DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8,814,776. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate” the claims of the instant application).
US 8,814,776 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 8:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, to a second end located outside of the pump device, wherein the pump device comprises: a proximal drive portion comprising a motor; a distal pump portion connected to a distal end of the drive portion; one or more discharge ports positioned between the drive portion and the pump portion; an inflow cannula connected to the distal end of the pump portion, the cannula having a distal end comprising an inflow opening; and a flexible tubular pigtail extension connected to the distal end of the inflow cannula; and the guidewire path runs through the tubular pigtail extension, from the pigtail extension into the inflow cannula, through the inflow cannula into the pump portion, and out through a selected one of the one or more discharge ports; and wherein positioning the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the pump device, into the pump device through the first opening in the pigtail extension, along the path for the guidewire, out of the pump device through the second opening comprising the selected one of the one or more discharge ports, and to a second end located outside of the pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path.
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 9:
The method of claim 8, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path.
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Claim 10:
The method of claim 9, further comprising attaching a label to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path using the lumen.
Claim 11:
The method of claim 10, further comprising attaching a label to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path for the guidewire using the lumen.
Claim 11:
The method of claim 9, wherein at least a portion of the lumen has a color which differs from the color of the pump device.
Claim 12:
The method of claim 10, wherein at least a portion of the lumen has a color which differs from the color of the intracardiac pump device.
Claim 12:
The method of claim 9, wherein the lumen is configured to allow the guide wire to be positioned through the device along the path without substantially flexing the guidewire.
Claim 13:
The method of claim 10, wherein the lumen is configured to allow the guidewire to be positioned through the intracardiac pump device along the path for the guidewire without substantially flexing the guidewire.
Claim 8:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, to a second end located outside of the pump device, wherein the pump device comprises: a proximal drive portion comprising a motor; a distal pump portion connected to a distal end of the drive portion; one or more discharge ports positioned between the drive portion and the pump portion; an inflow cannula connected to the distal end of the pump portion, the cannula having a distal end comprising an inflow opening; and a flexible tubular pigtail extension connected to the distal end of the inflow cannula; and the guidewire path runs through the tubular pigtail extension, from the pigtail extension into the inflow cannula, through the inflow cannula into the pump portion, and out through a selected one of the one or more discharge ports; and wherein positioning the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the pump device, into the pump device through the first opening in the pigtail extension, along the path for the guidewire, out of the pump device through the second opening comprising the selected one of the one or more discharge ports, and to a second end located outside of the pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path.
Claim 14:
The method of claim 10, wherein: the intracardiac pump device comprises: a drive portion comprising a motor; a pump portion connected to a distal end of the drive portion; one or more discharge ports positioned between the drive portion and the pump portion; an inflow cannula connected to the distal end of the pump portion, the inflow cannula having a distal end comprising an inflow opening; and the path for the guidewire runs through a pigtail extension, from the pigtail extension into the inflow cannula, through the inflow cannula into the pump portion, and out through a selected one of the one or more discharge ports; and wherein positioning the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the pigtail extension, along the path for the guidewire, out of the intracardiac pump device through the second opening comprising the selected one of the one or more discharge ports, and to a second end located outside of the intracardiac pump device.
Claim 6:
The apparatus of claim 1, wherein the second end of the lumen extends at least about 1 cm outside of the selected one of the one or more discharge ports. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 15:
The method of claim 14, wherein positioning the lumen comprises positioning the lumen such that the second end of the lumen extends at least about 1 cm outside of the selected one of the one or more discharge ports.
Claim 7:
The apparatus of claim 6, wherein the first end of the lumen extends at least about 4 mm outside of the first opening in the pigtail extension. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 16:
The method of claim 14, wherein positioning the lumen comprises positioning the lumen such that the first end of the lumen extends at least about 4 mm outside of the first opening in the pigtail extension.
Claims 9-12 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,402,942. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate”) the claims of the instant application.
