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 Amendment
This Action is in response to the Amendment filed June 3, 2026.
In view of the Amendment, the objections to the drawings and the rejection of claim 9-10 and 16-20 under 35 USC 112, as set forth in the Office Action date 05/13/2026, are withdrawn.
Claims 1, 9-11, and 16 are amended.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed June 3, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Zoll does not teach “a blood pump sized to be passed distally through the elastomeric seal into a lumen of the elongate shaft of the introducer sheath while a distal end of an outflow blocking sleeve is prevented from passing distally through the elastomeric seal during advancement of the blood pump through the elastomeric seal”, the Examiner disagrees. As admitted by Applicant, Zoll states that an intracardiac device is inserted into a patient’s vasculature through the hemostasis valve and the introducer (e.g., paragraph [0003] of Zoll). Zoll teaches providing an outflow blocking sleeve that removably surrounds the blood pump in order to seal the inlet and outlet of the intracardiac device (e.g., paragraph [0004] of Zoll). Thus, the intracardiac device or blood pump is sized to be passed distally through the elastomeric seal (hemostasis valve 120 of Zoll) and the introducer sheath of Zoll. In addition, paragraphs [0011]-[0013] of Zoll, as set forth on page 5, lines 10-18 of the Office Action, teach that an end of the outflow blocking sleeve is prevented from passing distally through the elastomeric seal of the blood pump through the elastomeric seal (e.g., the sleeve has a lip that ensures that the sleeve is never fully inserted into the introducer (i.e., and therefore is removable). Moreover, paragraph [0039] of Zoll recites: In various implementations, sleeve 100 is effectively blocked from passing through hemostasis valve 120. That is, the blood pump size together with the sleeve ensure that the blood pump is inserted into the elastomeric seal/hemostasis valve and prevent the outflow blocking sleeve/ sleeve from wholly passing the introducer through the hemostasis valve of Zoll (see claim 1).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 9, 11-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2020/0121905 to Zoll.
Regarding claim 1, Zoll discloses a system (e.g., abstract), comprising: an introducer sheath including a hub, an elongate shaft extending distally from the hub, and an elastomeric seal positioned in the hub (e.g., paragraphs [0030] and [0033]: Fig. 1 – introducer 118, hub material surrounding reference numeral 120, and seal/hemostasis valve 120); a catheter including an elongate shaft and a percutaneous blood pump positioned at a distal end of the elongate shaft (e.g., paragraphs [0007]: the catheter is an elongate multi-lumen catheter with a pump housing adjacent its distal end; and [0031]: elongate catheter 114 is coupled to a pump at its distal end), the percutaneous blood pump including a blood inlet, a blood outlet, and an impeller assembly positioned therebetween to pump blood from the blood inlet to the blood outlet during use (e.g., paragraphs [0031]-[0032]: the intracardiac device comprises a pump 107 and a cannula/catheter 106, where the pump includes a blood inlet 112, a blood outlet 11, a pump housing 109, and a motor housing 111 with a rotor where blood flows into the device through the distal openings 112 and exits the device through proximal openings 110); and an outflow blocking sleeve removably surrounding the blood outlet (e.g., abstract: the intracardiac device placement system includes an elongated catheter and a removable sleeve disposed over a portion of the pump and covering at least one of the distal openings and proximal openings; paragraphs [0004]: systems, methods and devices are designed to prevent leaks across a hemostasis valve during insertion of an intracardiac pumping device … a sleeve is placed advantageously over a portion of the intracardiac device to seal at least one of the openings … sealing the inlet and outlet area of the cannula; and [0041]: sleeve 300 has a lumen with a cross section and the catheter is inserted into the lumen so the sleeve fits snugly around elongate catheter 314 to prevent fluid from leaking out); wherein the blood pump is sized to be passed distally through the elastomeric seal into a lumen of the elongate shaft of the introducer sheath while a distal end of the outflow blocking sleeve is prevented from passing distally through the elastomeric seal during advancement of the blood pump through the elastomeric seal (e.g., paragraphs [0033] Hemostasis valve 120 is part of the introducer 118 and is designed to have medical devices inserted through and be able to be removed in-line from inserted medical devices; [0011]-[0013]: the sleeve may include a lip at the proximal end of the sleeve … one advantage of the lip is that it ensures that the sleeve is never fully inserted into the introducer (i.e., and therefore is removable); and [0039]: In various implementations, sleeve 100 is effectively blocked from passing through hemostasis valve 120). That is, the blood pump size together with the sleeve ensure that the blood pump is inserted into the elastomeric seal/hemostasis valve and prevent all of the outflow blocking sleeve/ sleeve from passing through the hemostasis valve of Zoll).
