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 .
Priority
The disclosure of the prior-filed applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitations of claims 1 is not adequately supported by the prior-filed applications. Therefore, they have a priority date of June 11, 2021.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 29, 2025 has been entered.
Response to Arguments
Applicant's arguments filed January 30, 2025 have been fully considered but they are not persuasive in view of the new grounds of rejection set forth below.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al (US 6517539) in view of Sharma (US 20170007279).
Regarding claim 1, Smith et al (hereafter Smith) teaches an endoscopic snare tool, comprising: a hollow outer sheath (12) with a proximal end and a distal end, wherein the distal end is configured to pass through a channel in an endoscope (C:5, L:10-11); an adjustable wire (18) substantially disposed within the hollow outer sheath, wherein the adjustable wire forms a loop portion (24) at the distal end of the hollow outer sheath. Sharma teaches a variable flexibility snare, wherein it was known in the art that circular, round, ovoid, and elliptical shapes were obvious variants at the time of the invention for adjustable snares (paragraph 0072) and that it was known in the art at the time of the invention to maintain the original shape of the snare loop when the size of the snare loop is adjusted (paragraph 0070). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the loop portion a circular loop portion, wherein the circular loop portion is maintained in a substantially circular shape as a diameter of the circular loop portion is expanded or reduced, as taught as known in the art by Sharma, in order to ensure that the shape of the snare loop is not distorted and retains its original shape to reliably and predictably open the device to the required shape.
Regarding claim 2, Smith in view of Sharma teaches all of the limitations set forth in claim 1, wherein an angle of rotation of the loop shape with respect to a lengthwise axis of the hollow outer sheath may be altered (C:2, L:20-25, rotating the snare).
Regarding claim 3, Smith in view of Sharma teaches all of the limitations set forth in claim 1, wherein an angle of the loop shape with respect to the hollow outer sheath is maintained as the diameter of the loop shape is expanded or reduced (C:2, L:38-50; angle of loop shape with respect to the sheath is independent of contraction of the snare).
Regarding claim 4, Smith in view of Sharma teaches all of the limitations set forth in claim 1, further comprising a coagulation marking device (see image below) disposed on a portion of the loop shape of the adjustable wire (C:5, L:23-25, cautery can be applied to snare, including to the tip, and thus the tip can function as a coagulation marking device).
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Regarding claim 8, Smith in view of Sharma teaches all of the limitations set forth in claim 1, further comprising a snare guide (298) positioned at a distal end of the hollow outer sheath (292), wherein the snare guide retains a distal end of the adjustable wire (294) with a freely rotating swivel ball (296) connected with the adjustable wire and retained within a housing (C:6, L:1-21).
Claims 1-4 and 9-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al (US 6517539) in view of Sharma (US 20170007279).
Regarding claim 1, Smith et al (US 20140276911, hereafter Smith ‘911) endoscopic snare tool, comprising: a hollow outer sheath (106 or 102) with a proximal end and a distal end, wherein the distal end is configured to pass through a channel in an endoscope (paragraph 0006); an adjustable wire (snare wires, 418, 706) substantially disposed within the hollow outer sheath (paragraph 0038), wherein the adjustable wire forms a loop portion at the distal end of the hollow outer sheath. Sharma teaches a variable flexibility snare, wherein it was known in the art that circular, round, ovoid, and elliptical shapes were obvious variants at the time of the invention for adjustable snares (paragraph 0072) and that it was known in the art at the time of the invention to maintain the original shape of the snare loop when the size of the snare loop is adjusted (paragraph 0070). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the loop portion a circular loop portion, wherein the circular loop portion is maintained in a substantially circular shape as a diameter of the circular loop portion is expanded or reduced, as taught as known in the art by Sharma, in order to ensure that the shape of the snare loop is not distorted and retains its original shape to reliably and predictably open the device to the required shape.
Regarding claim 2, Smith ‘911 in view of Sharma teaches discloses all of the limitations set forth in claim 1, wherein an angle of rotation of the loop shape with respect to a lengthwise axis of the hollow outer sheath may be altered (hollow outer sheath is interpreted as 102, and therefore snare and 106 can be rotated with respect to the hollow outer sheath) .
Regarding claim 3, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 1, wherein an angle of the loop shape with respect to the hollow outer sheath is maintained as the diameter of the loop shape is expanded or reduced (102 and 106 can be held still rotationally during expansion and retraction such that the angle of the loop shape remains the same).
