DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/23/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Status of Claims
Claims 1-22 are pending and currently under consideration for patentability.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7-10, 12, 15-17, and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duijsens (US 20220370701 A1).
Regarding Claim 1, Duijsens teaches an unloading system comprising:
a first cannula including a distal cannula body (primary arterial cannula 300, FIGS. 10-12, para(0044]) coupled to a proximal hub (proximal portion of 300, FIG. 10, para(0001 ],(0044],[0057]: "for performing peripheral VA-EC MO"; reasonably assuming a proximal connector/hub for connection to ECMO means), the distal cannula body having a first inner diameter (FIGS. 10-12), where the first cannula is configured to slidably receive a mechanical circulatory support (MCS) device through the first cannula (intended use, FIGS. 10-12),, and configured to receive a return flow of blood through the first cannula (intended use, FIGS. 10-12, para[0047]: "primary arterial channel 22 is for providing a flow of blood");
a second cannula including a distal cannula body having an outer diameter smaller than the outer diameter of the first cannula (secondary cannula 310, FIGS. 10-12, para[0057]), the second cannula configured to receive a return flow of blood through the second cannula (intended use, para[0009]: "the passage the second cannula is arranged for providing anterograde blood perfusion"); and
a connector (24) for splitting a flow of blood from an extracorporeal membrane oxygenation (ECMO) device to the first cannula and the second cannula (FIGS. 10-12, para(0001]: "for use in a veno-arterial extracorporeal membrane oxygenation (VA-ECMO) treatment" para(0009]: "The present invention provides a bi-directional perfusion .. : a distal end of the cannula main body for providing retrograde blood perfusion ... the second cannula is arranged for providing anterograde blood perfusion"; reasonably assuming a splitter for splitting the source from the ECMO to the two cannulas);
Duijsens fails to explicitly teach the use via an ECMO device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case the device is easily capable of being used as such.
Duijsens fails to explicitly teach wherein a first total pressure drop of the first cannula with the MCS device in place in the first cannula with the second cannula connected to the connector is equal to a second total pressure drop of the first cannula without the MCS device in place in the first cannula. It would have been an obvious matter of design choice to have the pressure drop equal, since applicant has not disclosed that this solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well without the pressure drop.
Regarding Claim 2, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the first inner diameter is between 5 and 6 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the first inner diameter is between 5 and 6 mm in order to fit the particular procedure being done since this claimed dimension of the first diameter is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0009 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 3, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein a thickness of a sidewall of the distal cannula body is 0.1-0.3 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a thickness of a sidewall of the distal cannula body is 0.1-0.3 mm in order to fit the particular procedure being done since this claimed dimension of the thickness of a sidewall of the distal cannula body is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0009 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 4, Duijsens teaches the unloading system of claim 1. Duijsens further teaches wherein the first cannula includes a thermoplastic polyurethane (TPU) (paragraph [0066]).
Regarding Claim 5, Duijsens teaches the unloading system of claim 4. The primary embodiment teaches Duijsens further wherein the first cannula further comprises one or more reinforcing coils coupled to the TPU. An alternative embodiment teaches wherein the first cannula further comprises one or more reinforcing coils coupled to the TPU(paragraph [0067]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment to have reinforced coils as taught in another embodiment of Duijens.
Regarding Claim 7, Duijsens teaches the unloading system of claim 1. Duijsens further teaches wherein the first cannula comprises one or more openings (320) from an inner surface to an outer surface of the first cannula adjacent to a distal end (figs. 10, 11, 12)(paragraph [0057]).
Regarding Claim 8, Duijsens teaches the unloading system of claim 1. Duijsens further teaches, wherein the proximal hub comprises a first (300, first arm of cannula) arm and a second arm (310, second arm of cannula, arms in various directions).
Regarding Claim 9, Duijsens teaches the unloading system of claim 8. Duijsens further teaches wherein the first arm is configured to slidably receive the mechanical circulatory support (MCS) device (paragraph [0044]).
Regarding Claim 10, Duijsens teaches the unloading system of claim 8. The primary embodiment teaches of Duijens fails to teach wherein the first arm comprises a hemostasis valve. An alternative embodiment teaches wherein the first arm comprises a hemostasis valve (paragraph [0077]).Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment to have a hemostasis valve on the first arm as taught in another embodiment.
Regarding Claim 16, Duijsens teaches the unloading system of claim 1. Duijsens further teaches wherein the second cannula includes a thermoplastic polyurethane (TPU) (paragraph [0066]).
Regarding Claim 17, Duijsens teaches the unloading system of claim 16. The primary embodiment teaches of Duijens fails to teach wherein the second cannula further comprises one or more reinforcing coils coupled to the TPU. An alternative embodiment teaches wherein the second cannula further comprises one or more reinforcing coils coupled to the TPU (paragraph [0067]).Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment to have the second cannula further comprises one or more reinforcing coils coupled to the TPU in order to reinforce the structure .
Regarding Claim 20, Duijsens teaches the unloading system of claim 1. Duijsens further comprising a third cannula operably coupled to the ECMO device and configured to pass blood from a patient to the ECMO device (paragraph [0064]). Duijsens fails to explicitly teach the use via an ECMO device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case the device is easily capable of being used as such.
