DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendment filed 05/01/26 has been entered. Claims 2, 7-8, 14-15, 18-20, and 25, claims 8-14 remain withdrawn, and claims 16-17 have been cancelled. Claims 2-7, 15, and 18-25 are addressed in the following office action.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-7, 15, and 18-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sepetka et al. (US 2002/0123765) in view of Dunfee et al. (US 2007/0049964), both cited in previous office action.
Regarding claim 2, an invention relating to vascular occlusion removal devices, Sepetka discloses (Figs. 10-14) an intravascular filter system (100) comprising: a delivery tube (107) having a proximal delivery tube end and a distal delivery tube end (see annotated figure below); a positioning tube (126) having a proximal positioning tube end and a distal positioning tube end (see annotated figure below), the proximal positioning tube end proximate to the proximal delivery tube end [i.e. when the capture element is withdrawn into the element 107 or 104, it can be withdrawn proximally such that the proximal positioning tube end is proximate the proximal delivery tube end] and the distal positioning tube end proximate the distal delivery tube end [i.e. when the capture element is advanced through the element 107 or 104, it can be advanced distally such that the distal positioning tube end is proximate the distal delivery tube end] (Par. 0133, 0135, 0137); a flexible capture sleeve (102) having mesh (114; Par. 0134) coupled with the positioning tube distal end (Par. 0133), the flexible capture sleeve includes: the flexible capture sleeve movable between an expanded capture sleeve conformation (Par. 0033) having a conical shaped portion (124) and an unexpanded capture sleeve conformation [i.e. when the capture sleeve is withdrawn into the delivery tube] (Par. 0035 & 0137); and wherein distal movement of the delivery tube compresses the flexible capture sleeve to the unexpanded capture sleeve conformation, and proximal movement of the delivery tube permits the flexible capture sleeve to radially expand to the expanded capture sleeve conformation (Par. 0116-0117 & 0137); a guidewire (108) having a proximal element end [i.e. the end outside the body from which it is controlled] and a distal element end (see annotated figure below), the guidewire includes: a flexible preformed memory obstruction engaging device (106; Par. 0113 & 0130) coupled to the guidewire (Par. 0111 & 0131), the obstruction engaging device having a proximal conical portion and a distal conical portion (see annotated figure below); wherein the guidewire is configured for advancement from the positioning tube such that the obstruction engaging device is positioned distal to a thrombus; wherein the obstruction engaging device is moveable between an expanded conformation and an unexpanded conformation (Par. 0111); and wherein the guidewire is moved proximally to pull the obstruction engaging device in the expanded conformation through the thrombus to engage and pull the thrombus into the flexible capture sleeve in the expanded capture sleeve conformation; and wherein the conical shaped portion of the flexible capture sleeve corresponds to the proximal conical portion of the obstruction engaging device to forcibly compress the obstruction engaging device to the unexpanded configuration as the obstruction device is withdrawn proximally into the positioning tube [Note, the positioning tube is of a diameter that would return the capture sleeve and obstruction engaging device to unexpanded conformations] (Par. 0111, 0118-0119, 0129-0130, 0136-0137). Sepetka further discloses the filaments may also form a filter which further prevents the obstruction or portions thereof from travelling downstream (Par. 0131).
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However, Sepetka fails to disclose the guidewire includes: a flexible preformed memory shaped filter coupled to the guidewire, the flexible preformed memory shaped filter having a proximal conical portion and a distal conical portion; wherein the guidewire is configured for advancement from the positioning tube such that the flexible preformed memory shaped filter is positioned distal to a thrombus; wherein the flexible preformed memory shaped filter is moveable between an expanded filter conformation and an unexpanded filter conformation.
