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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 21st, 2025, has been entered.
Response to Amendment
The claims filed on October 21st, 2025, have been entered. Claims 1-5, 7-15, and 18-23 remain pending in the Application.
Response to Arguments
Applicant's arguments filed October 21st, 2025, have been fully considered but they are not persuasive.
First, Applicant argues that Okada (Pub. No. 2017/0252052) does not disclose the newly added claim limitation to independent claim 1 that “the holding member is spaced apart from the distal end such that the holding member may be engaged by a user when the distal end is disposed at a surgical site” because unit main body 4 is not engaged by a user during use of a tissue removal tool or spaced apart from a distal end to be engaged by a user when the distal end is disposed at a surgical site, as manipulation section 2 is how a user engages with the device of Okada. Examiner respectfully disagrees. The claim language is functional language that the holding member only needs to be capable of being engaged by a user when the distal end of the device is at the surgical site, and while unit main body 4 is not depicted as being engaged by a user like manipulation section 2, the unit main body is a grippable structure that could be grabbed by a user during the operation. Since the proximal end of 4 could be gripped at the proximal end around 40, which is connected to the distal opening at the connection to 5 by the cylindrical 30, the “holding member” comprising the proximal end of 4 is spaced apart from the distal end.
Second, Applicant argues that Okada does not disclose the transmitting assembly has a handle connected to the elongated section of the body and is movable relative to the elongated section, wherein movement of the handle causes the link to move relative to the body and the conduit and the loop to move between the open and closed positions because the substantially cylindrical main body 30 cannot be reasonably construed as an elongated section. Examiner respectfully disagrees. The length of 30 is greater than the width of 30, and elongated is a relative term that only means that one dimension is greater than a second dimension, so 30 satisfies the claim limitation. Applicant also points out that the previous Final Rejection dated July 29th, 2025, mistakenly stated that “51 can be attached or detached to 2” when the correct citation was “51 can be attached or detached to 4” because the handle 51 of Okada is movable to the elongated section of the body, which in the rejection is cylindrical main body 30. This has been updated in the rejection below. Finally, Applicant asserts that the connection of manipulation section 2 to main unit body 4 is only part of the assembly of the device, and does not cause the advancement or retraction of basket section 6. Examiner recognizes the point being made by the Applicant; however, Okada still discloses a handle in 75 ([0084] and FIG. 9) which is connected to the elongated section of the body 30 (FIGs. 1 and 9: 75 connects to 30 through the rest of the body of 2) and is movable relative to the elongated section ([0085] 75 is rotated, which changes its orientation relative to 30), wherein the movement of the handle causes the link (17) to move relative to the body and the conduit ([0085] 75 advances or retracts 17, which in [0052] is relative to 4 and 5) and the loop to move between the open and closed positions ([0052] 6 is deployed by advancement or retracted by retraction of 17), and Okada satisfies the limitation.
Third, Applicant argues that Okada does not disclose a loop because the plurality of elastic wires 7 are a basket shape. Examiner respectfully disagrees. In FIGs. 2 and 6 and in [0047], the elastic wires 7 are combined to form the basket section 6, where the plurality of elastic wires are all connected together at the proximal end 13 to the distal end of 17 and also gathered together at the distal end 14 ([0044]). Therefore, if a path were started at 17 and followed one of the elastic wires to 14, then back along a second elastic wire to 13, then a loop would be created. The presence of additional loops and wires does not prevent the presence of a loop which satisfies the claim limitation.
Fourth, Applicant argues that Okada does not disclose the inner lumen of the conduit being continuous because the insertion section 5 consists of multiple components which are attached together, and the relevant lumen must be defined by a single conduit. Applicant makes a similar argument regarding independent claim 12, stating that 5 cannot be a single member because 5 consists of multiple subcomponents. Applicant also asserts that even if the lumen does not have to be defined by a single conduit, that the lumen is interrupted by the insertion of distal end cover 23 into the distal end of tube 20 and therefore not continuous. Examiner respectfully disagrees. The claim language “a single member” does not require that a monolithic component with no subdivisions be presented, and a single member can consist of multiple different subcomponents while still satisfying the claim language. Furthermore, a lumen is an open space or channel within a structure, and a lumen is only not continuous if there is a structure which blocks the lumen from continuing. While the diameter of the lumen is not continuous in Okada, the lumen is not interrupted by the distal end cover 23, and therefore satisfies the claim limitation.
