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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10 and 19-20) in the reply filed on 5/6/2026 is acknowledged.
Claims 21-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/6/2026.
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 1-10 and 19-20 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.
In regard to claim 1, the limitation “and to control medicament delivery via the sensing needle based on at least the first classification” renders the claim indefinite because it is unclear if the applicant is claiming the structure required to deliver medicament (ex., a pump) or if the applicant is merely reciting the ability to send a signal. For the purpose of this action, the examiner is interpreting the limitation to be the latter. If the applicant intends for the former interpretation, amendments positively reciting a medicament delivery structure as part of the system should be made.
The examiner notes that claim 4 does not obviate the issue because functionally “enabling” a medicament delivery pump is still not positively reciting the pump as part of the system.
All of the dependent claims are rejected by virtue of their dependency on the rejected independent claim.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carreel et al. (US 2019/0380651; hereafter Carreel).
As per claim 1, Carreel discloses a tissue classification system (detecting characteristics of tissues; Abstract) (classification processes; paragraph [0312]) for medicament delivery (deliver a treatment to the lesion; paragraph [0021]), comprising: a tube for inserting into an anatomy (such an insertable device would include a hollow tube; paragraph [0067]); a sensing needle at a distal end of the tube (the sensor may be disposed in diagnosis and/or treatment devices such as needles; In some embodiments, the sensor is disposed near the distal end of the medical device; paragraph [0348]), the sensing needle including: a first set of electrodes that are selectively activated in response to an activation signal to generate a first electric field that passes through a first group of cells of the anatomy (some of the electrodes may be driven with signals produced by one or both of the integrated circuits, and may cause the signals to propagate outside the guidewire in the form of electromagnetic waves. These electrodes are referred to as transmitting "TX" electrodes; paragraph [0177]), the first set of electrodes to generate a first sensing signal representing a sensed electrical characteristic of the first group of cells in response to the first electric field (the remaining electrodes, referred to as receiving "RX" electrodes, may receive the reflected electromagnetic waves; paragraph [0177]) (the electrodes may be operated in groups of three, and one of the electrodes of each group may be operated as a TX electrode while the others operate as RX electrodes; paragraph [0177]); and a controller (user interface) configured to apply the activation signal, to receive the first sensing signal, to obtain a first classification of the first group of cells (lesion) (operate a user interface of the medical device to trigger the invasive probe to use the sensors to detect the characteristics of the lesion; paragraph [0104]) as cancerous or non-cancerous based on the sensed electrical characteristic in the first sensing signal (the machine learning techniques can be used to differentiate between cancerous and non-cancerous cells; paragraph [0346]), and to control medicament delivery via the sensing needle based on at least the first classification (the invasive probe may be a component of a treatment device and wherein the lesion analysis facility may compare the characteristic(s) of the lesion to conditions associated with various treatment recommendations and output a treatment recommendation and therefore is capable of controlling medicament delivery via the sensing needle based on at least the first classification; paragraphs [0109, 0120]; see 112 rejection- the controller sends a signal which is in the interpretation of the current claims).
As per claim 2, Carreel discloses the tissue classification system of claim 1 further comprising a second set of electrodes (electrode rows; paragraph [0180]) to generate a second electric field (TX electrode may transmit electromagnetic waves; paragraph [0181]) that passes through a second group of cells of the anatomy, the second set of electrodes to generate a second sensing signal (RX electrodes may receive waves reflected from neighboring tissues; paragraph [0181]), wherein the controller furthermore obtains a second classification of the second group of cells based on the second sensing signal (In some such embodiments, the different RX electrodes of each row are arranged to detect impedance at different depths within a tissue; paragraph [0181]) and wherein the controller controls the medicament delivery further based on the second classification (detecting impedance at different depths may enhance the ability to characterize the clot such that the invasive probe may be a component of a treatment device that is capable of controlling the medicament delivery based on the second classification; paragraphs [0109, 0181]
As per claim 3, Carreel discloses the tissue classification system of claim 2 wherein the first set of electrodes and the second set of electrodes comprise respective radial arrays of electrodes (the distances between the electrode rows are sized such that, when the flexible circuit is wrapped around the housing, the rows are angularly offset by approximately 120°, thereby being evenly distributed around an exterior; paragraph [0180]) at different distances from a tip of the sensing needle (this may be accomplished by arranging the RX electrodes to have different distances with respect to the TX electrode; paragraph [0181]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Carreel in view of Klinghoffer et al. (US 2021/0170052; hereafter Klinghoffer).
