CTNF 19/210,552 CTNF 77702 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-03 AIA Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for the term “sufficiently small” , does not reasonably provide enablement for the degree or amount that reasonable is considered to be “sufficiently small” in order to have the result of exhibiting linear stress-strain behavior in the tissue compare to other amounts . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. How much or to what degree will be “sufficiently small” to exhibits linear stress-strain behavior? Is the “sufficiently small” means the minimum amount of compression required to have the tissue exhibiting linear stress-strain behavior? For examination purposes, as long as displacement of the tissue due to compression occurs at any measure amount regardless of the quantitative degree, it still will comply with being an amount enough to cause the biological tissue exhibits linear stress-strain behavior . 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “sufficiently small” in claim 6 is a relative term which renders the claim indefinite. The term “sufficiently small is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, as long as displacement of the tissue due to compression occurs at any measure amount regardless of the quantitative degree, it still will comply with being an amount enough to cause the biological tissue exhibits linear stress-strain behavior. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method for serially monitoring biological tissue in a subject. This judicial exception is not integrated into a practical application because the steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a processor is a well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). Furthermore, the method steps as recited can be performed by a person in the mind by observation, judgment or evaluation to make a decision or determination. Claims 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-24 has been analyzed to determine whether it is directed to any judicial exceptions. Each of Claims 1-24 recites at least one step or instruction for “acquiring a first ultrasound volumetric image dataset of a region of interest in the biological tissue using a first ultrasound imaging device; acquiring a second ultrasound volumetric image dataset of the same region of interest at a later time using the first ultrasound imaging device or a second co-registered ultrasound device; analyzing the first and second ultrasound volumetric image datasets to detect changes in mechanical tissue characteristics over time; and generating an output indicative of a biological response, progression, or recovery in biological the tissue”, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The steps as recited can be performed by a person in the mind by observation, judgment or evaluation to make a decision or determination Accordingly, each of Claims 1-24 recites an abstract idea. Specifically, Claim 1 recites A method for serially monitoring biological tissue in a subject over a period of time, comprising: acquiring a first ultrasound volumetric image dataset of a region of interest in the biological tissue using a first ultrasound imaging device; acquiring a second ultrasound volumetric image dataset of the same region of interest at a later time using the first ultrasound imaging device or a second co-registered ultrasound device; analyzing the first and second ultrasound volumetric image datasets to detect changes in mechanical tissue characteristics over time; and generating an output indicative of a biological response, progression, or recovery in biological the tissue. Claim 18 recites: 18. A method for evaluating a progression of biological tissue healing or pathology, comprising: acquiring a sequence of ultrasound volumetric image datasets of the biological tissue at two or more different times, at least one of the ultrasound volumetric image datasets being acquired while applying a strain to the biological tissue by compression; generating a time series of tissue property maps using the sequence of ultrasound volumetric image datasets; and evaluating temporal changes in the tissue property maps to characterize biological processes in the biological tissue . Claim 24 recites: 24. A biological tissue monitoring system, comprising: an ultrasonic imaging device; a processor in operative communication with the ultrasonic imaging device, the processor being configured to: based on ultrasound measurement data received from the ultrasonic imaging device, generate a sequence of ultrasound volumetric image datasets of the biological tissue at two or more different times, at least one of the ultrasound volumetric image datasets being acquired while applying a strain to the biological tissue by compression; generate a time series of tissue property maps using the sequence of ultrasound volumetric image datasets; and3evaluate, or cause to evaluate, temporal changes in the biological tissue property maps to characterize time-dependent mechanical properties of the biological tissue. The steps of “analyzing the first and second ultrasound volumetric image datasets to detect changes in mechanical tissue characteristics over time; and generating an output indicative of a biological response, progression, or recovery in biological the tissue” can be performed by observation, judgment or evaluation in a human mind, which is grouped as a mental process under the 2019 PEG; Accordingly, as indicated above, each of the above-identified claims recites an abstract idea. Further, dependent Claims 2-17 and 19-23 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed. The above-identified abstract idea in each of independent Claims 1, 18 and 24 (and their respective dependent Claims 2-17 and 19-23) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 18 and 24), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a processor, as recited in independent claim 24 are generically recited computer elements in independent Claim 24 which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 18 and 24 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG. Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., a processor, as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 18 and 24 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG. Accordingly, independent Claims 1, 18 and 24 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG. None of Claims 1-24 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons. These claims require the additional elements of: a processor, as recited in independent Claim 24. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am. , Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs. , 788 F.3d at 1363, 115 USPQ2d at 1092-93. Per Applicant’s specification, paragraph 261, describes the processor as “Examples of processors or controllers may also include general-purpose computers or computing platforms selectively activated or reconfigured by code to provide the necessary functionality.” Furthermore, the processor is generically described without structure or detailed drawings, e.g., schematic drawing or described as an iphone or ipad or mobile device or personal computer or laptop. Therefore, the processor, according to the Specification of the current application is well understood, routine and conventional. Accordingly, in light of Applicant’s specification, the claimed term processor, is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “ ‘well understood, routine, conventional activit[ies] previously known to the industry” will not make claims patent-eligible ( TLI Communications ). The recitation of the above-identified additional limitations in Claims 1-24 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV , 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto , LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc. , 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp. , 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016) , the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. For at least the above reasons, the system and methods of Claims 1-24 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general-purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-24 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself. Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 18 and 24 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-24 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR). Therefore, none of the Claims 1-24 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-24 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-19, 23 and 24 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Fisher et al. (US 2008/0242979 A1) . With respect to claim 1, Fisher discloses a method for serially monitoring biological tissue in a subject over a period of time, comprising: acquiring a first ultrasound volumetric image dataset of a region of interest in the biological tissue using a first ultrasound imaging device; acquiring a second ultrasound volumetric image dataset of the same region of interest at a later time using the first ultrasound imaging device or a second co-registered ultrasound device (see paragraphs 0029 and 0037; see also paragraphs 009-0010 where it discusses an imaging cycle where multiple images can be taken where some are under compression and other images are without the compression from current or previous studies, therefore, implicitly disclosing at least two acquisitions with the ultrasound imaging device); analyzing the first and second ultrasound volumetric image datasets to detect changes in mechanical tissue characteristics over time (see paragraph 0048 discussing the elastic properties of the tissue being determined where elastic property, ie. elasticity is considered to be the claimed mechanical tissue characteristic); and generating an output indicative of a biological response, progression, or recovery in biological the tissue (see paragraphs 0046-0048 and 0052 disclosing receiving a signal from the imaging device, turn it into an image considered as the claimed output to determine if a lesion is malignant, determine elastic properties etc. considered as the claimed biological response or progression in the tissue). With respect to claim 2, Fisher discloses the second ultrasound volumetric image dataset is acquired while applying a strain to the biological tissue by compression (see paragraph 0048 discussing imaging while applying a strain by compression; see Figure 2 showing breast tissue #50 under compression using compression plates #52). With respect to claim 3, Fisher discloses the output is indicative of one or more mechanical properties of the biological tissue (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be the claimed mechanical tissue characteristic). With respect to claim 4, Fisher discloses the one or more mechanical properties that are identified is a shear modulus or Young's modulus of the tissue (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be the claimed Young's modulus of the tissue). With respect to claim 5, Fisher discloses generating the output includes generating a biological displacement dataset of the biological tissue (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be a biological displacement of the biological tissue). With respect to claim 6, Fisher discloses a magnitude of the strain that is applied is sufficiently small to ensure that the biological tissue exhibits linear stress-strain behavior (see paragraph 0048 discussing imaging while applying a strain by compression; see Figure 2 showing breast tissue #50 under compression using compression plates #52). With respect to claim 7, Fisher discloses generating the output further include: generating at least one 2D image representing a 2D modulus distribution within the biological tissue using the displacement data of the biological tissue; and identifying one or more mechanical properties of the tissue based on the 2D modulus distribution (see paragraph 0048 discussing imaging while applying a strain by compression; see paragraphs 0059 and 0072 disclosing the images could be 2D or 3D). With respect to claim 8, Fisher discloses the acquiring includes transmitting ultrasonic waves using a beamforming scheme selected from the group including a coherent plane-wave compounding algorithm, a single plane-wave algorithm, and a mono-focus algorithm (see paragraph 0068 describing the desired focal depth, the desired steering angle for the ultrasound beam considered as the claimed coherent plane-wave compounding algorithm; see paragraph 0049 describing the use of HIFU which implicitly teaches the use of a mono-focus algorithm). With respect to claim 9, Fisher discloses generating at least one 2D image representing a 2D modulus distribution within the biological tissue using displacement data of the tissue (see paragraph 0048 discussing imaging while applying a strain by compression; see paragraphs 0059 and 0072 disclosing the images could be 2D or 3D). With respect to claim 10, Fisher discloses generating the at least one 2D image includes generating a plurality of 2D image slices each representing a 2D modulus distribution within the biological tissue using the displacement data of the tissue (see paragraph 0048 discussing imaging while applying a strain by compression; see paragraphs 0059 and 0072 disclosing the images could be 2D or 3D). With respect to claim 11, Fisher discloses generating a 3D image from the plurality of 2D images slices, the 3D image representing a 3D modulus distribution within the biological tissue (see paragraph 0048 discussing imaging while applying a strain by compression; see paragraphs 0059 and 0072 disclosing the images could be 2D or 3D). With respect to claim 12, Fisher discloses segmenting a target tissue region in the first and second ultrasound volumetric image datasets before analysis (see paragraphs 0029-0030 and 0037). With respect to claim 13, Fisher discloses the changes in tissue characteristics that are detected include at least one of tissue stiffness, echogenicity, a presence or extent of fibrosis and volumetric deformation (see paragraphs 0049 discussing the ultrasound imaging device to detect and treat fibroids as a type of fibrosis, see claim 32 discussing volumetric deformation; paragraph 0047 discussing echogenic lesions and paragraph 0048 discussing elasticity that relates to stiffness value). With respect to claim 14, Fisher discloses the output comprises a quantitative measure of tissue change over time (see paragraph 0048 discussing rate of change of displacement of tissue before and after the compression using, hence change over time). With respect to claim 15, Fisher discloses the biological tissue is cardiac tissue, skeletal muscle tissue, or dermal tissue undergoing wound healing (see paragraph 0043 discussing tissue close to skin lesion considered as the dermal tissue). With respect to claim 16, Fisher discloses the ultrasound imaging device is a wearable flexible and/or stretchable ultrasound array (see paragraph 0055 disclosing the panels of transducer made of flexible material considered as the claimed stretchable ultrasound array). With respect to claim 17, Fisher discloses the wearable flexible and/or stretchable ultrasound array is a two-dimensional ultrasound array (as described in paragraphs 0029,0031 and 0033-0036). With respect to claim 18, Fisher discloses a method for evaluating a progression of biological tissue healing or pathology, comprising: acquiring a sequence of ultrasound volumetric image datasets of the biological tissue at two or more different times (see paragraphs 0029 and 0037; see also paragraphs 009-0010 where it discusses an imaging cycle where multiple images can be taken where some are under compression and other images are without the compression from current or previous studies, therefore, implicitly disclosing at least two acquisitions with the ultrasound imaging device), at least one of the ultrasound volumetric image datasets being acquired while applying a strain to the biological tissue by compression (see paragraph 0048 discussing imaging while applying a strain by compression; see Figure 2 showing breast tissue #50 under compression using compression plates #52); generating a time series of tissue property maps using the sequence of ultrasound volumetric image datasets (see paragraph 0048 discussing the elastic properties of the tissue being determined by obtaining rate of change of displacement of the breast tissue considered to be the claimed tissue property maps); and evaluating temporal changes in the tissue property maps to characterize biological processes in the biological tissue (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be the claimed mechanical tissue characteristic being map when tissue is compressed and not compressed). With respect to claim 19, Fisher discloses the biological processes comprise fibrosis formation, inflammation resolution, or tissue regeneration deformation (see paragraphs 0049 discussing the ultrasound imaging device to detect and treat fibroids as a type of fibrosis, and see claim 32 discussing volumetric deformation). With respect to claim 23, Fisher discloses the tissue property maps are elastic property maps generated at each time and compared across time to detect progressive stiffening or softening of the biological tissue (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be the claimed mechanical tissue characteristic being map when tissue is compressed and not compressed). With respect to claim 24, Fisher discloses a biological tissue monitoring system, comprising (as seen on Figure 1): an ultrasonic imaging device (device #10); a processor (computer unit #16 in workstations #14 as a processor) in operative communication with the ultrasonic imaging device (connected to or in communication with device #10 as shown in Figure 1), the processor being configured to: based on ultrasound measurement data received from the