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 .
Response to Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 08/05/2026, with respect to rejections of claims 5-6 and 15-16 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claims 5-6 and 15-16 has been withdrawn.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 08/05/2026, with respect to rejections of claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20080217245 to Rambod et al. See full detail below.
Claim Objections
Claims 2-7, 10, 12-17, 21-24 are objected to because of the following informalities: dependent claims all recite “of Claim []” which should be amended to lowercase letter. Under MPEP § 608.01(m), each claim must begin with a capital letter and end with a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 depends on cancelled claim, rendering the dependent claim indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7, 11-14, 17, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub 20150290375 to Angwin et al. (hereinafter “Angwin” – previously presented) in view of US Pat Pub 20150290374 Bourque et al. (hereinafter “Bourque” – previously presented) and US 20080217245 A1 to Rambod et al. (hereinafter “Rambod”).
Regarding claims 1 and 11. Angwin discloses a method of managing a speed of implantable blood pump (para 0009 “transcutaneous energy system”, para 0033”the battery may be implanted”, and is therefore internal), the method comprising: starting the pump at a programmed set speed (para 0053 “patient set speed”, fig. 8); decreasing the speed of the pump from the programmed set speed (para 0053 “patient low speed”) to a minimum set speed in response to there is insufficient TETS power to maintain the programmed set speed (para 0053 “critical power hazard” or "pump …running on emergency backup battery”); and decreasing the speed of the pump from the programmed set speed if there is insufficient power to maintain the programmed set speed (para 0053 " target speed can be set to the lower of the patient low speed limit and the patient set speed").
Angwin does not teach progressively decreasing the speed of the pump.
Bourque, from a similar field of endeavor, teaches that pump speeds may be progressively decreased to target (para 0011, curvilinear reduction in speed, para 0016 various other gradual speed transitions), for a power hazard condition of no external power (para 0127), that is, insufficient TETS power (no power is insufficient power). 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 disclosure of Angwin with the teachings of Bourque to use a progressive decrease in pump speed in order to provide the predictable result of keeping the blood flow smooth while reducing the speed to a lower power mode.
Angwin as modified by Bourque renders obvious the limitations above but fails to disclose decreasing the speed of the pump from the programmed set speed toward and below the minimum set speed based on the available power in response to there being insufficient power to maintain the programmed set speed so as to maintain operation of the pump at a speed below the minimum speed.
Rambod, from a similar field of endeavor teaches a battery low condition may slow the pump, discussed herein below, to a very low volume of blood movement through the dialyzer in order to save energy and decrease a possibility of blood clotting. The pump may be slowed to one tenth to one half of its normal pumping rate in order to conserve energy until a battery recharge or new battery is provided (para 0040). ). 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 disclosure of Angwin as modified by Bourque with the teachings of Rambod, because doing so would allow for operating the pump at very low speeds, providing the predictable result of decreasing a possibility of blood clotting.
Regarding claims 2 and 12. Angwin as modified by Bourque and Rambod renders obvious the method of Claim 1 and 11, the method further includes progressively increasing the speed of the pump from the minimum set speed to the programmed set speed (returning to normal operation after new battery replacement).
Regarding claims 3 and 13. Angwin as modified by Bourque and Rambod renders obvious the method of Claim 2 and 12, wherein if the programmed set speed cannot be achieved with available power (Angwin, para 0053-0054), the method further includes decreasing the speed of the pump to the minimum set speed after progressively increasing the speed of the pump from the minimum set speed (Angwin, para 0015 “if a pump has just been started up, the pump’s speed would have been increased to a minimum set speed” 0053 “in the absence of power problems, the pump would operate at the patient’s appropriate set speed, which would have been reached by increasing the speed of the pump past the minimum set speed”; Bourque para 0011 teaching progressively increasing/decreasing the speed, Rambod, para 0040).
Regarding claims 4 and 14. Angwin as modified by Bourque and Rambod renders obvious the method of Claim 1 and 11, wherein if power is sufficient to maintain the minimum set speed, the method further includes increasing the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from the minimum set speed (it is understood that normal operation will resume once battery has been replaced/charged). It would have been obvious to one having ordinary skill in the art to configure the processing circuitry to maintain the minimum set speed if power is sufficient to do so, and further, to increase the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from the minimum set speed if power is available, in order to maintain the optimum pump speed in every situation where the power availability permits. Otherwise, it would make no sense to operate the pump at less than the appropriate set speed if all power requirements are currently being met by the apparatus.
