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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 25, 2024 and on March 12, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
¶0025, Line 13: “adacent” should read --adjacent--
Appropriate correction is required.
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 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.
Claims 1-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (CN106456308), hereinafter "Han", in view of Cheng et al. (CN111803253A), hereinafter "Cheng". For text citations of Han and Cheng, refer to the machine translations provided by the Examiner.
Regarding Claim 1, Han discloses a weaving method for a stent used in an intestinal track, applied to a cylindrical clamp (Figs. 6-17; ¶0002, Lines 1-2), the cylindrical clamp being provided with a first layer area (Fig. 6, Rows a1-a14, h1, b6-b7), a second layer area (Fig. 6, Rows a1-a14, b8-b10) and a third layer area (Fig. 6, Rows a1-a14, b11-12, h2) arranged sequentially in an axial direction (Fig. 6, L direction), the first layer area (Fig. 6, Rows a1-a14, h1, b6-b7) and the third layer area (Fig. 6, Rows a1-a14, b11-12, h2) each comprising at least two rows of positioning pins (Fig. 6, Rows a1-a14, h1, b6-b7, b11-b12, h2, Element P), the second layer area (Fig. 6, Rows a1-a14, b8-b10) comprising at least one row of positioning pins (Fig. 6; Rows b8-b10, Element P), each row of positioning pins (Fig. 6, Element P) in the first layer area (Fig. 6, Rows a1-a14, h1, b6-b7), the second layer area (Fig. 6, Rows a1-a14, b8-b10), and the third layer area (Fig. 6, Rows a1-a14, b11-12, h2) comprising at least four positioning pins (Fig. 6, Element P) uniformly distributed in a circumferential direction of the cylindrical clamp (Fig. 6, W direction; ¶0017, Lines 15-17), the stent for use in the intestinal tract (Figs. 6-17; ¶0002, Lines 1-2) comprising a head segment (Fig. 6, Element UH), a main body (Fig. 6, Element B) and a tail segment (Fig. 6, Element LH) connected in sequence (Fig. 6), the weaving method comprising: a weaving process of the head segment (Figs. 14-17) comprising: bending and moving a first wire (Figs. 14-17, Element 10) in a first V-shape between two adjacent rows of positioning pins (Fig. 6, Element P) in the first layer area (Fig. 14-17, Rows a1-a14, h1, b6-b7) until all positioning pins (Fig. 6, Element P) in the first layer area (Fig. 14-17, Rows a1-a14, h1, b6-b7) are fully wound around or half of the positioning pins (Fig. 6, Element P) in the first layer area (Fig. 14-17, Rows a1-a14, h1, b6-b7) are wound around (Figs. 14-15, Element 10, Rows h1, b6-b7); and allowing a second wire (Fig. 17, Element 20) to wind around the remaining positioning pins (Fig. 6, Element P) in the first layer area (Fig. 14-17, Rows a1-a14, h1, b6-b7) in a case that half of the positioning pins (Fig. 6, Element P) in the first layer area (Fig. 14-17, Rows a1-a14, h1, b6-b7) are wound around by the first wire (Fig. 17, Element 10) (Fig. 17; Element 20, Rows a1-a14, h1, b6-b7); a weaving process of the main body (Fig. 6, Element B) comprising: bending and moving the first wire (Figs. 6-12, Element 10) in a second V-shape between every two adjacent rows of positioning pins (Fig. 6, Element P) in an area from the last row (Fig. 6-12, Rows a1-a14, h1) of positioning pins (Fig. 6, Element P) in the first layer area (Figs. 6-12, Rows a1-a14, h1, b6-b7), the second layer area (Figs. 6-12, Rows a1-a14, b8-b10), to the first row (Fig. 6-12, Rows a1-a14, b11) of the positioning pins (Fig. 6, Element P) in the third layer area (Figs. 6-12, Rows a1-a14, b11-b12, h2), until all the positioning pins (Fig. 6, Element P) in the area from the last row (Figs. 6-12, Rows a1-a14, h1) of positioning pins (Fig. 6, Element P) in the first layer area (Figs. 6-12, Rows a1-a14, h1, b6-b7), the second layer area (Fig. 6-12, Rows a1-a14, b8-b10), to the first row (Fig. 6-12, Rows a1-a14, b11) of the positioning pins (Fig. 6, Element P) in the third layer area (Fig. 6-12, Rows a1-a14, b11-b12, h2) are fully wound around (Fig. 12); and a weaving processing of the tail segment (Fig. 6, Element LH) comprising: with the same movement mode as the first wire (Fig. 10, Element 10) in the weaving process of the head segment (Fig. 6, Element UH), allowing the first wire (Fig. 10, Element 10) to wind around all or half of the positioning pins (Fig. 6, Element P) in the third layer area (Fig. 10, Rows a1-a14, b11-12, h2); and in the case that half of the positioning pins (Fig. 6, Element P) in the third layer area (Fig. 6-12, Rows a1-a14, b11-b12, h2) are wound around by the first wire (Fig. 10, Element 10), allowing a second wire (Fig. 17, Element 20) to wind around the remaining positioning pins (Fig. 6, Element P) in the third layer area (Fig. 17, Rows a1-a14, b11-12, h2); and wherein when there exists two opposite V-shapes at the same positioning pin (Fig. 6, Element P), first wires (Figs. 16-18, Element 10) or second wires (Figs. 16-18, Element 20) of the two opposite V-shapes are interlocked with each other (Figs. 16-18, Elements 30 and 35).
