DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 5, 18, 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5, 6, 9 of U.S. Patent No. 11,850,414. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claim can be found in the patent claim.
Regarding claim 1 of the application, claim 5 of the patent, which includes claim 1, recites a fluid handling system (claim 1, line 54) comprising: a console configured to connect with a first electrical interface that is configured to connect to a plurality of components of the fluid handling system, the console including a second electrical interface configured to connect with the first electrical interface, a display, and one or more hardware processors (claim 1, lines 55-60); a control system comprising the one or more hardware processors and a non- transitory memory storing instructions that, when executed, cause the control system to (claim 1, lines 64-67): detect an electrical signal from a first component of the plurality of components of the fluid handling system responsive to a caretaker performing a first instruction (claim 1, lines 1-3); and determine a system state of the fluid handling system based at least in part on the electrical signal from the first component (claim 1, lines 4-6); compare the system state with a predetermined state condition corresponding to said first instruction (claim 1, lines 7-8); and output an indication on the display of the system state; and a motor for driving a percutaneously insertable pump for bodily fluids (claim 1, lines 9-10), wherein the instructions further cause the control system to: i) determine a temperature of an impeller motor that rotates the impeller to pump blood and ii) shut off the impeller motor responsive to the determination of the temperature of the impeller motor. (claim 5, lines 28-33). The difference between the application claim and the patent claims lies in the fact that the patent claims includes more elements and is therefore more specific. It has been held that the generic claims is anticipated by the specific claim. See In re Goodman, 29USPQ2d 2010 (Fed. Cir. 1993). therefore, the application claim is not patentably distinct from the patent claims.
Regarding claim 5 of the application, claim 6 of the patent recites the instructions further cause the control system to determine a current drawn by the motor and shut off the motor if the current drawn exceeds a predetermined threshold (claim 6, lines 35-38).
Regarding claim 18 of the application, claim 1 of the patent recites a catheter assembly, a biocompatible fluid source, and a waste fluid line (claim 1, lines 61-63).
Regarding claim 19 of the application, claim 9 of the patent, which includes claims 1 and 8, recites a fluid handling system (claim 1, line 54) comprising: a console configured to connect with a first electrical interface that is configured to connect to a plurality of components of the fluid handling system, the console including a second electrical interface configured to connect with the first electrical interface, a display, and one or more hardware processors (claim 1, lines 55-60); and a control system comprising the one or more hardware processors and a non- transitory memory storing instructions that, when executed, cause the control system to (claim 1, lines 64-67): detect an electrical signal from a first component of the plurality of components of the fluid handling system responsive to a caretaker performing a first instruction (claim 1, lines 1-3); determine a system state of the fluid handling system based at least in part on the electrical signal from the first component (claim 1, lines 4-6); compare the system state with a predetermined state condition corresponding to said first instruction (claim 1, lines 8-9); and output an indication on the display of the system state (claim 1, line 10); wherein the plurality of components comprises a priming pump and a catheter assembly, and wherein the instructions further cause the control system to: cause the priming pump to use a pressure to prime the catheter assembly with a biocompatible fluid (claim 8, lines 45-49); and monitor a back pressure or current draw of the priming pump and terminate the priming if the back pressure or current draw exceeds a predetermined threshold (claim 9, lines 52-54). The difference between the application claim and the patent claims lies in the fact that the patent claims includes more elements and is therefore more specific. It has been held that the generic claims is anticipated by the specific claim. See In re Goodman, 29USPQ2d 2010 (Fed. Cir. 1993). therefore, the application claim is not patentably distinct from the patent claims.
Claims 2-4, 6, 7, 15, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,850,414 as applied to claim 1 above, and further in view of Smisson, III et al (US 7,975,491).
Regarding claim 2, Smisson, III discloses a fluid handling system comprising a console 250, the console includes a display 1200 and a hardware processor (col. 25, lines 3-11; col. 26, lines 54-56, 65-67), and a control system 11100 comprising one or more hardware processors and a non-transitory memory storing instructions (col. 25, lines 1-11) causing the control system to perform in a similar manner to the claimed invention and further wherein the instructions cause the control system to generate on the display a first user interface including a visual indication of the first instruction (prime button 1220; fig. 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instructions of claim 5 of the patent to include instructions causing a display of a visual indication of the first instruction as taught by Smisson to allow the user to monitor the progression of the setup of the of the device.
