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 Arguments
Applicant’s arguments filed 9/29/2025 with respect to the rejections of claims 15-18, 20-25 and 27-30 utilizing Hinchliffe as a secondary reference have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Schultz (cited on the 9/29/2025 IDS).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15-18, 20-25 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (PG PUB 2013/0281788) in view of Kawai (2009/0264865) and Schultz (PG PUB 2011/0092910).
Re claim 15, Garrison discloses an intravascular access system 2010+2030+2652+2515 (Fig 1,8; it is noted that all reference characters cited below refer to Fig 8 unless otherwise noted) for facilitation of intraluminal medical procedures within a neurovasculature (Para 48), the system comprising: an inner catheter 2652 comprising: a flexible elongate body (the entire structure of 2652; Para 78) comprising a single lumen (through which guidewire 2515 extends in Fig 8) extending from a proximal opening (Para 76) near a proximal end (toward the bottom in Fig 1) of the flexible elongate body to a single distal opening (through which guidewire 2515 protrudes distally therefrom in Fig 8) at a distal end (toward the top in Fig 1) of the flexible elongate body (Para 76), wherein a length of the flexible elongate body between the proximal opening and the distal opening is sized to position the distal opening within a cerebral artery that is distal to a petrous portion of an internal carotid artery while the proximal opening remains positioned outside a patient's body (Para 126 discloses that the sheath 2010 has its distal end positioned in “the proximal or distal cervical, petrous, or cavernous portion of the internal carotid artery”; since the system 2030+2652 extends distally from the distal end of the sheath 2010 (Para 48), the system 2030+2652 is advanced to a cerebral vessel distal to the petrous portion; since the proximal end of the catheter 2030 extends outside the body, as seen in Fig 1, and the inner member 2652 extends through the catheter 2030, the proximal opening of the inner member must be positioned outside the body), wherein the flexible elongate body comprises a plurality of regions (the tapered distal region seen in Fig 8 and the cylindrical region that extends proximally therefrom in Fig 8) wherein one of the plurality of regions is a tapered region (as seen in Fig 8, Para 76), wherein a proximal end of the tapered region is connected to a cylindrical region (as seen in Fig 8); at least one marker (“radiopaque marker”, Para 79) disposed relative to the tapered region (Para 79); and an outer catheter 2030 comprising: a catheter lumen (“internal lumen”, Para 76) extending between a proximal opening (at the bottom of Fig 1) and a distal opening (from which inner catheter 2652 extends distally in Fig 8) at a distal end of the outer catheter (Para 76), wherein the inner catheter is sized to insert through and be removed entirely from the catheter lumen of the outer catheter (Para 76), and wherein the tapered region of the flexible elongate body is more flexible than the distal end of the outer catheter (Para 78 since the dilator creates “a smooth transition between the flexibility of the guide wire and the distal catheter”); wherein, when assembled for advancement through the petrous portion of the internal carotid artery to the cerebral artery, at least a portion of the cylindrical region of the inner catheter is located within the catheter lumen of the outer catheter and at least a portion of the tapered region is located distal to the distal opening of the outer catheter (as seen in Fig 8).
Garrison does not disclose the exact position of the at least one marker on the tapered region and, therefore, does not disclose that the at least one marker identifies the proximal end of the tapered region. Additionally, Garrison does not disclose that the system comprises at least one locking feature designed to be coupled to the proximal end of the flexible elongate body and coupled to a proximal end of the outer catheter such that the inner catheter is locked with the outer catheter by the at least one locking feature when the system is assembled for advancement.
Kawai, however, teaches a substantially similar access system of devices 61 (Fig 2B,6) comprising an outer catheter 31 (Fig 2B,6; comparable to the outer catheter 2030 of Garrison) and an inner catheter 1 (Fig 1A, 2B,6; comparable to the inner catheter 2652 of Garrison), wherein the inner catheter includes a flexible elongate body 2 (Fig 1A,2B) having a cylindrical region (extending proximally from tapered region 12, as seen in Fig 2B), a tapered region 12 (Fig 2B), and a marker 14 (Fig 2B) disposed relative to the tapered region 12 (Fig 2B) to identify the proximal end of the tapered region (as seen in Fig 2B) for the purpose of identifying the distal-most point to which the outer catheter can be positioned so as not to cause a different in level on the surface which is apt to inure blood vessels (Para 57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide Garrison’s marker such that it identifies the proximal end of the tapered region, as taught by Kawai, for the purpose of identifying the distal-most point to which the outer catheter can be positioned so as not to cause a difference in level on the surface which is apt to inure blood vessels (Para 57).
