blood flow through the blood vessels of the cuffed arm. The cuff is then deflated by the controller via the deflation valve of the device to a pressure below the systolic pressure so that blood once again flows through the arm. AS such Case reads to the claimed limitation.
Regarding claim 48, Case discloses the blood filtration system of claim 35, wherein the limb of the patient includes an arm of the patient (para. 0013).
Claim Rejections - 35 USC § 102/103
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) 42 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Case.
Regarding claim 42, Case discloses the blood filtration system of claim 35, wherein: the controller is configured to operate the cuff and increase the force applied to the limb based on a decrease in the monitored venous flow rate; and the controller is configured to operate the cuff and decrease the force applied to the limb based on an increase in the monitored venous flow rate. The examiner notes that as detailed under the rejection of claim 35, the device of Case was found to teach the limitations of inflating the cuff (thus increasing force applied to the limb) if the flow rate decreased below a desired amount. The examiner further notes that Case repeatedly teaches that the controller controls deflation of the cuff by controlling a deflation valve (abstract, para. 0006, 0014, 0016). Therefore the examiner notes that in the case that the “bad” value of flow rate/pressure is too high, as compared to too low in the example provided in para. 0025, the system would provide the opposite function and thus operate the deflation valve to deflate the cuff and thus decrease flow rate/pressure. As such Case reads to the claimed invention.
Should applicant argue that Case does not specifically teach the operation of the cuff to decrease the force applied to the limb based on an increased flow rate detected, the examiner notes that Case teaches that the controller controls the cuff to inflate or deflate (abstract, para. 0006, 0014, 0016), where control of the rate is monitored by a sensor (para. 0025). When the value is not a “good” value, thus out of the desired range, the device is operated to fix this sensed value to a desired range. The examiner notes that while the example given is directed toward too low of a level and thus the cuff pressure is increased, the examiner notes that Case clearly details that the controller can deflate the cuff as desired to reduce the cuff pressure thus allowing more flow. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to configure the controller of Case to decrease the pressure in the cuff to therefore lower the flow rate to within an accepted range as Case teaches that the controller is capable of inflating or deflating the cuff, monitoring the flow and pressure parameters and adjusting a non-acceptable parameter through the cuff such that the value become acceptable. Doing so would merely involve applying a known technique (controlling a cuff by inflation and deflation) to a known device (blood collection system) ready for improvement to yield predictable results (altering of non-acceptable parameters into an acceptable range) and thus a prima facie case of obviousness exists.
Claim Rejections - 35 USC § 103
The examiner notes that the statutory basis for 35 U.S.C 103 was provided under the section with the heading “Claim Rejections - 35 USC § 102/103”. See said section for further details.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case in view of Hill et al. US 20030216775 A1 hereafter Hill.
Regarding claim 49 The blood filtration system of claim 35, wherein the limb of the patient may be an arm or other limb (para. 0012, where an other limb may be interpreted to be a leg since an arm is disclosed). However, there is no specific disclosure that the “other” limb is a leg of the patient.
Hill teaches a device for controlling blood flow in a patient and is thus considered analogous to the claimed invention. Hill teaches that the device comprises a compression member, such as a cuff, that compresses an appropriate limb such as an arm or leg to achieve desired compression on a patient’s body (para. 0032). Said compression allows for controlling flow of blood (para. 0015). Therefore as Case teaches the cuff and blood system may be applied to an arm or other limb, and Hill teaches that blood flow controlling devices such as cuffs may be applied to arms and legs, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the cuff of Case on the leg of a patient, since Hill teaches that arms and legs are both suitable limbs for placing a blood flow controlling cuff. Doing so merely involves combining prior art elements according to known methods (applying a limb cuff to an arm or leg) to yield predictable results (controlling of blood flow) and thus a prima facie case of obviousness exists.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ganske et al. US 20170273695 A1, disclosing a system comprising a cuff, where said cuff’s inflation is controlled by a controller.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781