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
The amendments filed on 05/27/2026 has been entered. Claims 1-28 have been cancelled; claims 29-54 have been added. Accordingly, claims 29-54 are pending and under consideration.
According to Applicant’s remarks dated 05/27/2026, on page 1, first paragraph, the new claims 29-48 correspond to previous versions of claims 1-12. Upon further review and consideration, independent claims 29 and 41, which is claimed to correspond to previous claim 1 and claim 21, respectively, appear to have been modified to at least remove previous limitations and/or add new limitations that were not previously examined on the merits, i.e., newly added limitation of “the proximalmost inner tube end adjacent the proximal outer sheath end” of the current claim 29 and current claim 41, removed previous limitation of “the distalmost inner tube end extending across the radial width and being perpendicular to a longitudinal axis of the inner tube” of the previous claim 1 from current claim 29; newly added limitation of “the guidewire groove extending longitudinally distally from the proximal introducer end” of the current claim 41. These amendments hereby change the scope of the claimed invention; thus, a new ground of rejection is established below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 29 and 41 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s remarks stating that “it is respectfully noted that the antegrade cannula 106 of the '035 publication, which the Examiner analogizes to the claimed inner tube, is inserted completely into the lumen of the retrograde cannula 102 with the proximalmost end of the antegrade cannula 106 just barely held within the lumen of the retrograde cannula 102, as shown in, e.g., Fig. 7F of the '035 publication. Thus, the proximalmost inner tube end (of the antegrade cannula 106) of the Examiner's publication is not, and cannot be, located adjacent the proximal outer sheath end. If such were to be done, the function of the '035 device would be destroyed because the blood being infused through the retrograde cannula 102 could not enter the antegrade cannula 106 for infusion in a different direction than through the retrograde cannula 102, which is the entire goal of the '035 publication” on page 9 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Sotolongo, as recited for rejection herein, is not relied upon for any teachings of the subject matter as traversed. The limitation is read taught by the primary reference Yokoyama. See rejection of claims below.
Regarding Applicant’s remarks stating that “it is respectfully submitted that the '909 publication does not, and cannot, clearly show that the tube 34 (characterized by the Examiner as the claimed inner tube) is selectively inserted into the outer sheath lumen, when the introducer is absent from the outer sheath lumen. Careful review of the '909 publication did not turn up any description of the tube 34 as being inserted or placed into the outer sheath lumen as part of the operation of the described device; instead, the [0072] mention of " the third tube 34 is inserted into the blood removing lumen 62 of the second tube 33" appears, from context, to be a statement more akin to the third tube having been previously inserted into the blood removing lumen” on page 9 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Under broadest reasonable interpretation, the limitation is interpreted to not impart any chronological order or step of insertion of the inner tube with respect with the insertion of the dilator. Therefore, as Applicant stated above, it would have been within the skill of an artisan to broadly and reasonably understand that the inner tube 34 of Yokoyama could have been selectively inserted into the outer sheath 31 previously, i.e., during manufacturing, when there is no presence of the dilator 50 as the dilator 50 is not introduced until the catheter 60 is ready for insertion into the living body (Par. 48 of Yokoyama).
Applicant’s remarks of rib 70 on page 10 belong to an embodiment that has not been relied upon for any teaching/rejection; Examiner acknowledged the remarks.
Regarding Applicant’s remarks stating that “Tunnel 208 of the '035 publication is shown in Figs. 2D-2E as being an enclosed, internal antegrade tunnel extending from the receiving opening to the intermediate opening 110 and/or elbow socket 111 [0048]. However, it is respectfully submitted that elbow socket cut-out passage 202 of the '035 publication is more closely akin to the claimed guidewire groove, as shown in Fig. 2D--since the claimed groove is cut into the outer surface of the tube rather than enclosed therewithin as is the antegrade tunnel 208 of the '035 publication. The cut-out 202 of the '035 publication (which is the groove cut into the introducer wall) extends from substantially near (or adjacent to) the intermediate opening 110 to the distal end 206 of the retrograde introducer 100--i.e., the portion of the retrograde cannula distal to the intermediate opening 110--presumably to allow the retrograde introducer to slide over top of the intermediate opening 110 and/or elbow socket 111. The antegrade tunnel 208, in contrast extends from the receiving opening 108 to the intermediate opening 110 and/or elbow socket 111--i.e., proximal to the intermediate opening, which is the location of the claimed guidewire groove. ([0048])” on page 11 of Applicant’s remarks, Examiner acknowledged the remarks. However, the cut-out passage 202 of Sotolongo is not relied upon for any teaching of the claimed invention. See rejection of claims below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 49-54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 49 and claim 50, the limitation “a plurality of fluid removal apertures… being proximal to the side access aperture” is considered to be new matter. Said feature appears to be present in the embodiment of Fig. 6 and Fig. 9 of Applicant’s disclosure, particularly the embodiment of Fig. 9. Therefore, there is no support in the specification for said plurality of fluid removal apertures proximal to the side access aperture such that they are in the same embodiment with claim 29 and claim 50’s introducer, which appears to belong to the embodiment of Fig. 15, 16, and Fig. 19.
