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 .
Terminal Disclaimer
The terminal disclaimer filed on 17 September disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12,130,127 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
The amendment filed 17 September 2026 has been entered. Claim(s) 1-10 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection to the claims, and each and every rejection under 35 U.S.C. 112(a) and 112(b) previously set forth in the Office Action mailed 17 June 2026. The double patenting rejection in view of US Patent No. 12, 130, 127 is withdrawn in light of the terminal disclaimer.
However, applicant has not addressed via terminal disclaimer the double patenting rejection of the claims in view of US 11525670, also presented in the Office Action mailed 17 June 2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-10 of U.S. Patent No. 11525670. Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patent claims encompass all limitations of the instant application claims.
Instant Application
Reference Patent US 11525670
Claim 1
Claim 1
It is noted that claim 1 of the reference refers to a heartbeat detecting means which may encompass an ECG component configured for detecting a sequence of heartbeats and to a heartbeat converter algorithm which may encompass converting a sequence of heartbeats into a heartbeat frequency from diastolic or systolic points in the sequence.
Claim 2
Claim 1
Claim 3
Claim 1
Claim 4
Claim 3
Claim 5
Claim 9
It is noted that claim 9 of the reference refers to a heart determiner algorithm which may encompass identifying periodic changes by a plurality of plots including the plot of curvature vs. time for each FBG sensor.
Claim 6
Claim 2
Claim 7
Claim 5
Claim 8
Claim 6
Claim 9
Claim 6
Claim 10
Claim 10
Response to Arguments
Applicant’s arguments, see pages 5-8 of Applicant's response, filed 17 September 2026, with respect to the rejection of the claims under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims has been withdrawn.
Conclusion
The claims are not presently rejected under 35 U.S.C. 102/103. The prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “convert FBG sensor-reflected optical signals from the optical fiber into plottable data by a plurality of optical signal-converter algorithms, the optical signal-converter algorithms including a band-pass filtering algorithm for a selection of the FBG sensors along the length of the optical fiber, the band-pass filtering algorithm configured to pass the FBG sensor-reflected optical signals or corresponding data occurring with one or more frequencies within a range of frequencies around the heartbeat frequency while rejecting the FBG sensor-reflected optical signals or the corresponding data occurring with the one or more frequencies outside the range of frequencies around the heartbeat frequency”.
Duindam (US 20130204124 A1) discloses - a shape-sensing system (abstract—a shape sensor for measuring the shape of the needle), comprising:
- a stylet (Paragraph 0015, 0038—steerable needle…a stylet; Fig. 3D, needle 110) comprising:
- an integrated optical-fiber stylet having a plurality of fiber Bragg grating ("FBG") sensors along a distal-end portion of the optical-fiber stylet (Paragraph 0047-0048-- shape sensor 120 can be a fiber optic bend sensor that includes a backscatter mechanism such as fiber Bragg gratings (FBGs); paragraph 0032-0038-- shape sensor 120 can include multiple shape sensors, where each shape sensor measures the shape of a continuous portion of the overall length of needle 110; shape sensor 120 shown at a distal tip in Figs. 2A-3F);
- a console including memory and one or more processors (fig. 6; paragraph 0032, 0044— the data read by shape sensor 120 is acquired and converted into usable shape information by a processor 140…control over needle 110 is provided via a console) configured to:
- convert FBG sensor-reflected optical signals from the optical-fiber stylet into plottable data by way of a plurality of optical signal converter algorithms (Paragraph 0051-0053-- Processor 140 detects the shape and position of steerable needle 110 and processes that information to assist in surgical procedures… Interrogator 141 interrogates the optical fiber of shape sensor 120 and provides shape information to input/output module 142. Processor module 143 then processes the information from input/output module 142 using a shape data processing module 144 (e.g., stored in memory within processor 140). The generated shape information for needle 110 can then be used to model the in-situ pose and/or shape of needle 110), and
- a display screen configured for displaying any plot of a plurality of plots of the plottable data (graphics module 148), the plurality of plots including a plot of curvature vs. time for each FBG sensor of the selection of the FBG sensors (Paragraph 0046-- Shape sensor 120 can be any type of shape sensor capable of measuring the curvature of flexible needle 110 during surgical use; Paragraph 0051-0054, 0060-0063-- graphics module 148 can be included simply to provide a visual representation of the shape data measured by shape sensor 120).
