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 .
Election/Restrictions
Applicant’s election without traverse of Species B of Species Group I and Species A of Species Group II in the reply filed on 07/31/2024 was acknowledged in office action mailed 12/20/2024.
Claims 3-6 and 9-10 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim, as discussed in office action mailed 12/20/2024. Election was made without traverse in the reply filed on 07/31/2024.
Applicant Response
Applicant's response, filed 04/17/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 2 and 7 are canceled.
Claims 1, 3-6 and 8-14 are pending.
Claims 3-6 and 9-10 are withdrawn as discussed.
Claims 1, 8, and 11-14 are under examination herein.
Claims 1, 8, and 11-14 are rejected.
Priority
The instant application is a National Stage entry of PCT/JP2019/033057 , International Filing Date: 08/23/2019, which claims foreign priority to 2018-157561, filed 08/24/2018. As such, the effective filing date assigned to each of claims 1, 8, and 11-14 is 08/24/2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings were accepted by the examiner in the office action mailed 12/20/2024.
Claim Interpretation
The instant specification discloses the term “specific” in terms of the specific increase and decrease amounts means the amounts are specific for each patient or a group to which the patient belongs (p 8, lines 7-9).
Claims 1 recite steps for “at least one processor configured to execute the instructions to: measure, using a blood test, a target hemoglobin level of a patient and a current hemoglobin level of the patient” and claim 12 recites steps for “A non-transitory computer readable recording medium storing a program causing a computer of an administration managing apparatus to execute: measuring, using a blood test, a target hemoglobin level of a patient and a current hemoglobin level of the patient”. However, a processor or computer is not capable of administering a blood test to measure levels of biomarker in the blood. For the purposes of examination, under the broadest reasonable interpretation, these limitations are interpreted as measuring biomarker levels using data from a blood test.
Claim Rejections - 35 USC § 112
The rejections of claims 1, 8, and 11-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of claim amendments filed 04/17/2026.
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, 8, and 11-14 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). Newly recited portions are necessitated by claim amendments.
In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1, 11 and 12 recite measure, using a blood test, a target hemoglobin level of a patient and a current hemoglobin level of the patient; calculate an amount of an erythropoiesis stimulating agent to be administered to a patient per unit period based on a target hemoglobin level of the patient, a current hemoglobin level of the patient, a specific decrease amount per unit period, and a specific increase amount per unit periods; calculate the amount of the erythropoiesis stimulating agent to be administered per unit period by multiplying a value obtained by adding the specific decrease amount per unit period to a difference between the target hemoglobin level and the current hemoglobin level of the patient by a unit amount of the erythropoiesis stimulating agent per amount of increase in hemoglobin level of the patient obtained by dividing the maximum allowable unit amount per unit period by the specific increase amount per unit period; calculate the specific increase amount per unit period of the patient based on a specific increase amount calculation expression according to a physical characteristic group to which the patient belongs; and generate administration schedule information indicating the calculated amount of the erythropoiesis stimulating agent to be administered per unit period to display the administration schedule information on a display, and enable a doctor to determine the amount of the erythropoiesis stimulating agent to be administered per unit period; wherein the specific decrease amount per unit period indicates an amount of decrease of a hemoglobin level of the patient when the erythropoiesis stimulating agent is not administered during the unit period; wherein the specific increase amount per unit period is n amount of increase of the hemoglobin level of the patient when the erythropoiesis stimulating agent at a maximum allowable unit amount per unit period is administered during the unit period and indicates a relative amount of increase with a hemoglobin level when the erythropoiesis stimulating agent is not administered during the unit period serving as a reference; and wherein the maximum allowable unit amount per unit period is a predetermined maximum administer for each type of the erythropoiesis stimulating agent.
Claim 8 recites calculate the specific decrease amount per unit period of the patient based on a specific decrease amount calculation expression according to a physical characteristic group to which the patient belongs.
