DETAILED ACTION
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Status of the Claims
Claims 1-12 are pending.
Claim 7 is objected to.
Claims 1-12 are rejected.
Priority
This application US 18/498,968 (10/31/2023) is a DIV of US Application No. 18/148,809 (12/30/2022) which is a CON of US Application No. 16/398,345 (04/30/2019) which is a CON of PCT/JP2018/047963 (12/26/2018) and claims benefit of Foreign Application JP2017-252111 (12/27/2017), as reflected in the filing receipt mailed on 06/09/2026. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1-12 is 12/27/2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/31/2023, 0829//2024 and 05/15/2026 were considered.
Claim objections
Claim 7 is objected to because of the following informality: the recited “processing circuity” should read “a processing circuitry” for proper grammar. Appropriate correction is required.
35 USC § 112(b)
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.
Claims 1-12 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
Claim 1 recites “the diagram arranging the plurality of types of tissue properties in accordance with a relative relationship between the index values shown by the plurality of types of tissue properties in such a manner that a type of disease can be identified” which is indefinite. MPEP 2173.05(g) states that “Examiners should consider the following factors .. (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained.” In this instant case, the claim recites a solution or an arrangement that achieves a solution without explaining how that solution is achieved. To overcome this rejection, the claims may be amended to clarify how said “such a manner that a type of disease can be identified” is achieved.
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 1-12 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a system (claims 1-12); which falls within one of the categories of statutory subject matter. [Step 1: claims 1-12: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims found to recite abstract ideas that can fall into the grouping of mathematical concepts (in particular mathematical relationships and formulas) and mental processes (in particular procedures for observing, analyzing and organizing information). The identified grouping(s) for this instant claims are as follows:
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
• "obtain index values for each of a plurality of types of tissue properties relating to a region of interest of a subject" (independent claim 1);
• "generate a diagram showing the index values by the plurality of types of tissue properties, the diagram arranging the plurality of types of tissue properties in accordance with a relative relationship between the index values shown by the plurality of types of tissue properties in such a manner that a type of disease can be identified" (independent claim 1);
• "update the diagram every time the index value is obtained” (claim 5);
• "generate workflow information indicating procedure of obtaining the index values of the plurality of types of tissue properties” (claim 6);
• "acquire the index value corresponding to at least one of the plurality of types of tissue properties by analyzing a result of the scanning” (claim 8);
• "generate a chart of the region of interest based on the index values, and cause to display the chart, wherein an index value of elasticity, an index value of viscosity, and an index value of attenuation are arranged adjacent to each other in a discretionarily determined order in the chart” (claim 12).
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind (i.e. concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) or because the method only requires a user to manually determine action based on an added number. Under the BRI, the recited limitations are mental processes because a human mind is also sufficiently capable of obtaining data from a list, generating a diagram using pen and paper, updating said diagram as needed, acquiring values by analyzing/evaluating results and generate a chart using pen and paper.
Dependent claims 2-3 and 9-10 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claims 2-3 recite further details about the diagram; claims 9-10 recite further details about the index values.
[Step 2A Prong One: claims 1-12: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
Instant claims 1, 4-9 and 11-12 recite additional elements that are not abstract ideas:
• "processing circuitry” (claims 1, 4-9 and 12);
• "cause to display the diagram" (claim 1);
• "obtain, from an external apparatus, the index value corresponding to at least one of the plurality of types of tissue properties” (claim 4);
• "output the diagram to an external apparatus” (claim 7);
• "a scanner configured to perform scanning to the region of interest” (claim 8);
• "medical imaging processing apparatus" (claim 11) and
• "cause to display the chart” (claim 12).
Considerations under Step 2A, Prong Two
The limitations recited in claims 1, 4-9 and 11-12 are interpreted as requiring the use of a computer. The use of a computer is broadly interpreted as supported by this instant specification at pg. 10 lines 3-4. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer.
The recited "processing circuitry” (claims 1, 4-9 and 12); "a scanner configured to perform scanning to the region of interest” (claim 8) and "medical imaging processing apparatus" (claim 11) are directed to additional non-abstract elements of a computing device/computer do not describe any specific computational steps by which the "computer parts" perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute judicial exceptions.
The judicial exceptions in the claims are considered to perform the claimed abstract idea with a computer, which is not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and merely performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Claims directed to "obtain, from an external apparatus, the index value" (claim 4) read on receiving or transmitting data over a network -Symantec, 838 F.3d at 1321 - MPEP 2106.05(a) pertains; which constitutes just necessary data gathering and therefore correspond to insignificant extra-solution activity.