ultrasonic imaging device, generate a sequence of ultrasound volumetric image datasets of the biological tissue at two or more different times, at least one of the ultrasound volumetric image datasets being acquired while applying a strain to the biological tissue by compression (see paragraphs 0029 and 0037; see also paragraphs 009-0010 where it discusses an imaging cycle where multiple images can be taken where some are under compression and other images are without the compression from current or previous studies, therefore, implicitly disclosing at least two acquisitions with the ultrasound imaging device); generate a time series of tissue property maps using the sequence of ultrasound volumetric image datasets (see paragraph 0048 discussing the elastic properties of the tissue being determined were elastic property, ie. elasticity is considered to be the claimed mechanical tissue characteristic being map when tissue is compressed and not compressed); and evaluate, or cause to evaluate, temporal changes in the biological tissue property maps to characterize time-dependent mechanical properties of the biological tissue (see paragraphs 0046-0048 and 0052 disclosing receiving a signal from the imaging device, turn it into an image considered as the claimed output to determine if a lesion is malignant, determine elastic properties etc. considered as the claimed biological response or progression in the tissue) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (US 2008/0242979 A1) in view of Lu et al. (“Reconstruction of elasticity: a stochastic model-based approach in ultrasound elastography”) . With respect to claim 20, Fisher discloses the claimed invention except for the evaluating includes formulating and solving an inverse elasticity problem to derive a quantitative modulus distribution within the biological tissue. However, Lu discloses the evaluating includes formulating and solving an inverse elasticity problem to derive a quantitative modulus distribution within the biological tissue (see page 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to perform the step of evaluating includes formulating and solving an inverse elasticity problem to derive a quantitative modulus distribution within the biological tissue as taught by Lu in combination with Fisher’s processor for the purpose of obtaining an accurate quantification of material properties using more reasonable constraints, until an optimal estimation of the distribution of meaningful elastic modulus is obtained (as discussed in page 4). With respect to claim 21, Fisher discloses the claimed invention as stated above except for the inverse elasticity problem is solved by minimizing a cost function based on the difference between observed and predicted displacements under assumed boundary conditions. However, Lu discloses the inverse elasticity problem is solved by minimizing a cost function based on the difference between observed and predicted displacements under assumed boundary conditions (see page 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the inverse elasticity problem solved by minimizing a cost function based on the difference between observed and predicted displacements under assumed boundary conditions as taught by Lu in combination with Fisher’s processor for the purpose of measuring the goodness of fit between computed and measured data in order to self-correct from noises in measurement and complex tissue deformation (as discussed in page 4). With respect to claim 22, Fisher discloses the claimed invention as stated above except for the inverse elasticity problem incorporates regularization to enforce spatial smoothness. However, Lu discloses the inverse elasticity problem incorporates regularization to enforce spatial smoothness (page 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have inverse elasticity problem incorporating regularization to enforce spatial smoothness as taught by Lu in combination with Fisher’s processor for the purpose of stabilizing the reconstruction process in the presence of noise (as discussed in page 3) by providing smoothness in the kinematic function of the process (as discussed in page 4) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses ultrasound devices for elasticity measurement by compressing the tissue and ultrasound devices for elasticity measurement formulating and solving inverse elasticity problem . Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm. 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, Raymond Keith 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. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DIXOMARA VARGAS/Primary Examiner, Art Unit 3798 Application/Control Number: 19/210,552 Page 2 Art Unit: 3798 Application/Control Number: 19/210,552 Page 3 Art Unit: 3798 Application/Control Number: 19/210,552 Page 4 Art Unit: 3798 Application/Control Number: 19/210,552 Page 5 Art Unit: 3798 Application/Control Number: 19/210,552 Page 6 Art Unit: 3798 Application/Control Number: 19/210,552 Page 7 Art Unit: 3798 Application/Control Number: 19/210,552 Page 8 Art Unit: 3798 Application/Control Number: 19/210,552 Page 9 Art Unit: 3798 Application/Control Number: 19/210,552 Page 10 Art Unit: 3798 Application/Control Number: 19/210,552 Page 11 Art Unit: 3798 Application/Control Number: 19/210,552 Page 12 Art Unit: 3798 Application/Control Number: 19/210,552 Page 13 Art Unit: 3798 Application/Control Number: 19/210,552 Page 14 Art Unit: 3798 Application/Control Number: 19/210,552 Page 15 Art Unit: 3798 Application/Control Number: 19/210,552 Page 16 Art Unit: 3798 Application/Control Number: 19/210,552 Page 17 Art Unit: 3798 Application/Control Number: 19/210,552 Page 18 Art Unit: 3798 Application/Control Number: 19/210,552 Page 19 Art Unit: 3798 Application/Control Number: 19/210,552 Page 20 Art Unit: 3798 Application/Control Number: 19/210,552 Page 21 Art Unit: 3798 Application/Control Number: 19/210,552 Page 22 Art Unit: 3798
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