Referring to claim 11, Zoll discloses a system (e.g., abstract), comprising: a catheter including an elongate shaft and a percutaneous blood pump positioned at a distal end of the elongate shaft (e.g., paragraphs [0007]: the catheter is an elongate multi-lumen catheter with a pump housing adjacent its distal end; and [0031]: elongate catheter 114 is coupled to a pump at its distal end), the percutaneous blood pump including a blood inlet, a blood outlet, an impeller positioned therebetween to pump blood from the blood inlet to the blood outlet during use, and a motor housing positioned proximal of the impeller, the motor housing including a motor to rotationally drive the impeller (e.g., paragraphs [0031]-[0032]: the intracardiac device comprises a pump 107 and a cannula/catheter 106, where the pump includes a blood inlet 112, a blood outlet 11, a pump housing 109, and a motor housing 111 with a rotor where blood flows into the device through the distal openings 112 and exits the device through proximal openings 110); and an outflow blocking sleeve tightly surrounding the blood outlet and extending proximally therefrom to surround the motor housing (e.g., abstract: the intracardiac device placement system includes an elongated catheter and a removable sleeve disposed over a portion of the pump and covering at least one of the distal openings and proximal openings; paragraph [0041]: sleeve 300 has a lumen with a cross section and the catheter is inserted into the lumen so the sleeve fits snugly around elongate catheter 314 to prevent fluid from leaking out; and Figs. 1 and 3: openings 110, motor housing 111, sleeve 300); wherein the outflow blocking sleeve is configured to prevent blood egress from the blood outlet and configured to prevent a distal end of the outflow blocking sleeve from passing through an elastomeric seal of an introducer sheath during advancement of the blood pump into a vasculature at a vascular access site (e.g., paragraphs [0004]: systems, methods and devices are designed to prevent leaks across a hemostasis valve during insertion of an intracardiac pumping device … a sleeve is placed advantageously over a portion of the intracardiac device to seal at least one of the openings … sealing the inlet and outlet area of the cannula; and [0039]: In various implementations, sleeve 100 is effectively blocked from passing through hemostasis valve 120).
With respect to claims 2 and 12, Zoll discloses the system of claims 1 and 11, wherein the outflow blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter less than the inner diameter of the distal end region (e.g., paragraph [0041] and Fig. 3, sleeve 300 has an inner diameter that is reduced at its proximal end).
As to claims 3 and 13, Zoll discloses the system of claims 2 and 12, wherein the distal end region tightly surrounds the blood outlet to occlude blood flow therefrom and the proximal end region extends over a distal portion of the elongate shaft of the catheter (e.g., paragraph [0041]: sleeve 300 has a lumen with a cross section and the catheter is inserted into the lumen so the sleeve fits snugly around elongate catheter 314 to prevent fluid from leaking out).
With respect to claim 9, Zoll discloses the system of claim 1, wherein the outflow blocking sleeve includes a flared distal end configured to abut a proximal face of the elastomeric sleeve (e.g., paragraph [0013]: the sleeve may include a lip at the proximal end of the sleeve … one advantage of the lip is that it ensures that the sleeve is never fully inserted into the introducer (i.e., and therefore is removable)).
