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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 30, 2025 has been entered.
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 1-10, 12, 14, 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashir et al. (US 2018/0049761 A1, the PgPub of Bashir is relied on, it is noted the Patent US 10,123,814 may be referred to for clearer drawings) in view of Don Michael (US 2011/0077619 A1), Parodi (US 6,206,868), Mische et al. (US 5,279,546), and Krolik et al. (US 2010/0036410 A1).
With regard to claim 1, Bashir et al. teach a catheter system for treating thromboembolic conditions comprising: an infusion basket catheter component comprising a catheter component (Fig. 7 member 720) and an infusion basket component (Fig. 7 member 706), the infusion basket catheter component comprises a shaft comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end and defining a longitudinal axis, a plurality of tubes, each tube comprising a wall with an inner surface and an outer surface and a lumen extending between a distal end and a proximal end (Figs. 10 and 11 tubes 708/709); a plurality of helical cuts along a portion of the shaft between the inner and outer 2133272052Application No. 17/159,4353Amendment dated April 25, 2022Response to Office Action dated: January 24, 2022surface of the wall forms a plurality of tines (see Figs. 9, 11, and 12 showing cuts forming the individual tines 707b, Fig. 12 shows how the tines can be spiraled/helical), wherein each of the plurality of tines are disposed in the lumen of each of the plurality of tubes to form a plurality of limbs (Figs. 7, 10, and 11 the tines are inserted into tubes 708/709), the proximal end of the shaft is uncut (see Figs. 9 and 11 in the area of 707a the shaft is uncut); the plurality of tubes are melted together and to an outside of the shaft at the uncut proximal end of the shaft (Figs. 10 and 11 the tines are inserted into tubes 708/709, regarding limitations to the tubes being melted the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.), each of the plurality of tubes of the infusion basket catheter component comprises a plurality of infusion ports extending between the inner surface and outer surface of the wall of the tube (see [0049], Fig. 7 ports 710), the plurality of tubes are configured to be positioned against the clot, and the plurality of infusion ports are configured to administer the therapeutic fluid to the clot to dissolve the clot ([0053]).
Bashir et al. teach such an expandable member for treating thrombus may be delivered through a sheath ([0042], [0055]) but does not disclose a balloon component as recited. However, Don Michael teaches a balloon component comprising a lumen having a proximal region and a distal region (Fig. 3 member 68); and an infusion basket component (Fig. 6 member 601 and 620), wherein: the balloon component comprises: a balloon catheter shaft which surrounds the infusion basket catheter component (the baskets are introduced and removed through the balloon catheter 68, Figs. 1, 2, 6, [0032], [0043]), and a balloon assembly located in proximity to the infusion basket catheter component and coupled to an outer surface of the balloon catheter shaft, the balloon assembly being configured such that, once inflated, the balloon assembly can occlude blood flow in a vessel of interest, the infusion basket catheter component is configured to move through the balloon catheter shaft, enabling the infusion basket catheter component to be removed through the balloon catheter shaft when the balloon assembly is in an inflated and deflated state (Fig. 6 member 72, [0032], [0043], [0046]); providing a balloon inflation port and a suction point port for aspiration of a thrombus within the vessel of interest (balloon is necessarily inflated and occlusive material is suctioned though the inner lumen of the shaft 68, [0048], occlusive material can be treated with drugs [0041]). It would have been obvious to a person having ordinary skill in the art before the effective filing date to deliver the basket of Bashir with a balloon catheter as provided by Don Michael as the balloon is effective for blocking blood flow during treatment of the occlusion to prevent occlusive material from spreading ([0039], [0040]) and to use suction as this is beneficial for removing debris and allowing it to be analyzed ([0041]). The balloon catheter as provided by Don Michael would provide a suitable sheath for delivery of the basket of Bashir et al. The basket of Bashir would be inserted through and moved independently of the sheath to which the balloon has been added.
Bashir et al. as combined with Don Michael do not disclose a liner. However, Parodi teach a balloon which is used to retain a catheter while delivering a member may have a low-friction inner layer (Fig. 3C member 60, Col. 6 lines 20-22). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use a liner in Bashir et al. and Don Michael as Parodi teaches this material is suitable for providing a low-friction layer for insertion and would yield the same predictable result. As the liner is applied to the inner surface of the lumen of the balloon sheath this shaped and configured to enable movement of the basket catheter. As combined an intraluminal space would be created between the catheter basket component and the inner liner as the catheter basket component is inserted into the sheath with the balloon and liner
Bashir et al. and Don Michael include suction and inflation but do not explicitly show the arrangement of the ports together with a connector. However, Mische et al. teach a thrombolysis system in which the catheter assembly terminates in a connection assembly comprising a balloon port and a separate suction port which also allow insertion of an instrument through a port (Fig. 1 connector 42, inflation port 46, suction port 48, instrument inserted through 62). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use an aspiration lumen and to incorporate the aspiration lumen and inflation lumen into a connector of the shaft as provided by Bashir et al. and Don Michael as in Mische et al. as this provides an art effective connection for providing inflation and suction and would yield the same predictable result. Mische et al. do not disclose the connector is a hemostatic valve. However, Krolik et al. teach it is beneficial in a connector which may have a plurality of ports for inflation and suction to include hemostatic seals to prevent leakage ([0073]). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use hemostatic sealing in the connector as provided by Mische et al. as Krolik et al. teach this is beneficial for preventing leakage.
