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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered. Claims 31, 36-40, 53-58, 60-62, and 65-68 are pending in the application with claims 38-40 being withdrawn from further consideration. The previous rejections of claims under 35 U.S.C. 112(a) and the previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31, 36-37, 53-58, 60-62, and 65-67 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 31 recites one or more extraneous wires “is embedded by following a weave pattern of the different wire minimizing friction between the wires when the one or more crossings function as hinges, pivoting during expansion of the second region.” The feature of embedding a wire minimizing friction between the wires is not described in the specification in such a way as to reasonably convey possession of the claimed invention.
Paragraphs [0076]-[0081] of the Specification describe embedding or hiding one or more extraneous wires at a crossing. However, no mention is made of minimizing friction by such embedding of an extraneous wire.
Rather, the Specification attributes minimizing friction by a different wire arrangement. Paragraph [0064] of the Specification discloses that a pair of wires encircling only a single wire of another pair of wires “may lock the two pairs of wires relative to each other, such that each pair of wires cannot slide along the other pair, while minimizing friction between the two pairs of wires due to the minimal physical engagement between the two pairs of wires.”
Thus, the Specification does not describe embedding an extraneous wire as “minimizing friction between the wires when the one or more crossings function as hinges, pivoting during expansion of the second region,” as recited in claim 31, in such a manner as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 36-37, 53-58, 60-62, and 65-67 are rejected as being dependent upon rejected claim 31 and failing to remedy the new matter issue.
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 31, 36-37, 53-57, 60-61, and 65-67 are rejected under 35 U.S.C. 103 as being unpatentable over Sudin et al. (WO 2017/077393; cited in the IDS filed May 16, 2022 and hereinafter referred to as “Sudin ‘393”) in view of Khachin et al. (U.S. Patent Application Publication No. 20030050663; hereinafter “Khachin”).
Regarding claim 31, Sudin ‘393 discloses an intraluminal device (4000; Fig. 4) including an elongated body formed of a plurality of wires, the intraluminal device comprising:
a first region (4001) wherein the plurality of wires are twisted to form a first cable (para. [031]);
a second region (annotated Fig. 4 below), distal to the first region, in which the plurality of wires are woven to form an expandable mesh segment which is configured to capture a blood clot (para. [031]); and
a third region (annotated Fig. 4) distal to the second region and forming a distal tip of the elongated body, wherein the plurality of wires in the third region are twisted to form a second cable (para. [011] of Sudin ‘393 describes a “fifth region, adjacent to the fourth region,” with twisted wire),
wherein each of the wires extends continuously from the first region, through the second region to the third region (Fig. 4 depicts each of the wires being continuous; paras. [007], [011] describe the “plurality of wires” being in the first region, the second region, the third region, the fourth region, and the fifth region) providing a smooth device profile (Fig. 4 depicts the outer profile of the device being smooth as the wires are woven about the circumference of the device);
wherein the second region includes one or more wire crossings (annotated Fig. 4 below) configured to function as hinges, pivoting during expansion of the second region (para. [013]).
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Sudin ‘393 further teaches interweaving wires at a crossing (Figs. 8-9B; paras. [035]-[036]).
The device of Sudin ‘393 discloses the invention substantially as claimed, except for one or more extraneous wires being embedded by following a weave pattern of a different wire at the wire crossing minimizing friction between the wires.
Khachin, a reference in the obstruction retrieving device field of endeavor, teaches configuring wire crossing such that one or more extraneous wires of a plurality of wires, adjacent (i.e., nearby) a different wire of the plurality of wires (annotated Figs. 12C-12F below), is embedded by following a weave pattern of the different wire (annotated Figs. 12C-12F below) to provide an elongated body with sufficient structural rigidity to facilitate entrapping an object (paras. [0034], [0096]).
Additionally, Khachin teaches providing wires with an insulating layer having a low coefficient of mechanical friction to reduce trauma to a patient (para. [0124]).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the wire crossings such that one or more extraneous wires of the plurality of wires, adjacent to a different wire of the plurality of wires, is embedded by following a weave pattern of the different wire minimizing friction between the wires, in view of Khachin, in order to provide the elongated body with improved rigidity for entrapping an object for removal with reduced trauma to a patient.
Regarding claim 36, Sudin ‘393 discloses wherein the plurality of wires extend continuously from the first region to the third region (Fig. 4; paras. [007] and [011]).
Regarding claim 37, Sudin ‘393 discloses wherein the first region of the intraluminal device, the second region of the intraluminal device, and the third region of the intraluminal device are formed as a single unitary structure (Fig. 4; paras. [007] and [011]).
