Prosecution Insights
Last updated: April 18, 2026
Application No. 17/605,333

FLEXIBLE ELONGATED TUBE FOR A CATHETER SYSTEM

Final Rejection §102§103§112
Filed
Oct 21, 2021
Examiner
TURKOWSKI, KAYLA MARIE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BIOTRONIK SE & Co. KG
OA Round
4 (Final)
65%
Grant Probability
Favorable
5-6
OA Rounds
4y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allow Rate
39 granted / 60 resolved
-5.0% vs TC avg
Strong +54% interview lift
Without
With
+54.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
40 currently pending
Career history
100
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
32.4%
-7.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 60 resolved cases

Office Action

§102 §103 §112
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 Amendment This office action is responsive to the amendment filed on 01/08/2026. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and claims 15-17 have been added. Thus, claims 1-7 and 15-17 are presently pending in this application, with claims 5-7 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection set forth in the Non-Final Office Action mailed on 09/17/2025. Response to Arguments Applicant's arguments in “Remarks” filed on 01/08/2026 have been fully considered but they are not persuasive. In response to the applicant’s argument on p.4 of “Remarks” that Cohen fails to disclose or teach a flexible elongated tube in claim 1, the examiner respectfully disagrees. The applicant argues “Cohen gives a different meaning to flexible tube and vertebrae assembly in the exact same sentence”. This argument is not persuasive because the claim limitation “a flexible elongated tube” of claim 1 is interpreted under broadest reasonable interpretation (BRI) regardless of the specific language used in a prior art reference. Just because Cohen defines the structure “32” as a flexible tube does not disallow the articulating vertebrae assembly “36” to be interpreted as a flexible elongated tube under BRI. Under BRI, a flexible elongated tube is interpreted as a tubular structure that has a length and is capable of bending without breaking. Thus, the articulating vertebrae assembly “36” of Cohen anticipates the claim limitation as it is a tubular structure with a length as seen in Fig. 2 which is able to flex as explicitly stated in Col.5, lines 25-29 “thereby causing varying degrees of flexure to occur in the articulating vertebrae assembly 36.” In response to the applicant’s argument that examiner contradicts Cohen in the rejection of claim 1, the examiner respectfully emphasizes the recitation of “the assembly 34” in the Non-Final Office Action mailed on 09/17/2025 on p.5, line 10 and line 15 was a typographical error where the reference number “34” should be replaced with “36”. However, the examiner correctly mapped “the flexible elongated tube (36)” and “a tubing wall” as the wall formed by the vertebrae 52 of the assembly 36, discussed the remaining claimed structures with respect to the vertebrae 52 of the assembly 36, and correctly annotated the vertebrae 52 in Cohen Drawing 1, the examiner is of the opinion that the applicant had a reasonable awareness to the thrust of the rejection of record. Therefore, applicant’s arguments stating that the feature 34 is a transitional coupler that is not even a part of the assembly 36, and the examiner’s annotated drawing of the vertebrae 52 are of the assembly 36 which is separate from the feature 34 are both found moot as the thrust of the rejection as discussed above could have been reasonably ascertained by one of ordinary skill in the art. Thus, examiner notes as per MPEP 1207.03(a) II, the Final Rejection below will only be clarifying and elaborating upon the rejection of record. In response to the applicant’s argument on p.5-6 of “Remarks” that Cohen fails to disclose or teach the plurality of first and second indentations in claim 1, the examiner respectfully disagrees. The applicant argues “the Examiner relabels the figure [Cohen Drawing 2] to contradict the text of Cohen which describes two diametrically opposed indentations formed in its wall [58a and 58b].” This argument is not persuasive because the claim limitations regarding the plurality of first indentations and the plurality of second indentations of claim 1 are interpreted under broadest reasonable interpretation (BRI) regardless of the specific language used in a prior art reference. Just because Cohen defines the structures “58a” and “58b” as a two diametrically opposed indentations does not disallow the annotated indentations in Cohen drawings 1 and 2 below to be interpreted as the plurality of first and second indentations under BRI. Thus, the annotated indentations on each vertebrae 52 of the assembly 36 meet the claim limitations of claim 1. Therefore, the rejection is being maintained. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 15, the phrase “wherein the flexible elongated tube is a single, continuous tube” renders the claim indefinite because it is unclear. Interpreting the term “continuous” under BRI gives it the definition of forming an unbroken whole or marked by uninterrupted extension in space, time, or sequence as defined by Merriam Webster. Thus, the flexible elongated tube having the plurality of first and second indentations being a continuous tube would be contradictory as the indentations interrupt the tubing wall. Examiner is interpreting this limitation as the tubing wall of the flexible elongated tube forms at least one continuous length of tubing wall in a portion of the flexible elongated tube. Regarding claim 16, this claim is rejected due to its dependency upon an indefinite base claim. 