Regarding claim 16, Zoll discloses a method of percutaneously inserting a blood pump into a vasculature at a vascular access site (e.g., abstract: method for preventing leaks across a hemostasis valve during insertion of an intracardiac pumping device), the method including: advancing a catheter, including the blood pump positioned at a distal end of an elongate shaft of the catheter, into an introducer sheath having an elastomeric seal (e.g., paragraphs [0030]-[0031]: catheter 106 is advanced into an introducer 118 and hemostasis valve/elastomeric seal 120), the blood pump including a blood inlet, a blood outlet, and an impeller assembly positioned therebetween to pump blood from the blood inlet to the blood outlet during use (e.g., paragraphs [0030]-[0032]: the intracardiac device comprises a pump 107 and a cannula/catheter 106, where the pump includes a blood inlet 112, a blood outlet 11, a pump housing 109, and a motor housing 111 with a rotor where blood flows into the device through the distal openings 112 and exits the device through proximal openings 110), advancing the blood pump through the elastomeric seal while an outflow blocking sleeve occludes the blood outlet while the blood outlet is located proximal of the elastomeric seal and the blood inlet is located distal of the elastomeric seal such that blood egress from the blood outlet is prevented (e.g., paragraphs [0011]-[0012]: when inserting the blood pump through the hemostasis valve/elastomeric seal, the sleeve covers the proximal openings (or distal openings or both) to prevent fluid from flowing out of the openings to prevent blood from being sprayed toward the medical professional); and further advancing the blood pump through the elastomeric seal while a distal end of the outflow blocking sleeve abuts a proximal face of the elastomeric seal and remains exterior of the elastomeric seal so that the blood outlet passes through the elastomeric seal to a location distal of the elastomeric seal (e.g., paragraphs [0013]: the sleeve may have a lip at its proximal end that is sized and shaped to abut against the hemostasis valve and the sleeve then slides so that the sleeve is never inserted into the introducer; and [0039]: In various implementations, sleeve 100 is effectively blocked from passing through hemostasis valve 120).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zoll.
With respect to claims 4, and 14, Zoll discloses the system of claims 1 and 11, where the outflow blocking sleeve has a length, but does not expressly disclose that the length is 7 cm or less. However, 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 system as taught by Zoll so that the sleeve has a length of 7 cm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for length being less than 7 cm.
As to claim 10, Zoll discloses the system of claim 1, wherein the outflow blocking sleeve includes a lip at its distal end sized and shaped to abut against the hemostasis valve/elastomeric seal, but does not expressly disclose that the sleeve has a bulbous distal end configured to abut a proximal face of the elastomeric sleeve (sic). However, the courts have held that changes in shape would have been obvious in the absence of persuasive evidence that the particular configuration was significant (In re Daily, 357 F.2d 669, 149 149 USPQ 47 (CCPA 1966)).
Claims 5-6, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zoll in view of US Patent Application Publication No. 2022/0305250 to Heilmann.
With respect to 5, Zoll discloses the system of claim 1, but does not expressly disclose a guidewire extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the blood pump. However, Heilmann, in a related art: cannula system for guiding/advancing a catheter (e.g., paragraphs [0001]-[0002]), teaches that a catheter may be inserted using a guide wire and an introducing member (e.g., paragraph [0002] of Heilmann), and that an inner cannular I2 may be inserted in an outlet/opening of an outer cannula O2 (see paragraphs [0035]: first cannula may be coupled to an inlet port of the blood pump or to an outlet pf the blood pump; [0595]: guide wires may be used for insertion of cannulas; and Fig. 13). Accordingly, one of ordinary skill in the art would have recognized the benefits of a guidewire when inserting a blood pump into a body with an introducer member in view of the teachings of Heilmann. Accordingly, one of ordinary skill in the art would have modified the system of Zoll to further include a guidewire is capable of extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the blood pump in view of the teachings of Heilmann that such was a well-known engineering expedient and protocol in the insertion of medical device art, and because the combination would have yielded a predictable result.