Regarding claim 53, the modified device discloses wherein the plurality of wires form a plurality of groupings of wires in the second region (Sudin ‘393 Figs. 8-9B, paras. [035]-[036]), and wherein the one or more wires is embedded in a first group of wires of the plurality of groupings of wires (Khachin Figs. 12C-12E).
Regarding claim 54, the modified device discloses wherein the plurality of groupings of wires includes the first group of wires and a second group of wires, the first grouping of wires including three wires and the second grouping of wires including two wires (annotated Fig. 12F below).
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Regarding claim 55, the modified device discloses
wherein at the one or more wire crossings the intraluminal device includes a first group of wires and a second group of wires, the first group of wires including at least two wires and the second group of wires including the one or more extraneous wires and the different wire (annotated Fig. 12F of Khachin below); and
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wherein the one or more extraneous wires and the different wire pass over a first wire of the first group of wires and under a second wire of the first group of wires to embed the one or more extraneous wire.
Regarding claim 56, the modified device discloses wherein the second group of wires comprises a third wire, the first wire of the first group crossing under the third wire of the second group of wires; and the second wire of the first group crossing over the third wire of the second group (annotated Fig. 12F of Khachin above).
Regarding claim 57, the modified device discloses wherein the one or more extraneous wire and the different wire both pass over one of the wires of the first group of wires and under another of the wires of the second group of wires (annotated Fig. 12F of Khachin above). However, the modified device is not explicitly disclosed with such configuration being at a subsequent crossing.
Sudin ‘393 teaches the elongated body having multiple, subsequent wire crossings (annotated Fig. 4 below).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated body such that, at a subsequent crossing, the one or more extraneous wire and the different wire both pass over one of the wires of the first group of wires and under another of the wires of the second group of wires, in order to provide the elongated body with improved rigidity for entrapping an object for removal.
Regarding claim 60, the modified device discloses wherein at least the one or more extraneous wires extend continuously from the first region to the third region (Sudin ‘393 Fig. 4; paras. [007] and [011]; as paras. [007] and [011] describe the “plurality of wires” being in the first region, the second region, the third region, the fourth region, and the fifth region, then the extraneous wire extend continuously from the first region to the third region).
Regarding claim 61, the modified device discloses wherein a number of the plurality of wires is selected to provide a desired rigidity to the first region (Sudin ‘393 para. [011]-[012]).
Regarding claim 65, the modified discloses the device comprising a filter region (404) adjacent to the second region (Sudin ‘393 Fig. 4), wherein the second region weave pattern provides a larger diameter to the second region in an expanded configuration than a weave pattern of the filter region which provides a smaller diameter to the filter region in the expanded configuration (Sudin ‘393 Fig. 4).
Regarding claim 66, the modified device discloses wherein the one or more wire crossings includes a crossing of a first grouping of wires and a second grouping of wires (annotated Figs. 9A-9B of Sudin ‘393);
wherein the first grouping of wires includes at least two wires (Sudin ‘393 para. [036]), including the one or more extraneous wires;
wherein wires of the first grouping of wires are twisted together to provide at least one twist (e.g., the first grouping of wires are wound together leading into and leaving from a crossing; Sudin ‘393 Fig. 9B; para. [036]).
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Regarding claim 67, the modified device discloses wherein the at least one twist secures twisted wires of the first grouping against axial movement (e.g., winding of the first grouping of wires prevents relative axial movement between those wires; Sudin ‘393 Fig. 9B; par. [036]) while leaving the one or more extraneous wire free to move axially (e.g., the one or more extraneous wire is free to move axially relative to other wires of the group in the crossing where the wires are not wound together; Sudin ‘393).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Sudin ‘393 in view of Khachin, as applied to claim 31 above, and further in view of Sudin et al. (U.S. Patent Application Publication No. 20160081825; hereinafter “Sudin ‘825”).
Regarding claim 58, the modified device discloses the invention substantially as claimed, except for including an elongated control member.
Sudin ‘825 teaches providing an intraluminal device with an elongated control member (4; Fig. 1; paras. [0039]-[0044]) configured to apply force to the intraluminal device to affect expansion or contraction of a second region (110; para. [0044]) to control navigation and actuation of a retrieval device (pars. [0044]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified device with an elongated control member configured to apply force to the intraluminal device to affect expansion or contraction of the second region, in view of Sudin ‘825, in order to facilitate positioning and actuating the expandable body at a treatment site to retrieve an object.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Sudin ‘393 in view of Khachin, as applied to claim 61 above, and further in view of Klint (U.S. Patent Application Publication No. 20040082879).