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. Claim(s) 1-2 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen et al. (U.S Patent No. 4686963, “Cohen”). Regarding claim 1, Cohen discloses (Claim 1) a flexible elongated tube (36) for a catheter system (20, see Fig. 2 and Col.5, lines 8-11), comprising: a tubing wall of the flexible elongated tube (36, see Fig. 3 and Col.6, lines 23-28 and lines 51-54 – vertebrae assembly 36 maintains each pivot point 53 of each vertebrae 52 in contact such that a continuous tubing wall is formed); a plurality of first indentations in the tubing wall spaced apart from each other along a longitudinal axis of the flexible elongated tube (see Fig. 3 and 5A and annotated Cohen drawing 1 below- each vertebrae 52 has the structure shown in Fig. 5A and annotated below with a first indentation in the wall of the assembly 36 which would be spaced apart from each other along a longitudinal axis annotated below); and a plurality of second indentations of the tubing wall spaced apart from each other along the longitudinal axis (see Fig. 3 and 5A and annotated Cohen drawing 1 below - each vertebrae 52 has the structure shown in Fig. 5A and annotated below with a second indentation in the wall of the assembly 36 which would be spaced apart from each other along a longitudinal axis annotated below); PNG media_image1.png 1072 1340 media_image1.png Greyscale wherein each of the plurality of first indentations is paired with one of the plurality of second indentations to form an axially aligned pair of indentations and a corresponding non-impressed section of the tubing wall is present between the axially aligned pair of indentations (see Cohen Drawing 1 above – each first indentation, second indentation form a pair and the section of the tubing wall not altered by an indentation situated therebetween is a corresponding non-impressed section, each vertebrae 52 comprises these structures along the longitudinal axis annotated above) and wherein the axially aligned pair of indentations are arranged such that each corresponding non-impressed section forms a pull wire space between each of the corresponding first and second indentations of each axially aligned pair of indentations (see Fig. 3C and annotated Cohen drawing 2 below and Col.7, lines 59-66 – the space annotated below with each corresponding non-impressed section and each pair of indentations on each vertebrae 52 form a space for a working conduit such that the PNG media_image2.png 772 1124 media_image2.png Greyscale space is capable of being configured to carry a pull wire), wherein the pull wire space is arranged and dimensioned to receive and guide a pull wire within the flexible elongated tube (36, see Fig. 3C and Cohen drawing 2 above – examiner notes the pull wire is a functionally recited limitation and thus the structure of the pull wire space must be capable of being arranged and dimensioned to receive and guide a structure such a pull wire, thus the pull wire space of Cohen as annotated above would be capable of being arranged and dimensioned to receive and guide a working conduit 66) wherein the pull wire space is dimensioned to avoid wiggling or snaking of the pull wire in the flexible elongated tube (36, examiner notes the pull wire is a functionally recited limitation and thus the structure of the pull wire space must be capable of being dimensioned to avoid wiggling or snaking of a structure guided therewithin, see Fig. 3C and Cohen drawing 2 above – the working conduit 66 is received in said annotated space above such that it is capable of being dimensioned to avoid wiggling or snaking of it in the assembly 36). Regarding claim 2, Cohen discloses (Claim 2) a flexible elongated tube (36) according to claim 1, wherein at least some of the plurality of first indentations are structurally identical to one another or to one of the plurality of second indentations (see annotate Cohen 1 drawing above for indentations and see Col.5, lines 46-47 – each vertebrae 52 is identical and therefore each of the first indentations on each vertebrae 52 are structurally identical to one another). Regarding claim 17, Cohen discloses (Claim 17) a flexible elongated tube (36) according to claim 1, wherein the plurality of first indentations and the plurality of second indentations each comprise deformed portions of the tubing wall (see annotated Cohen drawing 2 above for indentations, see Fig. 5 – the indentations that form the 54 are portions of the tubing wall of the assembly 36 that are deformed inwards such that the shape of the inner lumen of the tubing wall is distorted). 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. Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Hinman et al. (U.S Patent Pub. No. 20050273085, “Hinman”). PNG media_image3.png 577 791 media_image3.png Greyscale Regarding claim 3, Cohen discloses the flexible elongated tube of claim 1, as discussed above. While Cohen discloses at least some of the plurality of first indentations and/or at least some of the plurality of second indentations are separated from a pair of axially adjacent non-impressed sections by a gap between each vertebrae (52) which contact each adjacent vertebrae (52) at pivot point (53, see Fig. 3 and annotate Cohen drawing 3 below for a pair of axially adjacent non-impressed sections), however Cohen fails to disclose this separation by a cut. Hinman teaches a similar articulating section (100) for a steering various instruments, wherein Hinman discloses the a flexible elongated tube (100) that is formed as a single piece with separate vertebrae (102, 104, 106, etc.) wherein each vertebrae (102, 104, 106, etc.) are separated by a gap formed by a cutout section of the flexible elongated tube (100, see annotated Hinman drawing 1 below for cutout section and para. 0032). PNG media_image4.png 506 586 media_image4.png Greyscale Since Cohen teaches an articulating section (36) having separate vertebrae (52) assembled together to have gaps there between, and Hinman teaches a similar articulating section (100) having separated vertebrae (102, 104, 106, etc.) with cutouts therebetween, it would have been obvious for one of ordinary skill in the art to have