Prosecution Insights
Last updated: April 18, 2026
Application No. 18/237,756

CATHETER AND METHOD FOR MANUFACTURING SAME

Non-Final OA §102§103
Filed
Aug 24, 2023
Examiner
TAYLOR, MARISSA ENVENESIA
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Terumo Kabushiki Kaisha
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
12 granted / 17 resolved
+0.6% vs TC avg
Strong +50% interview lift
Without
With
+50.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
26 currently pending
Career history
43
Total Applications
across all art units

Statute-Specific Performance

§103
44.3%
+4.3% vs TC avg
§102
28.4%
-11.6% vs TC avg
§112
26.3%
-13.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 17 resolved cases

Office Action

§102 §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. Election/Restrictions Applicant’s election without traverse of an invention in the reply filed on 03/11/2026 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/11/2026. Claim Rejections - 35 USC § 102 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-6 and 10-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Guo (US Pub No. 20160317220 A1) . Regarding claim 1 , Guo discloses a catheter comprising: a distal member having a cylindrical shape ( Shown between 24 and 22 in Fig.2 , Fig.4A) and connected to a distal end part of a catheter body (21 – Fig.2, 10 – Fig.4A) , wherein the distal member has a bending portion (111 – Fig.2, 211 – Fig.4A) located distal to a most distal end part of the catheter body (Fig.2, Fig.4A) , the bending portion being a section that bends when an external force in a bending direction is applied to a distal end part of the distal member with the distal end part of the catheter body being fixed (“a distal deflectable segment having anisotropic bending properties allows for improved catheter guidance and/or improved control for tissue access and tissue contact ” – [0025],Fig.3, Fig.4B) . Regarding claim 2 , Guo discloses the catheter set forth above, wherein the distal end part of the distal member is tapered (24 – Fig.2) . Regarding claim 3 , Guo discloses the catheter set forth above, wherein the distal member is formed of a thermoplastic resin (“Pebax” – Para [0037]) . Regarding claim 4 , Guo discloses the catheter set forth above, wherein the distal member includes only at least one thermoplastic resin layer (14 – Fig.5, “Pebax” – Para [0037]) . Regarding claim 5 , Guo discloses the catheter set forth above, wherein the bending portion (111 – Fig.2, 211 – Fig.4A) has a Young's modulus smaller (“a softer polymer” – Para [0029]) than a Young's modulus of a proximal end part (22 – Fig.2) of the distal member (“polymer with an intermediate material rigidity” – para [0029]) . Regarding claim 6 , Guo discloses the catheter set forth above, wherein the distal member comprises a proximal end part (22 – Fig.2) disposed opposite the distal end part of the distal member (24 – Fig.2) , wherein the bending portion is arranged between the proximal end part of the distal member and the distal end part of the distal member (Fig.2, “Between the shaft… and the deflectable segment… is a shaft transition region” - Para [0029]) , and wherein the distal member is connected to the distal end part of the catheter body at the proximal end part of the distal member (Fig.2) . Regarding claim 1 0 , Guo discloses a catheter comprising: a distal member having a cylindrical shape ( Shown between 24 and 22 in Fig.2 , Fig.4A) and connected to a distal end part of a catheter body (21 – Fig.2, 10 – Fig.4A) , wherein the distal member has a bending portion (111 – Fig.2, 211 – Fig.4A) having a Young's modulus smaller (“a softer polymer” – Para [0029]) than a Young's modulus of a proximal end part of the distal member (22 – Fig.2)(“polymer with an intermediate material rigidity” – para [0029]) , the bending portion being a section that bends when an external force in a bending direction is applied to a distal end part of the distal member (24 – Fig.2) with the distal end part of the catheter body being fixed (“a distal deflectable segment having anisotropic bending properties allows for improved catheter guidance and/or improved control for tissue access and tissue contact ” – [0025],Fig.3, Fig.4B) . Regarding claim 11 , Guo discloses the catheter set forth above, wherein the Young's modulus of the bending portion (111 – Fig.2, 211 – Fig.4A) of the distal member is smaller (“a softer polymer” – Para [0029]) than a Young's modulus of the distal end part of the distal member (22 – Fig.2)(“polymer with an intermediate material rigidity” – para [0029]) . Regarding claim 1 2 , Guo discloses the catheter set forth above, wherein the bending portion (111 – Fig.2, 211 – Fig.4A) is arranged between the proximal end part of the distal member (22 – Fig.2) and the distal end part of the distal member (24 – Fig.2) , and wherein the distal member is connected to the distal end part of the catheter body (21 – Fig.2) at the proximal end part of the distal member (Fig.2) . 