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 .
Claims 32, 34-59 are pending in this application. Claims 1-31 and 33 have been canceled by preliminary amendment.
Applicant’s election of the species “wherein the specific cause of the prolonged coagulation time is a decrease, deficiency or dysfunction of Factor VIII” #15, in the reply filed on 7/3/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 40, 43, 44 have been withdrawn as being drawn to non-elected species.
Claims 32, 34-39, 41, 45-59 are pending and under examination to the extent they read on the elected species: “wherein the specific cause of the prolonged coagulation time is a decrease, deficiency or dysfunction of Factor VIII.”
This application has published as a US PG Pub: US 2022/0115091 A1.
Applicant claims priority to a JP document, filed 9/10/2020. No certified translation of this document appears to be of record.
The preliminary amendment filed 3/3/2025 has been entered.
The Drawings as filed are suitable for examination.
Four IDS statements have been entered and considered.
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 32, 34-39, 41, 45-59 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Applicant is directed to MPEP 2106 and the Federal Register notice (FR89, no 137 (7/17/2024) p 58128-58138) for the most current and complete guidelines in the analysis of patent- eligible subject matter. The current MPEP is the primary source for the USPTO’s patent eligibility guidance.
With respect to step (1): YES. The claims are drawn to statutory categories: (computer systems, and a related method.
With respect to step (2A) (1): YES. The claims recite an abstract idea, law of nature and/or natural phenomenon. The claims recite an abstract idea of obtaining data including blood coagulation curves, or differential curve thereof, inputting the data into a generically described deep learning algorithm, and outputting a cause of prolongation of blood coagulation time of the blood specimen, using an analyzer that comprises a measurement unit and a controller. (See MPEP 2106.07(a)). The claims also embrace the natural law describing the naturally occurring correlations between naturally occurring changes in coagulation time and naturally occurring disease processes. (MPEP 2106.04). The claims explicitly recite elements that, individually and in combination, constitute one or more judicial exceptions (JE).
Mathematic concepts, Mental Processes or Elements in Addition (EIA) in the claim(s) include:
32. (Original) An analyzer for a blood specimen, comprising:
a measurement unit configured to prepare a measurement sample that contains the blood specimen and a coagulation time measurement reagent, and configured to output a plurality of pieces of detection information forming a blood coagulation curve, on the basis of the measurement sample; and
(EIA- a device, comprising a measurement unit that comprises the sample and a reagent, and that can output certain information; a data gathering element. Prior art known devices [0080]. This element does not specifically carry out the coagulation test.)
a controller,
wherein the controller is configured to
obtain a data group including a plurality of data forming the blood coagulation curve or a differential curve thereof, on the basis of the plurality of pieces of detection information,
(EIA- data gathering of data forming a curve, or a calculated differential thereof. [0081] this element appears to carry out the prior art known coagulation test, and take the required measurements, but is not explicitly recited. [0083] states the information can come from other sources, ie. EHR; Additionally, or Alternatively, a Mathematic Concept of using the obtained data from the measurement unit, and plotting a graph, then calculating a differential of the graph. [0092, 0096, 0103-0110])
input the data group into a deep learning algorithm, and
(Mathematic concept of applying data to a generically described algorithm, and calculating the results [0112]. The DL algorithm has not been trained [0113-0119], nor does the limitation describe how the DL algorithm acts on the data to achieve the desired results. No structural information about the algorithm. [0120-0123])
output, on the basis of a result obtained from the deep learning algorithm, information regarding a cause of prolongation of blood coagulation time of the blood specimen.
(EIA- routine output of correlated or labeled information in any format. [0124-0127])
34. (New) The analyzer of claim 32, wherein the plurality of the data included in the data group form the blood coagulation curve.
(EIA- a description of the data gathered, and an intended use.)
35. (New) The analyzer of claim 32, wherein the plurality of the data included in the data group form a first-order differential curve or a second-order differential curve of the blood coagulation curve.
(Mathematic concept of calculating types of differential curves)
36. (New) The analyzer of claim 32, wherein the plurality of the data included in the data group are obtained at a predetermined interval between start and end of coagulation reaction.
(EIA- a description of the data gathered.)
37. (New) The analyzer of claim 32, wherein the measurement unit is configured to optically measure the measurement sample to output the plurality of pieces of the detection information.
(EIA- describing an element of the device, used in the gathering of the data.)
