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 .
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 7-10 and 14-15 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 7, the claim recites the limitation “the application of therapeutic acoustic signals”. There is insufficient antecedent basis for this limitation in the claim, no application of therapeutic acoustic signals has previously been set forth. For examination purposes, this limitation will be interpreted as reciting “an application of therapeutic acoustic signals”.
Regarding claim 14, the claim recites the limitation “therapeutic acoustic signals”. There is unclear antecedent basis for this limitation in the claim. It is unclear how these therapeutic acoustic signals relate to the therapeutic acoustic signals previously set forth. For examination purposes, this limitation will be interpreted as reciting “the therapeutic acoustic signals”.
Regarding claim 14, the claim recites the limitation “target tissue”. There is unclear antecedent basis for this limitation in the claim. It is unclear how this target tissue relates to the target tissue previously set forth. For examination purposes, this limitation will be interpreted as reciting “the target tissue”.
Regarding claim 14, the claim recites the limitation “a patient”. There is unclear antecedent basis for this limitation in the claim. It is unclear how this patient relates to the patient previously set forth. For examination purposes, this limitation will be interpreted as reciting “the patient”.
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)(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.
(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.
Claims 1-5, 7, 14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wang, et al. (Wang et al. Thermostatic Hyperthermia with Non-invasive Temperature Monitoring through Speed of Sound Imaging. Med Phys. 2021; arXiv:2109.05709, https://doi.org/10.48550/arXiv.2109.05709, hereafter Wang).
Regarding claim 1, Wang discloses in a system for ultrasound-guided localized mild hyperthermia (Wang, Pg 5; “Through HIFU focusing operation, the ultrasound beams with high intensity is focused in the center of the tumor to generate acoustic pressure field that demonstrates a good focusing effect. Long-term thermostatic hyperthermia can be divided into two heating stages. The first heating stage aims to quickly heat the tissue to the target temperature by continuously heating at full power until the temperature of the tumor center is close to the target temperature. The second heating stage is thermostatic control realized according to the heat conduction equation”) comprising a closed geometry transducer (Wang, Pg 7; “We use the ring ultrasound transducer array to achieve the precise and variable focus position with good focusing effect at the tumor center.”), an imaging modality (Wang, Pg 4; “Through a correspondent B-mode ultrasound image, the boundary information and position information of human thigh tissues can be acquired.”), a thermometry modality (Wang, Pg 2; “According to the change of temperature during the last heating period, the heat source for the consequent heating period is changed accordingly to realize the accurate control of constant temperature. Based on the known relationship between temperature and SOS, the measurement of the temperature in heating area is converted to read the value in SOS image which is updated accordingly.”), and a therapeutic modality (Wang, Pg 2; “a multi-elements ring ultrasound transducer array is used to generate spatially variable focus that provides accurate HIFU heating for tumor”); wherein the imaging modality, the thermometry modality, and the therapeutic modality use the closed geometry transducer in common (Wang, Pg 2; “In our proposed model, the temperature measurement can share the same ultrasound transducer array for HIFU heating and B-mode ultrasound imaging, making the whole hyperthermia system concise and effective, which is of great guiding significance when this model is put into practical clinical application.”) (Wang, Abstract).
Regarding claim 2, Wang discloses all of the limitations of claim 1 as discussed above.
Wang further discloses wherein the closed geometry transducer is a ring array transducer (Wang, Pg 7; “We use the ring ultrasound transducer array to achieve the precise and variable focus position with good focusing effect at the tumor center.”).
Regarding claim 3, Wang discloses all of the limitations of claim 2 as discussed above.
Wang further discloses wherein the ring array transducer comprises 64 elements (Wang, Pg 2; “on ring ultrasound transducer array with the radius of R, which has 256 elements”) (Wang, Abstract; “realized by a ring ultrasound transducer array with 256 elements.”).
Regarding claim 4, Wang discloses all of the limitations of claim 2 as discussed above.
