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 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: “biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system” in claims 21-23, 26-38 and “biometric verification system” in claims 39-40.
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.
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) 21, 23-25, 31, 35-36, and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (US 3,682,172) in view of Ballantyne et al. (US 2013/0317837), both submitted in the December 18, 2023 IDS.
Regarding claim 21, Freedman discloses a parabiotic dialysis system (see Fig. 1), the system comprising: a device having a first side 24 and a second side 30, the device including a semipermeable membrane 44, 46 between the first side and the second side (see Fig. 1) that is structurally configured for permitting passage of one or more molecules through (see Fig. 1, purpose of membrane in dialysis); a first extracorporeal circuit 16, 18 including one more first fluid connectors for connecting the first side of the device to the vascular system of a first animal 10; a second extracorporeal circuit 27, 32 including one or more second fluid connectors for connecting the second side of the device to the vascular system of a second animal 12 (see Fig. 1); a first pump 29, 35 in fluid communication with at least one of the first and second extracorporeal circuits; and a driver mechanically coupled to the first pump, the driver configured to drive the first pump using energy from an energy source (see col. 4, l. 51-col. 5, l. 4).
Freedman does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As Freedman discloses two patients and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that Freedman and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 23, Freedman and Ballantyne disclose the system of claim 21, and as Freedman discloses a diseased human (see col. 2, lines 44-45) and normal human or animal (see col. 2, lines 46-47) being the first animal and second animal, and Freedman and Ballantyne together disclose the biometric verification system to identify the first animal and the second animal as the ones who are being treated by the system, then the verification would confirm the compatibility between the first animal and the second animal as they have already been decided as compatible in being the diseased human and the normal human or animal.
Regarding claim 24, Freedman and Ballantyne disclose the system of claim 23, but as disclosed above do not teach the biometric verification system is in communication with a database containing information regarding one or more of the first animal and the second animal.
Ballantyne discloses the monitoring client/biometric verification system is in communication with a database containing information regarding the patient (see par. 351, 106-109) and it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to then have the monitoring client/biometric verification system is in communication with a database containing information regarding the patient to allow the system to alert the user to modifications that may be indicated based on the patient’s allergies, existing medications, or other patient-condition parameters, preferably minimizing the amount of typed input from a user (see par. 43).
Regarding claim 25, Freedman and Ballantyne disclose the system of claim 21, and Ballantyne further discloses the biometric verification system includes a retinal scanner (see par. 351).
Regarding claim 31, Freedman and Ballantyne disclose the system of claim 21 and Freedman further discloses the first animal is a kidney patient (see col. 13, lines 33-36) and wherein the one or molecules include at least one of metabolic waste and excess water (see col. 11, lines 58-67).
Regarding claim 35, Freedman and Ballantyne disclose the system of claim 21 and Freedman further discloses a second pump (see Fig. 1, first pump 29 and second pump 35),wherein the first pump is in fluid communication with the first extracorporeal circuit and the second pump is in fluid communication with the second extracorporeal circuit (see Fig. 1).
Regarding claim 36, Freedman and Ballantyne disclose the system of claim 35 and Freedman further discloses one or more of the first pump, the second pump, and the driver are configured to establish a predetermined pressure gradient between the first and second extracorporeal circuits (see Fig. 1, the setup/settings of the pumps and driver would lead to the pressure gradient between the first and second extracorporeal circuits allowing for ultrafiltration to occur at membranes 44, 46 and, consequently, it would be predetermined by this setup/settings) and this predetermined pressure gradient would implement a predetermined molecular transfer between the first extracorporeal circuit and the second extracorporeal circuit due to the pump speeds and membrane configuration.
Regarding claim 39, Feedman discloses a method for parabiotic dialysis (see Abstract), the method comprising: moving blood of the first animal 10 through a first extracorporeal circuit 16, 18 including a first fluid connector that connects a first side of a device to the vascular system of the first animal (see Fig. 1), the device including a semipermeable membrane 44, 46 structurally configured for permitting passage of one or more molecules therethrough (see col. 5, lines 24-35); moving the one or more molecules through the device to a second extracorporeal circuit 27, 32 including a second fluid connector that connects a second side of the device to the vascular system of the second animal 12 (see Fig. 1).
Freedman does not disclose using a biometric verification system to identify one or more of a first animal and a second animal to determine a permission for use of a parabiotic dialysis system; upon receipt of permission from the biometric verification system, moving the blood, and upon receipt of permission from the biometric verification system, moving the one or more molecules.