Han fails to disclose when the first wire or the second wire completes the weaving of adjacent A-th row of positioning pins and B-th row of positioning pins, and the first wire or the second wire returns onto the A-th row of positioning pins, the first wire or the second wire winds around a weaved path between the A-th row of positioning pins and the B-th row of positioning pins, and is moved to the B-th row of positioning pins to form a reinforcing rib, and then starts to move between adjacent B-th row of positioning pins and C-th row of positioning pins.
Nonetheless, Cheng teaches when the first wire or the second wire completes the weaving of adjacent A-th row of positioning pins and B-th row of positioning pins (Fig. 13, Rows b0-b2 a0-a8; ¶0040), and the first wire or the second wire returns onto the A-th row of positioning pins (Fig. 13, Rows b0-b2 a0-a8; ¶0040), the first wire or the second wire winds around a weaved path between the A-th row of positioning pins and the B-th row of positioning pins (Fig. 13, Rows b0-b2 a0-a8; ¶0040), and is moved to the B-th row of positioning pins to form a reinforcing rib (see annotated Fig. 13 of Cheng reproduced below), and then starts to move between adjacent B-th row of positioning pins and C-th row of positioning pins (Fig. 13, Rows b0-b2 a0-a8; ¶0040).
Han and Cheng are considered analogous art to the claimed invention because they are in the same field of endeavor of stent manufacturing. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to incorporate the teachings of Chen of forming a reinforcing rib by after the first wire or the second wire completes the weaving of adjacent A-th row of positioning pins and B-th row of positioning pins, and the first wire or the second wire returns onto the A-th row of positioning pins, winding the first wire or the second wire around a weaved path between the A-th row of positioning pins and the B-th row of positioning pins and moving it to the B-th row of positioning pins and then move between adjacent B-th row of positioning pins and C-th row of positioning pins into the weaving method for a stent used in an intestinal track disclosed by Han to make the stent structure more robust and reliable (¶0022, Lines 7-14).
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Annotated Fig. 13 of Cheng
Regarding Claim 2, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Han further discloses bending and moving the second wire (Fig. 17, Element 20) in the first V-shape between two adjacent rows of positioning pins (Fig. 6, Element P) in the first layer area (Fig. 17, Rows a1-a14, h1, b6-b7) with starting from a position pin (Fig. 6, Element P) that the first wire (Fig. 17, Element 10) does not pass through (Fig. 17, Element f’4), until all positioning pins (Fig. 6, Element P) in the first layer area (Fig. 17, Rows a1-a14, h1, b6-b7) are wound around are wound around (Fig. 17; ¶0140-0141); and bending and moving the second wire (Fig. 17, Element 20) in the first V-shape between two adjacent rows of positioning pins (Fig. 6, Element P) in the third layer area (Fig. 17, Rows a1-a14, b11-12, h2) with starting from a position pin (Fig. 6, Element P) that the first wire (Fig. 17, Element 10) does not pass through (Fig. 17, Element f4), until all the positioning pins ((Fig. 6, Element P) in the third layer area (Fig. 17, Rows a1-a14, b11-12, h2) are wound around (Fig. 17; ¶0134-0135).
Regarding Claim 3, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Han further discloses wherein when the second wire (Fig. 17, Element 20) is moved between every two adjacent rows of positioning pins, the second wire (Fig. 17, Element 20) is interweaved up and down around the weaved path of the first wire (Fig. 17, Element 20) (see annotated Fig. 17 of Han reproduced below).
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Annotated Fig. 17 of Han
Regarding Claim 4, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Han further discloses wherein when the number of turns of the first wire (Figs. 14-15, Element 10) winding between every two adjacent rows of positioning pins (Fig. 6, Element P) is greater than or equal to 3 (Fig. 14), the first wire (Figs. 14-15, Element 10), starting from the third turn of weaving, is interweaved up and down around a weaved path in a previous turn or two previous turns (Fig. 14-15; ¶125).