In claim 51 and claim 52, the limitation “a channel tube extending longitudinally within the outer sheath lumen between the proximal outer sheath end and the side access aperture” is considered to be new matter. Said feature appears to be present in the embodiment of Fig. 6 of Applicant’s disclosure. Therefore, there is no support in the specification for said channel tube such that the channel tube is in the same embodiment with claim 29 and claim 50’s introducer, which appears to belong to the embodiment of Fig. 15, 16, and Fig. 19.
In claim 53 and claim 54, the limitation “at least one spacer frame located within the outer sheath lumen between the proximal outer sheath end and the side access aperture” is considered to be new matter. Said feature appears to be present in the embodiment of Fig. 9 of Applicant’s disclosure. Therefore, there is no support in the specification for said spacer frame such that the spacer frame is in the same embodiment with claim 29 and claim 50’s introducer, which appears to belong to the embodiment of Fig. 15, 16, and Fig. 19.
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 29-39, and 41-54 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama US 2020/0069909 A1 (previously cited, hereinafter Yokoyama) in view of Sotolongo US 2019/0366035 A1 (previously cited, hereinafter Sotolongo), as cited in the IDS.
Regarding claim 29, Yokoyama discloses a cannula apparatus 100 (Fig. 2 – catheter assembly 100 including catheter 60 in Fig. 1) for selective fluid flow in a removal direction V1 (Fig. 1 – blood removing direction V1) from a patient's body P (Fig. 1 – patient P; tube 5 for removing blood) and in a return direction V2 (Fig. 1 – blood feeding direction V2) into the patient's body P (Fig. 1; tube 6 for feeding blood), opposite the removal direction (Fig. 1 – V1 and V2 are opposite directions), the apparatus 100 (Fig. 2) comprising:
an outer sheath 31 (Fig. 2 – catheter tube 31) having proximal 33 (Fig. 2 – second tube 33) and distal outer sheath ends 41 (Fig. 2 – distal tip 41) spaced apart by a longitudinal outer sheath body 31 (Fig. 1) defining an outer sheath lumen 62 (Fig. 3 – blood removing lumen 62), at least one fluid removal aperture 47 (Fig. 3 – through-hole 47) extending entirely through the outer sheath body 31 (Fig. 3 – through-hole 47 extends and connect with the blood removing lumen 62) adjacent the distal outer sheath end 41 (Fig. 2-3) to place the outer sheath lumen 62 (Fig. 3) in fluid communication with an ambient space (Par. 53 – “each of through-hole… 47 (see FIGS. 2 and 3) of the distal end tip 41… into the living organs as blood removal targets”), the outer sheath 31 (Fig. 2-3) including a side access aperture 45b (Fig. 3 – side hole 45b) extending entirely through the outer sheath body 31 (Fig. 3 – side hole 45b extends longitudinally with the blood removing lumen 62);
an introducer 50 (Fig. 2 – dilator 50) having proximal (Fig. 2 – the right-side end) and distal introducer ends (Fig. 2 – the left-side end) spaced apart by a longitudinal introducer body 51 (Fig. 2 – dilator tube 51), the introducer body 50 (Fig. 2) at least partially defining a guidewire channel 54 (Fig. 2 – guide wire lumen 54) longitudinally therealong, the introducer 50 (Fig. 2) being configured for selective insertion at least partially into the outer sheath lumen 62 (Fig. 2, and Par. 48 – “the dilator 50 is inserted through the blood removing lumen 62 of the catheter 60”); and
an inner tube 34 (Fig. 3 – third tube 34) having a proximalmost inner tube end (Fig. 3 – the right-side of tube 34) and a distalmost inner tube end (Fig. 3 – the left-side of tube 34) spaced apart by a longitudinal inner tube body 34 (Fig. 3) defining an inner tube lumen 61 (Fig. 3 – blood feeding lumen 61), at least one fluid return aperture 63 (Fig. 3 – blood feeding hole 63) located at least one of at and adjacent the distalmost inner tube end (Par. 72 – “A blood feeding hole 63 communicating with the blood feeding lumen 61 is formed at the distal end of the blood feeding lumen 61 of the third tube 34”) to place the inner tube lumen 61 (Fig. 3) in fluid communication with an ambient space (Par. 72 – “A blood feeding hole 