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 Status
The amendment filed June 24th, 2025 has been entered. Claims 21-29, 32, 35-36, and 41-48 are currently pending in the application. Claims 21-28 remain withdrawn from consideration in response to a previously presented restriction requirement. Claim 37 has been newly cancelled. Claims 1-20 and 38-40 remain cancelled. Claims 29 and 41 have been amended. Thus, claims 29, 32, 35-36, and 41-48 are currently under consideration.
Response to Arguments
Applicant's arguments filed June 24th, 2025 have been fully considered but they are not persuasive.
Examiner agrees that the amended claim language overcomes the previously presented rejection of Spearman in view of Burbank and Gelfand as the claim amendments have changed the scope of the invention and have yet to have been addressed. However, as seen in the below rejection of claim 29, the amended claim limitations are seen to have been obvious as taught by Gelfand and therefore the rejection of the claims utilizing the prior art of Spearman in view of Burbank and Gelfand is maintained below.
Regarding applicant’s argument that Spearman does not teach that the entire amount of pumped blood is being oxygenated, while allowing a selected portion of the oxygenated blood to be conveyed to the filtering system, wherein the selected portion can be determined based on the condition of the subject, based on blood oxygen level, as currently claimed and that Spearman fails to teach a blood flow regulator having a valve coupled to the input shunt tubing of the blood filtering device and does not teach regulating blood paths dynamically in response to physiological parameters, while the examiner agrees, these features do not rely upon Spearman alone and rather rely upon Spearman in combination with the teachings of Burbank and Gelfand to arrive at the current rejection. As such this argument is not seen as persuasive.
Regarding applicant’s argument that Burbank fails to cure the deficiencies of Spearman as Burbank teaches static flow control in dialysis and not dynamic control of oxygenated blood routing, examiner disagrees in that Burbank discloses parameters being continuously measured by sensors (¶0049 measured continuously) and then corrected during treatment operation (¶0049), however, Burbank is not being relied upon in the current rejection and rather it is the teachings of Gelfand that are being relied upon to teach the dynamic control of oxygenated blood routing based on the monitored physiological parameter of blood oxygen level. As such this argument is not found to be persuasive
Regarding applicant’s argument that Gelfand does not teach or suggest diverting oxygenated blood to a filter in general, and in particular, does not teach diverting a selected portion amount of oxygenated blood and if any, Gelfand teaches controlling filtration rate with one aim being controlling fluid volume, examiner does not find this argument persuasive, firstly as Gelfand is not relied upon to teach the diverting of a selected portion amount of oxygenated blood as this is disclosed by Spearman, and therefore this argument is not pertinent to the current rejection, and secondly that Gelfand teaches controlling filtration rate through the rate of blood flow sent to the filtration device which inherently teaches controlling the blood flow amount and as such this is found pertinent to the current device which controls blood flow to a filtration device. Whether or not Gelfand is within a system that also provides oxygenation does not negate Gelfand’s teachings of controlling blood flow to a filtration device. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant's arguments appear to be against the references individually and not taken in combination of what they would teach one of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
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 29, 41-43, 48 are rejected under 35 U.S.C. 103 as being unpatentable over Spearman (U.S. Publication 2020/0179587) in view of Burbank et al. (U.S. Publication 2017/0296727) and further in view of Gelfand et al. (U.S. Publication 2002/0085951).
