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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 3, and 5-6 are objected to because of the following informalities:
Claim 1, line 10-11 “the optical signal-converter algorithms” should be “the plurality of optical signal-converter algorithms”.
Claim 1, line 12 “the FBG sensors” should be “the plurality of FBG sensors”.
Claim 3, line 3 “the selection of the FBG sensors” should be “the selection of the plurality of FBG sensors”.
Claim 5, line 4 “the selection of the FBG sensors” should be “the selection of the plurality of FBG sensors”.
Claim 6, line 2 “the FBG sensors” should be “FBG sensors”.
Claim 6, line 3 “the selection of the FBG sensors” should be “the selection of the plurality of FBG sensors”.
Appropriate correction is required.
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 1-10 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.
Specifically, claim 1 recites "a heartbeat-converter algorithm" 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. In each case, the written description fails to provide sufficient detail of the steps of the algorithm to perform the claimed functions of the algorithms.
Regarding “a heartbeat-converter algorithm”, some discussion of the algorithm takes place in paragraph 0065 of the instant specification. However, the disclosure appears to describe the outcome and use of the algorithm rather than the algorithm itself, as it merely describes that a determined heartbeat frequency can be used by further algorithms and that the frequency can be derived from a sequence of heartbeats using the algorithm. While the cited paragraph makes some discussion of how the sequence of heartbeats may change “with respect to the diastolic or systolic points” in the sequence, it fails to describe how this sequence is converted by the algorithm into a heartbeat frequency.
Regarding “a heart-determiner algorithm”, some discussion of the algorithm takes place in paragraph 0069 of the instant specification. However, the disclosure appears to merely describe how the algorithm is used (e.g., to determine the distinctive change in the strain of the stylet and to confirm that the tip of the stylet is in the heart), without the algorithm itself and how it performs this function.
Claims 2-10 are rejected under 35 U.S.C. 112(a) as dependents of claim 1, which has been rejected for lacking written description.
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 4, 7, and 9 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.
The term “substantially” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what range of heartbeat-related hydrodynamic noise is permitted under the phrase "substantially free".
Claim 7 recites the limitation “electrocardiogram (“ECG”) electrodes electrically connected by a cable to ECG componentry in the console for detecting the sequence of heartbeats”. It is not clear if this limitation is meant to describe the components of the “ECG component configured for detecting a sequence of heartbeats” as described in claim 1, if the ECG componentry of the console is itself the same as the ECG component, or if these each of these are separate components which are used for the detection of a sequence of heartbeats. The specification fails to provide clarity, as there is no mention of an ”ECG component” as claimed in claim 1 in the specification and the most relevant passage, paragraph 0064, describes that “electrocardiogram (“ECG”) electrodes electrically connected by a cable to ECG componentry in the console for detecting the sequence of heartbeats” may be heartbeat-detecting means rather than clarifying a relationship to the ECG component of claim 1. The limitation is currently interpreted as ECG component and ECG componentry referring to the same component, which is a component of the console for detecting the sequence of heartbeats.
Claim 9 recites the limitation “electrocardiogram (“ECG”) componentry in the console for detecting the sequence of heartbeats”. It is not clear if this limitation is meant to describe the components of the “ECG component configured for detecting a sequence of heartbeats” as described in claim 1, if the ECG componentry of the console is itself the same as the ECG component, or if these each of these are separate components which are used for the detection of a sequence of heartbeats. The specification fails to provide clarity, as there is no mention of an ”ECG component” as claimed in claim 1 in the specification and the most relevant passage, paragraph 0064, describes that “electrocardiogram (“ECG”) componentry in the console for detecting the sequence of heartbeats” may be heartbeat-detecting means rather than clarifying a relationship to the ECG component of claim 1. The limitation is currently interpreted as ECG component and ECG componentry referring to the same component, which is a component of the console for detecting the sequence of heartbeats.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11 of U.S. Patent No. 12130127. 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 12130127
Claim 1
Claim 1
It is noted that claim 1 of the reference refers to a heartbeat detecting device which may encompass an ECG component configured for detecting a sequence of heartbeats.
Claim 2
Claim 1
Claim 3
Claim 2
Claim 4
Claim 3
Claim 5
Claim 4
Claim 6
Claim 5
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 11
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.
Claim 2
Claim 1
Claim 3
Claim 1
Claim 4
Claim 3
Claim 5
Claim 9
Claim 6
Claim 2
Claim 7
Claim 5
Claim 8
Claim 6
Claim 9
Claim 6
Claim 10
Claim 10
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.
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
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