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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1: Claims 1-9 each fall within one of the four categories of statutory subject matter.
Claims 1-9 are drawn to “a computer-implemented method” (i.e., a process), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claims 1-9 recite abstract ideas, as explained below.
Eligibility Step 2A, Prong Two: Claims 1-9 do not recite additional elements that integrate the judicial exception into a practical application, as explained below.
Eligibility Step 2B: Claims 1-9 do not amount to significantly more than the abstract ideas recited therein, as explained below.
Regarding Independent Claim 1:
Step 2A, Prong One: Independent Claim 1 recites the following judicial exceptions:
“selecting a plurality of pairs of locations on the subject’s body, each pair of locations having a first location to locate a first transducer and a second location to locate a second transducer” recites a mental process. The human mind could practically select such a plurality of pairs of locations in the manner claimed. No particular manner of selecting is recited, nor are any specifics of how the claimed selecting is performed. A human could exercise judgment to select such a plurality of pairs of locations.
“selecting one or more recommended pairs of first locations and second locations based at least on the model of AC electrical conductivity and the indication of heat removal potential for each location” recites a mental process. The human mind could practically select such one or more recommended pairs of first locations and second locations in the manner claimed. No particular manner of selecting is recited, nor are any specifics of how the claimed selecting is performed. A human could observe data reflective of the model of AC electrical conductivity and the indication of heat removal potential for each location, and exercise judgment to select such one or more recommended pairs of first locations and second locations based thereupon.
Step 2A, Prong Two: Independent Claim 1 recites the following additional elements, none of which integrate the above-noted judicial exceptions into a practical application:
“A computer-implemented method to determine placement of transducers on a subject’s body for inducing tumor treating fields, the computer comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the method” (i.e., that the method is “computer-implemented,” and that the particular computer components which are responsible for implementing the “computer-implemented method”) amounts to merely reciting the words “apply it.” The recited processors and memory are what allow the recited judicial exceptions to be “computer-implemented.” “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I). Thus, neither the fact that the method is “computer-implemented” nor that the physical components of a processor and memory are used to carry out the recited judicial exception are sufficient to integrate the judicial exception into a practical application.
“obtaining a model of AC electrical conductivity in a portion of the subject’s body” amounts to necessary data gathering in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, an indication of heat removal potential at a surface of the subject’s body” amounts to necessary data gathering in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“outputting the one or more recommended pairs of first locations and second locations” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Eligibility Step 2B: Independent Claim 1 recites the following additional elements, none of which (either alone or in combination) cause the claimed invention to amount to significantly more than the abstract ideas recited therein:
“A computer-implemented method to determine placement of transducers on a subject’s body for inducing tumor treating fields, the computer comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the method” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
“obtaining a model of AC electrical conductivity in a portion of the subject’s body” does not contribute an inventive concept. The claimed model of AC electrical conductivity is described at a high level of generality. Such a model is well-understood, routine and conventional in the art. See, e.g., H.F. Poppendiek et al.; "ANNUAL REPORT ON THERMAL AND ELECTRICAL CONDUCTIVITIES OF BIOLOGICAL FLUIDS AND TISSUES;" DEFENSE DOCUMENTATION CENTER FOR SCIENTIFIC AND TECHNICAL INFORMATION, ONR CONTRACT NO. 4095 (00), April 1, 1963 to March 31, 1964 at Pg. 17.
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, an indication of heat removal potential at a surface of the subject’s body” does not contribute an inventive concept. The claimed indication of heat removal potential is described at a high level of generality. Such an indication is well-understood, routine and conventional in the art. See, e.g., H.F. Poppendiek et al.; "ANNUAL REPORT ON THERMAL AND ELECTRICAL CONDUCTIVITIES OF BIOLOGICAL FLUIDS AND TISSUES;" DEFENSE DOCUMENTATION CENTER FOR SCIENTIFIC AND TECHNICAL INFORMATION, ONR CONTRACT NO. 4095 (00), April 1, 1963 to March 31, 1964 at Pg. 14.
“outputting the one or more recommended pairs of first locations and second locations” does not contribute an inventive concept. The claimed outputting is described at a high level of generality. Such outputting is well-understood, routine and conventional in the art. See, e.g., US 2019/0259490 A1 at Para. [0032].
