DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 12, 2025 has been entered.
The examiner confirmed with applicant on January 5, 2026 that claim 8 is canceled and the claim status for claim 19 has changed. The cancelation of claim 8 and the amendment of claim 19 were noted in the remarks, but the copy of the claims submitted on 12/12/2025 included text for claim 8 and a status identifier of “(Original)” for claim 19. Claim dependency of claims 9-10 and minor amendments are made below. Therefore, claims 1-7 and 9-19 are under consideration.
Examiner’s Amendment
Regarding claims 9-10, with applicant’s authorization, as noted above, claims 9 and 10 are amended as follows:
9. (Currently Amended) The measurement system according to claim [[8]]1, wherein the plurality of Bragg gratings comprises at least two Bragg gratings positioned in [[a]] said tip of the multicore fiber and wherein momentary shape information is derived based on the optical signals from said gratings in the tip in the multicore fiber.
10. (Currently Amended) The measurement system according to claim [[8]]1, wherein the plurality of Bragg gratings comprises Bragg gratings positioned along substantially a full length of the multicore fiber.
Drawings
Regarding the drawing objections in Non-Final office action mailed December 12, 2025 pertaining to claims 8-10, claim 8 is cancelled, but the pertinent subject matter remains in claim 1, and 9-10. There are at least two species of the grating sensors. One species of such sensors locate at the tip of the fiber and one species of sensor locates along the entire length of the fiber. Furthermore, there is shown an embodiment in Fig. 3 wherein there are at least 7 fiber cores and all 7 cores have FBG sensors, but it is unclear from the sparse disclosure of drawings how the fibers are sensors interact in a cladding for 7 cores. The sole figure of the cross section does not clarify the positions of the sensors on each of the 7 cores or how the 7 fibers lay within the cladding (e.g., straight or sinusoidal longitudinally). For these reasons, the multicore fiber having plurality of FBG sensors being positioned along a length of the multicore fiber should be shown in the drawings.
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 for assisting in guiding an elongated medical device in a body (Figs 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 in Fig. 2), 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 wavelength (sensor-specific Bragg wavelength) and to transmit the remaining light (Para [0043]), a known shape 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 at least the patient’s body region is known and the tubular structure may correspond to a vascular structure or cardio structure, a vessel structure in the brain or a bronchi structure or a bowel, Para [0030]), and for deriving based thereon, a length of a portion of the multicore fiber that has been introduced in the body (measure total insertion lengths of the optical fiber 12 as the optical fiber 12 is inserted into the object 14, Para [0032]), or a position of the multicore fiber with respect to the body (Para [0028]-[0035]),
wherein the measurement device is adapted to combine momentary shape information measured using a plurality of gratings positioned along the length of the multicore fiber (“The spectrometer device 54 is configured to measure the wavelength reflected from each FBG sensor comprised by the bending sensor units 50” [page 7 lines 1-2]) with previously recorded shape information from gratings positioned (“Under consideration of sensor-specific calibration data (e.g., stored in the memory 30 of the processor device 24 as described with regard to Fig. 1A), the spectrometer device 54 is configured to derive optical feedback signals. The optical feedback signals may be three-dimensional bending radii assigned to the portions of the optical fiber 12 at which the respective bending sensor units 50 are arranged” [Page 7, lines 2-5]) at a tip of the multicore fiber as a function of total length of the multicore fiber portion inserted into the body to provide a resolution higher than a spacing between the gratings. Breisacher discloses the trajectory of the optical fiber 12 and thus the shape of the flexible instrument may be reconstructed within an arbitrary object, such as the highly curved and branched tubular structure 34; wherein the optical fiber 12 only require a small number of bending sensor units (50) to achieve sufficient reconstruction accuracy. This advantage results from the possibility to individually control the reconstruction accuracy, such as the resolution, by controlling the size of the length increments (Page 10, Para [0075]). The example provided by Breisacher is two bending sensor units (“two gratings”), thus, the sensor in Breisacher’s invention is capable of reconstructing an arbitrary object with high visibility of curves and branched tubular structure with only two Bragg gratings is considered to provide “a resolution higher than a spacing between the gratings.”
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]).
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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 (guidewire 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]).
Regarding 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]).
Regarding 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]).
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]).
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]).
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]).
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]).
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]).
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]).
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 on December 12, 2025 have been fully considered but they are not persuasive. Applicant’s main argument is to Breisacher do not teach the amended limitation in claim 1. In response, examiner clarified with interpretation and citation to Breisacher’s disclosure for teaching “combin[ing] momentary shape information measured using a plurality of gratings positioned along the length of the multicore fiber with previously recorded shape information”. The “calibration data” is the “previously recorded shape information”. The calibrated data is disclosed with respect to Fig. 1 and Fig. 3C wherein the spatial relation of the instrument 62 of the optical fiber 12 included in the instrument 62 is predetermined (calibrated). The processor device 24 is configured to reconstruct the shape of the instrument 62 based on the reconstructed trajectory of the optical fiber (Page 10, Para [0070]). The “momentary shape information” is the measured wavelength reflected from each FBG sensor (Para [0046]). The combination of the “momentary shape information” and the “previously recorded shape information” is referenced as data pairs by Breisacher (Para [0006]). Therefore, Breisacher anticipated claim 1 as amended.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PTO-892:A-D are patents granted to The Administrator of the National Aeronautics and Space Administration for the fiber optic shape sensing (FOSS) technology.
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.
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/ERIN D CHIEM/Examiner, Art Unit 2874
/THOMAS A HOLLWEG/Supervisory Patent Examiner, Art Unit 2874