DETAILED ACTION
This office action is in response to applicant’s amendment filed on July 13, 2026. Claims 1-7 and 9-19 are under consideration.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature of “the plurality of Bragg gratings comprises at least two Bragg gratings positioned in said tip of the multicore fiber” as recited in claim 9 and the feature of “the plurality of Bragg gratings comprises Bragg gratings positioned along substantially a full length of the multicore fiber” as recited in claim 10, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
In light of applicant’s arguments (Remark: 12/15, first partial paragraph) indicating the measurement device is a “single measurement device”, it is unclear to the examiner how Figs. 1-4 shows a single measurement device. The most comprehensive figure is Fig. 4 showing “an experimental set-up” with a catheter sleeve containing the optical fiber is inserted from the left side passing first the guiding means after which it enters the vessel phantom (Brief Description of the Drawings). This experimental set-up does not show a light source, a detector, a processor for collecting optical signals from the Bragg sensors and process the data into relevant parameters such as strain and stress. Thus, none of the figures shows “a measurement device”, as recited in claim 1 Therefore, the feature of “a measurement device” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breisacher (EP-3037056-A1, hereinafter “Breisacher”).
Claim 1. Breisacher discloses a measurement system (system shown in Fig. 1B) for assisting in guiding an elongated medical device in a body (Fig. 1A - 2), the measurement system comprising
a multicore fiber (12) for insertion into the elongated medical device (34), the multicore fiber comprising a plurality of cores (three fiber cores or three single-core fibers in Fig. 2, Para [0042]), whereby a plurality of Bragg gratings being positioned along a length of the multicore fiber (gratings are inscribed in the multicore fiber (FBG, Paras [0042]-[0043], claim 8), and
a measurement device (interrogation device 18, measuring device 20, tracked device 42, tracking device 40 as shown in Fig. 1B), being configured for determining, based on the optical signals measured from the multicore fiber after interaction with the plurality of Bragg gratings, from the plurality of cores (“the FBG sensors are configured to reflect light of a sensor-specific Bragg wavelength and to transmit the remaining light, Para [0043]), a known shape (Imaging device 22 captures 2-D or 3-D image data of object 14; Para [0033]. The processor device 24 controls the visualization device 26 to update the visualization as the insertion proceeds. The reconstructed trajectory of the optical fiber 12 superimposes image data of the tubular structure 34; Para [0059]) applied to the multicore fiber (the known shape is predetermined by a guide wire for the instrument may be placed in the object prior to the instrument, Para [0029] or data from imaging device 22), the known shape being a predetermined shape or a shape determined by the insertion path (“processor device 24 configured to reconstruct a shape of the catheter based on the reconstructed trajectory of the optical fiber. In this case, a spatial relation of the optical fiber 12 to the catheter may be predetermined (“known”) and evaluated for catheter shape reconstruction” Para [0036]);
wherein the measurement device is adapted for identifying a location of the known shape on the multicore fiber and for deriving based thereon, a length of a portion of the multicore fiber that has been introduced in the body or a position of the multicore fiber with respect to the body
(The tracking system comprises a tracking device 40 and a complementary tracked device 42 wherein the tracking system is configured to track a position of at least one of the bending sensor units of the optical fiber 12 within the object 14; Para [0039]. “The measurement device 20 is configured to measure insertion length increments of the optical fiber 12.” Para [0047], the detailed steps for measuring the length of a portion of the multicore fiber is described in Paras [0052]-[0056]).
Claim 2. The measurement system according to claim 1, wherein the known shape is a shape induced by the insertion of the elongated medical device in the body (guide wire, Para 0029]).
Claim 3. The measurement system according to claim 2, wherein the known shape is patient specific (patient vascular structure or cardio structure, Para [0030]).
Claim 4. The measurement system according to claim 3, wherein the known shape is induced by a patient’s physiological characteristics (e.g., brain, bronchi structure, bowel, cardio structure, Para [0030]).
Claim 5. The measurement system according to claim 1, wherein the known shape is determined using an imaging technique (CT scanner, PET scanner, X-ray fluoroscopy, Para [0033]).
Claim 6. The measurement system according to claim 1, wherein the known shape is a predetermined shape applied using a specific application means being a guiding element for guiding the elongated medical device (guide wire Para [0029]).
