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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
See the first list of references cited between [0164] and [0214], the second list of references cited between [0275] and [0357], and the third list of references cited between [0390] and [0447]. Applicant should provide copies of all documents cited in the specification and list each document on a newly filed IDS.
Specification
The disclosure is objected to because of the following informalities: [0118] of the PG pub defines that the recovery time constant can be “measured in accordance” with “Equation (1): y=−A*exp(−t/τ)+y0”. However, in [0123], describes “Equation 1 in Table 1” as being in reference to fluid hydrostatic pressure, shown in table 1 as “∇2Phs≈((ϕf/ϕs)/ρ0K)∇·〈ρ1V1〉≈-α(ϕf/ϕs)/c0Kω2ρ02[∇P1·∇P1*]. Further, [0118] describes “A is a constant of the region (e.g. first region), and y0 is a constant of the region (e.g. first region)”, applicant should correct the specification to clarify which equation is referred to as equation 1 and which constant is the constant of the first region. Appropriate correction is required.
Claim Objections
Claim 13 objected to because of the following informalities: recites acronym “USF” without previously introducing the full term. Appropriate correction is required.
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.
Claim(s) 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al. (US20190293498, hereafter “Yuan”).
Regarding claim 21, Yuan teaches an ultrasound system comprising:
one ultrasound source* ([0098] HIFU treatment transducer, a RF power amplifier, and a function generator);
a control system**,***([0098] a multi-channel pulser-delay generator is used to control the time sequence of the entire system); and
wherein the control system carries out****,***** one or more steps of the method of claim 1, such as: applying a focused ultrasound beam to a first target region of the porous material to compress at least a portion of the first target region ([0089] applying a high intensity focused ultrasound beam to the tissue, known in the art of ultrasound to result in localized tissue compression).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring one ultrasound source; or requiring more than one ultrasound source.
**For the purposes of examination, the limitation has been interpreted in the alternative, as the limitation recites that “a fluorophore excitation source” as being “optionally” part of the ultrasound system. Therefore, the fluorophore excitation source has been interpreted as not being part of the ultrasound system.
***For the purposes of examination, the limitation has been interpreted in the alternative, as the limitation recites that “an image recording device” as being “optionally” part of the ultrasound system. Therefore, the image recording device has been interpreted as not being part of the ultrasound system.
****For the purposes of examination, the limitation has been interpreted in the alternative, requiring the control system carries out one step of the method of claim 1; or requiring the control system carries out more than one of the steps of the method of claim.
*****For the purposes of examination, the limitation has been interpreted in under the broadest reasonable interpretation where one or more than of the steps of the method of claim 1 may refer to any one of the steps recited in claim 1 and not be limited to any one singular or a particular step or steps.
Regarding claim 22, Yuan discloses a method of characterizing a biological tissue, the method comprising:
disposing a population of ultrasound-switchable fluorophores in a first region of the biological tissue ([0032], [0045] disposing the population of fluorophores within the activation region of the environment which is a biological environment is an in vivo environment, such as a tissue, organ, blood vessel, or other portion of a living organism, tumor or tumor vasculature, or tissue culture, biological phantom material or tissue-mimicking phantom material);
applying a focused ultrasound beam to the first region to switch at least one fluorophore of the population from an off state to an on state ([0032] exposing the environment to an ultrasound beam to create an activation region within the environment, the activation region to switch at least one fluorophore of the population from an off state to an on state);
applying a beam of electromagnetic radiation to the first region to excite at least one fluorophore of the population in the on state ([0032] exposing the environment to a beam of electromagnetic radiation to excite at least one fluorophore of the population in the on state);
removing* the focused ultrasound beam from the first region ([0112] on-and-off exposure pattern, which means the bean is removed from the first target region); and
