DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered.
Response to Amendment
In response to the amendment filed on 06/29/2026, Claim 14 and 19 has been cancelled, and Claim 1-13, 15-18, and 20 are pending.
Terminal Disclaimer
The terminal disclaimer filed on 10/21/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 9,492,263, US Patent 10,321,924, and US Patent 11,648,021 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Martin (US PGPub 2009/0069828) in view of Freudenthal (US PGPub 2006/0155305)
Regarding Claims 1, Martin teaches a method for a clot within a body lumen of a patient, the method comprising (Figures 6A-6D):
introducing a proximal basket (260) and a distal basket (226) into the body lumen in a contracted condition (figure 6A; Paragraph 0089), wherein the proximal basket (260) and the distal basket (226) are configured to be spaced apart from one another (see Figure 6C; Paragraph 0092), each of the proximal (260) and distal baskets (226) comprising an open end communicating with an interior of the respective basket (as seen in Figure 6D-6E; Paragraph 0094), the open ends configured to be oriented towards one another (see Figures 6D-6E);
deploying the distal basket (226) such that the distal basket expands within the body lumen and the open end is disposed distal to the clot (2) to be removed (Figure 6B);
deploying the proximal basket (260) such that the proximal basket expands within the body lumen and the open end is disposed proximal to the clot (2) to be removed (see Figure 6C); and
directing at least one of the proximal (260) and distal baskets (226) towards the other to capture the clot through one or both of the open ends into interiors of one or both of the proximal and distal baskets (as seen in Figure 6C-6D the baskets are moving towards one another; Paragraph 0094);
Martin fails to disclose:
wherein the open end of the distal basket (226) is directed radially inwardly and received within the open end of the proximal basket (260) as the at least one of the proximal (260) and the distal baskets are advanced towards the other.
However, Martin teaches “the petals 238 on the open ends 228 and 262 can interact to nest once the capturing portions 226 and 260 are moved sufficiently close to one another. The outward force caused by the retained obstruction provides a frictional interaction between adjacent petals/flanges 238 to maintain the nesting” in Paragraph 0078 and furthermore Martin teaches “In another example, one basket may be undersized relative to the other to improve nesting” in Paragraph 0078.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify distal basket to be undersized relative to the proximal basket, as taught by Martin, which would result the proximal basket directing the open expanded end of the distal basket radially inward as the two baskets are drawn together, for the advantage of improving nesting between the proximal and distal baskets while retaining the clot in between (Paragraph 0078).
Martin further fails to disclose wherein the open end of the basket comprises one or more struts oriented radially inward.
Freudenthal teaches a method for removing a clot (Paragraph 0078) wherein
wherein the open end of the distal basket (10) is received within the open end of the proximal basket (20) as the at least one of the proximal (20) and the distal baskets (10) are advanced towards the other (Paragraph 0078 states “After the collecting baskets have been released, the clot is captured using the first collecting basket and the latter is drawn back into the second collecting basket 20 together with the clot. For further recovery of the clot, both collecting baskets, in the state with one drawn into the other, are then drawn back into the channel element”) and
wherein the open end of the basket comprises one or more struts (11; Figures 1, 4 and 27) and (16; Figure 5-9) oriented radially inward. (The examiner notes that adjustment element 11 is oriented radially inward such that it goes within the proximal basket (20) and Freudenthal teaches the adjustment elements can be part of the first collecting basket with wires being twisted together and thus the examiner is interpreting element 11 or 16 as struts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the deployment mechanism of the distal basket taught by Martin, with the radially inwardly directed adjustment struts, as taught by Freudenthal since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the radially inward struts of Freudenthal would be sufficient to actuate the distal filter of Martin towards the proximal basket and to ensure that the distal filter follows the adjustment struts into the interior of the proximal basket to the user (Paragraph 0060; Freudenthal)
Regarding Claim 2, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches the proximal basket (260) is introduced into the body lumen within a tubular member (102), the tubular member (102) constraining the proximal basket (260) in the contracted condition (Figure 6A and 6B; Paragraph 0089-0091).
Regarding Claim 3, the combination of references disclosed above teaches the method of Claim 2, wherein Martin teaches deploying the proximal basket (260) comprises exposing the proximal basket (260) from the tubular member (102) within the body lumen, the proximal basket (260) resiliently expanding from the contracted condition to an expanded condition within the body lumen (Figures 6B-6C).
Regarding Claim 4, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches the distal basket (226) is introduced into the body lumen within a tubular member (102), the tubular member (102) constraining the distal basket (226) in the contracted condition (Figure 6A).
Regarding Claim 5, the combination of references disclosed above teaches the method of Claim 4, wherein Martin teaches deploying the distal basket (226) comprises exposing the distal basket (226) from the tubular member (102) within the body lumen, the distal basket (226) resiliently expanding from the contracted condition to an expanded condition within the body lumen (Figures 6A-6B).
Regarding Claim 6, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches, when the proximal basket (260) and the distal basket (226) are deployed, the open ends of the proximal and distal baskets contact a wall of the body lumen (Figure 6C; Paragraph 0059).
Regarding Claim 7, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches introducing the proximal basket (260) and the distal basket (226) into the body lumen comprises advancing the proximal basket (260) and the distal basket (226) over a guidewire (Figure 6A; Paragraph 0089-0090).
Regarding Claim 8, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches further comprising applying aspiration via a catheter (12; Figure 1A) to aspirate at least a portion of the clot (Paragraph 0039 discloses inflation and vacuum sources; Figure 1A).