These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, measuring levels using blood test results, calculating an amount of an erythropoiesis stimulating agent to be administered to a patient per unit period based on a target hemoglobin level of the patient, a current hemoglobin level of the patient, a specific increase amount per unit period of the patient, generating administration schedule information to display, a specific decrease amount per unit period by multiplying a value obtained by adding the specific decrease amount per unit period to a difference between the target hemoglobin level and the current hemoglobin level of the patient by a unit amount of the erythropoiesis stimulating agent per amount of increase in hemoglobin level of the patient obtained by dividing the maximum allowable unit amount per unit period by the specific increase amount per unit period and calculating the specific increase/decrease amount per unit period of the patient based on a specific increase/decrease amount calculation expression according to a physical characteristic group to which the patient belongs can be practically performing the human mind as claimed and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps as claimed for calculating an amount of an erythropoiesis stimulating agent to be administered to a patient per unit period based on a target hemoglobin level of the patient, a current hemoglobin level of the patient, a specific decrease amount per unit period by multiplying a value obtained by adding the specific decrease amount per unit period to a difference between the target hemoglobin level and the current hemoglobin level of the patient by a unit amount of the erythropoiesis stimulating agent per amount of increase in hemoglobin level of the patient obtained by dividing the maximum allowable unit amount per unit period by the specific increase amount per unit period, and calculating the specific increase/decrease amount per unit period of the patient based on a specific increase/decrease amount calculation expression according to a physical characteristic group to which the patient belongs. equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations also fall under the “Mathematical Concepts” grouping of abstract ideas. Furthermore. the steps for enabling a doctor to determine the amount of the erythropoiesis stimulating agent to be administered per unit period using a generated administration schedule equates to managing personal behavior or relationships or interactions between people and is similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). Therefore, these limitations also fall under “Certain Methods Of Organizing Human Activity” grouping of abstract ideas. As such, claims 1, 8, and 11-14 recite an abstract idea (Step 2A, Prong 1: YES).
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). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses 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. Rather, the instant claims recite additional elements that amount to mere data gathering and mere instructions to implement the abstract ideas in a generic computing environment. Specifically, the claims recite the following additional elements:
Claim 1 recites an administration managing apparatus, comprising: at least one memory configured to store instructions and at least one processor.
Claim 11 recites an administration managing apparatus; measuring, using a blood test, a target hemoglobin level of a patient and a current hemoglobin level of the patient.
Claim 12 recites a non-transitory computer readable recording medium storing a program, a computer of an administration managing apparatus.
Claim 13 recites an input interface, wherein the at least one processor is configured to execute the instructions to acquire the current hemoglobin level of the patient from the input interface.
Claim 14 recites wherein the at least one processor is configured to execute the instructions to store, in a server, identification information of the patient, the current hemoglobin level of the patient, and date and time of acquiring the current hemoglobin level of the patient.
Claim 11 recites limitations for gathering data and on the type of data gathered through the steps for measuring hemoglobin levels of a patient using a blood test. The biomarker measurement steps are performed to gather data to perform the mental steps, and there is no indication that these steps are impacted by the recited the judicial exception, and therefore the recited judicial exception is not integrated into these additional elements. These limitations equate to mere data gathering and selecting a particular data source or type of data to be manipulated, which the courts have found to be insignificant extra-solution activity (see MPEP 2106.05(g)). Furthermore, steps for determining the level of a biomarker in blood are an insignificant extra-solution activity according to the court in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968 and PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012).
The computer system and computer program product as claimed fails to recite details of how a solution to a problem is accomplished and only recites the idea of a solution or outcome. There are no limitations that indicate that the claimed steps require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Furthermore, the use of 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 integrate a judicial exception into a practical application. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Therefore, there is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1, 8, and 11-14 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). Further analyzing the additional elements under step 2B, the additional elements as described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution 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).
With respect to the instant claims under the 2B analysis, the computer system limitations of the claims are generically recited and are well-understood, routine, conventional activities, as the use of 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); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Furthermore, the courts have found that limitations for determining the level of a biomarker in blood by any means is well-understood, routine and conventional (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)). Therefore, they do not change the conventionality of the additional elements recited in the claims.
Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1, 8, and 11-14 are not patent eligible.