As per claim 4, Carreel does not disclose wherein the controller controls the medicament delivery by enabling a medicament delivery pump responsive to the first classification and the second classification being indicative of the sensing needle penetrating a target tumor with a predefined penetration depth. However, Carreel discloses that different RX electrodes of each row are arranged to detect impedance at different depths within a tissue (Carreel; paragraph [0181]) as well as performing a first classification of tissue (detect the characteristics of the lesion; paragraph [104] and thus discloses being capable of a performing a second classification of tissue. Klinghoffer discloses wherein the controller controls the medicament delivery by enabling a medicament delivery pump (the controller is configured to control actuation; paragraph [0170]; the actuator may be a plunger or a pump; paragraph [0017]) being indicative of the sensing needle penetrating a target tumor with a predefined penetration depth (localized delivery depicted in FIG. 8 extends to various tumor depths; FIG 8; paragraph [0362]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Carreel with the teachings of Klinghoffer, because detecting impedance at different depths may enhance the ability to characterize the target tumor to infer the target tumor's type, composition or other characteristics (Carreel; paragraph [0181]).
As per claim 5, Carreel discloses wherein the first set of electrodes and the second set of electrodes are radially spaced on a surface of the sensing needle (the distances between the electrode rows are sized such that, when the flexible circuit is wrapped around the housing, the rows are angularly offset by approximately 120°, thereby being evenly distributed around an exterior; paragraph [0180]). Carreel does not disclose wherein the controller controls the medicament delivery by enabling a medicament delivery pump responsive to both the first classification and second classification classifying the first group of cells and the second group of cells respectively as cancerous. However, Carreel discloses that different RX electrodes of each row are arranged to detect impedance at different depths within a tissue (Carreel; paragraph [0181]) as well as performing a first classification of tissue (detect the characteristics of the lesion; paragraph [104] and thus discloses being capable of a performing a second classification of tissue. Klinghoffer discloses wherein the controller controls the medicament delivery by enabling a medicament delivery pump (the controller is configured to control actuation; paragraph [0170]; the actuator may be a plunger or a pump; paragraph [0017]) responsive to both the first classification and second classification classifying the first group of cells and the second group of cells respectively as cancerous (localized delivery depicted in FIG. 8 extends to various tumor depths; FIG 8; paragraph [0362]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Carreel with the teachings of Klinghoffer because detecting impedance at different depths may enhance the ability to characterize the target tumor to infer the target tumor's type, composition or other characteristics, including whether or not they are cancerous (Carreel; paragraph [0181]).
As per claim 6, Carreel discloses a controller (user interface; paragraph [104]) however, Carreel does not disclose wherein the controller activates a lockout mechanism of a medicament delivery pump to prevent the medicament delivery via the sensing needle in absence of a delivery criteria based at least in part on the first classification being met. Klinghoffer discloses a medicament delivery pump (the actuator may be a plunger or a pump; paragraph [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Carreel with the teachings of Klinghoffer, because values for characteristics of a lesion to use as conditions, as related to a lockout mechanism, may be hard-coded into a medical device (Carreel; paragraph [0304]) in order to determine which treatment option to recommend if any.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carreel in view of Gregory (US 2019/0216358).
