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 .
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.
Claims 1-5, 7, 9-12, 14-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by European Patent Application Publication No. EP 3689254 A1 (Yamada), as cited on Applicant’s IDS filed on April 8, 2025.
Regarding claim 1, Yamada discloses a tissue traction device (1) having a first end (7) and a second end (2) and comprising: a first section (one of 4 and 3) configured and adapted for attachment to tissue at a first location within a patient's body (see paragraphs [0001] and [0053], and Fig. 7A; section 4 attached to tissue via end 7 and second 3 attached to tissue via end 2); a second section (other of 4 and 3) configured and adapted for attachment to tissue at a second location within a patient's body spaced apart from the first location (see paragraphs [0001] and [0053], and Fig. 7A; section 4 attached to tissue via end 7 and second 3 attached to tissue via end 2); and at least one weakened region (41c) between the first end and the second end configured and adapted to be severed by a cutting tool more readily than surrounding regions (see paragraph [0063]).
Regarding claim 2, Yamada discloses wherein said first section and said second section are configured and adapted for attachment to tissue with a tissue-engagement member (first section configured and adapted for attachment to tissue with tissue-engagement member 7; second section configured and adapted for attachment to tissue with tissue-engagement member 2).
Regarding claim 3, Yamada discloses further comprising a tissue-engagement member having a first jaw and a second jaw (jaws 22 and 72 of members 2 and 7), wherein a first jaw (one of jaws 22/72) is coupled with said first section (first section can be section 4 or section 3; jaw 22 attached to section 3 and jaw 72 attached to section 4, see Figs. 1A, 6A, and 7A).
Regarding claim 4, Yamada discloses wherein said first section comprises an attachment section (section 32 or section 41) sized to engage and to remain in place on a jaw (22 or 72) of said tissue-engagement member (see Figs. 1A, 6A, and 7A).
Regarding claim 5, Yamada discloses wherein said at least one weakened region (41c) is provided along at least one of said first section of said second section (provided along section 4, see Fig. 4B).
Regarding claim 7, Yamada discloses further comprising a third section (42) between said first section and said second section (first section can be section 41 and second section can section 3).
Regarding claim 9, Yamada discloses wherein at least one of said first section or said second section comprises a loop (section 4 comprises a loop portion 4 and/or is itself a loop, see paragraph [0029], e.g.).
Regarding claim 10, Yamada discloses further comprising an attachment section (section 32 or section 41) positioned within said first section and sized to engage and to remain in place on a jaw (jaw 22 or jaw 72) of a tissue-engagement member (member 2 or 7) for attaching said tissue traction device to tissue at the first location (X or Y) (see Figs. 1A, 6A, and 7A and paragraphs [0001], [0053], and [0056]).
Regarding claim 11, Yamada discloses an elongated tissue traction device (1) extending between a first end (end of one of section 4 and section 2) and a second end (end of other of section 4 and section 2), said elongated tissue traction device comprising: two or more distinctly formed sections (sections 4 and 7) distinguishable from one another (see Fig. 7A and paragraph [0018]); and at least one weakened region (41c) along and/or between said two or more distinctly-formed sections and configured and adapted to be severed by a cutting tool more readily than surrounding regions (see paragraph [0063]; weakened region 41c is along section 4 of said two or more distinctly-formed sections).
Regarding claim 12, Yamada discloses wherein said at least one weakened region is a stepped reduced-diameter portion (see paragraph [0063]) along at least one of said two or more distinctly-formed sections (along section 4).
Regarding claim 14, Yamada discloses further comprising an attachment section (section 32 or section 41) sized to engage and to remain in place on a jaw (jaw 22 or jaw 72) of a tissue-engagement member (member 2 or member 7) delivered with said tissue traction device to a target tissue site (see Figs. 1A, 6A, and 7A and paragraphs [0001], [0053], and [0056]).
