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 .
Information Disclosure Statement
The information disclosure statement filed 04/16/26 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement filed 04/16/26 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,178,554 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are generic with respect to the claims of U.S. Patent No. 12,178,554 B2. See Concordance below:
Current application
U.S. Patent No. 12,178,554 B2
12. (New) A ventricular assist system comprising: an impeller; a cannula configured to be implanted in a body of a patient, wherein the cannula comprises: a lateral receiving interface distal to the impeller, configured to receive blood of the patient into an interior of the cannula; and an outlet interface, wherein the impeller is configured to convey the blood from the lateral receiving interface to the outlet interface; and a volumetric flow sensor positioned at a tip of the cannula distal to the impeller and configured to sense a volumetric flow (Q) of the blood of the patient through the cannula, the volumetric flow sensor comprising a Doppler ultrasonic sensor.
1. A ventricular assist system comprising: an impeller; a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); a pressure sensor device; and a determination device comprising: a cannula configured to be implanted in a body of a patient, wherein the cannula comprises: a lateral receiving interface distal to the impeller, configured to receive blood of the patient into an interior of the cannula; and an outlet interface, wherein the impeller is configured to convey the blood from the lateral receiving interface to the outlet interface; and a volumetric flow sensor positioned at a tip of the cannula distal to the impeller and configured to sense a volumetric flow (Q) of the blood of the patient through the cannula, the volumetric flow sensor comprising a Doppler ultrasonic sensor; wherein the pressure sensor device is configured to sense a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and wherein the determination device is configured to determine viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (ω) of the impeller or an electric power input Pel of a drive device for the impeller.
13. (New) The ventricular assist system of claim 12, further comprising a determination device configured to determine a viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller.
1. A ventricular assist system comprising: an impeller; a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); a pressure sensor device; and a determination device comprising: a cannula configured to be implanted in a body of a patient, wherein the cannula comprises: a lateral receiving interface distal to the impeller, configured to receive blood of the patient into an interior of the cannula; and an outlet interface, wherein the impeller is configured to convey the blood from the lateral receiving interface to the outlet interface; and a volumetric flow sensor positioned at a tip of the cannula distal to the impeller and configured to sense a volumetric flow (Q) of the blood of the patient through the cannula, the volumetric flow sensor comprising a Doppler ultrasonic sensor; wherein the pressure sensor device is configured to sense a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and wherein the determination device is configured to determine viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (ω) of the impeller or an electric power input Pel of a drive device for the impeller.
14. (New) The ventricular assist system of claim 13, wherein the determination device is configured to determine the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity.
2. The ventricular assist system of claim 1, wherein the determination device is configured to determine the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η).
15. (New) The ventricular assist system of claim 13, wherein the determination device is configured to determine the viscosity (il) using a lookup table.
3. The ventricular assist system of claim 1, wherein the determination device is configured to determine the viscosity (η) using a lookup table.
16. (New) The ventricular assist system of claim 15, wherein a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table.
4. The ventricular assist system of claim 3, wherein a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table.
17. (New) The ventricular assist system of claim 13, further comprising a pressure sensor device, wherein the pressure sensor device comprises at least one differential pressure sensor or two barometric pressure sensors, wherein the at least one differential pressure sensor or two barometric pressure sensors are configured to measure the pressure difference (Δp) between two sensor points.
6. The ventricular assist system of claim 1, wherein the pressure sensor device comprises at least one differential pressure sensor or two barometric pressure sensors, wherein the at least one differential pressure sensor or two barometric pressure sensors are configured to measure the pressure difference (Δp) between two sensor points.
18. (New) The ventricular assist system of claim 13, further comprising a pressure sensor device configured to sense the pressure difference (Δp) between two sensor points.
7. The ventricular assist system of claim 1, wherein the pressure sensor device is configured to sense the pressure difference (Δp) between two sensor points.
19. (New) The ventricular assist system of claim 12, wherein the impeller is positioned in a region of the outlet interface.
