DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 2-7 and 15-25, drawn to apparatus, classified in A61B17/221.
II. Claims 8-14, drawn to method, classified in A61F2/013.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used to practice another and materially different process. Specifically, for gripping calculi or similar types of obstruction such as kidney stone.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
An extensive search of multiple classifications would have to be conducted and applicable art for the two inventions would not necessarily be applicable to one another.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Thomas Obermark on 12/05/25 a provisional election was made without traverse to prosecute the invention I, claims 2-7 and 15-25. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-14 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 2 objected to because of the following informalities: In line 24, “moved distally” should read “moved proximally”. Appropriate correction is required.
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 and 15-25 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).
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); a positioning tube (126) having a proximal positioning tube end and a distal positioning tube end (see annotated figure below); 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); an elongated element (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 elongated element includes: a flexible preformed memory obstruction engaging device (106; Par. 0113 & 0130) coupled to the elongated element (Par. 0111 & 0131), the obstruction engaging device having a proximal conical portion and a distal conical portion (see annotated figure below); wherein the elongated element 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 elongated element 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 elongated element includes: a flexible preformed memory shaped filter coupled to the elongated element, the flexible preformed memory shaped filter having a proximal conical portion and a distal conical portion; wherein the elongated element 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 elongated element (120) includes: a flexible preformed memory shaped filter (100) coupled to the elongated element (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 elongated element 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 elongated element includes: a flexible preformed memory shaped filter coupled to the elongated element, the flexible preformed memory shaped filter having a proximal conical portion and a distal conical portion; wherein the elongated element 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 elongated element includes a radially projecting element (24 & 26) positioned distal to the flexible preformed memory shaped filter [Note, Sepetka discloses the elongated element 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: a 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); and an obstruction engaging device including: an elongated element (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 elongated element 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 elongated element 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 elongated element (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 elongated element 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 16, Sepetka, as modified by Dunfee, discloses wherein the elongated element includes a guidewire [i.e. guidewire 120 see Dunfee figure 1 and paragraph 0020].
Regarding claim 17, Sepetka, as modified by Dunfee, discloses the thrombectomy system of claim 15. Sepetka further discloses (Fig. 11) comprising a delivery tube (107) slidably coupled along the positioning tube, the delivery tube configured to transition the flexible capture sleeve between expanded sleeve conformations (Par. 0116-0117 & 0137).
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 elongated element [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 elongated element, 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 elongated element [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 elongated element, 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 elongated element].
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 elongated element 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 elongated element 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 elongated element, 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 elongated element].
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 elongated element comprises a radially projecting element (24 & 262) positioned distal to the flexible preformed memory shaped filter [Note, Sepetka discloses the elongated element 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).
Conclusion
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
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 December 24, 2025