Kawai does not teach that the system comprises at least one locking feature designed to be coupled to the proximal end of the flexible elongate body and coupled to a proximal end of the outer catheter such that the inner catheter is locked with the outer catheter by the at least one locking feature when the system is assembled for advancement.
Schultz, however, teaches an assembly (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) comprising an inner catheter 22 (comparable to the inner catheter 2652 of Garrison), an outer catheter 12 (comparable to outer catheter 2030 of Garrison), and at least one locking feature 30 (Para 22) designed to be coupled to a proximal end of the inner catheter and coupled to a proximal end of the outer catheter (since the locking feature can directly engage the inner catheter at any location upon it’s length, it is “coupled” to the proximal end of the inner catheter as claimed; since the locking feature is attached to hub 14, it is “coupled” to the proximal end of the outer catheter as claimed) such that the inner catheter is locked with the outer catheter by the at least one locking feature when the system is assembled for advancement to a target location (Para 3) for the purpose of aiding maneuverability of the inner catheter via manipulation and deflection of the outer catheter (Para 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garrison to include a locking feature that locks the proximal end of the inner catheter with the proximal end of the outer catheter when assembled for advancement to a target site, as taught by Schultz, for the purpose of aiding maneuverability of the inner catheter via manipulation and deflection of the outer catheter (Para 3).
Re claim 16, Garrison discloses that the plurality of regions of the flexible elongate body comprise a flexible material (Para 78) but does not explicitly disclose that this material is unreinforced polymer. Kawai, however, teaches the flexible elongate body 2 (Fig 2B) comprising an unreinforced polymer (“PEBAX”, Para 33) for the purpose of ensuring that the elongate body is soft and can be easily manufactured (Para 33). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garrison to include the plurality of regions such that they comprise unreinforced polymer, as taught by Kawai, for the purpose of ensuring that the elongate body is soft and can be easily manufactured (Para 33).
Re claim 17, Garrison as modified by Kawai and Schultz in the rejection of claim 15 above disclose all the claimed features with Schultz teaching that the at least one locking feature is configured to reversibly engage with the outer catheter when the inner catheter and the outer catheter are assembled (Para 22,23). The motivation cited in the rejection of claim 15 also pertains to this claim.
Re claim 18, Garrison as modified by Kawai and Schultz in the rejection of claim 15 above discloses all the claimed features with Schultz teaching that the at least one locking feature includes a gripping feature 36 (Para 22). The motivation cited in the rejection of claim 15 also pertains to this claim.
Re claim 20, Garrison discloses that the at least one marker is tungsten, platinum or tantalum-impregnated polymer (Para 79).
Re claim 21, Garrison discloses a guidewire 2515 sized to extend through the single distal opening of the flexible elongate body (Para 76).
Re claim 22, Garrison discloses that the flexible elongate body forms a smooth transition in flexibility between a flexibility of the distal end of the outer catheter to a flexibility of the guidewire extending outside the single distal opening of the flexible elongate body (Para 78).
Re claim 23, Garrison as modified by Kawai and Schultz in the rejection of claim 15 above discloses all the claimed features with Schultz teaching that the at least one locking feature is configured to be placed in a locked configuration to maintain a fixed position between the outer catheter and the inner catheter (“when the knob 36 is rotated in one direction”, Para 23) and in an unlocked configuration to allow for removal of the inner catheter from the catheter lumen (“when the knob 36 is rotated in the other direction”, Para 23). The motivation cited in the rejection of claim 15 also pertains to this claim.
Re claim 24, Garrison discloses that the flexible elongate body has an inner diameter of between 0.020" and about 0.024" and is sized to receive a guidewire, wherein the guidewire has an outer diameter of between 0.014" and about 0.018" (Para 76).