Regarding claims 7 and 17. Angwin as modified by Bourque and Rambod renders obvious the method of Claim 1 and 11, wherein the pump is in communication with an implanted controller (Angwin, para 0033, both the system controller and battery may be implanted, and therefore internal).
Regarding claim 10 . Angwin as modified by Bourque and Rambod renders obvious the method of Claim 8 and 18, wherein the power source is one from the group consisting of wall power and a battery (See rejection of claim 1).
Regarding claim 20, Angwin teaches a control circuit for controlling a speed of an implantable blood pump (para 0009 "implantable control unit" for a blood pump, transcutaneous energy system, para 0033, the battery may be implanted, and is therefore internal), the control circuit comprising: processing circuitry configured to start the pump to a programmed set speed (para 0053, “patient set speed"; Fig. 8, “sent speed for blood pump”); decrease the speed of the pump from the programmed set speed to a minimum set speed (para 0053, “patient low speed”) if there is insufficient power to maintain the programmed set speed(para 0053, " target speed can be set to the lower of the patient low speed limit and the patient set speed",”). Angwin does not teach progressively decreasing the speed of the pump.
Bourque teaches that pump speeds may be progressively decreased to target (para 0011, curvilinear reduction in speed, para 0106 various other gradual speed transitions), for a power hazard condition of no external power (para 0127), that is, insufficient TETS power (no power is insufficient power). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a progressive decrease in pump speed in order to keep the blood flow smooth while reducing the speed to a lower power mode. Angwin teaches that a pump is operated based on a programmed patient-specific set speed (Angwin, para 0015-0016) in the absence of power hazards that may lead to different speed choices.
Angwin further states that the pump is operated at the patient set speed in the absence of adverse power-related events (Angwin, para 0053). Although Angwin does not explicitly address a case in which power is sufficient to maintain the minimum set speed, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the processing circuitry to maintain the minimum set speed if power is sufficient to do so, and further, to increase the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from the minimum set speed if power is available, in order to maintain the optimum pump speed in every situation where the power availability permits. Otherwise, it would make no sense to operate the pump at less than the appropriate set speed if all power requirements are currently being met by the apparatus. Angwin teaches that if the pump speed is less than a critical cutoff speed, namely zero, Angwin teaches embodiments in which a pump may be stopped completely (Angwin, para 0053, target speed can be set to zero, therefore the pump is transitioned into a full stop), following progressively decreasing the speed of the pump, as taught by Bourque as explained above.
Angwin as modified by Bourque renders obvious the limitations above but fails to disclose if there is insufficient power to maintain the minimum set speed, progressively decrease the speed of the pump from the minimum set speed
Rambod, from a similar field of endeavor teaches a battery low condition may slow the pump, discussed herein below, to a very low volume of blood movement through the dialyzer in order to save energy and decrease a possibility of blood clotting. The pump may be slowed to one tenth to one half of its normal pumping rate in order to conserve energy until a battery recharge or new battery is provided (para 0040). ). 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 disclosure of Angwin as modified by Bourque with the teachings of Rambod, because doing so would allow for operating the pump at very low speeds, providing the predictable result of decreasing a possibility of blood clotting.
Regarding claims 21-24. (New) Angwin as modified by Bourque and Rambod renders obvious wherein the programmed set speed is in a range from 2400-3200 revolutions-per-minute; wherein the minimum set speed is in a range from 1800-2200 revolutions-per-minute; wherein the critical cutoff speed is in a range from 900-1200 revolutions-per-minute (MPEP, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, absent any evidence of criticality, it is understood that the mentioned RPMs are taken at arbitrary parameters. Furthermore, such RPMs are well known in the art as evident in US 20030233021 to Nose et al., US 20220032038 to Schilling et al.)
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Angwin in view of Bourque and Rambod, further in view of US Pat Pub No. 20070197854 to Marseille et al. (hereinafter “Marseille” – previously presented).
Regarding claims 5 and 15. Angwin as modified by Bourque and Rambod renders obvious the method of Claim 1 and 11, Angwin teaches embodiments in which a pump may be stopped completely (Angwin, para 0053, target speed can be set to zero, therefore the pump is transitioned into a full stop), following progressively decreasing the speed, as explained in view of Bourque in the rejection to claim 1. Angwin does not teach an the method further includes turning off the pump and acknowledging that the pump has stopped. Marseille teaches a heart assist system wherein an indicator light is used to indicate pump status, including a red light to indicate that the pump has stopped (Marseille, para 0016). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to acknowledge that the pump has stopped if the pump speed is less than a critical cutoff speed following progressively decreasing the speed of the pump, in order to let the user know that there is a problem and to address it quickly before the user suffers negative health effects.