However, Duindam is silent as to an ECG component configured for detecting a sequence of heartbeats; convert the sequence of heartbeats into a heartbeat frequency by a heartbeat-converter algorithm; convert FBG sensor-reflected optical signals from the optical fiber into plottable data by a plurality of optical signal-converter algorithms, the optical signal-converter algorithms including a band-pass filtering algorithm for a selection of the FBG sensors along the length of the optical fiber, the band-pass filtering algorithm configured to pass the FBG sensor-reflected optical signals or corresponding data occurring with one or more frequencies within a range of frequencies around the heartbeat frequency while rejecting the FBG sensor-reflected optical signals or the corresponding data occurring with the one or more frequencies outside the range of frequencies around the heartbeat frequency.
Flexman (US 20150209117 A1) discloses a shape-sensing system, comprising: one or more medical devices (para 0009-- shape sensing system includes a shape sensing enabled medical instrument) including: an integrated optical-fiber stylet (para 0032--an optical fiber lumen 105; para 0057--The present principles apply to any integration of optical shape sensing into medical devices including manual catheters, actuated catheters (both manual and robotic), guide wires, stylets; see Fig. 1) having a plurality of fiber Bragg grating ("FBG") sensors along a distal-end portion of the optical-fiber stylet (para 0039--Shape sensing sensor 104 with on fiber optics may be based on fiber optic Bragg grating sensors. A fiber optic Bragg grating (FBG) is a short segment of optical fiber that reflects particular wavelengths of light and transmits all others; para 0041--Along the length of the fiber, at various positions, a multitude of FBG sensors can be located (e.g., 3 or more fiber sensing cores));
a console including memory and one or more processors configured to (para 0030--Workstation 112 preferably includes one or more processors 114 and memory 116 for storing programs and applications):
convert FBG sensor-reflected optical signals from the optical-fiber stylet into plottable data by way of a plurality of optical signal-converter algorithms (para 0062--In block 406, optical signals are received from one or more optical fibers disposed in the lumen. In block 410, the optical signals are interpreted to determine a shape of the instrument.; para 0030--an optical sensing module 115 configured to interpret optical feedback signals from a shape sensing sensor); and a display screen configured for displaying any plot of a plurality of plots of the plottable data, (para 0043--Workstation 112 includes the display 118 for viewing internal images of a subject (patient) or volume 131 and may include the image as an overlay or other rendering of the sensing sensor 104).
However, Flexman fails to disclose or suggest an ECG component for detecting a sequence of heartbeats; convert the sequence of heartbeats into a heartbeat frequency by way of a heartbeat-converter algorithm; the optical signal-converter algorithms including a bandpass filtering algorithm for a selection of the FBG sensors along a distal end portion of the optical-fiber stylet, the band-pass filtering algorithm configured to pass therethrough the FBG sensor-reflected optical signals or corresponding data occurring with one or more frequencies within a range of frequencies around the heartbeat frequency while rejecting the FBG sensor-reflected optical signals or corresponding data occurring with one or more frequencies outside the range of frequencies around the heartbeat frequency.
Demirtas (US 20160354038 A1) discloses a system, comprising: one or more medical devices (Abstract --Heart rate monitors) including:
a component for detecting a sequence of heartbeats (para 0034--a heart rate monitoring apparatus, according to some embodiments of the disclosure);
a console including memory and one or more processors (para 0035--The processor 206 can be a digital signal processor; para 0041--Data and/or instructions for performing the functions can be stored and maintained in memory 218) configured to:
convert the sequence of heartbeats into a heartbeat frequency by way of a heartbeat-converter algorithm (para 0039--The tracker 212 implements functions related to tracking the varying frequency, e.g., the heartbeat, based on the output from the signal conditioner 210 (corresponding to tracking component 306 of the method shown in FIG. 3). In other words, the tracker monitors the incoming data samples (raw data or as provided by the signal conditioner 210) and attempts to determine the frequency of the varying frequency present in the one or more signals from the sensors)
and a display screen configured for displaying any plot of a plurality of plots of the plottable data (para 0039--The output of the tracker 212, e.g., determined heart rate in beats per minute, can be provided to a user via output 214 (e.g., a speaker, a display, a haptic output device, etc.)).
However, Demirtas fails to disclose or suggest an optical fiber including a plurality of fiber Bragg grating (“FBG”) sensors along a length of the optical fiber; and convert FBG sensor-reflected optical signals from the optical fiber into plottable data by a plurality of optical signal-converter algorithms, the optical signal-converter algorithms including a band-pass filtering algorithm for a selection of the FBG sensors along the length of the optical fiber, the band-pass filtering algorithm configured to pass the FBG sensor-reflected optical signals or corresponding data occurring with one or more frequencies within a range of frequencies around the heartbeat frequency while rejecting the FBG sensor-reflected optical signals or the corresponding data occurring with the one or more frequencies outside the range of frequencies around the heartbeat frequency.
THIS ACTION IS MADE FINAL. 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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