5. The ventricular assist system of claim 1, wherein the impeller is positioned in a region of the outlet interface.
20. (New) A method for determining a viscosity (ii) of blood of a patient in a ventricular assist system, comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of the ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the ventricular assist system, the cannula, configured to be implanted in a body of the patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula distal to the impeller to an outlet interface of the cannula.
8. A method for determining a viscosity (η) of blood of a patient in a ventricular assist system, comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of a determination device of the ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the determination device, the cannula, configured to be implanted in a body of the patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula distal to the impeller to an outlet interface of the cannula; and a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); sensing a pressure difference (Δp) of blood in a region of the receiving interface and the outlet interface; and determining the viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (ω) of the impeller or an electric power input Pel of a drive device for the impeller.
21. (New) The method of claim 20, further comprising determining a viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller.
8. A method for determining a viscosity (η) of blood of a patient in a ventricular assist system, comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of a determination device of the ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the determination device, the cannula, configured to be implanted in a body of the patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula distal to the impeller to an outlet interface of the cannula; and a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); sensing a pressure difference (Δp) of blood in a region of the receiving interface and the outlet interface; and determining the viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (ω) of the impeller or an electric power input Pel of a drive device for the impeller.
22. (New) The method of claim 21, wherein determining the viscosity (η) comprises determining the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η).
9. The method of claim 8, wherein determining the viscosity (η) comprises determining the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η).
23. (New) The method of claim 21, wherein determining the viscosity (ii) comprises using a lookup table.
10. The method of claim 8, wherein determining the viscosity (η) comprises using a lookup table.
24. (New) The method of claim 23, wherein a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table.
11. The method of claim 10, wherein a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table.
25. (New) The method of claim 21, further comprising determining the pressure difference (Δp) using a pressure sensor device comprising at least one differential pressure sensor or two barometric pressure sensors.
13. The method of claim 8, wherein the pressure sensor device comprises at least one differential pressure sensor or two barometric pressure sensors.
26. (New) The method of claim 21, further comprising determining the pressure difference (Δp) using a pressure sensor device configured to sense the pressure difference (Δp) between two sensor points.
14. The method of claim 8, wherein the pressure sensor device is configured to sense a pressure difference (Δp) between two sensor points.
27. (New) The method of claim 20, wherein the impeller is positioned in a region of the outlet interface.
12. The method of claim 8, wherein the impeller is positioned in a region of the outlet interface.
28. (New) A non-transitory computer-readable storage medium comprising instructions that, when executed, direct a processor to perform a method comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of a ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the ventricular assist system, the cannula, configured to be implanted in a body of a patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula that is distal to the impeller to an outlet interface of the cannula.
15. A non-transitory computer-readable storage medium comprising instructions that, when executed, direct a processor to perform a method comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of a determination device of a ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the determination device, the cannula, configured to be implanted in a body of a patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula that is distal to the impeller to an outlet interface of the cannula; and a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); sensing a pressure difference (Δp) of blood in a region of the receiving interface and the outlet interface; and determining a viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (co) of the impeller or an electric power input Pel of a drive device for the impeller.
29. (New) The non-transitory computer-readable storage medium of claim 28, wherein the method further comprises determining a viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller.
15. A non-transitory computer-readable storage medium comprising instructions that, when executed, direct a processor to perform a method comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of a determination device of a ventricular assist system, the volumetric flow sensor comprising a Doppler ultrasonic sensor arranged in a distal tip of a cannula of the determination device, the cannula, configured to be implanted in a body of a patient, wherein the ventricular assist system comprises: an impeller configured to convey blood from a lateral receiving interface of the cannula that is distal to the impeller to an outlet interface of the cannula; and a drive device coupled to the impeller, the drive device configured to drive the impeller at a rotational speed (ω); sensing a pressure difference (Δp) of blood in a region of the receiving interface and the outlet interface; and determining a viscosity (η) of the blood based on at least the sensed volumetric flow (Q) of the blood, the sensed pressure difference (Δp) of the blood, and either the rotational speed (co) of the impeller or an electric power input Pel of a drive device for the impeller.
30. (New) The non-transitory computer-readable storage medium of claim 29, wherein determining the viscosity (η) comprises determining the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η).