Claims reciting "display the diagram" (claim 1); "output the diagram to an external apparatus” (claim 7) and “display the chart” (claim 12) are interpreted as data outputting and as such insignificant extra-solution activity.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)).
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
[Step 2A Prong Two: claims 1-12: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during examination that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
Claims 1, 4-9 and 11-12 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Further, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versa ta 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, as discussed in MPEP 2106.05(d)(Il)(i)).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h).
The instant claims constitute insignificant extra solution activity, and when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)). Hence, these elements, when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(d)).
[Step 2B: claims 1-12: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(l) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bouzitoune ("Can early hepatic fibrosis stages be discriminated by combining ultrasonic parameters?." Ultrasonics 68:120-126 (2016)).
Claim 1 recites:
processing circuitry configured to:
obtain index values for each of a plurality of types of tissue properties relating to a region of interest of a subject,
generate a diagram showing the index values by the plurality of types of tissue properties, the diagram arranging the plurality of types of tissue properties in accordance with a relative relationship between the index values shown by the plurality of types of tissue properties in such a manner that a type of disease can be identified, and
cause to display the diagram
• Bouzitoune teaches the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) (i.e. obtain index values for each of a plurality of types of tissue properties relating to a region of interest of a subject), according to METAVIR Score (pg. 120 Abstract); wherein 421 radiofrequency signals were acquired and amplified (pg. 121 col. 2 para. 2) for 20 human liver specimens (pg. 121 col. 2 para. 1) and transferred to a computer for storage and off-line processing (i.e. processing circuitry) (pg. 122 col. 1 para. 1); wherein changes of the tissue microstructure (size, density, and compressibility of the scatterers) were evaluated (pg. 122 col. 1 para. 2) via ultrasonic parameters (i.e. index values) such as backscatter coefficient, speed of sound, attenuation coefficient, mean scatterer spacing and spectral slope (pg. 120 Abstract); wherein a diagram plot displays the discriminant functions for the different parameters of the three fibrosis stages depicting the classification of each stage based on the evaluated parameters (i.e. generate a diagram showing the index values by the plurality of types of tissue properties, the diagram arranging the plurality of types of tissue properties in accordance with a relative relationship between the index values shown by the plurality of types of tissue properties in such a manner that a type of disease can be identified) (pg. 124 Figs. 4-5); wherein the diagrams were displayed by a computer (pg. 124 Figs. 4-5) during off-line processing (i.e. cause to display the diagram) (pg. 122 col. 1 para. 1). Here, the interpretation for “index values” is supported by this instant specification pg. 17 lines 20-23.
Claim 4 recites:
wherein the processing circuitry is further configured to obtain, from an external apparatus, the index value corresponding to at least one of the plurality of types of tissue properties
• Bouzitoune teaches the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals (i.e. the index value corresponding to at least one of the plurality of types of tissue properties) to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) according to METAVIR Score (pg. 120 Abstract); wherein 421 radiofrequency signals were acquired and amplified (pg. 121 col. 2 para. 2) for 20 human liver specimens (pg. 121 col. 2 para. 1) and transferred to a computer for storage and off-line processing (i.e. wherein the processing circuitry is further configured to obtain, from an external apparatus) (pg. 122 col. 1 para. 1).
Claim 8 recites:
further comprising a scanner configured to perform scanning to the region of interest, wherein the processing circuitry is further configured to acquire the index value corresponding to at least one of the plurality of types of tissue properties by analyzing a result of the scanning
• Bouzitoune teaches the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) according to METAVIR Score (pg. 120 Abstract); wherein 421 radiofrequency signals were acquired by a moving transducer placed above the sample (i.e. a scanner configured to perform scanning to the region of interest to acquire the index value corresponding to at least one of the plurality of types of tissue properties by analyzing a result of the scanning ) (pg. 121 col. 2 para. 2).
Claim 10 recites:
wherein the index values comprise a quantified value obtained by measurement
• Bouzitoune teaches the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) (according to METAVIR Score (pg. 120 Abstract); wherein ultrasonic measurements were performed for each sample (pg. 121 col. 1 para. 1).
Claim 11 recites:
wherein the analysis apparatus is a medical imaging processing apparatus
• Bouzitoune teaches the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) according to METAVIR Score (pg. 120 Abstract); wherein 421 radiofrequency signals were acquired by a moving transducer placed above the sample (pg. 121 col. 2 para. 2) and a homemade software produced images from the acquired radiofrequency signals (pg. 121 col. 1 para. 1).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 2-3 and 6-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bouzitoune as applied to claim 1 in the 102 rejection above further in view of McDevitt (US 2014/0235487 A1), as cited on the attached Form PTO-892.