Regarding Claim 2:
Step 2A, Prong One: Claim 2 recites the following judicial exceptions:
“simulating, for each pair of locations, an induced electric field in the portion of the subject’s body between the first transducer and the second transducer of each pair, based on the model of AC electrical conductivity and the indication of heat removal potential at the surface of the subject’s body for the locations of each pair” recites a mathematical calculation. The claimed “simulating” is a mathematical calculation when afforded its broadest reasonable interpretation in view of the Present Specification, which suggests it to comprise using a Finite Element method analysis (see Present Specification at Para. [0041]).
“ranking simulation results of the pairs of first locations and second locations” recites a mental process. The human mind could practically rank such simulation results in the manner claimed. No particular manner of ranking is recited, nor are any specifics of how the claimed ranking is performed. A human could observe data reflective of the simulation results, and exercise judgment to rank them.
“selecting one or more ranked simulation results as the one or more recommended pairs of first locations and second locations” recites a mental process. The human mind could practically select such ranked simulation results in the manner claimed. No particular manner of selecting is recited, nor are any specifics of how the claimed selecting is performed. A human could observe data reflective of the ranked simulation results, and exercise judgment to select one.
Step 2A, Prong Two: Claim 2 does not recite any additional elements.
Step 2B: Claim 2 does not recite any additional elements
Regarding Claim 3:
Step 2A, Prong One: Claim 3 recites the following judicial exceptions:
“simulating, for each pair of locations, an induced electric field in the portion of the subject’s body between the first transducer and the second transducer of each pair based on the model of AC electrical conductivity” recites a mathematical calculation. The claimed “simulating” is a mathematical calculation when afforded its broadest reasonable interpretation in view of the Present Specification, which suggests it to comprise using a Finite Element method analysis (see Present Specification at Para. [0041]).
“ranking simulation results of the pairs of first locations and second locations” recites a mental process. The human mind could practically rank such simulation results in the manner claimed. No particular manner of ranking is recited, nor are any specifics of how the claimed ranking is performed. A human could observe data reflective of the simulation results, and exercise judgment to rank them.
“selecting two or more potential pairs of first locations and second locations based on the ranked simulation results” recites a mental process. The human mind could practically select such two or more potential pairs in the manner claimed. No particular manner of selecting is recited, nor are any specifics of how the claimed selecting is performed. A human could observe data reflective of the ranked simulation results, and exercise judgment to select two or more potential pairs based thereupon.
“comparing the indication of heat removal potential at the surface of the subject’s body for locations of the two or more potential pairs” recites a mental process. The human mind could practically compare such indication of heat removal potential in the manner claimed. No particular manner of comparing is recited, nor are any specifics of how the claimed comparing is performed. A human could observe data reflective of the indication of heat removal potential, and exercise judgment to it or locations of the two or more potential pairs.
“selecting one or more potential pairs having a highest indication of heat removal potential as the one or more recommended pairs of first locations and second locations” recites a mental process. The human mind could practically select such one or more potential pairs having a highest indication of heat removal potential in the manner claimed. No particular manner of selecting is recited, nor are any specifics of how the claimed selecting is performed. A human could observe data reflective of an indication of heat removal potential, and exercise judgment to select one or more potential pairs having a highest indication of heat removal potential.
Step 2A, Prong Two: Claim 3 does not recite any additional elements.
Step 2B: Claim 3 does not recite any additional elements.
Regarding Claim 4:
Step 2A, Prong One: Claim 4 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 4 does not recite any additional elements.
Step 2B: Claim 4 does not recite any additional elements.
Regarding Claim 5:
Step 2A, Prong One: Claim 5 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 5 does not recite any additional elements.
Step 2B: Claim 5 does not recite any additional elements.
Regarding Claim 6:
Step 2A, Prong One: Claim 6 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two:
“accessing a mapping of relative muscle mass at surface locations of the subject’s body” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, the amount of muscle mass at the location of the subject’s body from the mapping” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Step 2B:
“accessing a mapping of relative muscle mass at surface locations of the subject’s body” does not contribute an inventive concept. The claimed mapping is described at a high level of generality. Such mapping is well-understood, routine and conventional in the art. See, e.g., Baracos V. et al., "Clinical outcomes related to muscle mass in humans with cancer and catabolic illnesses," The International Journal of Biochemistry & Cell Biology, Volume 45, Issue 10, Pages: 2302-2308, October 2013 at Pg. 2303, Left Column, Third Paragraph through Right Column, Last Paragraph, under the heading “Muscle mass measured from early times to the present”).
