DETAILED ACTION
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 1-4, 6-10, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0360006 (Sluti) in view of European Patent Application Publication No. EP 3689254 A1 (Yamada).
Regarding claim 1, Sluti discloses a tissue traction device (305) having a first end (301) and a second end (303) comprising: a first section (310 and/or 301) configured and adapted for attachment to tissue (340) at a first location within a patient’s body (see Figs. 3C-3D); a second section (300p and/or 303) configured and adapted for attachment to tissue at a second location within a patient’s body spaced apart from the first location (see Figs. 3C-3D); a third section (300 and/or 302) positioned between said first section and said second section (see Figs. 3C-3D).
Further regarding claims 1, 6, and 8, Sluti is silent regarding at least one weakened region positioned along at least one of said second section or said third section and configured to be severed to adjust traction applied by the tissue traction device. However, Sluti suggests increasing the length of the tissue traction device 305 by releasing a portion of the tissue traction device between first and second ends of the device, thus decreasing the traction on the tissue at the first location (see paragraphs [0050] and [0051]). Further, Yamada discloses tissue traction device (1) having a first end (7) and a second end (2) attached to spaced apart tissue locations (X and Y), wherein parts of the tissue traction device can be separated by severing the tissue traction device at a weakened region (41c) (see paragraph [0063]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide at least one weakened region positioned along a third section or on an elongated section between the first and third sections and configured to be severed to adjust traction applied by the traction device in order to release the portion of the tissue traction device between first and second ends of the device, thus lengthening the tissue traction device and decreasing the traction on the tissue at the first location (see paragraphs [0050] and [0051]).
Regarding claim 2, Sluti discloses wherein said first section and said second section are configured and adapted for attachment to tissue with a tissue-engagement member (via clips 321 and 322, see Figs. 3C and 3D).
Regarding claim 3, Sluti discloses further comprising a tissue-engagement member (321/322) having a first jaw and a second jaw (arms 800 in paragraph [0065]; labeled 900 in Figs. 9A and 9B), wherein a first jaw is coupled with said first section (one of arms 800/900 is shown coupled with portion 301 of the first section, see Figs. 3C and 3D).
Regarding claim 4, Sluti discloses wherein said first section comprises an attachment section (301) sized to engage and to remain in place on a jaw of said tissue-engagement member (see Figs. 3C and 3D).
Regarding claim 7, Sluti discloses wherein said second section and said third section are each in the form of closed shapes with an opening therethrough (closed loops 303 and 302).
Regarding claim 9, Sluti discloses wherein said first section and said third section each comprise a loop (loops 301 and 302).
Regarding claim 10, Slut discloses further comprising an attachment section (301) positioned within said first section and sized to engage and to remain in place on a jaw (arm 800/900) of a tissue-engagement member (321) for attaching said tissue traction device to tissue at the first location (see Figs. 3C and 3D).
Regarding claim 16, Sluti discloses a method of applying traction to tissue within a patient's body (see Abstract), said method comprising: anchoring a first end (310) of a tissue traction device (305) to tissue (340) at a first location within a patient's body (see Fig. 3D); anchoring a second end (300p) of the tissue traction device to tissue (344) at a second location within the patient's body spaced apart from the first location to apply traction to the tissue at the first location (see Fig. 3D and paragraph [0051]); anchoring a portion (302/304) of the tissue traction device between the first end and the second end to tissue (346) at a third location within the patient's body spaced apart from the first location and the second location to modify traction applied to the tissue at the first location (see Fig. 3D and paragraph [0051]; shortens a length of the device 305 between tissues 340 and 344, increasing traction applies to tissue 340).
Further regarding claim 16, Sluti is silent regarding severing the tissue traction device along a weakened region of the tissue traction device between the first end of the tissue traction device and the portion of the tissue traction device while the portion of the tissue traction device is attached to tissue at the third location. However, Sluti suggests increasing the length of the tissue traction device 305 by releasing the portion of the tissue traction device between first and second ends of the device, thus decreasing the traction on the tissue at the first location (see paragraphs [0050] and [0051]). Further, Yamada discloses tissue traction device (1) having a first end (7) and a second end (2) attached to spaced apart tissue locations (X and Y), wherein parts of the tissue traction device can be separated by severing the tissue traction device at a weakened region (41c) (see paragraph [0063]). Regarding claim 17, Yamada discloses further comprising severing the tissue traction device to release traction on the tissue at the first location (see paragraphs [0005] and [0057]-[0059]).
