DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 36-37, 40 and 45 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 2010/0204539 to Tansley et al. (herein Tansley - cited by applicant).
In reference to at least claim 36
Tansley discloses an apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject (e.g. “counter-pulsed”, para. [0008], “counter-pulsation with the patient’s heart”, para. [0023], [0029]), the apparatus comprising a controller (e.g. controller 42) configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line (e.g. “The control unit 42 may be used to set up controllable parameters of the drive unit 30 and/or to download patient and blood pump data which may be stored on the drive unit 30.”, para. [0057]); while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line (e.g. “the blood pump system further comprises a pressure sensor operable to measure pressure in the fluid conduit, and the drive unit is responsive to the measured pressure.”, para. [0021], [0051], “The pressure sensor 38 (and/or other pressure sensors described above) is used to assist with the timing of the fluid flow into and out of the fluid chamber 22 of the blood pump 10.”, para. [0063]); and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal (e.g. “The pressure sensor 38 (and/or other pressure sensors described above) is used to assist with the timing of the fluid flow into and out of the fluid chamber 22 of the blood pump 10.”, para. [0063]), by alternately and in a pulsatile manner exposing the CPD drive line to a negative pressure of a vacuum chamber to fill the CPD as a heart is contracting and exposing the CPD drive line to a positive pressure of a pressure chamber to empty the CPD as the heart is relaxing (e.g. “In a preferred embodiment, the contraction of the blood pump 10 is controlled such that it occurs in anti-phase with the contractions of the natural heart 1. In other words, when the heart 1 is in diastole, the blood pump 10 is in systole, and vice-versa.”, para. [0063],[0061] therefore in anti-phase a negative pressure is used to fill the CPD when a heart is contracting and a positive pressure is provided to empty the chamber when the heart is relaxing).
In reference to at least claim 37
Tansley discloses wherein the CPD drive line is in pneumatic communication with the CPD (e.g. “The fluid may be a liquid or a gas, so that the drive unit 30 is operable to provide pulses of hydraulic or pneumatic fluid flow into the fluid conduit 28.”, para. [0055], [0058]).
In reference to at least claim 40
Tansley discloses wherein the controller is configured to adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full or an empty condition of the CPD by analyzing change in drive line pressure as a function of time (e.g. “The pressure sensor 38 (and/or other pressure sensors described above) is used to assist with the timing of the fluid flow into and out of the fluid chamber 22 of the blood pump 10. In particular, the pressure measurements from the pressure sensor 38 (and/or other pressure sensors described above) are relayed to the drive unit 30 and/or the control unit 42…. Other measurements may also be used to control the timing and/or amount of fluid flow into and out of the fluid chamber 22.”, para. [0063]).
In reference to at least claim 45
Tansley discloses wherein the controller is configured to adjust the pressure supplied to the CPD drive line by adjusting one or more operating parameters of a pump device pneumatically coupled to the CPD drive line (e.g. “a control unit 42 which is programmable and operable to run software 44 to control the drive unit 30…. The control unit 42 may be used to set up controllable parameters of the drive unit 30”, para. [0057], since the control unit 42 can provide controllable parameters the control unit has the capability to adjust the pressure supplied by adjusting one or more operating parameters of a pump device pneumatically coupled to the CPD drive line).
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 36-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,549,020. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 10,549,020 recite similar apparatus for controlling couterpulsation that includes a controller that controls couterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that the instant application recites that the adjusting is done alternately and in a pulsatile manner which is within the scope of U.S. Patent No. 10,549,020, therefore the scope of the claims within U.S. Patent No. 10,549,020 anticipate the scope of the claims recited in the instant application fully anticipating the claims within the instant application, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 10,549,020
Analysis
36. (New) An apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject, the apparatus comprising a controller configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line; while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal, by alternately and in a pulsatile manner exposing the CPD drive line to a negative pressure of a vacuum chamber to fill the CPD as a heart is contracting and exposing the CPD drive line to a positive pressure of a pressure chamber to empty the CPD as the heart is relaxing.
1. An apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject, the apparatus comprising a controller configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line; while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal, by performing at least one of: exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing.