In the analogous art of vascular filters, Dunfee teaches (Figs. 1 & 3) an guidewire (120) includes: a flexible preformed memory shaped filter (100) coupled to the guidewire (Abstract & Par. 0020 & 0022-0024), the flexible preformed memory shaped filter having a proximal conical portion (303) and a distal conical portion (304); wherein the guidewire is configured for advancement from the positioning tube such that the flexible preformed memory shaped filter is positioned distal to a thrombus (Par. 0018); wherein the flexible preformed memory shaped filter is moveable between an expanded filter conformation and an unexpanded filter conformation (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Sepetka to have the guidewire includes: a flexible preformed memory shaped filter coupled to the guidewire, the flexible preformed memory shaped filter having a proximal conical portion and a distal conical portion; wherein the guidewire is configured for advancement from the positioning tube such that the flexible preformed memory shaped filter is positioned distal to a thrombus; wherein the flexible preformed memory shaped filter is moveable between an expanded filter conformation and an unexpanded filter conformation, as taught by Dunfee. Sepetka discloses the elongate element including a filter is desired (Par. 0131), thus Dunfee’s filter would have provided Sepetka with the desired filter.
Regarding claim 3, Sepetka, as modified by Dunfee, discloses further wherein the flexible preformed memory shaped filter is between about 2 mm and about 48 mm in the expanded filter conformation [Note, Sepetka discloses the obstruction engaging element’s length to be within the claimed range, and in order for the filter of Dunfee to be used in the same location as Sepetka’s obstruction engaging element/filter it would obviously be the same size] (Par. 0121).
Regarding claim 4, Sepetka, as modified by Dunfee, discloses further wherein the flexible preformed memory shaped filter includes a one-piece slotted tube [i.e. see Dunfee paragraphs 0008 & 0027].
Regarding claim 5, Sepetka, as modified by Dunfee, discloses further wherein the distal conical portion includes a first plurality of diamond shaped openings and the proximal conical portion includes a second plurality of diamond shaped openings; wherein the second plurality of diamond shaped openings are larger than the first plurality of diamond shaped openings [i.e. openings see Dunfee paragraphs 0021 & 0023].
Regarding claim 6, Sepetka, as modified by Dunfee, discloses the intravascular filter system of claim 2. Sepetka further discloses wherein the flexible capture sleeve includes woven nitinol wires (Par. 0113 & 0133).
Regarding claim 7, Sepetka, as modified by Dunfee, discloses the intravascular filter system of claim 2. Sepetka further discloses (Fig. 3) wherein the guidewire includes a radially projecting element (24 & 26) positioned distal to the flexible preformed memory shaped filter [Note, Sepetka discloses the guidewire includes the claimed radially projecting element, and in order for the filter of Dunfee to be used in the same location as Sepetka’s obstruction engaging element/filter it would obviously located such that the radially projecting element is positioned distal to the filter] (Par. 0113).
Regarding claim 15, an invention relating to vascular occlusion removal devices, Sepetka discloses (Figs. 10-14) a thrombectomy system (100) comprising: an elongate positioning tube (126) extending between a proximal positioning tube end and a distal positioning tube end (see annotated figure below), the positioning tube includes: a flexible capture sleeve (102) coupled with the distal positioning end (Par. 0133), the flexible capture sleeve extending between a proximal sleeve end [i.e. the end coupled to the element 126] and a distal open sleeve end (116), the capture sleeve configured to transition between: an unexpanded sleeve conformation [i.e. when the capture sleeve is withdrawn into the delivery tube] (Par. 0035 & 0137); and an expanded sleeve conformation (Par. 0033), wherein in the expanded sleeve conformation the flexible capture sleeve tapers from the distal open sleeve end toward the proximal sleeve end [i.e. cone shape] (Par. 0133); a delivery tube (107) slidably coupled along the positioning tube [i.e. element 102 is coupled and moves as a unit with the positioning tube, hence the delivery tube and positioning tube would be slidable relative to one another], the delivery tube configured to transition the flexible capture sleeve between the expanded and unexpanded sleeve conformations [i.e. when the sleeve is within element 107] (Par. 0137), the delivery tube including proximal and distal delivery tube ends (see annotated figure below) proximate the respective proximal and distal positioning tube ends [i.e. when the capture element is withdrawn into the element 107 or 104, it can be withdrawn proximally such that the proximal positioning tube end is proximate the proximal delivery tube end; and when the capture element is advanced through the element 107 or 104, it can be advanced distally such that the distal positioning tube end is proximate the distal delivery tube end] (Par. 0133, 0135, 0137); and an obstruction engaging device including: an guidewire (108) extending from a proximal element end [i.e. the end outside the body from which it is controlled] to a distal element end (see annotate figure below), the guidewire slidably received in the positioning tube (Par. 0111, 0130, 0133); and a flexible obstruction engaging element (106) having a proximal end and a distal end (see annotated figure below) both coupled with the distal element end, wherein at least one of the proximal or distal filter ends is statically fixed to the distal element end (Par. 0131). Sepetka further discloses the filaments may also form a filter which further prevents the obstruction or portions thereof from travelling downstream (Par. 0131).
