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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Response to Amendment
This action is in response to the RCE amendments filed on 11/20/2025. The amendments filed on 11/20/2025 have been entered. Amended Drawings are entered and previous Drawing objections are withdrawn. Claims 1-12 and 17 are canceled. Accordingly Claims 13-14 and 18 are pending.
Claim Rejections - 35 USC § 112
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 13-14 and 18 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.
Regarding Claim 13, limitation “…controlling at least one operating state indicating light element that is assigned to a localizer input port used to connect the localizer to the navigation unit to indicate visually the determined localizer operating state of the localizer…” is unclear what is entailed in “visually”. It is unclear if the indication is on a display or a signal or the metes and bounds with respect to the preamble. It is also unclear the connection of the controlling of the operating state with the visual indication. The metes and bounds of the claim as a whole is unclear.
Regrading claim 18, it is unclear the connection, if any, to the “…determining the localizer operating state…” limitation with that of claim 13 from which it depends. It is unclear if the signal-to-noise ratio is intended to be obtained in the “…receiving a localizer signal…” step of claim 1 and the correlation to position and orientation indication of the localizer, if any. Claim 13 and 18 determination limitations are conditional limitations it is unclear the metes and bound of the claim limitations in the instance conditions for determining the localizer state are met or not.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et. al. (U. 20160058322, March 3, 2016)(hereinafter, “Brister”) in view of Moctezuma de la Barrera et. al. (U.S. 20160361101, December 15, 2016)(hereinafter, “Moctezuma”).
Regarding Claim 13, Brister teaches: A method for visually indicating a localizer operating state of a localizer (“…a method is provided for electromagnetically locating an intragastric device inside the body of a patient…” [0063]), the method comprising the steps of:
operatively connecting a localizer to a navigation unit, the localizer being configured for capturing a navigation field and for providing a localizer signal (“…the system control unit 1535 provides an interface between components of the system 1500. The system control unit 1535 may also supply power to the field generator 1510 and/or control the field generator's 1510 electromagnetic output. The system control unit 1535 may also collect sensor data (via the sensor interface unit 1530) and calculates sensor positions and orientations...” [0641];“The sensor interface unit ports 1925 connect the sensor interface units to the system control unit, allowing for communication with the connected sensors. For example, the ports 1925 may be used to connect the sensor interface unit 1630 to the system control unit 1635 to enable communication with the sensors 1506.” [0683]),
generating a navigation field for determining position and orientation of the localizer in the navigation field (“…the system control unit 1535 provides an interface between components of the system 1500. The system control unit 1535 may also supply power to the field generator 1510 and/or control the field generator's 1510 electromagnetic output. The system control unit 1535 may also collect sensor data (via the sensor interface unit 1530) and calculates sensor positions and orientations...” [0641]),
receiving a localizer signal from the localizer and processing the received localizer signal in order to determine position and orientation of the localizer in the navigation field (“The sensor interface unit ports 1925 connect the sensor interface units to the system control unit, allowing for communication with the connected sensors. For example, the ports 1925 may be used to connect the sensor interface unit 1630 to the system control unit 1635 to enable communication with the sensors 1506.” [0683]),
determining a localizer operating state based on the received localizer signal and whether or not the received localizer signal represents position and orientation of the localizer in the navigation field (“…the system control unit 1535 may also interface with the computer. The system control unit 1535 may also provide visual status indications.” [0641]), and
controlling at least one operating state indicating light element that is assigned to a localizer input port used to connect the localizer to the navigation unit to indicate visually the determined localizer operating state of the localizer (“The panel 1915 includes a field generator port 1920 and multiple sensor interface unit ports 1925 and status lights 1926. The port 1920 may be used to synchronize the system control unit 1910 to other equipment. The sensor interface unit ports 1925 connect the sensor interface units to the system control unit, allowing for communication with the connected sensors. For example, the ports 1925 may be used to connect the sensor interface unit 1630 to the system control unit 1635 to enable communication with the sensors 1506. The status lights 1926 may indicate whether the corresponding port 1925 is connected with a sensor or catheter.” [0683]).
Brister does not explicitly state the localizer operating state and the light element is visualized based on the operating state determined by the state determination unit.
Moctezuma in the field of tracking and navigation systems teaches LED indicators visualized color representing when the determined rotational position is reached of a tracker determined by a navigation computer [state determination unit] [0221-0222].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the localizer operating state and light element visualization of Brister to be based on the operating state determined by the state determination unit as taught in Moctezuma for providing indications of current operating state and visual references to identify when target state has been reached to a user.