Wang further discloses wherein the ring array transducer comprises 128 elements (Wang, Pg 2; “on ring ultrasound transducer array with the radius of R, which has 256 elements”) (Wang, Abstract; “realized by a ring ultrasound transducer array with 256 elements.”).
Regarding claim 5, Wang discloses all of the limitations of claim 2 as discussed above.
Wang further discloses wherein the ring array transducer comprises 256 elements (Wang, Pg 2; “on ring ultrasound transducer array with the radius of R, which has 256 elements”) (Wang, Abstract; “realized by a ring ultrasound transducer array with 256 elements.”).
Regarding claim 7, Wang discloses all of the limitations of claim 1 as discussed above.
Wang further discloses in Figure 5 wherein the therapeutic modality comprises an application of therapeutic acoustic signals to target tissue of a patient wherein the therapeutic acoustic signals are configured to cause heating of a specified portion of the target tissue of the patient (Wang, Pg 1; “HIFU uses the characteristic that ultrasound can penetrate human body without damage and focus on vivo causing thermal effect (main effect), cavitation effect and mechanical effect. Since the high temperature can destroy the cell structure and damage the protein, the high temperature generated by thermal effect on the focus will lead to the coagulation necrosis of the tumor target [10-12] instead of burning out the surrounding normal tissue outside the focus. The sensor emits HIFU signals to the tissue target and then the tissue absorbs ultrasonic energy to convert it into thermal energy during tumor therapy. This heat deposition can cause the tissue temperature to rise rapidly. Due to the focusing of the ultrasound beam, thermal power is mainly added to the tumor target of a small area at the desired range of temperatures (e.g., 5℃-6℃ above the ambient temperature of 37℃), which means there is almost no obvious heat deposition on the surrounding tissue so as to avoid the unpredictable growth of healthy tissues caused by excessive temperature [13].”).
Regarding claim 14, Wang discloses all of the limitations of claim 7 as discussed above.
Wang further discloses wherein the application of the therapeutic acoustic signals to the target tissue of the patient is controlled by the thermometry modality (Wang, Pg 3; “the temperature control is necessary to the thermostatic hyperthermia system. Due to the available relationship between the temperature and the SOS (the temperature and the SOS vary in direct proportion) [31], the temperature monitoring in the medium is realized by the SOS imaging”) and the imaging modality (Wang, Pg 5; “In order to build a simulation model with more details, the inner structure information of human thigh needs to be obtained by B-mode ultrasound imaging, especially around the tumor. Therefore, we make a B-mode ultrasound image of human thigh tissue through Verasonics Vantage system as shown in Fig.2(b), which helps us to find the focus position for HIFU heating and provides us with the priori information of the internal medium in SOS imaging.”).
Regarding claim 19, Wang discloses in Figure 1 a system for ultrasound-guided localized mild hyperthermia (Wang, Pg 5; “Through HIFU focusing operation, the ultrasound beams with high intensity is focused in the center of the tumor to generate acoustic pressure field that demonstrates a good focusing effect. Long-term thermostatic hyperthermia can be divided into two heating stages. The first heating stage aims to quickly heat the tissue to the target temperature by continuously heating at full power until the temperature of the tumor center is close to the target temperature. The second heating stage is thermostatic control realized according to the heat conduction equation”) comprising a closed geometry transducer (Wang, Pg 7; “We use the ring ultrasound transducer array to achieve the precise and variable focus position with good focusing effect at the tumor center.”), an imaging component (Wang, Pg 4; “Through a correspondent B-mode ultrasound image, the boundary information and position information of human thigh tissues can be acquired.”), a thermometry component (Wang, Pg 2; “According to the change of temperature during the last heating period, the heat source for the consequent heating period is changed accordingly to realize the accurate control of constant temperature. Based on the known relationship between temperature and SOS, the measurement of the temperature in heating area is converted to read the value in SOS image which is updated accordingly.”), and a therapeutic component (Wang, Pg 2; “a multi-elements ring ultrasound transducer array is used to generate spatially variable focus that provides accurate HIFU heating for tumor”); wherein the imaging component, the thermometry component and the therapeutic component use the closed geometry transducer in common (Wang, Pg 2; “In our proposed model, the temperature measurement can share the same ultrasound transducer array for HIFU heating and B-mode ultrasound imaging, making the whole hyperthermia system concise and effective, which is of great guiding significance when this model is put into practical clinical application.”) (Wang, Abstract).