38. (New) The analyzer of claim 37, wherein the measurement unit is configured to
optically measure the measurement sample by applying a first light having a first wavelength to the measurement sample to output a first set of the plurality of pieces of the detection information and
by applying a second light having a second wavelength different from the first wavelength to the measurement sample to output a second set of the plurality of pieces of the detection information.
(EIA- additional data gathering steps, by carrying out measurements)
39. (New) The analyzer of claim 32, wherein the measurement unit is configured to prepare, as the measurement sample,
a first measurement sample that contains the blood specimen and a first coagulation time measurement reagent for a first blood coagulation parameter and
a second measurement sample that contains the blood specimen and a second coagulation time measurement reagent for a second blood coagulation parameter, and
(EIA- description of the structure of the data gathering element)
configured to output, as the plurality of pieces of detection information,
a third set of the plurality of pieces of detection information on the basis of the first measurement sample and a fourth set of the plurality of pieces of detection information on the basis of the second measurement sample.
(Mathematic Concept of applying the data from the two sample measurements to the algorithm, to produce the third set of information.)
41. (Currently Amended) The analyzer of claim 32, wherein the cause of the prolongation of the blood coagulation time comprises decrease, deficiency, or dysfunction of a coagulation factor.
(EIA- a label, or a description of the output of the method)
42. (Currently Amended) The analyzer of claim 41, wherein the decrease, deficiency, or dysfunction of the coagulation factor comprises decrease, deficiency, or dysfunction of factor VIII.
(EIA- a label, or a description of the output of the method)
45. (New) The analyzer of claim 32, wherein the information regarding the cause of the prolongation of the blood coagulation time includes:
a label indicating a cause candidate for the prolongation of the blood coagulation time;
and probability information relating to a probability that the cause candidate indicated by the label is actually a cause of the prolongation of the blood coagulation time.
(EIA- a label or description of the intended output of the method AND a mathematic concept of calculation of a probability.)
46. (New) The analyzer of claim 32, wherein the controller is configured to output the information regarding the cause of the prolongation of the blood coagulation time in a form of a graph.
(EIA- specifying a routine graphic output.)
47. (New) The analyzer of claim 45, wherein the controller is configured to output, as the information regarding the cause of the prolongation of the blood coagulation time,
a label indicating a cause candidate for which the probability is highest among the probabilities of the cause candidates.
(EIA- a label or description of the intended output of the method AND a mathematic concept of calculation of a probability.)
48. (New) The analyzer of claim 45, wherein the controller is configured to output, as the information regarding the cause of the prolongation of the blood coagulation time,
a label indicating a cause candidate for which the probability is not less than a predetermined threshold.
(EIA- a label or description of the intended output of the method AND a mathematic concept of comparing a calculated probability to a threshold.)
49. (New) The analyzer of claim 48, wherein the controller is further configured to receive a setting of the predetermined threshold.
(EIA- data gathering element)
50. (New) The analyzer of claim 32, wherein the controller is further configured to
output information regarding an additional test on the basis of the result obtained from the deep learning algorithm.
(Mental Process or Mathematic concept of observing the result, and correlating the result to a label, or additional test required.)
51. (New) The analyzer of claim 50, wherein the additional test comprises:
a test regarding a coagulation factor;
a test regarding a coagulation factor inhibitor; or
a re-test regarding a measurement item of measurement performed on the measurement sample.
(EIA- additional data gathering steps for the additional test of claim 50.)
52. (New) The analyzer of claim 50, wherein the controller is further configured to,
in response to that the information regarding the additional test indicates a plurality of additional tests,
output a priority ranking of each additional test.
(Mathematic concept of ranking based on a value.)
53. (New) The analyzer of claim 50, wherein the controller is further configured to,
in response to obtaining second information regarding a cause of prolongation of blood coagulation time for the additional test,
store the second information in association with the data group.
(EIA- routine storage of data)
54. (New) The analyzer of claim 32, wherein the controller is further configured to
determine whether or not the blood specimen has prolongation of blood coagulation time on the basis of the plurality of data forming the blood coagulation curve, and
(Mathematic concept of calculating blood coagulation time, and comparing it to a standard)
configured to,
in response to determining that the blood specimen has the prolongation of blood coagulation time,
execute the input of the data group into the deep learning algorithm, and
(Mathematic concept of applying the data to the algorithm and calculating the results)
the output of the information regarding the cause of prolongation of blood coagulation time of the blood specimen.
(EIA- routine output of a label or result in any form.)
55. (New) The analyzer of claim 32, wherein the controller is further configured to
receive an output request for the information regarding the cause of prolongation of the blood coagulation time, and configured to,
in response to receiving the output request,
execute the output of the information regarding the cause of prolongation of blood coagulation time of the blood specimen.