Ballantyne discloses a system for patient care including cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As permission allows for use of system and use of the system requires moving blood and the one or more molecules, the moving of the blood and one or more molecules would be upon receipt of permission from the biometric system.
Regarding claim 40, Freedman discloses method for parabiotic dialysis (see Abstract), the method comprising: connecting a first side 24 of a device to the vascular system of a first animal 10 to form a first extracorporeal circuit (see Fig. 1), the device including a semipermeable membrane 44, 46 structurally configured for permitting passage of one or more molecules therethrough (see Fig. 1, col. 5, lines 24-35); connecting a second side 30 of the device to the vascular system of a second animal 12 to form a second extracorporeal circuit (see Fig. 1); using a biometric verification system to identify and determine a permission for use for each of the first animal and the second animal; and when it is determined by the biometric verification system that there is permission for use for each of the first animal and the second animal, moving blood of the first animal through the first extracorporeal circuit thereby moving the one or more molecules from the blood of the first animal through the semipermeable membrane to the second extracorporeal circuit.
Freedman does not disclose using a biometric verification system to identify and determine a permission for use for each of the first animal and the second animal; and when it is determined by the biometric verification system that there is permission for use for each of the first animal and the second animal, moving the blood and the one or more molecules.
Ballantyne discloses a system for patient care including cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow each patient to communicate with a remote care provider and/or to confirm the identify of each patient using retinal scans prior to commencing a treatment, so as to ensure the right patients receive the treatment, such as disclosed by Ballantyne. As permission allows for use of system and use of the system requires moving blood and the one or more molecules, the moving of the blood and one or more molecules would be upon receipt of permission from the biometric system.
Claim(s) 21-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view Tenenbaum et al. (US 2017/0065757).
Regarding claim 21, Freedman discloses a parabiotic dialysis system (see Fig. 1), the system comprising: a device having a first side 24 and a second side 30, the device including a semipermeable membrane 44, 46 between the first side and the second side (see Fig. 1) that is structurally configured for permitting passage of one or more molecules through (see Fig. 1, purpose of membrane in dialysis); a first extracorporeal circuit 16, 18 including one more first fluid connectors for connecting the first side of the device to the vascular system of a first animal 10; a second extracorporeal circuit 27, 32 including one or more second fluid connectors for connecting the second side of the device to the vascular system of a second animal 12 (see Fig. 1); a first pump 29, 35 in fluid communication with at least one of the first and second extracorporeal circuits; and a driver mechanically coupled to the first pump, the driver configured to drive the first pump using energy from an energy source (see col. 4, l. 51-col. 5, l. 4).
Freedman does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Tenenbaum discloses a dialysis system (see par. 1) with a biometric verification system configured to identify a user of the dialysis system to determine a permission for use of the system (see par. 6, 8, 73-74). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the dialysis system of Freedman include a biometric system like that of Tenenbaum allowing for identification of the user/patient of the system and allowing for the user to control the machine without touching the machine, thereby eliminating the need for the user to wear gloves and/or reducing the risk of facilitating the spread of infection that is more likely to occur when using a touch-based input device (see Tenenbaum, par. 67).
Regarding claim 22, Freedman and Tenenbaum disclose the system of claim 21 and while Tenenbaum discloses a controller in communication with the biometric verification system and one or more other components of the system (see par. 72-73) but does not disclose the controller configured to prevent or stop operation of the one or more other components of the system upon receipt of a predetermined signal form the biometric verification system.
Tenenbaum discloses control buttons that can be operated by a user to terminate dialysis treatment (see par. 69) as well as the recognize and process voice commands to control the dialysis treatment (see par. 72-74). It would have been obvious to a person having ordinary skill in the art to have the termination of dialysis treatment be via recognized and processed voice commands, as Tenenbaum teaches termination of treatment being a control and allowing for the user to control the machine without touching the machine, thereby eliminating the need for the user to wear gloves and/or reducing the risk of facilitating the spread of infection that is more likely to occur when using a touch-based input device (see Tenenbaum, par. 67). This would cause the controller to be configured to prevent or stop operation of the one or more other components of the system upon receipt of the predetermined signal for termination from the biometric verification system.
Regarding claim 27, Freedman and Tenenbaum disclose the system of claim 21 and Tenenbaum further discloses the biometric verification system is configured to identify one or more of the first animal and the second animal at least once during operation of the system (see par. 73-76, voice recognition occurs before following directions from voice).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Lee et al. (WO 2011/002189). Citations below are to the English Translation provided with this office action.