Regarding Claim 14, the combination of Brister in view of Moctezuma substantially teach the claim limitations as noted above.
Brister further teaches: determining an internal operating state of the navigation unit, and controlling at least one internal state indicating light element to indicate visually the determined internal operating state of the navigation unit (“… the external display may be on the controller 86, the external display 87 and/or the wireless external display 88 shown in FIGS. 69A-B. The external display may also contain the ability to perform analysis of the collected data for further diagnostic capabilities. The external display may have the capability to gather the data and display it in a variety of presentations. It may display raw data, averages, or it could analyze the data and diagnose a generalized state as being appropriate or inappropriate…an inappropriate state might be displayed with a red light while an appropriate state might be indicated with a green light. Similarly, the external display could be shown in a lighted bar graph where a more appropriate state is indicated by more bars and a less appropriate state is indicated by less bars.” [1053]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Brister and Moctezuma as applied to claim 13 above, and further in view of Acker et. al. (6366799, April 2, 2002)(hereinafter, “Acker”).
Regarding Claim 18, the combination of Brister in view of Moctezuma substantially teach the claim limitations as noted above.
Brister further teaches comprising determining a localizer operating state based on the received localizer signal and whether or not the received localizer signal represents position and orientation of the localizer in the navigation field (“…the system control unit 1535 may also interface with the computer. The system control unit 1535 may also provide visual status indications.” [0641]).
Brister does not teach signal-to-noise in correlation to signal position and orientation.
Acker in the field of systems for probe disposition determination teaches: “…with the use one or more transducers in a probe locating system, there is a region of volume associated with the transducers in which the signal-to-noise ratio of the assembly is optimized…allowing higher accuracy field measurements to be made. With prior probe location systems in which the reference transducers are mounted in fixed positions about the patient bed, however, this optimal region will typically encompass a large area to account for possible movement of the probe throughout the patient.” (column 12, lines 31-40).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the signal position and orientation of Brister to correlate to signal-to-noise ratio as taught in Acker for “…higher accuracy field measurements to be made.” (Acker, column 12, lines 31-33).
Response to Arguments
With regards to Applicant’s remarks regarding claim 13 limitation “..determining a localizer operating state based on the received localizer signal and whether or not the received localizer signal represents position and orientation of the localizer in the navigation field…”, as discussed in the interview on 1/14/26, the limitation interpretation may be construed as a conditional limitation where the conditional limitations may not be given a full weight in light of: In the recent Ex parte Gopalan decision, the PTAB addressed a claim where all of the features were recited in a conditional manner. A first step of “identifying … an outlier” was performed if “traffic is outside of a prediction interval.” A second step of “identifying” was performed “only when a count of outliers … is greater than or equal to two, and exceeds an anomaly threshold.” These were the only two elements of the independent claim. Thus, if the traffic is never outside Gopalan’s prediction interval, then the steps of the method are never performed.
However, the PTAB distinguished Schulhauser and noted that this construction “would render the entire claim meaningless.” Gopalan at p. 5. The Board went on to state, “Although each of these steps is conditional, they are integrated into one method or path and do not cause the claim to diverge into two methods or paths, as in Schulhauser. Thus, we conclude that the broadest reasonable interpretation of claim 1 requires the performance of both steps…” Id. at p. 6.”
Thus, respectfully Applicant’s interpretations of the limitation and the proceeding “controlling” limitations are narrower than that of the recited claims. Further, Applicant’s arguments are circular and do not provide clear factual explanation as to Applicant’s reasoning the combination of Brister and Moctezuma do not teach the recited claim limitation. Applicant provides opinions regarding deemed shortcomings of the prior art combination not leading to claimed invention but not the specific limitations nor factual evidence as to why the combination would not provide the recited claim limitations. Applicant argues “…There is no guidance provided in either Brister or Moctezuma as to how the ordinarily skilled artisan can combine the Brister and Moctezuma to not only visually indicate that the localizer is transmitting and also process the position and orientation of the localizer to visually indicate the localizer operating state, as is required by the present claims.” (Remarks pg. 4), yet respectfully this interpretation is narrower than the recited claim as the claims do not currently visually indicate the information but rather a controlling of operation step that is connected to a conditional limitation is recited. Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).”
Conclusion
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/AMAL ALY FARAG/ Primary Examiner, Art Unit 3798