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 .
Election/Restrictions
Applicant’s election without traverse of Species C in the reply filed on 7/30/2025 is acknowledged. Accordingly, claims 10 and 11 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Information Disclosure Statement
The IDSes filed 9/12/2022 through 7/30/2025 include more than 800 references. Although a concise explanation of the relevance of the reference is not required for English language references, Applicants are encouraged to provide a concise explanation of why any of the English-language references is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where a large number of documents are submitted and Applicant is aware that one or more are highly relevant to patentability and where documents are lengthy and complex and Applicant is aware of a section that is highly relevant to patentability.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “the interior of the aspiration lumen” on lines 5-6 lacks proper antecedent basis since this is the first time that this feature is being introduced. It is suggested to amend this phrase to recite “[[the]] an interior of the aspiration lumen” in order to overcome this objection. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Commas should be inserted around the phrase “when the concave portion engages the distal end of the aspiration catheter” in order to be grammatically correct. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The phrase “the interior of the aspiration lumen” on lines 5-6 lacks proper antecedent basis since this is the first time that this feature is being introduced. It is suggested to amend this phrase to recite “[[the]] an interior of the aspiration lumen” in order to overcome this objection. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Commas should be inserted around the phrase “when the concave portion engages the distal end of the aspiration catheter” in order to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the phrase “the distal end” on line 8, but this phrase lacks proper antecedent basis because claim 1 introduces multiple distal ends prior to this recitation and it is unclear as to which of these distal ends that the phrase “the distal end” refers. Specifically, “a distal end” of the supply lumen is introduced on line 3, “an open distal end” of the aspiration lumen is introduced on line 3, and “a distal end” of the mandrel is introduced on line 8. For the sake of examination, the phrase “the distal end” on line 8 is interpreted as referring to the distal end of the mandrel; therefore, it is suggested to amend line 8 to recite “the distal end of the mandrel”. Claims 2-9 are rejected due to their dependence on claim 1.
Claims 3, 4, and 6 recite the phrase “the distal end”, but – like the issue on line 8 of claim 1 – this phrase lacks proper antecedent basis because claim 1 introduces multiple distal ends and it is unclear as to which of these distal ends that the phrase “the distal end” refers to in each of claims 3, 4 and 6. For the sake of examination, the phrase “the distal end” in each of claims 3, 4 and 6 is interpreted as referring to the distal end of the mandrel; therefore, it is suggested to amend claims 3, 4 and 6 to recite “the distal end of the mandrel”.
Claim 12 recites the phrase “the distal end” on line 11, but this phrase lacks proper antecedent basis because claim 12 introduces multiple distal ends prior to this recitation and it is unclear as to which of these distal ends that the phrase “the distal end” refers. Specifically, “a distal end” of the supply lumen is introduced on line 3, “an open distal end” of the aspiration lumen is introduced on line 3, “a distal end” of the aspiration catheter is introduced on line 9, and “a distal end” of the elongate wire is introduced on line 11. For the sake of examination, the phrase “the distal end” on line 11 is interpreted as referring to the distal end of the elongate wire; therefore, it is suggested to amend line 8 to recite “the distal end of the elongate wire”. Claims 13-20 are rejected due to their dependence on claim 12.
Claims 15, 16 and 18 recite the phrase “the distal end”, but – like the issue on line 11 of claim 12 – this phrase lacks proper antecedent basis because claim 1 introduces multiple distal ends and it is unclear as to which of these distal ends that the phrase “the distal end” refers to in each of claims 15, 16 and 18. For the sake of examination, the phrase “the distal end” in each of claims 15, 16 and 18 is interpreted as referring to the distal end of the elongate wire; therefore, it is suggested to amend claims 15, 16 and 18 to recite “the distal end of the elongate wire”.
