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 03/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 03/16/2026 has been entered. Claims 1 and 16 have been amended. Accordingly, claims 1-20 are pending and under consideration.
Response to Arguments
Applicant’s arguments, see page 7-10, filed on 08/18/2025, with respect to the rejection(s) of claim 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Keren US 2018/0280667 A1 (previously cited), as cited in the IDS, in view of Aiba et al. US 6221096 B1 (hereinafter Aiba), as cited in the IDS, and Gallagher et al. US 2013/0261531 A1 (previously cited, hereinafter Gallagher), as cited in the IDS.
In response to applicant's argument on page 12 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this instant case, Keren already discusses that the presence of a sheath for the guidewire is well-known in the art. Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Keren to further include a lumen as taught by Gainor to accommodate the guidewire sheath of Keren. See rejection of claims below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-6, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Keren US 2018/0280667 A1 (previously cited, hereinafter Keren), as cited in the IDS, in view of Aiba et al. US 6,221,096 B1 (newly cited, hereinafter Aiba), as cited in the IDS, and Gallagher et al. US 2013/0261531 A1 (previously cited, hereinafter Gallagher), as cited in the IDS.
Regarding claim 1, Keren discloses an apparatus 28 (Fig. 1 – apparatus 28) for temporarily shunting blood across an atrial septum of a patient (Title – “Temporary Interatrial Shunts”), the apparatus 28 (Fig. 1) comprising:
a catheter 31 (Fig. 1 – sheath 31) having a proximal region (Fig. 1 – region near control handle 34) and a distal region (Fig. 1 – region near shunt 26);
a plurality of wires 25 (Fig. 2 – plurality of leaves 25), each of the plurality of wires 25 (Fig. 2) diverging into multiple wires (Fig. 2 – each leave 25, i.e., the outline of leave 25, branches into multiple wires inside said leave 25) to thereby integrally form a stent 26 (Fig. 1-2 – shunt 26; Par. 51 – “the shunt comprises a plurality of leaves 25…”) having a flared proximal region 44 (Fig. 2 – flared proximal region 44), a flared distal region 40 (Fig. 2 – flared distal region 40), and a neck region 42 (Fig. 2 – intermediation portion 42) therebetween (Fig. 2 – intermediate portion 42 is between region 40 and region 44), the stent 26 (Fig. 1-2) configured to transition between a contracted delivery state and an expanded deployed state (Par. 50 – “shunt 26 comprises a shape-memory material, such as Nitinol, such that the shunt expands to its natural shape (the shape shown in FIGS. 1-2) upon being released from a delivery catheter”, which implies a contracted delivery state and an expanded deployed state; embodiment of Fig. 4A-4B and Par. 70 for demonstrative purposes – “…that shunt 56 may move from a collapsed state (shown in FIG. 4A) to a preconfigured open state (shown in FIG. 4B)…”), the neck region 42 (Fig. 2) configured to be positioned within a puncture (Par. 71 – “…the opening in the septum”) of the atrial septum 24 (Fig. 4A-4B – interatrial septum 24) of the patient in the expanded deployed state (Fig. 4B for demonstrative purposes – deployed state of shunt between the atrial septum);
a cinching cord 38 (Fig. 2 – holding wire 38) having first “E1” and second ends “E2” (see annotated Fig. 2 below – first end “E1” and second end “E2” of wire 38; Fig. 1 in lumen 39 depicts two ends of wire 38 via the two circles), the cinching cord 38 (Fig. 2) extending around the neck region 42 (Fig. 2) of the stent 26 (Fig. 2) such that the first “E1” and second ends “E2” extend through the lumen 39 (see annotated Fig. 2 below, Fig. 1, and Par. 56 – “a wire 38 that loops around the intermediate portion of the shunt, both ends of the wire passing through the vasculature of the subject (e.g.,… within a separate lumen 39…”),
wherein movement of the first “E1” and second ends “E2” (see annotated Fig. 2 below) of the cinching cord 38 (Fig. 2) causes the neck region 42 (Fig. 2) of the stent 26 (Fig. 2) to transition between the contracted delivery state (Fig. 3B-C show a contracted state of shunt 26) and the expanded deployed state (Fig. 2-3A show an expanded deployed state), and
temporarily shunting the blood across the atrial septum (Par. 10 – “an interatrial shunt is required only temporarily”) via the neck region 42 (Fig. 2) positioned within the puncture of the atrial septum in the expanded deployed state (Par. 50 – “Distal portion 40 and proximal portion 44 anchor the shunt to septum 24 (i.e., prevent migration of the shunt from within the septum), while intermediate portion 42 provides a passageway across the septum, through which blood may flow”).
