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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/18/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 9-11 is/are amended and claim(s) 7-8 and 18 is/are canceled. Claims 2-5 were previously canceled. Claims 1, 6, and 9-17 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 18 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 7/2/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues the rejection fails to teach “wherein a distance between the merger point and the opening is 5-15 mm”. Examiner respectfully disagrees. Based on the claim language, there is no definition of the term “merger point”, or definition of the area between the merger point and the opening of the loop, thus it is not required to solely be a section of wires straightly attached together as described by Applicant (Remarks Page 4). In Shiro, the merger point refers to the area depicted as loop 9, thus the resulting distance, formed by wires, as in Applicant’s disclosure, and would comprise of the distance between the loop 9 and the opening of loop 8, defines as distance 13 minus distance 12 (Shiro Figure 2A; Paragraph 0031). Therefore, Shiro teaches “wherein a distance between the merger point and the opening is 5-15 mm”.
Further, Applicant argues the rejection fails to disclose “a diameter of the nickel-titanium monofilament is .018 mm, which enables the loop to perform a cold cutting on polyps having a maximum external diameter of 25 mm or less.
In response to applicant's argument that Smith is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicant argues the invention is directed to a cold snare while Smith is directed to a hot snare. The technical fields of the inventions are indeed the same, as both the present invention and Smith are directed to capturing polyps with loop snares. Thus, the reference is fully considered to be applicable prior art.
In response to applicant's argument that Smith cannot be used as a cold snare, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Further, there is no structure or indication in Smith that would prevent the device from being operated without applying electricity nor is there any part the claimed language preventing using a device that allows heat.
Lastly, Applicant argues the diameter range disclosed in Smith is large and would not be obvious to one of ordinary skill in the art to use a diameter of 0.18 mm. However, Smith discloses a range (0.127 mm to 1.27 mm) that encompasses the claimed 0.18 mm, thus the value is not novel. Further, it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144, thus it would be obvious to one of ordinary skill in the art to use any of the values in the claimed range of Smith, as they are known in the art. Further, Smith states “the diameter of wire 20 may be chosen based on the length of snare”, thus Smith is directing one of ordinary skill in the art to choose a diameter from the disclosed range to best suit their desired function. Furthermore, the present disclosure does not disclose any criticality to the dimension or any undue experimentation required to obtain the value of 0.18 mm. Thus, one of ordinary skill in the art could choose any value from amongst the range taught by Smith, including 0.18 mm, and arrive at the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6, and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saunders et al. (US 20170231647 A1) (previously of record) in view of Nomura et al (US 20090247820 A1) (previously of record) in view of Shiro et al. (US 20040039249 A1) (previously of record) in view of Smith (US 20180028220 A1) (previously of record).
Regarding claim 1 and 12, Saunders discloses a cold snare (100), ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Although Saunders discloses a snare with electromagnetic energy (Paragraph 0012), the present claims do not exclude such a structure, thus the disclosed invention is fully capable of being a cold snare.) comprising:
a tube (124) (Figure 2; Paragraph 0043);
a drive wire (128) (Figure 2; Paragraph 0045), passing through the tube (Figure 2; Paragraph 0045), and performing a reciprocating motion in a direction of a longitudinal axis of the spring tube (Paragraph 0042); and
a loop (112), fixedly connected to a distal end of the drive wire (Figure 1; Paragraph 0043; 0048), and the reciprocating motion (sliding) of the drive wire being used to manipulate the loop to enter and exit the tube (Paragraph 0042);
an end member (130) fixedly connected to a distal end of the spring tube (Figure 3; Paragraph 0043);
wherein the end member has an inner hole (134) in communication with the spring tube (Figure 3; Paragraph 0045); the loop enters and exits the spring tube through the inner hole (Paragraph 0048)
