Office Action Predictor
Application No. 17/840,626

BILE DUCT STENT AND METHOD OF MANUFACTURING THE SAME

Final Rejection §103
Filed
Jun 15, 2022
Examiner
PELLEGRINO, BRIAN E
Art Unit
3799
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sewoon Medical Co., LTD.
OA Round
2 (Final)
55%
Grant Probability
Moderate
3-4
OA Rounds
5y 0m
To Grant
92%
With Interview

Examiner Intelligence

55%
Career Allow Rate
356 granted / 646 resolved
Without
With
+36.9%
Interview Lift
avg trend
5y 0m
Avg Prosecution
54 pending
700
Total Applications
career history

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
42.6%
+2.6% vs TC avg
§102
23.2%
-16.8% vs TC avg
§112
25.6%
-14.4% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103
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 . Response to Arguments Applicant's arguments filed 11/13/25 have been fully considered but they are not persuasive. In response to applicant's argument that Shin ‘126 is for a different use or in other words 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, both bile ducts and blood vessels are conduits within the body to transport body fluids, while the material or fluid may differ, providing a passage or lumen for body fluid is the same. Applicant also argues the reference teaches away. Again as mentioned above, both devices or stent are to provide a lumen for passage of the body fluid and thus it is not unreasonable to consider other body vessel stents in considering construction of stents. Please note claims are to a product and not a method of manufacture. Thus, Applicant’s arguments of methods of manufacture of the prior art stents being different than the claimed stent is moot. Please note the recitation of “wires are woven on a pin and another pin disposed in the circumferential direction at a lower end of the jig….weaving the metal wires on pins disposed in the circumferential direction at a lower end of the jig….” is a product-by-process limitation and thus the claimed product patentability depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 U.S.P.Q. 161 (CCPA 1964). In an ex parte case product-by- process claims are not construed as being limited to the product formed by the specific process recited. In re Hirao, 535 F2d 67, 190 U.S.P.Q. 15 see footnote 3 (CCPA 1976). 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) 2,4 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (KR 20190014335) in view of Shin et al. (7041126). Please note the recitations of “formed ...on a plurality of pins each disposed in a circumferential direction X and a longitudinal direction Y of a cylindrical jig... woven on a pin and another pin disposed in the circumferential direction X at a lower end of the jig” are product-by process limitations and only require the product to be capable of being made possibly by the structural elements. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Shin et al. (KR ‘335) Fig. 3 shows a bile duct stent 10 comprising: a cylindrical body 14 having a mesh structure formed by crossing metal wires 11 of a shape memory alloy (page 3 of translation). Shin et al. (KR ‘335) also shows (Fig. 4) a backflow-preventing pattern film 13 in which the metal wires are and the metal wires cross an outlet end 20 of the cylindrical body one time or more to form a network structure. However, Shin et al. (KR 20190014335) did not explicitly state the woven wires are in a form of zigzags for the body section. Shin et al. (US ‘126) teach (Fig. 1) a stent 50 with a woven pattern. Shin et al. (US ‘126) also teach (Fig. 2) the woven pattern is formed as a zigzag. It would have been obvious to one of ordinary skill in the art to alternatively form the woven stent wires in a zigzag as taught by Shin et al. (US ‘126) for the stent of Shin et al. (KR ‘335) in order to provide force against contraction thus maintaining its longitudinal length, see Shin et al. (US ‘126) col. 2, lines 45-52. Regarding claim 4, Shin et al. (KR ‘335) show (Fig. 4) the backflow-preventing pattern film is finished with a twist knot after one line of metal wires is continuously woven from a start-point pin to an end-point pin via at least one other pin. Regarding the limitation of multiple wires woven in the pattern (see Shin ‘126), the backflow-preventing pattern film is thus forming a radial backflow-preventing pattern film by sequentially weaving the metal wires as Shin (KR ‘335) states a plurality of strands of metal alloy used (page 3 of translation) and thus multiple lines of metal wires woven on the vertical pin are fixed by intersecting each other in a bent state, see Shin (US ‘126) Figs. 1,2 that the wires (col. 3, lines 7,8,56-58) are woven and zigzag along the vertical axis of pins on an assembly to manufacture to thus result in the established longitudinal axis of the stent. 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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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Prosecution Timeline

Jun 15, 2022
Application Filed
Aug 26, 2025
Non-Final Rejection — §103
Nov 13, 2025
Response Filed
Dec 14, 2025
Final Rejection — §103
Jan 27, 2026
Interview Requested
Feb 03, 2026
Examiner Interview Summary
Mar 12, 2026
Request for Continued Examination
Apr 01, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
55%
Grant Probability
92%
With Interview (+36.9%)
5y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 646 resolved cases by this examiner