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 .
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.
Claim(s) 1-2, 11, 14-15, 24, 27-29, 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyle et al. (US Patent 6537294 hereinafter “Boyle”) in view of Lockhart et al. (US Patent Pub. 20100204672 hereinafter “Lockhart”) and Bacich et al. (US Patent 5376084 hereinafter “Bacich”).
Regarding Claim 1, Boyle teaches (Fig 7) A clot removal device, comprising:
a catheter body (60) having an outer layer (outer walls of 62 and 64), an inner layer (inner wall of 62 and 64), an aspiration lumen (64; the examiner takes the position that the lumen 64 could function as an aspiration lumen), and a distal opening (opening where 14 extends out of 60) at a distal end (50) of the catheter body (60);
a first luminal channel (lumen 62) positioned between the outer layer (outer walls of 62 and 64) and the inner layer (inner wall of 62 and 64), and having a first channel opening (see annotated Fig 7.1) positioned at a distal end of the first luminal channel (62) and passing through the inner layer, and in fluid connection with the aspiration lumen (64) of the catheter body (60);and
a first elongated mandrel (14) at least partially positioned within the first luminal channel (62), wherein the first elongated mandrel extends distal to the first channel opening into the aspiration lumen (See Fig 7, 14 extends distal the first channel opening and into the aspiration lumen) and is movable within the aspiration lumen, and the first channel opening is proximal to a distal end of the aspiration lumen (see annotated Fig 7.1).
The examiner believes that Boyle functionally meets all the limitations of claim 1. However, in the instance that Boyle does not meet the limitations of "an aspiration lumen" and "a first elongated mandrel", the examiner provides Lockhart as a secondary reference.
Lockhart teaches (Fig 1) an aspiration catheter (14) with an aspiration pump (18) and an elongated mandrel (16) which may be used instead of a guidewire (see [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clot removal device of Boyle such that it includes an aspiration pump, and substituted the guidewire with an elongated mandrel as taught by Lockhart. One of ordinary skill in the art would have been motivated to do so in order to use the same multi-lumen catheter of Boyle in an alternative way that also results in thromboembolic removal.
The combination of Boyle and Lockhart does not specify wherein the first elongated mandrel extends distal to the first channel opening into the aspiration lumen at an angle.
Bacich teaches (Fig 9; Col 6 lines 45-54) an elongate mandrel (15) that has an angled distal region (47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first elongated mandrel of the modified Boyle such that the mandrel has an angle at the distal portion as taught by Bacich. This modification would result in the first elongated mandrel extends distal to the first channel opening into the aspiration lumen at an angle (the mandrel is always angled, as such the mandrel will extend distal to the first channel at an angle). One of ordinary skill in the art would have been motivated to do so in order to provide reduced friction during movement of the mandrel through the lumen (Bacich Col 6 lines 45-54).
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Annotated Fig 7.1 (Boyle)
Regarding Claim 2, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 1 as described above. Boyle further teaches the clot removal device wherein a distal portion of the first elongated mandrel is translationally moveable within the aspiration lumen (See Boyle Col 8 line 4-28 teaches how 14 is translationally movable).
Regarding Claim 11, Boyle teaches (Fig 7) a clot removal catheter, comprising:
a catheter body (60) having an aspiration lumen (64; the examiner takes the position that the lumen 64 could function as an aspiration lumen) having a first opening at a first distal end (annotated Fig 7.2) of the catheter body (60);
a first luminal channel (lumen 62) extending through the catheter body and opening (Annotated Fig 7.2) within a distal region of the aspiration lumen and at a proximal region of the catheter body, wherein a second opening (annotated Fig 7.2) of the first luminal channel (62) is in fluid connection with the aspiration lumen (64) and is proximal to the first opening of the catheter body (See annotated Fig 7.2); and
a first mandrel (14) having a second distal end that is moveable within a distal portion of the aspiration lumen from the first luminal channel (See Fig 7, 14 extends distal the first channel opening and into the aspiration lumen) to fatigue a clot that is partially pulled into the aspiration lumen, wherein the first luminal channel is positioned outside of the aspiration lumen (this is considered a functional limitation, since Boyle meets all structural elements of the claim, it would necessarily meet the functional limitation).
The examiner believes that Boyle functionally meets all the limitations of claim 1. However, in the instance that Boyle does not meet the limitations of "an aspiration lumen" and "a first elongated mandrel", the examiner provides Lockhart as a secondary reference.