US 9,402,942 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 1:
An apparatus comprising: an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; and a lumen which extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, to a second end located outside of the pump device; wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path; and wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 1:
An apparatus comprising: an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; and a lumen which extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, to a second end located outside of the pump device; wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path; and wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Claim 9:
The apparatus of claim 2, further comprising a label attached to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path using the lumen. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 11:
The method of claim 10, further comprising attaching a label to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path for the guidewire using the lumen.
Claim 10:
The apparatus of claim 2, wherein at least a portion of the lumen has a color which differs from a color of the pump device. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 12:
The method of claim 10, wherein at least a portion of the lumen has a color which differs from the color of the intracardiac pump device.
Claims 2-7-8:
The apparatus of claim 1, wherein the intracardiac pump device comprises: a proximal drive portion comprising a motor; and a distal pump portion connected to a distal end of the drive portion; further comprising: an inflow cannula connected to the distal end of the pump portion, the cannula having a distal end comprising an inflow opening; and a flexible tubular pigtail extension connected to the distal end of the inflow cannula; wherein the guidewire path runs through the tubular pigtail extension, from the pigtail extension into the inflow cannula, through the inflow cannula into the pump portion, and out through a selected one of the one or more discharge ports. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 14:
The method of claim 10, wherein: the intracardiac pump device comprises: a drive portion comprising a motor; a pump portion connected to a distal end of the drive portion; one or more discharge ports positioned between the drive portion and the pump portion; an inflow cannula connected to the distal end of the pump portion, the inflow cannula having a distal end comprising an inflow opening; and the path for the guidewire runs through a pigtail extension, from the pigtail extension into the inflow cannula, through the inflow cannula into the pump portion, and out through a selected one of the one or more discharge ports; and wherein positioning the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the pigtail extension, along the path for the guidewire, out of the intracardiac pump device through the second opening comprising the selected one of the one or more discharge ports, and to a second end located outside of the intracardiac pump device.
Claim 16:
The intracardiac pump of claim 12, wherein the second end of the lumen extends at least about 1 cm outside of one of the one or more discharge ports. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 15:
The method of claim 14, wherein positioning the lumen comprises positioning the lumen such that the second end of the lumen extends at least about 1 cm outside of the selected one of the one or more discharge ports.
Claim 17:
The intracardiac pump of claim 11, further comprising: an inflow cannula connected to a distal end of the pump portion, the cannula having a distal end comprising an inflow opening; and a flexible pigtail extension connected to the distal end of the inflow cannula; wherein the first end of the lumen extends at least about 4 mm outside of a first opening in the pigtail extension. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 16:
The method of claim 14, wherein positioning the lumen comprises positioning the lumen such that the first end of the lumen extends at least about 4 mm outside of the first opening in the pigtail extension.
Claims 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9,750,861. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate” the claims of the instant application).
US 9,750,861 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 1:
A blood pump assembly comprising: a cannula having proximal and distal ends; a first opening and a second opening; and a loading guide lumen configured to receive a guidewire therethrough, the loading guide lumen having a first end, a second end, and a middle portion; wherein the first end of the loading guide lumen is located outside of the first opening, the middle portion of the loading guide lumen extends into the first opening, through the cannula, and through the second opening such that the second end of the loading guide lumen is located outside of the second opening; wherein the loading guide lumen is configured to, after the guidewire is received by the loading guide lumen, be withdrawn from the first and second openings of the blood pump assembly while leaving the guidewire in a position extending through the first and second openings. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 1:
A blood pump assembly comprising: a cannula having proximal and distal ends; a first opening and a second opening; and a loading guide lumen configured to receive a guidewire therethrough, the loading guide lumen having a first end, a second end, and a middle portion; wherein the first end of the loading guide lumen is located outside of the first opening, the middle portion of the loading guide lumen extends into the first opening, through the cannula, and through the second opening such that the second end of the loading guide lumen is located outside of the second opening; wherein the loading guide lumen is configured to, after the guidewire is received by the loading guide lumen, be withdrawn from the first and second openings of the blood pump assembly while leaving the guidewire in a position extending through the first and second openings. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Claim 4:
The assembly of claim 1, further comprising a label attached to the lumen, wherein the label includes instructions for placing the guidewire in the lumen. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 11:
The method of claim 10, further comprising attaching a label to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path for the guidewire using the lumen.
