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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/2025 has been entered. Claims 1, 3-13 and 17-20 are currently pending and under examination.
Specification
In view of the response filed on 11/10/2025 amending paragraph [0056] to match the drawings the objections made against the claims in the office action of 9/8/2025 have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8, 17 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 6 recites the limitation " the threader" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 6 recites “wherein the radius of the distal extended portion faces the threader”, however a threader has not been previously recited so it is unclear what direction the radius of the distal extended portion faces, clarification is required. Claim 7 recites “wherein threader is substantially parallel to the longitudinal axis” it is unclear what “threader” applicant is referring to since a threader has not been previously recited, clarification is required. Claim 8 directly depends from claim 7 and is also rejected to for the reason stated above regarding claim 7. Claim 17 recites the limitation " inner sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 recites the limitation " inner sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim. As best understood for the purposes of examination, claims 7-8 have been interpreted to include a threader parallel to the longitudinal axis. As best understood for the purposes of examination, claims 17 and 20 have been interpreted to include an inner side of the sheath.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1,3-5, 10 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0264106 to Taube et al. (Taube).
In reference to at least claim 1
Taube discloses a snaring system (e.g. 10) comprising: a sheath (e.g. sheath 30) having a lumen (e.g. sheath 30 has a lumen, Figs. 7-9); a pusher disposed within the lumen of the sheath (e.g. core cable 17), wherein the pusher comprises a longitudinal axis (e.g. core cable 17 has a longitudinal axis, Figs. 7-9); a closed loop having an opening (e.g. loop 12 has an opening, Figs. 5,7-9), wherein the closed loop is shaped to have two sides (e.g. loop 12 has two sides, Figs. 5,7-9) wherein each of the two sides comprises a proximal extended portion (e.g. loop 12 has a proximal portion 12a, Figs. 5,7-9), an S-curve portion (see annotated figure below) and a distal extended portion (e.g. extended distal portion including 12b,12c and 12d, Figs. 5,7-9), wherein the distal extended portion of each of the two sides have a common distal end (e.g. common distal end 12b, Figs. 5,7-9),wherein the distal end points in a direction away from the proximal extended portion (e.g. distal end 12b points away form a proximal end, Figs. 5,7-9), wherein the proximal extended portion of the closed loop is coupled to the pusher (e.g. “The proximal end portions 12a, 14a, and 16a of the loops 12, 14, and 16 may be fixedly coupled to the distal end portion 19 of the core cable 17 by a soldering process.”, para. [0014]), wherein the proximal extended portion is substantially parallel to the longitudinal axis to the pusher (e.g. proximal end portion is substantially parallel to the longitudinal axis of the core cable, Figs. 1-2), wherein the S-curve portion comprises a proximal curve with a first radius and a distal curve with a second radius, wherein the first radius is configured to orient the proximal curve to face proximally (see annotated fig. below).
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In reference to at least claim 3
Taube discloses wherein the second radius is configured to orient the distal curve to face distally such that the distal curve faces the direction that the distal end points in (e.g. second radius faces distally, see annotated Fig. 5 above).
In reference to at least claim 4
Taube discloses wherein the distal extended portion is disposed substantially perpendicular to the S-curve portion (e.g. distal extended portion substantially perpendicular to S-curve portion of loop 12, see annotated Fig. 5 above).
In reference to at least claim 5
Taube discloses wherein the distal extended portion comprises a radius (e.g. extended distal portion including 12b has a radius, Figs. 5,7-9),
In reference to at least claim 10
Taube discloses wherein the closed loop is constructed of a shape- memory metal (e.g. “Each of the loops 12, 14, and 16 may be formed from a solid or multi-strand material. In some embodiments the loops 12, 14, and 16 are formed from a multi-strand composite of nitinol wire and platinum wire (e.g., five strands of nitinol wire and two strands of platinum wire) so that the platinum wire provides radiopacity while the nitinol wire provides shape memory and/or superelastic characteristics.”, para. [0013]).
