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 . 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.
Claim Objections
Claims 18 and 24 are objected to because of the following informalities: In claims 18 and 24, line 3 of both claims, “waves has” should be replaced with -waves have-. 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 12, 13, 18, 19, and 21-28 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.
Claims 12 and 23 recite the limitation ‘measuring temperature via thermoacoustic thermometry by using pulsed microwaves to quantify temperature and generate thermal images due to changes in the Gruneisen parameter’. However, there does not appear to be sufficient support in Applicant’s disclosure for this specific language. More specifically, while the Gruneisen parameter is briefly mentioned in the Specification, it is merely described as “the strong dependence of the conversion of heat to acoustic pressure on water temperature”. It does not appear as though Applicant’s disclosure describes this parameter changing, or the role that this parameter plays in measuring temperature. Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 12, 13, 18, 19, and 21-28 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.
Claims 12 and 23 recite the limitation "pulsed microwaves" in lines 12 and 17 (respectively). The antecedent basis for this limitation is confusing, since it’s unclear how/whether it is related to the previously-recited “microwave pulse”.
Claims 12 and 23 recite the limitation "temperature" in lines 13 and 17 (respectively). The antecedent basis for this limitation is confusing, since it’s unclear how/whether it is related to the previously-recited “temperature of the region of interest”.
Claims 12 and 23 recite the limitation "thermal images" in lines 13 and 17 (respectively). The antecedent basis for this limitation is confusing, since it’s unclear how/whether it is related to the previously-recited “thermoacoustic map”.
Claim 23 is found to be indefinite because Examiner is unsure of what is meant by “measuring the temperature of the region of interest, via the thermoacoustic thermometry system by using pulsed microwaves to quantify temperature and generate thermal images due to changes in the Gruneisen parameter”, especially at this location in the claims. More specifically, the scope of this limitation is unclear, since it appears as though it would make more sense if it were grouped into the “generating” step before the “guiding” step (as in claim 12).
Claims 26 and 27 are found to be indefinite for their recitation of a method comprising a structure (i.e., “an array of antennas”) which renders the scope of the claims unclear. Applicant is encouraged to amend the claims to recite that the microwave therapy method ‘utilizes’ the structure, or to recite a step of ‘providing’ the structure.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base 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) 12, 13, 18, 19, 21, 23, 24, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman, U.S. 2016/0022976 (hereinafter Peyman).
Regarding claims 12 and 23, Peyman discloses (note fig. 1; as best understood by Examiner) a method for applying microwave therapy, the method comprising: emitting, with an emitter, a microwave pulse to heat a region of interest of tissue to increase a temperature of the region of interest of the tissue by a first amount greater than 0 degrees Celsius and less than 1 degree Celsius (note paragraph 51); detecting, with a detector, ultrasound or acoustic waves produced by the region of interest of the tissue due to thermal expansion of the tissue caused by the increase in the temperature of the region of interest of the tissue; generating, via a combined thermoacoustic imaging and thermometry system (necessarily – note paragraphs 84, 136, and 310), a thermoacoustic map of the region of interest of the tissue based upon the detected ultrasound or acoustic waves necessarily ‘produced by the region of interest of the tissue’ (i.e., produced by nanoparticles that are disposed within this region of interest of the tissue - note paragraphs 279-281), wherein the temperature of the region of interest is measured via thermoacoustic thermometry by using pulsed microwaves to quantify temperature and generate thermal images (see above) due to changes in the Gruneisen parameter (necessarily - note paragraphs 81-84, 136, and 310); guiding the microwave therapy, using the thermoacoustic map, to target the region of interest of the tissue to induce hyperthermia by heating the region of interest to increase the temperature of the region of interest of the tissue by a second amount, wherein the temperature of the region of interest of the tissue does not exceed 60 degrees Celsius during the microwave therapy (note paragraphs 293-294); monitoring, via the combined thermoacoustic imaging and thermometry system, any changes in temperature of the region of interest of the tissue (note paragraphs 235-236 and 243) at the same time as guiding the microwave therapy to the region of interest of the tissue to induce hyperthermia (note paragraphs 13 and 136); and adjusting the guiding of the microwave therapy based on feedback from monitoring any changes in temperature of the region of interest of the tissue (note paragraphs 169 and 325).
