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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/18/2025 has been entered.
Response to Amendment
The amendments filed on 08/18/2025 has been entered. Claims 1, 10, 11, 21, and 26-28 have been amended; claims 13-20, and 25 have been cancelled. Accordingly, claims 1-12, 21-24, and 26-28 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Office action mailed on 06/03/2025. Therefore, all claim objections are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see paragraph 3 from page 13 to page 16, filed 08/02/2025, with respect to the rejection(s) of claim 21 under 35 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 Therefore, the rejection has been withdrawn.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 a new interpretation of Yokoyama US 2020/0069909 A1 (previously cited,) in view of Sotolongo US 2019/0366035 A1 (previously cited).
Applicant's arguments filed 08/02/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “If one looks at the distalmost end of the inner tube 34, it is a point where one wall curves 90 degrees, but this point does not extend across a radial width of the lumen of the inner tube and arranged perpendicular to the longitudinal axis of the inner tube 34. Similarly, if one looks at the last spot where the radial width between opposing walls is perpendicular to the longitudinal axis of the inner tube, this is at the proximal end of feeding hole 63, and not the distalmost inner tube end. Regardless of how the device of Yokoyama is viewed, though, the structure differs significantly from that claimed”, in conjunction with the detailed recitation of Par. 77, 79, 80, and 83 of Yokoyama on page 11-12 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Yokoyama also discusses that the specific shape of the distal end of inner tube 34, i.e. wall 63c, are not particularly limited, and can be appropriately changed. Therefore, Yokoyama does not teach away from modification of the distal end of the inner tube. Therefore, one of ordinary skill in the art would have been motivated to modify and substituted said distal end of Yokoyama’s inner tube to have a distal end extends past the side hole 45b as taught by Sotolongo, in order to provide a desired directed flow into the desired target vessel (Par. 55 of Sotolongo) and provide a fluidic seal for preventing blood leakage (Par. 55 of Sotolongo). See rationale established in previous Office action and the rejection of claims below.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning in the first paragraph on page 13 of Applicant’s remarks, 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).
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 1-11, 21-24, and 26-27 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 1, 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 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 (Fig. 2), 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 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) having an outer side wall (see annotated Fig. 3 below) and an opposing inner side wall (see annotated Fig. 3 below), the inner side wall (see annotated Fig. 3 below) defining an inner tube lumen 61 (Fig. 3 – blood feeding lumen 61) with a radial width (see annotated Fig. 3 below, and Par. 80 – “The blood feeding hole 63 has an outer shape decreasing gradually in width from the proximal side to the distal side, in plan view illustrated in FIG. 6”), 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 distalmost inner tube end (Fig. 3 – left-side of tube 34) being perpendicular to a longitudinal axis of the inner tube 34 (Fig. 3, Fig. 7, and Par. 81 – the left-side end of tube 34 curves upward in the Z-direction which is perpendicular to the longitudinal axis X-direction in Fig. 7), 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);
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) 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”).
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Annotated Fig. 3 of Yokoyama
However, Yokoyama does not disclose with the guidewire channel in fluid communication with the side access aperture; the distalmost inner tube end extending across the radial width, 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 with the guidewire channel 208 (Fig. 2E) in 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);
the distalmost inner tube end (see annotated Fig. 6A below) extending across the radial width (Fig. 7B, Fig. 7D – distalmost inner tube end near 708 extends past the radial width of opening 110); and
to place the distal 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 21, 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 at least partially defining a guidewire channel 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 proximal (Fig. 3 – the right-side of tube 34) and distal inner tube ends (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).
However, Yokoyama does not disclose the introducer body being contoured along a longitudinal length thereof from a first cross-sectional area at the proximal introducer end to a reduced second cross-sectional area at the distal introducer end, wherein the change from the first cross-sectional area to the second cross-sectional area defines a tapered distal portion, the introducer body including a guidewire groove extending partially into the introducer body from a laterally outermost surface thereof, a distal end of the guidewire groove spaced proximally away from the tapered distal portion such that the tapered distal portion is devoid of the guidewire groove, 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 distal end of the guidewire groove positioned under the side access aperture; and to place the distal 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 (see annotated Fig. 2E of Sotolongo below) being 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), wherein the change from the first cross-sectional area (see annotated Fig. 4B below) to the second cross-sectional area (see annotated Fig. 4B below) defines a tapered distal portion (see annotated Fig. 4B below – distal tip of the introducer 100 is tapered),
the introducer body (see annotated Fig. 2E below) including a guidewire groove 208 (Fig. 2E – tunnel 208) extending partially into the introducer 100 body from a laterally outermost surface thereof (Fig. 2D-2E – tunnel 208 concaves into the introducer 100 body from the outermost surface), a distal end of the guidewire groove 208 (Fig. 2E) positioned proximal of the distal introducer end (Fig. 2E shows that the distal end of tunnel 208 is proximal to the pointy tip of introducer 100), the guidewire groove 208 (Fig. 2C) at least partially defining a guidewire channel 208 (Fig. 2E-2F and Fig. 4D), when the introducer 100 is at least partially located within the outer sheath 102 lumen (Fig. 4D shows the inserted configuration), with the distal end of the guidewire groove 208 (Fig. 4D – the end of tunnel 208) positioned under 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 with the tunnel 208 being under/within the cannula 102); and
to place the distal inner tube end (see annotated Fig. 6A above) 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. 2E of Sotolongo
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Annotated Fig. 4B 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 2 and claim 22, Yokoyama in view of Sotolongo discloses the invention of claim 1 and claim 21, 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 3, Yokoyama in view of Sotolongo discloses the invention of claim 1. 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. 2D of Sotolongo and see annotated Fig. 2E of Sotolongo above – tunnel 208 concaves into the introducer 100 body from the outermost surface), 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 distal end of tunnel 208 to also partially 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) 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 4 and claim 24, Yokoyama in view of Sotolongo discloses the invention of claim 1 and claim 21, respectively. Yokoyama in view of Sotolongo further discloses including a guidewire (Par. 69 of Sotolongo – “guide-wire insertion”) configured for selective introduction 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 5, Yokoyama in view of Sotolongo discloses the invention of claim 1. Yokoyama in view of Sotolongo further discloses wherein the introducer body (see annotated Fig. 2E of Sotolongo above) 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 above – first cross-sectional area at the proximal end 204) at the proximal introducer end 204 (see annotated Fig. 4B of Sotolongo above) to a reduced second cross-sectional area (see annotated Fig. 4B of Sotolongo above – reduced second cross-sectional area at the distal end 206) at the distal introducer end 206 (see annotated Fig. 4B of Sotolongo above).
