DETAILED ACTION
Claims 11-18 remain withdrawn. Claims 1 and 19 are amended. A complete action on the merits of pending claims 1, 3-9, and 19-20 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 12/11/2025.
Claim Rejections - 35 USC § 103
Claim(s) 1, 3-9, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Look (US PGPUB No. 20220387073 A1), in view of Yang (US PGPUB No. 20170239440 A1).
Regarding claim 1, Look discloses, a system for treating a patient having thrombus. Look teaches, a device configured to retrieve an obstruction from a blood vessel (Figure 38, system for treating thrombus (4246); Paragraphs [0100] and [0095]), the device comprising:
an aspiration catheter (Figures 34 and 38, aspiration catheter (3000); Paragraph [0095]) comprising:
an elongate body (Figure 38, shaft (4252); Paragraph [0100], further, Paragraph [0095], discloses in part, “…the aspiration catheter (3000) may have a length of between 100 cm and 180 cm…”) comprising a single continuous structure (Figure 38) having a proximal end (Figure 38, proximal end (4256); Paragraph [0100]), a distal end (Figure 38, distal end (3158); Paragraph [0101]), and a lumen (Figures 34 and 38, aspiration lumen (3160); Paragraph [0095]) sized to receive at least a first portion of the obstruction therein (Figure 34, thrombus (3164); Paragraphs [0095] and [0101]); and
a guide wire (Figures 34 and 38, guidewire (3102); Paragraph [0095]) sized to slide through the lumen (aspiration lumen (3160); Paragraph [0096]) and comprising one or more auger fins (Figure 34, curved portions (3147 & 3149); Paragraphs [0095]-[0096], describes curved portions (3147 & 3149) comprising a single arc or multiple arcs and as helical such as a single diameter helix or a tapering diameter helix (The tapering diameter helix may taper such that the diameter increases as it extends distally, or such that the diameter decreases as it extends distally), given that guidewire (3102) may comprise an outer coil extending along its longitudinal axis, which comprise external contours that will serve to macerate or translate a portion of thrombus, further, guidewire (3102) is operated to rotate, longitudinally cycle, or otherwise move the guidewire (3102). Thus, curved portions (3147 & 3149) function as an Archimedes screw, effectively an auger) disposed at a distal end of the guide wire (Figures 34 and 38, distal end (3143); Paragraphs [0095]-[0096]);
wherein the guide wire (guidewire (3102)) is configured to be torqued such that the one or more auger fins (curved portions (3147 & 3149)) macerate the obstruction (thrombus (3164)) into fragments as one or more of the fragments of the obstruction are aspirated in a proximal direction (Figure 34, direction of arrow (3180); Paragraph [0095]) through the aspiration catheter (thrombus (3164)) (Paragraph [0096]), and
wherein the guide wire (guidewire (3102)) is configured such that the distal end of the guide wire (distal end (3143)) is located proximal of the aspiration catheter mouth/tip (Figure 34, skive (3162) at open distal end (3158); Paragraph [0095]) and within the lumen (aspiration lumen (3160)) when the one or more auger fins (curved portions (3147 & 3149)) macerate the obstruction (thrombus (3164)) (Paragraph [0096], discloses, curved potion (3149) of distal end (3143) of guidewire (3102) and that it is located as seen in Figure 34 within the aspiration lumen (3160) of the aspiration catheter (3000) making it proximal of skive (3162) at open distal end (3158). It is further disclosed in paragraph [0101] that an exemplary manipulation routine of guidewire (3102) may include rotating the guidewire continuously in one direction while repeatedly translating the guidewire (3102) distally and proximally (longitudinal cycling), thus, guidewire (3102) is indeed capable of having the distal end (3143) be fully located proximal of the skive (3162) at open distal end (3158) and within the aspiration lumen (3160) when curved portions (3147 & 3149) macerate the thrombus (3164)).
Look fails to teach, a funnel continuous with the distal end of the elongate body and comprising a funnel mouth at a distal end of the funnel, the funnel mouth sized to receive at least a second portion of the obstruction therein.