(EIA- routine receipt of request, and routine output of information)
56. (New) The analyzer of claim 32, wherein the controller is further configured to
receive a blood coagulation parameter to be tested and
configured to select the deep learning algorithm into which the data group is inputted from a plurality of deep learning algorithms on the basis of the received blood coagulation parameter.
(EIA- routine receipt of data parameter, and mental process of observing the parameter, and judging what algorithm should be applied.)
57. (New) The analyzer of claim 32, wherein the deep learning algorithm has been trained by data sets, each data set including:
data group, including a plurality of data forming the blood coagulation curve or a differential curve thereof, obtained from a second measurement sample that contains a second blood specimen for which a cause for prolongation of blood coagulation time is known and the coagulation time measurement reagent; and
a label indicating the cause of the prolongation of the blood coagulation time of the second blood specimen.
(Mathematic concept modification, wherein the deep learning algorithm was trained with certain data)
58. (New) The analyzer of claim 32, wherein the deep learning algorithm includes a convolution neural network.
(Mathematic concept modification, selecting a type of algorithm)
59. (New) An analysis method of a blood specimen, comprising:
preparing a measurement sample that contains the blood specimen and a coagulation time measurement reagent;
(EIA- preamble setting forth the goal of the method, and a data gathering step of preparing a sample and reagent, by any means)
measuring coagulation of the blood specimen;
(EIA- data gathering step of measuring, by any means, blood coagulation, and obtaining measurements)
outputting a plurality of pieces of detection information forming a blood coagulation curve, on the basis of the measured measurement sample;
(EIA- outputting measurements of the coagulation in any form / means)
obtaining a data group including a plurality of data forming the blood coagulation curve or a differential curve thereof, on the basis of the plurality of pieces of detection information;
(EIA- data gathering of data forming a curve, or a calculated differential thereof. [0081];[0083] states the information can come from other sources, ie. EHR; Additionally, or Alternatively, a Mathematic Concept of using the obtained data from the measurement unit, and plotting a graph, then calculating a differential of the graph. [0092, 0096, 0103-0110])
inputting the data group into a deep learning algorithm; and
(Mathematic concept of applying data to a generically described algorithm, and calculating the results [0112]. The DL algorithm has not been trained [0113-0119], nor does the limitation describe how the DL algorithm acts on the data to achieve the desired results. No structural information about the algorithm. [0120-0123])
outputting, on the basis of a result obtained from the deep learning algorithm, information regarding a cause of prolongation of blood coagulation time of the blood specimen.
(EIA- routine output of a label or result correlated with the output, by any form/ means)
Natural law embraced by independent claim(s) 32-34-39, 41, 45-59:
The claims recite the naturally occurring correlations between a naturally occurring difference in or extension of blood coagulation time and naturally occurring disease processes. The difference in the length of time that it takes for a subject’s blood to clot is a natural phenomenon and the relationship of that information to a naturally occurring phenotypic trait (the disease, or identified cause) is simply put a natural law. Nothing more than this observation is required by the claims. In Mayo, the discovery underlying the claims was that when blood levels were above a certain level harmful effects were more likely and when they were below another level the drug's beneficial effects were lost. Mayo, 566 U.S. at 74--76. The claims provided that particular levels of measured metabolite indicated a need to increase or decrease the amount of drug subsequently administered to the subject. Id. at 75. However, the claims did not require any actual action be taken based on the measured level of metabolite. Id. at 75-76. Thus, the claims which required only the observation of a natural law were deemed patent-ineligible. Similarly, here, the claim requires only the observation of the natural law, and for this reason too are properly deemed patent-ineligible.
The encompassed natural law exists whether or not it is measured. These correlate to at least the following examples provided in MPEP 2106.04b:
“iii. a correlation between variations in non-coding regions of DNA and allele presence in coding regions of DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016);
iv. a correlation that is the consequence of how a certain compound is metabolized by the body, Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012);
v. a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017);
vii. qualities of bacteria such as their ability to create a state of inhibition or non-inhibition in other bacteria, Funk Bros., 333 U.S. at 130, 76 USPQ at 281; and
xi. the natural relationship between a patient’s CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc prolongation after administration of a medication called iloperidone, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 (Fed. Cir. 2018).”
With respect to step 2A (2): NO. The claims were examined further to determine whether they integrated any JE into a practical application (MPEP 2106.04(d)). The claimed additional elements are analyzed alone, or in combination to determine if the JE is integrated into a practical application (MPEP 2106.05(a-c, e, f and h)).