Fifth, Applicant argues that Okada does not disclose a chamfered distal end because the Specification states in [0099] that the conduit is chamfered such that the width of the distal portion gradually increases from a first width to a second width and in [0100] that in certain embodiments, the width of the distal portion gradually increases by an angle that is between 10 degrees and about 20 degrees. However, neither of these quotations requires that the change in width be a straight line, and a gradual increase can also occur with a rounded edge, just as a rapid increase can occur with a straight edge. A change by an angle also does not require a straight edge, as the rounded edge also changes the angle of the inner surface. Applicant also asserts that cutting or shaping an edge at an angle means that it is flat, sloped, or inclined. However, slopes and inclines do not have to be straight lines, and as discussed above, at an angle does not require a straight line either. None of the definitions cited by Applicant actually state that a chamfered end must have a straight line, or a consistent change in diameter.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okada (Pub. No. 2017/0252052).
Regarding claim 1, Okada discloses a tissue removal tool for use with an endoscope (1; [0042]; FIGs. 1-15), the tissue removal tool comprising:
a body (4; [0043]) comprising a holding member (40) disposed at a proximal end (FIG. 1: 40 is at the proximal end of 4), a distal opening ([0074] 17 is inserted through 35 at the proximal end of 4 and comes out after passing through 5, which means there must be a distal opening in 4 which connects to 5) disposed at a distal end (FIG. 1: the distal end of 4 is at the connection with 5), and an elongated section (30) disposed between the holding member and the distal opening, wherein the holding member spaced apart from the distal end such that the holding member may be engaged by a user when the distal end is disposed at a surgical site ([0075] 40 is separated from the distal opening in FIG. 1, and, as discussed above in the Response to Arguments, is capable of being engaged by a user while the distal end is at a surgical site);
a conduit (5; [0066]; FIGs. 2 and 6) attached to the body ([0043] and FIG. 1: 5 is attached to the distal end of 4), the conduit defining an inner lumen (24), the inner lumen being continuous (FIG. 6: 5 24 has an uninterrupted space) and having a proximal portion (25) extending from the distal opening of the body to a chamfered distal end (26), wherein the proximal portion has a proximal width that is continuous (FIG. 6: 25 has a continuous width going back through 20), wherein a width of the chamfered distal end gradually increases along a length of the chamfered distal end (FIG. 6: the width of 26 gradually increases) from a first width (FIG. 6: the width where 26 meets 25) to a second width (FIG. 6: the width where 26 ends), and wherein the second width is greater than the proximal width (FIG. 6: the width at the distal end of 26 is greater than the width of 25);
a loop (6; [0044]) that is movable between an open position ([0053] when 6 projects from 5, 6 has a deployed position outside of 5; FIG. 1) in which the loop is at least partially disposed outside of the conduit and a closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5) in which the loop is disposed within the conduit; and
a transmitting assembly (2; FIG. 9) comprising a handle (75) and a link (17; [0077]), wherein the handle is connected to the elongated section of the body ([0043] 2 is attached to 4) and movable relative to the elongated section ([0080] 75 can be attached or detached to 4), wherein the link has a first end attached to the handle ([0077] the proximal end of 17 is attached to 2) and a second end attached to the loop ([0044] the distal end of 17 is attached to 6) such that movement of the handle causes the link to move relative to the body and the conduit ([0052] 17 is advanced and retracted relative to 4 and 5 by the movement of 75 disclosed in [0085]) and the loop to move between the open and closed positions ([0052] 6 is deployed by advancement or retracted by retraction of 17);
wherein the chamfered distal end is sized to house at least a portion of the loop when the loop is in the closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5).
Regarding claim 7, Okada further discloses the proximal width is equal to the first width of the chamfered distal end (FIG. 6: the proximal width of the chamfered distal end 26 is equal to the width of 25, which is continuous going back to the proximal end of 20).