As per claim 7, Carreel does not disclose wherein the controller obtains the first classification by: determining a Cole relaxation frequency from the sensed electrical characteristic of the first group of cells; and classifying the first group of cells as cancerous in response to the Cole relaxation frequency being within a specified range of frequencies or classifying the first group of cells as non-cancerous in response to the Cole relaxation frequency being outside the specified range of frequencies. Gregory discloses wherein the controller (analyzer) obtains the first classification by: determining a Cole relaxation frequency from the sensed electrical characteristic of the first group of cells (computing a first Cole relaxation frequency for the first section of the first sample; claim 1); and classifying the first group of cells as cancerous in response to the Cole relaxation frequency being within a specified range of frequencies (thresholds) or classifying the first group of cells as non-cancerous in response to the Cole relaxation frequency being outside the specified range of frequencies (the analyzer compares the computed Cole relaxation frequency given to one or more thresholds relating to concentration of cancerous cells; paragraphs [0037], [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gregory with the teachings of Carreel because the Cole relaxation frequency is a known specific frequency which reflects the rate at which a cell membrane discharges a stored electrical charge. Furthermore, due to the contrasting electrical properties of malignant cells and non-malignant cells, malignant cells have a Cole relaxation frequency that is over one thousand times larger than the Cole relaxation frequency of a non-malignant cell (Gregory; paragraph [0037]), enabling a specified range of frequencies for cell classification.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Carreel in view of CN 109124759 B to SHANGHAI RUIDAO MEDICAL TECHNOLOGY CO LTD (hereinafter "RUIDAO") in further view of Tehrani et al. (US 2021/0204922; hereafter Tehrani).
As per claim 8, Carreel discloses wherein the controller is configured to generate the activation signal as an optical activation signal and to receive the first sensing signal as an optical sensing signal (in some embodiments, the sensors may be or include one or more electrical, mechanical, optical, biological, or chemical sensors; paragraph [0118]). Carreel does not disclose wherein the sensing needle further comprises: an optical-to- electrical converter to convert the optical activation signal to an electrical activation signal applied to the first set of electrodes; and an electrical-to-optical converter to convert an electrical sensing signal to the optical sensing signal for outputting to the controller; and wherein the tube comprises a fiber optic link for communicating the optical activation signal and the optical sensing signal. RUIDAO discloses wherein the sensing needle further comprises: an optical-to-electrical converter to convert the optical activation signal to an electrical activation signal applied to the first set of electrodes (optical/electrical converter K2 may transfer the converted electric signal into the electric field pulse generating circuit 1; paragraph [0165]); and an electrical-to-optical converter to convert an electrical sensing signal to the optical sensing signal for outputting to the controller (the electric/optical converter J1 may convert the electric signal received by the FPGA module 21 into an optical signal; paragraph [0165]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of RUIDAO with the teaching of Carreel to incorporate an optical-to-electrical converter as well as an electrical-to- optical converter, since it was known in the art that in fiber optic communication systems, conversion is used for the advantages of enabling a higher data bandwidth, lower signal degradation, and preventing signal interference. Tehrani discloses wherein the tube comprises a fiber optic link (fiber optic bundle; paragraph [0119]) for communicating the optical activation signal (receiving optical fiber 80; paragraph [0076]) and the optical sensing signal (transmitting fiber optic 78; paragraph [0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tehrani with the teachings of Carreel to include a fiber optic link coupled with the converters previously mentioned to design a fiber optic-based system since it was known in the art that they offer the advantages of faster data transmission, higher bandwidth capacity, and higher resistance to interference than traditional copper wiring.
As per claim 9, Carreel does not disclose wherein the fiber optic link includes: a first fiber optic channel for communicating the optical activation signal; and a second fiber optic channel for communicating the optical sensing signal. Tehrani discloses wherein the fiber optic link (hollow tube paragraph [0076]) includes: a first fiber optic channel for communicating the optical activation signal (receiving optical fiber 80; paragraph [0076]); and a second fiber optic channel for communicating the optical sensing signal (transmitting fiber optic 78; paragraph [0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tehrani with the teachings of Carreel to design a device with multiple separate fiber optic channels for use with the converters previously described, since it was known in the art that shared fiber optic channel connection may lead to increased signal degradation from interference effects.