As stated above, both the claims in the instant application and those within U.S. Patent No. 10,549,020 recite similar apparatus for controlling couterpulsation that includes a controller that controls couterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that the instant application recites that the adjusting is done alternately and in a pulsatile manner which is within the scope of U.S. Patent No. 10,549,020, therefore the scope of the claims within U.S. Patent No. 10,549,020 anticipate the scope of the claims recited in the instant application fully anticipating the claims within the instant application
37. (New) The apparatus of claim 36, wherein the CPD drive line is in pneumatic communication with the CPD
2. The apparatus of claim 1, wherein the CPD drive line is in pneumatic communication with the CPD.
See analysis above regarding claim 36. Claim 37 of the instant application is fully disclosed within claim 2 of US Patent No. 10,549,020.
38. (New) The apparatus of claim 36, wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the CPD drive line and a pressure lower limit corresponding to a lower limit of the pressure in the CPD drive line, wherein the controller adjusts the pressure supplied to the CPD drive line by: in response to determining that the pressure in the CPD drive line exceeds the
pressure upper limit, venting the pressure chamber until the pressure in the CPD drive line is below the pressure upper limit; and in response to determining that the pressure in the CPD drive line is below the
pressure lower limit, opening a valve corresponding to the vacuum chamber until the pressure in the CPD drive line is above the pressure lower limit.
3. The apparatus of claim 1, wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the CPD drive line and a pressure lower limit corresponding to a lower limit of the pressure in the CPD drive line, wherein the controller adjusts the pressure supplied to the CPD drive line by: in response to determining that the pressure in the CPD drive line exceeds the pressure upper limit, venting the pressure chamber until the pressure in the CPD drive line is below the pressure upper limit, and in response to determining that the pressure in the CPD drive line is below the pressure lower limit, opening a valve corresponding to the vacuum chamber until the pressure in the CPD drive line is above the pressure lower limit.
See analysis above regarding claim 36. Claim 38 of the instant application is fully disclosed within claim 3 of US Patent No. 10,549,020.
39. (New) The apparatus of claim 38, wherein venting the pressure chamber induces a
negative pressure in the CPD drive line, causing the CPD to fill with blood from the human or
animal subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the CPD drive line, causing the CPD to empty of blood.
4. The apparatus of claim 3, wherein venting the pressure chamber induces a negative pressure in the drive line, causing the CPD to fill with blood from the subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the CPD drive line, causing the CPD to empty of blood.
See analysis above regarding claim 38. Claim 39 of the instant application is fully disclosed within claim 4 of US Patent No. 10,549,020.
40. (New) The apparatus of claim 36, wherein the controller is configured to adjust the
pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
5. The apparatus of claim 1, wherein the controller is configured to adjust the pressure supplied to the CPD drive line based at least in part on the CDP drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
See analysis above regarding claim 36. Claim 40 of the instant application is fully disclosed within claim 5 of US Patent No. 10,549,020.
41. (New) The apparatus of claim 40, wherein:
the CPD comprises a drive chamber in pneumatic communication with the CPD
drive line and a blood chamber that is sealed from the drive chamber by a membrane; and
the controller analyzes the CPD drive line pressure signal to determine the full or the empty condition of the CPD by detecting a feature in the CPD drive line pressure signal
indicative of the membrane reaching a substantially stationary end position.
6. The apparatus of claim 5, wherein: the CPD comprises a drive chamber in pneumatic communication with the drive line and a blood chamber that is sealed from the drive chamber by a membrane, and the controller analyzes the CPD drive line pressure signal to determine the full or the empty condition of the CPD by detecting a feature in the drive line pressure signal indicative of the membrane reaching a substantially stationary end position.
See analysis above regarding claim 40. Claim 41 of the instant application is fully disclosed within claim 6 of US Patent No. 10,549,020.
42. (New) The apparatus of claim 40, wherein the controller is further configured to:
detect a temporal location of the full or the empty condition during an operational cycle of the CPD;
compare the temporal location to a desired range; and
if the temporal location is outside of the desired range, adjust the pressure supplied
to the CPD drive line.
7. The apparatus of claim 5, wherein the controller is further configured to: detect a temporal location of the full or the empty condition during an operational cycle of the CPD; compare the temporal location to a desired range; and if the temporal location is outside of the desired range, adjust the pressure supplied to the CPD drive line.