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However, Sepetka fails to disclose a filter device including: an guidewire extending from a proximal element end to a distal element end; and a flexible mesh filter having a proximal filter end and a distal filter end both coupled with the distal element end, wherein at least one of the proximal or distal filter ends is statically fixed to the distal element end; and wherein the flexible mesh filter includes: a proximal filter portion having proximal filter openings; a distal filter portion having distal filter openings, and the proximal filter openings are larger than the distal filter openings; an intermediate filter portion; and the proximal filter portion tapers from the filter intermediate portion to the proximal filter end, and the distal filter portion tapers from the filter intermediate portion to the distal filter end.
In the analogous art of vascular filters, Dunfee teaches (Figs. 1 & 3) a filter device including: an guidewire (120) extending from a proximal element end [i.e. the end outside the body from which it is controlled] to a distal element end (see annotate figure below); and a flexible mesh filter (100) having a proximal filter end (301) and a distal filter end (306) both coupled with the distal element end (Abstract & Par. 0020 & 0022-0024), wherein at least one of the proximal or distal filter ends is statically fixed to the distal element end (Par. 0020 & 0023); and wherein the flexible mesh filter includes: a proximal filter portion (303) having proximal filter openings (Par. 0021); a distal filter portion (304) having distal filter openings (Par. 0023), and the proximal filter openings are larger than the distal filter openings (Par. 0021 & 0023); an intermediate filter portion (316); and the proximal filter portion tapers from the filter intermediate portion to the proximal filter end, and the distal filter portion tapers from the filter intermediate portion to the distal filter end (Fig. 3).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Sepetka to a filter device including: an guidewire extending from a proximal element end to a distal element end; and a flexible mesh filter having a proximal filter end and a distal filter end both coupled with the distal element end, wherein at least one of the proximal or distal filter ends is statically fixed to the distal element end; and wherein the flexible mesh filter includes: a proximal filter portion having proximal filter openings; a distal filter portion having distal filter openings, and the proximal filter openings are larger than the distal filter openings; an intermediate filter portion; and the proximal filter portion tapers from the filter intermediate portion to the proximal filter end, and the distal filter portion tapers from the filter intermediate portion to the distal filter end, as taught by Dunfee. Sepetka discloses the elongate element including a filter is desired (Par. 0131), thus Dunfee’s filter would have provided Sepetka with the desired filter.
Regarding claim 18, Sepetka, as modified by Dunfee, discloses further wherein the filter device is configured to transition from an entrapment conformation to a capture conformation: in the entrapment configuration the flexible mesh filter has a filter perimeter spaced from the guidewire [i.e. see Dunfee Abstract and figure 1]and the flexible mesh filter is distally spaced from the flexible capture sleeve [Note, given Sepetka’s disclosure in figure 11, obviously Dunfee’s filter would be distally spaced form the flexible capture sleeve of Sepetka]; and in the capture conformation the flexible mesh filter is: proximally moved into the capture sleeve with proximal movement of the guidewire, thrombus is captured with the flexible mesh filter and the capture sleeve extending over the flexible mesh filter; and the capture sleeve compresses the thrombus and the flexible mesh filter toward the guidewire [Note, given Sepetka’s disclosure in paragraphs 0116-0117 & 0137, obviously Dunfee’s filter would function similar to the obstruction engaging element and would proximally move into the capture sleeve with proximal movement of the guidewire, and the thrombus would be captured with the flexible mesh filter and the capture sleeve extending over the flexible mesh filter; and the capture sleeve would compress the thrombus and the flexible mesh filter toward the guidewire].