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, the amount of muscle mass at the location of the subject’s body from the mapping” does not contribute an inventive concept. The claimed obtaining is described at a high level of generality. Such obtaining is well-understood, routine and conventional in the art. See, e.g., Baracos V. et al., "Clinical outcomes related to muscle mass in humans with cancer and catabolic illnesses," The International Journal of Biochemistry & Cell Biology, Volume 45, Issue 10, Pages: 2302-2308, October 2013 at Pg. 2303, Left Column, Third Paragraph through Right Column, Last Paragraph, under the heading “Muscle mass measured from early times to the present”).
Regarding Claim 7:
Step 2A, Prong One: Claim 7 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 7 does not recite any additional elements.
Step 2B: Claim 7 does not recite any additional elements.
Regarding Claim 8:
Step 2A, Prong One: Claim 8 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two: Claim 8 does not recite any additional elements.
Step 2B: Claim 8 does not recite any additional elements.
Regarding Claim 9:
Step 2A, Prong One: Claim 9 further limits the judicial exceptions recited in Claim 1, and thus recite a judicial exception for the same reasons as does Claim 1.
Step 2A, Prong Two:
“accessing a mapping of at least one of veins, arteries, or capillaries proximate surface locations of the subject’s body” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, the concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body from the mapping” amounts to necessary data outputting in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Step 2B:
“accessing a mapping of at least one of veins, arteries, or capillaries proximate surface locations of the subject’s body” does not contribute an inventive concept. The claimed mapping is described at a high level of generality. Such mapping is well-understood, routine and conventional in the art. See, e.g., Sigel, B., "A Brief History of Doppler Ultrasound in the Diagnosis of Peripheral Vascular Disease;" Ultrasound in Medicine & Biology Volume 24, Issue 2, February 1998, Pages 169-176 at Abstract.
“obtaining, for each location in the plurality of pairs of locations on the subject’s body, the concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body from the mapping” does not contribute an inventive concept. The claimed obtaining is described at a high level of generality. Such obtaining is well-understood, routine and conventional in the art. See, e.g., Sigel, B., "A Brief History of Doppler Ultrasound in the Diagnosis of Peripheral Vascular Disease;" Ultrasound in Medicine & Biology Volume 24, Issue 2, February 1998, Pages 169-176 at Abstract.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”).
Regarding Independent Claim 1, Wenger teaches:
A computer-implemented method to determine placement of transducers on a subject’s body for inducing tumor treating fields, … , the method comprising: (Claim 1, “ A method of optimizing positions of a plurality of electrodes placed on a subject's body, wherein the electrodes are used to impose an electric field in target tissue within an anatomic volume…;” Para. [0065]);
Wenger describes such a method as claimed, and explains at Para. [0065] that the method is computer-implemented. However, Wenger does not disclose the specifics of the computer structure recited by Claim 1. This deficiency is addressed below.
selecting a plurality of pairs of locations on the subject’s body, each pair of locations having a first location to locate a first transducer and a second location to locate a second transducer; (Fig. 4, “transducer arrays 42, 44;” Para. [0081], “ FIG. 4, which is a front view of the scalp 40 with the Optune ™ transducer arrays 42, 44 affixed to the scalp depicts this layout;” Para. [0024], “FIG. 4 depicts a front view of the scalp with transducer arrays affixed to the scalp;” see Annotated Fig. 4, below);
PNG
media_image1.png
515
805
media_image1.png
Greyscale
obtaining a model of AC electrical conductivity in a portion of the subject’s body; (Claim 1, “…the method comprising the steps of: obtaining electrical conductivity or resistivity measurements in the anatomic volume…;” Fig. 1, “S14 MAP CONDUCTIVITY WITHIN THE MODEL;” Paras. [0043] through [0044]);
selecting one or more recommended pairs of first locations and second locations based at least on the model of AC electrical conductivity… (Fig. 1, “S22,” “S23,” and “S24;” Claim 1, “…determining positions for the electrodes based on the 3D map of electrical conductivity or resistivity generated in the generating step and the location of the target tissue identified in the identifying step…”)
Wenger does not disclose:
the computer comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the method
obtaining, for each location in the plurality of pairs of locations on the subject’s body, an indication of heat removal potential at a surface of the subject’s body;
selecting one or more recommended pairs of first locations and second locations based at least on the model of AC electrical conductivity and the indication of heat removal potential for each location;
Although Wenger teaches such “selecting” as claimed “based at least on the model of AC electrical conductivity,” Wenger is silent with respect to such an “indication of heat removal potential for each location” as claimed.
and outputting the one or more recommended pairs of first locations and second locations.