63 communicating with the blood feeding lumen 6…”, and Par. 79 – “the operator such as a doctor feeds blood to the living body by causing the blood oxygenated by the artificial lung 2 to flow out of the blood feeding hole 63 while the blood feeding hole 63 is positioned in the vicinity of the blood feeding target (e.g., the right atrium) of the living body”), the inner tube 34 (Fig. 3) being configured for selective insertion into the outer sheath lumen 62 (Fig. 3, and Par. 72 – “…the third tube 34 is inserted into the blood removing lumen 62”), when the introducer 50 (Fig. 3) is absent from the outer sheath lumen 62 (Fig. 3 shows no dilator 50), with the inner tube body 34 (Fig. 3) extending completely through the side access aperture 45b (Fig. 3 – tube 34 extends to circumferentially cover the hole 45b) and the proximalmost inner tube end (Fig. 3 – the left-side of tube 34) adjacent the proximal outer sheath end 33 (Fig. 2 – second tube 33);
wherein the cannula apparatus 100 (Fig. 2-3) is configured to remove fluid from the patient's body through the outer sheath lumen 62 (Fig. 1-3, and Par. 28 – “The blood removing tube 5 includes a blood removing lumen in communication with a blood removing lumen 62 (see FIG. 3) in the catheter 60”) concurrently (Fig. 1 shows two blood flow directions during treatment) concurrently with returning fluid to the patient's body through the inner tube lumen 61 (Fig. 1-3, and Par. 28 – “The blood feeding tube 6 includes a blood feeding lumen in communication with a blood feeding lumen 61 (see FIG. 3) in the catheter 60”).
However, Yokoyama does not disclose the introducer body at least partially defining a guidewire channel longitudinally therealong an outer surface thereof; with the guidewire channel placing the proximal outer sheath end in direct fluid communication with the side access aperture, and to place the distalmost inner tube end in an ambient space outside the outer sheath.
Sotolongo, in the same field of endeavor of apparatus for cardiopulmonary bypass and catheters (Par. 2-3), teaches the introducer body 100 (Fig. 2E – introducer 100) at least partially defining a guidewire channel 208 (Fig. 2E – tunnel 208) longitudinally therealong an outer surface thereof (Fig. 2E – tunnel 208 has a partial region/channel, in other words at its end where it is formed from an outer surface of the introducer body 100); with the guidewire channel 208 (Fig. 2E) placing the proximal outer sheath end 102 (Fig. 4D – the top end of cannula 102) in direct fluid communication with the side access aperture 110 (Fig. 4D – since the introducer 100 itself has an intermediate opening 110, which is the end point for tunnel 208, tunnel 208 is in fluid communication with the opening 110 of the cannula 102; in other words, the opening 110 of the introducer 100 and the opening 110 of the cannula 102 align with each other), and to place the distalmost inner tube end (see annotated Fig. 6A below) in an ambient space 802 (Fig. 8F – artery 802) outside the outer sheath 102 (Fig. 8F – the distal inner tube end extends out of the opening 110 of cannula 102 and into the artery 802).
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Annotated Fig. 6A of Sotolongo
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dilator of Yokoyama that allows the apparatus system to be positioned at the correct position within the patient’s body, for the introducer with the guidewire channel as taught by Sotolongo, since these mechanisms perform the same function of delivering the catheter system to the desired place within a patient for further blood treatment. Simply substituting one delivery means for another would yield the predicable result of allowing proper positioning of the catheter system within a patient’s vasculature. See MPEP 2143.
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 distal end of the inner tube of Yokoyama to extend outside the outer sheath as taught by Sotolongo, in order to provide a desired directed flow into the desired target vessel (Par. 55 of Sotolongo). Furthermore, the inner tube extending out of the outer sheath can also provide a fluidic seal for preventing blood leakage (Par. 55 of Sotolongo).