Regarding claim 29, Spearman discloses an integrated apparatus 100 for oxygenation and filtration of blood, the apparatus comprising:
an oxygenator 114 for oxygenating blood (¶0006, oxygenator adds oxygen to blood);
a blood filtering system 106;
blood flow tubing (¶0038, tubing connects components of system) integrating the blood filtering system 106 with the oxygenator 114, the blood flow tubing comprising:
an oxygenator input tubing (see illustrative diagram of Figure 1 below), oxygenator output tubing (see illustrative diagram of Figure 1 below), an input shunt tubing (see illustrative diagram of Figure 1 below) and an output shunt tubing (see illustrative diagram of Figure 1 below);
a single blood pump 104 configured to induce blood circulation (¶0031, blood drawn by pump and pushed to components) from a subject's 102 cardiovascular system (¶0031) to both (¶0031, sent to oxygenator; ¶0031 sent to toxin removal system) the oxygenator 114 and to the blood filtering system 106 and back to the subject 102,
wherein the blood flow tubing is configured to connect the subject’s 102 cardiovascular system ¶0032 to the oxygenator 114 via the oxygenator input tubing (see illustrative diagram of Figure 1 below), to circulate the subject's 102 blood (¶0031) through (¶0031) the oxygenator 114 and back to the subject 102 via the oxygenator output tubing (see illustrative diagram of Figure 1 below),
wherein the input shunt tubing (see illustrative diagram of Figure 1 below) is configured to direct a selected (¶0183 flow rate can be selected) partial (presence of multiple flow paths naturally devices blood flow) portion (¶0054, portion) of oxygenated blood (¶0031, blood sent to oxygenator prior to going to toxin removal system based on oxygenator being in circuit before toxin removal system), from the oxygenator output tubing (see illustrative diagram of Figure 1 below) to the blood filtering system,
wherein the output shunt tubing (see illustrative diagram of Figure 1 below) is configured to return (¶0031, blood sent to the path in which pump draws blood from patient, i.e., the circulating blood) the selected (¶0183 flow rate can be selected) portion of the blood (¶0054) filtered by the blood filtering system 106 to the blood circulation (¶0031, circulation of blood by pump 104); and
wherein blood oxygenation and blood filtration are configured to take place simultaneously (¶0117, step 216 portion of heated blood diverted from entering into the body into the toxin removal system and sent back to join portion of blood that was not diverted; and
a controller (¶0071 element controlling oxygenator) for controlling the oxygenation (¶0071, oxygenator controlled to deliver different rates during different portions of time of treatment); and the filtration rate (¶0183 flow rates selected) of the blood being controlled (¶0183 flow rates selected).
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Illustrative diagram of Figure 1 of Spearman (U.S. Publication 2020/0179587).
Spearman does not expressly disclose the blood filtering system comprises a blood flow regulator comprising a valve coupled to the input shunt tubing, said regulator being configured to control the partial portion amount of the oxygenated blood flowing from the oxygenator output tubing to the blood filtering system by regulating the partial portion amount of blood flowing to the blood filtering system, via the valve, said valve having a less than completely closed configuration and an open configuration, wherein the portion amount is determined based on monitored parameters indicative of the condition of the subject, or the controller monitoring a normative range of the oxygenated blood flowing to the blood filtering system and controlling the oxygenation and filtration of the blood by controlling the blood flow through the regulator to the oxygenator to maintain the normative range of the oxygenated blood and by controlling the blood flow regulator directing the partial portion amount of oxygenated blood to the blood filter system based on the monitored parameters comprising blood oxygen level.
However, Burbank, in the same field of endeavor of blood filtering systems, teaches a blood flow regulator (¶0137 selectable flow restrictor), comprising a valve (¶0190 flow restricting actuator), said regulator being configured to control an amount of blood flowing to a blood filtering system by regulating the amount of blood flowing to the blood filtering system, via the valve, said valve having a less than completely closed configuration and an open configuration (¶0190 states flow-restricting actuator is adjustable and capable of a magnitude of flow restriction being selected indicating multiple restriction configurations between open and closed configurations), wherein the amount is determined based on monitored parameters indicative of the condition of the subject (¶0106 flow balance confirmed by a common flow meter in order to regulate transmembrane pressure), and a controller (¶0190 a controller) controlling the filtration of the blood by controlling the blood flow regulator (¶0137 controller regulates).
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 the blood filtering system and the controller disclosed by Spearman to have included and controlled a blood flow regulator comprising a valve having less than completely closed configurations and open configurations, as taught by Burbank, for the purpose of actively regulating blood flow to the blood filtering system in order to regulate transmembrane pressure which would regulate the filtration rate of the blood filtering system (¶0106 of Burbank).
Spearman in view of Burbank do not expressly disclose or suggest the monitored parameters comprising blood oxygen level, or the controller monitoring a normative range of the oxygenated blood flowing to the blood filtering system and controlling the oxygenation and filtration of the blood by controlling the blood flow through the regulator to the oxygenator to maintain the normative range of the oxygenated blood and by controlling the blood flow regulator directing the partial portion amount of oxygenated blood to the blood filter system based on the monitored parameters comprising blood oxygen level. .