Wong describes “System and methods for cancer treatment using alternating electric fields” (Title). Wong is analogous art.
Wong teaches:
the computer comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the method (Fig. 12, “System Memory 1230;” “Processing Unit 1220;” Para. [0092], “FIG. 12 illustrates an example of a suitable computing system environment 1200 on which the invention may be implemented;” Paras. [0093] through [0102], detailing Wong’s computer architecture);
obtaining, for each location in the plurality of pairs of locations on the subject’s body, an indication of heat removal potential at a surface of the subject’s body; (Para. [0006], “In some embodiments, the representation of the subject's head includes at least one material property value for the plurality of structures. In some embodiments, the at least one material property includes electric conductivity, relative permittivity, thermal conductivity, heat capacity, physical density, and/or Young's modulus.”);
Wong’s “thermal conductivity” is such “an indication of heat removal potential at a surface of the subject’s body” as claimed.
selecting one or more recommended pairs of first locations and second locations based at least on the model of AC electrical conductivity and the indication of heat removal potential for each location; (Para. [0006], “In some embodiments, the representation of the subject's head includes at least one material property value for the plurality of structures. In some embodiments, the at least one material property includes electric conductivity, relative permittivity, thermal conductivity, heat capacity, physical density, and/or Young's modulus;” Claim 1, “…construct, based on at least one image, a representation of a subject's head that includes information for a plurality of structures including at least one tumor positioned within the subject's brain; tumor positioned within the subject's brain; determine, by using the representation of the subject's head to calculate electric field propagation for a plurality of arrangements of at least one transducer on a surface of the subject's head, at least one rate of energy absorption distribution for the plurality of arrangements, … generate, based on the at least one rate of energy absorption distribution, an indication of how to place at least one transducer…;” Claims 10 and 11, “wherein the representation of the subject's head includes at least one material property … wherein the at least one material property includes electric conductivity, relative permittivity, thermal conductivity, heat capacity, physical density, and/or Young's modulus.” (emphasis added));
and outputting the one or more recommended pairs of first locations and second locations. (Claim 1, “…a user interface configured to present, to a user, the indication of how to place the at least one transducer relative to the subject's head.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wenger with the teachings of Wong (i.e., to use such a computer comprising one or more processors and memory accessible by the one or more processors as taught by Wong in the method of Wenger) in order to effectively implement the method (Wong at Para. [0095]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wenger with the teachings of Wong (i.e., to select one or more recommended pairs of first locations and second locations based at least on the model of AC electrical conductivity and the indication of heat removal potential for each location in the manner of Wong) in order to improve treatment by accounting for material properties known to impact electrical field propagation (Wong at Para. [0037]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wenger with the teachings of Wong (i.e., to outputting the one or more recommended pairs of first locations and second locations in the manner of Wong) in order to indicate to a user which positioning parameters have been determined as optimal (Wong at Para. [0046]).