Claim 5:
The assembly of claim 1, wherein at least a portion of the lumen has a color which differs from a color of the blood pump. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 12:
The method of claim 10, wherein at least a portion of the lumen has a color which differs from the color of the intracardiac pump device.
.
Claims 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 12 of U.S. Patent No. 10,617,808. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate” the claims of the instant application).
US 10,617,808 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 1:
A method comprising: passing a guidewire through a tubular lumen from a first end of the tubular lumen to a second end of the tubular lumen, the tubular lumen positioned in a blood pump assembly, the blood pump assembly comprising: a cannula having proximal and distal ends, a suction head positioned distal to the distal end of the cannula, an outlet opening proximal of the proximal end of the cannula, and a flexible tubular extension positioned distal to the suction head, the flexible tubular extension having a through lumen, wherein the tubular lumen is positioned such that the first end of the tubular lumen is located outside of the outlet opening, a portion of the tubular lumen extends within the cannula, and the second end of the tubular lumen is located outside of the flexible tubular extension; and removing the tubular lumen from the blood pump assembly while leaving the guidewire, such that the guidewire extends through the outlet opening, through the cannula, and through the flexible tubular extension.
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 1:
A method comprising: passing a guidewire through a tubular lumen from a first end of the tubular lumen to a second end of the tubular lumen, the tubular lumen positioned in a blood pump assembly, the blood pump assembly comprising: a cannula having proximal and distal ends, a suction head positioned distal to the distal end of the cannula, an outlet opening proximal of the proximal end of the cannula, and a flexible tubular extension positioned distal to the suction head, the flexible tubular extension having a through lumen, wherein the tubular lumen is positioned such that the first end of the tubular lumen is located outside of the outlet opening, a portion of the tubular lumen extends within the cannula, and the second end of the tubular lumen is located outside of the flexible tubular extension; and removing the tubular lumen from the blood pump assembly while leaving the guidewire, such that the guidewire extends through the outlet opening, through the cannula, and through the flexible tubular extension.
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Claim 9:
The method of claim 1, wherein the blood pump assembly comprises a label attached to the tubular lumen, wherein the label includes instructions for placing the guidewire in the tubular lumen.
Claim 11:
The method of claim 10, further comprising attaching a label to the second end of the lumen, wherein the label includes instructions for placing the guidewire along the path for the guidewire using the lumen.
Claim 12:
The method of claim 1, wherein at least a portion of the tubular lumen has a color which differs from a color of the blood pump.
Claim 12:
The method of claim 10, wherein at least a portion of the lumen has a color which differs from the color of the intracardiac pump device.
Claims 9, 10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 6 of U.S. Patent No. 11,511,101. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate” the claims of the instant application).
US 11,511,101 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 1:
An intracardiac pump device comprising: a drive portion and a pump portion, the pump portion having a path for a guidewire extending through the pump portion from a first opening interposed between the drive portion and the pump portion to a second opening in operative connection with the pump portion wherein the drive portion is coaxial with the pump portion; a catheter, wherein the catheter is coupled to a proximal end of the drive portion; and a lumen positioned in the pump portion, the lumen extending from a first end of the lumen located outside of the pump portion into the pump portion through the first opening in the pump portion, along the path for the guidewire, and out of the pump portion through the second opening in the pump portion to a second end located outside of the pump portion, wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end of the lumen to the second end of the lumen, the guidewire is positioned along the path. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 2:
The intracardiac pump device according to claim 1, wherein the lumen is removably positioned in the intracardiac pump device, such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed from the pump portion without disturbing the guidewire from the path through the pump portion. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Claim 6:
The intracardiac pump device according to claim 1, wherein the lumen has a first color, the lumen has a second color and the intracardiac pump device has a third color, wherein the first, second and third colors are different from each other. (Although the issued claims are drawn to apparatus claims and the instant claims are drawn to process claims, a prior art device anticipates a claimed process if the device carries out the process during normal operation; see MPEP 2112.02).