16. The non-transitory computer-readable storage medium of claim 15, wherein determining the viscosity (η) comprises determining the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η).
31. (New) The non-transitory computer-readable storage medium of claim 29, wherein determining the viscosity (η) comprises using a lookup table.
17. The non-transitory computer-readable storage medium of claim 15, wherein determining the viscosity (η) comprises using a lookup table.
18. The non-transitory computer-readable storage medium of claim 17, wherein a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12 and 28 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nunez et al. (US 2018/0064860 A1).
With respect to claim 12, Nunez discloses a ventricular assist system comprising (see Figure 1B showing a ventricular assist device or “VAD” #10): an impeller (impeller #32); a cannula configured to be implanted in a body of a patient (see cannula #40), wherein the cannula comprises: a lateral receiving interface distal to the impeller (see lateral inlet #20 distal to the impeller #32), configured to receive blood of the patient into an interior of the cannula (see Figures 1B and 1C showing portion #42 as further defined in Figure 1C and labeled as #39 in Figure 1B of the cannula #40 distal from impeller
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#32); and an outlet interface, proximal to the lateral receiving interface wherein the impeller is configured to convey the blood from the lateral receiving interface to the outlet interface (see Figure 1B showing apertures #41 as outlet apertures to outflow the blood from the cannula #40; see also outlet #39 proximal to lateral receiving interface/gap #18; see paragraphs 0042-0046); and a volumetric flow sensor positioned at a tip of the cannula distal to the impeller (see sensor #60 in Figure 1B mounted at the tip end of cannula #40 and distal from impeller #32) and configured to sense a volumetric flow (Q) of the blood of the patient through the cannula, the volumetric flow sensor comprising a Doppler ultrasonic sensor (see paragraphs 0046 and 0052-0053) wherein the impeller is positioned in a region of the outlet interface (see Figure 1B showing the outlet #39 from outlet systems housing #36 considered as an outlet interface where housing #36 has the impeller #32 and hence; the impeller is positioned in the an outlet interface).
With respect to claim 28, Nunez discloses a non-transitory computer-readable storage medium comprising instructions that, when executed, direct a processor to perform a method comprising (see processor discusses in paragraph 0054): sensing a volumetric flow (Q) using a volumetric flow sensor of a ventricular assist system (see Fig. 1B having a sensor #60 in a ventricular assist device or “VAD” #10 to obtain the blood flow; see paragraphs 0046 and 0052-0053), the volumetric flow sensor comprising a Doppler ultrasonic sensor (see paragraphs 0046 and 0052-0053) arranged in a distal tip of a cannula of the ventricular assist system (see sensor #60 in Figure 1B mounted at the tip end of cannula #40), the cannula, configured to be implanted in a body of a patient (see Figure 1A showing the “VAD” implanted in the patient’s heart #100 as described in paragraph 0051), wherein the ventricular assist system comprises: an impeller is positioned in a region of the outlet interface of a cannula and (see Figure 1B showing the outlet #39 from outlet systems housing #36 considered as an outlet interface where housing #36 has the impeller #32 and hence; the impeller is positioned in the an outlet interface of cannula #40) configured to convey blood from a lateral receiving interface of the cannula to the outlet interface of the cannula (see Figures 1B and 1C showing portion #42 as further defined in Figure 1C and labeled as #39 in Figure 1B of the cannula #40 distal from impeller #32 to convey blood from a lateral receiving interface of the cannula to an outlet interface of the cannula as described in paragraph 0052), wherein the lateral receiving interface of the cannula is distal to the impeller and the outlet interface (see lateral inlet #20 distal to the impeller #32 and the outlet interface #39).
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.
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.
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 13-18, 20-26 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nunez et al. (US 2018/0064860 A1) in view of Muller et al. (2015/0290372 A1).