Regarding claims 6 and 16. Angwin as modified by Bourque Rambod and Marseille renders obvious the method of Claim 5 and 15, Angwin does not explicitly teach attempting to restart the pump after it has stopped. However, considering that Angwin teaches that the pump should be operated at a speed aiming for the patient target speed (Angwin, para 0053), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that when the power is returned to the pump, the system should attempt to restart the pump, in order to keep the pump operational for assisting in keeping the patient healthy.
Double Patenting
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12138440. Although the claims at issue are not identical, they are not patentably distinct from each other. See details below.
1. A method of managing a speed of implantable blood pump, the implantable blood pump being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the method comprising: starting the pump at a programmed set speed; decreasing the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient TETS power to maintain the programmed set speed; and progressively decreasing the speed of the pump from the programmed set speed if there is insufficient power to maintain the programmed set speed.
1. A method of managing a speed of implantable blood pump, the implantable blood pump being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the method comprising: starting the pump at a programmed set speed; decreasing the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient TETS power to maintain the programmed set speed; progressively decreasing the speed of the pump from the minimum set speed to maintain a speed below the minimum set speed that is supported by available power if there is insufficient power to maintain the minimum set speed; and stopping the pump if the speed below the minimum set speed is less than a critical cutoff speed.
2. The method of Claim 1, wherein if the capacity of the internal battery is greater than the predetermined reserve level or TETS power is available, and there is sufficient TETS power headroom, the method further includes progressively increasing the speed of the pump from the minimum set speed to the programmed set speed.
2. The method of claim 1, wherein if the capacity of the internal battery is greater than the predetermined reserve level or TETS power is available, and there is sufficient TETS power headroom, the method further includes progressively increasing the speed of the pump from the minimum set speed to the programmed set speed.
3. The method of Claim 2, wherein if the programmed set speed cannot be achieved with available power, the method further includes decreasing the speed of the pump to the minimum set speed after progressively increasing the speed of the pump from the minimum set speed.
3. The method of claim 1, wherein if power is sufficient to maintain the minimum set speed, the method further includes increasing the speed of the pump to the minimum set speed after progressively decreasing the speed of the pump from the programmed set speed.
4. The method of Claim 1, wherein if power is sufficient to maintain the minimum set speed, the method further includes increasing the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from the minimum set speed.
3. The method of claim 1, wherein if power is sufficient to maintain the minimum set speed, the method further includes increasing the speed of the pump to the minimum set speed after progressively decreasing the speed of the pump from the programmed set speed.
5. The method of Claim 1, wherein if the pump speed is less than a critical cutoff speed following progressively decreasing the speed of the pump, and acknowledge that the pump has stopped.
claim 1. [] stopping the pump if the speed below the minimum set speed is less than a critical cutoff speed.
6. The method of Claim 5, further including attempting to restart the pump after it has stopped.
4. The method of claim 1, further including attempting to restart the pump after it has stopped.
7. The method of Claim 1, wherein the pump is in communication with an implanted controller and wherein the implanted controller includes the internal battery.
5. The method of claim 1, wherein the pump is in communication with an implanted controller and wherein the implanted controller includes the internal battery.
8. The method of Claim 7, wherein the internal battery is in communication with an internal coil of the TETS.
6. The method of claim 5, wherein the internal battery is in communication with an internal coil of the TETS.
9. The method of Claim 8, wherein the internal coil of the TETS is in communication with an external coil of the TETS, the external coil being further in communication with a power source.
7. The method of claim 6, wherein the internal coil of the TETS is in communication with an external coil of the TETS, the external coil being further in communication with a power source.
10. The method of Claim 9, wherein the power source is one from the group consisting of wall power and a battery.
8. The method of claim 7, wherein the power source is one from the group consisting of wall power and a battery.
11. A control circuit for controlling a speed of an implantable blood pump, the control circuit being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the control circuit comprising: processing circuitry configured to: start the pump to a programmed set speed; decrease the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient power headroom; and progressively decrease the speed of the pump from the programmed set speed if there is insufficient power to maintain the programmed set speed.