Regarding claim 12, Okada discloses a tissue removal tool for use with an endoscope (1; [0042]; FIGs. 1-15), the tissue removal tool comprising:
a body (4; [0043]) comprising a holding member (40) disposed at a proximal end (FIG. 1: 40 is at the proximal end of 4), a distal opening ([0074] 17 is inserted through 35 at the proximal end of 4 and comes out after passing through 5, which means there must be a distal opening in 4 which connects to 5) disposed at a distal end (FIG. 1: the distal end of 4 is at the connection with 5), and an elongated section (30) disposed between the holding member and the distal opening, wherein the holding member is spaced apart from the distal end such that the holding member may be engaged by a user when the distal end is positioned at a surgical site ([0075] 40 is separated from the distal opening in FIG. 1, and, as discussed above in the Response to Arguments, is capable of being engaged by a user while the distal end is at a surgical site);
a conduit (5; [0066]; FIGs. 2 and 6) comprising a single member (FIG. 1: 5 is a single member) that is attached to and extending from the body ([0043] and FIG. 1: 5 is attached to the distal end of 4), the single member defining an inner lumen (24), wherein the inner lumen has a proximal portion (25) having a first width (FIG. 6: 25 has a continuous width going back through 20) and a distal portion having a second width (FIG. 6: the width where 26 ends), wherein the second width of the distal portion is greater than the first width of the proximal width (FIG. 6: the width at the distal end of 26 is greater than the width of 25), wherein the proximal portion of the inner lumen extends from the distal opening of the body (FIG. 1: the proximal portion of 24 extends from the distal portion of 4);
a loop (6; [0044]) that is movable between an open position ([0053] when 6 projects from 5, 6 has a deployed position outside of 5; FIG. 1) in which the loop is at least partially disposed outside of the conduit and a closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5) in which the loop is disposed within the conduit; and
a transmitting assembly (2; FIG. 9) comprising a handle (75) and a link (17; [0077]), wherein the handle is connected to the elongated section of the body ([0043] 2 is attached to 4) and movable relative to the elongated section ([0080] 75 can be attached or detached to 4), wherein the link has a first end attached to the handle ([0077] the proximal end of 17 is attached to 2) and a second end attached to the loop ([0044] the distal end of 17 is attached to 6) such that movement of the handle causes the link to move relative to the body and the conduit ([0052] 17 is advanced and retracted relative to 4 and 5 by the movement of 75 disclosed in [0085]) and the loop to move between the open and closed positions ([0052] 6 is deployed by advancement or retracted by retraction of 17);
wherein the distal portion is sized to house at least a portion of the loop when the loop is in the closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5).
Regarding claim 13, Okada further discloses the width of the distal portion gradually increases from an initial width (FIG. 6: the width where 26 meets 25) to the second width (FIG. 6: the width where 26 ends).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada.
Regarding claim 5, Okada discloses the invention as claimed in claim 1, as discussed above. Okada is silent regarding the width of the chamfered distal end gradually increasing by an angle of between about 10 degrees and about 20 degrees. However, Okada discloses a chamfered distal end with a width that increases gradually from the first width to the second width by an angle. It would have been obvious to one of ordinary skill in the art at the time of filing to modify the chamfered distal end of Okada such that the width gradually increases by an angle of between about 10 degrees and about 20 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, Okada would not operate differently with the claimed gradual change in width and since both the prior art and the present invention are directed towards removing tissue from the intestinal track using a loop-snare device, Okada would function appropriately with the claimed gradual change in width. Further, applicant places no criticality on the dimensions claimed, indicating that “in certain embodiments” the angle is between about 10 degrees and about 20 degrees (specification [0100]).
Claim(s) 2-4, 8-11, 14-15, and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Roue et al. (Pub. No. 2021/0093336).
Regarding claims 2-4 and 8-11, Okada discloses the invention as claimed in claim 1, as discussed above. Okada is silent regarding the dimensions of the various claimed elements.