Regarding claim 19, Sepetka, as modified by Dunfee, discloses wherein the capture sleeve includes a tapered profile [i.e. cone] (Par. 0133), and the tapered profile of the capture sleeve compresses the thrombus and the flexible mesh filter toward the guidewire in the capture conformation tube [Note, the positioning tube is of a diameter that would return the capture sleeve and obstruction engaging device to unexpanded conformations] (Par. 0111, 0118-0119, 0129-0130, 0136-0137).
Regarding claim 20, Sepetka, as modified by Dunfee, discloses wherein the capture sleeve transitioning from the expanded sleeve conformation to the unexpanded sleeve conformation is configured to compress the thrombus and the flexible mesh filter toward the guidewire in the capture conformation [Note, given Sepetka’s disclosure in paragraphs 0116-0117 & 0137, obviously Dunfee’s filter would function similar to the obstruction engaging element and would proximally move into the capture sleeve with proximal movement of the guidewire, and the thrombus would be captured with the flexible mesh filter and the capture sleeve extending over the flexible mesh filter; and the capture sleeve would compress the thrombus and the flexible mesh filter toward the guidewire].
Regarding claim 21, Sepetka, as modified by Dunfee, discloses wherein the flexible mesh filter is between about 2 mm and about 48 mm in the expanded conformation [Note, Sepetka discloses the obstruction engaging element’s length to be within the claimed range, and in order for the filter of Dunfee to be used in the same location as Sepetka’s obstruction engaging element/filter it would obviously be the same size] (Par. 0121).
Regarding claim 22, Sepetka, as modified by Dunfee, discloses wherein the flexible mesh filter includes a one-piece slotted tube [i.e. see Dunfee paragraphs 0008 & 0027].
Regarding claim 23, Sepetka, as modified by Dunfee, discloses wherein the proximal filter openings include proximal diamond shaped openings and the distal filter openings include distal diamond shaped openings, and the proximal diamond shaped openings are larger than the distal diamond shaped openings [i.e. openings see Dunfee paragraphs 0021 & 0023].
Regarding claim 24, Sepetka, as modified by Dunfee, discloses wherein the flexible mesh filter is woven from nitinol wires [i.e. see Dunfee paragraph 0024].
Regarding claim 25, Sepetka, as modified by Dunfee, discloses the intravascular filter system of claim 15. Sepetka further discloses (Fig. 3) wherein the guidewire comprises a radially projecting element (24 & 262) positioned distal to the flexible preformed memory shaped filter [Note, Sepetka discloses the guidewire includes the claimed radially projecting element, and in order for the filter of Dunfee to be used in the same location as Sepetka’s obstruction engaging element/filter it would obviously located such that the radially projecting element is positioned distal to the filter] (Par. 0113).
Response to Arguments
Applicant’s arguments, see page 10, filed 05/01/26, with respect to claim 2 have been fully considered and are persuasive. The objection of claim 2 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive. Applicant argues the previously cited prior art as combined fails to teach or suggest the positioning tube with a flexible capture sleeve and delivery tube slidably coupled along the positioning tube wherein respective proximal and distal ends of the positioning tube and the delivery tube are proximate each other, as fully recited in claims 2 and 15. Examiner respectfully disagrees.
Previously cited prior art reference Sepetka discloses (Figs. 10-14) an intravascular filter system (100) comprising: a delivery tube (107) having a proximal delivery tube end and a distal delivery tube end (see annotated figure below); a positioning tube (126) having a proximal positioning tube end and a distal positioning tube end (see annotated figure below), the proximal positioning tube end proximate to the proximal delivery tube end [i.e. when the capture element is withdrawn into the element 107 or 104, it can be withdrawn proximally such that the proximal positioning tube end is proximate the proximal delivery tube end] and the distal positioning tube end proximate the distal delivery tube end [i.e. when the capture element is advanced through the element 107 or 104, it can be advanced distally such that the distal positioning tube end is proximate the distal delivery tube end] (Par. 0133, 0135, 0137).
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/ Primary Examiner, Art Unit 3771
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