Regarding claim 26, Freedman and Ballantyne disclose the limitations of claim 21 and that the biometric verification system is configured to identify the first animal and the second animal (see rejection of claim 21 above) but do not disclose the system is structurally configured to concurrently identify the first animal and the second animal.
Lee discloses a biometric authentication apparatus with authentication succeeds when two people simultaneously (concurrently) both succeed in authentication (see Abstract; page 4, par. 2-3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the two people authenticating via biometric verification of the system of Freedman and Ballantyne be authenticated/verified simultaneously, as disclosed by Lee, in order to predictably ensure that all patients are verified, adding a level of security in use of the system.
Claim(s) 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Storr et al. (US 2012/0305486), submitted in the December 18, 2023 IDS.
Regarding claim 28, Freedman and Ballantyne disclose the system of claim 21 but do not disclose the semipermeable membrane having an average pore size allowing for passage of molecules having a molecular weight of between about 70 kDa and 140 kDa.
Freedman discloses it is known to use a parabiotic dialysis system for liver dialysis (see col. 2, ll. 5-13). Storr discloses liver dialysis to support the liver during conditions of liver failure (see para. 43) and liver dialysis carried out using a dialyzer with a high cut-off dialysis membrane allowing passage of molecules having a molecular weight below 200kDa (see para. 32) in order to remove albumin-bound toxins and inflammatory mediators (see Abstract). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the dialysis system be a liver dialysis system, Freedman disclosing the use of a parabiotic dialysis system, in order to treat a patient having liver failure, as disclosed by Storr, and have the liver dialysis carried out using a dialyzer with a high cut-off dialysis membrane allowing passage of molecules having a molecular weight below 200kDa in order to remove albumin-bound toxins and inflammatory mediators during liver dialysis, as disclosed by Storr. Consequently, molecules between 70 kDa and 140 kDa would be allowed passage through pores of the membrane due to them being smaller than 200kDa.
Regarding claim 29, teachings of Freedman, Ballantyne, and Storr are described above and, consequently, the molecules would include albumin (see rejection of claim 28 and para. 44 of specification of current application, showing that albumin can pass if molecular weight allowed passage is greater than 66kDa) and the molecules would include a water-soluble toxin (see rejection of claim 28 and para. 6 of specification of current application, showing that water-soluble toxin can pass if molecular weight allowed passage is greater than 100kDa).
Regarding claim 30, teachings of Freedman, Ballantyne, and Storr are described above and the first animal can be an animal with a liver disorder (see Freedman, Fig. 1, claim only requires the connectors can be connected to the vascular system of a first animal that has a liver disorder, and the connectors can be connected to such an animal) and the first animal can be an animal with jaundice (see Freedman, Fig. 1, claim only requires the connectors can be connected to the vascular system of a first animal that has jaundice, and the connectors can be connected to such an animal).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Kelly et al. (WO 2013/028809), submitted in the December 18, 2023 IDS.
Regarding claim 32, teachings of Freedman and Ballantyne are described above and do not disclose the system further comprising a physiological sensor coupled to one or more of the first animal and the second animal; and a controller in communication with the physiological sensor, the controller configured to control operation of the system at least in part based upon a signal from the physiological sensor, and to pause or stop operation of the system upon receipt of a predetermined signal from the physiological sensor.
Kelly discloses an extracorporeal blood processing apparatus with a physiological sensor in the form of relative blood volume monitor (see para. 39, 89, 2222, 225) coupled to the one system (it would have to be coupled to the system (see Fig. 11); and a controller in communication with the physiological sensor, the controller configured to control operation of the system at least in part based upon a signal from the physiological sensor (see para. 225), and to pause or stop operation of the system upon receipt of a predetermined signal from the physiological sensor (see para. 225, fluid removal stopped based on unsafe hydration status) and the patient is alerted. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system of Freedman and Ballantyne further include a physiological sensor and controller controlling the system in relation to the physiological sensor such as those disclosed by Kelly in order to stop the fluid removal and alert the patient when the hydration status becomes unsafe, as disclosed by Kelly. Due to the coupling of the sensor to the system and the animals to the system in order for dialysis to be performed (see Freedman, Fig. 1), the sensor would be coupled to the animals.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Bernard et al. (US 2004/0044302), submitted with the December 18, 2023 IDS.
