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 16-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The following is Examiner's analysis of the claimed invention under the 2019 Revised Patent Subject Matter Eligibility Guidance (PEG)
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. Claim 16 recites a machine (apparatus), claim 29 recites a process (method), claim 30 recites a manufacture (non-transitory computer readable medium).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. Claim 16 (and similar claims 29 and 30) recites “generate a first equation for a first axis of an image and generate a second equation for a second axis of the image based on factors and modulation methods selected via a control signal, and calculate coordinate points including first axis coordinate points from the first equation and calculate second axis coordinate points from the second equation for each medicine user” which falls within the mathematical concepts grouping of abstract ideas. The claim steps “generating a first equation” and “generating a second equation” are mathematical algorithms. The claim step of “calculating coordinate points” is a mathematical calculation. Accordingly, the claim is directed to a judicial exception (abstract idea).
Claim 16 (and similar claims 29 and 30) recites “the coordinate points being supplemented with the objective variable information to generate the image data, which includes medicine user data plotted based on the coordinate points” which falls within the mental processes grouping of abstract ideas. The step of “plotting medicine user data based on coordinate points” covers the performance of the limitation in a human mind. Accordingly, the claimed invention is directed to a judicial exception (abstract idea).
Claim 16 (and similar claims 29 and 30) recites “generate a demarcation line on the image indicating a boundary between classifications of different patient groups including response group on which the medicine takes effect and non-response group on which the medicine does not take effect” which falls within the mathematical concepts grouping of abstract ideas. The step of “generating a demarcation line” corresponds to the mathematical calculation recited in the specification (Para 0153, The data processing apparatus 100 can be thereby applied to regression analysis). Accordingly, the claimed invention is directed to a judicial exception (abstract idea).
Claim 16 (and similar claims 29 and 30) recites “execute a reinforcement-based controller based on the selected factor and modulation method, and that treats the image data as a state, and an accuracy of the classification of the different patient groups via the demarcation line as a reward, and update the control signal thereby selecting one or more different factors, and one or more different modulation methods, or both until the accuracy of the classification of the different patient groups via the demarcation line in the image generated based on the updated control signal is equal to or greater than a target value” which falls within the mathematical concepts grouping of abstract ideas. The step of “execute a reinforcement-based controller” corresponding to the mathematical algorithm recited in the specification Paragraph 0147. Accordingly, the claimed invention is directed to a judicial exception (abstract idea).
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. Claim 16 recites “an image generation apparatus, comprising: a memory that stores medicine user data for each medicine user, the data including a plurality of factors and objective variable information which indicates whether a medicinal effect is present, and that stores pattern information including types of factors and types of modulation methods for the factors; and a processor, programmed to” which amount to merely including instructions to implement the abstract idea on a computer.
Claim 29 recites “an image generation method, comprising: storing, in a memory medicine user data for each medicine user, the data including a plurality of factors and objective variable information indicates whether a medicinal effect is present, and that stores pattern information including types of factors and types of modulation methods for the factors” which amounts to merely including instructions to implement the abstract idea on a computer.
Claim 30 recites “a non-transitory computer readable medium storing a program for image generation, the program, upon execution by a processor, configures the process to perform steps comprising: storing, in a memory medicine user data for each medicine user being a patient, the data including a plurality of factors and objective variable information indicates whether a medicinal effect is present, and pattern information including types of factors and types of methods for the factors” which amounts to merely including instructions to implement the abstract idea on a computer.
Claim 16 (and similar claims 29 and 30) recites “the coordinate points being supplemented with the objective variable information to generate the image data, which includes medicine user data plotted based on the coordinate points” which is mere necessary data gathering and outputting because all uses of the recited judicial exception require such data gathering or data outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
The courts have determined merely including instructions to implement the abstract idea on a computer does not qualify as “significantly more” when recited in a claim with a judicial exception (See Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984).
There is no indication that the elements of the claim, individually nor in combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
For the reasons above, claims 16, 29, and 30 are rejected as being directed to nonpatentable
subject matter under §101. This rejection applies equally to the dependent claims. The additional limitations of the dependent claims are addressed briefly below:
Regarding claim 17
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “generate the control signal, which causes a first modulation section to select a first element and a second modulation section to select a second element using the pattern information, and which controls the first modulation section and the second modulation section according to the selected first element and second element” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 18
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “generate the control signal, which causes the first modulation section to select the first factor and the second modulation section to select the second factor using the pattern information, and which controls the first modulation section and the second modulation section according to the selected first factor and second factor” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 19
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “generate the control signal, for causing the first modulation section to select a first modulation method and the second modulation section to select a second modulation method using the pattern information, and which controls the first modulation section and the second modulation section based on the selected first modulation method and the second modulation method” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 20
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “generate the control signal, for causing the first modulation section to select one element out of at least either the first factor or a first modulation method, and cause the second modulation section to select one element out of at least either the second factor or a second modulation method, and which controls the first modulation section and the second modulation section based on the selected one element out of at least either the first factor or a first modulation method and the selected one element out of at least either the second factor or a second modulation method” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 21
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “update at least one element in the control signal by referring to the pattern information, and control the first modulation section and the second modulation section by an updated control signal in which the at least one element has been updated, and generate second image data by controlling the first modulation section and the second modulation section based on the updated control signal” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 22
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “implement a first action value function that outputs a value of each element in the pattern information in a case of taking a first action in a first state on a basis of a first learning parameter when first image data of the first image is assumed as the first state and a first element group contained in the control signal is assumed as the first action, update an element in the control signal, the element corresponding to a specific value output from the first action value function among values of elements in the pattern information, to a specific element corresponding to the specific value in the pattern information, and control the first modulation section and the second modulation section on a basis of the updated control signal” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Regarding claim 23
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “wherein the specific value is a value indicating a maximum value among the value of each element in the pattern information” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Regarding claim 24
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “implement a second action value function that outputs the value of each element in the pattern information in a case of taking a second action in a second state on a basis of a second learning parameter when input image data is assumed as the second state and a second element group contained in the updated control signal is assumed as the second action, calculate a value of the first action as supervisory data by adding, as a reward, an evaluation result to an output result in a case of inputting the second image data to the second action value function, update the second learning parameter on a basis of the supervisory data and an output result in a case of inputting the first image data to the second action value function, and update the first learning parameter based on an updated second learning parameter” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Regarding claim 25
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “evaluate the objective variable on a basis of the first modulation result, the second modulation result, and information associated with the objective variable, and display the first image data, on the display, in a case in which an evaluation result by the evaluation section is equal to or greater than a target value” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Regarding claim 26
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “generate the demarcation line based on the objective variable for each medicine user” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Regarding claim 27
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim inherits the abstract idea of the parent claim.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. The claim recites “wherein the factors are biological information, and the objective variable is information indicating a medicinal effect” which is mere necessary data gathering and outputting.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The courts have determined mere data gathering to not be enough to qualify as “significantly more” when recited in a claim with a judicial exception (See CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)).