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Annotated Fig. 2 of Keren
However, Keren does not disclose a catheter comprising a head portion, the head portion comprising at least one receptacle; a plurality of wires having a proximal end configured to engage the at least one receptacle of the head portion, each of the plurality of wires extending distally from the at least one receptacle, and a proximal connection region extending from the at least one receptacle to the flared proximal region; a cinching tube extending distally from the distal region of the catheter toward the neck region of the stent, the cinching tube having a lumen extending therethrough; the first and second ends pass through an outlet of the cinching tube and extend through the lumen of the cinching tube, wherein movement of the first and second ends of the cinching cord relative to the cinching tube causes the neck region of the stent to transition, and wherein the proximal connection region, the flared proximal region, the neck region, and the flared distal region are integrally formed from a common metal frame, and wherein the proximal end of the plurality of wires is specifically designed to remain coupled to the head portion of the catheter while temporarily shunting the blood.
Aiba, in the same field of endeavor of temporary stent (Col. 3, line 17-18), teaches disclose a catheter 31 (Fig. 4 – catheter 31) comprising a head portion 32 (Fig. 4 – exit end 32), the head portion 32 (Fig. 4) comprising at least one receptacle (Fig. 4 – the lumen within catheter 31); a plurality of wires 28 (Fig. 4 – support wires 28) having a proximal end 28 (Fig. 4-5) configured to engage the at least one receptacle of the head portion 32 (Fig. 4, and Col. 5, line 3-4 – “FIG. 4 shows the stent proper 22 folded in the catheter 3”), each of the plurality of wires 28 (Fig. 4-5) extending distally from the at least one receptacle (Fig. 5 – support wires 28 extending outwardly and distally from the lumen of exit end 32), and a proximal connection region 21 (Fig. 4-5 – stent 21) extending from the at least one receptacle to the flared proximal region (Fig. 5 – the stent 21 transitions from region 21 to the base of the stent proper 22/elastic cylinder 23), the flared proximal region, the middle region, and the flared distal region (Fig. 5 – the proximal base of stent proper 22, middle region, and the distal base of stent proper 22) are integrally formed from a common metal frame 28 (Fig. 5), and wherein the proximal end 28 (Fig. 5) of the plurality of wires 28 (Fig. 5) is specifically designed to remain coupled to the head portion 32 (Fig. 5) of the catheter 31 (Fig. 5) while temporarily shunting the blood (Fig. 5 demonstrates that the plurality of wires 28 remain coupled at the exit end 32 during operation, Col. 4, line 58-59 – “When the stent proper 12 is temporarily left in the blood vessel”, and Col. 5, last paragraph – “The stent proper contracted and contained in the catheter was pushed into the inside of the aneurysm via the catheter sent from an dissected end of a peripheral artery (an aorta is chosen in most cases). The stent proper was allowed to expand on its own and left in the desired position. By leaving the stent proper in the desired position for a desired period of time, information about obstruction or hindrance to vascular flow was obtained”).
Gallagher, in the same field of endeavor of shunt assembly (Par. 1), teaches a cinching tube 128 (Fig. 1-2 – elongated shaft 128) extending toward the neck region “N” (see annotated Fig. 2 below – neck region “N”) of the stent 102 (Fig. 1-2 – tubular shunt 102), the cinching tube 128 (Fig. 1-2) having a lumen 130 (Fig. 1B – lumen 130) extending therethrough (Par. 28 – “Shaft 128 is an extruded tubular component defining a first lumen 130”); and
the first 324 and second ends 326 (Fig. 3 – ends 324, 326) pass through an outlet “O” (see annotated Fig. 2 below – outlet “O”) of the cinching tube 128 (see annotated Fig. 2 below – outlet “O” of shaft 128) and extend through the lumen 130 (Fig. 1-2) of the cinching tube 128 (Fig. 1-2 – end 324 and 326 extend through the lumen 130 of shaft 128, Par. 28 – “Alternatively, shaft 128 may have only a single lumen through which both ends of wire 116 extend side-by-side”),
wherein movement of the first 324 and second ends 326 (Fig. 1-3) of the cinching cord 116 (Fig. 1-2) relative to the cinching tube 128 (Fig. 1-2 and Par. 29 – “ When wrapped around the shunt circumference, wire 116 may also be described as having a first proximal end 324 and a second proximal end 326 with each end 324, 326 of wire 116 proximally extending out of shaft 128 to be operatively coupled within a subcutaneous port to permit manipulation by a clinician…”) causes the neck region “N” (see annotated Fig. 2 below) of the stent 102 (Fig. 1-2) to transition.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Keren to have at least one receptacle as taught by Aiba and the plurality of wires forming the stent of Keren to extend from said receptacle as taught by Aiba, in order to allow retraction of the temporary stent into the catheter and rearrangement to another position (Col. 5, line 51-57 of Aiba). This provides ease of repositioning of the medical device within the body cavity of a patient.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Keren in view of Aiba to further include a cinching tube where the cinching cord extends therethrough as taught by Gallagher, in order to provide housing for the cinching cord/wire and allow extension to any longitudinal location or position along the stent where it is desirable for the cinching cord/wire to encircle the stent (Par. 28 of Gallagher).