Regarding claim 20, Wang discloses all of the limitations of claim 19 as discussed above.
Wang further discloses wherein the closed geometry transducer is a ring array transducer (Wang, Pg 7; “We use the ring ultrasound transducer array to achieve the precise and variable focus position with good focusing effect at the tumor center.”).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Miller (US 20120071761).
Regarding claim 6, Wang discloses all of the limitations of claim 2 as discussed above.
Wang does not clearly and explicitly disclose wherein the ring array transducer comprises multiple sparsed element ring arrays.
In an analogous ultrasound array field of endeavor Miller discloses wherein a ring array transducer comprises multiple sparsed element ring arrays (Miller, Para 43; “the array is optionally fully populated or sparsely populated by the dedicated transmit elements and the dedicated receive elements. In case of semi-sparsely populated rings, a predetermined Apodization function is applied to weight the detected signals for the purpose of shaping a beam profile.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the ring array transducer comprises multiple sparsed element ring arrays as taught by Miller in order to lower component costs and increase processing efficiency.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Watmough et al. (US4646756, hereafter Watmough).
Regarding claim 8, Wang discloses all of the limitations of claim 7 as discussed above.
A person having ordinary skill in the art would understand that the ultrasound therapy system of Wang uses a microprocessor to control the application of therapeutic signals. However, for the sake of compact prosecution the following rejection is presented.
Wang does not clearly and explicitly disclose, wherein the application of therapeutic acoustic signals is controlled by a microprocessor.
In an analogous ultrasound hyperthermia device field of endeavor Watmough discloses wherein an application of therapeutic acoustic signals is controlled by a microprocessor (Watmough, Col 1, line 50 – Col 2 line 8; “According to the present invention, therefore, there is provided an ultrasound hyperthermia unit including ultrasound transducer means angled to direct sonic energy towards an acoustic focus, […] The transducer means may be an array which is conveniently controlled by an on-line microprocessor.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the application of therapeutic acoustic signals is controlled by a microprocessor as taught by Watmough in order to improve imaging quality, system flexibility, and diagnostic efficiency by transitioning traditional analog hardware into software-driven digital architectures.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 15, Wang discloses all of the limitations of claim 14 as discussed above.
A person having ordinary skill in the art would understand that the ultrasound therapy system of Wang uses a microprocessor to control the application of therapeutic signals. However, for the sake of compact prosecution the following rejection is presented.
Wang does not clearly and explicitly disclose wherein the control is with a microprocessor.
In an analogous ultrasound hyperthermia device field of endeavor Watmough discloses wherein an application of therapeutic acoustic signals is controlled by a microprocessor (Watmough, Col 1, line 50 – Col 2 line 8; “According to the present invention, therefore, there is provided an ultrasound hyperthermia unit including ultrasound transducer means angled to direct sonic energy towards an acoustic focus, […] The transducer means may be an array which is conveniently controlled by an on-line microprocessor.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the control is with a microprocessor as taught by Watmough in order to improve imaging quality, system flexibility, and diagnostic efficiency by transitioning traditional analog hardware into software-driven digital architectures.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Larson et al. (US20050165298, hereafter Larson).
Regarding claim 9, Wang discloses all of the limitations of claim 7 as discussed above.
Wang does not clearly and explicitly disclose wherein the therapeutic acoustic signals are applied using time reversal (TR) focusing.