As per claim 10, Carreel does not disclose wherein the fiber optic link includes a shared fiber optic channel for bidirectionally communicating the optical activation signal and the optical sensing signal. Tehrani discloses wherein the fiber optic link includes a shared fiber optic channel for bidirectionally communicating the optical activation signal and the optical sensing signal (in one form, the transmitter and receiver fibers can be the same fiber; paragraph [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tehrani with the teachings of Carreel to design the system with a shared fiber optic channel, since the use of a one-piece construction instead of the structure disclosed previously, would have required only routine skill in the art. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of Tehrani with the teachings of Carreel to engineer the device with a shared fiber optic channel to provide the known advantages which include design simplification and performance monitoring.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carreel in view of Ouyang (US 2023/0128303).
As per claim 19, Carreel discloses a system for controlling medicament delivery (deliver a treatment to the lesion; paragraph [0021]) to a target tumor based on tissue classification (if the lesion has been preliminarily diagnosed as a brain lesion that may be a brain tumor, the medical device may determine whether the invasive probe has contacted abnormal brain tissue and/or whether the invasive probe has contacted cancerous brain tissue; paragraph [0352]). Carreel further discloses a tissue classification system (detecting characteristics of tissues; Abstract) (classification processes; paragraph [0312]) for controlling medicament delivery (deliver a treatment to the lesion; paragraph [0021]), including: a tube for inserting into an anatomy (such an insertable device would include a hollow tube; paragraph [0067]); a sensing needle at a distal end of the tube (the sensor may be disposed in diagnosis and/or treatment devices such as needles; In some embodiments, the sensor is disposed near the distal end of the medical device; paragraph [0348]), the sensing needle including: a first set of electrodes that are selectively activated in response to an activation signal to generate a first electric field that passes through a first group of cells of the anatomy (some of the electrodes may be driven with signals produced by one or both of the integrated circuits, and may cause the signals to propagate outside the guidewire in the form of electromagnetic waves. These electrodes are referred to as transmitting "TX" electrodes; paragraph [0177]) the first set of electrodes to generate a first sensing signal representing a sensed electrical characteristic of the first group of cells in response to the first electric field (the remaining electrodes, referred to as receiving "RX" electrodes, may receive the reflected electromagnetic waves; paragraph [0177]) (the electrodes may be operated in groups of three, and one of the electrodes of each group may be operated as a TX electrode while the others operate as RX electrodes; paragraph [0177]); and a controller (user interface) configured to apply the activation signal, to receive the first sensing signal, to obtain a first classification of the first group of cells (lesion) (operate a user interface of the medical device to trigger the invasive probe to use the sensors to detect the characteristics of the lesion; paragraph [104]) as cancerous or non- cancerous based on the first sensing signal (the machine learning techniques can be used to differentiate between cancerous and non-cancerous cells; paragraph [0352]), and to control medicament delivery via the sensing needle based on at least the first classification (the invasive probe may be a component of a treatment device and wherein the lesion analysis facility may compare the characteristic(s) of the lesion to conditions associated with various treatment recommendations and output a treatment recommendation and therefore is capable of controlling medicament delivery via the sensing needle based on at least the first classification; paragraphs [0109, 0120]). Carreel does not disclose the medical targeting system comprising: an imaging system including an endoscope for capturing images of an anatomy. Ouyang discloses the medical targeting system comprising: an imaging system including an endoscope for capturing images of an anatomy (the compact robotic endoscope, further including a display mounted on said reusable portion and coupled with said imaging module and configured to display images acquired therewith; claim 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ouyang with the teachings of Carreel because as disclosed in the Carreel system, the clinician may monitor a position of the invasive probe within a subject using imaging techniques, including using known techniques, such as those taught in Ouyang (Carreel; paragraph [0103]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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