Claim 12:
The method of claim 10, wherein at least a portion of the lumen has a color which differs from the color of the intracardiac pump device.
Claims 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,161,855. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the issued patent are narrower than (i.e., “anticipate” the claims of the instant application).
US 12,161,855 (reference patent, corresponding limitations underlined)
18/935,922 (instant application, corresponding limitations in bold)
Claim 1:
A method comprising the steps of: passing a guidewire through a tubular lumen from a first end of the tubular lumen to a second end of the tubular lumen, the tubular lumen positioned in a blood pump assembly, the blood pump assembly comprising: a cannula having a proximal end and a distal end; a suction head positioned distal to the distal end of the cannula; an outlet opening proximal of the proximal end of the cannula; and a flexible tubular extension positioned distal to the suction head, the flexible tubular extension having a through lumen and a pigtail tip, wherein the tubular lumen is positioned such that the first end of the tubular lumen is located outside of the outlet opening, a portion of the tubular lumen extends within the cannula, and the second end of the tubular lumen is located outside of the flexible tubular extension; removing the tubular lumen from the blood pump assembly while leaving the guidewire, such that the guidewire extends through the outlet opening, through the cannula, and through the flexible tubular extension; and after removing the tubular lumen, introducing the blood pump assembly into a subject using the guidewire.
Claim 9:
A method comprising: obtaining a lumen; and inserting the lumen into an intracardiac pump device having a path for a guidewire extending through the intracardiac pump device from a first opening to a second opening; wherein inserting the lumen comprises positioning the lumen such that the lumen extends from a first end located outside of the intracardiac pump device, into the intracardiac pump device through the first opening in the intracardiac pump device, along the path for the guidewire, out of the intracardiac pump device through the second opening, to a second end located outside of the intracardiac pump device; and wherein the lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path for the guidewire.
Claim 1:
A method comprising the steps of: passing a guidewire through a tubular lumen from a first end of the tubular lumen to a second end of the tubular lumen, the tubular lumen positioned in a blood pump assembly, the blood pump assembly comprising: a cannula having a proximal end and a distal end; a suction head positioned distal to the distal end of the cannula; an outlet opening proximal of the proximal end of the cannula; and a flexible tubular extension positioned distal to the suction head, the flexible tubular extension having a through lumen and a pigtail tip, wherein the tubular lumen is positioned such that the first end of the tubular lumen is located outside of the outlet opening, a portion of the tubular lumen extends within the cannula, and the second end of the tubular lumen is located outside of the flexible tubular extension; removing the tubular lumen from the blood pump assembly while leaving the guidewire, such that the guidewire extends through the outlet opening, through the cannula, and through the flexible tubular extension; and after removing the tubular lumen, introducing the blood pump assembly into a subject using the guidewire.
Claim 10:
The method of claim 9, wherein the lumen is configured such that, after the guidewire is received by the lumen and positioned along the path for the guidewire, the lumen may be removed without disturbing the guidewire from the path for the guidewire.
Allowable Subject Matter
Claims 9-16 avoid the prior art, but are rejected under double-patenting grounds above. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is to Marseille et al. (US 2009/0182188). Although Marseille generally teaches of inserting an intracardiac pump using a guidewire and dilator device (“lumen”), Marseille discloses that this procedure is carried out by first implanting a catheter, and then attaching the catheter to the intracardiac pump after implantation (Figs. 1B-1I), and not by inserting the lumen into and out from an intracardiac pump device from a first opening to a second opening, as required by the claims.
Conclusion
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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