Regarding claim 18, Yamada discloses further comprising removing the tissue at the first location (see paragraphs [0056]-[0059]). Additionally, Sluti discloses further comprising removing the tissue at the first location (see paragraph [0037]).
Regarding claim 20, Yamada discloses further comprising visually identifying the weakened region before severing the tissue traction device along the weakened region (see paragraphs [0010], [0063], and [0067]; identification and selection of weakened section easiest for cutting, e.g.).
Further regarding claims 16-18 and 20, it would have been prima facie obvious to modify the method of Sluti to severing the tissue traction device along a weakened region of the tissue traction device between the first end of the tissue traction device and the portion of the tissue traction device while the portion of the tissue traction device is attached to tissue at the third location in order to release the portion of the tissue traction device between first and second ends of the device, thus lengthening the tissue traction device and decreasing the traction on the tissue at the first location (see paragraphs [0050] and [0051]). The target tissue (such as a diseased lesion, e.g.) may also be removed for the health of the patient.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0360005 (Rodriguez-Salazar) in view of Yamada.
Regarding claim 11, Rodriguez-Salazar discloses an elongated tissue traction device (100) extending between a first end (112/116) and a second end (114/118), said elongated tissue traction device comprising: two or more distinctly formed sections (section 112/116 and section 114/118) distinguishable from one another and each configured and adapted for attachment to tissue (via clips 136 and 137, see Fig. 4A); and at least one region along and/or between each of said two or more distinctly-formed sections and configured and adapted to be severed by a cutting tool to facilitate adjustment of traction applied by said tissue traction device (see paragraph [0038]; swivels 116/118 or band 110 between the sections may be cut by a cutting tool to release traction applied by said tissue traction device).
Further regarding claim 11 and regarding claim 12, Rodriguez-Salazar fails to disclose the regions being weakened and adapted to be severed by a cutting tool more readily than surrounding regions. However, Yamada discloses tissue traction device (1) having a first end (7) and a second end (2) attached to spaced apart tissue locations (X and Y), wherein parts of the tissue traction device can be separated by severing the tissue traction device at a weakened region (41c) (see paragraph [0063]). It would have been prima facie obvious to use a weakened region at the regions of the traction device to be severed, as Yamada suggests using a weakened region on a traction device facilitates severing of the traction device (see Yamada, paragraph [0063]).
Regarding claim 12, Yamada discloses wherein said at least one weakened region is a stepped reduced-diameter portion (see paragraph [0063]), and Rodriguez-Salazar discloses the region being along at least one of said two or more distinctly-formed sections (portions 116/118 of the sections may be the severed regions, see paragraph [0038]).
Regarding claim 13, Rodriguez-Salazar discloses wherein said at least one region (weakened as suggested by Yamada in claim 11 above) is positioned along an elongated section (110) spacing apart adjacent distinctly-formed sections (see paragraph [0038]; elongated section 110 may be cut).
Regarding claim 14, Rodriguez-Salazar discloses further comprising an attachment section (112) sized to engage and to remain in place on a jaw (136a/136b) of a tissue-engagement member (136) delivered with said tissue traction device to a target tissue site (see Fig. 4A).
Regarding claim 15, Rodriguez-Salazar discloses wherein said attachment section is positioned within a section at the first end of said tissue traction device (attachment section 112 is positioned within section 112/116 at the first end of said tissue traction device, see Fig. 4A).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sluti in view of Yamada, and further in view of Rodriguez-Salazar.
Regarding claim 19, Sluti is silent regarding further comprising severing the portion of the tissue traction device between the first end and the second end along a weakened region along the portion of the tissue traction device. However, Rodriguez Salazar discloses a tissue traction device (100) having a first end (136) and a second end (137), wherein a method of using the traction device comprises severing the device along a portion of the device between the first and second end (see paragraph [0038]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Sluti in view of Yamada to further comprise the step of severing the device along a portion of the device between the first and second end in order to facilitate removal of the excised target tissue and target device from the patient (see Rodriguez Salazar, paragraph [0038]). Additionally, it would be obvious to use a weakened region along the device, as Yamada suggests using a weakened region of a traction device to facilitate severing of the device (see Yamada, paragraph [0063]).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 1-4 and 6-20 have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bhowmick and Smith disclose additional traction devices.
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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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