Claim(s) 32, 34, 36-39, 41-42, 45-49, 51, 53-56, 59 recite the additional non-abstract element(s) of data gathering, or a description of the data gathered.
Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data needed to carry out the JE. The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04/.05, citing Intellectual Ventures LLC v. Symantec Corp, McRO, TLI communications, OIP Techs. Inc. v. Amason.com Inc., Electric Power Group LLC v. Alstrom S.A.).
Independent claim(s) 32 recites the additional non-abstract element (EIA) of a generally described device, comprising a measurement unit and a controller.
The device has no particular physical aspects beyond the measurement unit containing reagents, and the sample, and a controller. This is not a particular machine, as it can be met by any number of prior art known blood analyzer devices. The device is not affected by the JE, nor do the results of the JE depend upon the device.
The EIA do not provide any details of how specific structures of the computer/ device elements are used to implement the JE. The computer / device elements of the claims do not provide improvements to the functioning of the computer. device itself (as in DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (as in Diamond v. Diehr); nor do they utilize a particular machine (as in Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the JE using a computer, and therefore the claim does not recite integrate that JE into a practical application.
Dependent claim(s) 35, 40, 45, 47, 48, 50, 52, 54, 56-58 recite(s) an abstract limitation in addition to the JE reciting additional mathematic concepts, or mental processes. Additional abstract limitations cannot provide a practical application of the JE as they are a part of that JE.
In combination, the limitations of data gathering, for the purpose of carrying out the JE, using a general-purpose computer merely provide extra-solution activity, and fail to integrate the JE into a practical application.
With respect to step 2B: NO. The claims recite a JE, do not integrate that JE into a practical application, and thus are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The additional elements were considered individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to claim(s) 32, 34, 36-39, 41-42, 45-49, 51, 53-56, 59: The limitation(s) identified above as non-abstract elements (EIA) related to data gathering do not rise to the level of significantly more than the judicial exception.
With respect to the device, comprising a measurement unit, which comprises a sample and a reagent, and a controller:
Katayama et al. 7,276,376 B2 discloses a device for analyzing blood coagulation reaction, which comprises a measurement unit, a sample, and a reagent (See at least Fig 3).
Shima et al. US 2018/0031539 A1, discloses a blood specimen analyzer, comprising a measurement unit, a sample and a reagent (See at least Figs 4 and 9).
Koshimura, N. US 2016/0291040 A1, discloses a sample analyzer comprising a measurement unit, a sample and a reagent (See Figs 1 and 2).
Ieko et al. US 2017/0350907 A1, discloses a blood sample analyzer, for identifying a cause of prolongation of coagulation time, which comprises a measurement unit, a sample and a reagent (see at least Figs 1 and 7).
With respect to measuring a blood coagulation reaction:
Katayama et al. 7,276,376 B2 discloses measuring a blood coagulation reaction, to output data forming a blood coagulation curve.
Ieko et al. US 2017/0350907 A1, discloses measuring a blood coagulation reaction, to output data forming a blood coagulation curve.
Uchida et al US 2019/0346426 A1, discloses measuring a blood coagulation reaction, to output data forming a blood coagulation curve.
These elements meet the BRI of the identified data gathering limitations. As such, the prior art recognizes that this data gathering element is routine, well understood and conventional in the art (as in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook).
Activities such as data gathering do not improve the functioning of a computer/ device, or comprise an improvement to any other technical field. The limitations do not require or set forth a particular machine, they do not effect a transformation of matter, nor do they provide an unconventional step (citing McRO and Trading Technologies Int’l v. IBG). Data gathering steps constitute a general link to a technological environment. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp.,).
With respect to independent claim 32: the limitations identified above as non-abstract elements (EIA) related to general-purpose devices/ computer elements do not rise to the level of significantly more than the judicial exception.
Each of Katayama, Shima, Koshimura, Ieko and Uchida disclose controllers configured to measure and store data, analyze data, and output data, which each meet the BRI of the claimed device or system elements, comprising input, output/ display, a processor/controller, and memory.
As such, the prior art recognizes that these computing elements are routine, well understood and conventional in the art.
These elements do not improve the functioning of the computer/ device itself, or comprise an improvement to any other technical field (Trading Technologies Int’l v IBG, TLI Communications). They do not require or set forth a particular machine (Ultramercial v. Hulu, LLC., Alice Corp. Pty. Ltd v. CLS Bank Int’l), they do not effect a transformation of matter, nor do they provide an unconventional step. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook, Versata Development Group v. SAP America).