See analysis above regarding claim 40. Claim 42 of the instant application is fully disclosed within claim 7 of US Patent No. 10,549,020.
43. (New) The apparatus of claim 42, wherein the controller is further configured to,
during emptying of the CPD:
determine if the temporal location of the empty condition occurs at a time earlier
than the desired range and, if so, adjust the drive line pressure to slow the emptying; and
determine if the temporal location of the empty condition occurs at a time later than
the desired range or does not occur and, if so, adjust the drive line pressure to speed up the
emptying.
8. The apparatus of claim 7, wherein the controller is further configured to, during emptying of the CPD: determine if the temporal location of the empty condition occurs at a time earlier than the desired range and, if so, adjust the drive line pressure to slow the emptying; and determine if the temporal location of the empty condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the emptying.
See analysis above regarding claim 42. Claim 43 of the instant application is fully disclosed within claim 8 of US Patent No. 10,549,020.
44. (New) The apparatus of claim 42, wherein the controller is further configured to,
during filling of the CPD:
determine if the temporal location of the full condition occurs at a time earlier than
the desired range and, if so, adjust the drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the filling.
9. The apparatus of claim 7, wherein the controller is further configured to, during filling of the CPD: determine if the temporal location of the full condition occurs at a time earlier than the desired range and, if so, adjust the drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the filling.
See analysis above regarding claim 42. Claim 44 of the instant application is fully disclosed within claim 9 of US Patent No. 10,549,020.
45. (New) The apparatus of claim 36, wherein the controller is configured to adjust the
pressure supplied to the CPD drive line by adjusting one or more operating parameters of a pump
device pneumatically coupled to the CPD drive line.
10. The apparatus of claim 1, wherein the controller is configured to adjust the pressure supplied to the drive line by adjusting one or more operating parameters of a pump device pneumatically coupled to the CPD drive line.
See analysis above regarding claim 36. Claim 45 of the instant application is fully disclosed within claim 10 of US Patent No. 10,549,020.
Claims 36-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,577,068. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 11,577,068 recite similar apparatus for controlling couterpulsation that includes a controller that controls counterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that U.S. Patent No. 11,577,068 recites several additional elements that are included within a system and additional capabilities of the controller making the claims within U.S. Patent No. 11,577,068 more specific than the generic claims within the instant application, therefore the scope of the claims within U.S. Patent No. 11,577,068 anticipates the scope of the claims recited in the instant application fully anticipating the claims within the instant application, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 11,577,068
Analysis
36. (New) An apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject, the apparatus comprising a controller configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line; while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal, by alternately and in a pulsatile manner exposing the CPD drive line to a negative pressure of a vacuum chamber to fill the CPD as a heart is contracting and exposing the CPD drive line to a positive pressure of a pressure chamber to empty the CPD as the heart is relaxing.
1. A system for providing hemodynamic support, the system comprising: a blood pump, a controller, and a counterpulsation device (CPD) comprising… wherein the controller is configured to: receive a heartbeat signal indicative of a heartbeat of a subject; control a pressure supplied to the drive line to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heartbeat signal; receive a drive line pressure signal indicative of the pressure in the drive line; and adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal, by performing at least one of: exposing the drive line to a negative pressure to fill the blood chamber as the heart of the subject is contracting and exposing the drive line to a positive pressure to empty the blood chamber as the heart of the subject is relaxing, wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the drive line and a pressure lower limit corresponding to a lower limit of the pressure in the drive line, wherein the controller adjusts the pressure supplied to the drive line by: in response to determining that the pressure in the drive line exceeds the pressure upper limit, venting a pressure chamber until the pressure in the drive line is below the pressure upper limit, and in response to determining that the pressure in the drive line is below the pressure lower limit, opening a valve corresponding to a vacuum chamber until the pressure in the drive line is above the pressure lower limit, and wherein venting the pressure chamber induces a negative pressure in the drive line, causing the CPD to fill with blood from the subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the drive line, causing the CPD to empty of blood.