Lockhart teaches (Fig 1) an aspiration catheter (14) with an aspiration pump (18) and an elongated mandrel (16) which may be used instead of a guidewire (see [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clot removal device of Boyle such that it includes an aspiration pump, and substituted the guidewire with an elongated mandrel as taught by Lockhart. One of ordinary skill in the art would have been motivated to do so in order to use the same multi-lumen catheter of Boyle in an alternative way that also results in thromboembolic removal.
The combination of Boyle and Lockhart does not specify wherein the first mandrel extends into the aspiration lumen at an angle.
Bacich teaches (Fig 9; Col 6 lines 45-54) an elongate mandrel (15) that has an angled distal region (47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first mandrel of the modified Boyle such that the mandrel has an angle at the distal portion as taught by Bacich. This modification would result in wherein the first mandrel extends into the aspiration lumen at an angle (the mandrel is always angled, as such the mandrel will extend distal to the first channel at an angle). One of ordinary skill in the art would have been motivated to do so in order to provide reduced friction during movement of the mandrel through the lumen (Bacich Col 6 lines 45-54).
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Annotated Fig 7.2 (Boyle)
Regarding Claim 14, the combination of Boyle, Lockhart and Bacich teaches the clot removal catheter of claim 11, wherein the first luminal channel (62) is positioned at a periphery of the aspiration lumen (64; see Fig 7).
Regarding Claim 15, the combination of Boyle, Lockhart and Bacich teaches the clot removal catheter of claim 11, wherein the first luminal channel (62) is positioned within a wall of the catheter body (60; see Fig 7).
Regarding Claim 24, Boyle teaches (Fig 7) a clot removal device, comprising:
a catheter body (60);
an aspiration lumen (64; the examiner takes the position that the lumen 64 could function as an aspiration lumen) located within the catheter body, wherein the aspiration lumen has a first opening (Annotated Fig 7.3) at a distal end of the catheter body ;
a first luminal channel (62) having a second opening (Annotated Fig 7.3) within a distal region of the aspiration lumen and a third opening (Annotated Fig 7.3) at a proximal region of the catheter body, wherein the second opening is in fluid connection with the aspiration lumen and is proximal to the first opening of the aspiration lumen (See annotated Fig 7.3); and
a first mandrel (14) means for fatiguing a clot at least partially positioned within the aspiration lumen (this is considered a functional limitation, since Boyle meets all structural elements of the claim, it would necessarily meet the functional limitation).
The examiner believes that Boyle functionally meets all the limitations of claim 1. However, in the instance that Boyle does not meet the limitations of "an aspiration lumen" and "a first elongated mandrel", the examiner provides Lockhart as a secondary reference.
Lockhart teaches (Fig 1) an aspiration catheter (14) with an aspiration pump (18) and an elongated mandrel (16) which may be used instead of a guidewire (see [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clot removal device of Boyle such that it includes an aspiration pump, and substituted the guidewire with an elongated mandrel as taught by Lockhart. One of ordinary skill in the art would have been motivated to do so in order to use the same multi-lumen catheter of Boyle in an alternative way that also results in thromboembolic removal.
The combination of Boyle and Lockhart does not specify wherein the first mandrel means extends into the aspiration lumen at an angle.
Bacich teaches (Fig 9; Col 6 lines 45-54) an elongate mandrel (15) that has an angled distal region (47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first mandrel of the modified Boyle such that the mandrel has an angle at the distal portion as taught by Bacich. This modification would result in wherein the first mandrel means extends into the aspiration lumen at an angle (the mandrel is always angled, as such the mandrel will extend distal to the first channel at an angle). One of ordinary skill in the art would have been motivated to do so in order to provide reduced friction during movement of the mandrel through the lumen (Bacich Col 6 lines 45-54).
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Annotated Fig 7.3 (Boyle)
Regarding Claim 27, the combination of Boyle, Lockhart and Bacich teaches the clot removal device of claim 1, wherein the first luminal channel (62) is positioned along a periphery of the catheter body (60; see Fig 7).
Regarding Claim 28, the combination of Boyle, Lockhart and Bacich teaches the clot removal device of claim 1, wherein the first luminal channel (62) is positioned within a wall of the catheter body (60; See Fig 7).