Re claim 25, Garrison/Kawai/Schultz are silent as to the dimensions of the taper of the distal tip; accordingly, Garrison as modified by Kawai and Schultz does not disclose that the taper is between 1.5 cm and 3 cm. However, since Applicant discloses that the size of the taper is a result effective variable as it affects the smoothness of the transition between the catheter and the guidewire (Para 92, for example), it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Garrison to include the taper so that it is between 1.5 cm and 3 cm since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Re claim 27, Garrison/Kawai/Schultz are silent as to the difference between the outer diameter of the cylindrical region and the inner diameter of the catheter lumen; therefore, Garrison as modified by Kawai and Schultz does not disclose that an outer diameter of the cylindrical region is about 0.003” – 0.010” smaller than an inner diameter of the catheter lumen. However, it would have been an obvious matter of design choice to provide the cylindrical region of the inner catheter with a diameter that is about 0.003” to about 0.010” smaller than the inner diameter of the catheter lumen since Applicant has not disclosed that this size different solves any stated problem or is for any particular purpose. Because no criticality has been given to this size difference, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 28, Garrison discloses that the inner diameter of the catheter lumen is about 0.040" - 0.088" (0.070” – Para 67).
Re claim 29, Garrison discloses a guide sheath 2010 (Fig 1,2) comprising a working lumen (“internal lumen”, Para 45) extending between a proximal end region of the guide sheath (toward the bottom of Fig 2) and a distal end region of the guide sheath (toward the top of Fig 2), the distal end region of the guide sheath having at least one opening (through which the catheter 2030 extends distally out of in Fig 1; Para 48) in communication with the working lumen of the guide sheath (as seen in Fig 1, Para 48).
Re claim 30, Garrison discloses that the outer catheter is an aspiration catheter (Para 48,67) and the system further comprises an aspiration pump (Para 67,88) to apply negative pressure through the aspiration catheter upon removal of the inner catheter from the catheter lumen to perform aspiration thrombectomy (Para 48,67).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (PG PUB 2013/0281788)/Kawai (PG PUB 2009/0264865)/Schultz (PG PUB 2011/0092910) in view of Bose (PG PUB 2009/0030400).
Re claim 25, Garrison/Kawai/Schultz fail to explicitly disclose that the distal end of the tapered inner member tapers over a length between 1.5 cm and 3 cm. Bose et al., however, teaches a medical device 12 (Fig 1,2A) for insertion into the intra-cranial vasculature (Para 2) having a distal end 30b-30i (Fig 2a) with a taper that tapers over a length between 1.5 cm and 3 cm (Para 23 sets forth that the length of the taper 30b-30i is between 18 and 24 cm – with each of segments 30b-30g having a length of 2 cm and segments 30h and 30i having a combined length of 6-12 cm; it is noted that the language of the claim does not limit the total length of the taper to be between 1.5 and 3 cm) for the purpose of providing stable supportive, distal flexibility and kink resistance (Para 21,24). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garrison/Kawai/Schultz to include distal end of the tapered inner member with a taper over a length between 1.5 cm and 3 cm, as taught by Bose, for the purpose of providing stable support, distal flexibility and kink resistance (Para 21,24).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (PG PUB 2013/0281788)/Kawai (PG PUB 2009/0264865)/Schultz (PG PUB 2011/0092910) in view of Itou (US Pat 7,736,355).
Re claim 27, Garrison/Kawai/Schultz discloses all the claimed features except that an outer diameter of the cylindrical region is about 0.003″ and about 0.010″ smaller than an inner diameter of the catheter lumen. Itou, however, teaches a system of devices (Fig 5) comprising an inner member 2 (Fig 5; comparable to the inner catheter 2652 of Garrison) and an outer catheter 1 (Fig 5; comparable to the aspiration catheter 2030 of Garrison) wherein an outer diameter of the cylindrical body of the inner member is between about 0.003" - about 0.010" smaller than an inner diameter of the lumen of the catheter (0.15 mm (= 0.006”), Col 6, Lines 47-55) for the purpose of ensuring that the sliding performance between the inner member and the catheter is high and the convenience of use is good (Col 6, Lines 55-58). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garrison/Kawai/Schultz to include the first diameter of the inner member such that it is about 0.003" – about 0.010” smaller than an inner diameter of the catheter, as taught by Itou, for the purpose of ensuring that the sliding performance between the inner member and the catheter is high and the convenience of use is good (Col 6, Lines 55-58).
Re claim 28, Garrison discloses that the inner diameter of the catheter lumen is between about 0.040″ to about 0.088″ (0.070”, Para 67).
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783