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 submitted on September 11th, 2023, has been entered. Claims 1-2, 4-6, 10-11, 14-16, 21, 24-29, 31, 34, and 105 are currently pending. Claim 10 has been amended. Claims 3, 7-9, 12-13, 17-20, 22-23, 30, 32-33, 35-104, and 106-107 have been cancelled. Claim 34 is herein withdrawn from consideration as being drawn toward a non-elected group in accordance with the restriction requirement mailed on January 5th, 2026 and applicant’s response received April 2nd, 2026.
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.
Claim(s) 1, 2, 6, 21, 24-25, 27, 29, 31, and 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears et al. (U.S. Patent No. 6,248,087) in view of Drasler (U.S. Publication 2013/0023852) and Kopp (U.S. Patent No. 3,830,234).
Regarding claim 1, 2, and 6, Spears discloses a method for delivering gas-enriched blood within a vasculature of a patient (Abstract system and method for increasing gas concentration in blood…by mixing blood with an oxygen supersaturated solution…infused back to the patient), the method comprising: providing a gas-enrichment system (Fig. 1), the gas-enrichment system comprising a mixing chamber 39 and a blood pump 14; inserting (Col. 4 lines 18-32 inserted and advanced into an artery or vein) a catheter 32 for drawing blood (Col. 4 lines 33-46 blood withdrawn from patient via an annular opening defined around catheter by sheath 32) from the patient into an artery of the patient (Col. 4 lines 18-32 inserted and advanced into an artery via introducer or sheath); drawing blood from the artery; generating a gas-enriched blood by mixing withdrawn blood with a gas-enriched liquid in the mixing chamber (Col. 5 lines 6-19 delivers blood at a steady flow rate to mixing region where the aqueous oxygen is introduced via channels 18); and delivering the gas-enriched blood to the vasculature of the patient (Col. 4 lines 6-17 blood withdrawn from patient…aqueous oxygen mixed with the blood…hyperoxemic blood then returned to patient).
Spears does not expressly disclose the artery in which the catheter is inserted into being a radial artery, or from which blood is drawn being a radial artery or from a vessel upstream of the radial artery at a blood flow rate without collapsing the artery or vessel to a degree that would substantially impede drawing blood.
Regarding the insertion of the catheter and withdrawal location of the blood, however, Drasler, in the same field of endeavor of methods of delivering blood and oxygenated fluids (¶0008 oxygenated fluid can alternatively or as an auxiliary be supplied from an external supply source and delivered via pump) to a patient’s vasculature (¶0028 blood is drawn into intermediate lumen from subclavian, axillary, brachial, and radial arteries as the pump is activated. Blood is pulled into the pump via the intermediate lumen port (70) and through the pump inlet tube (85). Blood is pumped back to the fluid protection catheter (5) via the pump outflow tube (90) to the distal lumen port (65) and into the distal lumen (20) and out of the distal end opening (35) or distal side opening (40)), teaches (Fig. 5 embodiment) a catheter 5 for drawing blood (¶0028 blood is drawn) being inserted into a radial artery of a patient (¶0023 catheter is introduced into the right radial artery) and advanced to a vessel, subclavian artery (claim 6) upstream of the radial artery (Claim 2) and drawing blood from the radial artery (¶0028 blood is drawn into the intermediate lumen via the intermediate end orifices or intermediate side orifices from the subclavian, axillary, brachial and radial arteries) and from a vessel, subclavian artery (Claim 6) upstream of the radial artery (Claim 2)(¶0028 subclavian) for the purpose of withdrawing blood that is free of embolic debris (¶0028 blood found in the subclavian, axillary, brachial, and radial arteries is expected to be free of embolic debris and filtration may not be required).
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 method disclosed by Spears to have the artery of insertion be the radial artery as well as the artery of withdrawal of blood, as taught by Drasler, for the purpose of sourcing blood expected to be free of embolic debris (¶0028 of Drasler).
Regarding claim 21, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears further discloses the gas-enriched blood is formed in the mixing chamber 39 by mixing the blood withdrawn from the patient with the gas-enriched liquid (Col. 5 lines 6-19 delivers blood at a steady flow rate to mixing region where the aqueous oxygen is introduced via channels 18) generated by a gas enrichment chamber 16.