Regarding Claim 29, the combination of Boyle, Lockhart and Bacich teaches the clot removal device of claim 1, wherein the first channel opening of the first luminal channel (62) has a fixed position opening into the aspiration lumen (64; see annotated Fig 7.1).
Regarding Claim 34, the combination of Boyle, Lockhart and Bacich teaches the clot removal catheter of claim 11, wherein the second opening of the first luminal channel (see annotated Fig 7.2) comprises a first port of the first luminal channel (the opening is considered to be a “first port”), wherein the second distal end of the first mandrel comprises a distal portion of the first mandrel (See annotated Fig 7.2), wherein the first port is in fluid connection with the aspiration lumen (See Fig 7), wherein the second distal end comprises a distal end of the first mandrel moveable within the distal portion of the aspiration lumen (See Fig 7, the mandrel 14 is extended through the distal portion of the aspiration lumen 64).
Regarding Claim 35, the combination of Boyle, Lockhart and Bacich teaches the clot removal device of claim 24, wherein the second opening (see annotated Fig 7.3) of the first luminal channel (62) comprises a first port of the first luminal channel (the opening is considered to be a “first port”), wherein the first port is in fluid connection with the aspiration lumen (See Fig 7, the port is in fluid communication with lumen 64).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyle (US Patent 6537294) in view of Lockhart (US Patent Pub. 20100204672) and Bacich (US Patent 5376084) as applied to claims 1 and 11 above, and further in view of Reever et al. (US Patent Pub. 20150164528 hereinafter “Reever”).
Regarding claim 9, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 1 as described above. The combination does not specify wherein at least a distal portion of the first elongated mandrel is composed of a shape memory material with a memory shape to cause the distal portion of the first elongated mandrel to bias radially inwardly into the aspiration lumen.
Reever teaches (Fig 3) a distal portion (336) of the first elongated mandrel (306) is composed of a shape memory material with a memory shape (See [0044] teaching 336 may be made of a shape memory material) to cause the distal portion of the first elongated mandrel to bias radially inwardly into the aspiration lumen (312; see [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongated mandrel of Boyle such that at least a distal portion of the first elongated mandrel is composed of a shape memory material with a memory shape to cause the distal portion of the first elongated mandrel to bias radially inwardly into the aspiration lumen as taught by Reever. One of ordinary skill in the art would have been motivated to do so in order to allow for the distal end of the mandrel to translate into the desired shape suitable to engage the excised tissue (Reever [0044]). Additionally, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Regarding Claim 19, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 11 as described above. The combination does not specify the clot removal catheter wherein the first mandrel comprises a shape memory material with a memory shape to cause a second distal portion of the first mandrel to bias radially inwardly into the aspiration lumen.
Reever teaches (Fig 3) a distal portion (336) of the first elongated mandrel (306) is composed of a shape memory material with a memory shape (See [0044] teaching 336 may be made of a shape memory material) to cause the distal portion of the first elongated mandrel to bias radially inwardly into the aspiration lumen (312; see [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongated mandrel of Boyle such that at least a distal portion of the first elongated mandrel is composed of a shape memory material with a memory shape to cause the distal portion of the first elongated mandrel to bias radially inwardly into the aspiration lumen as taught by Reever. One of ordinary skill in the art would have been motivated to do so in order to allow for the distal end of the mandrel to translate into the desired shape suitable to engage the excised tissue (Reever [0044]). Additionally, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyle (US Patent 6537294) in view of Lockhart (US Patent Pub. 20100204672) and Bacich (US Patent 5376084) as applied to claims 1 and 11 above, and further in view of Yang et al. (US Patent Pub. 20170252536 hereinafter “Yang”).
Regarding Claim 10, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 1 as described above. The combination does not specify the clot removal device further comprising a handle portion connected at a proximal end of the catheter body, wherein the handle portion comprises an actuator connected to the first elongated mandrel, wherein the actuator is able to move the first elongated mandrel translationally, rotationally, or both.
Yang teaches (Fig 27a) a handle portion (2628; see [0172]) connected to a proximal end of the catheter body (Fig 19, 1902; 2628 is indirectly connected to 1902 via agitator 1900 [0171-0172]), wherein the handle portion comprises an actuator (2604) connector to the first elongated mandrel (1900; [0174]) wherein the actuator is able to move the first elongated mandrel translationally, rotationally (See [0174]) or both.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Boyle such that it includes a handle portion connected at a proximal end of the catheter body, wherein the handle portion comprises an actuator connected to the first elongated mandrel, wherein the actuator is able to move the first elongated mandrel translationally, rotationally, or both as taught by Yang. One of ordinary skill in the art would have been motivated to do so in order to allow the user more control over the device (Yang [0172]).