Claim 15 recites the phrase “the concave portion” but this phrase lacks proper antecedent basis since no such portion has been introduced in claim 12 and it is unclear as to what this “concave portion” is intended to belong to. The specification sets forth that the elongate wire includes a concave portion; therefore, this is the interpretation applied for the sake of examination. It is suggested to amend claim 15 to recite “[[the]] a concave portion of the enlarged portion”.
Claim 17 recites “the mandrel” but this phrase lacks proper antecedent basis since no such structure has been introduced in claim 12 and it is unclear as to how this “mandrel” relates to the claimed elements. Based on the disclosure, it appears that the “mandrel” is intended to refer to the “elongate wire”; therefore, this is the interpretation applied for the sake of examination. It is suggested to amend claim 17 to recite “the elongate wire”.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (PG PUB 2010/0204712) in view of Jackowski (US Pat 4,920,980).
Re claim 1, Mallaby discloses a system (Fig 1; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for aspirating thrombus (Para 61) comprising: an aspiration catheter 104 (Fig 1,2) having a supply lumen 98 and an aspiration lumen 100, the supply lumen having a distal end (to the right in Fig 2,5) and a wall (not labeled but seen distal to orifice 92 in Fig 2,5), the aspiration lumen having an open distal end (to the left in Fig 2,5) and an interior wall surface (facing radially inward in Fig 2,5); an orifice 92 adjacent the distal end of the supply lumen (as seen in Fig 2,5), in fluid communication with the interior of the aspiration lumen (as seen in Fig 5; Para 62,68), wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen (as seen in Fig 5, Para 68). Mallaby does not disclose a mandrel having a proximal end and a distal end, the distal end including a curve greater than 90 degrees, and including a concave portion configured to engage a distal end of the aspiration catheter, wherein the orifice is translatable in a transverse direction to a longitudinal axis of the aspiration catheter by traction applied on the mandrel. Jackowski, however, teaches an aspiration catheter 10 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) having a lumen 14 and a mandrel 16 therein (as seen in Fig 2), wherein the mandrel has a proximal end (not shown but to the right in Fig 2) and a distal end (to the left in Fig 2), the distal end including a curve greater than 90 degrees (as seen in Fig 2, the distal end has a 180 degree curve) and including a concave portion (facing to the left in Fig 2) configured to engage a distal end (the portion of catheter 12 extending the length of electrode 18) of the aspiration catheter (as seen in Fig 2), wherein when traction is applied on the mandrel, the inside surface of the catheter opposite to the location of the concave portion is translatable in a transverse direction to a longitudinal axis of the aspiration catheter (as seen in shadow in Fig 2) for the purpose of flexing the catheter so that it can traverse the irregularly shaped path defined by blood vessels (Col 1, Lines 7-11; Col 3, Line 58 - Col 4, Line 6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mallaby to include an mandrel with a curve greater than 90 degrees and a concave portion, as taught by Jackowski, for the purpose of flexing the catheter so that it can traverse the irregularly shaped path defined by blood vessels (Col 1, Lines 7-11; Col 3, Line 58 - Col 4, Line 6).
Re claim 2, Mallaby discloses that the spray pattern comprises a jet (Para 68).
Re claim 3, Mallaby as modified by Jackowski in the rejection of claim 1 above discloses all the claimed features with Jackowski teaching that, when the concave portion engages the distal end of the aspiration catheter, a portion of the distal end is disposed outside of the aspiration lumen (within slot 22, as seen in Fig 2) and a portion of the distal end is disposed within the aspiration lumen (within lumen 14, as seen in Fig 6).
Re claim 4, Mallaby as modified by Jackowski in the rejection of claim 1 above discloses all the claimed features with Jackowski teaching that the distal end comprises a plurality of curved portions (as seen in Fig 2, the distal end includes a curved portion embedded in slot 22 and a curved portion residing in the lumen 14).
Re claim 5, Mallaby discloses a grasping tool 74 configured to grasp an end of the elongate wire (Para 61; it is noted that since the grasping tool 74 is disclosed as grasping guidewire 16, one of ordinary skill in the art would recognize that it is structurally capable of grasping the wire 16 of Jackowski).