Regarding Claim 2, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
Wong additionally teaches:
further comprising: simulating, for each pair of locations, an induced electric field in the portion of the subject’s body between the first transducer and the second transducer of each pair, based on the model of AC electrical conductivity and the indication of heat removal potential at the surface of the subject’s body for the locations of each pair; (Para. [0012], “The method further includes determining, by using the representation of the subject's head to calculate electric field propagation for a plurality of arrangements of at least one transducer on a surface of the subject's head, at least one rate of energy absorption distribution for the plurality of arrangements;” Para. [0059], “The method may continue by repeating steps 230, 240, and 250 for different transducer array arrangements until a desired number of unique arrangements have an associated electric field and/or rate of energy absorption distribution;” Paras. [0055] through [0059]; Para. [0006]; Claim 1; Claim 10; Claim 11)
ranking simulation results of the pairs of first locations and second locations; (Para. [0061], “At step 270, a transducer array arrangement may be selected. In some embodiments, selection of a transducer array arrangement may include identifying one or more transducer arrangements from among multiple arrangements as having the highest amount of energy absorption and/or electric field intensity at a tumor. For example, an amount of energy absorption and/or electric field intensity at a tumor may be determined for multiple transducer arrangements, and identifying one of the arrangements may include comparing the amount of energy absorption and/or electric field intensity at the tumor. When the amount of energy absorption and/or electric field intensity is higher for first transducer arrangement in comparison to a second transducer arrangement, then the first transducer arrangement may be selected.”);
and selecting one or more ranked simulation results as the one or more recommended pairs of first locations and second locations. (Para. [0061], “At step 270, a transducer array arrangement may be selected. … When the amount of energy absorption and/or electric field intensity is higher for first transducer arrangement in comparison to a second transducer arrangement, then the first transducer arrangement may be selected.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of combined Wenger and Wong with the teachings of Wong (i.e., to additionally perform such simulations as taught by Wong, and to select recommended pairs of first locations and second locations based on such ranking as taught by Wong) in order to optimize treatment by accounting for the influence of parameters of how the transducers in the array are operated on electric field propagation (Wong at Para. [0056]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) as applied to Claim 1 above, and further in view of Ahmed, M., Liu, Z., Humphries, S., & Nahum Goldberg, S. (2008). Computer modeling of the combined effects of perfusion, electrical conductivity, and thermal conductivity on tissue heating patterns in radiofrequency tumor ablation. International Journal of Hyperthermia, 24(7), 577–588 (“Ahmed”).
Regarding Claim 3, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
Wong additionally teaches:
further comprising: simulating, for each pair of locations, an induced electric field in the portion of the subject’s body between the first transducer and the second transducer of each pair based on the model of AC electrical conductivity; (Para. [0012]; Paras. [0055] through [0059]; Para. [0006]; Claim 1; Claim 10; Claim 11);
ranking simulation results of the pairs of first locations and second locations; (Para. [0061]);
selecting two or more potential pairs of first locations and second locations based on the ranked simulation results; (Para. [0061]);
The combination of Wenger and Wong does not disclose:
comparing the indication of heat removal potential at the surface of the subject’s body for locations of the two or more potential pairs;
and selecting one or more potential pairs having a highest indication of heat removal potential as the one or more recommended pairs of first locations and second locations.
Ahmed describes “Computer modeling of the combined effects of perfusion, electrical conductivity, and thermal conductivity on tissue heating patterns in radiofrequency tumor ablation” (Title). Ahmed is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Ahmed teaches:
comparing the indication of heat removal potential at the surface of the subject’s body for locations of the two or more potential pairs; (Pg 580, Right Column, Second Paragraph, “For both single and cluster electrodes, resultant 50°C isotherms were used to construct contour maps(surface responses) expressing the relationship between inner and outer perfusion and heating, using Dataplot graphing software (D-plot, Vicksburg, MS).”);
and selecting one or more potential pairs having a highest indication of heat removal potential as the one or more recommended pairs of first locations and second locations. (Pg. 581, Left Column, Second Paragraph through Right Column, First Paragraph, “Increasing surrounding tissue thermal conductivity (i.e., from fat to soft tissue to fluid; 0.23–0.7 kg/m 3-s), increases the time required to achieve complete ablation such that tumor surrounded by fluid takes longer compared to soft tissue, followed by fat. This effect was most apparent at lower perfusions; as it was more difficult to achieve complete ablation at higher tumor/surrounding tissue perfusions regardless of surrounding tissue thermal conductivity (Figure 2).For example, inner thermal conductivity of soft tissue surrounded by fat had the greatest tumor heating in the shortest time, while ablation of soft tissue surrounded by ascites often could not be achieved despite increased heating times up to 20 minutes(Figure 2). As a clinical example, in treating renal cell carcinoma (with representative inner/outer perfusion characteristics denoted by the ‘R’ in Figure 2), increasing outer thermal conductivity increases the time required to achieve ablation;” Pg. 584, Left Column, Second Paragraph through Right Column, First Paragraph, “…continued variation in treatment outcomes and the ability to successfully treat tumors is also influenced by other tissue characteristics such as thermal and electrical conductivity. This effect is most apparent in the clinically relevant range of tumor sizes (3–5 cm) and treatment application times (8–20 minutes), and in commonly encountered clinical scenarios. For example, the presence of fat surrounding the tumor (with lower outer thermal conductivity) continues to increase inner tumor heating, and reduces the time required to achieve complete ablation. … this effect is likely related to the lower thermal conductivity of fat, which serves as a heat insulator for tumor ablation.”).