Regarding Claim 5, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Chen further teaches allowing the second wire to form another reinforcing rib parallel to the reinforcing rib (Figs. 13-14, ¶0040), which comprises: allowing the second wire (Figs. 13-14), starting from a positioning pin that the reinforcement rib (see annotated Fig. 13 of Cheng reproduced above) doesn’t pass through (Fig. 13, a6, b3), wind around a weaved path of the first wire between rows of positioning pins (¶0040, Lines 6-17) in a direction parallel (¶0040, Lines 17-18) to the reinforcement rib (see annotated Fig. 13 of Cheng reproduced above) to form another reinforcing rib (Fig. 14, starting from a6,b3; ¶0040, Lines 6-18).
Regarding Claim 6, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 5 unpatentable.
Chen further teaches wherein the reinforcing rib (see annotated Fig. 13 of Cheng reproduced above) and the another reinforcing rib (Fig. 14, starting from a6,b3; ¶0040, Lines 6-18) are arranged symmetrically with respect to an axis of the stent (Fig. 14, diagonal axis).
Regarding Claim 14, the prior art combination of Han and Chen renders a stent for use in an intestinal tract, wherein the stent is formed by weaving with the weaving method as claimed in Claim 1 unpatentable (see explanation provided above in Claim 1).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Cheng as applied to claim 1 above, and further in view of Tokimoto (WO2020054027A1), hereinafter “Tokimoto”. For text citations of Tokimoto, refer to the machine translations provided by the Examiner.
Regarding Claim 7, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 6 unpatentable.
Han and Chen fail to teach wherein when all the positioning pins in the first layer area and the third layer area are fully wound around, at least one third wire is further provided, the third wire is weaved to form a reinforcing rib using the same weaving method as the second wire, and a plurality of the reinforcing ribs are uniformly distributed in the circumferential direction.
Nonetheless, Tokimoto teaches a third wire (Fig. 8, W1) weaved to form a reinforcing rib (Fig. 8) using the same weaving method as the second wire (described above).
Han, Chen, and Tokimoto are considered analogous art to the claimed invention because they are in the same field of endeavor of stent manufacturing. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to incorporate the teachings of Tokimoto of introducing a third wire into the weaving method for a stent used in an intestinal track disclosed by Han and modified by Chen so that when all the positioning pins in the first layer area and the third layer area are fully wound around, the third wire is weaved to form a reinforcing rib using the same weaving method as the second wire, and a plurality of the reinforcing ribs are uniformly distributed in the circumferential direction, so that the intersection between the first and the second wire is unable to undergo sliding deformation in the circumferential direction and conversely create a repulsive force against expansion and contraction in the circumferential direction (¶055).
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Cheng as applied to claim 1 above, and further in view of Wang (CN102973341B), hereinafter “Wang”. For text citations of Wang, refer to the machine translations provided by the Examiner.
Regarding Claim 8, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Han further discloses wherein the number of positioning pins (Fig. 6, Element P) in each row in the first layer area (Fig. 6, Rows a1-a14, h1, b6-b7) is the same as the number of positioning pins (Fig. 6, Element P) in each row in the third layer area (Fig. 6, Rows a1-a14, b11-12, h2), and adjacent rows of positioning pins (Fig. 6, Element P) are aligned with each other (Fig. 6); the first V-shape (Figs. 9-10, Rows b11 (a1-a7), b12 (a3-a6), h2 (a4)) spans (2m+1) positioning pins (Fig. 6, Element P) located in the same row (Figs. 9-10, Rows b11 (a1-a7)) where m is an integer greater than 1 (in this case, 2, see Figs. 9-10); the number of positioning pins (Fig. 6, Element P) in the last row (Fig. 6, Rows a1-a14, b7) in the first layer area (Fig. 6, Rows a1-a14, h1, b6-b7), the number of positioning pins (Fig. 6, Element P) in each row of the second layer area (Fig. 6, Rows a1-a14, b8-b10), and the number of positioning pins (Fig. 6, Element P) in the first row (Fig. 6, Rows a1-a14, b11) in the third layer area (Fig. 6, Rows a1-a14, b11-b12, h2) are the same (Fig. 6).
Han and Chen fail to teach wherein two adjacent rows of positioning pins are staggered from each other; and the second V-shape spans 2m’ positioning pins located in the same row, where m’ is an integer greater than 1.
Nonetheless, Wang teaches wherein two adjacent rows of positioning pins (Fig. 10-14, rows 51 and 52) are staggered from each other (¶0074, Lines 3-5) and a V-shape that spans 2m’ positioning pins located in the same row (Fig. 14, Element 52), where m’ is an integer greater than 1 (in this case, 2, see Fig. 14).
Han, Chen, and Wang are considered analogous art to the claimed invention because they are in the same field of endeavor of stent manufacturing. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to incorporate the teachings of Wang of staggering two adjacent rows of positioning pins from each other resulting in a second V-shape that spans 2m’ positioning pins located in the same row into the weaving method for a stent used in an intestinal track disclosed by Han and modified by Chen. One of ordinary skill in the art would have recognized that applying the technique of staggering two adjacent rows would have yielded predictable results while forming more cross points than fixed cross-linking points and increasing the grid density (¶0033, Lines 13-19).