In reference to at least claim 17
Taube discloses wherein the pusher and the closed loop are slidable relative to the inner sheath (e.g. core cable 17 and loop 12 slide relative to sheath 30, Figs. 7-9), whereupon being in a deployed configuration, the closed loop is disposed distally of the sheath (e.g. loop 12 is positioned distally of sheath 30 when deployed, Figs. 7-8) and the S-curve portion is disposed substantially perpendicular to the proximal extended portion (e.g. upon deployment the S-curve portion of loop 12 is disposed substantially perpendicular to the proximal extended portion, Figs. 7-8).
In reference to at least claim 18
Taube discloses wherein the proximal curve is relatively closer to the proximal extended portion relative to the distal extended portion (e.g. S-curve portion has a first radius closer to the proximal portion, Fig. 5 ), wherein the distal curve is relatively closer to the distal extended portion (e.g. S-curve portion has a second radius closer to the distal extended portion, see annotated Fig. 5 below).
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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.
Claim(s) 7-8, 11-13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0264106 to Taube et al. (Taube) in view of US 2005/0209609 to Wallace (Wallace).
In reference to at least claim 7
Taube discloses a device according to claim 1 but does not explicitly teach a threader that is substantially parallel to the longitudinal axis.
Wallace discloses a foreign body retrieval device which discloses a sheath (e.g. 70) and a closed loop (e.g. 55) that can be any shape (e.g. “The loop may have any suitable shape, including but not limited to an oval or a circle.”, para. [0037]) and includes a threader (e.g. 10) that is substantially parallel to a longitudinal axis (e.g. Figs. 1A, 2-3, 13-16) and includes a main hook portion (e.g. 17).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Taube to include a threader that is substantially parallel to the longitudinal axis, as taught by Wallace, in order to allow initial engagement of a foreign body at a point along the foreign body other than at its end(s) (e.g. ‘609, para. [0003], [0035]).
In reference to at least claim 8
Taube modified by Wallace renders obvious a snaring system according to claim 7. Wallace further discloses wherein the threader has a radius (e.g. both the main hook portion 17 and reverse hook tip portion 12 have a radius, Fig. 1A-3. 13-16), and wherein the radius of the threader faces the closed loop (e.g. the radius of the main hook portion 17 faces loop element 55, Fig. 1A-3. 13-16). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Taube to include the threader having a radius that faces the closed loop in order to allow initial engagement of a foreign body at a point along the foreign body other than at its end(s) (e.g. ‘609, para. [0003], [0035]).
In reference to at least claim 11
Taube discloses a device according to claim 1. Taube further discloses a second closed loop comprising a second opening and a second S-curve portion (e.g. multiple loops 12, 14 and 16 that have substantially identical size and shape, therefore the other loops also include an S-curve portion, Figs. 1-3, 7-8, “In this example, the loops 12, 14, and 16 are substantially identical in size and shape, however, it will be appreciated that different numbers, sizes, and shapes may be used for the loops of a snare.”, para. [0015]), wherein the S-curve portion of the closed loop and the second S-curve portion of the second closed loop extend in radially opposite directions (e.g. multiple loops 12, 14 and 16 that have substantially identical size and shape in which the loops can extend in radially opposite directions , Figs. 1-3, 7). Taube does not explicitly disclose a threader coupled to the sheath, wherein, when the closed loop and the second closed loop are pulled proximally; the second closed loop is configured to collapse over the closed loop and the threader, the closed loop is configured to collapse over the threader; and the threader is configured to be disposed within the opening of the closed loop and the second opening of the second closed loop.
Wallace discloses a foreign body retrieval device which discloses a sheath (e.g. 70) and a closed loop (e.g. 55) that can be any shape (e.g. “The loop may have any suitable shape, including but not limited to an oval or a circle.”, para. [0037]) and includes a threader (e.g. 10) that is substantially parallel to a longitudinal axis (e.g. Figs. 1A, 2-3, 13-16) and includes a main hook portion (e.g. 17). Wallace further discloses wherein, when the closed loop is pulled proximally; the closed loop is configured to collapse over the threader; and the threader is configured to be disposed within the opening of the closed loop (e.g. loop element 55 collapses over the retriever 10 Figs. 1A, 2-3, 13-16).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Taube to include a threader coupled to the sheath that is configured to engage the multiple loops, wherein, when the loops are pulled proximally, the closed loop is configured to collapse over the threader and the threader is disposed within an opening of the multiple loops, as taught by Wallace, in order to allow initial engagement of a foreign body at a point along the foreign body other than at its end(s) (e.g. ‘609, para. [0003], [0035]).