Yang discloses, an intracranial aspiration catheter. Yang teaches, a funnel-mouth aspiration catheter (Figures 1-2, catheter (10); Paragraph [0062]), wherein the funnel (Figures 2, distal segment (34); Paragraph [0066]) is continuous with the elongate body (Figures 1-2, elongate tubular body (16); Paragraph [0065]), and the funnel mouth (Figures 4E-4K, distal end (38); Paragraphs [0066]) is sized larger than the catheter lumen (Figures 4E, 4K, lumen (40)) to receive obstruction portions (Paragraphs [0078] and [0084]-[0086]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to combine the aspiration catheter of Look with the funnel of Yang, such that the funnel is continuous with the distal end of the elongate body and comprises a funnel mouth at a distal end of the funnel, the funnel mouth sized to receive at least a second portion of the obstruction therein, and wherein the guide wire is configured such that the distal end of the guidewire is located proximal of the funnel mouth and within the lumen when the one or more auger fins macerate the obstruction, as both references and the claimed invention are directed to aspiration catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aspiration catheter of Look with the funnel of Yang, such that the funnel is continuous with the distal end of the elongate body and comprises a funnel mouth at a distal end of the funnel, the funnel mouth sized to receive at least a second portion of the obstruction therein, and wherein the guide wire is configured such that the distal end of the guidewire is located proximal of the funnel mouth and within the lumen when the one or more auger fins macerate the obstruction, as such a modification would have been predictable, namely, to increase clot capture efficiency (see Yang, Paragraphs [0084]-[0086]) while retaining Look’s effective maceration and aspiration technique, including the ability to position the guidewire distal end within the lumen during operation (see Look, Paragraph [0101]).
Regarding claim 3, modified Look teaches, wherein the funnel mouth (distal end (38) of Figures 4E-4K of Yang) is perpendicular to a longitudinal axis of the elongate body (As seen in Figures 4E-4K of Yang, distal end (38) is clearly perpendicular to a longitudinal axis of the elongate body).
Regarding claim 4, Look teaches, the aspiration catheter lumen sized to receive clot fragments (Paragraph [0096]).
Look does not expressly teach, wherein the second portion of the obstruction is larger than the first portion of the obstruction.
Yang teaches, the funnel mouth larger than the catheter lumen capable of engaging a larger clot portion at the mouth, while only a reduced portion enters the lumen (Paragraph [0078]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to combine the aspiration catheter of Look with the funnel of Yang, such that the second portion of the obstruction is larger than the first portion of the obstruction, as both references and the claimed invention are directed to aspiration catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aspiration catheter of Look with the funnel of Yang, such that the second portion of the obstruction is larger than the first portion of the obstruction, as such a modification would have been predictable, namely, in a combined system, the funnel captures a “second portion” larger than the “first portion” inside the lumen, which allows larger obstructions to be engaged and reduced prior to aspiration.
Regarding claim 5, modified Look teaches, wherein the elongate body comprises a first inner diameter and the funnel mouth comprises a second inner diameter, the first inner diameter being smaller than the second inner diameter (Paragraph [0078] of Yang).
Regarding claim 6, Look further teaches, wherein each of the one or more auger fins (curved portions (3147 & 3149)) are sized to have a minimal clearance with the first inner diameter in order to displace the obstruction (thrombus (3164)) in the proximal direction (direction of arrow (3180)) jointly with aspiration force (curved portions (3147 & 3149) are disclosed as rotating within the catheter lumen (Paragraph [0096] and [0101]), it is also described that the curved portions (3147 & 3149) assist in propelling clot proximally along the lumen. This indicates minimal clearance between curved portions (3147 & 3149) and lumen wall to permit transport).
Regarding claim 7, Look further teaches, wherein each of the one or more auger fins (curved portions (3147 & 3149)) are the same size (Paragraph [0095], discloses, “The curved portion 3147, 3149 may comprise a single arc or multiple arcs, but may generally comprise any non-straight pattern. The one or more arcs may be contained within a plane, or they may be three-dimensional. The curved portion (3147, 3149) may comprise a helix, such as a single diameter helix…”).
Regarding claim 8, Look further teaches, wherein the one or more fragments of the obstruction (thrombus (3164)) are configured to be aspirated in the proximal direction (direction of arrow (3180)) around the one or more auger fins (curved portions (3147 & 3149)) (Paragraph [0096], discloses, clot maceration and aspiration proximally by guidewire screw effect, with clot fragments transported proximally along lumen while rotating guidewire remains in place – fragments inherently move “around” the fins as aspiration draws them).
Regarding claim 9, Look teaches, the aspiration catheter lumen and clot fragments entering proximally (Paragraphs [0096]-[0097]).
Look does not expressly teach, wherein the one or more fragments of the obstruction are configured to be aspirated through the funnel mouth of the aspiration catheter.