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. Claims 7 - 9 and 1 3-14 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Chappel (US Pub No. 20110196315 A1) . Regarding claim 7 , Guo discloses the catheter as set forth above, but Guo does not expressly disclose wherein the proximal end part of the distal member, the bending portion, and the distal end part of the distal member are made from a single unitary piece of material . Chappel teaches a catheter wherein a proximal end part (35 – Fig.3B) of a distal member (20 – Fig.3B) , a bending portion (Shown at 30 – Fig.3B) , and a distal end part of the distal member are made from a single unitary piece of material ( Fig.3A, “combining two otherwise contradictory parameters into one catheter tip” – Para [0019]) . I t would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the distal member disclosed by Guo to be made from a single unitary piece of material as taught by Chappel i n order to enhance deliverability of an endovascular catheter (Chappel, Para [0019]) . Regarding claim 8 , Guo , as modified, discloses the catheter set forth above, wherein the proximal end part of the distal member comprises a material section of the single unitary piece of material (Chappel, Para [0019]) , having a greater Young's modulus (“polymer with an intermediate material rigidity” – para [0029]) than a Young's modulus of the bending portion (“a softer polymer” – Para [0029]) . Further, the limitation, “ heat-transformed material ” is a product-by-process limitation , the a pplicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. Regarding claim 9 , Guo, as modified, discloses the catheter set forth above, wherein the distal end part of the distal member comprises a material section of the single unitary piece of materia l (Chappel, Para [0019]) , but Guo, as modified, does not expressly disclose wherein the distal end part of the distal member having a greater Young's modulus than a Young's modulus of the bending portion . Chappel teaches a distal end part (40 – Fig.3B) of a distal member (20 – Fig.3B) having a greater Young's modulus than a Young's modulus of a bending portion (30 – Fig.3B)(“a flexible section with a pushability characteristic… and a stiff and radially rigid section at the distal end ” – Para [0026]) . It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the distal member disclosed by Guo, as modified, to have the distal end part of the distal member having a greater Young's modulus than a Young's modulus of a bending portion as taught by Chappel since Chappel teaches it minimize s the risk that the distal edge of the catheter tip will catch on the rough surface of the lumen wall of a curved vessel (Chappel, Para [0026]) . Further, the limitation, “heat-transformed material” is a product-by-process limitation , the a pplicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. Regarding claim 1 3 , Guo discloses the catheter as set forth above, but Guo does not expressly disclose wherein the proximal end part of the distal member, the bending portion, and the distal end part of the distal member are made from a single unitary piece of material. Chappel teaches a catheter wherein a proximal end part (35 – Fig.3B) of a distal member (20 – Fig.3B) , a bending portion (Shown at 30 – Fig.3B) , and a distal end part of the distal member are made from a single unitary piece of material (Fig.3A, “combining two otherwise contradictory parameters into one catheter tip” – Para [0019]). It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the distal member disclosed by Guo to be made from a single unitary piece of material as taught by Chappel in order to enhance deliverability of an endovascular catheter (Chappel, Para [0019]) . Regarding claim 14 , Guo , as modified, discloses the catheter as set forth above, wherein the proximal end part (22 – Fig.2) of the distal membe r ( Shown between 24 and 22 in Fig.2) comprises a material section of the single unitary piece of material (Chappel, Para [0019]) . Further, the limitation, “ melted-and-cured material” is a product-by-process limitation , the Applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Chappel as applied to claim 13 above, and further in view of Cragg et al. (US 20180015254 A1, herein, Cragg) . Regarding claim 15 , Guo, as modified, discloses the catheter as set forth above , but Guo, as modified, does not expressly disclose wherein the Young's modulus of the proximal end part of the distal member is equal to the Young's modulus of the distal end part of the distal member . Cragg teaches a catheter wherein the Young's modulus of the proximal end part of the distal member (302 – Fig.6) is equal to the Young's modulus of the distal end part of the distal member (“the distal portion can have a generally uniform stiffness profile along a length of the distal portion” – Para [0057]) . It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the distal member disclosed by Guo, as modified, wherein the Young's modulus of the proximal end part of the distal member is equal to the Young's modulus of the distal end part as taught by Cragg since fewer transition points between sections of varying stiffness, reduces the number of transition points that are prone to kinking (Cragg, Para [0057]) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Marissa Taylor whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3542 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 6:30am-3:30pm EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-3383 . 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. /MARISSA TAYLOR/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
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Prosecution Timeline

Aug 24, 2023
Application Filed
Apr 02, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+50.0%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 17 resolved cases by this examiner. Grant probability derived from career allow rate.

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