wherein a proximal end of the end member (132) is a spring tube accommodating cavity (proximal opening of 130) for accommodating the distal end of the spring tube (Figure 2; Paragraph 0043; 0045) and a distal end (140) of the end member is a contraction port (Figure 3; Paragraph 0045) (The present disclosure does not define a contraction port, nor is it a term known in the art. Cased on broadest reasonable interpretation, a “contraction port” is seen as an opening at the end of a taper.);
a radial dimension (radius of distal end of 130) of the inner hole is less than a radial dimension (radius of proximal end of 130) of the spring tube accommodating cavity (endcap 130 is tapered such that the distal end of the end cap has a smaller radius than the proximal end of the end cap, as shown in Figure 2.)( (Figure 2, 5; Paragraph 0045), wherein the radial dimension of the inner hole is a distance between an edge of the inner hole and the longitudinal axis, and the radial dimension of the spring tube accommodating cavity is a distance between an edge of the spring tube accommodating cavity and the longitudinal axis (Figure 2, 5);
wherein the end member has a distal end face (136) and an inner circumferential surface corresponding to the inner hole (inner surface of 132 surrounding 134), and a round corner (labeled in Annotated Figure 3) is arranged between the distal end face and the inner circumferential surface (Figure 3; Paragraph 0045);
wherein the loop comprises a first ring segment (labeled in Annotated Figure 2), a necking segment (labeled in Annotated Figure 2) and a second ring segment (labeled in Annotated Figure 2) connected sequentially (Figure 2, 5; Paragraph 0047); the loop has an opening (labeled in Annotated Figure 2), the opening is located at a place where the first ring segment and the second ring segment begin to enter the end member and the opening is a point from which the loop begins to gradually open up to enclose the polyp to be cut (Figure 2; Paragraph 0047); and
wherein the loop is made of a nickel-titanium monofilament (Paragraph 0046-47).
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Saunders fails to explicitly disclose wherein the tube is a spring tube and a riveted tube; the first ring segment and the second ring segment are merged at the distal end of the riveted tube and are fixed by the riveted tube, to form a merger point; wherein a distance between the merger point and the opening is 5-15 mm; and a diameter of the nickel- titanium monofilament is 0.18 mm, which enables the loop to perform a cold cutting on polyps having a maximum external diameter of 25 mm or less.
However, Nomura is directed to a snare device and teaches a spring tube (4) (sheath 4 is a multi-threaded coiled tube, thus is seen as a “spring tube”) (Figure 1; Paragraph 0054); a drive wire (5), passing through the spring tube, and performing a reciprocating motion in a direction of a longitudinal axis of the spring tube (Figure 24; Paragraph 0098); a loop (91), fixedly connected to a distal end of the drive wire (distal end of 5) (Figure 24; Paragraph 0098), and the reciprocating motion of the drive wire being used to manipulate the loop to enter and exit the spring tube (Paragraph 0096; 0098); and a riveted tube (93) (Figure 24; Paragraph 0098), an outer circumferential surface of the riveted tube (outer circumference of 93) is a cylindrical surface, the distal end of the drive wire is fixedly connected into the riveted tube, and a proximal end of the loop (proximal end of 108) is fixedly connected into the riveted tube (Figure 24; Paragraph 0098); wherein the loop comprises a first ring segment, a necking segment and a second ring segment connected sequentially; the first ring segment and the second ring segment are merged at the distal end of the riveted tube and are fixed by the riveted tube, to form a merger point (Figure 24; Paragraph 0098).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Saunders with the teachings of Nomura by incorporating a spring tube in order to increase rotational torque and improving rotational trackability (Nomura Paragraph 0065-66). A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Saunders such that the tube is a spring tube, as taught by Nomura , as both references and the claimed invention are directed to snares. Further, the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Further, It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Saunders with the teachings of Nomura by incorporating a riveted tube; the first ring segment and the second ring segment are merged at the distal end of the riveted tube and are fixed by the riveted tube, to form a merger point in order to secure the shape of the loop to prevent deformation and ensure stability.