With respect to claims 13, 21 and 29, Nunez discloses the claimed invention as stated above except for specifying that the determination device is configured to determine a viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller. However, Muller discloses the determination device is configured to determine a viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller (see paragraphs 0113-0115; and 0118-0119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a determination device configured to determine a viscosity (η) of blood in the body of the patient based on at least the sensed volumetric flow (Q) of the blood, a pressure difference (Δp) of the blood in a region of the receiving interface and a region of the outlet interface, and either a rotational speed (ω) of the impeller or an electric power input (Pel) of a drive device for the impeller as taught by Muller in combination with Nunez determination device, like an ultrasound sensor, for the purpose of determining the correct placement of the ventricular device that will be conductive to a continuous flow of blood at the proper rate and avoid a rate that could negatively affect patient’s outcome as taught by Muller (see paragraphs 0113-0115).
With respect to claim 20, Nunez discloses a method for determining a viscosity (ii) of blood of a patient in a ventricular assist system, comprising: sensing a volumetric flow (Q) using a volumetric flow sensor of the ventricular assist system (see Fig. 1B having a sensor #60 in a ventricular assist device or “VAD” #10 to obtain the blood flow; see paragraphs 0046 and 0052-0053), the volumetric flow sensor comprising a Doppler ultrasonic sensor (see paragraphs 0046 and 0052-0053) arranged in a distal tip of a cannula of the ventricular assist system (see sensor #60 in Figure 1B mounted at the tip end of cannula #40), the cannula, configured to be implanted in a body of the patient (see Figure 1A showing the “VAD” implanted in the patient’s heart #100 as described in paragraph 0051), wherein the ventricular assist system comprises: an impeller positioned in a region of the outlet interface of a cannula and (see Figure 1B showing the outlet #39 from outlet systems housing #36 considered as an outlet interface where housing #36 has the impeller #32 and hence; the impeller is positioned in the an outlet interface of cannula #40) configured to convey blood from a lateral receiving interface of the cannula to the outlet interface of the cannula (see Figures 1B and 1C showing portion #42 as further defined in Figure 1C and labeled as #39 in Figure 1B of the cannula #40 distal from impeller #32 to convey blood from a lateral receiving interface of the cannula to an outlet interface of the cannula as described in paragraph 0052), the lateral receiving interface being positioned distal to the impeller and the outlet interface (see lateral inlet #20 distal to the impeller #32 and the outlet interface #39). Furthermore, Nunez discloses the claimed invention as stated above except for specifying the step of determining a viscosity (η) of blood based on at least the sensed volumetric flow (Q) of the blood. However, Muller discloses the step of determining a viscosity (η) of blood based on at least the sensed volumetric flow (Q) of the blood (see paragraphs 0113-0115; and 0118-0119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to perform the step of determining a viscosity (η) of blood based on at least the sensed volumetric flow (Q) of the blood as taught by Muller in combination with Nunez determination device, like an ultrasound sensor, for the purpose of determining the correct placement of the ventricular device that will be conductive to a continuous flow of blood at the proper rate and avoid a rate that could negatively affect patient’s outcome as taught by Muller (see paragraphs 0113-0115).
With respect to claims 14, 22 and 30, Nunez discloses the claimed invention as stated above except for specifying that a determination device is configured to determine the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η). However, Muller discloses the determination device is configured to determine the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) (see paragraphs 0113-0115 and 0118-0119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a determination device configured to determine the viscosity (η) based on a functional relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) as taught by Muller in combination with Nunez determination device, like an ultrasound sensor, for the purpose of determining the correct placement of the ventricular device that will be conductive to a continuous flow of blood at the proper rate and avoid a rate that could negatively affect patient’s outcome as taught by Muller (see paragraphs 0113-0115).
With respect to claims 15, 23 and 31, Nunez discloses the claimed invention as stated above except for specifying that the determination device is configured to determine the viscosity (η) using a lookup table. However, Muller discloses the determination device is configured to determine the viscosity (il) using a lookup table (see paragraph 0116). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a determination device configured to determine the viscosity (η) using a lookup table as taught by Muller in combination with Nunez determination device for the purpose of understanding and analyzing the signal when compared to a baseline value in order to identify a disturbance event when the received value is sufficiently different from the baseline value and allow the clinician to act accordingly (see paragraph 0116).