detecting a dynamic ultrasound fluorescence (USF) signal emitted by the population of fluorophores during a recovery period after removal of the focused ultrasound beam from the first region ([0073] using short exposure times of a biological environment to an ultrasound beam permits the time-gating of fluorescence signals, such that a desired USF signal can be temporally separated[such as during times when the ultrasound beam is off/removed] from one or more undesired or non-analyte fluorescence signals, such as when the biological environment/first region is exposed to the ultrasound beam for only a limited duration, for instance, when the ultrasound beam is provided to the environment for less than about 1 second or less than about 500 ms, or when the ultrasound beam is provided to the first region for less than about 300 ms, less than about 100 ms, less than about 50 ms, or less than about 10 ms; or when the ultrasound beam is provided for about 1 ms to about 1 second, about 1 ms to about 500 ms, about 1 ms to about 300 ms, about 1 ms to about 100 ms, about 1 ms to about 50 ms, about 1 ms to about 10 ms, about 10 ms to about 300 ms, about 10 ms to about 100 ms, about 10 ms to about 50 ms, or about 50 ms to about 100 ms);
measuring** at least one of the following:
a recovery time constant (τ) for the first region ([0099]-[0100], FIGS. 3B, 4B, see were high τON/τOFF as been determined for certain NIR fluorophores and the tissue temperature with certain fluorophores at the HIFU focal area will decrease after the exposure/during recovery time as indicated by the curve plotted against the temperature thresholds (i.e., Tth1, Tth2, Tth3) of three different USF temperature contrast agents, the emission fluorescence pulse has a relatively long tail, the decay curve in the 4th row, gain of the intensifier of the ICCD is turned on for 10 ns (via an electronic gate pulse) to integrate the emission photons in each emission pulse, then USF photons and come from the HIFU focal volume, the USF signal/dynamic USF fluorescence signal on each frame image can be spatially integrated (or summed), which is so-called “spatial integration,” therefore, a number/constants representing the USF signal strength can be found for each 50-ms CCD exposure for the first region).
*For the purposes of examination, the term has been interpreted henceforth as defined in [0135], FIG. 20 of the PG pub to mean when the ultrasound is turned off.
**For the purposes of examination, the limitation has been interpreted in the alternative, requiring measuring a recovery time constant (τ) for the first region; or requiring measuring a transportability coefficient (M) for the first region.
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, 3-9, 12-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen et al. (US20230165468, hereafter “Mahadevan-Jansen”), in view of Yuan.
Regarding claim 1, Mahadevan-Jansen discloses a method of selectively transporting an agent* within a porous material** ([0021]-[0022] contrast agent is indocyanine green (ICG) is injected directly into area of identified parathyroid tissue), the method comprising:
disposing a population of agents* in the porous material ([0021]-[0022] contrast agent is indocyanine green (ICG) is injected directly into area of identified parathyroid tissue); but does not explicitly disclose applying a focused ultrasound beam to a first target region of the porous material to compress at least a portion of the first target region; and removing the focused ultrasound beam from the first target region, wherein the focused ultrasound beam has a duty cycle greater than 5%.
However, in the same field of endeavor, Yuan teaches applying a focused ultrasound beam to a first target region of the porous material to compress at least a portion of the first target region ([0089] applying a high intensity focused ultrasound beam to the tissue, known in the art of ultrasound to result in localized tissue compression); and
removing the focused ultrasound beam from the first target region ([0112] on-and-off exposure pattern, which means the bean is removed from the first target region), wherein the focused ultrasound beam has a duty cycle greater than 5% ([0112] the HIFU beam is on for 0.02 s and off for 0.08s, therefore the duty cycle would be 0.02/0.1=20% which is greater than 5%).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Mahadevan-Jansen with the applying a focused ultrasound beam to a first target region of the porous material to compress at least a portion of the first target region; and removing the focused ultrasound beam from the first target region, wherein the focused ultrasound beam has a duty cycle greater than 5% as taught by Yuan in order to provide improved resolution of the individual emission profiles of the fluorophores ([0070] of Yuan).