Once the combination is made as discussed above and since the cinching cord 38 of Keren is already within the lumen 39 of catheter 31 (Fig. 1 of Keren), it would have been obvious for the incorporation of the cinching tube 128 of Gallagher to be disposed within said lumen 39 of Keren, and said cinching tube 128 of Gallagher then houses the cinching cord as seen in Fig. 1-2 of Gallagher. Furthermore, since Gallagher already discusses that a cinching tube 128 can extend to any longitudinal location along the stent; thus, the combined device will have the cinching tube 128 extend out of the lumen 39, which is from the distal region of the catheter 31. Thus, the limitation of “a cinching tube extending distally from the distal region of the catheter” is met.
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Annotated Fig. 2 of Gallagher
Regarding claim 2, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. The combination further discloses further comprising a sheath 46 (Fig. 1 of Keren – catheter 46) having a proximal end (Fig. 3A of Keren – end near control handle 34), a distal end (Fig. 3A of Keren – end near shunt 26), and a lumen (Fig. 1 of Keren – catheter 46 has a hollow space inside) extending therethrough, the lumen (Fig. 1 of Keren – hollow space inside catheter 46) sized and shaped to receive the catheter 31 (Fig. 1 of Keren and Fig. 3A of Keren – sheath 31 disposed within the hollow space of catheter 46) and the stent 26 (Fig. 3C of Keren) in the contracted delivery state (Fig. 3C of Keren shows a contracted tubular shunt 26 within the catheter 46, and Par. 59 of Keren – “the shunt is first collapsed and placed inside a delivery catheter 46”).
Regarding claim 4, Keren in view of Aiba in view of Gallagher discloses the invention of claim 2. The combination further discloses wherein the catheter 31 (Fig. 1 of Keren) is slidably disposed within the lumen of the sheath 46 (Fig. 3A-3B of Keren – sheath 31 is within catheter 46, and Par. 66 – “stopper 52 prevents sheath 31 from moving proximally”, indicating that sheath 31 can move proximally within the catheter 46) such that as the sheath 46 moves over the plurality of wires 25 (Fig. 2 and Fig. 3A-3C of Keren) extending from the distal region of the catheter 31 (Fig. 3C of Keren depicts a right-oriented arrow indicating advancement of catheter 46 over the shunt 26 that extends from the sheath 31 as seen in Fig. 3A, and Par. 64 of Keren – “catheter 46… is then advanced until the distal end of the catheter is close to proximal portion 44 of the shunt”), the flared proximal region 44 (Fig. 3A-3C of Keren) of the stent 26 (Fig. 3A-3C of Keren) transitions from the expanded deployed state (Fig. 3A of Keren depicts the expanded deployed state of shunt 26) to the contracted delivery state (Fig. 3B- 3C of Keren depicts the contracted delivery state of shunt 26, specifically with the region 44, as advancement of catheter 46 takes place, and Par. 64 of Keren – “as shown in FIG. 3C, the catheter is advanced distally over the shunt. (In passing over the shunt, the catheter may at least partly pass through the interatrial septum.) As the catheter continues to pass over the shunt from the position shown in FIG. 3C, the catheter collapses the distal end of the shunt…”).
However, the combination does not explicitly disclose the sheath moves distally relative to the catheter.
Keren, in another embodiment, teaches that the sheath moves distally relative to the catheter (Par. 76 – “a catheter is advanced over the sheath, until the distal end of the catheter is near the proximal end of the shunt. Subsequently, upon collapse of the shunt, the shunt is pulled into the catheter, and/or the catheter is advanced over the shunt”).
Examiner notes and emphasizes that Keren consistently refers to the outermost tube as a catheter, e.g. catheter 46, and the tube disposed within said outermost tube is a sheath, e.g. sheath 31; this nomenclature is reversed compared to the claimed nomenclature. Regardless of the different naming systems, Examiner has consistently mapped the corresponding claimed structure.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath of the combination to have it move relatively to the catheter, also as taught by Keren, as Keren teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath in such a manner as taught by Keren, in order to provide isolation movement of the sheath relative to the catheter that is known in the art for easy and flexible maneuver of stent deployment.