Regarding claim 41, Yokoyama discloses a cannula apparatus 100 (Fig. 2 – catheter assembly 100 including catheter 60 in Fig. 1) for selective fluid flow in a removal direction V1 (Fig. 1 – blood removing direction V1) and a return direction V2 (Fig. 1 – blood feeding direction V2), opposite the removal direction (Fig. 1 – V1 and V2 are opposite directions), the apparatus 100 (Fig. 2) comprising:
an outer sheath 31 (Fig. 2 – catheter tube 31) having proximal 33 (Fig. 2 – second tube 33) and distal outer sheath ends 41 (Fig. 2 – distal tip 41) spaced apart by a longitudinal outer sheath body 31 (Fig. 1) defining an outer sheath lumen 62 (Fig. 3 – blood removing lumen 62), at least one fluid removal aperture 47 (Fig. 3 – through-hole 47) extending entirely through the outer sheath body 31 (Fig. 3 – through-hole 47 extends and connect with the blood removing lumen 62) adjacent the distal outer sheath end 41 (Fig. 2-3) to place the outer sheath lumen 62 (Fig. 3) in fluid communication with an ambient space (Par. 53 – “each of through-hole… 47 (see FIGS. 2 and 3) of the distal end tip 41… into the living organs as blood removal targets”), the outer sheath 31 (Fig. 2-3) including a side access aperture 45b (Fig. 3 – side hole 45b) extending entirely through the outer sheath body 31 (Fig. 3 – side hole 45b extends longitudinally with the blood removing lumen 62);
an introducer 50 (Fig. 2 – dilator 50) having proximal (Fig. 2 – the right-side end) and distal introducer ends (Fig. 2 – the left-side end) spaced apart by a longitudinal introducer body 51 (Fig. 2 – dilator tube 51), the introducer body 51 (Fig. 2) including a guidewire groove 54 (Fig. 2 – guide wire lumen 54), the introducer 50 (Fig. 2) being configured for selective insertion at least partially into the outer sheath lumen 62 (Fig. 2, and Par. 48 – “the dilator 50 is inserted through the blood removing lumen 62 of the catheter 60”); and
an inner tube 34 (Fig. 3 – third tube 34) having a proximalmost inner tube end (Fig. 3 – the right-side of tube 34) and a distalmost inner tube end (Fig. 3 – the left-side of tube 34) spaced apart by a longitudinal inner tube body 34 (Fig. 3) defining an inner tube lumen 61 (Fig. 3 – blood feeding lumen 61), at least one fluid return aperture 63 (Fig. 3 – blood feeding hole 63) located at least one of at and adjacent the distal inner tube end (Par. 72 – “A blood feeding hole 63 communicating with the blood feeding lumen 61 is formed at the distal end of the blood feeding lumen 61 of the third tube 34”) to place the inner tube lumen 61 (Fig. 3) in fluid communication with an ambient space (Par. 72 – “A blood feeding hole 63 communicating with the blood feeding lumen 6…”, and Par. 79 – “the operator such as a doctor feeds blood to the living body by causing the blood oxygenated by the artificial lung 2 to flow out of the blood feeding hole 63 while the blood feeding hole 63 is positioned in the vicinity of the blood feeding target (e.g., the right atrium) of the living body”), the inner tube 34 (Fig. 3) being configured for selective insertion into the outer sheath lumen 62 (Fig. 3, and Par. 72 – “…the third tube 34 is inserted into the blood removing lumen 62”), when the introducer 50 (Fig. 3) is absent from the outer sheath lumen 62 (Fig. 3 shows no dilator 50), with the inner tube body 34 (Fig. 3) extending completely through the side access aperture 45b (Fig. 3 – tube 34 extends to circumferentially cover the hole 45b) and the proximalmost inner tube end (Fig. 3 – the left-side of tube 34) adjacent the proximal outer sheath end 33 (Fig. 2 – second tube 33).
However, Yokoyama does not disclose a guidewire groove extending partially into the introducer body from a laterally outermost surface thereof, the guidewire groove extending longitudinally distally from the proximal introducer end, a distal end of the guidewire groove positioned proximal of the distal introducer end, the guidewire groove at least partially defining a guidewire channel when the introducer is at least partially located within the outer sheath lumen, with the guidewire channel placing the proximal outer sheath end in direct fluid communication with the side access aperture, and to place the distalmost inner tube end in an ambient space outside the outer sheath.
Sotolongo, in the same field of endeavor of apparatus for cardiopulmonary bypass and catheters (Par. 2-3), teaches a guidewire groove 208 (Fig. 2E – tunnel 208) extending partially into the introducer body 100 (Fig. 2E) from a laterally outermost surface thereof (Fig. 2E – tunnel 208 has a partial region/channel, in other words at its end where it is formed from an outer surface of the introducer body 100), the guidewire groove 208 (Fig. 2E) extending longitudinally distally from the proximal introducer end 204 (Fig. 2E – proximal end 204; the partial region of tunnel 208 is longitudinally and distally from the proximal end 204), a distal end 110 (Fig. 2E – opening 110) of the guidewire groove 208 (Fig. 2E) positioned proximal of the distal introducer end 206 (Fig. 2E – distal end 206; the partial region of tunnel 208 is proximal to end 206), the guidewire groove 208 (Fig. 2E) at least partially defining a guidewire channel 208 (Fig. 4D) when the introducer 100 (Fig. 4D) is at least partially located within the outer sheath lumen 102 (Fig. 4D – cannula 102), with the guidewire channel 208 (Fig. 4D) placing the proximal outer sheath end 102 (Fig. 4D – the top end of cannula 102) in direct fluid communication with the side access aperture 110 (Fig. 4D – since the introducer 100 itself has an intermediate opening 110, which is the end point for tunnel 208, tunnel 208 is in fluid communication with the opening 110 of the cannula 102; in other words, the opening 110 of the introducer 100 and the opening 110 of the cannula 102 align with each other), and to place the distalmost inner tube end (see annotated Fig. 6A above) in an ambient space outside the outer sheath 102 (Fig. 8F – the distal inner tube end extends out of the opening 110 of cannula 102 and into the artery 802).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dilator of Yokoyama that allows the apparatus system to be positioned at the correct position within the patient’s body, for the introducer with the guidewire channel as taught by Sotolongo, since these mechanisms perform the same function of delivering the catheter system to the desired place within a patient for further blood treatment. Simply substituting one delivery means for another would yield the predicable result of allowing proper positioning of the catheter system within a patient’s vasculature. See MPEP 2143.