Re claim 6, Mallaby as modified by Jackowski in the rejection of claim 1 above discloses all the claimed features with Jackowski teaching that the distal end has a preformed shape (as seen in Fig 2).
Re claim 7, Mallaby as modified by Jackowski in the rejection of claim 1 above discloses all the claimed features with Jackowski teaching that the mandrel is configured to be rotatable such that the curve is capable of disrupting at least a portion of a thrombus (since the mandrel 16 extends proximally out of the hub 30, one of ordinary skill in the art would recognize that a user could grip the proximal end of the mandrel and rotate it along with the rest of catheter 10 (it is noted that the claim does not require the mandrel to be rotated relative to any specific structure or require the curve to directly disrupt a thrombus)).
Re claim 8, Mallaby discloses that the spray pattern traverses the aspiration lumen (as seen in Fig 5, Para 68).
Re claim 9, Mallaby discloses that the orifice is located proximally of the open distal end of the aspiration lumen (as seen in Fig 2,5).
Claims 12-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (PG PUB 2010/0204712) in view of Auth et al. (US Pat 5,695,507).
Re claim 12, Mallaby discloses a system (Fig 1; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for aspirating thrombus (Para 61) comprising: an aspiration catheter 104 (Fig 1,2) having a supply lumen 98 and an aspiration lumen 100, the supply lumen having a distal end (to the right in Fig 2,5) and a wall (not labeled but seen distal to orifice 92 in Fig 2,5), the aspiration lumen having an open distal end (to the left in Fig 2,5) and an interior wall surface (facing radially inward in Fig 2,5); an orifice 92 adjacent the distal end of the supply lumen (as seen in Fig 2,5), in fluid communication with the interior of the aspiration lumen (as seen in Fig 5; Para 62,68), the orifice located proximally of the open distal end of the aspiration lumen (as seen in Fig 2,5), wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment (as seen in Fig 5, Para 68). Mallaby discloses an elongate wire 16 (Fig 1, Para 61) having a proximal end (to the left in Fig 1) and a distal end (to the right in Fig 1), wherein the elongate wire is configured to be rotatable such that the elongate wire is capable of disrupting at least a portion of a thrombus (Para 61 sets forth that bung 74 can be compressed to restrict movement of wire 16 only when lock 72 is turned; based on this, one of ordinary skill in the art would recognize that the wire 16 can move – including both longitudinally and rotatably – when the lock 72 is not turned and the bung 74 is not compressed; therefore, one of ordinary skill in the art would interpret wire 16 as being rotatable such that the wire is capable of disrupting at least a portion of a thrombus), but does not explicitly disclose that the distal end of the elongate wire includes an enlarged portion and it is the enlarged portion that is capable of disrupting at least a portion of a thrombus. Auth, however, teaches a substantially similar catheter 1 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) comprising an aspiration lumen (Col 4, Lines 44-47) and an elongate wire 3+2 therein, wherein the elongate wire has a distal end (tip 2 + the distal-most quarter of wire 3) with an enlarged portion 2 and the elongate wire is configured to be rotatable such that the enlarged portion is capable of disrupting at least a portion of a thrombus (Col 3, Lines 51-55) for the purpose of performing transluminal thrombectomy by removing a clot by stripping away an interior volume of the clot’s fibrin framework, thus allowing release of red blood cells back into the circulatory system without emboli-producing large fragments (Col 4, Lines 23-36). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mallaby to include the system with an elongate wire having an enlarged portion, as taught by Auth, for the purpose of performing transluminal thrombectomy by removing a clot by stripping away an interior volume of the clot’s fibrin framework, thus allowing release of red blood cells back into the circulatory system without emboli-producing large fragments (Col 4, Lines 23-36). It is noted that, in this modification, the elongate wire of Auth would not replace the guidewire 16 of Mallaby (as they serve different purposes); instead, Mallaby would be provided with another elongate wire – one having an enlarged portion – that can be used after the catheter has been placed by the guidewire 16.