Regarding claim 3, Smisson, III teaches that the instructions further cause the control system to generate one the display a second user interface including visual indication of a second instruction based on at least the comparison indicating that the system state is within the predetermined state condition and the first instruction is complete (col. 27, lines 33-35: after priming the pump may be operated in various modes as chosen by the operator – col. 30, line 63 – col. 31, line 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instructions of claim 5 of the patent to include instructions causing a display including indication of a second a visual indication of the second instruction as taught by Smisson to allow the user to monitor the progression of the setup of the of the device.
Regarding claim 4, Smisson, III discloses that if the system state is not within the predetermined state, the control system generates an error (col. 27, line 66 – col. 28, line 2). Smisson, III does not explicitly disclose that the error generates an alarm. However, Smisson, III teaches that various undesirable operating behaviors may cause an alarm to be generated (col. 26, lines 43-48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 of the patent and Smisson, III so that when the control system creates the error determined when the system state is not within the predetermined state condition an alarm is generated because Smisson, III acknowledges that various alarms can be generated when the device is not operating in the desired state so that the user can address the error.
Regarding claim 6, Smisson, III discloses that one of the components is a catheter (col. 35, lines 12-13), and the instructions further cause the control system to determine a flow state of the fluid in the catheter and trigger an alarm based in the flow state is indicative of a blockage (col. 32, lines 4-6; col. 26, lines 43-48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 of the patent to include instructions that cause the system to determine a flow state and trigger an alarm if the flow state is indicative of a blockage as taught by Smisson, III to alert the user that the pump is not moving fluid as desired.
Regarding claim 7, Smisson, III teaches that the plurality of components include a priming pump (col. 27, lines 50-55) and a catheter assembly (col. 35, lines 12-15), and wherein the instructions cause the control system to cause the priming pump to use positive pressure to prime the catheter with biocompatible fluid (col. 27, lines 50-55; it is understood that the fluid is biocompatible as this is the purpose of priming). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 of the patent to include a priming pump and catheter assembly, and instructions that cause the system to cause the priming pump to prime the catheter as taught by Smisson, III to ready the catheter for use.
Regarding claim 15, Smisson, III discloses that the instructions cause the control system to automatically begin a priming operation upon the system state being a predetermined condition (col. 27, lines 44-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 of the patent to include instructions that cause the system to automatically begin a priming operation as taught by Smisson, III to remove user error in operation of the device.
Regarding claim 20, Smisson, III discloses a fluid handling system comprising a console 250, the console includes a display 1200 and a hardware processor (col. 25, lines 3-11; col. 26, lines 54-56, 65-67), and a control system 11100 comprising one or more hardware processors and a non-transitory memory storing instructions (col. 25, lines 1-11) causing the control system to perform in a similar manner to the claimed invention and further wherein the instructions cause the control system to generate on the display a first user interface including a visual indication of the first instruction (prime button 1220; fig. 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instructions of claim 5 of the patent to include instructions causing a display of a visual indication of the first instruction as taught by Smisson to allow the user to monitor the progression of the setup of the of the device.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,850,414 as applied to claim 1 above, and further in view of Paden et al (US 2012/0048407).
Regarding claim 17, Paden teaches a medical pump including a control system that determines system errors and includes instructions to display an alert history so that the operator can determine all the errors that occurred (page 10, para. 0135) which allows the user to determine if the treatment has occurred as prescribed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 of the patent to include instructions for generating on the display an alert history as taught by Paden to allow the user to determine if the procedure has been completed as prescribed.
Claim Objections
Claim 20 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 2. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Allowable Subject Matter
Claims 8-14, 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.
Claims 1-7, 15, 17-20 are allowable over the prior art of record but for the double patenting rejections above.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter of the listed claims could not be found and was not suggested by the prior art of record.
For further reasons for allowance, see prosecution history for parent application 17/144091.
The closest prior art or record is Smisson, III et al (US 7,975,491) which teaches a fluid handling system comprising a console 250, the console includes a display 1200 and a hardware processor (col. 25, lines 3-11; col. 26, lines 54-56, 65-67), and a control system 11100 comprising one or more hardware processors and a non-transitory memory storing instructions (col. 25, lines 1-11) that when executed, cause the control system to detect an electrical signal from a first component of the plurality of component of the fluid handling system responsive to a caretaker performing a first instruction (col. 27, lines 44-66: caretaker performing priming by depressing and releasing prime input 1220, detect electrical signal from lower level sensor), determine a state of the fluid handling system based at least in part of the electrical signal from the first component (col 27, lines 61-62), compare the system state with a predetermined state condition corresponding to the first instruction (col. 27, line 62-66: determining if the predefined volume of fluid has been pumped after purging requires comparing volume of fluid pumped with predetermined volume of fluid), and output an indication on the display of the system state (col. 27, lines 5-7).
Conclusion
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783