Roue et al. teaches in the same field of endeavor of tissue removal tools (Abstract), and discloses: the length of the chamfered distal end is between 0.015 inches and 0.0185 inches ([0146] the length of the taper of the distal most portion can be less than 5 cm); the first width is between 0.05 inches and 0.06 inches ([0146] the inner diameter that the taper decreases to is between 0.03 inches and 0.06 inches); the second width is between 0.06 inches and 0.075 inches ([0145-146] the inner diameter of the catheter is initially between 0.06 inches and 0.08 inches, where the addition of the taper makes the inner diameter in the proximal portion before the taper at a decreased inner diameter; therefore, the diameter at the distal most portion would correspond to the previous inner diameter of the catheter between 0.06 inches and 0.08 inches); the proximal width is between 0.05 inches and 0.06 inches ([0146] the inner diameter that the taper decreases to is between 0.03 inches and 0.06 inches); a wall of the conduit defining the proximal portion of the inner lumen has a thickness between 0.0175 inches and 0.02 inches ([0128] the outer diameter of 3000 can be 0.07 inches, and the inner diameter can be 0.05 inches, which would yield a thickness of the wall defining the inner lumen of 0.02 inches); a difference between the proximal width of the proximal portion of the inner lumen and an outer diameter of the link of the transmitting assembly is less than or equal to 0.035 inches ([0146] the proximal width is 0.03-0.06 inches; [0146] the outer diameter of the transmitting assembly is 0.65 mm, or 0.026 inches, for a difference of less than 0.035 inches); and a ratio of the second width to the first width of the chamfered distal end is between 1.1:1 and 2:1 ([0145-146] the second width can be 0.06 inches to the first width being 0.03 inches, which would be 2:1), all for the purpose of being the proper size to operate in the intestinal track ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have adapted the claimed dimensions to Okada as taught by Roue et al., as Applicant has placed no criticality on the claimed range (see present Spec [0068-69], [0082], and [0099-100] for descriptions of the claimed ranges which include numerous alternatives) and since it has been held that "in the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 14-15 and 18-19, Okada discloses the invention as claimed in claim 12, as discussed above. Okada is silent regarding the dimensions of the various claimed elements.
Roue et al. teaches in the same field of endeavor of tissue removal tools (Abstract), and discloses: a ratio of the second width to the initial width is between 1.1:1 and 2:1 ([0145-146] the second width can be 0.06 inches to the initial width being 0.03 inches, which would be 2:1); the second width is between 0.06 inches and 0.075 inches ([0145-146] the inner diameter of the catheter is initially between 0.06 inches and 0.08 inches, where the addition of the taper makes the inner diameter in the proximal portion before the taper at a decreased inner diameter; therefore, the diameter at the distal most portion would correspond to the previous inner diameter of the catheter between 0.06 inches and 0.08 inches) and the first width is between 0.05 inches and 0.06 inches ([0146] the inner diameter that the taper decreases to is between 0.03 inches and 0.06 inches); a wall of the conduit defining the proximal portion of the inner lumen has a thickness between 0.0175 inches and 0.02 inches ([0128] the outer diameter of 3000 can be 0.07 inches, and the inner diameter can be 0.05 inches, which would yield a thickness of the wall defining the inner lumen of 0.02 inches); and a difference between the proximal width of the proximal portion of the inner lumen and an outer diameter of the link of the transmitting assembly is less than or equal to 0.035 inches ([0146] the proximal width is 0.03-0.06 inches; [0146] the outer diameter of the transmitting assembly is 0.65 mm, or 0.026 inches, for a difference of less than 0.035 inches), all for the purpose of being the proper size to operate in the intestinal track ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have adapted the claimed dimensions to Okada as taught by Roue et al., as Applicant has placed no criticality on the claimed range (see present Spec [0068-69], [0082], and [0099-100] for descriptions of the claimed ranges which include numerous alternatives) and since it has been held that "in the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 20, Okada discloses a tissue removal tool for use with an endoscope (1; [0042]; FIGs. 1-15), the tissue removal tool comprising:
a body (4; [0043]) comprising a holding member (40) disposed at a proximal end (FIG. 1: 40 is at the proximal end of 4), a distal opening ([0074] 17 is inserted through 35 at the proximal end of 4 and comes out after passing through 5, which means there must be a distal opening in 4 which connects to 5) disposed at a distal end (FIG. 1: the distal end of 4 is at the connection with 5), and an elongated section (30) disposed between the holding member and the distal opening, wherein the holding member is spaced apart from the distal end such that the holding member may be engaged by a user when the distal end is positioned at a surgical site ([0075] 40 is separated from the distal opening in FIG. 1, and, as discussed above in the Response to Arguments, is capable of being engaged by a user while the distal end is at a surgical site);