As stated above, both the claims in the instant application and those within U.S. Patent No. 11,577,068 recite similar apparatus for controlling couterpulsation that includes a controller that controls counterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that U.S. Patent No. 11,577,068 recites several additional elements that are included within a system and additional capabilities of the controller making the claims within U.S. Patent No. 11,577,068 more specific than the generic claims within the instant application, therefore the scope of the claims within U.S. Patent No. 11,577,068 anticipates the scope of the claims recited in the instant application fully anticipating the claims within the instant application.
36. (New) An apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject, the apparatus comprising a controller configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line; while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal, by alternately and in a pulsatile manner exposing the CPD drive line to a negative pressure of a vacuum chamber to fill the CPD as a heart is contracting and exposing the CPD drive line to a positive pressure of a pressure chamber to empty the CPD as the heart is relaxing.
2. A system for providing hemodynamic support, the system comprising: a blood pump, a controller, and a counterpulsation device (CPD) comprising:..and a drive line in pneumatic communication with the drive chamber, wherein the controller is configured to: receive a heartbeat signal indicative of a heartbeat of a subject; control a pressure supplied to the drive line to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heartbeat signal; receive a drive line pressure signal indicative of the pressure in the drive line; and adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal, by performing at least one of: exposing the drive line to a negative pressure to fill the blood chamber as the heart of the subject is contracting and exposing the drive line to a positive pressure to empty the blood chamber as the heart of the subject is relaxing wherein the controller is configured to adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal by analyzing the drive line pressure signal to I determine a full condition or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
As stated above, both the claims in the instant application and those within U.S. Patent No. 11,577,068 recite similar apparatus for controlling couterpulsation that includes a controller that controls counterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that U.S. Patent No. 11,577,068 recites several additional elements that are included within a system and additional capabilities of the controller making the claims within U.S. Patent No. 11,577,068 more specific than the generic claims within the instant application, therefore the scope of the claims within U.S. Patent No. 11,577,068 anticipates the scope of the claims recited in the instant application fully anticipating the claims within the instant application.
37. (New) The apparatus of claim 36, wherein the CPD drive line is in pneumatic communication with the CPD
1. A system for providing hemodynamic support, the system comprising…and a drive line in pneumatic communication with the drive chamber, wherein the controller is configured to: receive a heartbeat signal indicative of a heartbeat of a subject; control a pressure supplied to the drive line to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heartbeat signal; receive a drive line pressure signal indicative of the pressure in the drive line; and adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal, by performing at least one of: exposing the drive line to a negative pressure to fill the blood chamber as the heart of the subject is contracting…
See analysis above regarding claim 36. Claim 37 of the instant application is fully disclosed within claim 1 of U.S. Patent No. 11,577,068.
37. (New) The apparatus of claim 36, wherein the CPD drive line is in pneumatic communication with the CPD
2. A system for providing hemodynamic support, the system comprising: a blood pump, a controller, and a counterpulsation device (CPD) comprising:..and a drive line in pneumatic communication with the drive chamber,…..receive a drive line pressure signal indicative of the pressure in the drive line; and…
See analysis above regarding claim 36. Claim 37 of the instant application is fully disclosed within claim 2 of U.S. Patent No. 11,577,068.
38. (New) The apparatus of claim 36, wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the CPD drive line and a pressure lower limit corresponding to a lower limit of the pressure in the CPD drive line, wherein the controller adjusts the pressure supplied to the CPD drive line by: in response to determining that the pressure in the CPD drive line exceeds the pressure upper limit, venting the pressure chamber until the pressure in the CPD drive line is below the pressure upper limit; and in response to determining that the pressure in the CPD drive line is below the pressure lower limit, opening a valve corresponding to the vacuum chamber until the pressure in the CPD drive line is above the pressure lower limit.
1. A system for providing hemodynamic support, the system comprising a blood pump, a controller, and a counterpulsation device (CPD) comprising…: wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the drive line and a pressure lower limit corresponding to a lower limit of the pressure in the drive line, wherein the controller adjusts the pressure supplied to the drive line by: in response to determining that the pressure in the drive line exceeds the pressure upper limit, venting a pressure chamber until the pressure in the drive line is below the pressure upper limit, and in response to determining that the pressure in the drive line is below the pressure lower limit, opening a valve corresponding to a vacuum chamber until the pressure in the drive line is above the pressure lower limit, and wherein venting the pressure chamber induces a negative pressure in the drive line, causing the CPD to fill with blood from the subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the drive line, causing the CPD to empty of blood.