Yang teaches, the funnel mouth through which clot enters (Paragraph [0078]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to combine the aspiration catheter of Look with the funnel of Yang, such that the one or more fragments of the obstruction are configured to be aspirated through the funnel mouth of the aspiration catheter, as both references and the claimed invention are directed to aspiration catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aspiration catheter of Look with the funnel of Yang, such that the one or more fragments of the obstruction are configured to be aspirated through the funnel mouth of the aspiration catheter, as such a modification would have been predictable, namely, it is an inherent function once the funnel is applied to the aspiration catheter of Look.
Regarding claim 19, Look teaches, a method of retrieving an obstruction from a blood vessel (Paragraph [0107]), the method comprising:
positioning an aspiration catheter (Figures 34 and 38, aspiration catheter (3000); Paragraph [0095]) is proximate the obstruction (Figure 34, thrombus (3164); Paragraphs [0095] and [0101]);
wherein the aspiration catheter (aspiration catheter (3000)) comprises an elongate body (Figure 38, shaft (4252); Paragraph [0100], further, Paragraph [0095], discloses in part, “…the aspiration catheter (3000) may have a length of between 100 cm and 180 cm…”) having a single continuous structure (Figure 38); and
aspirating in a proximal direction (Figure 34, direction of arrow (3180); Paragraph [0095]) through the aspiration catheter (aspiration catheter (3000)) (Paragraphs [0095]-[0097] and [0100]);
positioning a clot macerating device (Figures 34 and 38, guidewire (3102); Paragraph [0095]) inside a lumen of the aspiration catheter (Figures 34 and 38, aspiration lumen (3160); Paragraphs [0095]-[0096]); and
actuating the clot macerating device (guidewire (3102)) thereby macerating the obstruction (thrombus (3164)) into fragments while simultaneously aspirating one or more of the fragments of the obstruction (thrombus (3164)) in a proximal direction (direction of arrow (3180)) through the aspiration catheter (Paragraph [0096]), and
wherein a distal end (Figures 34 and 38, distal end (3143); Paragraphs [0095]-[0096]) of the clot macerating device (guidewire (3102)) is located proximal of the aspiration catheter mouth/tip (Figure 34, skive (3162) at open distal end (3158); Paragraph [0095]) and within the lumen (aspiration lumen (3160)) when the clot macerating device (guidewire (3102)) macerates the obstruction (thrombus (3164)) (Paragraph [0096], discloses, curved potion (3149) of distal end (3143) of guidewire (3102) and that it is located as seen in Figure 34 within the aspiration lumen (3160) of the aspiration catheter (3000) making it proximal of skive (3162) at open distal end (3158). It is further disclosed in paragraph [0101] that an exemplary manipulation routine of guidewire (3102) may include rotating the guidewire continuously in one direction while repeatedly translating the guidewire (3102) distally and proximally (longitudinal cycling), thus, guidewire (3102) is indeed capable of having the distal end (3143) be fully located proximal of the skive (3162) at open distal end (3158) and within the aspiration lumen (3160) when curved portions (3147 & 3149) macerate the thrombus (3164)).
Look fails to teach, the positioning of the aspiration catheter such that a funnel mouth of a funnel disposed at a distal end of the aspiration catheter is proximate the obstruction; wherein the funnel is continuous with a distal end of the elongate body; the aspirating in the proximal direction through the aspiration catheter until a proximal portion of the obstruction becomes lodged in the funnel mouth; and wherein the funnel mouth is disposed at a distal end of the funnel.
Yang teaches, a funnel-mouth aspiration catheter (Figures 1-2, catheter (10); Paragraph [0062] comprising a funnel-shaped distal portion (Figures 2, distal segment (34); Paragraph [0066]) continuous with the elongate catheter body (Figures 1-2, elongate tubular body (16); Paragraph [0065]), with a funnel mouth (Figures 4E-4K, distal end (38); Paragraphs [0066]) oriented perpendicular to the catheter axis and larger than the catheter lumen (Figures 4E, 4K, lumen (40)), configured to receive and capture a portion of the obstruction at the funnel mouth (Paragraphs [0078] and [0084]-[0086]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the catheter of Look to include the funnel mouth of Yang, and when combined, the modified method inherently performs each step of the claimed method, including positioning the funnel mouth proximate the obstruction, aspirating until a portion becomes lodged in the funnel, positioning and actuating a macerating guidewire, and aspirating fragments proximally while the guidewire distal end remains proximal of the funnel mouth and within the lumen, as both references and the claimed invention are directed to aspiration catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Look to include the funnel mouth of Yang, and when combined, the modified method inherently performs each step of the claimed method, including positioning the funnel mouth proximate the obstruction, aspirating until a portion becomes lodged in the funnel, positioning and actuating a macerating guidewire, and aspirating fragments proximally while the guidewire distal end remains proximal of the funnel mouth and within the lumen, as such a modification would have been predictable, namely, to increase clot engagement and aspiration efficiency (see Yang, Paragraphs [0084]-[0086]) while retaining Look’s effective maceration and aspiration technique, including the ability to position the guidewire distal end within the lumen during operation (see Look, Paragraph [0101]).