Regarding claim 33, teachings of Freedman and Ballantyne are described above and do not disclose a controller in communication with the first pump, the controller configured to control a flow rate of one or more of the first extracorporeal circuit and the second extracorporeal circuit, though Freedman discloses controlling the pumps and related flow rates of the pumps in the first and second extracorporeal circuits (see col. 7, ll. 19-26).
Bernard discloses it is well known in an extracorporeal blood circuit to have a controller control the desired blood flow based on the blood pumps, therefore having the controller configured to control a flow rate based on the pumps (see para. 84, 142-144, 179). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system of Freedman and Ballantyne further include a controller or controlling the speed of the pumps and therefore flow rate throughout the system, this addition disclosed by Bernard, as this would allow for easier settings control by the user (one center – the controller - for control) while still allowing for controlling the pumps and related flow rates of the pumps, shown as desirable by Freedman.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Becker et al. (US 2009/0120873), submitted with the December 18, 2023 IDS.
Regarding claim 37, Freedman and Ballantyne disclose the limitations of claim 21 and while Freedman discloses a setting establishing a nonzero pressure gradient between the first and second extracorporeal circuits (see col. 9, ll. 25-43, disclosing transfer of waste from human to other human and col. 10, ll. 35-39, 47-61 describing speed of pumps and implementing ultrafiltration, with a pressure gradient, which would be a non-zero number in order for ultrafiltration to exist, at the membranes being required for ultrafiltration to occur at the membranes), Freedman does not specifically disclose a selector switch having at least a first setting and a second setting, the first setting establishing a zero-pressure gradient between the first and second extracorporeal circuits and the second setting establishing the nonzero pressure gradient.
Becker discloses having various modes of operation of a filtration system (see para. 54), with these modes requiring different settings, which would require switching between these settings (see para. 54, 164, 165). Additionally, Becker discloses a mode allowing for a setting establishing a zero-pressure gradient on an ultrafiltration membrane in order to clean the membrane (see para. 128). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have multiple settings/modes of operation allowing for switching between modes as well as to have a cleaning mode allowing for a setting establishing a zero-pressure gradient on an ultrafiltration membrane in order to clean the membrane, as disclosed by Becker, in order to allow for cleaning of the membrane in addition to ultrafiltration across the membrane. Additionally, it would have been obvious to a person having ordinary skill in the art to also have a setting/mode for ultrafiltration establishing a nonzero pressure gradient between the extracorporeal circuits, as Freedman discloses the desirability of using this setting and having it as a mode of operation that can be switched to, as disclosed by Becker, would allow for easy/quick setup of the system for use.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of Ballantyne as applied to claim 21 above, and further in view of Gorsuch et al. (US 5,151,082), submitted with the December 18, 2023 IDS.
Regarding claim 38, Freedman and Ballantyne disclose the limitations of claim 21 but do not specifically disclose a resistive element in fluid communication with one or more of the first extracorporeal circuit and the second extracorporeal circuit, the resistive element configured to establish a predetermined pressure gradient between the first and second extracorporeal circuits.
Gorsuch discloses a kidney dialysis system wherein ultrafiltration is controlled by a pump and variable resistive element (valve 52), the resistive element in fluid communication with an extracorporeal circuit, which controls the differential pressure gradient across a membrane (see Fig. 1) col. 6, ll. 48-51). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have the first and/or second extracorporeal circuit of Freedman and Ballantyne include a resistive element in fluid communication with the circuit(s), the resistive element configured to help establish the differential pressure gradient across the membrane for ultrafiltration, as disclosed by Gorsuch. As a nonzero pressure gradient is required for ultrafiltration, the resistive element would help with this nonzero pressure gradient and due to the settings of the circuits, the pressure gradient would be predetermined by those settings.
Double Patenting
Claims 21, 23, 25, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,759,556, hereinafter ‘556. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 21 and 39-40, claim 7 of ‘556 discloses all limitations required by claim 21.
Regarding claim 23, and as parabiotic dialysis requires the first animal and second animal, and claim 7 discloses one or more of the first animal and second animal, being both the first animal and second animal, then the verification would confirm the compatibility between the first animal and the second animal as they have already been decided as compatible in being the diseased human and the normal human or animal if parabiotic dialysis is to be performed between the two.
Regarding claim 25, claim 7 of ‘556 discloses all limitations required by claim 25 in light of the 112(f) interpretation of “biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.”
