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 .
Election/Restrictions
Applicant’s election without traverse of claims 11-19 in the reply filed on 03/26/2026 is acknowledged. Claims 27-37 are new. Claims 11-19 and 27-37 are pending.
Information Disclosure Statement
The information disclosure statement(s) filed 10/26/2023 has/have been considered by the Examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 11-19 and 27-37 is/are rejected under 35 U.S.C. §101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim(s) 11 is/are interpreted to read on a human organism because the claims recite, “…the expanding member thereby securing a distal end of the catheter in place in the coronary sinus”, thereby improperly defining the structure (catheter) in positive relation/connection with a living being (coronary sinus). The claims should define the elements as being “configured to” to avoid the positive recitation. Dependent claims 12-19 inherit this rejection.
Claim(s) 16 is/are interpreted to read on a human organism because the claims recite, “…the expanding member to press against a vessel wall to provide wall apposition for the catheter to facilitate puncturing the vessel wall”, thereby improperly defining the structure (expanding member) in positive relation/connection with a living being (vessel wall). The claims should define the elements as being “configured to” to avoid the positive recitation.
Claim(s) 27 is/are interpreted to read on a human organism because the claims recite, “…the expanding member thereby securing a distal end of the catheter in place in the coronary sinus”, thereby improperly defining the structure (catheter) in positive relation/connection with a living being (coronary sinus). The claims should define the elements as being “configured to” to avoid the positive recitation. Dependent claims 28-37 inherit this rejection.
Claim(s) 33 is/are interpreted to read on a human organism because the claims recite, “…the expanding member to press against a vessel wall to provide wall apposition for the catheter to facilitate puncturing the vessel wall”, thereby improperly defining the structure (expanding member) in positive relation/connection with a living being (vessel wall). The claims should define the elements as being “configured to” to avoid the positive recitation.
Claim Interpretation
The term(s) “configured to”, “permits” and “used to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-12, 14-16, 19, 27-28, 30-35 and 37 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Addis (US 20020058964 A1 – hereinafter Addis).
Re. claim 11, Addis teaches a guidewire delivery catheter used to implant a shunt between a coronary sinus and a left atrium,
the catheter including a securing mechanism that comprises:
an activation member including a wire (figure 2, flexible lines 5); and
an expanding member activated by the activation member (figure 2, filter mesh 30 connected to the flexible wires 5),
a proximal side of the expanding member coupled to a distal end of the activation member (figure 2, distal end of the filter mesh 30 connected to the flexible wires 5),
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the expanding member configured to expand out of the catheter responsive to the activation member being advanced distally, the expanding member thereby securing a distal end of the catheter in place in the coronary sinus (paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 12, Addis further teaches wherein the expanding member comprises a mesh structure (figure 2, distal end of the filter mesh 30),
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Re. claim 14, Addis further teaches wherein the expanding member is configured to be retracted by pulling the activation member proximally (paragraph 0014 – “…the flexible lines are pulled and the filter mesh is contracted tightly against the elongate element”; paragraph 0030 – “After a surgeon has performed surgery on the heart, the balloon occluder may be deflated. The lines are pulled to contract the mesh”).
Re. claim 15, Addis further teaches wherein a distal portion of the expanding member is fixed to the catheter (figure 2 shows the distal end of the mesh 30 fixed to the distal end 22 of catheter 1).