modified the discrete and then assembled vertebrae of Cohen to be a singular tube with cutouts between each vertebrae as taught by Hinman such that the vertebrae (52) of modified Cohen would maintain the pair of axially adjacent non-impressed sections as annotated above in Cohen drawing 3 and be separated by a cutout as taught by Hinman. The motivation for this modification is that rather than the conventional articulating sections with unconnected vertebrae, Hinman’s mechanism provides links connected through living hinges which can allows the section to take on various complex three-dimensional configurations and geometries (see para. 0029). Examiner further notes that a singular tubing structure alleviates manufacturing and assembly costs that come with an articulating section formed from separate vertebrae. Regarding claim 4, modified Cohen discloses the flexible elongated tube of claim 3, as discussed above. In modified Cohen, the flexible elongated tube (36) of Cohen has been modified to be a singular tubing structure with the vertebrae (52) separated by cutout sections as taught by Hinman and annotated in the Hinman drawing 1 above such that modified Cohen discloses (Claim 4) a gap between at least some of the plurality of first indentations and some of the pairs of axially adjacent non-impressed sections and/or between at least some of the plurality of second indentations and some of the pairs of axially adjacent non-impressed sections, wherein the gap provides fluid communication between an interior of the flexible elongated tube (36) and an exterior thereof (see annotated Cohen drawing below for axially adjacent non-impressed section). PNG media_image3.png 577 791 media_image3.png Greyscale Examiner notes the gap formed by the modified cutout section of modified Cohen would be formed between each first indentation and its respective pair of axially adjacent non-impressed section and each second indentation and its respective pair of axially adjacent non-impressed section wherein the gap would be capable of providing fluid communication between an interior of the flexible elongated tube (36) and exterior thereof. Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Banik et al. (U.S Patent Pub. No. 20050075538 A1, “Banik”). Regarding claim 15, Cohen discloses the flexible elongated tube of claim 1, as discussed above. However, Cohen fails to disclose (Claim 15) wherein the flexible elongated tube is a single, continuous tube. Banik discloses a similar articulating section (750 in Fig. 13) for steering an endoscope (20 in Fig 1A, see para. 0135), wherein Banik discloses a flexible elongated tube (750 in Fig. 13) that is formed as a single piece with interconnected segments attached to one another through living hinges (760 in Fig. 13 and para. 0135-0136 and 0139). Thus, Banik teaches (Claim 15) the flexible elongated tube (750) is a single, continuous tube having a tubing wall of the flexible elongated tube (750) forming at least one continuous length of tubing wall in a portion of the flexible elongated tube (750) that follows each interconnected segment and living hinge (760) therebetween (see para. 0135-0136 and 0139). Since Cohen discloses an articulating section (36 in Fig. 3) formed of interconnected vertebrae (52 in Fig. 5) attached to one another at pivot points (53) and using the stiffening member (60 in Fig. 3), and Banik discloses a similar articulating section (750 in Fig. 13) formed as a single, continuous tube having interconnected segments attached to one another through living hinges (760 in Fig. 13), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pivot points taught by Cohen to be living hinges as taught by Banik. Examiner notes Banik teaches the living hinges (760) preserve the v-shaped cross-section of Cohen that allow the vertebrae to pivot relative to one another and thus bend the articulating assembly, and the stiffening member (60) of Cohen would still be present to ensure alignment of the interconnected segments and allow for substantially uniform flexure of the segments. Banik provides an easily manufactured and assembled articulating assembly that is either cut or molded from a single tube and remains one single piece (see para. 0139). Regarding claim 16, modified Cohen discloses the flexible elongated tube of claim 15, as discussed above. In modified Cohen, Cohen discloses (Claim 16) wherein the plurality of first indentations and the plurality of second indentations each comprise deformed portions of the tubing wall (see annotated Cohen drawing 2 above for indentations, see Fig. 5 – the indentations that form the 54 are portions of the tubing wall of the assembly 36 that are deformed inwards such that the shape of the inner lumen of the tubing wall is distorted). 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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM 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, Bhisma Mehta can be reached at 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. /KAYLA M. TURKOWSKI/ Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Oct 21, 2021
Application Filed
Nov 12, 2024
Non-Final Rejection — §102, §103, §112
Feb 14, 2025
Response Filed
Apr 16, 2025
Final Rejection — §102, §103, §112
Jul 02, 2025
Examiner Interview Summary
Jul 02, 2025
Applicant Interview (Telephonic)
Jul 10, 2025
Response after Non-Final Action
Jul 10, 2025
Applicant Interview (Telephonic)
Jul 29, 2025
Request for Continued Examination
Aug 01, 2025
Response after Non-Final Action
Sep 09, 2025
Non-Final Rejection — §102, §103, §112
Jan 08, 2026
Response Filed
Mar 26, 2026
Final Rejection — §102, §103, §112 (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

5-6
Expected OA Rounds
65%
Grant Probability
99%
With Interview (+54.4%)
4y 2m
Median Time to Grant
High
PTA Risk
Based on 60 resolved cases by this examiner. Grant probability derived from career allow rate.

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