Bashir et al. teach a connector 808 to enable the supply of therapeutic fluid (Fig. 14, [0054]) but do not specifically disclose the connector is a luer. However, Krolik et al. teach luer connectors as equivalent to other connection means (exemplary [0113]). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use a luer connector in Bashir et al. as Krolik et al. teach this is an art effective equivalent means for providing a suitable connection between components.
With regard to claim 2, see Bashir et al. see Figs. 7, 10, and 11 which show the tines within the tubes forming the plurality of limbs, the tines are not connected between the ends, and the distal ends are attached together.
With regard to claim 3, see [0047] and [0053]-[0054].
With regard to claims 4 and 5, see [0047], in the relaxed state the arms lay flat which would form a closed state and then expand such that the arms bow outwards as the distal end is moved proximally which reduces the length of the basket.
With regard to claim 6, see [0052], basket is made of nitinol.
With regard to claim 7, see at least [0052] regarding the material of the shaft which is the same as the basket material.
With regard to claim 8, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. The resultant product is the same if the cuts are made by a laser or other means.
With regard to claims 9 and 10, see Fig. 12. If this is not found to show the rotation as claimed, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have the cuts extend as recited as it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With regard to claims 12 and 14, see [0049], Fig. 7 ports 710.
With regard to claim 17, as combined with Don Michael, the balloon is necessarily compliant as it inflates and necessarily includes an inflation lumen, as combined with the overall device the suction lumen would also run through the balloon as the balloon is provided around the end of the catheter.
With regard to claim 18, see the rejection to claim 1 above regarding the balloon as provided by Don Michael.
With regard to claim 19, Bashir et al. as combined with Don Michael teach a device substantially as claimed but are silent as to the material of the balloon. However, Parodi teach a balloon which is used to retain a catheter while delivering a basket may be made of polyurethane (Figs. 3-5, balloon 42/55, Col. 6 lines 7-13). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use polyurethane in Bashir et al. and Don Michael as Parodi teaches this material is suitable for use in the body and would yield the same predictable result.
With regard to claim 20, Bashir et al. and Don Michael do not disclose the specific size of the balloon and basket. As combined the area between the basket and balloon changes as the balloon is inflated prior to the basket being pushed out. It would have been obvious to a person having ordinary skill in the art before the effective filing date to size the components to achieve the area claimed as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One of ordinary skill in the art would be able to size the balloon as desired to have sufficient pressure for retention in the vasculature and understand the basket needs to be of such a size that it can fit within the vasculature and the balloon.
With regard to claim 21, see Figs. 7 and 8, lumen in 722 and 720.
With regard to claim 22, the lumen within 722 receives guidewire 712, the lumen within 720 is capable of extracting a clot.
Claim 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashir et al. (US 2018/0049761 A1, the PgPub of Bashir is relied it is noted the Patent US 10,123,814 may be referred to for clearer drawings), Don Michael (US 2011/0077619 A1), Parodi (US 6,206,868), Mische et al. (US 5,279,546), and Krolik et al. (US 2010/0036410 A1) as applied to claim 1 above, and further in view of Vale et al. (WO 2018/033401 A1).
With regard to claim 28, Bashir et al. as combined with Don Michael teach a device substantially as claimed but do not disclose the shape of the balloon to be a funnel. However, Vale et al. teach a funnel shape is beneficial in thrombus removal devices because it reduces shear stress on occlusive material which is removed through the device and there is little or no dead space between the balloon and the tip to catch fragments (Pg. 23 lines 2-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use a funnel shaped balloon in Bashir et al. and Don Michael as Vale et al. teach this is beneficial in reducing shea stress on occlusive material which is removed through the device and there is little or no dead space between the balloon and the tip to catch fragments.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashir et al. (US 2018/0049761 A1, the PgPub of Bashir is relied it is noted the Patent US 10,123,814 may be referred to for clearer drawings), Don Michael (US 2011/0077619 A1), Parodi (US 6,206,868), Mische et al. (US 5,279,546), and Krolik et al. (US 2010/0036410 A1) as applied to claim 1 above, and further in view of Zadno-Azizi et al. (US 2001/0049517 A1).
With regard to claim 29, Bashir et al. as combined with Don Michael teach a device substantially as claimed and Don Michael teach the balloon is inflated against the inner lumen of the vessel ([0039]) but do not disclose the diameter of the balloon. However, Zadno-Azizi et al. teach a balloon use in the treatment of an occlusion should be able to inflate to various diameters to meet the changing size of the vessel as treatment occurs such that it is able to remain expanded against the vessel wall which includes a diameter such as 5 mm ([0165], [0167]). It would have been obvious to a person having ordinary skill in the art before the effective filing date to use a balloon which has an inflation diameter in the range recited in Bashir et al. and Don Michael as Zadno-Azizi et al. teach this is effective to seal the vessel.
Response to Arguments
Applicant's arguments filed September 30, 2025 have been fully considered but they are not persuasive. Applicant argues Don Michael, Parodi, Mische, and Krolik are to entirely different types of devices. The Examiner refers to the response in the action dated October 1, 2024. The Examiner further maintains her response as in the action dated October 8, 2025. The action does not state nor does it rely upon Parodi to deliver a basket catheter through a balloon lumen. Parodi does teach delivering an instrument through a lined lumen. The benefits of lining the lumen are beneficial to situations where one instrument is inserted through the other as is the case with Don Michael and Bashir as combined to which the teachings of Parodi are relevant.
Conclusion
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783