Regarding claim 5, Keren in view of Aiba in view of Gallagher discloses the invention of claim 4. The combination further discloses wherein, when the neck region 42 (Fig. 2 of Keren) of the stent 26 (Fig. 2 of Keren) is in the contracted delivery state (Fig. 3B-3C of Keren – neck region 42 is in a transition to the contracted state for removal), as the sheath 46 (Fig. 3B-3C of Keren) moves distally relative to the catheter 31 (Examiner notes that once the modification is made as discussed in claim 4, the sheath, in this instant case the catheter 46, moves distally relative to the catheter, in this instant case sheath 31) from the neck region 42 (Fig. 3C of Keren – catheter 42 already advances over the neck region 42) and toward the flared distal region 40 (Fig. 2 and Fig. 3C of Keren – right-oriented arrow indicating advancement of catheter 46 over the flared distal region 40) of the stent 26 (Fig. 3C of Keren and Par. 64 of Keren – “As the catheter continues to pass over the shunt from the position shown in FIG. 3C, the catheter collapses the distal end of the shunt…”), the flared distal region 40 (Fig. 2 and Fig. 3C of Keren) of the stent 26 (Fig. 3C of Keren) transitions from the expanded deployed state (Fig. 3C of Keren – flared distal region 40 of shunt 26 being transitioned from the expanded state to the contracted state) to the contracted delivery state (Fig. 3C of Keren and Par. 64 of Keren – “As the catheter continues to pass over the shunt from the position shown in FIG. 3C, the catheter collapses the distal end of the shunt, such that the shunt becomes entirely collapsed within the catheter”).
Regarding claim 6, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. The combination further discloses wherein a diameter “D” (see annotated Fig. 3A of Keren below – diameter “D” of the flared proximal region 44) of the flared proximal region 44 (Fig. 3A of Keren) of the stent 26 (Fig. 3A of Keren) increases from the neck region 42 (Fig. 2 and 3A of Keren – neck region 42 expands into flared proximal region 44) towards the catheter 31 (Fig. 3A of Keren – neck region 42 expands toward the direction of sheath 31) until an apex “A” (see annotated Fig. 3A of Keren below – apex “A”) of the flared proximal region 44 (Fig. 2 and 3A of Keren) in the expanded deployed state (Fig. 2 and Fig. 3A of Keren show deployed shunt 26), and then decreases from the apex “A” (see annotated Fig. 3A of Keren below – decreases from the apex “A”) of the flared proximal region 44 (Fig. 2 and Fig. 3A of Keren) toward distal region of the catheter 31 (see annotated Fig. 3A of Keren below – there is a slight bend towards the direction of sheath 31, which reduces in diameter) in the expanded deployed state (Fig. 3A of Keren shows an expanded shunt 26).
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Annotated Fig. 3A of Keren
Regarding claim 11, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. The combination further discloses wherein the cinching tube 128 (Fig. 2 of Gallagher) extends distally from the distal region (Fig. 1 of Keren – region near shunt 26) of the catheter 31 (Fig. 1 of Keren; Examiner notes that once the combination is made as discussed in claim 1, the combined device will have the cinching tube 128 of Gallagher extend out of the lumen 39 of Keren, which is from the distal region of the catheter 31) toward the neck region 42 (Fig. 2 of Keren) of stent 26 (Fig. 2 of Keren; Examiner notes that once the combination is made as discussed in claim 1, the cinching tube 128 of Gallagher will be incorporated in its entirety to the device of Keren; therefore, the cinching tube 128 of Gallagher that extends to the neck region “N” of the stent as seen in annotated Fig. 2 of Gallagher above will also be incorporated into the stent of Keren; thus, the limitation is met) along an inner surface (Par. 28 of Gallagher – “…shaft 128 is coupled to an inside surface of tubular shunt 102) of the flared proximal region 44 (Fig. 2 of Keren) and the neck region 42 (Fig. 2 of Keren) of the stent 26 (Fig. 2 of Keren; Fig. 2 of Gallagher and Par. 28 of Gallagher – “…shaft 128 is coupled to an inside surface of tubular shunt 102…”; Examiner notes that once the combination is made as discussed in claim 1, the cinching tube 128 of Gallagher will be incorporated in its entirety to the device of Keren; therefore, the cinching tube 128 of Gallagher that extends along the inner surface of the stent from the proximal region to the neck region as seen in Fig. 2 of Gallagher will also be incorporated into the stent of Keren; thus, the limitation is met).