Ahmed assesses the impact of “thermal conductivity” (a measure of heat removal potential) on tumor ablation, and determines that higher thermal conductivity “increases the time required to achieve complete ablation such that tumor surrounded by fluid takes longer compared to soft tissue.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger and Wong with the teachings of Ahmed (i.e., to compare Wong’s indication of heat removal potential at the surface of the subject’s body for locations of the two or more potential pairs, and select one or more potential pairs having a highest indication of heat removal potential as the one or more recommended pairs of first locations and second locations) in order to refine and tailor treatment for specific clinical scenarios (Ahmed at Pg. 587, Left Column, Second Paragraph) via the influence of thermal conductivity/heat removal potential on treatment time (Ahmed at Pg. 581, Left Column, Second Paragraph through Right Column, First Paragraph).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) as applied to Claim 1 above, and further in view of Haemmerich D, Wright AW, Mahvi DM, Lee Jr FT, Webster JG. Hepatic bipolar radiofrequency ablation creates coagulation zones close to blood vessels: A finite element study. Med Biol Eng Comput 2003; 41:317–323 (“Haemmerich”).
Regarding Claim 4, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
The combination of Wenger and Wong does not disclose:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to an amount of blood circulation proximate the surface at the location of the subject’s body
Haemmerich describes a finite element study on the distribution of temperature and current density under three different blood flow conditions in hepatic bipolar radiofrequency ablation. Haemmerich is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Haemmerich teaches:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to an amount of blood circulation proximate the surface at the location of the subject’s body (Pg. 321, Right Column, First Paragraph, “It is well known that cooling mediated by large blood vessels has a major impact on RF lesion formation during hepatic RF ablation. … This may result in sub-optimum heating of a tumour located close to this vessel, ultimately leading to a lack of complete destruction or tumour recurrence.”).
The Examiner notes that this limitation is being interpreted as structural rather than as an inherent property of heat removal potential at a particular location. More particularly, the above limitation is being interpreted to mean that that the method accounts for the impact of an amount of blood circulation proximate the surface at the location of the subject’s body on the indication of heat removal potential at the surface of the subject’s body.
Haemmerich makes clear that the impact of blood circulation on heat removal potential is quite impactful.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger and Wong with the teachings of Haemmerich (i.e., to account for the impact of an amount of blood circulation proximate the surface at the location of the subject’s body on the indication of heat removal potential at the surface of the subject’s body) in order to improve treatment by reducing tumor cell survival next to blood vessels, thus reducing recurrence rates (Haemmerich at Abstract).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) as applied to Claim 1 above, and further in view of Cheng, H.-L.M. and Plewes, D.B. (2002), Tissue thermal conductivity by magnetic resonance thermometry and focused ultrasound heating. J. Magn. Reson. Imaging, 16: 598-609 (“Cheng”).
Regarding Claim 5, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
The combination of Wenger and Wong does not disclose:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to an amount of muscle mass at the location of the subject’s body
Cheng describes “the combined use of magnetic resonance (MR) temperature imaging and focused ultrasound (FUS) for the noninvasive determination of tissue thermal properties” in the context of cancer treatment (Abstract). Cheng is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Cheng teaches:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to an amount of muscle mass at the location of the subject’s body (Pg. 598, Right Column, First Paragraph, “…tissue perfusion and conductivity are different between tumors and normal tissue (2);” Pg. 608, Left Column, Third Paragraph through Fourth Paragraph, “Therefore, heating was performed in muscle, chosen for its uniform perfusion and reduced undesirable conductive effects from large vessel flow. The effect of heat transfer by large vessel flow was further minimized with the use of a localized heat source. Lastly, the dissipation process was evaluated in a local volume from which perfusion-related heat flow does truly exit the system and can be regarded as a heat sink. This work has applications in thermal therapy planning of tumor ablation….”).
The Examiner notes that this limitation is being interpreted as structural rather than as an inherent property of heat removal potential at a particular location. More particularly, the above limitation is being interpreted to mean that that the method accounts for the impact of an amount of muscle mass at the location of the subject’s body on the indication of heat removal potential.