a conduit (5; [0066]; FIGs. 2 and 6) attached to the body ([0043] and FIG. 1: 5 is attached to the distal end of 4), the conduit defining an inner lumen (24), the inner lumen being continuous (FIG. 6: 5 24 has an uninterrupted space) and having a proximal portion (25) extending from the distal opening of the body to a chamfered distal end (26), wherein the proximal portion has a proximal width that is continuous (FIG. 6: 25 has a continuous width going back through 20), wherein a width of the chamfered distal end gradually increases along a length of the chamfered distal end (FIG. 6: the width of 26 gradually increases) from a first width (FIG. 6: the width where 26 meets 25) to a second width (FIG. 6: the width where 26 ends), and wherein the second width is greater than the proximal width (FIG. 6: the width at the distal end of 26 is greater than the width of 25);
a loop (6; [0044]) that is movable between an open position ([0053] when 6 projects from 5, 6 has a deployed position outside of 5; FIG. 1) in which the loop is at least partially disposed outside of the conduit and a closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5) in which the loop is disposed within the conduit; and
a transmitting assembly (2; FIG. 9) comprising a handle (75) and a link (17; [0077]), wherein the handle is connected to the elongated section of the body ([0043] 2 is attached to 4) and movable relative to the elongated section ([0080] 75 can be attached or detached to 4), wherein the link has a first end attached to the handle ([0077] the proximal end of 17 is attached to 2) and a second end attached to the loop ([0044] the distal end of 17 is attached to 6) such that movement of the handle causes the link to move relative to the body and the conduit ([0052] 17 is advanced and retracted relative to 4 and 5 by the movement of 75 disclosed in [0085]) and the loop to move between the open and closed positions ([0052] 6 is deployed by advancement or retracted by retraction of 17);
wherein the chamfered distal end is sized to house at least a portion of the loop when the loop is in the closed position ([0054] when 6 is retracted within 5, 6 has a deformed position within 5).
Okada is silent regarding a width of the chamfered distal end gradually increases along a length of the chamfered distal end from an initial width to a second width; that the first width of the proximal portion is between 0.05 inches and 0.06 inches; that the length of the chamfered distal end is between 0.015 inches and 0.06 inches, that the second width of the chamfered distal end is between 0.06 inches and 0.075 inches; and that the second width of the chamfered distal end is greater than the first width of the proximal portion.
Roue et al. teaches in the same field of endeavor of tissue removal tools (Abstract), and discloses: the first width of the proximal portion is between 0.05 inches and 0.06 inches ([0146] the inner diameter that the taper decreases to is between 0.03 inches and 0.06 inches); that the length of the chamfered distal end is between 0.015 inches and 0.06 inches ([0146] the length of the taper of the distal most portion can be less than 5 cm); and that the second width of the chamfered distal end is between 0.06 inches and 0.075 inches ([0145-146] the inner diameter of the catheter is initially between 0.06 inches and 0.08 inches, where the addition of the taper makes the inner diameter in the proximal portion before the taper at a decreased inner diameter; therefore, the diameter at the distal most portion would correspond to the previous inner diameter of the catheter between 0.06 inches and 0.08 inches), all for the purpose of being the proper size to operate in the intestinal track ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have adapted the claimed dimensions to Okada as taught by Roue et al., as Applicant has placed no criticality on the claimed range (see present Spec [0068-69], [0082], and [0099-100] for descriptions of the claimed ranges which include numerous alternatives) and since it has been held that "in the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 21, Okada further discloses the conduit comprises a single member (FIG. 1: 5 is a single member) that is attached to and extending from the body ([0043] and FIG. 1: 5 is attached to the distal end of 4), and wherein the single member includes the inner lumen having the proximal portion and the chamfered distal (FIG. 6: 5 includes the lumen containing 25 and 26).
Regarding claim 22, Okada further discloses the handle of the transmitting assembly is mounted over the elongated section of the body (FIGs. 1 and 9: transmitting assembly 2 is connected to body 4 by the handle 51 being placed over 40, which is a part of elongated section 30; therefore, 51 is mounted over 30).
Regarding claim 23, Okada further discloses a majority of the link of the transmitting assembly extends through the proximal portion of the inner lumen of the conduit (FIG. 1: the majority of 17 extends through 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771