Regarding Claim 9, the prior combination of Han, Chen, and Wang renders the weaving method for a stent used in an intestinal track as claimed in Claim 8 unpatentable.
As explained above in the rejection of Claim 8, Han further discloses wherein m is equal to 2 (see Figs. 9-10); while Wang teaches wherein m’ is equal to 2 (see Fig. 14); thus, m≥m’ (see Figs. 9-10 of Han and Fig. 14 of Wang).
Regarding Claim 10, the prior combination of Han, Chen, and Wang renders the weaving method for a stent used in an intestinal track as claimed in Claim 8 unpatentable.
As explained above in Claim 8, Han further discloses wherein m is equal to 2 or 3 (in this case, 2, see Figs. 9-10); while Wang teaches wherein m’ is equal to 2 or 3 (in this case, 2, see Fig. 14).
Regarding Claim 11, the prior combination of Han and Chen renders the weaving method for a stent used in an intestinal track as claimed in Claim 1 unpatentable.
Han further discloses wherein the number of positioning pins (Fig. 6, Element P) in each row in the first layer area (Fig. 6, Rows a1-a14, h1, b6-b7), the number of positioning pins (Fig. 6, Element P) in each row of the second layer area (Fig. 6, Rows a1-a14, b8-b10), and the number of positioning pins (Fig. 6, Element P) in the first row (Fig. 6, Rows a1-a14, b11) in each row in the third layer area (Fig. 6, Rows a1-a14, b11-b12, h2) are the same (Fig. 6); the first V-shape (Figs. 9-10, Rows b11 (a1-a7), b12 (a3-a6), h2 (a4)) spans (2n) positioning pins (Fig. 6, Element P) located in the same row (Figs. 9-10, Rows b11 (a1-a7)) where n is an integer greater than 1 (in this case, 2, see Figs. 9-10).
Han and Chen fail to teach wherein two adjacent rows of positioning pins are staggered from each other; and the second V-shape spans 2n’ positioning pins located in the same row, where n’ is an integer greater than 1.
Nonetheless, Wang teaches wherein two adjacent rows of positioning pins (Fig. 10-14, rows 51 and 52) are staggered from each other (¶0074, Lines 3-5) and a V-shape that spans 2n’ positioning pins located in the same row (Fig. 14, Element 52), where n’ is an integer greater than 1 (in this case, 2, see Fig. 14).
Han, Chen, and Wang are considered analogous art to the claimed invention because they are in the same field of endeavor of stent manufacturing. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to incorporate the teachings of Wang of staggering two adjacent rows of positioning pins from each other resulting in a second V-shape that spans 2n’ positioning pins located in the same row into the weaving method for a stent used in an intestinal track disclosed by Han and modified by Chen. One of ordinary skill in the art would have recognized that applying the technique of staggering two adjacent rows would have yielded predictable results while forming more cross points than fixed cross-linking points and increasing the grid density (¶0033, Lines 13-19).
Regarding Claim 12, the prior combination of Han, Chen, and Wang renders the weaving method for a stent used in an intestinal track as claimed in Claim 11 unpatentable.
While Han, Chen, and Wang are silent on wherein n>n’; however, the number of positioning pins located in the same row that a V-shape can span is a result effective variable (i.e., Han discloses V-shapes that span 1, 3, and 5 positioning pins in the same row, see Fig. 14 and further mentions how the positioning pins are removable in ¶0103, Lines 4-5, which suggests the V-shape can span a greater or less number of positioning pins).
Han, Chen, and Wang are considered analogous art to the claimed invention because they are in the same field of endeavor of stent manufacturing. It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to make n>n’, since it has been held that discovering an optimum value of a result effective parameter involves only routine skill in the art. In re Boesh, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding Claim 13, the prior combination of Han, Chen, and Wang renders the weaving method for a stent used in an intestinal track as claimed in Claim 11 unpatentable.
As explained above in Claim 11, Han further discloses wherein n is equal to 2 or 3 (in this case, 2, see Figs. 9-10); while Wang teaches wherein n’ is equal to 2 or 3 (in this case, 2, see Fig. 14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US20110054589A1; US10588762B2; KR101076721B1; WO2007079153A2- Stent manufacturing method
CN115553972A; JP2005110778A; KR20180046802A; WO2007011122A1- Reinforcing Rib
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALONDRA MICHELLE ORTIZ-ORTIZ whose telephone number is (571)272-9539. The examiner can normally be reached M-Th 7-5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Templeton can be reached at (571) 270-1477. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.M.O./Examiner, Art Unit 3725
/Christopher L Templeton/Supervisory Patent Examiner, Art Unit 3725
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