Regarding claim 13, Peyman discloses (see above) a method wherein a microwave therapy system is necessarily provided by a ‘focused’ microwave therapy system, and the applied microwave therapy is necessarily ‘focused’ microwave therapy (note paragraph 200).
Regarding claims 18, 19, and 24, Peyman discloses (note paragraphs 322, 335, and 340) a method further comprising: transmitting, via an ultrasound system ultrasound waves at the region of interest of the tissue; and receiving, via the ultrasound system, the ultrasound waves after the ultrasound waves have interacted with the region of interest of the tissue, wherein generating the map of the region of interest is further based upon the ultrasound waves received via the ultrasound system after the ultrasound waves have interacted with the region of interest of the tissue; wherein the ultrasound system is necessarily an ‘acoustoelectric imaging’ type (see above).
Regarding claims 21 and 28, Peyman discloses (see above) a method wherein the feedback is necessarily in ‘real-time’ (note paragraphs 136 and 325).
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.
Claim(s) 22 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman.
Regarding claims 22 and 25, Peyman discloses (see above) a method comprising generating a map using a thermoacoustic system, and providing a microwave therapy system for performing hyperthermia. While this embodiment of Peyman fails to expressly teach generating a map and performing hyperthermia using a single probe, a different (laser) embodiment of Peyman teaches this (note fig. 1; paragraph 203). It is well known in the art that these different configurations (using different power sources) are widely considered to be interchangeable (note paragraphs 249 and 323). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Peyman to comprise generating a map and performing hyperthermia using a single probe. This is because this modification would have merely comprised a simple substitution of interchangeable ‘power source configurations’ in order to produce a similar/predictable result (see MPEP 2143).
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Prakash, U.S. 2003/0195499 (hereinafter Prakash).
Regarding claims 26 and 27, Peyman discloses (see above) a microwave therapy method that utilizes a microwave therapy system to induce hyperthermia in tissue. However, Peyman fails to explicitly disclose a microwave therapy system comprising an array of antennas, wherein the antennas surround the tissue and generate focused microwaves during hyperthermia. Prakash teaches (note figs. 3A-4) a similar method that utilizes a microwave therapy system, wherein this system comprises an array of antennas that surround the tissue and generate focused microwaves during the procedure. It is well known in the art that these different ‘energy emitter’ configurations (i.e., one energy emitter near a target vs multiple energy emitters that surround a target) are widely considered to be interchangeable, and that the use of multiple energy emitters in this configuration would minimize unwanted tissue damage (due to increased energy focus) and result in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Peyman to utilize a microwave therapy system comprising an array of antennas, wherein the antennas surround the tissue and generate focused microwaves during hyperthermia. This is because this modification would have merely comprised a simple substitution of interchangeable ‘energy emitter’ configurations in order to (predictably) increase safety and efficiency (see MPEP 2143).
Response to Arguments
Applicant's arguments filed July 2, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Peyman does not disclose thermoacoustic thermometry, Examiner respectfully disagrees. More specifically, Examiner maintains that Peyman discloses both thermoacoustic thermometry and thermoacoustic imaging, as can be seen in paragraphs 136, , 310, and 81-84. While Examiner acknowledges that certain embodiments of Peyman utilize dyes to determine temperature, Examiner asserts that other embodiments (cited above) measure temperature in the claimed manner (as best understood by Examiner).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., ‘using thermoacoustic thermometry as a technique whose primary purpose is to measure temperature by analyzing sound waves produced by thermal fluctuations’; ‘specifically measuring temperature without creating photoacoustic images’; and ‘a dedicated, quantitative temperature measurement tool’) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, Examiner asserts that Peyman does necessarily disclose measuring temperature by analyzing sound waves produced by thermal fluctuations, as can be seen in the above citations.
Finally, Examiner asserts (as can be seen in the above citations) that different embodiments of Peyman disclose measuring temperature prior to displaying it, as well as using thermoacoustic images to calculate temperature, and that the new claims have been met by these embodiments as they are currently written (due to their breadth). Therefore, Examiner maintains that the claims are still met by Peyman, as can be seen above.
Conclusion
THIS ACTION IS MADE FINAL. 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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794