Regarding Claim 9, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches the distal basket comprises a closed end opposite the open end (Paragraph 0045; Figure 2D).
Regarding Claim 10, the combination of references disclosed above teaches the method of Claim 1, wherein Martin teaches each of the proximal basket and the distal basket comprise a mesh structure (Paragraph 0043, 0055, 0066).
Claim 11-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Martin (US PGPub 2009/0069828) in view of Boyle (US PGPub 2003/0120303)
Regarding Claims 11, Martin teaches a method for a clot within a body lumen of a patient, the method comprising (Figures 6A-6D):
deploying a proximal basket (260; Figure 8C) in the body lumen such that the proximal basket expands within the body lumen from a contracted position (Figures 6A-6B) to an expanded position (Figures 6C-6D), the proximal basket (260) comprising an open end disposed proximal to the clot to be removed and communicating with an interior of the proximal basket (260; Figure 6C);
deploying a distal basket (226) in the body lumen such that the distal basket expands within the body lumen from a contracted position (6A) to an expanded position (Figure 6B-6D), the distal basket (226) comprising an open end disposed distal to the clot to be removed and communicating with an interior of the distal basket (Figures 6C-6D), wherein, when the proximal basket and the distal basket are deployed (Figure 6C), the open ends of the distal basket (226) and the proximal basket (260) are oriented towards one another (Figure 6C),
directing at least one of the proximal (260) and distal baskets (226) towards the other to capture the clot through one or both of the open ends into one or both of the interiors of the proximal (260) and distal baskets (226; as seen in Figure 6E; Paragraph 0094);
Martin fails to teach:
wherein the distal basket comprises a closed end opposite the open end and an atraumatic tip extending distally from the closed end, and wherein the distal basket is advanced through the body lumen in the contracted position within a tubular member with the atraumatic tip extending beyond a distal end of the tubular member while the tubular member is advanced past the clot to a position distal to the clot; and
wherein the distal basket is directed radially inwardly and into the proximal basket as the at least one of the proximal and distal baskets are advanced towards the other.
However, Martin teaches “the petals 238 on the open ends 228 and 262 can interact to nest once the capturing portions 226 and 260 are moved sufficiently close to one another. The outward force caused by the retained obstruction provides a frictional interaction between adjacent petals/flanges 238 to maintain the nesting” in Paragraph 0078 and furthermore Martin teaches “In another example, one basket may be undersized relative to the other to improve nesting” in Paragraph 0078.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify distal basket to be undersized relative to the proximal basket, as taught by Martin, which would result the proximal basket directing the open expanded end of the distal basket radially inward as the two baskets are drawn together, for the advantage of improving nesting between the proximal and distal baskets while retaining the clot in between (Paragraph 0078).
Boyle teaches an embolic filter device (20) which is equivalent to the distal basket of Martin in that, the filter (20) is meant to trap a clot with the open proximal end (see Figure 1 and 4), and wherein the distal basket (20; Figure 1) comprises a closed end (32) opposite the open end (Figure 1 and Figure 4) and an atraumatic tip (76) extending distally from the closed end (32; Figure 1, 3 and 4), and wherein the distal basket (20) is advanced through the body lumen in the contracted position within a tubular member (30; as seen in Figure 3) with the atraumatic tip (76) extending beyond a distal end of the tubular member (30) while the tubular member (30) is advanced past the clot (38; Figure 3) to a position distal to the clot (as seen in Figures 3-4).
It would have been obvious to one of ordinary skill in the art to modify the device of Martin to include the atraumatic tip delivery configuration teachings of Boyle for the advantage of eliminating the use of a guidewire as taught by Martin (see Figure 6A of Martin, element 104) and Boyle teaches the lack of a guidewire may help increase the flexibility and bendability of the filtering assembly as its being delivered through the patients vasculature (Paragraph 0043; Boyle).
Regarding Claim 12, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches deploying the proximal basket (260) comprises introducing the proximal basket into the body lumen within a tubular member (102), the tubular member (102) constraining the proximal basket (260) in the contracted condition (Figure 6A and 6B; Paragraph 0089-0091).
Regarding Claim 13, the combination of references disclosed above teaches the method of Claim 12, wherein Martin teaches deploying the proximal basket (260) comprises exposing the proximal basket (260) from the tubular member (102) within the body lumen, the proximal basket (260) resiliently expanding from the contracted condition to an expanded condition within the body lumen (Figures 6B-6C).
Regarding Claim 15, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches deploying the distal basket (226) comprises exposing the distal basket (226) from the tubular member (102) within the body lumen, the distal basket (226) resiliently expanding from the contracted condition to an expanded condition within the body lumen (Figures 6A-6B).
Regarding Claim 16, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches, when the proximal basket (260) and the distal basket (226) are deployed, the open ends of the proximal and distal baskets contact a wall of the body lumen (Figure 6C; Paragraph 0059).
Regarding Claim 17, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches deploying the proximal basket (260) and the distal basket (226) into the body lumen comprises advancing the proximal basket (260) and the distal basket (226) over a guidewire (Figure 6A; Paragraph 0089-0090).
Regarding Claim 18, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches further comprising applying aspiration via a catheter (12; Figure 1A) to aspirate at least a portion of the clot (Paragraph 0039 discloses inflation and vacuum sources; Figure 1A).
Regarding Claim 20, the combination of references disclosed above teaches the method of Claim 11, wherein Martin teaches each of the proximal basket and the distal basket comprise a mesh structure (Paragraph 0043, 0055, 0066).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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