In reference to at least claim 12
Taube discloses a device according to claim 11. Taube further discloses wherein the second S-curve portion of the second closed loop is axially offset from the S-curve portion of the closed loop (e.g. multiple loops 12, 14 and 16 that have substantially identical size and shape, therefore the other loops also include an S-curve portion that includes the S-curve portions being axially offset, Figs. 1-2, 7-8, “In this example, the loops 12, 14, and 16 are substantially identical in size and shape, however, it will be appreciated that different numbers, sizes, and shapes may be used for the loops of a snare.”, para. [0015]).
In reference to at least claim 13
Taube discloses a device according to claim 11. Taube further discloses wherein the second closed loop comprises a second proximal extended portion that is longer than the proximal extended portion of the closed loop (e.g. multiple loops 12, 14 and 16 that have substantially identical size and shape, therefore the other loops also include a n S-curve portion that includes the S-curve portions being axially offset, Figs. 1-3, 7-8, “In this example, the loops 12, 14, and 16 are substantially identical in size and shape, however, it will be appreciated that different numbers, sizes, and shapes may be used for the loops of a snare.”, para. [0015], therefore the loops can have different sizes and shapes including one loop having a proximal extended portion that is longer than the proximal extended portion of another loop).
In reference to at least claim 20
Taube discloses a device according to claim 1. Taube does not explicitly disclose a threader fixedly coupled to the inner sheath, wherein, when the closed loop is pulled proximally:, the closed loop is configured to collapse over the threader; and the threader is configured to be disposed within the opening of the closed loop.
Wallace discloses a foreign body retrieval device which discloses a sheath (e.g. 70) and a closed loop (e.g. 55) that can be any shape (e.g. “The loop may have any suitable shape, including but not limited to an oval or a circle.”, para. [0037]) and includes a threader (e.g. 10) that is substantially parallel to a longitudinal axis (e.g. Figs. 1A, 2-3, 13-16) and includes a main hook portion (e.g. 17). Wallace further discloses wherein, when the closed loop is pulled proximally; the closed loop is configured to collapse over the threader; and the threader is configured to be disposed within the opening of the closed loop (e.g. loop element 55 collapses over the retriever 10 Figs. 1A, 2-3, 13-16).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Taube to include a threader coupled to the inner sheath and disposed within an opening of the closed loop, wherein, when the closed loop is pulled proximally, the closed loop is configured to collapse over the threader and the threader is configured to be disposed within the opening of the closed loop, as taught by Wallace, in order to allow initial engagement of a foreign body at a point along the foreign body other than at its end(s) (e.g. ‘609, para. [0003], [0035]).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0264106 to Taube et al. (Taube).
In reference to at least claim 9
Taube teaches a device according to claim 1. It would have been an obvious matter of design choice to modify the Taube reference, to have a height from a beginning of the first radius to a distal end of the closed loop is about 0.80 inches and wherein a width from the beginning of the first radius to the distal end of the closed loop is about 0.60 inches, since applicant has not disclosed that having a height from a beginning of the first radius to a distal end of the closed loop is about 0.80 inches and wherein a width from the beginning of the first radius to the distal end of the closed loop is about 0.60 inches solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that a height from a beginning of the first radius to a distal end of the closed loop is about 0.80 inches and wherein a width from the beginning of the first radius to the distal end of the closed loop is about 0.60 inches, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 19
Taube discloses a device according to claim 1 and further discloses that the multiple loops 12, 14 and 16 can be substantially identical size and shape or that different numbers, sizes, and shapes may be used for the loops of a snare (e.g. para. [0015]). It would have been an obvious matter of design choice to modify the Taube reference, to shape the closed loop such that the first radius is greater than the second radius, since applicant has not disclosed that having the first radius is greater than the second radius solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that the first radius is greater than the second radius, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796