Regarding claim 4, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 1, further comprising a coagulation marking device (422) disposed on a portion of the loop shape of the adjustable wire (paragraph 0050).
Regarding claim 9, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 1, further comprising a guide tip (figure 7) with bisecting bores (702, 704) positioned on a distal end of the hollow outer sheath for guiding the circular loop shape out of the distal end (figure 7).
Regarding claim 10, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 9, wherein the bisecting bores are disposed on opposing lateral sides of the hollow outer sheath (figure 7).
Regarding claim 11, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 9, wherein the guide tip further comprises a cutting edge adjacent to a section which guides the loop shape out of the distal end (paragraph 0039, guide tip 106 can allow passage of electric current through it adapting it to serve as an electrical path for cautery cutting of the resected tissue).
Regarding claim 12, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 1, wherein the adjustable wire is a monofilament formed of superelastic nitinol with a circular cross-section (paragraph 0054).
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al (US 6517539) in view of Sharma (US 20170007279), as applied to claim 1 above, and further in view of Uspenski et al (US 20180206878).
Regarding claim 5, Smith in view of Sharma teaches all of the limitations set forth in claim 1, wherein the adjustable wire further comprises a spring (40) at the circular loop portion, but does not specifically disclose a torsion spring at a distal tip of the circular loop portion. However, Uspenski et al (hereafter Uspenski) teaches it was known in the art at the time of the invention to include a torsion spring at a distal tip of a snare device, to allow for dissipation of stress through the snare and allow for stress to be distributed more evenly around the entire circumference upon closing, minimizing plastic deformation. Therefore, it would have been within the skill of one with ordinary skill in the art at the time of the invention to include a torsion spring at a distal tip of the snare device of Smith in view of Sharma, as taught as known in the art at the time of the invention by Uspenski, in order to allow for dissipation of stress through the snare and allow for stress to be distributed more evenly around the entire circumference upon closing, minimizing plastic deformation.
Regarding claims 6, Smith in view of Sharma in view of Uspenski teaches all of the limitations set forth in claim 5, wherein Uspenski teaches it was known in the art at the time of the invention to locate the torsion spring on an outer circumference of the circular loop shape (figure 7, paragraph 0042-0043).
Regarding claim 7 Smith in view of Sharma in view of Uspenski teaches all of the limitations set forth in claim 5, wherein Uspenski teaches it was known in the art at the time of the invention to locate the torsion spring on an inner circumference of the circular loop shape (paragraph 0043, US 20150066045, 20140052142, loops 40 and 64, respectively, located on inner circumference of the circular loop shape).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al (US 6517539) in view of Sharma (US 20170007279), as applied to claim 1 above, and further in view of Haack et al (US 20150157345).
Regarding claim 14, Smith in view of Sharma teaches all of the limitations set forth in claim 1, but does not disclose the adjustable wire is a square profile wire comprising a plurality of cutting edges along a diameter. However, Haack et al (hereafter Haack) teaches an endoscopic snare device, wherein it was known in the art at the time of the invention to make the wire to form the loop of snare devices at the time of the invention different cross-sectional shapes, such as a square-shaped cross section comprising a plurality of cutting edges along a diameter (figure 12a-12d, paragraph 0123). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the adjustable wire of Smith a square profile wire comprising a plurality of cutting edges along a diameter, as taught as a known art-recognized equivalent cross-sectional shape for snare wires in the art by Haack, and it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al (US 20140276911) in view of Sharma (US 20170007279), as applied to claim 1 above, and further in view of Haack et al (US 20150157345).
Regarding claim 14, Smith ‘911 in view of Sharma teaches all of the limitations set forth in claim 1, but does not disclose the adjustable wire is a square profile wire comprising a plurality of cutting edges along a diameter. However, Haack teaches an endoscopic snare device, wherein it was known in the art at the time of the invention to make the wire to form the loop of snare devices at the time of the invention different cross-sectional shapes, such as a square-shaped cross section comprising a plurality of cutting edges along a diameter (figure 12a-12d, paragraph 0123). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the adjustable wire of Smith ‘911 a square profile wire comprising a plurality of cutting edges along a diameter, as taught as a known art-recognized equivalent cross-sectional shape for snare wires in the art by Haack, and it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771