The combination of Saunders and Nomura fails to disclose wherein a distance between the merger point and the opening is 5-15 mm.
However, Shiro is directed to a snare device and teaches wherein a distance (13 minus 12) between the merger point (9) and the opening (opening into 8) is 5-15 mm (Figure 2A; Paragraph 0031).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a distance between the merger point and the opening is 5-15 mm as taught by Shiro, since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Further, Smith is directed to a snare device and teaches a loop (18) made of a nickel-titanium monofilament (20) (Paragraph 0050), and a diameter of the nickel- titanium monofilament is 0.005-0.050 inches, which encompasses the claimed range of 0.18 mm (Paragraph 0050), which enables the loop to perform a cold cutting on polyps with a maximum external diameter of 25 mm or less (Paragraph 0050) ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a diameter of the nickel- titanium monofilament is 0.18 mm as taught by Smith, since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Regarding claim 6, Saunders further discloses wherein the end member is made of a metal (Paragraph 0043).
Regarding claim 9, Saunders further discloses wherein the nickel-titanium monofilament has a flat cross section (a cross section is flat, thus the cross section of the drive wire would be flat) (Figure 2).
Regarding claim 10, the combination further teaches wherein the first ring segment has a first intersection point (labeled in Annotated Figure 2) connected with the necking segment, and the first ring segment is in a streamlined shape with smooth transition from a proximal end of the first ring segment to the first intersection point (Annotated Figure 2); the second ring segment has a second intersection point (labeled in Annotated Figure 2) connected with the necking segment, and the second ring segment is in a streamlined shape with smooth transition from a proximal end of the second ring segment to the second intersection point (Annotated Figure 2).
Regarding claim 11, Smith further discloses wherein the loop is in a water drop or an oval shape (Figure 1-2).
Regarding claim 13, Saunders further discloses an outer skin (110) cladding on outside of the spring tube (Figure 2; Paragraph 0040).
Regarding claim 14, Saunders further discloses wherein the outer skin (92) comprises a polymer tube (Paragraph 0041).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saunders in view of Nomura and Shiro as applied to claim 1 above, and further in view of Csiky et al. (WO 2010063313 A1) (previously of record).
Regarding claim 15, Saunders as modified by Nomura and Shiro discloses the cold snare according to claim 1, but fails to explicitly disclose wherein a distal end of the spring tube is further provided with a scale for measuring a size of a polyp to be cut.
However, Csiky is directed to a resection device and teaches a distal end of the tube (3) is provided with a scale (17) (Figure 17; Page 11, lines 4-11).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Saunders as modified by Nomura and Shiro with the teachings of Csiky by incorporating wherein a distal end of the tube is further provided with a scale in order to visualize insertion depth of the device (Csiky Page 11, line 7-9). As a result of the modification, the distal end of the spring tube would also be provided with a scale for measuring a size of a polyp to be cut. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Saunders as modified by Nomura and Shiro such that wherein a distal end of the spring tube is further provided with a scale, as taught by Csiky, as both references and the claimed invention are directed to resection devices.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saunders in view of Nomura and Shiro as applied to claim 1 above and further in view of Reiley et al. (US 20020188299 A1) (Previously of record).
Regarding claims 16-17, Saunders as modified by Nomura and Shiro discloses the cold snare according to claim 1, and Nomura further discloses wherein the spring tube comprises a flexible tube (Paragraph 0039); wherein the tube comprises a metal wire wound spring tube (multithread coil sheath) (Paragraph 0038; 0081), but fails to explicitly disclose wherein the spring tube comprises a flexible metal tube.
However, Reiley is directed to an endoscopic device and teaches a spring tube (142) comprises a flexible metal tube, wherein the flexible metal tube comprises a metal wire wound spring tube (twisted wire filaments) (Figure 9; Paragraph 0068).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Saunders as modified by Nomura and Shiro with the teachings of Reiley by incorporating a spring tube comprising metal in order to improve resilience and rigidity. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the spring tube to comprise metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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