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 .
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not persuasive. Applicant argues that the emitted light of Nelsen never exits the fiber and never enters the tissue and therefore the light interaction is within the glass of the fiber, not in the tissue. The Office respectfully disagrees. Nelsen discloses a tissue contacting surface (paragraph [0015]) of which light will contact. Pure internal fiber reflection without tissue would not support the claimed utility. In other words, the fibers are conduits for delivery and collection or light. Light is delivered via the fibers to the tissue interface and interacts with the tissue then is reflected back to the fiber for analysis (paragraphs [0063-68]). It is also noted that the optical sensors and sources must be fully capable of functioning in such a manner as the tissue itself cannot be claimed. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 and 16-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nelsen et al. (US 2023/0085418 A1).
Regarding claim 1, Nelsen discloses a system for measuring pressure exerted on a tissue (Title, paragraph [0053]), the system comprising:
a medical device (paragraph [0014] discloses a plurality of medical devices, e.g. a retractor) for exerting pressure on the tissue when the medical device is in contact with the tissue (a retractor is configured to hold tissue apart, thus exerting pressure on tissue that it is in contact with), the medical device comprising:
one or more optical sources (paragraph [0012] discloses a light emitter) configured to emit an incident light signal to the tissue (paragraphs [0012-13]); and
one or more optical sensors (paragraph [0058], ref. 106) configured to receive a reflected light signal that is reflected from the tissue (paragraphs [0003, 25, 58]) and further configured to measure light intensity as a function of time of the reflected light signal (the sensors emit incident light and detect reflected/transmitted light signals from the tissue, paragraph [0063]);
a processor in electronic communication with the one or more optical sensors (paragraph [0075]), the processor provided with machine-executable instructions to analyze the light-intensity as a function of the time to derive the pressure that the medical device exerts on the tissue at any given time (paragraph [0075] discloses that the processor(s) are configured to facilitate sensing strain along the fiber optic cable and paragraph [0079] discloses the function of executing instructions); and,
one or more output devices for reporting information about the pressure that the medical device exerts on the tissue at any given time (paragraph [0075] discloses display screens configured to work with the sensors and processors to display data).
Regarding claim 2, Nelsen discloses the system of claim 1, wherein at least one of the one or more optical sources emits light at one or more wavelengths (paragraph [0068] discloses a select wavelength and plural wavelengths).
Regarding claim 3, Nelsen discloses the system of claim 2, wherein at least one of the one or more optical sources emits continuous light or pulsed light (paragraph [0074] discloses continuous light).
Regarding claim 4, Nelsen discloses the system of claim 2, wherein at least one of the one or more optical sources comprises light-emitting diode or a laser (paragraph [0071] discloses LEDs and lasers).
Regarding claim 5, Nelsen discloses the system of claim 2, wherein at least one of the one or more optical sensors detects light within a range of wavelengths that includes the one or more wavelengths of the emitted light (paragraph [0068]).
Regarding claim 6, Nelsen discloses the system of claim 1, wherein the one or more optical sources and the one or more optical sensors are integrated into a single module in the medical device (the optical sources and sensors are considered to be a single module since they are independent units used to construct a more complex structure).
Regarding claim 7, Nelsen discloses the system of claim 1, wherein the medical device further comprises a flexible covering (paragraph [0106] discloses the retractor may be flexible, thus the outer surface is considered a flexible covering) and the one or more optical sources and the one or more optical sensors are built into the medical device or are part of the flexible covering (the components are built into the medical device/retractor).
Regarding claim 8, Nelsen discloses the system of claim 1, wherein the medical device comprises light guides (the fibers are considered to the light guides).
Regarding claim 9, Nelsen discloses the system of claim 8, wherein the light guides comprise fiber optic fibers (paragraph [0003]).
Regarding claim 10, Nelsen discloses the system of claim 1, wherein the medical device is a retractor configured to retract a portion of the tissue (paragraph [0014]).
Regarding claim 11, Nelsen discloses the system of claim 1, wherein the one or more optical sensors is configured to:
digitally measure the reflected light signal received by each of the one or more optical sensors (paragraph [0056]);
communicate the light-intensity measurement to the processor;
store a time series of the light-intensity measurements in an electronic memory (paragraphs [0054, 56, 73]); and,
report the light-intensity measurements using the one or more output devices (paragraph [0081]).
Regarding claim 16, Nelsen discloses the system of claim 1, wherein the information comprises at least one of a report of when a specified pressure threshold is reached or a plot showing a history of the exerted pressure over time (paragraph [0119] discloses visual indica and graphics to report information).
Regarding claim 17, Nelsen discloses the system of claim 1, wherein the processor is configured to measure vital signs of a patient using the light intensity of the reflected light signal and the one or more output devices is configured to output the vital signs of the patient (the system is used to measure loads/forces on the patient’s tissue, therefore being fully capable of measuring vital signs since the system uses a time varying signal related to the body).