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Re. claim 16, Addis further teaches wherein activation of the expanding member causes the expanding member to press against a vessel wall to provide wall apposition for the catheter to facilitate puncturing the vessel wall (mesh 30 contracts to push against the aortic wall, paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 19, Addis further teaches wherein the expanding member is not activated through inflation using liquid or gas (no mention of inflation by liquid or gas, only paragraph 0028 – “The flexible lines or wires are pushed distally to expand the mesh radially outward so that the first edge of the filter mesh is in close contact with the inner aortic wall”; paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 27, Addis teaches guidewire delivery catheter used to implant a shunt between a coronary sinus and a left atrium, the catheter including a securing mechanism that comprises:
an activation member (figure 2, flexible lines 5);
and an expanding member activated by the activation member that causes the expanding member to expand out of the catheter (figure 2, filter mesh 30 connected to the flexible wires 5),
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the expanding member thereby securing a distal end of the catheter in place in the coronary sinus (paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 28, Addis further teaches wherein the expanding member comprises a mesh structure (figure 2, distal end of the filter mesh 30),
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Re. claim 30, Addis further teaches wherein the expanding member is configured to be expanded responsive to pushing the activation member distally (paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 31, Addis further teaches wherein the expanding member is configured to be retracted by pulling the activation member proximally (paragraph 0014 – “…the flexible lines are pulled and the filter mesh is contracted tightly against the elongate element”; paragraph 0030 – “After a surgeon has performed surgery on the heart, the balloon occluder may be deflated. The lines are pulled to contract the mesh”).
Re. claim 32, Addis further teaches wherein a distal portion of the expanding member is fixed to the catheter (figure 2 shows the distal end of the mesh 30 fixed to the distal end 22 of catheter 1).
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Re. claim 33, Addis further teaches wherein activation of the expanding member causes the expanding member to press against a vessel wall to provide wall apposition for the catheter to facilitate puncturing the vessel wall (mesh 30 contracts to push against the aortic wall, paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 34, Addis further teaches wherein the expanding member is not activated through inflation using liquid or gas (no mention of inflation by liquid or gas, only paragraph 0028 – “The flexible lines or wires are pushed distally to expand the mesh radially outward so that the first edge of the filter mesh is in close contact with the inner aortic wall”; paragraph 0029 – “Filter mesh 30 is mounted on the framework. In use, the balloon occluder is inflated through inflation lumen 46 to provide circulatory isolation, and the filter mesh is expanded to contact the interior aortic wall by pushing on flexible lines or wires”).
Re. claim 35, Addis further teaches wherein the expanding member permits fluid to flow through the coronary sinus when the expanding member is expanded out of the guidewire delivery catheter (figure 2, filter mesh 30 would allow liquid to flow through).
Re. claim 37, Addis further teaches wherein the expanding member forms a part of an outer wall of the guidewire delivery catheter during delivery (figure 2 shows the filter mesh 30 forming a wall from the end 3).
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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.
Claim(s) 13 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addis (US 20020058964 A1 – hereinafter Addis) in view of Deveraux (US 20180126127 A1 – hereinafter Deveraux).
Re. claim 13, Addis teaches the expanding member as stated above in claim 1, but does not explicitly teach wherein the expanding member comprises a compliant wire material.
Deveraux teaches a catheter system (abstract – A chordae management catheter…“) comprising an expanding member (figure 26, displacement component 2330 with flat or planar element 2672), wherein the expanding member comprises a compliant wire material (paragraph 0103 – “Displacement component 2630 is a flat or planar element 2672 that is formed from a self-expanding material and shape-set in the deployed or expanded configuration shown best in FIG. 26, which may be described as a conical or funnel configuration or profile 2674. In an embodiment hereof, flat or planar element 2672 is a mesh formed from Nitinol or another self-expanding material”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable mesh member of Addis, to incorporate the compliant wire mesh material Nitinol, as taught by Deveraux, since such modification would predictably result in fixing the expanded nitinol mesh of the catheter to a target region in the body.
Re. claim 29, Addis teaches the expanding member as stated above in claim 27, but does not explicitly teach wherein the expanding member comprises a compliant wire material.
Deveraux teaches a catheter system (abstract – A chordae management catheter…“) comprising an expanding member (figure 26, displacement component 2330 with flat or planar element 2672), wherein the expanding member comprises a compliant wire material (paragraph 0103 – “Displacement component 2630 is a flat or planar element 2672 that is formed from a self-expanding material and shape-set in the deployed or expanded configuration shown best in FIG. 26, which may be described as a conical or funnel configuration or profile 2674. In an embodiment hereof, flat or planar element 2672 is a mesh formed from Nitinol or another self-expanding material”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable mesh member of Addis, to incorporate the compliant wire mesh material Nitinol, as taught by Deveraux, since such modification would predictably result in fixing the expanded nitinol mesh of the catheter to a target region in the body.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addis (US 20020058964 A1 – hereinafter Addis) in view of Rafiee (US 20180008248 A1 – hereinafter Rafiee).