However, Gelfand, in the same field of endeavor of extracorporeal treatment of blood, teaches controlling (adjusting) a filtration rate of a hemofiltration device based on the oxygen blood level (Abstract) through a controller 110 that monitors a normative range of blood oxygen level (¶0061 physiologic parameter monitored, ¶0062 oxygen saturation, Fig. 5 SVO2) of the blood flowing to the hemofiltration device (sensor 109 oxygen sensor in line 106) by controlling flow of fluid through the hemofiltration device to maintain a normative range of oxygen blood level measured in the blood flow (¶0061 if parameter falls below 93% baseline ultrafiltration is stopped or rate is slowed until condition is restored which shows the purpose of control being to maintain a normative range of blood oxygen saturation SVO2, ¶0062, above 93%) for the purpose of avoiding a hypotensive crisis in the patient undergoing therapy (Abstract) as oxygen blood level is used to detect when hypotension is about to occur in a patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have programmed the controller to have monitored a normative range of blood oxygen level in the blood flowing to the hemofiltration device and adjusted the flow rate to the toxin removal system by controlling flow of fluid through the regulator of Spearman as modified by Burbank to utilize the blood flow regulator based on the oxygen blood level of the patient in order to maintain the normative range of blood oxygen based on the monitored parameter of blood oxygen level, as taught by Gelfand, for the purpose of avoiding a hypotensive crisis in the patient undergoing therapy (Abstract of Gelfand).
Regarding claim 41, Spearman in view of Burbank and Gelfand suggest the apparatus according to claim 29. Burbank further discloses the parameter comprising blood flow rate , and provided motivation to do so (¶0106 flow meter to regulate transmembrane pressure).
Regarding claim 42, Spearman in view of Burbank and Gelfand suggest the apparatus according to claim 29. Burbank further discloses the valve being a pinch valve, and provided motivation to do so (Fig. 12A element 760 and 761 show flow restrictors being of a pinch form pinching the tubing between two portions).
Regarding claim 43, Spearman in view of Burbank and Gelfand suggest the apparatus according to claim 29. Spearman further discloses the blood filtering system being a hemodialysis system (¶0047 hemodialysis).
Regarding claim 48, Spearman in view of Burbank and Gelfand suggest the apparatus according to claim 29. Spearman does not expressly disclose the selected portion amount of blood being up to 10% of the oxygenated blood flowing in oxygenator output tubing.
However, Spearman does disclose the blood portion heading to the blood filtering system being taken as a slip stream from the full flow of blood from the patient at flow rates of, as examples 600-900 milliliters per minute, 0.2 liters per minute, 0.25 liters per minute, 0.3 liters per minute, 0.35 liters per minute, 0.4 liters per minute, 0.45 liters per minute, 0.5 liters per minute, 0.55 liters per minute, 0.6 liters per minute, 0.65 liters per minute, 0.7 liters per minute, 0.75 liters per minute, 0.8 liters per minute, 0.85 liters per minute, 0.9 liters per minute, 0.95 liters per minute, 1 liter per minute, 1.1 liters per minute, 1.2 liters per minute, 1.3 liters per minute, 1.4 liters per minute, 1.5 liters per minute, 1.6 liters per minute, 1.7 liters per minute, 1.8 liters per minute, 1.9 liters per minute, 2 liters per minute, 2.1 liters per minute, 2.2 liters per minute, 2.3 liters per minute, 2.4 liters per minute, 2.5 liters per minute, 2.6 liters per minute, 2.7 liters per minute, 2.8 liters per minute, 2.9 liters per minute, and 3 liters per minute (¶0051) and further discloses the full flow rates being in the range of 4 to 7 liters per minute. As such the example flow rates of 0.2-.4 constitute up to 10% when a flow of 4 liters per minute is utilized and flow rates of 0.2-0.7 constitute up to 10% when a flow of 7 liters per minute is utilized.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the portion amount of Spearman to be upto 10% of the oxygenated blood flowing in oxygenator output tubing as applicant appears to have placed no criticality on the claimed range (¶0026 optionally between about 5% and 10%) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Spearman would not operate differently with the claimed range and has further disclosed operating flow rates that would be within the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the portion amount is “optionally” between “about” 5% and 10%. As such the claimed structure would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Spearman (U.S. Publication 2020/0179587) in view of Burbank et al. (U.S. Publication 2017/0296727) and Gelfand (U.S. Publication 2002/0085951) and further in view of Buckberry (WIPO Publication 2017/085543).
Regarding claim 32, Spearman in view of Burbank suggest the apparatus according to claim 29. Spearman in view of Burbank do not expressly disclose or suggest the blood flow regulator comprising a controllable aperture.