Claim 7. The measurement system according to claim 6, the measurement system furthermore comprising the guiding element for guiding the elongated medical device, said guiding element being positionable at a known distance with reference to an entrance point of the elongated medical device in the body (catheter, Para [0018]), the guiding element (guidewire) inducing known shape to the elongated medical device and the multicore fiber inserted therein and the measurement device being adapted for determining, based on the optical signals measured from the multicore fiber, the position of the known shape on the elongated medical device and for determining the length of the inserted portion of the elongated medical device based thereon (Paras [0029]-[0032]).
Claim 9, Breisacher discloses the plurality of Bragg gratings comprises at least two Bragg gratings positioned in the tip of the multicore fiber and wherein the shape information is derived based on the optical signals from said gratings in the tip in the multicore fiber (two sensor units 50 in Fig. 2, Paras [0042]-[0043]).
Claim 10. Breisacher discloses the plurality of Bragg gratings comprises Bragg gratings positioned along substantially the full length of the multicore fiber (1-50 sensors would necessarily occupy the full length of the fiber, Para [0007]).
Claim 11. The measurement system according to claim 1, wherein length information of the portion of the multicore fiber inserted in the body or the position is being determined based on optical signals from the plurality of cores of the multicore fiber (data pair is of optical feedback signals and insertion length increments of the optical fiber measured by successive points in time, Para [0035]).
Claim 12. The measurement system according to claim 1, wherein the measurement device is adapted for obtaining information regarding the length of the portion of the multicore fiber inserted in the body or the position of the multicore fiber based on fitting obtained shape information of the optical fiber at the location of the known shape (a spatial relation of the multicore fiber 12 to the catheter may be predetermined and evaluated for the catheter shape reconstruction, Paras [0035]- [0036]).
Claim 13. The measurement system according to claim 1, wherein the measurement device is adapted for obtaining information regarding the shape of the portion of the multicore fiber inserted in the body based on optical signals obtained during insertion or retraction of the multicore fiber from the Bragg gratings in the tip of the multicore fiber (sensors 50 in Fig. 2, Paras [0035]-[0036]).
Claim 14. The measurement system according to claim 1, wherein the measurement device is adapted for obtaining information regarding the shape of the elongated medical device including a view of the 3D shape of the elongated medical device with respect to the known shape (Paras [0033] and [0046]).
Claim 15. The measurement system according to claim 1, wherein the measurement system furthermore comprises a data output, an auditive output or a visual output for outputting shape information taking into account referencing of a coordinate system coupled to the multicore fiber with respect to a coordinate system of the body or an image thereof (visualization device 26, Para [0021]).
Claim 16. The measurement system according to claim 1, wherein the measurement device is adapted for determining a relative orientation of the tip of an elongated medical device with respect to a coordinate system of the body or an image thereof (Para [0032]).
Claim 17. The measurement system according to claim 1, wherein the measurement device is adapted for determining, based on the optical signals, a speed of inserting or retracting of the elongated medical device comprising the multicore fiber (data pair is of optical feedback signals and insertion length increments of the optical fiber measured by successive points in time, Para [0035]).
Claim 18. A graphical user interface adapted for showing a length of a portion of an elongated medical device that has been introduced in a body or for showing a position of an elongated medical device in a body, based on determination of a known shape applied to the elongated medical device, the known shape being determined based on optical signals measured using a measurement system according to claim 1 (visualization device 26, Para [0021]).
Claim 19. A non-transitory computer program product adapted for, when run on a processor, performing the steps of determining a length of a portion of an elongated medical device that has been introduced in a body for determining a position of an elongated medical device in a body, based on a determination of a known shape applied to the elongated medical device, the known shape being determined based on optical signals measured using a measurement system according to claim 1 (Para [0033]-[0038]).
Response to Arguments
Applicant's arguments filed July 13, 2026 have been fully considered but they are not persuasive.
Applicant argues Breisacher does not teach the amended limitations of claim 1. The rejection to claim 1 above has been modified to address the newly amended limitations.
The examiner respectfully notes the invention of claim 1 is drawn to a measurement system. The physical structures are:
Elongated medical device
Multicore fiber comprising a plurality of cores
Bragg gratings are inscribed in the multicore fiber along a length of the multicore fiber; and
A measurement device.