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 distal end of the inner tube of Yokoyama to extend outside the outer sheath as taught by Sotolongo, in order to provide a desired directed flow into the desired target vessel (Par. 55 of Sotolongo). Furthermore, the inner tube extending out of the outer sheath can also provide a fluidic seal for preventing blood leakage (Par. 55 of Sotolongo).
Regarding claim 30 and claim 42, Yokoyama in view of Sotolongo discloses the invention of claim 29 and claim 41, respectively. However, Yokoyama in view of Sotolongo does not disclose wherein the distal outer sheath end has a solid, nonapertured sidewall at the distalmost tip.
Examiner notes that the sidewall at the distalmost tip 41 (Fig. 2-3 of Yokoyama) of the outer sheath 31 (Fig. 2-3 of Yokoyama) currently has apertures 46 (Fig. 2-3 of Yokoyama).
Though Yokoyama discloses the sidewall has apertures 46 (Fig. 2-3), there is no disclosure such that the absence of apertures 46 would prevent the catheter assembly to become inoperable, because through-hole 47 alone can still perform the function of removing blood out of the patient’s body (Par. 95 of Yokoyama). Since the criticality of the presence of aperture 46 in Yokoyama is not described in more detail, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have removed the elements if said apertures of Yokoyama were not desired, and one would have a reasonable expectation of success, since the aperture 47 of Yokoyama would still be capable of removing blood. The omission of an element and its function is obvious if the function of the element is not desired. See Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) and MPEP 2144.04.
Regarding claim 31, Yokoyama in view of Sotolongo discloses the invention of claim 29. Yokoyama in view of Sotolongo further discloses wherein the introducer body (see annotated Fig. 2E of Sotolongo above) includes a guidewire groove 208 (Fig. 2D of Sotolongo – tunnel 208; Examiner contends that Sotolong discusses in Par. 44 that “insertion of the introducers into the target vessel using guide wires and ultrasound placement/location monitoring for precise placement of the dual flow cannulas into the target vessel”, thus indicating that guidewires are fully capable of passing through the channels/openings of introducers for placement of cannulas) extending partially into the introducer 100 body from a laterally outermost surface thereof (Fig. 2E of Sotolongo – tunnel 208 has a partial region/channel, in other words at its end where it is formed from an outer surface of the introducer body 100), an innermost wall of the outer sheath body 31 (Fig. 2 of Yokoyama) at least partially defining, in cooperation with the guidewire groove 208 (Fig. 4D of Sotolongo) of the introducer 100 body, the guidewire channel 208 (Fig. 2E-2F of Sotolongo and Fig. 4D of Sotolongo – in the inserted configuration of Fig. 4D, the inner surface of cannula 102 faces the partial region of tunnel 208 to also enclose the tunnel 208; thus, upon the modification as discussed in claim 1, the combination of Sotolongo’s introducer 100 within Yokoyama’s outer sheath 31 will form the same configuration) extending distally from the proximal outer sheath end (Fig. 4D of Sotolongo) when the introducer 100 (Fig. 4D of Sotolongo) is at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, and Fig. 4D of Sotolongo demonstrates the introducer 100 being inserted fully into the cannula 102).
