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
Acknowledgment is made to the amendment received 2/13/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Bitzer in view of Dreschel. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Bitzer in view of Brown.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 1, the claim recites the language “wherein the transducer body is made of silicon dioxide with crystallinity that is equal to or lower than 20%”. However, applicant’s specification states that “the amount of crystallinity is below 20%” on page 2, lines 20-25. Thus, there is no support in the disclosure for the claim language “wherein the transducer body is made of silicon dioxide with crystallinity that is equal to … 20%”. Therefore, claim 1 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement
Regarding dependent claims 2-15, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(a).
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 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.
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, 6-8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bitzer, US 20150359484, herein referred to as “Bitzer”, in view of Brown et al., US 20180031432, herein referred to as “Brown”.
Regarding claim 1, Bitzer discloses a catheter device (Figures 1A-B) comprising a measuring device (Figure 1A: planar force transducer element 1) for measuring a force effect on the catheter device ([0024] and [0035]), the measuring device comprising an elastically deformable transducer body ([0026] and [0041]) having a plurality of transducer portions (Figures 2A-B: recesses 1b, 1c, and 1d) and a sensor device arranged on the transducer body (Figures 2A-B: FBG sensor 1e), the transducer portions forming at least one pair of adjacent transducer portions (Figures 2A-B: recesses 1b, 1c, and 1d are adjacent to each other), which are connected to each other via a connecting portion (Figures 2A-B: substrate 1a) and are movable relative to each other with deformation of the connecting portion ([0041]), and the sensor device being designed to measure a force effect between the transducer portions of the at least one pair of adjacent transducer portions ([0024] and [0041]-[0042]). Bitzer does not explicitly disclose a catheter device wherein the transducer body is made of silicon dioxide with crystallinity that is equal to or lower than 20%.
However, Brown teaches a device (Figure 2) wherein the transducer body (Figure 2: pressure transducer 10a) is made of silicon dioxide with low crystallinity ([0017]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so that the transducer body is made of silicon dioxide with low crystallinity as taught by Brown because silicon dioxide is an elastic material that flexes in response to pressure being applied thereto, while at the same time is a sufficiently rigid to allow for a variety of different pressure ranges (Brown [0019]). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the crystallinity of the silicon dioxide is equal to or lower than 20%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Bitzer in view of Brown discloses the catheter device according to claim 1, and Bitzer further discloses a catheter device wherein a plurality of transducer portions are arranged in a line along a longitudinal axis (Figure 2B: recesses 1b, 1c, and 1d are arranged in a line along a longitudinal axis).
Regarding claim 7, Bitzer in view of Brown discloses the catheter device according to claim 6, and Bitzer further discloses a catheter device wherein the connecting portion of at least one pair of adjacent transducer portions (Figures 2A-B: substrate 1a) is bendable about a defined spatial direction extending transversely to the longitudinal axis in such a way that the transducer portions of the at least one pair of adjacent transducer portions are movable relative to each other about the defined spatial direction via the connecting portion (Figures 3A-C and [0041]-[0042]).
Regarding claim 8, Bitzer in view of Brown discloses the catheter device according to claim 6, and Bitzer further discloses a catheter device wherein the transducer body forms at least two pairs of adjacent transducer portions (Figures 2A-B: recesses 1b, 1c, and 1d are adjacent), which are each connected to each other via a connecting portion (Figures 2A-B: substrate 1a) and are movable relative to each other about different spatial directions extending transversely to the longitudinal axis (Figures 3A-C and [0041]-[0042]).
Regarding claim 10, Bitzer in view of Brown discloses the catheter device according to claim 1, and Bitzer further discloses a catheter device further comprising a protective sleeve in which the transducer body is arranged (Figures 1A-B: planar force transducer element 1 is arranged within resilient line body 3b) and to which the transducer body is firmly connected ([0033]: “FIG. 1A shows a planar force transducer element 1, mounted on a catheter tip 3a of an ablation electrode line” wherein catheter tip 3a and resilient line body 3b are connected thus planar force transducer element 1 and resilient line body 3b are connected).
Regarding claim 11, Bitzer in view of Brown discloses the catheter device according to claim 10, and Bitzer further discloses a catheter device further comprising a gap arranged radially between the transducer body and the protective sleeve (Figures 1A-B: there is a gap arranged radially between planar force transducer element 1 and resilient line body 3b).
Regarding claim 12, Bitzer in view of Brown discloses the catheter device according to claim 10, and Bitzer further discloses a catheter device wherein the transducer body is firmly connected at a first end to the protective sleeve ([0033]: “FIG. 1A shows a planar force transducer element 1, mounted on a catheter tip 3a of an ablation electrode line” wherein catheter tip 3a and resilient line body 3b are connected thus planar force transducer element 1 and resilient line body 3b are connected) and is movable with a second end, which is remote from the first end, relative to the protective sleeve (Figure 1A: planar force transducer element 1 is movable relative to the proximal end of resilient line body 3b).