Re claim 13, Mallaby as modified by Auth in the rejection of claim 12 above disclose all the claimed features with Auth teaching that the at least a portion of the thrombus comprises a fibrous cap of the thrombus (as this is a device claim, the cited art only has to be capable of disrupting a portion of a thrombus having a fibrous cap and does not have to explicitly disclose disruption of a fibrous cap; this limitation is met by Col 4, Lines 23-36).
Re claim 14, Mallaby discloses that the spray pattern comprises a jet (Para 68).
Re claim 16, Mallaby as modified by Auth in the rejection of claim 12 above disclose all the claimed features with Auth teaching that the distal end of the elongate wire comprises a plurality of curved portions (as seen in Fig 1,2, the distal end of the elongate wire consists of the distal quarter of wire 3 and a capsule shaped tip 2; as seen in Fig 1,2, the tip 2 has a first curved portion at the distal end of the tip 2 and has a second curved portion at the proximal end of the tip 2).
Re claim 17, Mallaby discloses a grasping tool 74 configured to grasp an end of the elongate wire (Para 61; it is noted that since the grasping tool 74 is disclosed as grasping guidewire 16, one of ordinary skill in the art would recognize that it is structurally capable of grasping the wire 3+2 of Auth).
Re claim 18, Mallaby as modified by Auth in the rejection of claim 12 above discloses all the claimed features with Auth teaching that the distal end of the elongate wire has a preformed shape (as seen in Fig 1,2, the distal end 2 has a preformed capsule shape).
Re claim 19, Mallaby discloses that the orifice is configured to direct the spray pattern obliquely in relation to a longitudinal axis of the aspiration lumen (as seen in Fig 5; Para 68).
Re claim 20, Mallaby discloses that the supply lumen is configured to transport at least one of a lytic agent or a contrast agent (it is noted that “a lytic agent” and “a contrast agent” are only functionally recited and, therefore, not a part of the claimed invention; therefore, Mallaby’s supply lumen only has to be structurally capable of transporting a lytic agent and/or a contrast agent; this limitation is met in view of Para 68 that states the supply lumen is structurally capable of delivering saline or another biocompatible fluid).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (PG PUB 2010/0204712)/Auth et al. (US Pat 5,695,507) in view of Aklog et al. (PG PUB 2011/0213392).
Re claim 15, Mallaby as modified by Auth in the rejection of claim 12 above discloses all the claimed features with Auth teaching that the enlarged portion includes a concave portion (at the proximal end thereof, since the enlarged portion 2 has a capsule shape, as seen in Fig 1,2). Mallaby/Auth do not disclose that the concave portion engages the distal end of the aspiration catheter and, therefore, do not disclose that, when the concave portion engages the distal end of the aspiration catheter, a portion of the distal end is disposed outside of the aspiration lumen and a portion of the distal end is disposed within the aspiration lumen. Aklog, however, teaches an aspiration catheter 10+20 (Fig 2E-2G) comprising an aspiration lumen 12 (Fig 2E-2G) and an elongate wire 25+26 (Fig 2E-2G) having a distal end (the distal-most quarter of wire 25 + 26) comprising an enlarged portion 26 with a concave portion (at the proximal end thereof), wherein the concave portion engages the distal end of the aspiration catheter (as seen in Fig 2G) such that a portion of the distal end of the elongate wire is disposed outside of the aspiration lumen and a portion of the distal end disposed within the aspiration lumen (as seen in Fig 2G) for the purpose of enhancing the aspiration force acting on the thrombus (Para 46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mallaby/Auth to include the elongate wire and concave portion being structurally capable of being withdrawn against the distal end of the aspiration catheter such that a portion of the distal end of the elongate wire is within the aspiration catheter and a portion of the distal end of the elongate wire is outside the aspiration lumen, as taught by Aklog, for the purpose of enhancing the aspiration force acting on the thrombus (Para 46).
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783