Re. claim 17, Addis teaches the claimed invention of claim 11 including the expandable member as stated above, but does not explicitly teach wherein the expanding member comprises a fabric covering that contains a distal portion of the activation member such that as the activation member is advanced distally, the distal portion of the activation member curves within the fabric covering to cause the fabric covering to form a dome shape.
Rafiee teaches a similar catheter system (paragraph 0004 – “The present disclosure relates to a device and method for transcatheter correction of cardiovascular abnormalities, such as the delivery of prosthetic valves to the heart”). Rafiee further teaches an expandable member (figure 1B, expandable mesh discs 112 with the dome shapes; paragraph 0012 – “In some implementations, a prosthesis is provided having a proximal end and a distal end, the prosthesis having a radially expandable body, the radially expandable body being configured to expand into at least one distal disc after becoming unconstrained”; paragraph 0064 – “The mesh covering preferably defines at least one proximal lobe, or disc 112…”),
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And wherein the expanding member comprises a fabric covering that contains a distal portion of the activation member such that as the activation member is advanced distally, the distal portion of the activation member curves within the fabric covering to cause the fabric covering to form a dome shape (paragraph 0022 – “The prosthesis further includes an outer fabric covering connecting the plurality of radially expandable braided mesh bodies, the outer fabric being disposed outside of the braiding of the plurality of radially expandable braided mesh bodies”, and therefore the outer fabric covering the dome shaped discs would in turn form the dome shape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable mesh member of Addis, to incorporate the dome shaped expandable mesh AND fabric covering, as taught by Rafiee, since such modification would predictably result in fixing the expanded mesh of the catheter to a target region in the body.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addis (US 20020058964 A1 – hereinafter Addis) in view of Gambale (US 20010004690 A1 – hereinafter Gambale).
Re. claim 18, Addis teaches the claimed invention of claim 11 including the wire as stated above, but does not explicitly teach wherein the wire comprises a hypotube.
Gambale teaches a similar catheter system (paragraph 0107 – “The steerable delivery catheter 36 is not shown in FIGS. 6A and 6B but is understood to be part of the delivery system”), and further teaches an expandable member (figures 5A-5B, mesh tube 40),
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Connected to a hypotube which expands the mesh tube 40 (paragraph 0108 – “In the case of implantation in the myocardium, the sharp piercing distal tip 64 of the release wire 54 penetrates the endocardial surface 6 to provide access to the myocardium 4. After placement of the mesh tube within the myocardium 4, it is expanded to its second configuration by moving the hypotube, which engages the proximal end 56 of the tube, in a proximal direction…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify wire of Addis, to hypotube, as taught by Gambale, since such modification would predictably result in ease of use in fixing the expanded mesh of the catheter to a target region in the body.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addis (US 20020058964 A1 – hereinafter Addis) in view of Arevalos (US 20200289196 A1 – hereinafter Arevalos).
Re. claim 36, Addis teaches the claimed invention of claim 27 including the wire as stated above, but does not explicitly teach wherein the expanding member is at least partially housed within the guidewire delivery catheter during delivery.
Arevalos teaches a similar catheter system (abstract – “The device assembly comprises a delivery catheter…”), and further teaches an expanding member (tissue stabilizer, paragraph 0070 – “In some embodiments, the tissue stabilizer is connected to the guidewire and is made of a self-expanding mesh…”), and further teaches wherein the expanding member is at least partially housed within the guidewire delivery catheter during delivery (paragraph 0070 – “In some embodiments, the tissue stabilizer is connected to the guidewire and is made of a self-expanding mesh that is constrained within a separate catheter prior to delivery to the left atrium. In some embodiments, this self-expanding mesh resides in a collapsed state within the guide catheter (catheter 1) prior to deployment”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable mesh member of Addis, to incorporate the expanding mesh housed within the catheter, as taught by Arevalos, since such modification would predictably result in easier catheter delivery to a target region in the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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