Besides the structures listed above, the entirety of the claim is reciting the functional limitations.
Applicant further argues Breisacher uses “data pair” in the system “to reconstruct the trajectory of the optical fiber along its inserted length,” as not meeting the limitations of claim 1 (Remarks page 11/15, second paragraph).
Examiner disagrees. Breisacher teaches all the structures listed above and Breisacher teaches the fiber optic sensing system for detecting the shape and length/position of the body by “identifying a location of the known shape” based on “a length of a portion of the multicore fiber that has been introduced in the body” (Paras [0039], [0047], and [0052]-[0056]).
In contrast, claim 1 recites:
a measurement device being configured for determining, based on optical signals measured in the multicore fiber – (lines 7-8)
a known shape is applied to the multicore fiber – (line 9)
the measurement device is adapted for identifying a location of the known shape -- (line 13-14)
None of the functional limitations cited above imparts any structural differences from the measurement system of Breisacher. Therefore, applicant’s argument is not persuasive.
Applicant argues Breisacher does not teach the “known shape” and Breisacher does not teach “a known shape appears on the fiber” (Remarks, page 11/15, third and fourth paragraph).
The examiner disagrees. Breisacher teaches the known shape can be obtained through the guide leading the optical fiber and the data pairs can be reconstructed (Paras [0049]-[0050]). Breisacher goes further to teach the known shape can be obtained through 2-D or 3-D imaging and he reconstructed trajectory of the optical fiber 12 superimposes image data of the tubular structure 34; Para [0059]). This technique is the same as applicant’s method of obtaining the “known shape” (Specification Para [0023]). Moreover, applicant argues Breisacher does not teach “a known shape appears on the fiber.” This argument is not persuasive because this limitation is not found in the Specification or the claims.
Applicant argues Breisacher fails to disclose “two-step process (shape location identification and length derivation based thereon), and further fails to disclose such using a single measurement device to achieve such” (Remarks: page 12/15, first partial paragraph).
Respectfully, claim 1 recites a measurement system, a device claim, wherein the Breisacher teaches all the structures required by claim 1. Since claim 1 is not a process or method claim, anticipation rejection of Breisacher does not require the art to anticipate the same method steps. Breisacher teach all the structural limitations and the functional limitations of claim 1 then the measurement device of Breisacher is capable of being “adapted for identifying a location of the known shape on the multicore fiber and for deriving based thereon, a length of a portion of the multicore fiber that has been introduced in the body or a position of the multicore fiber with respect to the body” (MPEP § 2114 (II)).
Applicant further argues the components of Breisacher cannot achieve the functions as recited in claim 1 because it is not a simple modification, but a fundamental inversion of Breisacher’s operating principle and Breisacher cannot achieve the functions of a “single sensing modality (e.g., optical signals from the multicore fiber’s Bragg gratings) to perform both shape detection and insertion length/position derivation” (Remarks: 12/15, third and fourth full paragraphs).
Examiner disagrees. Breisacher teaches multicore fiber’s Bragg gratings (Paras [0018] and [0042]-[0043]) and a “known shape” is available via imaging data (Paras [0049]-[0050]). Therefore, the examiner considers Breisacher teaches the measurement system of claim 1, as broadly recited.
As for the remaining arguments in on pages 13/15 and 14/15, applicant continues to argue Breisacher not teaching “a known shape” and not teaching the shape detection and insertion length/position derivation.
Respectfully, the rejections and responses above addressed the similarity between applicant’s invention of determining “known shape” using imaging device is the same as Breisacher (Para [0033]). And the measurement system of Breisacher teaches deriving shape detection and insertion length/position derivation in details throughout the publication and more focused in Paras [0051]-[0056]). Therefore, the examiner finds these arguments not persuasive.
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 Erin D Chiem whose telephone number is (571)272-3102. The examiner can normally be reached 10 am - 6 pm.
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 A. Hollweg can be reached at (571) 270-1739. 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.
/ERIN D CHIEM/Examiner, Art Unit 2874
/THOMAS A HOLLWEG/Supervisory Patent Examiner, Art Unit 2874