Examiner notes that once the modification is made as discussed in claim 1, the dilator of Yokoyama will be substituted by the introducer of Sotolongo, including the construct of said introducer. Thus, the limitation is met.
Regarding claim 6, Yokoyama in view of Sotolongo discloses the invention of claim 5. Yokoyama in view of Sotolongo further discloses wherein the introducer body (see annotated Fig. 2E of Sotolongo above), 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 7, Yokoyama in view of Sotolongo discloses the invention of claim 5. Yokoyama in view of Sotolongo further discloses wherein the introducer body (see annotated Fig. 2E of Sotolongo above) 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 1, 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 8, Yokoyama in view of Sotolongo discloses the invention of claim 1. 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 1, 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 9, Yokoyama in view of Sotolongo discloses the invention of claim 1. 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 10, Yokoyama in view of Sotolongo discloses the invention of claim 9. 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 11, Yokoyama in view of Sotolongo long discloses the invention of claim 1. 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 distalmost 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 23, Yokoyama in view of Sotolongo discloses the invention of claim 21. 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) 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 21, 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 26, Yokoyama in view of Sotolongo suggests the invention of claim 21. Yokoyama in view of Sotolongo further discloses wherein the first cross-sectional area (see annotated Fig. 7B of Sotolongo below – first cross-sectional area) of the introducer body (see annotated Fig. 2E of Sotolongo above), 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), is substantially constant along a length (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 change 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).
Regarding claim 27, Yokoyama in view of Sotolongo suggests the invention of claim 21. Yokoyama in view of Sotolongo further discloses wherein 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), the tapered distal portion 206 (Fig. 4B of Sotolongo, and Par. 49 of Sotolongo – “The retrograde introducer has… a distal (or pointed or internal) end 206”) of the introducer body (see annotated Fig. 2E of Sotolongo above) 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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Sotolongo as applied to claim 4 above, and further in view of Nash et al. US 2004/0193046 A1 (previously cited, hereinafter Nash).
Regarding claim 12, Yokoyama in view of Sotolongo suggests the invention of claim 1. 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).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama in view of Sotolongo as applied to claim 21 above, and further in view of Castelli et al. US 2019/0015088 A1 (newly cited, hereinafter Castelli).
Regarding claim 28, Yokoyama in view of Sotolongo suggests the invention of claim 21. However, Yokoyama in view of Sotolongo does not disclose wherein the introducer includes an intermediate taper between the proximal introducer end and the tapered distal portion, wherein when the introducer is at least partially located within the outer sheath lumen, the intermediate taper is located a chosen one of laterally adjacent to and distal of the side access aperture of the outer sheath.
Castelli, in the same field of endeavor of introducer apparatuses (Par. 2), teaches wherein the introducer 30 (Fig. 3 – dilator 30) includes an intermediate taper 34 (Fig. 3 – intermediate section 34) between the proximal introducer end 32 (Fig. 3 – proximal section 32) and the tapered distal portion 36 (Fig. 3 – distal section 36, which also tapers), wherein when the introducer 30 (Fig. 3) is at least partially located within the outer sheath 20 (Fig. 3 – outer elongated member 20) lumen 24 (Fig. 3 – lumen 24), the intermediate taper 34 (Fig. 7) is located laterally adjacent to the access aperture 60 (Fig. 1 – region 60) of the outer sheath 20 (Fig. 1).
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 introducer of the combination to further have an intermediate taper as taught by Castelli, since Castelli discusses that it is well-known to provide such a region within an introducer with a length relative to its proximal and distal region, depending on the length of the insertion path through tissue that is dilated using an introducer (Par. 98 of Castelli). This intermediate taper/section can be modified to accommodate longer insertion paths (Par. 98 of Castelli).
Conclusion
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781