Regarding Claim 21, Duijsens teaches a kit, comprising:
a first cannula including a distal cannula body (primary arterial cannula 300, FIGS. 10-12, para(0044]) coupled to a proximal hub (proximal portion of 300, FIG. 10, para(0001 ],(0044],[0057]: "for performing peripheral VA-EC MO"; reasonably assuming a proximal connector/hub for connection to ECMO means), the distal cannula body having a first inner diameter (FIGS. 10-12), where the first cannula (FIGS. 10-12)is configured to slidably receive a mechanical circulatory support (MCS) device through the first cannula, and configured to receive a return flow of blood through the first cannula (intended use, FIGS. 10-12, para[0047]: "primary arterial channel 22 is for providing a flow of blood");
a second cannula including a distal cannula body having an outer diameter smaller than the outer diameter of the first cannula (secondary cannula 310, FIGS. 10-12, para[0057]), the second cannula configured to receive a return flow of blood through the second cannula (intended use, para[0009]: "the passage the second cannula is arranged for providing anterograde blood perfusion"); and
a connector for splitting a flow of blood from an extracorporeal membrane oxygenation (ECMO) device to the first cannula and the second cannula (FIGS. 10-12, para(0001]: "for use in a veno-arterial extracorporeal membrane oxygenation (VA-ECMO) treatment" para(0009]: "The present invention provides a bi-directional perfusion .. : a distal end of the cannula main body for providing retrograde blood perfusion ... the second cannula is arranged for providing anterograde blood perfusion"; reasonably assuming a splitter for splitting the source from the ECMO to the two cannulas);
a first tubular member (24) for coupling the connector to the proximal hub (figs. 10-12); and
a second tubular member (300) for coupling the connector to the second cannula (figs. 10-12).
Duijsens fails to explicitly teach the use via an ECMO device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case the device is easily capable of being used as such.
Regarding Claim 22, Duijsens teaches the kit of claim 21. The primary embodiment of Duijsens fails to teach a third cannula configured to be inserted into a blood vessel to receive blood from a patient. An alternative embodiment teaches a third cannula configured to be inserted into a blood vessel to receive blood from a patient (paragraph [0068] [0081]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment to include a third cannula inserted to a blood vessels.
Regarding Claim 23, Duijsens teaches the kit of claim 21. Duijsens fails to explicitly teach the use via an ECMO device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case the device is easily capable of being used as such.
Regarding Claim 12, Duijsens teaches the unloading system of claim 8. Duijsens further teaches wherein the second arm includes a barb connector for connection to an ECMO return [0071].
Duijsens fails to explicitly teach the use via an ECMO return. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case the device is easily capable of being used as such.
Regarding Claim 13, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the MCS device has a maximum crossing profile of 4-6 mm during insertion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the MCS device has a maximum crossing profile of 4-6 mm during insertion in order to fit the particular procedure being done since this claimed dimension of the maximum crossing profile is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0010 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 14, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the MCS device has a catheter with an outer diameter of 2.5-3.5 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the MCS device has a catheter with an outer diameter of 2.5-3.5 mm in order to fit the particular procedure being done since this claimed dimension of the outer diameter is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0010 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 15, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the second cannula has an inner diameter equal to an outer diameter of a catheter of the MCS device. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the wherein the second cannula has an inner diameter equal to an outer diameter of a catheter of the MCS device in order to fit the particular procedure being done since this claimed dimension of the outer diameter is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0010 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duijsens (US 20220370701 A1) in view of Farnan (US 9861728 B2).
Regarding Claim 11, Duijsens teaches the unloading system of claim 8. Duijsens fails to wherein the first arm comprises a side-arm for flushing. Farnan teaches a cannula system with a side arm for flushing (column 4, lines 52-67). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Duijsens to include a flushing port similar to Farnan to keep the system clean.
Claim(s) 6 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duijsens (US 20220370701 A1) and Dale (US 20160279386 A1).
Regarding Claim 6, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the first cannula comprises a laser-cut distal tip. Dale teaches an introducer wherein the first cannula comprises a laser-cut distal tip (paragraph [0033] FIG. 3A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the distal tip so it was laser-cut, similar to Dale, so the cut is more precise and steerable (paragraph [0033]).
Regarding Claim 18, Duijtsens teaches the unloading system of claim 16. Duijsens fails to teach wherein the second cannula comprises a laser-cut distal tip. Dale teaches an introducer wherein the first cannula comprises a laser-cut distal tip (paragraph [0033] FIG. 3A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the distal tip so it was laser-cut, similar to Duijsens, so the cut is more precise and steerable (paragraph [0033]).
Regarding Claim 19, Duijsens teaches the unloading system of claim 1. Duijsens fails to teach wherein the second cannula comprises one or more openings from an inner surface to an outer surface of the second cannula adjacent to a distal end. Dale teaches an introducer wherein the second cannula comprises one or more openings (40) from an inner surface to an outer surface of the second cannula adjacent to a distal end. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify to have openings in the second cannula similar to Dale for better control.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20220168488 A1, and US 20200114062 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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