Regarding claim 12, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. The combination further discloses wherein the neck region 42 (Fig. 2 of Keren) of the stent 26 (Fig. 2 of Keren) comprises a plurality of eyelets 50 (Fig. 2 of Keren – a plurality of orifices 50) disposed circumferentially around the neck region 42 (Fig. 2 of Keren – orifices 50 are disposed around the neck region 42) of the stent 26 (Fig. 2 of Keren), and wherein the cinching cord 38 (Fig. 2 of Keren) extends through at least one eyelet of the plurality of eyelets 50 (Fig. 2 of Keren, and Par. 57 of Keren – “the wire passes circumferentially along the intermediate portion by passing through the orifices”) around the neck region 42 (Fig. 2 of Keren).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of Aiba in view of Gallagher as applied to claim 2 above, and further in view of Hill et al. US 2006/0282157 A1 (previously cited, hereinafter Hill), as cited in the IDS.
Regarding claim 3, Keren in view of Aiba in view of Gallagher discloses the invention of claim 2. The combination further discloses that wherein, when the stent 26 (Fig. 1 of Keren) is disposed within the lumen of the sheath 46 in the contracted delivery state (Par. 59 of Keren – “the shunt is first collapsed and placed inside a delivery catheter 46”), proximal movement of the sheath 46 (Par. 59 of Keren – “The catheter is then withdrawn from over the shunt while the shunt is held in place…”) causes the stent 26 to be exposed from the distal end of the sheath 46 (Par. 59 of Keren – “The catheter is then withdrawn from over the shunt while the shunt is held in place…”, indicating that the withdrawal of sheath results in the reveal of shunt 26) and transition from the contracted delivery state to the expanded deployed state (Par. 50 of Keren – “shunt 26 comprises a shape-memory material, such as Nitinol, such that the shunt expands to its natural shape… upon being released from a delivery catheter…”, and Par. 59 of Keren – “The catheter is then withdrawn from over the shunt while the shunt is held in place. As the catheter is withdrawn from over the shunt, the shunt reassumes its natural, non-collapsed shape”).
However, the combination does not explicitly disclose proximal movement of the sheath relative to the catheter.
Hill, the same field of endeavor of catheter and retractable sheath (Par. 96), teaches proximal movement (Fig. 7 – arrow pointing to the left at valve 700, and Par. 96 – “the retractable sheath 796 can move longitudinally along the elongate body 784”) of the sheath 796 (Fig. 7 – retractable sheath 796) relative to the catheter 784 (Fig. 7 – elongate body 784).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath and catheter of the combination to have the sheath move relative to the catheter as taught by Hill, in order to deploy the valve (Par. 96 of Hill), or in this instant case, to deploy the stent of the combined device. Furthermore, it is also well-known in the art of stent deployment system to have multi-sheath slide relative to each other to perform deployment.
Claims 7, 9, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of Aiba in view of Gallagher as applied to claim 1, 12, and 16 above, and further in view of Eigler et al. US 2018/0243071 A1 (previously cited, hereinafter Eigler), as cited in the IDS.
Regarding claim 7, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. However, the combination does not disclose further comprising a biocompatible material encapsulating the distal region, the neck region, and at least a portion of the flared proximal region of the stent.
Eigler, in the same field of endeavor of shunt for redistributing atrial blood volume (Title), teaches a biocompatible material 57 (Fig. 4B – biocompatible material 57) encapsulating (Par. 110 – “a fully encapsulated hourglass shunt” and “Shunt 50 includes anchor 51… includes a conduit formed of biocompatible material 57 as also described hereinabove”) the distal region 53 (Fig. 4B – end region 53), the neck region 54 (Fig. 2 – neck region 54), and at least a portion of the flared proximal region 52 (Fig. 2 – right atrial end region 52; biocompatible material 57 encapsulates the region 52 fully) of the stent 50 (Fig. 4A – shunt 50; Fig. 4B shows biocompatible material being present in all three regions).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent of the combination to further include a biocompatible material encapsulating all regions the stent as taught by Eigler, in order to limit or inhibit excessive tissue ingrowth into the lumen of the conduit (Par. 77 of Eigler).