*For the purposes of examination, the terms “agent” and “agents” have been interpreted under the broadest reasonable interpretation to mean any drugs, drug carriers, or imaging contrast agents used for therapeutic or diagnostic means any known in the diagnostic and therapeutic arts, as defined by the applicant in [0003] of the PG Pub.
**For the purposes of examination, the term “porous material” has been interpreted under the broadest reasonable interpretation to mean any known type of solid matrix material, for example in some instances cells and/or tissue (e.g. biological tissue), and a fluid material, for example in some instances interstitial fluid, including one or more biological compartments, non-biological material such as an inorganic material (e.g., a porous ceramic material) or a non-biological organic material such as a polymeric material (e.g., a polyurethane foam or other polymeric material), porous media can be fiber or cellulose based material, a hydrogel based material, a zeolite, and/or a silica based material, and/or any combination of these above, as known in the diagnostic and therapeutic arts, as defined by the applicant in [0108].
Regarding claim 3, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein:
the focused ultrasound beam has a frequency of 1-30 MHz*([0071] the ultrasound beam has a frequency between 2 MHz and about 20 MHz).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation in the alternative requiring the focal volume of the focused ultrasound beam has a peak pressure of 1 kPa to 10 MPa; or requiring the focused ultrasound beam has a frequency of 1-30 MHz.
Regarding claim 4, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, specifically, Mahadevan-Jansen discloses wherein the porous material comprises solid matrix material* and fluid material* (abstract, the porous material comprises parathyroid tissues, which as biological tissue, comprises both cells and interstitial fluid as known in the art of cellular biology).
*See as defined in claim 1.
Regarding claim 5, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, specifically, Mahadevan-Jansen discloses wherein the porous material comprises a biological compartment* (abstract, the porous material comprises parathyroid tissues, which as biological tissue, comprises a biological compartment as known in the art of cellular biology).
*See as defined in claim 1.
Regarding claim 6, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, specifically, Mahadevan-Jansen discloses wherein the solid matrix material comprises cells or tissue (abstract, the porous material comprises parathyroid tissues, which as biological tissue, comprises both cells and tissue as known in the art of cellular biology).
*See as defined in claim 1.
Regarding claim 7, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, specifically, Mahadevan-Jansen discloses wherein the fluid material comprises interstitial fluid (abstract, the porous material comprises parathyroid tissues, which as biological tissue, comprises both cells and interstitial fluid as known in the art of cellular biology).
*See as defined in claim 1.
Regarding claim 8, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein applying the focused ultrasound beam to the first target region forces at least a portion of the population of agents out of the first target region ([0081] raster scanning of one or more ultrasound beams across or within the environment, such that the ultrasound beam sequentially generates a series of activation regions at different locations within the environment to detect a plurality of photoluminescence signals at a plurality of locations within the environment by scanning the detector from a first location/target region within the environment where the he focused ultrasound beam is applied in order to generate photoluminescence signals from the portion of the population of agents at the first location/target region).