Cheng makes clear that the impact of muscle mass on heat removal potential is significant.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger and Wong with the teachings of Cheng (i.e., to account for the impact of an amount of muscle mass at the location of the subject’s body on the indication of heat removal potential) it order to facilitate differentiation between tumors from normal tissue during treatment (Cheng at Pg. 598, Right Column, First Paragraph).
Regarding Claim 8, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
The combination of Wenger and Wong does not disclose:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to a concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body.
Cheng describes “the combined use of magnetic resonance (MR) temperature imaging and focused ultrasound (FUS) for the noninvasive determination of tissue thermal properties” in the context of cancer treatment (Abstract). Cheng is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Cheng teaches:
wherein the indication of heat removal potential at the surface of the subject’s body is proportional to a concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body (Pg. 598, Right Column, First Paragraph, “…tissue perfusion and conductivity are different between tumors and normal tissue (2);” Pg. 608, Left Column, Third Paragraph through Fourth Paragraph, “Therefore, heating was performed in muscle, chosen for its uniform perfusion and reduced undesirable conductive effects from large vessel flow. The effect of heat transfer by large vessel flow was further minimized with the use of a localized heat source. Lastly, the dissipation process was evaluated in a local volume from which perfusion-related heat flow does truly exit the system and can be regarded as a heat sink. This work has applications in thermal therapy planning of tumor ablation….”).
The Examiner notes that this limitation is being interpreted as structural rather than as an inherent property of heat removal potential at a particular location. More particularly, the above limitation is being interpreted to mean that that the method accounts for the impact of concentration of at least one of veins, arteries, or capillaries on the indication of heat removal potential.
Cheng teaches that the impact of perfusion on heat removal potential is significant. As such, Cheng teaches that heat removal potential is “proportional to a concentration of at least one of veins, arteries, or capillaries” by virtue of Cheng’s emphasis on perfusion.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger and Wong with the teachings of Cheng (i.e., to account for the impact of concentration of at least one of veins, arteries, or capillaries on the indication of heat removal potential) it order to facilitate differentiation between tumors from normal tissue during treatment (Cheng at Pg. 598, Right Column, First Paragraph).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) and Cheng, H.-L.M. and Plewes, D.B. (2002), Tissue thermal conductivity by magnetic resonance thermometry and focused ultrasound heating. J. Magn. Reson. Imaging, 16: 598-609 (“Cheng”) as applied to Claim 5 above, and further in view of Baracos V. et al., "Clinical outcomes related to muscle mass in humans with cancer and catabolic illnesses," The International Journal of Biochemistry & Cell Biology, Volume 45, Issue 10, Pages: 2302-2308, October 2013 (“Baracos”).
Regarding Claim 6, the combination of Wenger, Wong and Cheng renders obvious the entirety of Claim 5 as explained above.
Cheng additionally teaches:
and obtaining, for each location in the plurality of pairs of locations on the subject’s body, the amount of muscle mass at the location of the subject’s body… (Pg. 598, Right Column, First Paragraph; Pg. 608, Left Column, Third Paragraph through Fourth Paragraph)
The combination of Wenger, Wong and Cheng does not disclose:
further comprising: accessing a mapping of relative muscle mass at surface locations of the subject’s body;
and obtaining, for each location in the plurality of pairs of locations on the subject’s body, the amount of muscle mass at the location of the subject’s body from the mapping
That is, none of Wenger, Wong and Cheng disclose such a mapping as claimed, and thus do not disclose obtaining the amount of muscle mass “from the mapping.”
Baracos describes “Clinical outcomes related to muscle mass in humans with cancer and catabolic illnesses” (Title). Baracos is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Baracos teaches:
further comprising: accessing a mapping of relative muscle mass at surface locations of the subject’s body; and obtaining, for each location in the plurality of pairs of locations on the subject’s body, the amount of muscle mass at the location of the subject’s body from the mapping (Pg. 2303, Right Column, Second Paragraph, “Computed tomography and MRI are increasingly used as research tools for body composition analysis. These are particularly important because they allow segmentation of individual tissues and provide direct measures of tissue cross sectional area in single images or of tissue volume in a series of images that encompass an entire organ. These methods have been extensively developed and validated….”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger, Wong and Cheng with the teachings of Baracos (i.e., to access a mapping of relative muscle mass at surface locations of the subject’s body) because such mapping is part of routine diagnostic imaging (Baracos at Abstract) as loss of skeletal muscle is detrimental (Baracos at Pg. 2302, Right Column, First Paragraph) and has been associated with poor outcomes of cancer surgery (Baracos at Pg. 2305, Left Column, Fourth Paragraph).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) as applied to Claim 1 above, and further in view of US 2005/0187581 A11 to Hara et al. (“Hara”).