Regarding claim 20, Look further teaches, wherein the one or more fragments of the obstruction (thrombus (3164)) are configured to be aspirated in the proximal direction (direction of arrow (3180)) around the clot macerating device (guidewire (3102) having at distal end (3143), curved portions (3147 & 3149)) (Paragraph [0096], discloses, clot maceration and aspiration proximally by guidewire screw effect, with clot fragments transported proximally along lumen while rotating guidewire remains in place – fragments inherently move “around” the fins as aspiration draws them).
Response to Arguments
Applicant's arguments filed on 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that Look fails to teach or suggest that the distal end of the guidewire (3102) is located within the lumen (aspiration lumen (3160)) when the auger fins (curved/helical portions (3147 & 3149)) macerate the obstruction (thrombus (3164)), because Figure 34 of Look shows the distal end positioned in the skive (3162) rather than within the lumen proper. Applicant further contends that Look’s disclosure of longitudinal cycling (Paragraph [0101] of Look) does not necessarily retract the distal end fully into the lumen during maceration and that there is no motivation or reasonable expectation of success to modify Look to achieve the claimed positioning.
The Examiner respectfully disagrees.
First, the limitation at issue is recited in functional “configured such that” language in apparatus of claim 1 and as a step limitation in method of claim 19. Under well-established precedent, when a prior art reference discloses a device that is structurally capable of performing the recited function without modification, or when the reference teaches a method step that is inherently capable of being performed in the claimed manner, the limitation is met. See MPEP § 2114 (apparatus claims cover what a device is capable of doing); In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997) (functional limitations satisfied if prior art structure is capable of performing the function); In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (capability is sufficient for anticipation/obviousness of functional language).
Look explicitly discloses the guidewire (3102) is configured to be rotated and longitudinally cycled (“repeatedly translating the guidewire (3102) distally and proximally (longitudinal cycling)”) while macerating thrombus (Paragraph [0101] of Look). This cycling operation necessarily includes retracting the distal end (3143) proximally into the aspiration lumen (3160) during at least part of the maceration cycle. Paragraph [0096] states that the curved/helical portions (3147 & 3149) of the guidewire “serve to macerate or translate a portion of thrombus” and that the guidewire is “rotate[d], longitudinally cycle[d], or otherwise move[d]” within the aspiration lumen. When the guidewire is cycled proximally, the distal end (3143) – including the macerating curved portions – moves fully into the lumen (3160), proximal of the skive/open distal end (3158). Thus, Look’s device is structurally configured and its method is capable of performing the claimed positioning during maceration.
The argument that the lumen “stops where the skive begins” is not supported by the reference or by ordinary catheter art. The skive (3162) is an angled cut at the distal tip that facilitates entry into the aspiration lumen (Paragraph [0095] of Look). The lumen (3160) extends continuously to the open distal end (3158); the skive is part of the tip geometry leading into the lumen, not a separate non-lumen region. See also Figure 34 of Look (lumen (3160) is shown extending to the beveled opening). Accordingly, when the distal end (3143) is retracted during cycling, it is within the lumen (3160) and proximal of the funnel mouth/opening (in the Look/Yang combination, proximal of the funnel mouth taught by Yang).
Second, the motivation to combine Look with Yang remains unchanged and is not rebutted. Yang teaches a funnel-shaped distal portion continuous with the elongate body for improved clot capture (Paragraphs [0078] and [0084]-[0086] of Yang). Combining Yang’s funnel with Look’s aspiration catheter and guidewire maceration system is a simple substitution of one known distal tip configuration (skive) for another (funnel) to achieve the predictable result for better obstruction engagement and ingestion – a rationale expressly supported by KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (simple substitution of one known element for another yielding predictable results). Look’s cycling capability is retained in the combination, and the distal end remains configurable within the lumen during maceration, satisfying the newly added limitation.
For these reasons, the combination of Look and Yang renders claims 1 and 19 obvious under 35 USC § 103. The rejections of claims 3-9 and 20 are maintained for at least the reasons set forth above.
See updated rejections above of claims 1 and 19.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771