Regarding claim 32 and claim 44, Yokoyama in view of Sotolongo discloses the invention of claim 29 and claim 41, respectively. Yokoyama in view of Sotolongo further discloses including a guidewire (Par. 69 of Sotolongo – “guide-wire insertion”) configured for selective introduction distally through the guidewire channel 208 (Fig. 2E of Sotolongo) while the introducer 100 (Fig. 4D of Sotolongo) is at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama; Fig. 4D of Sotolongo as exemplary demonstration for when the introducer is within the outer sheath lumen 102, and Par. 69 of Sotolongo – “the cannulas 102, 106 can be deployed with a known Seldinger technique (guide-wire insertion)…” and “Deployment of the antegrade cannula 106 occurs through the guided track (or tunnel 208, FIGS. 2D and 2F) tunneled within the core of the retrograde introducer 100. A wire is first passed through the guided track and passed into the target artery. After confirmation that the guide-wire is correctly positioned…, the antegrade cannula 106 and introducer are loaded onto the wire and deployed through the guided track with the introducer barbs in the deployed position…allowing for antegrade cannula 106 to be fully deployed through the exit port 110”; Examiner contends that such statement in Par. 69 of Sotolongo discusses the presence of a guidewire within the introducer of Sotolongo within the guidewire channel 208),
a distalmost end of the guidewire egressing the outer sheath lumen 62 (Fig. 3 of Yokoyama) via the side access aperture 45b (Fig. 3 of Yokoyama, Fig. 7E of Sotolongo; Examiner contends and emphasizes that according to Par. 69 cited above of Sotolongo, it is understood that guidewire has to follow the guided track that is tunnel 208 to deploy the inner tube 106 out of the opening 110 into the target artery as seen in Fig. 7E-7F and 8F of Sotolongo; therefore, in the combined device, the guidewire of Sotolongo has to extend out of the side hole 45b to deploy the inner tube 34 of Yokoyama).
Regarding claim 33 and claim 45, Yokoyama in view of Sotolongo discloses the invention of claim 29 and claim 41, respectively. Yokoyama in view of Sotolongo further discloses wherein the introducer body (Fig. 2E of Sotolongo) is contoured along a longitudinal length thereof (Fig. 4B of Sotolongo – the introducer body has an outline along its length) from a first cross-sectional area (see annotated Fig. 4B of Sotolongo below – first cross-sectional area at the proximal end 204) at the proximal introducer end 204 (see annotated Fig. 4B of Sotolongo below) to a reduced second cross-sectional area (see annotated Fig. 4B of Sotolongo below – reduced second cross-sectional area at the distal end 206) at the distal introducer end 206 (see annotated Fig. 4B of Sotolongo below).
Examiner notes that once the modification is made, the dilator of Yokoyama will be substituted by the introducer of Sotolongo, including the construct of said introducer. Thus, the limitation is met.
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Annotated Fig. 4B of Sotolongo
Regarding claim 34, Yokoyama in view of Sotolongo discloses the invention of claim 33. Yokoyama in view of Sotolongo further discloses wherein the introducer body (Fig. 2E of Sotolongo), when at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, Fig. 7B of Sotolongo for exemplary demonstration of when the introducer 100 is disposed within outer sheath 102), has a substantially constant first cross-sectional area along a length thereof (see annotated Fig. 7B of Sotolongo below – first cross-sectional area along the length of the introducer 100) located proximal to the side access aperture 45b (Fig. 3 of Yokoyama) of the outer sheath 31 (Fig. 3 of Yokoyama; see annotated Fig. 7B of Sotolongo below – the annotated first cross-sectional area is proximal to the opening 110, thus said feature is also incorporated into the device of Yokoyama) and the reduction to the second cross-sectional area (see annotated Fig. 7B of Sotolongo below – reduced second cross-sectional area) occurs distal to the side access aperture 45b of the outer sheath 31 (Fig. 3 of Yokoyama; see annotated Fig. 7B of Sotolongo below – the annotated second cross-sectional area is distal to the opening 110, thus said feature is also incorporated into the device of Yokoyama).
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Annotated Fig. 7B of Sotolongo
Regarding claim 35, Yokoyama in view of Sotolongo discloses the invention of claim 33. Yokoyama in view of Sotolongo further discloses wherein the introducer body (Fig. 2E of Sotolongo) has a tapered distal portion (Fig. 4B of Sotolongo – distal end 206 has a tapered tip, and Par. 49 of Sotolongo – “The retrograde introducer has… a distal (or pointed or internal) end 206”) which, when the introducer 100 (Fig. 4B of Sotolongo) is at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, and Fig. 4B of Sotolongo for exemplary demonstration for when the introducer 100 is inserted into the outer sheath 102), protrudes distally from the outer sheath 31 (Fig. 4 of Yokoyama, and Fig. 4B of Sotolongo for exemplary demonstration for when the introducer 100 protrudes out of the distal end of the outer sheath 102, and Par. 59 of Sotolongo – “the retrograde introducer 100 is inserted until the distal end 206 of the retrograde introducer 100 protrudes from the outlet opening 304 of the retrograde cannula 102”) through an open portion 47 (Fig. 3 of Yokoyama) of the distal outer sheath end 41 (Fig. 3 of Yokoyama).
Examiner notes that once the modification is made as discussed in claim 29, the dilator of Yokoyama will be substituted by the introducer of Sotolongo, including the configuration of said introducer inside the outer sheath lumen. Thus, the limitation is met.