See analysis above regarding claim 36. Claim 38 of the instant application is fully disclosed within claim 1 of U.S. Patent No. 11,577,068.
39. (New) The apparatus of claim 38, wherein venting the pressure chamber induces a
negative pressure in the CPD drive line, causing the CPD to fill with blood from the human or
animal subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the CPD drive line, causing the CPD to empty of blood.
1. A system for providing hemodynamic support, the system comprising a blood pump, a controller, and a counterpulsation device (CPD) comprising…: wherein the controller is further configured to receive a pressure upper limit corresponding to an upper limit of the pressure in the drive line and a pressure lower limit ….and wherein venting the pressure chamber induces a negative pressure in the drive line, causing the CPD to fill with blood from the subject, and opening the valve corresponding to the vacuum chamber induces a positive pressure in the drive line, causing the CPD to empty of blood.
See analysis above regarding claim 38. Claim 39 of the instant application is fully disclosed within claim 1 of U.S. Patent No. 11,577,068.
40. (New) The apparatus of claim 36, wherein the controller is configured to adjust the
pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
2. A system for providing hemodynamic support, the system comprising: a blood pump, a controller, and a counterpulsation device (CPD) comprising: a blood chamber, a drive chamber, a membrane configured to separate the blood chamber from the drive chamber, and a drive line in pneumatic communication with the drive chamber, wherein the controller is configured to:…. wherein the controller is configured to adjust the pressure supplied to the drive line based at least in part on the drive line pressure signal by analyzing the drive line pressure signal to I determine a full condition or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
See analysis above regarding claim 36. Claim 40 of the instant application is fully disclosed within claim 2 of U.S. Patent No. 11,577,068.
41. (New) The apparatus of claim 40, wherein:
the CPD comprises a drive chamber in pneumatic communication with the CPD
drive line and a blood chamber that is sealed from the drive chamber by a membrane; and
the controller analyzes the CPD drive line pressure signal to determine the full or the empty condition of the CPD by detecting a feature in the CPD drive line pressure signal
indicative of the membrane reaching a substantially stationary end position.
2. A system for providing hemodynamic support, the system comprising: a blood pump, a controller, and a counterpulsation device (CPD) comprising: a blood chamber, a drive chamber, a membrane configured to separate the blood chamber from the drive chamber, and a drive line in pneumatic communication with the drive chamber, wherein the controller is configured to:…
3. The system of claim 2, wherein: the controller analyzes the drive line pressure signal to determine the full condition or the empty condition of the CPD by detecting a feature in the drive line pressure signal indicative of the membrane reaching a substantially stationary end position.
See analysis above regarding claim 40. Claim 41 of the instant application is fully disclosed within claim 3 of U.S. Patent No. 11,577,068.
42. (New) The apparatus of claim 40, wherein the controller is further configured to:
detect a temporal location of the full or the empty condition during an operational cycle of the CPD;
compare the temporal location to a desired range; and
if the temporal location is outside of the desired range, adjust the pressure supplied
to the CPD drive line.
4. The system of claim 2, wherein the controller is further configured to: detect a temporal location of the full condition or the empty condition during an operational cycle of the CPD; compare the temporal location to a desired range; and if the temporal location is outside of the desired range, adjust the pressure supplied to the drive line.
See analysis above regarding claim 40. Claim 42 of the instant application is fully disclosed within claim 4 of U.S. Patent No. 11,577,068.
43. (New) The apparatus of claim 42, wherein the controller is further configured to,
during emptying of the CPD:
determine if the temporal location of the empty condition occurs at a time earlier
than the desired range and, if so, adjust the drive line pressure to slow the emptying; and
determine if the temporal location of the empty condition occurs at a time later than
the desired range or does not occur and, if so, adjust the drive line pressure to speed up the
emptying.
5. The system of claim 4, wherein the controller is further configured to, during emptying of the CPD: determine if the temporal location of the empty condition occurs at a time earlier than the desired range and, if so, adjust the drive line pressure to slow the emptying; and determine if the temporal location of the empty condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the emptying.