Regarding claim 13, Bitzer in view of Brown discloses the catheter device according to claim 12, and Bitzer further discloses a catheter device further comprising a functional electrode for introducing an electrical signal into tissue (Figure 1B: ring electrodes 7’), wherein the functional electrode is arranged at the second end of the transducer body (Figure 1B: the ring electrode 7’ at the top of the figure is arranged at the second end of the transducer body).
Regarding claim 14, Bitzer in view of Brown discloses the catheter device according to claim 12, and Bitzer further discloses a catheter device further comprising an elastically deformable sealing element (Figure 1A: resilient plastic overmoulding 9) for sealing a transition between the protective sleeve and the second end of the transducer body (Figures 1A-B and [0033]).
Regarding claim 15, Bitzer in view of Brown discloses the catheter device according to claim 10, and Bitzer further discloses a catheter device wherein the protective sleeve forms a stop for limiting elastic deformation of the transducer body (Figures 1A-B: resilient line body 3b forms a stop for limiting elastic deformation of planar force transducer element 1).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bitzer in view of Brown, further in view of Udd, US 20090123111, herein referred to as “Udd”.
Regarding claim 2, Bitzer in view of Brown discloses the catheter device according to claim 1, but does not explicitly disclose a catheter device wherein the sensor device comprises an optical fiber arranged on the transducer body, said optical fiber comprising at least one optical grating for measuring a force effect between the transducer portions of the at least one pair of adjacent transducer portions.
However, Udd teaches a catheter device wherein the sensor device comprises an optical fiber arranged on the transducer body (Figure 10: fibers 116), said optical fiber comprising at least one optical grating (Figure 10: gratings 302 and [0100]: “an optical fiber sensor 115 including multiple fibers 116 having one or more respective gratings 302”) for measuring a force effect between the transducer portions of the at least one pair of adjacent transducer portions ([0100] and [0106]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so the sensor device comprises an optical fiber arranged on the transducer body, said optical fiber comprising at least one optical grating for measuring a force effect between the transducer portions of the at least one pair of adjacent transducer portions as taught by Udd to provide information or feedback to the surgeon to accurately navigate extension tools and place the working portions of the extension tools at the target site for performing diagnostic and/or interventional procedures on the target tissue (Udd [0016]).
Regarding claim 3, Bitzer in view of Brown and Udd discloses the catheter device according to claim 1, and Udd further discloses a catheter device wherein the optical fiber (Figure 10: fibers 116) is formed by a glass fiber ([0094]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so that the optical fiber is formed by a glass fiber as taught by Udd to provide information or feedback to the surgeon to accurately navigate extension tools and place the working portions of the extension tools at the target site for performing diagnostic and/or interventional procedures on the target tissue (Udd [0016]).
Regarding claim 4, Bitzer in view of Brown and Udd discloses the catheter device according to claim 2, and Udd further discloses a catheter device wherein the optical fiber is connected to the transducer portions of the transducer body by bonding, glass soldering, eutectic soldering or welding ([0094]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so that the optical fiber is connected to the transducer portions of the transducer body by bonding, glass soldering as taught by Udd to ensure that the components are fused together (Udd [0094]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bitzer in view of Brown and Udd, further in view of Pratten et al., US 20180168729, herein referred to as “Pratten”.
Regarding claim 5, Bitzer in view of Brown and Udd discloses the catheter device according to claim 2, but does not explicitly disclose a catheter device wherein a pigtail, which is connected to the transducer body, is separate from the optical fiber, and is optically coupled to the optical fiber at a connection point on the transducer body.
However, Pratten teaches a catheter device (Figure 1) wherein a pigtail (Figure 8A: pigtail 606), which is connected to the transducer body (Figure 8A: platform member 616), is separate from the optical fiber (Figure 8A: optical fibre 614 and size optical fibres 610A and 610D), and is optically coupled to the optical fiber at a connection point on the transducer body ([0206] and Figure 8A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so that it includes a pigtail, which is connected to the transducer body, is separate from the optical fiber, and is optically coupled to the optical fiber at a connection point on the transducer body as taught by Pratten to retain the leading ends of a plurality of first conduits for optical imaging beams (Pratten [0206]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bitzer in view of Brown, further in view of Pratten.
Regarding claim 9, Bitzer in view of Brown discloses the catheter device according to claim 1, but does not explicitly disclose a catheter device wherein the transducer body has a cooling channel for conducting a coolant.
However, Pratten teaches a catheter device wherein the transducer body has a cooling channel for conducting a coolant ([0108]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter device of Bitzer so that it the transducer body has a cooling channel for conducting a coolant as taught by Pratten to remove debris from the ablation site of the catheter (Pratten [0108]).
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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794