Dependent claim(s) 35, 40, 45, 47, 48, 50, 52, 54, 56-58 each recite a limitation requiring additional mathematic concepts or mental processes. Additional abstract limitations cannot provide significantly more than the JE as they are a part of that JE (MPEP 2106.05).
In combination, the data gathering steps providing the information required to be acted upon by the JE, performed in a generic computer or generic computing environment fail to rise to the level of significantly more than that JE. The data gathering steps provide the data for the JE, which is carried out by the general-purpose computers. No non-routine step or element has clearly been identified.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. This is not a rejection, but an analysis:
Such claim limitation(s) is/are:
In claim 32 the generic placeholder is “measurement unit”, and the specialized function is: “to prepare a sample”.
In claim 32 the generic placeholder is “measurement unit”, and the specialized function is: “configured to output a plurality of pieces of detection information forming a blood coagulation curve on the basis of the measurement sample”.
In claim 32 the generic placeholder is “controller”, and the specialized function is: “obtain a data group… input the data group into a deep learning algorithm”.
In claim 32 the generic placeholder is “controller”, and the specialized function is: “output on the basis of a result obtained from the deep learning algorithm information regarding a cause of prolongation of blood coagulation time of the blood specimen”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32, 34-37, 41, 45-58 are rejected under 35 USC 112(b) or 112 (second paragraph) as they fail to particularly point out and distinctly claim the subject matter which applicant regards as his invention.
As set forth above, claim limitations identified above invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
With respect to claim 32, and the “measurement unit”, Claim 32 fails to particularly point out and distinctly claim the algorithms, structures, or step-by-step instructions for performing the specialized function of “preparing a sample” or “output a plurality of pieces of detection information forming a blood coagulation curve on the basis of the measurement sample”. The measurement unit has no particular structural elements of any kind, nor does the specification clearly set forth how the measurement unit outputs detection information which has not yet been measured, or even after. The “configured to” does not specify any particular algorithms, step-by-step-instructions, or structures for carrying out these limitations. One of skill would not be apprised as to what particular functions Applicant applies to achieve the desired result. While the claims are read in light of the specification, limitations from the specification cannot be read into the claims.
With respect to claim 32 and the “controller” Claim 32 fails to particularly point out and distinctly claim the algorithms, structures, or step-by-step instructions for performing the specialized functions of “obtain a data group…” “input the data group into a deep learning algorithm” and “output on the basis of a result obtained from the deep learning algorithm information regarding a cause of prolongation of blood coagulation time of the blood specimen.” The controller does not set forth any particular structures, algorithms, or step-by-step instructions by which each specialized function should be achieved. No particular algorithm is identified to meet the “deep learning algorithm.” No particular aspect of the algorithm carries out the intended result of “information regarding a cause…” There is no link between the measured data, the algorithm, and any specific cause of prolongation. The claim fails to address how any differential diagnosis can be achieved, or how any one cause is identified based on the data from the deep learning algorithm. It is unclear if this is a mathematic correlation, a predictive or risk calculation, or a look up table to which a data value should be compared. No particular algorithms are pointed out or particularly linked to these limitations. One of skill would not be apprised as to what particular functions Applicant applies to achieve the desired result. While the claims are read in light of the specification, limitations from the specification cannot be read into the claims.
With respect to claims dependent on claim 32:
Claims 34-36 are directed to descriptions of the data, or intended results.
Claim 37 provides optical configuration, without specifying any particular structure for the measurement unit, nor any particular measurement reaction instructions, or capture of the data describing the coagulation, nor how to output the desired data.
Claims 41-42 are directed to identifying the cause of the prolongation as a coagulation factor, particular factor VIII, but provide no particular instructions on how to identify this particular cause. The claims fail to set forth algorithms, structures or step-by-step instructions that clearly obtain the required information related to Factor VIII, obtain or calculate the various curves, the particular deep learning algorithm to be used, and how that deep learning algorithm takes the curves, and specifically identifies the cause as related to Factor VIII.
Claim 45 is directed to identifying certain information- labels and probability information, but lacks the algorithms, structures or step-by-step instructions to label data, and calculate the particular probability information to identify the actual cause of the prolongation.
Claims 46-55 are directed to various outputs provided by the controller, but fail to set forth the particular algorithms, structures or step-by-step instructions for carrying out these specialized functions. Each specialized function or intended result of these claims requires information not clearly linked to these limitations in the specification, nor does the claim provide the information necessary.