Regarding Claim 20, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 11 as described above. The combination does not specify the clot removal catheter further comprising a handle portion connected at a proximal end of the catheter body, wherein the handle portion comprises an actuator connected to the first mandrel, wherein the actuator is able to move the first mandrel translationally, rotationally, or both.
Yang teaches (Fig 27a) a handle portion (2628; see [0172]) connected to a proximal end of the catheter body (Fig 19, 1902; 2628 is indirectly connected to 1902 via agitator 1900 [0171-0172]), wherein the handle portion comprises an actuator (2604) connector to the first elongated mandrel (1900; [0174]) wherein the actuator is able to move the first elongated mandrel translationally, rotationally (See [0174]) or both.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Boyle such that it includes a handle portion connected at a proximal end of the catheter body, wherein the handle portion comprises an actuator connected to the first elongated mandrel, wherein the actuator is able to move the first elongated mandrel translationally, rotationally, or both as taught by Yang. One of ordinary skill in the art would have been motivated to do so in order to allow the user more control over the device (Yang [0172]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyle (US Patent 6537294) in view of Lockhart (US Patent Pub. 20100204672) and Bacich (US Patent 5376084) as applied to claim 1 above, and further in view of To et al. (US Patent Pub. 20100049225 hereinafter “To”).
Regarding Claim 33, the combination of Boyle, Lockhart and Bacich teaches all elements of claim 1 as described above. The combination further teaches the first channel opening comprises a first port (the opening in annotated Fig 7.1 is considered a port) in fluid connection with the aspiration lumen (64), wherein a distal portion of the first elongated mandrel (14) is distal to the first port (See Fig 7, 14 extends out the distal end of the catheter body), wherein the distal portion of the first elongated mandrel is within the aspiration lumen (See Fig 7, 14 extends through the distal portion of the catheter body, therefore, is extending within the distal portion of the aspiration lumen).
The combination does not specify wherein the outer layer comprises a cylindrical jacket, wherein the inner layer comprises an inner cylindrical liner.
To teaches [0140] that a catheter body may include coatings, sleeves or liners in the inner and outer surfaces of the tube (this is considered to be a cylindrical liner as it will be on a tubular surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer and inner layers of Boyle such that the outer layer comprises a cylindrical jacket and the inner layer comprises an inner cylindrical liner as taught by To. One of ordinary skill in the art would have been motivated to do so in order to achieve desired properties of stiffness along the shaft (To [0140])
Allowable Subject Matter
Claims 5-6, 17-18 and 31-32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 3/30/26 have been fully considered but they are not persuasive.
As to the remarks on Pg. 8 last paragraph – Pg. 10, the applicant argues that Bacich does not teach the limitation “wherein the first elongated mandrel extends distal to the first channel opening into the aspiration lumen at an angle”. The applicant argues that Bacich only teaches a curved mandrel that remains within mandrel lumen 33 and does not extend into lumen 31, and therefore does not teach the recited limitation of the independent claims 1, 11 and 24. The examiner does not find this to be persuasive. The applicant’s remarks are regarding the Bacich reference as a singular reference rather than the combination of Boyle, Lockhart and Bacich. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner has shown the multiple lumens (64 and 62) in Boyle Fig 7. Boyle also teaches the first elongated mandrel (14) extends distal to the first channel opening (See Fig 7). However, Boyle does not specify that the mandrel extends distal to the first channel opening into the aspiration lumen at an angle. The examiner relies on the teaching of Bacich which discloses that a mandrel could be curved/angled at a distal end. Modifying Boyle such that the mandrel 14 has a curved distal end as taught by Bacich would result in a mandrel that would necessarily extend distal to the first channel opening into the aspiration lumen at an angle since the mandrel’s distal end is always at an angle. One of ordinary skill in the art would have been motivated to do make this modification since Bacich Col 6 lines 45-54 teaches that a curved mandrel provides the benefit of reduced friction during movement of the mandrel through the lumen. For these reasons the rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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