As to claim 6, Zoll in view of Heilmann teaches the system of claim 5, but does not expressly teach that the outflow blocking sleeve surrounds the guidewire extending along the exterior of the blood pump. Zoll in view of Heilmann teaches all the limitations of the claim 6, except for functional language that the outflow blocking sleeve surrounds the guidewire extending along the exterior of the blood pump. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the arrangement of the guidewire to be inside the sleeve of the system of Heilmann in view of Zoll, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
With respect to claim 15, Zoll discloses the system of claim 11, but does not expressly disclose a guidewire extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the motor housing, wherein the outflow blocking sleeve surrounds the guidewire extending along the exterior of the motor housing. However, as discussed above with respect to claims 5-6, Heilmann teaches that a guidewire was well-known in the medical arts to insert catheters with an introducer, and the arrangement of the parts would have been obvious to those skilled in the art in view of In re Japikse. Thus, one of ordinary skill in the art would have modified the system of Zoll to have a guidewire that is arranged as recited in the claim in view of the teachings of Heilmann and the indicated case law, and because the combination would have yielded a predictable result.
As to claim 17, Zoll discloses the method of claim 16, but does not expressly disclose that the blood pump is advanced over a guidewire extending out of an outflow window of the blood outlet and the guidewire extends proximally therefrom along an exterior of the blood pump. However, Heilmann, in a related art, teaches that a catheter may be inserted using a guide wire and an introducing member (e.g., paragraph [0002] of Heilmann), and that an inner cannular I2 may be inserted in an outlet/opening of an outer cannula O2 (see paragraphs [0035]: first cannula may be coupled to an inlet port of the blood pump or to an outlet pf the blood pump; [0595]: guide wires may be used for insertion of cannulas; and Fig. 13). Accordingly, one of ordinary skill in the art would have modified the method of Zoll to advance the blood pump with a guidewire extending out of an outflow window of the blood outlet and extending proximally therefrom along an exterior of the blood pump in view of the teachings of Heilmann that such was a well-known engineering expedient and protocol in the insertion of medical device art, and because the combination would have yielded a predictable result.
With respect to claim 18, Zoll in view of Heilmann teaches the method of claim 17, but does not expressly teach that the outflow blocking sleeve surrounds the guidewire extending along the exterior of the blood pump. . However, as discussed above with respect to claim 17, Heilmann teaches that a guidewire was well-known in the medical arts to insert catheters with an introducer, and the arrangement of the parts would have been obvious to those skilled in the art in view of In re Japikse. Thus, one of ordinary skill in the art would have modified the method of Zoll to have a guidewire that is arranged between the sleeve and the blood pump of the catheter in view of the teachings of Heilmann and the indicated case law, and because the combination would have yielded a predictable result.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zoll in view of US Patent Application Publication No. 2023/0226315 to Jahangir et al. (EFD: at least 07/20/2023 and hereinafter referred to as “Jahangir”).
With respect to claim 7, Zoll discloses the system of claim 1, but does not expressly disclose that the outflow blocking sleeve includes a preferential separation line extending along a length of the outflow blocking sleeve. However, Jahangir, in a related art: vascular access system, teaches that a sheath/introducer, a slitted sleeve with a sealing portion/outflow blocking sleeve are used to insert a medical device/catheter having two different radial sections into the vascular of a subject where the sheath is inserted into a blood vessel first and then the slitted sleeve is inserted into the sheath where the slitted sleeve is disposed over a portion of the medical device/intracardiac blood pump and catheter so that, in operation, blood from the blood from the blood vessel is prevent from migrating past the seal of the sleeve (e.g., paragraphs [0008],[0044]-[0045], [0048]-[0052] of Jahangir). Accordingly, one of ordinary skill in the art would have modified the system of Zoll so that the outflow blocking sleeve includes a preferential separation line extending along a length of the outflow blocking sleeve in view of the teachings of Heilmann that such was a well-known engineering expedient and protocol in the insertion of medical device art, and because the combination would have yielded a predictable result.