Regarding claim 36 and claim 48, Yokoyama in view of Sotolongo discloses the invention of claim 29. Yokoyama in view of Sotolongo further discloses wherein, when the introducer 100 (Fig. 4B of Sotolongo or 7B of Sotolongo) is at least partially located within the outer sheath lumen 61 (Fig. 4 of Yokoyama; see Fig. 4B of Sotolongo or 7B of Sotolongo for exemplary demonstration for when the introducer in within the outer sheath 102), the distal introducer end 206 (Fig. 4B of Sotolongo or 7B of Sotolongo) is located distally to the side access aperture 45b (Fig. 4 of Yokoyama, see Fig. 7B of Sotolongo for exemplary demonstration) of the outer sheath 31 (Fig. 3-4 of Yokoyama, see Fig. 7B of Sotolongo for exemplary demonstration – the distal end 206 of the introducer 100 is distal to the opening 110 when the introducer 100 is within the outer sheath 102).
Examiner notes that once the modification is made as discussed in claim 29, the dilator of Yokoyama will be substituted by the introducer of Sotolongo, including the configuration of said introducer inside the outer sheath lumen. Thus, the limitation is met.
Regarding claim 37, Yokoyama in view of Sotolongo discloses the invention of claim 29. Yokoyama in view of Sotolongo further discloses wherein the inner tube 34 (Fig. 3 of Yokoyama) has only one fluid return aperture 63 (Fig. 3 of Yokoyama).
Regarding claim 38, Yokoyama in view of Sotolongo discloses the invention of claim 37. Yokoyama in view of Sotolongo further discloses wherein the one fluid return aperture 63 (Fig. 3 of Yokoyama) is located at a distalmost end of the inner tube 34 (Fig. 3 of Yokoyama, and Par. 72 of Yokoyama – “A blood feeding hole 63 communicating with the blood feeding lumen 61 is formed at the distal end of the blood feeding lumen 61 of the third tube 34”).
Regarding claim 39, Yokoyama in view of Sotolongo long discloses the invention of claim 29. Yokoyama in view of Sotolongo further discloses wherein the inner tube 34 (Fig. 3 of Yokoyama) includes at least one fluid return aperture 63 (Fig. 3 of Yokoyama), located adjacent to the distal inner tube end (Fig. 3 of Yokoyama, and Par. 72 of Yokoyama – “A blood feeding hole 63 communicating with the blood feeding lumen 61 is formed at the distal end of the blood feeding lumen 61 of the third tube 34”).
Regarding claim 43, Yokoyama in view of Sotolongo discloses the invention of claim 41. Yokoyama in view of Sotolongo further discloses wherein an innermost wall of the outer sheath body 31 (Fig. 2 of Yokoyama) at least partially defines, in cooperation with the guidewire groove 208 (Fig. 4D of Sotolongo) of the introducer 100 body, the guidewire channel 208 (Fig. 2E-2F of Sotolongo and Fig. 4D of Sotolongo – in the inserted configuration of Fig. 4D, the inner surface of cannula 102 faces tunnel 208 to partially enclose the distal end of tunnel 208; thus, upon the modification as discussed in claim 1, the combination of Sotolongo’s introducer 100 within Yokoyama’s outer sheath 31 will form the same configuration) extending distally from the proximal outer sheath end (Fig. 4D of Sotolongo) when the introducer 100 (Fig. 4D of Sotolongo) is at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, and Fig. 4D of Sotolongo demonstrates the introducer 100 being inserted fully into the cannula 102).
Examiner notes that once the modification is made as discussed in claim 41, the substitution of Yokoyama’s dilator by Sotolongo’s introducer will be made, including the construct/configuration of said introducer. Thus, the limitation is met.
Regarding claim 46, Yokoyama in view of Sotolongo suggests the invention of claim 45. Yokoyama in view of Sotolongo further discloses wherein the first cross-sectional area (see annotated Fig. 7B of Sotolongo above – first cross-sectional area) of the introducer body (Fig. 2E of Sotolongo), when at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, Fig. 7B of Sotolongo for exemplary demonstration of when the introducer 100 is disposed within outer sheath 102), has a substantially constant first cross-sectional area along a length thereof (see annotated Fig. 7B of Sotolongo below – first cross-sectional area along the length of the introducer 100) located proximal to the side access aperture 45b (Fig. 3 of Yokoyama) of the outer sheath 31 (Fig. 3 of Yokoyama; see annotated Fig. 7B of Sotolongo above – the annotated first cross-sectional area is proximal to the opening 110, thus said feature is also incorporated into the device of Yokoyama) and the reduction to the second cross-sectional area (see annotated Fig. 7B of Sotolongo above – reduced second cross-sectional area) occurs distal to the side access aperture 45b of the outer sheath 31 (Fig. 3 of Yokoyama; see annotated Fig. 7B of Sotolongo above – the annotated second cross-sectional area is distal to the opening 110, thus said feature is also incorporated into the device of Yokoyama).