In an analogous therapeutic ultrasound field of endeavor Larson discloses wherein therapeutic acoustic signals are applied using time reversal (TR) focusing (Larson, Para 35; “transducer/transponder in (a) above may be utilized with time-reversal algorithms to remove phase aberrations resulting from multiple acoustic path”) (Larson, Para 60; “a source signal received by the therapy array and utilized with time-reversal algorithms to dynamically correct for phase aberrations resulting from multiple acoustic paths and compensate for the target motion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the therapeutic acoustic signals are applied using time reversal (TR) focusing in order to correct for phase aberrations and compensate for target motion as taught by Larson (Laron, Para 35 and 60), therefore improving quality.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 10, Wang as modified by Larson above discloses all of the limitations of claim 9 as discussed above.
Wang does not clearly and explicitly disclose wherein the time reversal (TR) focusing comprises aberration correction.
In an analogous therapeutic ultrasound field of endeavor Larson discloses wherein therapeutic acoustic signals are applied using time reversal (TR) focusing (Larson, Para 35; “transducer/transponder in (a) above may be utilized with time-reversal algorithms to remove phase aberrations resulting from multiple acoustic path”) (Larson, Para 60; “a source signal received by the therapy array and utilized with time-reversal algorithms to dynamically correct for phase aberrations resulting from multiple acoustic paths and compensate for the target motion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the time reversal (TR) focusing comprises aberration correction in order to correct for phase aberrations and compensate for target motion as taught by Larson (Laron, Para 35 and 60), therefore improving quality.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Slayton et al. (US20130296697, hereafter Slayton).
Regarding claim 11, Wang discloses all of the limitations of claim 1 as discussed above.
Wang does not clearly and explicitly disclose wherein the imaging modality comprises ultrasound tomography (UST).
In an analogous imaging and therapy ultrasound system field of endeavor Slayton discloses wherein an imaging modality comprises ultrasound tomography (UST) (Slayton, claim 1; “imaging a region containing the target tissue by transmission ultrasound computerized tomography”) (Slayton, Para 83; “In accordance with a particularly preferred aspect, as will be described in more detail below, the array can be rotated to allow for a three-dimensional imaging as well as a map of temperature to be measured.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the imaging modality comprises ultrasound tomography (UST) as taught by Slayton in order to capture sharper 3D internal views to give an improved view of the tissue.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 12, Wang discloses all of the limitations of claim 1 as discussed above.
Wang does not clearly and explicitly disclose wherein the thermometry modality comprises ultrasound tomography (UST).
In an analogous imaging and therapy ultrasound system field of endeavor Slayton discloses wherein a thermometry modality comprises ultrasound tomography (UST) (Slayton, Pg 25; “These imaging requirements are also extended to the acoustic temperature monitoring function of the treatment region. In accordance with various aspects of the present invention, an acoustic temperature measurement subsystem disclosed herein is capable of non-invasively mapping the temperature distribution or profile in the target tissue in real-time”) (Slayton, Para 83; “In accordance with a particularly preferred aspect, as will be described in more detail below, the array can be rotated to allow for a three-dimensional imaging as well as a map of temperature to be measured.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the thermometry modality comprises ultrasound tomography (UST) in order to capture sharper 3D internal views to give an improved view of the temperature of the tissue.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 13, Wang discloses all of the limitations of claim 1 as discussed above.
Wang does not clearly and explicitly disclose wherein the thermometry modality further comprises tomographic temperature mapping.
In an analogous imaging and therapy ultrasound system field of endeavor Slayton discloses wherein a thermometry modality further comprises tomographic temperature mapping (Slayton, Pg 25; “These imaging requirements are also extended to the acoustic temperature monitoring function of the treatment region. In accordance with various aspects of the present invention, an acoustic temperature measurement subsystem disclosed herein is capable of non-invasively mapping the temperature distribution or profile in the target tissue in real-time”) (Slayton, Para 83; “In accordance with a particularly preferred aspect, as will be described in more detail below, the array can be rotated to allow for a three-dimensional imaging as well as a map of temperature to be measured.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the thermometry modality further comprises tomographic temperature mapping in order to capture sharper 3D internal views to give an improved view of the temperature of the tissue.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Zeng et al. (US20120209150, hereafter Zeng).