See analysis above regarding claim 42. Claim 43 of the instant application is fully disclosed within claim 5 of U.S. Patent No. 11,577,068.
44. (New) The apparatus of claim 42, wherein the controller is further configured to,
during filling of the CPD:
determine if the temporal location of the full condition occurs at a time earlier than
the desired range and, if so, adjust the drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the filling.
6. The system of claim 4, wherein the controller is further configured to, during filling of the CPD: determine if the temporal location of the full condition occurs at a time earlier than the desired range and, if so, adjust the drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the filling.
See analysis above regarding claim 42. Claim 44 of the instant application is fully disclosed within claim 6 of U.S. Patent No. 11,577,068.
Claims 36-37 and 40-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,280,251. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and those within U.S. Patent No. 12,280,251 recite similar apparatus for controlling couterpulsation that includes a controller that controls counterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that U.S. Patent No. 12,280,251 recites several additional elements that are included within a system and additional capabilities of the controller making the claims within U.S. Patent No. 12,280,251 more specific than the generic claims within the instant application, therefore the scope of the claims within U.S. Patent No. 12,280,251 anticipates the scope of the claims recited in the instant application fully anticipating the claims within the instant application, see claim chart below for claim to claim comparison.
Instant Application
U.S. Patent No. 12,280,251
Analysis
36. (New) An apparatus for controlling operation of a counterpulsation device (CPD) in a human or animal subject, the apparatus comprising a controller configured to: provide counterpulsation therapy by controlling pressure supplied to a CPD drive line; while providing counterpulsation therapy, receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal, by alternately and in a pulsatile manner exposing the CPD drive line to a negative pressure of a vacuum chamber to fill the CPD as a heart is contracting and exposing the CPD drive line to a positive pressure of a pressure chamber to empty the CPD as the heart is relaxing.
1. A counterpulsation device (CPD) comprising: a blood chamber; a drive chamber; a membrane configured to separate the blood chamber from the drive chamber; a CPD drive line in pneumatic communication with the drive chamber; and a controller configured to: receive a heartbeat signal indicative of a heartbeat of a subject; control a pressure supplied to the CPD drive line to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heartbeat signal; receive a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal, by performing at least one of: exposing the CPD drive line to a negative pressure to fill the blood chamber as the heart of the subject is contracting and exposing the CPD drive line to a positive pressure to empty the blood chamber as the heart of the subject is relaxing, wherein the controller is configured to adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full condition or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
As stated above, both the claims in the instant application and those within U.S. Patent No. 12,280,251 recite similar apparatus for controlling couterpulsation that includes a controller that controls counterpulsation therapy, receives a drive line pressure signal and adjust the pressure supplied by exposing the drive line to a negative pressure of a vacuum chamber to fill a CPD chamber as a heart is contracting and exposing the driveline to a positive pressure of a pressure chamber to empty the CPD chamber as the heart is relaxing with the only differences being that U.S. Patent No. 12,280,251 recites several additional elements that are included within a system and additional capabilities of the controller making the claims within U.S. Patent No. 12,280,251 more specific than the generic claims within the instant application, therefore the scope of the claims within U.S. Patent No. 12,280,251 anticipates the scope of the claims recited in the instant application fully anticipating the claims within the instant application.
37. (New) The apparatus of claim 36, wherein the CPD drive line is in pneumatic communication with the CPD
1. A counterpulsation device (CPD) comprising: a blood chamber; a drive chamber; a membrane configured to separate the blood chamber from the drive chamber; a CPD drive line in pneumatic communication with the drive chamber; and a controller configured to…..
See analysis above regarding claim 36. Claim 37 of the instant application is fully disclosed within claim 1 of U.S. Patent No. 12,280,251.
40. (New) The apparatus of claim 36, wherein the controller is configured to adjust the
pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
1. A counterpulsation device (CPD) comprising: a blood chamber; a drive chamber; a membrane configured to separate the blood chamber from the drive chamber; a CPD drive line in pneumatic communication with the drive chamber; and a controller configured to:…. wherein the controller is configured to adjust the pressure supplied to the CPD drive line based at least in part on the CPD drive line pressure signal by analyzing the CPD drive line pressure signal to determine a full condition or an empty condition of the CPD by analyzing change in drive line pressure as a function of time.