Claim 2 recites:
wherein the diagram is a radar chart
Claim 3 recites:
wherein the diagram is a bar graph
• Bouzitoune does not teach the recitation above. However, McDevitt teaches methods of computing a risk score of oral cancer [0003] that integrates multiple measurements from demographic, morphological indicator inputs [0007]; wherein the process includes sample collection, processing, analysis by lab-on-chip, to image processing, and data analysis [0071]; wherein Figs. 9-10 shows radar charts that display morphological and biomarkers parameters (i.e. index values) for different classes of oral cancer (0077-0078]; wherein Fig. 11-13 shows bar charts that display AUC values for parameter models [0079-0081].
Claim 6 recites:
wherein the processing circuitry is further configured to generate workflow information indicating procedure of obtaining the index values of the plurality of types of tissue properties
• Bouzitoune does not teach the recitation above. However, McDevitt teaches a Figure generated to depict the overall process from sample collection to lab-on-chip analysis, to image collection and analysis (i.e. workflow information indicating procedure of obtaining the index values of the plurality of types of tissue properties) [0107].
Claim 7 recites:
wherein the processing circuity is further configured to output the diagram to an external apparatus
• Bouzitoune does not teach the recitation above. However, McDevitt teaches methods of computing a risk score of oral cancer [0003] that integrates multiple measurements from demographic, morphological indicator inputs[0007]; wherein Figs. 9-10 shows radar charts that display morphological and biomarkers parameters (i.e. index values) for different classes of oral cancer (0077-0078]; wherein the risk scores calculated from said morphological and biomarkers parameters is displayed on an output device [0039-0040].
Rationale for combining (MPEP §2142-2143)
Regarding claims 2-3 and 6-7, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Bouzitoune in view of McDevitt because all references disclose methods for the investigation of biological tissues and related parameter measurements involving ultrasound image processing. The motivation would have been to integrate the results (morphological, biomarker and demographics information) from multiple binary classifications as inputs, according to 3-way ordinal and 5-way ordinal scales of disease progression to create a continuous numerical scale and guide clinicians in their management of patients with potentially malignant lesions [0009] McDevitt).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the investigation of biological tissues and related parameter measurements involving ultrasound image processing of Bouzitoune to the methods by McDevitt because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for the investigation of biological tissues and related parameter measurements involving ultrasound image processing.
B. Claim 5 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bouzitoune as applied to claim 1 in the 102 rejection above further in view of Dalecki (“Quantitative ultrasound for nondestructive characterization of engineered tissues and biomaterials." Annals of biomedical engineering 44.3:636-648 (2016)), as cited on the attached Form PTO-892.
Claim 5 recites:
wherein the processing circuitry is further configured to update the diagram every time the index value is obtained
• Bouzitoune does not teach the recitation above. However, Dalecki teaches a non-invasive, non-destructive technologies for imaging and quantitatively monitoring the development of artificial tissues during fabrication and post implantation (pg. 636 Abstract); wherein after application of the radiation force, tissue deformation associated with shear wave propagation is monitored spatially over time using conventional pulse-echo ultrasound (pg. 643 col. 2 para. 3); wherein updated results over time are depicted in a series of biweekly (pg. 644 Fig. 4) multimodal imaging analysis to monitor mechanical and structural changes (pg. 644 col. 2 para. 1) (i.e. update the diagram every time the index value is obtained).
Rationale for combining (MPEP §2142-2143)
Regarding claim 5, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Bouzitoune in view of Dalecki because all references disclose methods for ultrasound imaging and quantitative analysis of biological tissues. The motivation would have been to incorporate real-time qualitative and quantitative analysis of ultrasound imaging, quantitative ultrasound techniques, and elastography (pg. 637 col. 1 para. 4 Dalecki).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the ultrasound imaging and quantitative analysis of biological tissues of Bouzitoune to the methods by Dalecki because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for ultrasound imaging and quantitative analysis of biological tissues.
C. Claim 9 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bouzitoune as applied to claim 1 in the 102 rejection above further in view of Nenadic (“Application of attenuation measuring ultrasound shearwave elastography in 8 post-transplant liver patients." 2014 IEEE International Ultrasonics Symposium. IEEE, 2014), as cited on the attached Form PTO-892.