Regarding claim 24, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears further discloses the gas-enriched blood comprises a supersaturated oxygen enriched blood (Abstract mixing the blood with an oxygen supersaturated solution to generate hyperoxemic blood to be infuse back to the patient).
Regarding claim 25, Spears in view of Drasler and Kopp suggest the method of claim 24. Spears further discloses the supersaturated oxygen enriched blood comprising a supersaturated oxygen enriched blood having a pO2 of greater than 1000 mm Hg.
While Spears does not expressly disclose the range of 600-1500 mmHg as claimed, 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, the claimed range lies inside the range disclosed by Spears of greater than 1000 mm Hg and Spears would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply in ¶0031 that in some implementations, the supersaturated oxygen enriched blood comprises a supersaturated oxygen enriched blood having a pO2 of 600-1500 mmHg.
Regarding claims 27 and 29, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears further discloses measuring a blood pressure in the artery in which the catheter is placed using one or more pressure sensors (Col. 10 9-16 infusion guidewire can also be used to monitor intracoronary pressure either continuously or intermittently; guidewire thus acts as pressure sensor), wherein a controller 25 of the gas-enrichment system receives signals from one or more pressure sensors (Col. 8 lines 20-32 if the blood pressure is not within predetermined limits, controller may activate system shut-down actuators to discontinue circulation of blood from patient; signal constitutes blood pressure not within predetermined limit) and controls a pump to adjust a blood draw flow rate (Col. 9 lines 5-6 adjust blood pump to vary the blood flow rate) in response to monitoring devices (Col. 8 lines 51-63 controls for controlling parameters such as the blood withdrawal and delivery rate…at least in part in response to the output of monitoring devices), as well as disclosing the extracorporeal system immediately terminating infusion when the blood pressure is indicated to exceed a threshold (Col. 10. Lines 17-25 excess infusion of hyperoxemic blood can be prevented. When there is an excessive increase in mean intracoronary pressure, for example, approximately 50 mm Hg increase to approximately 150 mm Hg intracoronary pressure, excess infusion of hyperoxemic blood can be prevented by immediate termination of hyperoxemic blood infusion by extracorporeal system).
While, Spears does not expressly disclose the terminating infusion being through the controllers adjustment of the blood pump, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the controller of Spears to perform this termination through the controller of the blood pump as Spears suggests the termination being “immediate” which would reasonable suggest to one of ordinary skill in the art that the process is automated by the controller and termination of infusion would naturally require the termination of blood flow through the pump in order to effectively terminate the infusion process as infusion is driven by the blood pump directly.
Regarding claims 31 and 105, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears further discloses a preferred withdrawal blood flow rate between approximately 50-300 ml/min (Col. 4 lines 47-67).
While this blood flow rate does not exactly match the claimed blood flow rate of 10-500 ml/min, the range of 10-500 ml/min is seen to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention 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, Spears would not operate differently within the claimed range and the range of 50-300 ml/min disclosed by Spears lies inside the claimed range and as such the claimed range is seen to overlap the range disclosed by the prior art. Further, applicant appear to place no criticality on the claimed range indicating simply “in some implementation, the blood flow rate is a predetermined blood flow rate of 10-500 ml/min” (¶0011 of applicant’s specification).
Spears in view of Drasler and Kopp do not expressly disclose or suggest the drawing blood without collapsing the artery or vessel to a degree that would substantially impede drawing blood comprising preventing a collapse that would result in more than 5-10% reduction in cross-sectional area of an artery or vessel, or preventing a reduction of blood flow over a threshold percentage of about 10-15%, however, the method step disclosed by Spears in view of Drasler and Kopp of selecting the blood flow to prevent arterial collapse suggested by Spears in view of Drasler and Kopp is seen to inherently perform these functions as prevention of a collapse of the artery would inherently prevent the reduction in cross-sectional area of the artery or vessel as the artery or vessel does not collapse and therefore any collapse including those that would result in more than 5-10% reduction would be prevented and the prevention of collapse would prevent any reduction of blood flow associated with said collapse. As such these steps are seen to be inherent to the method suggested by Spears in view of Drasler and Kopp.