9. A control circuit for controlling a speed of an implantable blood pump, the control circuit being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the control circuit comprising: processing circuitry configured to: start the pump to a programmed set speed; decrease the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient power headroom; progressively decrease the speed of the pump from the minimum set speed to maintain a speed below the minimum set speed that is supported by available power if there is insufficient power to maintain the minimum set speed; and stop the pump if the speed below the minimum set speed is less than a critical cutoff speed.
12. The control circuit of Claim 11, wherein if the power level of the internal battery is greater than the predetermined reserve level or TETS power is available, and there is sufficient power headroom, the processing circuitry is further configured to progressively increase the speed of the pump from the minimum set speed to the programmed set speed.
10. The control circuit of claim 9, wherein if the capacity of the internal battery is greater than the predetermined reserve level or TETS power is available, and there is sufficient power headroom, the processing circuitry is further configured to progressively increase the speed of the pump from the minimum set speed to the programmed set speed.
13. The control circuit of Claim 12, wherein if the programmed set speed cannot be achieved with available power, the processing circuitry is further configured to decrease the speed of the pump to the minimum set speed after progressively increasing the speed of the pump from the minimum set speed.
11. The control circuit of claim 9, wherein if power is sufficient to maintain the minimum set speed, the processing circuitry is further configured to increase the speed of the pump to the minimum set speed after progressively decreasing the speed of the pump from to the programmed set speed.
14. The control circuit of Claim 11, wherein if power is sufficient to maintain the minimum set speed, the processing circuitry is further configured to increase the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from to the minimum set speed.
11. The control circuit of claim 9, wherein if power is sufficient to maintain the minimum set speed, the processing circuitry is further configured to increase the speed of the pump to the minimum set speed after progressively decreasing the speed of the pump from to the programmed set speed.
15. The control circuit of Claim 11, wherein if the pump speed is less than a critical cutoff speed following progressively decreasing the speed of the pump, the processing circuitry is further configured to acknowledge that the pump has stopped.
9. and stop the pump if the speed below the minimum set speed is less than a critical cutoff speed.
16. The control circuit of Claim 15, wherein the processing circuitry is further configured to attempt to restart the pump after the pump has stopped.
12. The control circuit of claim 9, wherein the processing circuitry is further configured to attempt to restart the pump after the pump has stopped.
17. The control circuit of Claim 11, wherein the pump is in communication with an implanted controller and wherein the implanted controller includes the internal battery.
13. The control circuit of claim 9, wherein the pump is in communication with an implanted controller and wherein the implanted controller includes the internal battery.
18. The control circuit of Claim 17, wherein the internal battery is in communication with an internal coil of the TETS.
14. The control circuit of claim 13, wherein the internal battery is in communication with an internal coil of the TETS.
19. The control circuit of Claim 18, wherein the internal coil of the TETS is in communication with an external coil of the TETS, the external coil being further in communication with a power source, and wherein the power source is one from the group consisting of wall power and a battery.
15. The control circuit of claim 14, wherein the internal coil of the TETS is in communication with an external coil of the TETS, the external coil being further in communication with a power source, and wherein the power source is one from the group consisting of wall power and a battery.
20. A control circuit for controlling a speed of an implantable blood pump, the control circuit being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the control circuit comprising: processing circuitry configured to: start the pump to a programmed set speed; decrease the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient TETS power to maintain the programmed set speed; if there is insufficient power to maintain the minimum set speed, progressively decrease the speed of the pump from the minimum set speed if power is sufficient to maintain the minimum set speed, increase the speed of the pump to the programmed set speed after progressively decreasing the speed of the pump from the minimum set speed; and if the pump speed is less than a critical cutoff speed following progressively decreasing the speed of the pump, turn off the pump.
16. A control circuit for controlling a speed of an implantable blood pump, the control circuit being in communication with an internal battery and a transcutaneous energy transfer system (TETS), the control circuit comprising: processing circuitry configured to: start the pump to a programmed set speed; decrease the speed of the pump from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient TETS power to maintain the programmed set speed; if there is insufficient power to maintain the minimum set speed, progressively decrease the speed of the pump from the minimum set speed to maintain a speed below the minimum set speed that is supported by available power; if power is sufficient to maintain the minimum set speed, increase the speed of the pump to the minimum set speed after progressively decreasing the speed of the pump from the programmed set speed; and if the speed below the minimum set speed is less than a critical cutoff speed, stop the pump.
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 SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANA SAHAND/Examiner, Art Unit 3796
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