Regarding claim 47, Yokoyama in view of Sotolongo suggests the invention of claim 45. Yokoyama in view of Sotolongo further discloses wherein the introducer body (Fig. 2E of Sotolongo) has a tapered distal portion which 206 (Fig. 4B of Sotolongo, and Par. 49 of Sotolongo – “The retrograde introducer has… a distal (or pointed or internal) end 206”), when the introducer 100 (Fig. 4B of Sotolongo) is at least partially located within the outer sheath lumen 62 (Fig. 3 of Yokoyama, and Fig. 4B of Sotolongo for exemplary demonstration for when the introducer 100 is inserted into the outer sheath 102), protrudes distally from the outer sheath 31 (Fig. 4 of Yokoyama, and Fig. 4B of Sotolongo for exemplary demonstration for when the introducer 100 protrudes out of the distal end of the outer sheath 102, and Par. 59 of Sotolongo – “the retrograde introducer 100 is inserted until the distal end 206 of the retrograde introducer 100 protrudes from the outlet opening 304 of the retrograde cannula 102”) through an open portion 47 (Fig. 3 of Yokoyama) of the distal outer sheath end 41 (Fig. 3 of Yokoyama).
Regarding claim 49 and claim 50, Yokoyama in view of Sotolongo suggests the invention of claim 29 and claim 41, respectively. The combination further discloses wherein a fluid removal aperture 64 (Fig. 3 of Yokoyama – blood removing hole 65) extend entirely through the outer sheath body 31 (Fig. 2 of Yokoyama), at least the fluid removal aperture being proximal to the side access aperture 45b (Fig. 3 of Yokoyama).
However, the combination does not disclose a plurality of fluid removal apertures.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the fluid removal aperture of the combination, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. The plurality of fluid removal apertures can be disposed in different blood removal targets and efficiently perform blood removal (Par. 97 of Yokoyama). The redundancy of fluid removal apertures allows for continuous blood removal if one of the holes sticks to the vascular wall or is closed (Par. 97 of Yokoyama).
Regarding claim 51 and claim 52, Yokoyama in view of Sotolongo suggests the invention of claim 29 and claim 41, respectively. The combination further discloses including a channel tube 6 (Fig. 3 of Yokoyama – tube 6) extending longitudinally within the outer sheath lumen 31 (Fig. 3 of Yokoyama) between the proximal outer sheath end 31 (Fig. 3 of Yokoyama) and the side access aperture 45b (Fig. 3 of Yokoyama), the inner tube 34 (Fig. 3 of Yokoyama) being selectively inserted into the channel tube 6 (Fig. 3 of Yokoyama) with the distalmost inner tube end (Fig. 3 of Yokoyama – the right-side of tube 34) passing out the side access aperture 45b (Fig. 3 of Yokoyama modified by Sotolongo) and into the ambient space outside the outer sheath 31 (Fig. 3 of Yokoyama modified by Fig. 8F of Sotolongo).
Regarding claim 53 and claim 54, Yokoyama in view of Sotolongo suggests the invention of claim 29 and claim 41, respectively. The combination further discloses including at least one spacer frame 6 (Fig. 3 of Yokoyama – tube 6) located within the outer sheath lumen 31 (Fig. 3 of Yokoyama) between the proximal outer sheath end 31 (Fig. 3 of Yokoyama) and the side access aperture 45b (Fig. 3 of Yokoyama), the at least one spacer frame 6 (Fig. 3 of Yokoyama) holding the inner tube 34 (Fig. 3 of Yokoyama) away from the outer sheath body 31 (Fig. 3 of Yokoyama).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Sotolongo as applied to claim 32 above, and further in view of Nash et al. US 2004/0193046 A1 (previously cited, hereinafter Nash).
Regarding claim 40, Yokoyama in view of Sotolongo suggests the invention of claim 32. However, Yokoyama in view of Sotolongo does not explicitly disclose wherein the guidewire comprises a balloon tipped catheter.
Nash, in the same field of endeavor of catheter (Title), teaches wherein the guidewire 18 (Fig. 1 – guidewire 18) comprises a balloon tipped catheter (Fig. 1 – balloon at the tip of guidewire 18, and Par. 39 – “the guidewire 18 is shown having a distal protection device, in this case a balloon is depicted”).
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 system of Yokoyama in view of Sotolongo to further include a guidewire with a balloon tipped catheter as taught by Nash, in order to prevent any debris generated during the procedure from traveling throughout the vasculature, and potentially causing a stroke or embolism (Par. 42 of Nash).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wortley et al. US 5,009,636 A teaches a dual-lumen catheter apparatus with a tube channel and a plurality of apertures.
Karuppasamy US 2020/0367927 A1 teaches an apparatus with an outer sheath with various guidewire placements therein.
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
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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