Regarding claim 9, Keren in view of Aiba in view of Gallagher in view of Eigler discloses the invention of claim 7. The combination further discloses wherein a diameter “D” (see annotated Fig. 3A of Keren above – diameter “D” of the flared proximal region 44) of the flared proximal region 44 (Fig. 3A of Keren) of the stent 26 (Fig. 3A of Keren) increases from the neck region 42 (Fig. 2 and 3A of Keren – neck region 42 expands into flared proximal region 44) towards the catheter 31 (Fig. 3A of Keren – neck region 42 expands toward the direction of sheath 31) until an apex “A” (see annotated Fig. 3A of Keren above – apex “A”) of the flared proximal region 44 (Fig. 2 and 3A of Keren) in the expanded deployed state (Fig. 2 and Fig. 3A of Keren show deployed shunt 26), and then decreases from the apex “A” (see annotated Fig. 3A of Keren above – decreases from the apex “A”) of the flared proximal region 44 (Fig. 2 and Fig. 3A of Keren) toward distal region of the catheter 31 (see annotated Fig. 3A of Keren above – there is a slight bend towards the direction of sheath 31, which reduces in diameter) in the expanded deployed state (Fig. 3A of Keren shows an expanded shunt 26), such that the biocompatible material 57 (Fig. 4B of Eigler) encapsulates the distal region 44 (Fig. 2 of Keren; Examiner notes that once the combination is made as discussed in claim 7, the distal region 44 of Keren will be encapsulated by the biocompatible material 57 as taught by Eigler; thus, the limitation is met), the neck region 42 (Fig. 2 of Keren; similarly, the neck region 42 of Keren will be encapsulated by the biocompatible material 57 as taught by Eigler), and the portion of the flared proximal region 44 (Fig. 2 of Keren) of the stent 26 (Fig. 2 of Keren) between the neck region 42 (see annotated Fig. 3A of Keren above) and the apex “A” of the flared proximal region 44 (see annotated Fig. 3A of Keren above – the portion from neck 42 to apex “A”; as established in claim 7, the proximal region of Eigler is encapsulated by the biocompatible material 57 fully as taught by Eigler; thus, the portion between the neck region 42 and the apex “A” of the flare proximal region 44 of Keren will be fully encapsulated by the biocompatible material 57 as taught by Eigler in the combined device; thus, the limitation is met).
Regarding claim 10, Keren in view of Aiba in view of Gallagher in view of Eigler discloses the invention of claim 7. The combination further discloses a plurality of eyelets 50 (Fig. 2 of Keren – a plurality of orifices 50) disposed circumferentially around the neck region 42 (Fig. 2 of Keren – orifices 50 are disposed around the neck region 42) of the stent 26 (Fig. 2 of Keren), and wherein the cinching cord 38 (Fig. 2 of Keren) extends through at least one of the plurality of eyelets 50 (Fig. 2 of Keren, and Par. 57 of Keren – “the wire passes circumferentially along the intermediate portion by passing through the orifices”) around the neck region 42 (Fig. 2 of Keren).
However, the combination does not currently disclose wherein the biocompatible material comprises at least one opening adjacent to the neck region of the stent, the at least one opening aligned with a plurality of eyelets, and wherein the cinching cord extends through at least one opening in the biocompatible material.
Gallagher, in the same field of endeavor of shunt assembly (Par. 1), teaches wherein the biocompatible material 110 (Fig. 1-2 – graft material 110) comprises one or more openings (see annotated Fig. 2 above – opening “OP” of biocompatible material 110; Par. 29 – “Wire 116 extends through shaft lumen 130, exits from a distal end of shaft 128, passes through shunt graft material 110, loops around the outside of tubular shunt 102, passes back through graft material 110 of tubular shunt 102, reenters the distal end of shaft 128, and extends through shaft lumen 132”, implying that there are openings/passageways for wire 116 to traverse) adjacent to the neck region “N” (see annotated Fig. 2 above – the openings “OP” are in the neck region “N”) of the stent 102 (Fig. 2 – tubular shunt 102), and wherein the cinching cord 116 (Fig. 2 – wire 116) extends through one or more openings “OP” (see annotated Fig. 2 above) in the biocompatible material 110 (see annotated Fig. 2 above, and Par. 29 – “Wire 116… passes through shunt graft material 110, loops around the outside of tubular shunt 102, passes back through graft material 110 of tubular shunt 102,…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biocompatible material of the combination to further include one or more openings adjacent to the neck region of the stent as taught by Gallagher, in order to permit the cinching cord/wire to be selectively tightened or loosened in order to vary the size of fluid passageway and thereby regulate the rate of blood flow through shunt assembly (Par. 29 of Gallagher).
Furthermore, since the primary stent 26 of Keren originally possess a plurality of eyelets 50, along with the addition of the biocompatible material 57 as taught by Eigler and its plurality of openings “OP” as taught by Gallagher, it would have been within the technological capability of one of ordinary skill in the art to have made these openings of the biocompatible material aligned with the eyelets of the stent, because the cinching cord (both wire 38 of Keren and wire 36 of Gallagher) has to pass through these eyelets/openings to adjust the neck region of the stent. Therefore, it is obvious and reasonably expected for a skilled artisan to match the positions of the biocompatible material with the eyelets. Thus, the limitation “the one or more openings aligned with a plurality of eyelets” is met.