Regarding claim 16, Wang discloses all of the limitations of claim 1 as discussed above.
Wang does not clearly and explicitly disclose an ultrasound tomography guided mild hyperthermia treatment management software.
In an analogous therapeutic ultrasound field of endeavor Zeng discloses an ultrasound tomography guided hyperthermia treatment management software (Zeng, Para 57; “The functions, acts or tasks are independent of the particular type of instructions set, storage media, processor or processing strategy and may be performed by software, hardware, integrated circuits, firmware, micro code and the like, operating alone or in combination”) (Zeng, Para 2; “The present embodiments relate to sub-aperture control for high intensity focused ultrasound (HIFU) therapy.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to include an ultrasound tomography guided mild hyperthermia treatment management software as taught by Zeng in order to automate manual tasks and streamline clinical workflow, therefore improving efficiency.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 17, Wang as modified by Zeng above discloses all of the limitations of claim 16 as discussed above.
Wang does not clearly and explicitly disclose wherein the ultrasound tomography guided mild hyperthermia treatment management software comprises ultrasound tomography lesion identification, mild hyperthermia region identification, mild hyperthermia aperture and waveform configuration, and ultrasound tomography thermometry feedback.
Zeng further discloses wherein the ultrasound tomography guided hyperthermia treatment management software comprises ultrasound tomography lesion identification (Zeng, Para 59; “In act 30, one or more lesions are identified.”), hyperthermia region identification (Zeng, Para 88; “the change in temperature is measured. The resulting tissue temperature is measured by a tissue temperature detector. MR, ultrasound, or other thermometry is used. For ultrasound, one or more characteristics of the tissue are measured. The characteristics are input to a model. The model maps the characteristics to the tissue temperature”), mild hyperthermia aperture and waveform configuration (Zeng, Para 35; “Relative delays and/or phasing of the waveforms focus the transmitted acoustic energy. By applying relatively delayed and/or apodized waveforms to different elements of a transducer, a beam of acoustic energy may be formed with one or more foci along a scan line”), and ultrasound tomography thermometry feedback (Zeng, Para 105; “Feedback from a tissue temperature or displacement detector may be used to adjust dose on the fly. For example, the average temperature around the target, the shape of focus, or other information is used to identify a change”) (Zeng, Para 57; “The functions, acts or tasks are independent of the particular type of instructions set, storage media, processor or processing strategy and may be performed by software, hardware, integrated circuits, firmware, micro code and the like, operating alone or in combination”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang wherein the ultrasound tomography guided mild hyperthermia treatment management software comprises ultrasound tomography lesion identification, mild hyperthermia region identification, mild hyperthermia aperture and waveform configuration, and ultrasound tomography thermometry feedback as taught by Zeng in order to improve accuracy and reduce unnecessary damage to healthy tissue.
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Peyman et al. (US20220096873, hereafter Peyman).
Regarding claim 18, Wang discloses all of the limitations of claim 1 as discussed above.
Wang does not clearly and explicitly disclose a thermosensitive chemotherapeutic agent that is acted on by the therapeutic modality.
In an analogous therapeutic ultrasound field of endeavor Peyman discloses a thermosensitive chemotherapeutic agent that is acted on by a therapeutic modality (Peyman, Para 80; “This temperature profile is chosen as a typical one that can be used in targeted drug delivery applications with e.g. thermosensitive liposomes”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to include a thermosensitive chemotherapeutic agent that is acted on by the therapeutic modality in order to perform targeted drug delivery as needed for treatment as taught by Peyman (Peyman, Para 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pattyn A, et al. Feasibility of ultrasound tomography–guided localized mild hyperthermia using a ring transducer: Ex vivo and in silico studies. Med Phys. 2022; 49: 6120–6136. https://doi.org/10.1002/mp.15829 - discloses a substantial number of the limitations in the claims but shares authors and its publication date is within a 102 exception
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
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, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN D LI/Primary Examiner, Art Unit 3798
Prosecution Insights