With respect to claims 16 and 24, Nunez discloses the claimed invention as stated above except for specifying that a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table. However, Muller discloses that a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table (see paragraphs 0113-0116; and 0118-0119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a relationship between the volumetric flow (Q), the pressure difference (Δp), and the viscosity (η) is stored in the lookup table as taught by Muller in combination with Nunez data storage for the purpose of understanding and analyzing the signal when compared to a baseline value in order to identify a disturbance event when the received value is sufficiently different from the baseline value and allow the clinician to act accordingly (see paragraph 0116).
With respect to claims 17 and 25, Nunez discloses a pressure sensor device, wherein the pressure sensor device comprises at least one differential pressure sensor or two barometric pressure sensors, wherein the at least one differential pressure sensor or two barometric pressure sensors are configured to measure the pressure difference (Δp) between two sensor points (see Figure 2, showing the pressure sensors #260-#261 and Figure 4 showing sensors #460a and #460b).
With respect to claims 18 and 26, Nunez discloses a pressure sensor device configured to sense the pressure difference (Δp) between two sensor points (see Figure 4 showing sensors #460a and #460b at two different points hence sensing a difference between both locations).
Response to Arguments
Applicant’s arguments in conjunction with amendment, see page 6, filed 04/16/26, with respect to the indefiniteness of the claim language in claims 20-27 have been fully considered and are persuasive. The 35 U.S.C 112 rejections of claims 20-27 has been withdrawn.
Applicant's arguments filed 04/16/26 have been fully considered but they are not persuasive.
Regarding the Double patenting rejection, applicant argues: “Solely in the interest of advancing prosecution, independent Claims 12, 20, and 28 have been amended. Accordingly, Applicant respectfully submits that the double patenting rejections are moot.”
The examiner points out that the amendment filed incorporates the subject matter from now cancelled claim 19 into independent claims 1, 20 and 28; wherein claim 19 was also under Double patenting rejection. Therefore, the Double patenting rejection still applies and is considered as proper. The examiner suggests filing a Terminal Disclaimer.
Applicant argues as follows: “The Office Action cited Nunez as disclosing an impeller 32, a cannula 40, a lateral receiving interface 39, and an outlet interface 41. Office Action at pp. 16-17. Nunez discloses that a pump housing 36 defines an inlet 31 and an outlet 39 at a distal end thereof. Nunez at para. [0039]. Paragraph [0052] of Nunez states that blood flows into inlet 31 of the pump housing, is urged by impeller 32 into bore 46 of outflow cannula 40, and then passes through outlet apertures 41 a-c. Accordingly, the outlet apertures 41 a-c of Nunez, cited as an outlet interface, are distal to the outlet 39 of Nunez, cited as a lateral receiving interface, and distal to the impeller 32. Therefore, Nunez does not disclose a system having "a lateral receiving interface distal to the impeller" and "an outlet interface proximal to the lateral receiving interface . . . wherein the impeller is positioned in a region of the outlet interface," as recited in Claim 12.
The examiner disagrees with applicant’s argument as Nunez discloses a lateral receiving interface distal to the impeller (see lateral inlet section #20 distal to the impeller #32 as seen on Figure 1B) and "an outlet interface proximal to the lateral receiving interface, wherein the impeller is positioned in a region of the outlet interface”. (see Figure 1B showing the outlet #39 from outlet systems housing #36 considered as an outlet interface also where housing #36 has the impeller #32 and hence; the impeller is positioned in the outlet interface). For the reasons as stated above, the 35 U.S.C 102 and 35 U.S.C 103 rejections are maintained and considered proper.
Applicant argues as follows: “Muller fails to remedy the deficiencies of Nunez with respect to independent Claims 12, 20, and 28. Claims 13-18, 21-26, and 29-31 each depend, directly or indirectly, from one of independent Claims 12, 20, and 28. Therefore, Applicant respectfully submits that dependent Claims 13-18, 21-26, and 29-31 are patentable at least because they each depend from an allowable base claim, in addition to being patentable on their own merits. Accordingly, Applicant respectfully requests withdrawal of the foregoing rejections.”
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Conclusion
THIS ACTION IS MADE FINAL. 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 DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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