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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a first ultrasound output unit that outputs” and “a second ultrasound output unit that outputs in claims 1-13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 9-10, 14-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sokka et al (2008/0200845) in view of Vince et al (2022/0331459).
Regarding claim 1, Sokka et al disclose a device for generating bubbles based on microparticles, the device comprising:
a first ultrasound output unit that outputs a first ultrasound signal for microparticles in a blood vessel (an ultrasound treatment comprises applying ultrasound at a first energy level to a region of interest in a subject for activating a cavitation nucleation agent – abstract; perfluorocarbon-filled nanoparticles/microparticles – [0026]); and
a second ultrasound output unit that outputs a second ultrasound signal so as to generate bubbles based on the microparticles (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]).
Sokka et al fail to explicitly disclose a first ultrasound signal for moving microparticles in a blood vessel to a predetermined site.
However, Vince et al teach in the same medical field of endeavor, a first ultrasound signal for moving microparticles in a blood vessel to a predetermined site (applying ultrasound to the insertion site that generates gas bubbles by cavitation…and drives movement of the gas bubbles such that the gas bubbles drives movement of the microparticles - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first ultrasound signal for microparticles of Sokka et al with moving microparticles in a blood vessel to a predetermined site of Vince et al as it would provide movement of the microparticles into a desired spatial distribution in a tumor.
Regarding claim 2, Sokka et al disclose wherein the second ultrasound output unit outputs the second ultrasound signal towards the microparticles or surroundings of the microparticles (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]).
Regarding claim 3, Sokka et al disclose wherein the second ultrasound output unit generates the bubbles based on the second ultrasound signal reflected and scattered from the microparticles or the surroundings of the microparticles (ultrasound therapy pressure…an initial high pressure, short duration phase conversion pulse is used to focally create gas bubbles in response to phase-conversion of the nucleation cavitation agent – [0022]).
Regarding claim 4, Sokka et al disclose wherein the bubbles are cavitation bubbles for fragmenting a tissue approaching within a predetermined distance from the predetermined site ([0039]).
Regarding claim 5, Sokka et al disclose wherein the first ultrasound output unit generates a sound field that captures the microparticles using the first ultrasound signal (gas bubbles in a focused ultraosund field yield higher ultrasound absorption and therefore higher bulk temperatures in a zone near the focus – [0007]).
Regarding claim 6, Sokka et al disclose wherein the second ultrasound output unit outputs the second ultrasound signal toward the sound field and generates the bubbles based on the second signal reflected and scattered from a microparticle cluster composed of the microparticles captured within the sound field (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]; fig.2; clusters – [0026]).
Regarding claim 9, Sokka et al disclose wherein the first ultrasound output unit outputs a plurality of channel signals having different phase differences (first pulse corresponds to a first phase and second pulse corresponds to second phase – [0022]; the first portion comprises an ultrasound induced phase conversion portion – claim 2) through a plurality of ultrasound output channels (phased array – [0020]).
Regarding claim 10, Sokka et al disclose wherein the second ultrasound signal has a pressure amplitude less than a cavitation threshold (during the second phase, there can occur an absence of cavitation, for example, as a result of no more nuclei present or lower pressures/different frequencies provided by the transducer – [0022]).
Regarding claim 14, Sokka et al disclose a method for generating based on microparticles, comprising:
outputting a first ultrasound signal for microparticles in a blood vessel (an ultrasound treatment comprises applying ultrasound at a first energy level to a region of interest in a subject for activating a cavitation nucleation agent – abstract; perfluorocarbon-filled nanoparticles/microparticles – [0026]); and
outputting a second ultrasound signal so as to generate bubbles based on the microparticles (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]).
Sokka et al fail to explicitly disclose a first ultrasound signal for moving microparticles in a blood vessel to a predetermined site.
However, Vince et al teach in the same medical field of endeavor, a first ultrasound signal for moving microparticles in a blood vessel to a predetermined site (applying ultrasound to the insertion site that generates gas bubbles by cavitation…and drives movement of the gas bubbles such that the gas bubbles drives movement of the microparticles - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first ultrasound signal for microparticles of Sokka et al with moving microparticles in a blood vessel to a predetermined site of Vince et al as it would provide movement of the microparticles into a desired spatial distribution in a tumor.
Regarding claim 15, Sokka et al disclose wherein the outputting of the second ultrasound signal includes outputting the second ultrasound signal towards the microparticles or surroundings of the microparticles (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]).
Regarding claim 16, Sokka et al disclose wherein the outputting of the second ultrasound signal includes generating the bubbles based on the second ultrasound signal reflected and scattered from the microparticles or the surroundings of the microparticles (ultrasound therapy pressure…an initial high pressure, short duration phase conversion pulse is used to focally create gas bubbles in response to phase-conversion of the nucleation cavitation agent – [0022]).
Regarding claim 17, Sokka et al disclose wherein the outputting of the first ultrasound signal includes generating a sound field that captures the microparticles using the first ultrasound signal (gas bubbles in a focused ultraosund field yield higher ultrasound absorption and therefore higher bulk temperatures in a zone near the focus – [0007]).
Regarding claim 18, Sokka et al disclose wherein the outputting the second ultrasound signal includes outputting the second ultrasound signal toward the sound field and generating the bubbles based on the second signal reflected and scattered from a microparticle cluster composed of the microparticles captured within the sound field (ultrasound at a second level is applied to the region of interest during a second portion of the treatment cycle for implementing a desired thermal therapy in the presence of the cavitation nucleation agent – abstract; cavitation-enhanced heating, microbubbles created at the focus during heat exposure – [0005]; fig.2; clusters – [0026]).
Regarding claim 20, Sokka et al disclose wherein the outputting of the first ultrasound signal includes outputting a plurality of channel signals having different phase differences (first pulse corresponds to a first phase and second pulse corresponds to second phase – [0022]; the first portion comprises an ultrasound induced phase conversion portion – claim 2) through a plurality of ultrasound output channels (phased array – [0020]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sokka et al (2008/0200845) in view of Vince et al (2022/0331459) as applied to claim 5 above, and further in view of Yasuda Kenji et al (JP 3488732).
Regarding claim 7, Sokka et al as modified by Vince et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the sound field has a ring-shaped pressure distribution in which no pressure exists in a central region and pressure exists in a peripheral region.
However, Yasuda Kenji et al teach in the same medical field of endeavor, wherein a sound field has a ring-shaped pressure distribution in which no pressure exists in a central region and pressure exists in a peripheral region (concentric sound field to reduce the size of the concentric circles - p.10, last paragraph – p.11, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sound field of Sokka et al as modified by Vince et al with a ring-shaped pressure distribution in which no pressure exists in a central region of Yasuda Kenji et al as it would form a portion where the particles are concentrated in the fluid and a portion where the particles do not exist.
Allowable Subject Matter
Claims 8, 11-13, 19 and 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
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