Regarding claim 28
STEP 1 ls the claim to a Process, Machine, Manufacture or Composition of matter? Yes. The claim recites a machine (apparatus).
STEP2A Prong one: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? Yes. The claim recites “generate a regression line based on the coordinate points and the objective variables, and display the regression line instead of the demarcation line on the image” which falls within the mathematical concepts grouping of abstract ideas.
STEP2A Prong two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception into A Practical Application? No. There is no indication that the elements of the claim
integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. There is no indication that the elements of the claim, individually nor in
combination, integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Taken alone, the additional elements of the dependent claims do not amount to significantly
more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an
ordered combination adds nothing that is not already present when looking at the elements taken
individually. There is no indication that the combination of elements improves the functioning of a
computer or improves any other technology. Their collective functions merely provide conventional
computer implementation.
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, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Van Ness et al (US 20190214136 A1) hereafter Van Ness in view of Rawlinson et al (US 20200337773 A1) hereafter Rawlinson
Regarding claim 1, Van Ness teaches an image generation apparatus, comprising: a memory that stores medicine user data for each medicine user, the data including a plurality of factors and objective variable information which indicates whether a medicinal effect is present, and that stores pattern information including types of factors and types of modulation methods for the factors; and a processor, programmed to: generate a first equation for a first axis of an image and generate a second equation for a second axis of the image based on factors and modulation methods selected via a control signal, and calculate coordinate points including first axis coordinate points from the first equation and calculate second axis coordinate points from the second equation for each medicine user, the coordinate points being supplemented with the objective variable information to generate the image data (Para 0071, Unsupervised clustering of the gene expression signature that discriminates Responders from Non-Responders Cell lines are listed along the x-axis while the 5 genes most associated with dasatinib response are on the y-axis ), which includes medicine user data plotted based on the coordinate points (Para 0111, Processing circuitry 228 of server 224 then compares the tumor expression profile of the patient to the drug-response expression profiles stored in memory 226 (274) and generates a patient-specific drug-response prediction that indicates drugs to which the patient is likely to respond), generate a demarcation line on the image indicating a boundary between classifications of different patient groups including response group on which the medicine takes effect and non-response group on which the medicine does not take effect (Para 0084, In FIG. 8D, Generalized Linear Regression and k-Nearest Neighbor (using the caret package) was used to create models).
Van Ness does not appear to explicitly teach execute a reinforcement-based controller based on the selected factor and modulation method, and that treats the image data as a state, and an accuracy of the classification of the different patient groups via the demarcation line as a reward, and update the control signal thereby selecting one or more different factors, and one or more different modulation methods, or both until the accuracy of the classification of the different patient groups via the demarcation line in the image generated based on the updated control signal is equal to or greater than a target value.
In analogous art, Rawlinson teaches execute a reinforcement-based controller based on the selected factor and modulation method, and that treats the image data as a state, and an accuracy of the classification of the different patient groups via the demarcation line as a reward, and update the control signal thereby selecting one or more different factors, and one or more different modulation methods, or both until the accuracy of the classification of the different patient groups via the demarcation line in the image generated based on the updated control signal is equal to or greater than a target value (Para 0047, At block 320, the modeling software 110 is configured to perform point regression using the 3D ordered point cloud. Linear regression consists of finding the best-fitting straight line through the points. The best-fitting line is called a regression line). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Van Ness to include the teaching Rawlinson. One of ordinary skill in the art would be motivated to implement this modification in order to provide accurate health diagnosis, as taught by Rawlinson (Para 0026, Accurate treatment decisions are important not only for the individual patient's prognosis, but also for overall healthcare cost and efficient resource management, since sub-optimal treatments can lead to further complications, such as restenosis).
Claim 29 is the method claim corresponding to the apparatus claim 1 and is analyzed and rejected accordingly.
Claim 30 is the medium claim corresponding to the apparatus claim 1 and is analyzed and rejected accordingly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brooks Hale whose telephone number is 571-272-0160. The examiner can normally be reached 9am to 5pm est.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sanjiv Shah can be reached on (571) 272-4098. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.T.H./Examiner, Art Unit 2166
/SANJIV SHAH/Supervisory Patent Examiner, Art Unit 2166
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