Regarding claim 62, the modified device discloses the invention substantially as claimed, except for the number of the plurality of wires being selected to provide a desired coiling angle in the first region.
Klint, a reference in the coil vascular device field of endeavor, teaches selecting a number of wound wires to provide a desired coiling angle in a first region, the desired coiling angle providing a desired flexibility/rigidity to the first region (para. [0079]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the modified device such that the number of the plurality of wires is selected to provide a desired coiling angle in the first region, the desired coiling angle providing the desired rigidity of the first region, in view of Klint in order to provide the first region sufficient flexibility/rigidity to be delivered through the vasculature of a patient to treat the patient.
Allowable Subject Matter
Claim 68 is allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 68, the prior art does not disclose an intraluminal device “wherein wires of the first grouping of wires excluding the one or more extraneous wires are twisted together to provide at least one twist at least one location away from the crossing,” as recited with all the limitations of the claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed November 17, 2025 have been fully considered but they are not persuasive.
On page 9 of the Response, Applicant argues that a person having ordinary skill in the art “would not learn to incorporate embedding to improve rigidity” (Response pg. 9) alleging that Khachin teaches interlacing wires as being analogous weaving and alleging that Khachin teaches overlapping wires as being analogous to the claimed “embedding” of wires. (Response pg. 9). This argument is not persuasive.
To the extent that Applicant’s argues that a person having ordinary skill in the art would not incorporate embedding because embedding includes overlapping wires but not interlacing wires, such argument is inapposite because feature upon which Applicant relies (e.g., embedding involving overlapping but not interlacing) is not recited in the claim.
Claim 31 merely recites that embedding an extraneous wire be “by following a weave pattern of the different wire.” Thus, embedding, as claimed, does not require the presence or absence of a particular interlacing or overlapping of wires, but merely one wire following a different wire in the embedding.
In Khachin, both the interlacing and overlapping of wires is by a wire following a weave pattern of an adjacent/nearby different wire (annotated Figs. 12C-12F below); thus, meeting the limitation of being “embedded by following a weave pattern of the different wire,” as recited in claim 31.
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Furthermore, a person having ordinary sill in the art would fund sufficient teachings and reasoning in Khachin and Sudin ‘393 to find obvious the proposed combination. Khachin teaches that its weave patterns include overlapping and/or interlacing (para. [0114]) and that the patterns provide structural rigidity to facilitate entrapping an object (paras. [0034], [0096]).
Sudin ‘393 teaches its device being used to capture emboli or clot particles (para. [031]).
Therefore, a person having ordinary skill in the art would have found sufficient reason to combine the teachings of Sudin ‘393 and Khachin to facilitate entrapping emboli or clot particles within a patient.
Applicant’s description of claim 31 being amended to recite extraneous wire(s) being “adjacent to a different wire” (Response pg. 9) is acknowledged. Examiner notes that Khachin teaches configuring a wire crossing such that one or more extraneous wires of a plurality of wires, adjacent (i.e., nearby) a different wire of the plurality of wires (annotated Figs. 12C-12F above), is embedded by following a weave pattern of the different wire (annotated Figs. 12C-12F above).
Applicant’s description of claim 31 being amended to recite “minimizing friction between the wires when the one or more crossings function as hinges, pivoting during expansion of the second region” (Response pg. 9) is acknowledged. Examiner notes that Khachin teaches providing wires with an insulating layer having a low coefficient of mechanical friction to reduce trauma to a patient (para. [0124]).
On page 11 of the Response, Applicant argues that a person having ordinary skill in the art would not have been motivated to combine the teachings of Sudin ‘393 and Khachin because Khachin teaches self-opening devices suitable for use in biliary or urinary systems. This argument is not persuasive.
Khachin discloses that its retrieval device is suitable for treatments within a blood vessel (para. [0127]). Hence, a person having ordinary skill in the art would understand the weave patterns taught by Khachin to be suitable for retrieval devices used in delicate vascular tissue.
Further, Sudin ‘393 teaches its device being used to capture emboli or clot particles in a blood vessel (para. [031]). Thus, a person having ordinary skill in the art would have understood the weave patterns taught by Khachin to be applicable to the retrieval device of Sudin ‘393.
Therefore, a person having ordinary skill in the art would have found sufficient reason and/or motivation modify the wire crossings in the retrieval device of Sudin ‘393 such that one or more extraneous wires of the plurality of wires, adjacent to a different wire of the plurality of wires, is embedded by following a weave pattern of the different wire minimizing friction between the wires, in view of Khachin, in order to provide the elongated body with improved rigidity for entrapping an object for removal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771