Claim(s) 4-5 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears et al. (U.S. Patent No. 6,248,087) in view of Drasler (U.S. Publication 2013/0023852), Kopp (U.S. Patent No. 3,830,234), and Myrick et al. (U.S. Publication 2004/0013566).
Regarding claim 4, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears further discloses a preferred blood flow rate between approximately 50-300 ml/min (Col. 4 lines 47-67). Spears does not expressly disclose the inner diameter and length of the catheter being sufficient to support a predetermined blood flow rate of 50-150 ml/min while avoiding a pressure drop that would cause pump cavitation.
However, in the same field of endeavor of providing gas-enriched fluids to a patient, Myrick, teaches selecting the length-to internal diameter ratio of the catheter to create a relatively low pressure drop from the oxygenation device (¶0090 length-to-internal diameter ratio of the catheter may be selected to create a relatively low pressure drop from the oxygenation device to the patient) for the purpose of preventing cavitation (¶0090 typically designed to reduce or eliminate the creation of cavitation nuclei which may cause a portion of the gas to come out of solution).
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 length and inner diameter of the catheter of Spears to have been sufficient to support the preferred blood flow rate of Spears between approximately 50-300 ml/min, while avoiding a pressure drop that would cause pump cavitation, as taught by Myrick, for the purpose of preventing cavitation (¶0090 of Myrick typically designed to reduce or eliminate the creation of cavitation nuclei which may cause a portion of the gas to come out of solution).
While Spears does not expressly disclose the range of 50-150 ml/min exactly, 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, the claimed range lies inside the range disclosed by Spears of 50-300 ml/min and Spears would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply in ¶0011 that in some implementations, the blood flow rate is a predetermined blood flow rate of…50-150 mL/min. As such a prima facie case of obviousness is seen to exist.
Regarding claim 5, Spears in view of Drasler, Kopp and Myrick suggest the method of claim 4. Spears does not expressly disclose the inner diameter being 6-7 French, the length being 10 to 100 cm, and the pressure drop being from 0 mmHg to at least negative 50 mmHg, however, Myrick, as detailed above, teaches selecting the length to internal diameter ratio of a catheter to create a relatively low pressure drop from the oxygenation device to the patient (¶0090) which causes the reduction or elimination of cavitation nuclei (¶0090) and as such discloses the length, inner diameter, and pressure drop being adjustable result dependent variable in that these variable affect the rate of creation of cavitation nuclei.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date for inner diameter to be 6-7 French, the length be 10 to 100 cm, and the pressure drop be from 0 mmHg to at least negative 50 mmHg since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation and is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Myrick teaches the necessity to optimize the length-to-inner diameter of a catheter to arrive at a low pressure drop value that reduces the amount of cavitation nuclei created.
Regarding claim 28, Spears in view of Drassler and Kopp suggest the method of claim 27. Spears further discloses that monitoring of the blood pressure allows for excess infusion of hyperoxemic blood from being prevented when an excessive increase in mean pressure is monitored (Col. 10 lines 17-25). Spears in view of Drassler and Kopp fail to disclose or suggest the controller generating an alert in response to receiving a signal from the pressure sensor indicating a blood pressure or change in blood pressure that exceeds a threshold or is below a threshold.
However, Myrick, in the same field of endeavor of providing gas-enriched fluids to a patient, teaches a controller generating an alert in response to receiving a signal from a pressure sensor indicating a pressure or change in measured pressure is outside of a threshold value (¶0107 conditioning circuit receives the analog pressure signals…these pressures may be monitored…delivers a warning signal if either pressure drops below the minimum pressure setting).
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 controller of Spears to have generated an alert, as taught by Myrick, in response to the measured arterial pressure showing an excessive increase, thus exceeding the threshold increase, for the purpose of providing a warning that would ensure that attention is brought to the increase of arterial pressure to ensure that it is properly addressed to avoid any damage to the patient.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears et al. (U.S. Patent No. 6,248,087) in view of Drasler (U.S. Publication 2013/0023852), Kopp (U.S. Patent No. 3,830,234), and Fischell et al. (U.S. Publication 2024/0009013).