See analysis above regarding claim 36. Claim 40 of the instant application is fully disclosed within claim 1 of U.S. Patent No. 12,280,251.
41. (New) The apparatus of claim 40, wherein:
the CPD comprises a drive chamber in pneumatic communication with the CPD
drive line and a blood chamber that is sealed from the drive chamber by a membrane; and
the controller analyzes the CPD drive line pressure signal to determine the full or the empty condition of the CPD by detecting a feature in the CPD drive line pressure signal
indicative of the membrane reaching a substantially stationary end position.
1. A counterpulsation device (CPD) comprising: a blood chamber; a drive chamber; a membrane configured to separate the blood chamber from the drive chamber; a CPD drive line in pneumatic communication with the drive chamber; and a controller configured to:
2. The CPD of claim 1, wherein the controller analyzes the CPD drive line pressure signal to determine the full condition or the empty condition of the CPD by detecting a feature in the CPD drive line pressure signal indicative of the membrane reaching a substantially stationary end position.
See analysis above regarding claim 40. Claim 41 of the instant application is fully disclosed within claim 2 of U.S. Patent No. 12,280,251.
42. (New) The apparatus of claim 40, wherein the controller is further configured to:
detect a temporal location of the full or the empty condition during an operational cycle of the CPD;
compare the temporal location to a desired range; and
if the temporal location is outside of the desired range, adjust the pressure supplied
to the CPD drive line.
3. The CPD of claim 1, wherein the controller is further configured to: detect a temporal location of the full condition or the empty condition during an operational cycle of the CPD; compare the temporal location to a desired range; and if the temporal location is outside of the desired range, adjust the pressure supplied to the CPD drive line.
See analysis above regarding claim 40. Claim 42 of the instant application is fully disclosed within claim 3 of U.S. Patent No. 12,280,251.
43. (New) The apparatus of claim 42, wherein the controller is further configured to,
during emptying of the CPD:
determine if the temporal location of the empty condition occurs at a time earlier
than the desired range and, if so, adjust the drive line pressure to slow the emptying; and
determine if the temporal location of the empty condition occurs at a time later than
the desired range or does not occur and, if so, adjust the drive line pressure to speed up the
emptying.
4. The CPD of claim 3, wherein the controller is further configured to, during emptying of the CPD: determine if the temporal location of the empty condition occurs at a time earlier than the desired range and, if so, adjust the CPD drive line pressure to slow the emptying; and determine if the temporal location of the empty condition occurs at a time later than the desired range or does not occur and, if so, adjust the CPD drive line pressure to speed up the emptying.
See analysis above regarding claim 42. Claim 43 of the instant application is fully disclosed within claim 4 of U.S. Patent No. 12,280,251.
44. (New) The apparatus of claim 42, wherein the controller is further configured to,
during filling of the CPD:
determine if the temporal location of the full condition occurs at a time earlier than
the desired range and, if so, adjust the drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the drive line pressure to speed up the filling.
5. The CPD of claim 3, wherein the controller is further configured to, during filling of the CPD: determine if the temporal location of the full condition occurs at a time earlier than the desired range and, if so, adjust the CPD drive line pressure to slow the filling; and determine if the temporal location of the full condition occurs at a time later than the desired range or does not occur and, if so, adjust the CPD drive line pressure to speed up the filling.
See analysis above regarding claim 42. Claim 44 of the instant application is fully disclosed within claim 5 of U.S. Patent No. 12,280,251.
45. (New) The apparatus of claim 36, wherein the controller is configured to adjust the
pressure supplied to the CPD drive line by adjusting one or more operating parameters of a pump device pneumatically coupled to the CPD drive line.
6. The CPD of claim 1, wherein the controller is configured to adjust the pressure supplied to the CPD drive line by adjusting one or more operating parameters of a pump device pneumatically coupled to the CPD drive line.
See analysis above regarding claim 36. Claim 45 of the instant application is fully disclosed within claim 6 of U.S. Patent No. 12,280,251.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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