Regarding claim 13, Keren in view of Aiba in view of Gallagher discloses the invention of claim 12. However, the combination does not disclose wherein at least one eyelet of the plurality of eyelets comprise a radiopaque material.
Eigler, in the same field of endeavor of shunt assembly (Par. 1), teaches wherein one or more eyelets of the plurality of eyelets 64 (Fig. 5A – eyelets 64) comprise a radiopaque material 65 (Fig. 5A – radiopaque markers 65, and Par. 111 – “alternating eyelets 64 include radiopaque markers 65”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the eyelets of the combination to further have a radiopaque material as taught by Eigler, in order to enhance visualization of the shunt under fluoroscopy (Par. 111 of Eigler).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of Aiba in view of Gallagher in view of Eigler as applied to claim 7 above, and further in view of Levine et al. US 2010/0298632 A1 (previously cited, hereinafter Levine).
Regarding claim 8, Keren in view of Aiba in view of Gallagher in view of Eigler discloses the invention of claim 7. However, the combination does not disclose wherein the biocompatible material extends a preselected distance beyond the flared distal region of the stent to thereby reduce injury to surrounding tissue during deployment and retrieval of the stent.
Levine, in the same field of endeavor of stent (Par. 60), teaches wherein the biocompatible material 810 (Fig. 9C – liner 810, and Par. 67 – “The liner 210 can be formed from a thin yet durable biocompatible material…”) extends a preselected distance (Par. 89 – “the liner 810 may extend for a predetermined length…”) beyond the stent 800 (Fig. 9C – implant 800).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biocompatible material of the combination to have an extended length as taught by Levine, in order to fit the particular procedure being done since this claimed dimension of the biocompatible material beyond the flared distal region does not change the biocompatible material’s ability to prevent tissue ingrowth as discussed by Eigler in Par. 77. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 43 of Applicant’s 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. Therefore, once medication is made as discussed, the extended biocompatible material beyond the distal flared region will indeed be capable of “reduce injury to surrounding tissue during deployment and retrieval of the stent”, since one of ordinary skill in the art would have understood that the encapsulation of biocompatible material provides a smooth layer around the struts/wires of the stent that might cause unwanted probing of surrounding tissue. Thus, the limitation is met.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of Aiba in view of Gallagher as applied to claim 1 above, and further in view of Kusumoto et al. US 8,660,667 B1 (previously cited, hereinafter Kusumoto).
Regarding claim 14, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. However, the combination does not disclose wherein the cinching tube comprises a fairlead adjacent to the outlet of the cinching tube, the fairlead configured to guide the first and second ends of the cinching cord through the outlet of the cinching tube.
Kusumoto, in the same field of endeavor of medical device delivery catheter (Title), teaches wherein the cinching tube S (Fig. 11 – sheath S) comprises a fairlead 40 (Fig. 11 – bead 40) adjacent to the outlet (Fig. 11 – bead 40 is near the right outlet of sheath S) of the cinching tube S (Fig. 11), the fairlead 40 (Fig. 11) configured to guide the first 22 (Fig. 11 – proximal end 22) and second ends 24 (Fig. 11 – distal end 24) of the cinching cord 20 (Fig. 11 – cord 20) through the outlet (Fig. 11 – right outlet of sheath S) of the cinching tube S (Fig. 11 and Col. 6, line 6-9 – “bead 40 can also be utilized to secure a proximal end 22 of the cord 20 to a distal end 24 of the cord 20…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cinching cord of the combination to further include a fairlead adjacent to the outlet of the cinching tube as taught by Kusumoto, in order to secure a proximal end of the cord to a distal end of the cord (Col. 6, line 6-9 of Kusumoto). This fairlead would act as an anchor for the cinching cord and provide more control over the cinching cord during deployment/removal because the movement of cinching cord is limited by this fairlead.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of Aiba in view of Gallagher as applied to claim 1 above, and further in view of Gainor et al. US 2013/0197629 A1 (previously cited, hereinafter Gainor), as cited in the IDS.
Regarding claim 15, Keren in view of Aiba in view of Gallagher discloses the invention of claim 1. However, the combination does not currently disclose wherein the catheter further comprises a guidewire lumen extending therethrough, the guidewire lumen sized and shaped to receive a guidewire tube slideably disposed therewithin, the guidewire tube lumen sized and shaped to receive a guidewire.