Response to applicant’s arguments
Applicant states instant claim 1 does not recite mental processes, as it recites a process that is performed by at least one processor configured to execute the instructions and that from a practical standpoint, a person cannot generate administration schedule information indicating the calculated amount of ESA to be administered per unit period to display the information on a display and enable a doctor to determine the amount of the erythropoiesis stimulating agent to be administered per unit period (Applicant’s Arguments, p 10, last paragraph- p 11, para 2).
It is respectfully submitted that this is not persuasive. The examiner disagrees that a human mind, with the aid tools, is incapable of generating an administration schedule that can be displayed and would enable a doctor to determine the dosage to administer, as recited in the instant claim, as the human mind is capable of analyzing blood test result data and calculating the amount of ESA to be administered, as recited in the claim, and then creating/writing a schedule that can then be displayed and used. Furthermore, as discussed in the MPEP, the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. The claims are still considered to recite a mental process even if the claims use a computer as a tool to perform the concept. Therefore, the claim recites mental processes.
Furthermore, as discussed in MPEP 2106.04(I)(A), Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception. In other words, Step 2A, Prong 1 simply evaluates whether the claim recites any judicial exceptions, and the absence or presence of additional elements, such as processors, which are not judicial exceptions do not influence the evaluation. If any judicial exceptions are found to be recited by the claim under the analysis under Step 2A, Prong 1, the analysis then moves to Step 2A, Prong 2. And, as discussed above, the claims were found to recite judicial exceptions under Step 2A, Prong 1.
Applicant further states any recited judicial exceptions are integrated into practical application when considering the claims as a whole, and that any use of "administration schedule information" and "the calculated amount of the erythropoiesis stimulating agent" in Applicant's claims is clearly integrated into the practical application of enabling a doctor to determine the amount of the erythropoiesis stimulating agent to be administered per unit period, and request withdrawal of the rejection (Applicant’s Arguments, p 13, para 2-5).
It is respectfully submitted that this is not persuasive. As discussed above, the steps for generating the administration schedule for use by a doctor amounts to an abstract idea. Enabling a doctor to determine the amount of the erythropoiesis stimulating agent to be administered per unit period using a generated administration schedule is not considered an additional element, but is part of the judicial exception itself and would amount to “certain methods of organizing human activity”, similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).
This judicial exceptions are not integrated into a practical application because, as discussed above, the claims do not recite an additional element or a combination of elements that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses 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. Rather, the instant claims recite additional elements that amount to mere data gathering and mere instructions to implement the abstract ideas in a generic computing environment. There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, the claims are directed to an abstract idea, and the rejections are maintained.
Claim Rejections - 35 USC § 102
The rejection of claim 1, 8 and 11-14 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Rodriguez et al. (US20170128532A1; 02/08/2021 IDS; hereafter referred to as Rodriguez) were withdrawn in the office action mailed 01/21/2026, in view of the claim amendments filed 11/05/2025, as Rodriguez does not appear to teach or fairly imply calculating the amount of the erythropoiesis stimulating agent to be administered per unit period by multiplying a value obtained by adding the specific decrease amount per unit period to a difference between the target hemoglobin level and the current hemoglobin level of the patient by a unit amount of the erythropoiesis stimulating agent per amount of increase in hemoglobin level of the patient obtained by dividing the maximum allowable unit amount per unit period by the specific increase amount per unit period. Rodriguez discloses determining a dosage of an Erythropoiesis Stimulating Agent (ESA) that is sufficient for treating anemia in a patient by calculating a degradation of hemoglobin per time for the patient from a hemoglobin concentration of the patient from at least two separate time points, determining a present hemoglobin concentration of the patient, and calculating an ESA dosage based on the degradation of hemoglobin per time and the present hemoglobin concentration to treat anemia in the patient. However, Rodriquez appears to be silent on calculating the amount of the erythropoiesis stimulating agent to be administered per unit period by multiplying a value obtained by adding the specific decrease amount per unit period to a difference between the target hemoglobin level and the current hemoglobin level of the patient by a unit amount of the erythropoiesis stimulating agent per amount of increase in hemoglobin level of the patient obtained by dividing the maximum allowable unit amount per unit period by the specific increase amount per unit period.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687
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