Claim 56 sets forth that the controller is configured to receive certain data, and based on that data, to select a deep learning algorithm, but fails to set forth how the received data influences the choice of algorithm, nor does it set forth any algorithms or instructions that take the parameter information, analyze or compare it, and then select a specific algorithm. The algorithm of claim 32, from which this depends, merely states a “deep learning algorithm” and has no clear ability to be influenced by the input of a parameter.
Claim 57 sets forth that the deep learning algorithm “has been trained” and lists certain information including curves, and labels, but fails to clearly set forth whether these are reference data that have a known cause, and fails to clearly set forth how to make any association between the label and the cause. The claim fails to set forth how the training influences the identification of a specific cause of prolongation.
Claim 58 specifies a type of deep learning algorithm, but fails to set forth how the algorithm has been trained, how the algorithm takes the input from the measurement unit, or the controller, and calculates or determines a particular cause of prolongation. The claim fails to set forth particular algorithms, structures, or step-by-step instructions for using a convolution neural network to achieve the desired goal: a cause of prolongation.
MPEP 2181.II.B: “For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b) (b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367 (Fed. Cir. 2008).” Additionally, “To claim a means for performing a specific computer-implemented function and then to disclose only a general-purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239.” Finally, “Mere reference to a general-purpose computer with appropriate programming without providing an explanation of the appropriate programming, or simply reciting "software" without providing detail about the means to accomplish a specific software function, would not be an adequate disclosure of the corresponding structure to satisfy the requirements of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239...”
Therefore, claims 32, 34-37, 41, 45-58 are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 59 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 59 are unclear, with respect to how the generically described deep learning algorithm actually performs the desired result of determining a cause of prolongation of blood coagulation time in a specimen. The claim sets forth no reference information or reference curves to which the sample curves could be compared. The deep learning algorithm has not been trained to identify a cause of prolongation, nor does it set forth how the deep learning algorithm acts to identify that cause, based on the curve information input from the sample. no clear discriminative steps are set forth that would allow the identification of a single cause, nor are any particular differences in information set forth such that a comparison or algorithm could make such identifications. No clear normalization or error analysis is performed. No particular training data sets have been applied or verified by test data. The claim is written in results-based language which fails to set forth how the result is to actually be obtained. While the claims are read in light of the specification, limitations from the specification cannot be read into the claims.
Claims 32, 34-39, 41, 45-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The function of the written description requirement is to ensure that the inventor had possession of the specific subject matter later claimed as of the filing date of the application relied on... In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979), further reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983); see also MPEP §§ 2163 - 2163.04.
Original, amended, or new claims are each given their broadest reasonable interpretation in light of, and consistent with the written description of the invention. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or how the result is to be achieved. For computer-implemented inventions, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps or procedures taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed to achieve the desired results. See MPEP §§ 2163.02 and 2181, subsection IV. As set forth in MPEP 2161, 2181 and 2185, “the claims must be supported by adequate written description of the step-by-step directions, algorithms, or structures to carry out the claimed steps.”
Functional claim limitations may be adequately described if: (1) The written description adequately links or associates adequately described particular structure, material, or acts to perform the function recited; or (2) it is clear based on the facts of the application that one skilled in the art would have known what specific structure, material, or acts disclosed in the specification perform the specialized function. See Aristocrat Techs. Australia PTY Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1336-37, 86 USPQ2d 1235, 1242 (Fed. Cir. 2008)
Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. For example, in Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1380[, 53 USPQ2d 1225, 1230] (Fed. Cir. 1999), the court embraced the proposition that ‘consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification.’
It is not enough for the patentee simply to state or later argue that persons of ordinary skill in the art would know what structures to use to accomplish the claimed function. The court in Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946, 953[, 83 USPQ2d 1118, 1123] (Fed. Cir. 2007), put the point this way: "The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure."
Additionally, "[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general-purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’") (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999))
"Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function." Additionally, "[a] bare statement that known techniques or methods can be used does not disclose structure" in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp..” An invention described solely in terms of a method of its desired function lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.
The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
Considering claims 32, 34-39, 41, 45-59, the claimed technology of determining a cause of prolongation of blood coagulation time of a blood specimen is considered in the art to be unpredictable.
The level of the skill and knowledge of one skilled in the art of bioinformatics is high. Bioinformatics combines biological and technical knowledge with skills related to computers and sophisticated data analysis. In particular, the prior ar