Keren, in another embodiment, teaches wherein the catheter 62 (Fig. 4B – sheath 62) further comprises a guidewire tube (Par. 71 – “To introduce guidewire 58, a vascular sheath (not shown)… may be used, as is known in the art”) slideably disposed therewithin (Par. 71 – “…a guidewire 58 is inserted…”, indicating the sliding ability of the tube in order to deliver the guidewire 58), the guidewire tube lumen sized and shaped to receive a guidewire 58 (Fig. 4B – guidewire 58, and Par. 71 – “To introduce guidewire 58, a vascular sheath (not shown), which may alternatively be referred to as a catheter, may be used”).
Gainor, in the same field of endeavor of delivery device (Title) and cardiovascular surgeries (Par. 2), teaches wherein the catheter 30 (Fig. 2A – pusher catheter 30) further comprises a guidewire lumen 32 (Fig. 2A – guidewire lumen 32) extending therethrough (Fig. 2A – lumen 32 extends throughout the length of the pusher catheter 30).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter (sheath 31 of Keren) of the combined device to further include a guidewire tube housing a guidewire as taught by another embodiment of Keren, as Keren teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of the combined device to further have a guidewire lumen as taught by Gainor, in order to provide a multi-lumen catheter for containing cables (Par. 52 of Gainor) and enable precise positioning of the implant (Par. 20 of Gainor). The isolated guidewire lumen would permit separate movement of the guidewire for better control. Once the combination is made as discussed, the guidewire lumen as taught by Gainor would be intended to receive the guidewire tube of Keren in view of Gallagher. Thus, the limitation is met.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 16, no art on record, alone, or in combination could be found to teach: a head portion at a distal region of the catheter comprising at least one receptacle coupled to a proximal end of a plurality of wires, each of the plurality of wires extending distally from the at least one receptacle, the proximal end of the plurality of wires specifically designed to remain coupled to the head portion of the catheter, the flared proximal region of the stent coupled to the distal region of the catheter via a proximal connection region formed by the plurality of wires, and wherein the proximal connection, the flared proximal region, the neck region, and the flared distal region are integrally formed from a common metal frame, in combination with the remaining claimed method steps.
The closest prior arts of record are Keren, Aiba, and Todd US 2015/0313596 A1 (newly cited, hereinafter Todd).
Keren substantially discloses the invention of claim 15 as previously established in the Office Action mailed on 12/16/2025. However, Keren does not disclose the proximal end of the plurality of wires specifically designed to remain coupled to the head portion of the catheter. The proximal end 44 of the plurality of wires 25 of Keren does not remain coupled to any head portion of the catheter 31 (Fig. 1 of Keren) in an expanded deployed state as there is no proximal connection region formed by wires coupled to the distal region of the catheter. The wires 25 forming stent 26 fully come out of the catheter 31 upon deployment and during shunting, and the cords 36 are the only wires that come out of the distal of catheter 31. However, cords 36 are not an integral part of stent 26 and does not form stent 26. There is no teaching or suggestion to modify the method to reach the claimed limitation of the proximal end of the plurality of wires specifically designed to remain coupled to the head portion of the catheter. No prior arts of record have been found to teach the claimed limitation.
Aiba teaches the structure as established above in claim 1. However, the method applied for the device of Aiba is that for blood vessel to monitor and treat aneurysm. There is no teaching or suggestion of using said structure for temporarily shunting blood across an atrial septum in the heart. It would not have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have sought the method of treating diseases of blood vessels of Aiba, alone or in combination with Keren, and applied it to the method of treating excessive pressure between the right and left atria of the heart. It is also noted that the method of Aiba operates under the principle of restoring a continuous blood flow within the blood vessel, while the claimed method is for moving bodily fluids, i.e. blood, from a bodily region/cavity/part to another.
Todd teaches a method/an implantable device (Fig. 4) for forming anastomosis. The device of Todd discloses tethers 810a, 810b, 810c, but does not explicitly disclose the connection of said tethers to the catheter. Therefore, one of ordinary skill in the art would have been motivated to use Todd, alone or in combination with Keren, and/or Aiba, to teach the method of the proximal end of the plurality of wires specifically designed to remain coupled to the head portion of the catheter. No other prior arts of record have been found to teach the claimed limitation.
Therefore, claim 16 is allowed.
Accordingly, claims 17-20 are also allowed due to dependency on claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marino et al. US 2004/0225324 A1 teaches a delivery system with safety tether that can remain connected to the implant and catheter.
Amin et al. US 2013/0165967 A1 teaches heart occlusion devices.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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