Regarding claim 18, Nelsen discloses the system of claim 17, wherein the vital signs comprise one or more of a heart rate, a blood oxygenation and a blood pressure (because the vital signs are not part of the claimed invention, and because the system uses a time varying signal related to the body, it is fully capable of measuring vital signs such a pulse rate).
Regarding claim 19, Nelsen discloses the system of claim 1, further comprising a temperature sensor for measuring temperature where the medical device contacts the tissue (paragraph [0053] discloses temperature measurement).
Regarding claim 20, Nelsen discloses the system of claim 1, wherein the processor is external to the medical device and the system further comprises a communication port for coupling the one or more optical sensors to the processor (paragraph [0054] discloses an interrogator coupled to the device which is separate from the device and the coupling is the optical fiber link).
Regarding claim 21, Nelsen discloses the system of claim 20, wherein the communication port comprises at least one of a Universal Serial Bus (USB) port, an IEEE 1384 port, a serial port, a parallel port, a Personal Computer Memory Card International Association (PCMCIA) port, an Inter-Integrated Circuit (I2C) port, a Small Computer System Interface (SCSI) port, an optical port, a coaxial port, a Registered Jack 45 (RJ45) port and a Registered Jack 11 (RJ11) port, or a connector/connection for a mobile electronic device (paragraph [0081] discloses a USB port).
Regarding claim 22, Nelsen discloses the system of claim 1, wherein the processor is external to the medical device and the system further comprises a wireless protocol for the electronic communication between the one or more optical sensors and the processor (paragraphs [0081-82]).
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.
Claim(s) 12, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelsen et al. (US 2023/0085418 A1) in view of Henning et al. (US 2019/0132399 A1).
Regarding claim 12, Nelsen discloses the system of claim 1, wherein the machine executable instructions comprise instructions to:
determine the exerted pressure from the light-intensity as a function of the time using an algorithm that has been trained to correlate the light-intensity as a function of the time to the exerted pressure at any given time (paragraphs [0054, 76, 77, 138, 140]); and, report the information about the pressure using the one or more output devices (paragraph [0081]),
but is silent that the processor is a single-board micro-controller and
Henning teaches a system for programming an embedded system in the related configured for use with medical devices (Abstract, paragraph [0002]) comprising a processor that is a single-board micro-controller (paragraphs [0002, 24, 33, 41]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Nelsen to use a single-board micro-controller processor, as taught by Henning, for the purpose of smaller and faster electronic data analysis while also supporting a greater number of increasingly complex and sophisticated functions (paragraph [0002]).
Regarding claim 14, Nelsen in view of Henning discloses the system of claim 12, wherein the information about the pressure comprises a warning (Nelson, paragraph [0077] discloses an alarm and alert), the analysis program determines when at least one of a pre-set pressure or time threshold has been exceeded, and the analysis program provides the warning as part of the information reported using the one or more output devices (Nelson, paragraph [0077]).
Regarding claim 15, Nelsen in view of Henning discloses the system of claim 14, wherein the warning comprises at least one of a warning light, a tactile indication, a sound, or any combination thereof (Nelsen, paragraph [0077] discloses a sound).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelsen et al. (US 2023/0085418 A1) in view of Henning et al. (US 2019/0132399 A1) and further in view of Cella et al. (US 2019/0324439 A1).
Regarding claim 13, Nelsen in view of Henning discloses the system of claim 12, except wherein the algorithm comprises at least one of a decision tree, Kth nearest neighbours, a neural network, support vectors, or XGBoost™.
Cella teaches a data monitoring system in the related field of micro-controller processors for use in medical environments (Abstract, paragraph [0322]) wherein the data analysis comprising the use of decision tree based learning, artificial neural networks, support vector machines and K-nearest neighbors (paragraph [0328]). ]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Nelsen in view of Henning such that the algorithm comprises decision trees, Kth nearest neighbours, neural networks, support vectors or XGBoost™, as taught by Cella, for the purpose of enabling derivation-based learning outcomes from computers without the need to program them.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelsen et al. (US 2023/0085418 A1) in view of Mao et al. (US 2019/0150810 A1).
Regarding claim 23, Nelsen discloses the system of claim 22, except for further comprising a power source for the providing electrical power to the system, the power source comprising a battery.
Mao teaches a tissue retractor (Abstract) comprising a power source in the form of a battery (paragraph [0012]) and a power warning (paragraph [0012]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Nelsen to include the battery as a power source, as taught by Mao, for the purpose of better preventing functional loss due to power loss.
Regarding claim 24, Nelsen discloses the system of claim 1, except wherein the one or more optical sources are located at a tip of the medical device.
Mao teaches a tissue retractor (Abstract) comprising a sensor (ref. 355 paragraph [0093], Fig. 3) located on a tip of the rector (Fig. 3, 6A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Nelsen such that the one or more optical sources are located at a tip of the medical device to enable direct, localized, and real-time optical interaction of the tissue at the point of contact.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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