Claims 22 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of ‘556 in view of Tenenbaum.
Regarding claim 22, claim 7 of ‘556 discloses substantially all limitations required by claim 22 except a controller in communication with the biometric verification system and one or more other components of the system, the controller configured to prevent or stop operation of the one or more other components of the system upon receipt of a predetermined signal from the biometric verification system.
Tenenbaum discloses a controller in communication with the biometric verification system and one or more other components of the system (see par. 72-73). Tenenbaum discloses control buttons that can be operated by a user to terminate dialysis treatment (see par. 69) as well as the recognize and process voice commands to control the dialysis treatment (see par. 72-74). It would have been obvious to a person having ordinary skill in the art to have the termination of dialysis treatment be via recognized and processed voice commands, as Tenenbaum teaches termination of treatment being a control and allowing for the user to control the machine without touching the machine, thereby eliminating the need for the user to wear gloves and/or reducing the risk of facilitating the spread of infection that is more likely to occur when using a touch-based input device (see Tenenbaum, par. 67). This would cause the controller to be configured to prevent or stop operation of the one or more other components of the system upon receipt of the predetermined signal for termination from the biometric verification system.
Regarding claim 27, claim 7 of ‘556 discloses substantially all limitations required by claim 27 except the biometric verification system is configured to identify one or more of the first animal and the second animal at least once during operation of the system.
Tenenbaum further discloses the biometric verification system is configured to identify one or more of the first animal and the second animal at least once during operation of the system (see par. 73-76, voice recognition occurs before following directions from voice). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the biometric verification system is configured to identify one or more of the first animal and the second animal at least once during operation of the system allowing for the user to control the machine without touching the machine, as disclosed by Tenenbaum, thereby eliminating the need for the user to wear gloves and/or reducing the risk of facilitating the spread of infection that is more likely to occur when using a touch-based input device (see Tenenbaum, par. 67).
Claims 24 and 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, 12-13 of ‘556 in view of Ballantyne.
Regarding claim 24, claim 7 of ‘556 does not teach the biometric verification system is in communication with a database containing information regarding one or more of the first animal and the second animal.
Ballantyne discloses the monitoring client/biometric verification system is in communication with a database containing information regarding the patient (see par. 351, 106-109) and it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to then have the monitoring client/biometric verification system is in communication with a database containing information regarding the patient to allow the system to alert the user to modifications that may be indicated based on the patient’s allergies, existing medications, or other patient-condition parameters, preferably minimizing the amount of typed input from a user (see par. 43).
Regarding claim 28, claim 1 of ‘556 discloses all limitations required by claim 28 except claim 1 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 1 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 1 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 29, claims 2 or 3 of ‘556 discloses all limitations required by claim 29 except claims 2 or 3 of ‘556 do not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claims 2 or 3 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claims 2 or 3 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 30, claims 4 or 5 of ‘556 discloses all limitations required by claim 30 except claims 4 or 5 of ‘556 do not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claims 4 or 5 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claims 4 or 5 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 31, claim 1 of ‘556 discloses all limitations required by claim 31 (dialysis inherently requires removal of metabolic waste and excess water via filtration of blood) except claim 1 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 1 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 1 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 32, claim 6 of ‘556 discloses all limitations required by claim 32 except claim 6 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 6 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 6 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 33, claim 8 of ‘556 discloses all limitations required by claim 33 except claim 8 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 8 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 8 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 34, claim 1 of ‘556 discloses all limitations required by claim 34 except claim 1 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 1 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 1 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 35, claim 9 of ‘556 discloses all limitations required by claim 35 except claim 9 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim 9 of ‘556 discloses two patients (required for parabiotic dialysis) and Ballantyne provides motivation for each patient to be confirmed, it is interpreted that claim 9 of ‘556 and Ballantyne disclose identifying the first animal and the second animal.
Regarding claim 36, claim 10 of ‘556 discloses all limitations required by claim 36 except claim 10 of ‘556 does not disclose a biometric verification system configured to identify one or more of the first animal and the second animal to determine a permission for use of the system.
Ballantyne discloses a system for patient care including a monitoring client with cameras that are used to allow a patient to communicate with a remote care provider and/or to confirm the identify of a patient using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment (see para. 351). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the system further include cameras that are used to allow patients to communicate with a remote care provider and/or to confirm the identity of the patients using retinal scans prior to commencing a treatment, so as to ensure the right patient receives the treatment, such as disclosed by Ballantyne. As claim