Regarding claim 9, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses further comprising:
applying the focused ultrasound beam to a second target region of the porous material to compress at least a portion of the second target region ([0038], [0089] repeated steps after moving the activation region to a different/second target location within the environment/porous material, applying a high intensity focused ultrasound beam to the tissue, known in the art of ultrasound to result in localized tissue compression);
removing the focused ultrasound beam from the second target region ([0108]-[0109], [0112] during a cooling period the HIFU is off/removed),
wherein the second target region is different than the first target region ([0038], [0076] repeated steps after moving the activation region to a different/second target location within the environment/porous material, the first activation/target region comprises a region of high temperature compared to other portions/second target region of the environment);
applying the focused ultrasound beam to n additional target regions of the porous material to compress at least a portion of the n additional target regions ([0037], [0075], [0077], [0089], the focused ultrasound beam is raster scanned across or within the porous material, thereby producing a plurality/ number “n” of activation/additional target regions in different regions/locations within the porous material in a sequential manner, applying a high intensity focused ultrasound beam to the tissue, known in the art of ultrasound to result in localized tissue compression, ); and
removing the focused ultrasound beam from the n additional target regions ([0037]-[0108]-[0109], [0112] during a cooling period the HIFU is off/removed),
wherein n is an integer* up to 10,000 ([0037]-[0038], [0081], by raster scanning the environment or a portion thereof with the ultrasound beam, which yield a plurality of photoluminescence signals at a plurality of locations within an environment is detected by raster scanning the environment so that ultrasound beam sequentially generates a series of activation regions at different/n number of target locations within the environment as an activation region within the environment is created by exposing the environment to an ultrasound beam which allows switching of at least one fluorophore of the population from an off state to an on state where the activation region having a temperature greater than or equal to one or more of the n differing switching threshold temperatures, the correlation is carried out in a one-to-one manner, wherein an nth photoluminescence signal is correlated with an nth temperature or temperature range including an nth switching threshold temperature. Therefore, n can be any desired integer, such as 2, 3, 4, 5, 6, 7, 8, 9, or 10).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to mean any number greater than 1 but less than 10,000 and to be inclusive of a broadly described number of plurality of additional target regions in the target environment as known in the ultrasonic arts.
Regarding claim 12, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein the agent changes size* when exposed to a temperature change ([0057] a nanoparticle can exhibit a temperature-dependent size when dispersed in a polar or non-polar solvent, such as water, above the threshold temperature, the nanoparticle can exhibit a smaller size due to the exclusion of water from the now hydrophobic interior of the nanoparticle. In this manner, a fluorescent material dispersed in the nanoparticle can have a temperature-dependent concentration, which can result in temperature-dependent fluorescence properties of the overall fluorophore).
*For the purposes of examination, the limitation has been interpreted in the alternative requiring the agent changes size when exposed to the focused ultrasound beam; or requiring the agent changes size when exposed to a temperature change.
Regarding claim 13, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein the agent comprises a USF contrast agent ([0003], [0048] the fluorophore is a USF contrast agent).
Regarding claim 14, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein the population of agents has an average size, prior to applying the focused ultrasound beam, that is smaller than a pore size of the porous material ([0077], a fluorophore enters or is disposed within an activation region of an environment/ porous material by diffusing into the activation region from an adjacent area of the environment, accordingly, as the fluorophore moves into the activation region via diffusion, it would be understood by one of ordinary skill in the art that the fluorophore size would be smaller than that of the porous sizes within the matrix of the porous material in order to move by diffusion and thus moving from a high concentration to a low concentration passively).
Regarding claim 15, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein the population of agents has an average size, prior to applying the focused ultrasound beam, of less than 300 nm ([0059] the a thermoresponsive polymer nanoparticle of which each of the population of agents is comprised, has a diameter between 10 nm and 300 nm).
Regarding claim 16, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein the population of agents has an average size between 10 nm and 40 nm ([0059] the average diameter may be between 20 and 77 mm, and that other sizes are also possible. Therefore, under the broadest reasonable interpretation, the cited disclosure of Yuan reads on the limitation as so claimed as one of ordinary skill in the art would understand that a value between 10 nm and 40 nm could also be possible).
Regarding claim 17, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses wherein applying the focused ultrasound beam to the first target region increases the temperature of the first target region by less than 5° C ([0089], see FIG. 1B).
Regarding claim 19, Mahadevan-Jansen, in view of Yuan, substantially discloses all the limitations of the claimed invention, specifically, Yuan discloses further comprising:
imaging the population of agents ([0043] imaging may be achieved by deconvoluting or resolving individual photoluminescence signals primarily associated with individual ultrasound-switchable fluorophores by carrying out one or more signal processing steps, as described further hereinbelow and/or as known to one of ordinary skill in the art).
Claim(s) 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen, in view of Yuan, as applied to claim 1 above, further in view of Jiang et al. (US20210267614, hereafter “Jiang”).