Claim 9 recites:
wherein the index values of the plurality of types of tissue properties at least include an index value of elasticity, an index value of viscosity, and an index value of attenuation, and the processing circuitry is further configured to generate the diagram in which the index value of elasticity, the index value of viscosity, and the index value of attenuation are arranged adjacent to each other
• Bouzitoune does not teach the recitation above. However, Nenadic teaches a method for assessing mechanical properties of soft tissues namely (pg. 1 Abstract); wherein shear wave velocity and attenuation results were outputted via a diagram (pg. 4 Fig. 4); wherein said method independently measures both shear wave velocity and attenuation in tissue and therefore allows measurement of tissue elasticity and viscosity (pg. 1 Abstract).
Rationale for combining (MPEP §2142-2143)
Regarding claim 9, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Bouzitoune in view of Nenadic because all references disclose methods for ultrasound imaging and quantitative analysis of biological tissues. The motivation would have been to characterize tissue mechanical properties by measuring shear wave velocity and attenuation independently to estimate tissue elasticity and viscosity (pg. 1 col. 1 para. 1 Nenadic).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the ultrasound imaging and quantitative analysis of biological tissues of Bouzitoune to the methods by Nenadic because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for ultrasound imaging and quantitative analysis of biological tissues.
D. Claim 12 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bouzitoune as applied to claim 1 in the 102 rejection above further in view of Zhu ("The role of viscosity estimation for oil-in-gelatin phantom in shear wave based ultrasound elastography." Ultrasound in medicine & biology 41.2:601-609 (2015)), as cited on the attached Form PTO-892.
Claim 12 recites:
wherein the processing circuitry is further configured to: generate a chart of the region of interest based on the index values, and cause to display the chart, wherein an index value of elasticity, an index value of viscosity, and an index value of attenuation are arranged adjacent to each other in a discretionarily determined order in the chart
• Bouzitoune teaches “index value of attenuation” and “generate a chart of the region of interest based on the index values” as the classification of early stages of fibrosis based on a multiparametric characterization using backscatter ultrasonic signals to discriminate between the stages of liver fibrosis: F0 (normal), F1, F3, and/without F4 (cirrhosis) according to METAVIR Score (pg. 120 Abstract); wherein changes of the tissue microstructure (size, density, and compressibility of the scatterers) were evaluated (pg. 122 col. 1 para. 2) via ultrasonic parameters (i.e. index values) such as backscatter coefficient, speed of sound, attenuation coefficient, mean scatterer spacing and spectral slope (pg. 120 Abstract); wherein a diagram plot outputs the discriminant functions for the different parameters of the three fibrosis stages displaying the classification of each stage based on the evaluated parameters (i.e. generate a chart of the region of interest based on the index values) (pg. 124 Figs. 4-5).
• Bouzitoune does not teach “wherein an index value of elasticity, an index value of viscosity, … are arranged adjacent to each other in a discretionarily determined order in the chart.” However Zhu teaches the comparison between two shear wave-based elasticity imaging methods, shear wave dispersion ultrasound vibrometry (SDUV) and acoustic radiation force impulsive (ARFI) imaging simultaneously characterizing elasticity and viscosity parameters (i.e. index value of elasticity and an index value of viscosity) (pg. 601 Abstract); wherein mimicked soft tissue was analysed and its shear viscosity µ2 and shear elasticity µ was charted in order of increasing amount of castor oil in the sample i.e. wherein an index value of elasticity, an index value of viscosity, … are arranged adjacent to each other in a discretionarily determined order in the chart) (pg. 608 Table 2).
Rationale for combining (MPEP §2142-2143)
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Bouzitoune in view of Zhu because all references disclose methods for imaging and quantitative analysis of biological tissues. The motivation would have been to characterized the biological soft tissues and its inherent viscosity and elasticity simultaneously to assist clinical disease diagnosis (pg. 601 Abstract Zhu).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the imaging and quantitative analysis of biological tissues of Bouzitoune to the methods by Zhu because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for imaging and quantitative analysis of biological tissues.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-6, 8-9 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7 and 21 of copending Application No 16/398,345.
• Reference claim 1 teaches instant claim 1.
• Reference claim 1 teaches instant claim 2.
• Reference claim 5 teaches instant claim 4.
• Reference claim 6 teaches instant claim 5.
• Reference claim 7 teaches instant claim 6.
• Reference claim 21 teaches instant claim 8.
• Reference claim 1 teaches instant claim 9.
• Reference claim 1 teaches instant claim 11.
Reference claim 1 teaches instant claim 12.
Conclusion
No claims are allowed.
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/F.F.L./Examiner, Art Unit 1685
/JANNA NICOLE SCHULTZHAUS/Examiner, Art Unit 1685
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