Regarding claim 10, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears in view of Drasler and Kopp do not expressly disclose or suggest wherein inserting the catheter into a radial artery of the patient comprises: advancing the catheter into the radial artery of the patient until distal band on the catheter alignment with a predetermined location in the vasculature of the patient.
However, Decker, in the same field of endeavor of catheter placement within the vasculature of a patient, teaches advancing a catheter into an artery (710 ¶0045 access to an artery) of a patient until a distal band on the catheter is in alignment with a predetermined location in the vasculature of the patient (¶0045 user positions the catheter viewing via a display of a marker band at the distal end of the catheter to the desired position).
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 method of Spears in view of Drasler and Kopp to have included the distal band and alignment method as taught by Decker for the purpose of allowing the user to visualize the alignment of the catheter in the desired placement position within the patient vasculature.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears et al. (U.S. Patent No. 6,248,087) in view of Drasler (U.S. Publication 2013/0023852), Kopp (U.S. Patent No. 3,830,234), and Schultz et al. (U.S. Publication 2021/0100987).
Regarding claim 26, Spears in view of Drasler and Kopp suggest the method of claim 1. Spears in view of Drasler and Kopp as applied in the rejection of claim 1 above do not expressly disclose inserting a second catheter into a second radial artery of the patient for delivering the gas-enriched blood to the vasculature of the patient.
However, Spears, in a separate embodiment (Fig 2), teaches blood withdrawal being from a separate artery or vein of patient from the blood return catheter (Col. 4 lines 33-46 alternatively, as shown in Fig. 2, blood withdrawal may occur via a separate sheath inserted and advanced into another artery of vein or patient), as well as the possibility of blood flow into the withdraw tubing being inadequate when the withdrawal catheter and return catheter are included together (Col. 4 lines 33-46 blood flow into tubing 12 is inadequate because of tight fit between catheter and sheath, a larger sheath may be used), as well as the utilization of a smaller sized catheter when utilizing separate artery insertion points (Col. 4 lines 33-46 sheath is preferably approximately 8.0 French or 8.5 French I size…such a separate withdrawal sheath may be preferably approximately 6 French in size).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have inserted a second catheter, i.e. the return catheter) into a second artery of the patient for delivering the gas-enriched blood to the vasculature of the patient, as taught by Spears, for the purpose of improving withdrawal rates of the blood from the patient as well as providing the ability to utilize a smaller gauge withdrawal catheter (Col. 4 lines 33-46 of Spears).
While Spears does not expressly suggest the second catheter being placed in a second radial artery, Schultz in the same field of endeavor of oxygenating blood in a patient with use of an infusion catheter, teaches placing a catheter configured to return fluid in the radial artery (¶0320 catheter configured to return fluid in the radial artery).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the second catheter in a radial artery as Schultz teaches the radial artery being an appropriate artery for the return of fluid to a patient and simply substituting the return catheter artery placement of Spears for the return catheter artery placement of Schultz would yield the predictable result of allowing fluid to be returned to a patient through their artery.
Allowable Subject Matter
Claims 11 and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the cited references or the prior art suggest the limitations of claim 1 in combination with the limitation of claim 11 wherein a maximum draw rate is based on a size of the radial artery with the above mentioned prior art simply suggesting that a maximum draw rate can be determined to prevent arterial collapse and thus does not suggest the determination based on a size of the radial artery itself. While size of an artery directly correlates to its blood pressure/flow of blood through the artery which correlates to the arteries ability to resist collapse, there fails to be provided a method wherein a maximum draw rate of blood from such an artery is determined based on the size itself.
As such claim 11 if presented as written in independent form to include all the limitations of claim 1 from which it depends upon would be considered allowable over the prior art. Furthermore claims 14-16 would be considered allowable based on their dependency upon the limitations of claim 11.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Steingraber et al. (U.S. Patent No. 12,409,314) discloses a method of operating a pump to prevent collapsing of blood vessel.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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