Regarding Claim 7, the combination of Wenger and Wong renders obvious the entirety of Claim 1 as explained above.
The combination of Wenger and Wong does not disclose:
wherein the one or more recommended pairs of first locations and second locations comprise at least one location in a region of a shoulder, thigh, or thorax of the subject.
Hara describes “Methods of treating disorders with electric fields” (Title), which disorders include cancer/tumors (Para. [0190]). Hara is analogous art.
Hara teaches:
wherein the one or more recommended pairs of first locations and second locations comprise at least one location in a region of a shoulder, thigh, or thorax of the subject (Para. [0231], “The first electrode (8 a) is placed at head, shoulders, abdomen, legs and hips of a human body or other areas.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Wenger and Wong with the teachings of Hara (i.e., to locate Wenger’s electrodes in a region of a shoulder, thigh, or thorax of the subject in the manner of Hara) in order to “treat[] hyperproliferative and cardiovascular disorders” (Hara at Abstract).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170120041 A1 to Wenger et al. (“Wenger”) in view of WO 2018/057953 A2 to Wong et al. (“Wong”) and Cheng, H.-L.M. and Plewes, D.B. (2002), Tissue thermal conductivity by magnetic resonance thermometry and focused ultrasound heating. J. Magn. Reson. Imaging, 16: 598-609 (“Cheng”) as applied to Claim 8 above, and further in view of Bardet, S., Carr, L., Soueid, M. et al. Multiphoton imaging reveals that nanosecond pulsed electric fields collapse tumor and normal vascular perfusion in human glioblastoma xenografts. Sci Rep 6, 34443 (2016) (“Bardet”).
Regarding Claim 9, the combination of Wenger, Wong and Cheng renders obvious the entirety of Claim 8 as explained above.
The combination of Wenger, Wong and Cheng does not disclose:
further comprising: accessing a mapping of at least one of veins, arteries, or capillaries proximate surface locations of the subject’s body; and obtaining, for each location in the plurality of pairs of locations on the subject’s body, the concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body from the mapping
Bardet describes nanosecond pulsed electrical fields for treatment of cancer (Abstract). Bardet is analogous art.
Bardet teaches:
further comprising: accessing a mapping of at least one of veins, arteries, or capillaries proximate surface locations of the subject’s body; (Pg. 5, Figure 5, Caption “. Rhodamine B-dextran was injected intravascularly in the CAM for visualization with multiphoton microscopy, allowing the observation of capillaries (cp) and vessels (v).”);
and obtaining, for each location in the plurality of pairs of locations on the subject’s body, the concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body from the mapping (Pg. 6, Figure 6, Caption, “A significant change in volume and fluorescence intensity over time was observed in CAM vessels exposed to nsPEF: (a) Δ V/V0 and (b) Δ F/F0 mean + standard error of the mean (SEM) of control group (solid line, n = 5), nsPEF group w/o bleeding (dashed line, n = 17) and nsPEF group + bleeding (dotted line, n = 6). (c) Vessel diameters were measured from average Z-stacks: the change in diameter is shown as Δ d/d0 mean + standard error of the mean (SEM) for the control (grey dotted: capillaries and dashed line: vessels) and pulsed group (black dotted: capillaries+ nsPEF and dashed line: vessels+ nsPEF). Panels on the right show the morphologic change of the treated or non-treated zone over time. Asterisks indicate significant differences between pulsed samples and controls (p < 0.05).”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Wenger, Wong and Cheng with the teachings of Bardet (i.e., to accessing a mapping of at least one of veins, arteries, or capillaries proximate surface locations of the subject’s body and obtain the concentration of at least one of veins, arteries, or capillaries proximate the surface at the location of the subject’s body from the mapping) in order to determine tumor blood flow (Bardet at Pg. 6, First Paragraph).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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, Jennifer McDonald can be reached at 571-270-3061. 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.
/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 US 2005/0187581 A1 was disclosed by Applicant in the IDS dated 1/30/2025.
Prosecution Insights