As to claim 19, Zoll teaches the method of claim 16, but does not expressly disclose laterally removing the outflow blocking sleeve from the catheter after the blood outlet of the blood pump is advanced to a location distal of the elastomeric seal. However, Jahangir, in a related art, teaches that the outflow blocking sleeve may have a slit along its length. Zoll discloses that its sleeve is removably disposed over a portion of the pump and covering at least one of the distal openings or proximal openings where the removable sleeve is prevented from passing through the hemostasis valve/elastomeric sleeve (e.g., abstract and paragraphs [0009], [0013] of Zoll). Thus, one of ordinary skill in the art would have recognized that an outflow blocking sleeve with slit could be removed laterally from the catheter after the blood outlet of the blood pump is advanced to a location distal of the elastomeric seal/hemostasis valve in view of the teachings of Jahangir’s slitted sleeve. Consequently, one of ordinary skill in the art would have modified the method of Zoll to remove the outflow blocking sleeve laterally when using a slitted sleeve as taught by Jahangir as it would have been obvious to try as there are only a finite number of identified, predictable solutions to remove the sleeve from the catheter: laterally removing a slitted sleeve, or, reversing the sleeve, with a reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll in view of Chinese Patent Document ID CN 113 398 463 A to Tang et al (hereinafter referred to as Tang – see attached English translation and the Chinese document).
Zoll discloses the system of claim 1, wherein the outflow blocking sleeve includes a removable sleeve but, does not expressly disclose a strip of material configured to separate from a tubular wall of the outflow blocking sleeve when pulled. However, Tang, in a related art: a sleeve/envelope for a blood pump during insertion into a subject (see abstract and background sections of the English translation), where the sleeve is a sealing sleeve and is provided with a micro-groove and/or weakened area so that the sealing sleeve can be torn away when blood pump enters the human body (see Contents of the Invention section of the English translation and Fig. 6, open slot 121, tear-off structure/weakened area 122). Accordingly, one of ordinary skill in the art would have recognized the benefits of a tear-off structure or weakened area of the sleeve in order to remove the sleeve blocking outflow from the inserted blood pump in view of the teachings of Tang. Consequently, one of ordinary skill in the art would have modified the system of Zoll so that its outflow blocking sleeve includes a strip of material configured to separate from a tubular wall of the sleeve when pulled/torn in view of the teachings of Tang that such was a well-known engineering expedient in the blood pump insertion art, and because the combination would have yielded a predictable result.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll in view of Chinese Patent Document ID CN 113 398 463 A to Tang et al (hereinafter referred to as Tang – see attached English translation and the Chinese document).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zoll in view of Jahangir and Tang.
Zoll in view of Jahangir teaches the method of claim 19, wherein the outflow blocking sleeve has a slitted sleeve but does not expressly teach that the sleeve is splittable along its length to separate the outflow blocking sleeve from the catheter.
However, Tang, in a related art: a sleeve/envelope for a blood pump during insertion into a subject (see abstract and background sections of the English translation), where the sleeve is a sealing sleeve and is provided with a micro-groove and/or weakened area so that the sealing sleeve can be torn away when blood pump enters the human body (see Contents of the Invention section of the English translation and Fig. 6, open slot 121, tear-off structure/weakened area 122). Accordingly, one of ordinary skill in the art would have recognized the benefits of a tear-off structure or weakened area of the sleeve in order to remove the sleeve blocking outflow from the inserted blood pump in view of the teachings of Tang. Consequently, one of ordinary skill in the art would have modified the method of Zoll in view of Jahangir so that its outflow blocking sleeve is splittable along its length to separate the sleeve from the catheter and blood pump combination when the tearing structure is pulled/torn in view of the teachings of Tang that such was a well-known engineering expedient in the blood pump insertion art, and because the combination would have yielded a predictable result.
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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