Regarding claim 15, Yamada discloses wherein said attachment section is positioned within a section at the first end of said tissue traction device (section 32 is positioned within section 3; section 41 is positioned within section 4).
Regarding claim 16, Yamada discloses a method of applying traction to tissue within a patient's body, said method comprising: anchoring a first end (one of end 7 or end 2) of a tissue traction device to tissue at a first location (Y or X) within a patient's body (see paragraphs [0001] and [0053], and Fig. 7A); anchoring a second end (other of end 7 or end 2) of a tissue traction device to tissue at a second location (Y or X) within a patient's body spaced apart from the first location to apply traction to the tissue at the first location (see paragraphs [0001], [0004], [0053], and [0056], and Fig. 7A); severing the tissue traction device along a weakened region (41c) of the tissue traction device (see paragraphs [0058], [0059], and [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 [0056]-[0059]).
Regarding claim 18, Yamada discloses further comprising removing the tissue at the first location (see paragraphs [0056]-[0059]).
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.).
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 6, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of U.S. Patent Application Publication No. 2005/0070758 (Wells).
Regarding claim 6, Yamada is silent regarding, wherein said at least one weakened region is provided between said first section and said second section. However, Wells discloses a surgical clipping device (100) including a first section (118) and a second section (90) wherein a weakened region (214) is provided between the first and second sections (see paragraphs [0052], [0052], [0056], and [0069]). 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 the weakened region on a section between said first and second section, as Yamada suggests providing a weakened region between two sections is a suitable mechanism for separating a surgical clip from the rest of the device (see Wells, paragraphs [0052], [0052], [0056], and [0069]), and such a modification allows for the elongated section to be made from a different material to facilitate breaking of the weakened region (see Wells, paragraph [0069]).
Regarding claim 8, Yamada is silent regarding, wherein said weakened region is positioned along an elongated section spacing apart said first section and said third section and/or said second section and said third section. However, Wells discloses a surgical clipping device (100) including a first section (118) and a second section (90) wherein a weakened region (214) is provided on an elongated section (204/206) spacing apart the first and second sections (see paragraphs [0052], [0052], [0056], and [0069]). 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 the weakened region on an elongated section spacing apart different sections, as Yamada suggests providing a weakened region between two sections is a suitable mechanism for separating a surgical clip from the rest of the device (see Wells, paragraphs [0052], [0052], [0056], and [0069]), and such a modification allows for the elongated section to be made from a different material to facilitate breaking of the weakened region (see Wells, paragraph [0069]).
Regarding claim 13, Yamada is silent regarding wherein said at least one weakened region is positioned along an elongated section spacing apart adjacent distinctly-formed sections. However, Wells discloses a surgical clipping device (100) including a first section (118) and a second section (90) distinctly-formed sections wherein a weakened region (214) is provided along an elongated section (204/206) spacing apart the adjacent first and second sections (see paragraphs [0052], [0052], [0056], and [0069]). 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 the weakened region on an elongated section spacing apart different sections, as Yamada suggests providing a weakened region between two sections is a suitable mechanism for separating a surgical clip from the rest of the device (see Wells, paragraphs [0052], [0052], [0056], and [0069]), and such a modification allows for the elongated section to be made from a different material to facilitate breaking of the weakened region (see Wells, paragraph [0069]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of U.S. Patent Application Publication No. 2020/0360005 (Rodriguez Salazar).
Regarding claim 19, Yamada is silent regarding further comprising anchoring a portion of the tissue traction device between the first end and the second end to tissue at a third location within a patient's body. However, Rodriguez Salazar discloses a tissue traction device (100) that is anchored to tissue at a first end (136) and a second end (137), and a portion (138) of the tissue traction device between the first and second ends also anchored to tissue within a patient’s body (see Fig. 4B). 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 Yamada to anchor a third portion of the device to tissue at a third location as suggested by Rodriguez Salazar in order to adjust the angle or direction or amount of the traction provided by the traction device (see paragraph [0034]).
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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