However, Buckberry, in the same field of endeavor of blood filtration systems, discloses a valve (70 for regulating blood flow (Page 10 lines 1-6, aperture 77 closes preventing flow through the blood inlet valve) that comprises a controllable (Page 9 lines 27-31; controlled by controller 65) aperture 77.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the controllable valve of Burbank that performs the function of controlling blood flow to the dialysis device for the controllable valve of Buckberry since these elements perform the same function of controlling blood flow to the dialysis device. Simply substituting one blood flow controlling means for another would yield the predictable result of allowing a system to control the amount of blood flow to the blood filtration unit. See MPEP 2143.
Claims 35, 36, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Spearman (U.S. Publication 2020/0179587) in view of Burbank et al. (U.S. Publication 2017/0296727) and Gelfand (U.S. Publication 2002/0085951), and further in view of Rohde et al. (U.S. Publication 2014/0276376).
Regarding claims 35 and 36, Spearman in view of Burbank and Gelfand suggest the apparatus according to claim 29. Spearman discloses the blood filtering system being a dialysis system (¶0047, may perform dialysis) with a semipermeable membrane, but does not provide details on what components the dialysis system comprises and therefore does not expressly disclose or suggest a dialysate pump configured to pump dialysate from a dialysate container to a hemodialysis filter (claim 35) or a drainage pump configured to drain effluent fluid out of a hemodialysis filter.
However, Rohde, in the same field of endeavor of dialysis, discloses a dialysis system comprising a dialysate pump (64) configured to pump dialysate ¶0052 from a dialysate container 88 to a hemodialysis filter 40 and a drainage pump 96 configured to drain effluent fluid out of (¶0053, pushes used dialysate to drain) a hemodialysis filter 40.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dialysis system of Spearman that performs the function of dialysis for the dialysis system of Rohde since these elements perform the same function of dialysis on patient’s blood. Simply substituting dialysis means for another would yield the predictable result of allowing a system to perform dialysis. See MPEP 2143.
Regarding claims 44-46, Spearman in view of Burbank and Gelfand suggest the apparatus according to claims 29 and 43. Spearman discloses the blood filtering system being a dialysis system (¶0047, may perform dialysis), but does not provide details on what components the dialysis system comprises and therefore does not expressly disclose or suggest the water and waste products moving toward a flow of dialysate (Claim 44), a dialysate pump configured to pump dialysate from a dialysate container to a hemodialysis filter (claim 45) or a drainage pump configured to drain effluent fluid out of a hemodialysis filter (Claim 46).
However, Rohde, in the same field of endeavor of dialysis, discloses a dialysis system comprising a dialysate pump (64) configured to pump dialysate ¶0052 from a dialysate container 88 to a hemodialysis filter 40 , wherein water and waste products removed from blood move toward the flow of dialysate, and a drainage pump 96 configured to drain effluent fluid out of (¶0053, pushes used dialysate to drain) a hemodialysis filter 40.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dialysis system of Spearman that performs the function of dialysis for the dialysis system of Rohde since these elements perform the same function of dialysis on patient’s blood. Simply substituting dialysis means for another would yield the predictable result of allowing a system to perform dialysis. See MPEP 2143.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Spearman (U.S. Publication 2020/0179587) in view of Burbank et al. (U.S. Publication 2017/0296727) and Gelfand (U.S. Publication 2002/0085951), and further in view of Rohde et al. (U.S. Publication 2014/0276376) as applied above to claim 36 and further in view of Groeber et al. (U.S. Publication 2016/0216150).
Regarding claim 47, Spearman in view of Burbank, Gelfand, and Rohde suggest the apparatus according to claim 46. Rohde further suggests the using weigh scales to determine dialysate flow volume control ¶0111 but does not give any further details on placement of the weight scales or how the weigh scales are used to determine this flow volume control.
However, Groeber in the same field of endeavor of dialysis, teaches a means of evaluating dialysate flow using weight sensors (3 and 4) monitoring weight of dialysate in a container and effluent in a receptacle for the purpose of determining ultrafiltration weights from the patient ¶0045.
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 the device of Spearman in view of Burbank and Rohde to have included the weight sensors monitoring weight of dialysate in the container and effluent in the receptacle, as taught by Groeber, for the purpose of determining ultrafiltration weights from the patient (¶0045 of Groeber).
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 PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781