Regarding claim 2, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, specifically Mahadevan-Jansen discloses wherein applying the focused ultrasound beam creates a first order ultrasound oscillation wave having a pressure ([0071] ultrasound beam comprises an oscillating sound pressure), but does not explicitly disclose a pressure gradient (∇P1) in one, two, or three dimensions of 0.1 MPa/mm to 10 MPa/mm.
However, in solving the same problem, a pressure gradient (∇P1) in one*, two, or three dimensions of 0.1 MPa/mm to 10 MPa/mm** ([0054] a high acoustic pressure output (>3 MPa in the peak-to-peak level) to a relatively far distance (>3 mm) is delivered by the transducer and output in a forward direction/x-axial dimension, as 3 MPA/3mm would yield a pressure gradient (∇P1) of 1 MPa/mm, which is within the recited range of 0.1 MPa/mm to 10 MPa/mm, the cited disclosed of Jiang reads on the limitation as claimed).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Mahadevan-Jansen with the pressure gradient (∇P1) in one, two, or three dimensions of 0.1 MPa/mm to 10 MPa/mm as taught by Jiang in order to produce an ultrasound wave with a long focal distance ([0055] of Jiang).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring a pressure gradient (∇P1) in one dimensions of 0.1 MPa/mm to 10 MPa/mm, or requiring a pressure gradient (∇P1) in two dimensions of 0.1 MPa/mm to 10 MPa/mm; or requiring a pressure gradient (∇P1) in three dimensions of 0.1 MPa/mm to 10 MPa/mm.
**For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation requiring a pressure gradient (∇P1) to be any value within the recited range of 0.1 MPa/mm to 10 MPa/mm along any axial direction with respect to the outputting transducer.
Regarding claim 11, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein exposure of the porous material to the focused ultrasound beam is associated with a mechanical index (MI) of less than 1.9.
However, in solving the same problem, wherein exposure of the porous material to the focused ultrasound beam is associated with a mechanical index (MI) of less than 1.9 ([0026], [0051], beam provided by the transducer has a mechanical index of 1.52, but less than 1.9).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the with the method disclosed by Mahadevan-Jansen with the exposure of the porous material to the focused ultrasound beam is associated with a mechanical index (MI) of less than 1.9 as taught by Jiang in order to produce an ultrasound wave with a long focal distance with a MI level over 1.5 is enough to stimulate both stable and inertial cavitation effects while restricting MI over 1.9 during in vivo application of contrast agents ([0051], [0055] of Jiang).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan-Jansen, in view of Yuan, as applied to claim 1 above, further in view of Yuan (US20140206031, hereafter “Yuan ‘6031”).
Regarding claim 20, Mahadevan-Jansen substantially discloses all the limitations of the claimed invention, but does not explicitly disclose further comprising: releasing a payload from the population of agents.
However, in the same field of endeavor, Yuan ‘6031 teaches further comprising:
releasing a payload from the population of agents ([0094] fluorophores comprised a plurality of FRET donor species/population of agents and a plurality of FRET acceptor species/the payload is coupled to a linear thermoresponsive polymer structure which are partially dispersed/released within and partially coupled to the surface of a thermoresponsive polymer NP).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the with the method disclosed by Mahadevan-Jansen with the further comprising: releasing a payload from the population of agents by Yuan ‘6031 in order to allow for a temperature-controlled release of a subset of the population of agents due to the properties and environment provided by the physical conformation or polarity of a thermoresponsive polymer changes in a temperature-dependent manner, and the thermoresponsive polymer exhibits a first conformation below a threshold temperature and a second, substantially different conformation above the threshold temperature so that the change in fluorescence intensity or lifetime can be due to differences in the microenvironment of the fluorescent species when the polymer is in the chain conformation compared to the globular conformation and the fluorescence properties of the fluorescent material can be dependent on a change of the conformation, polarity, or other physical or chemical property of the polymer nanoparticle. The property change can be a temperature-dependent change ([0050], [0053]-[0054] of Yuan ‘6031).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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