DETAILED ACTION
This action is made in response to the communication filed on December 19, 2024. This action is made non-final.
Claims 1-7 are pending. Claims 1-7 have been amended by preliminary amendment. Claims 1 and 7 are independent claims.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-6 recites a condition analysis device for presenting patient data, which is within the statutory class of a machine. Claim 7 recites a method for presenting patient data, which is within the statutory category of a process.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1-7, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The limitations of:
Claims 1 and 7 (claim 7 being representative)
acquiring rank information obtained by ranking a degree of self-support or magnitude of disorder of a patient and biometric information of the patient; deriving, for each rank, range information indicating a range in which the biometric information is distributed; and displaying the range information as an image for each rank, and superimposing and displaying a predetermined image on the image at a position corresponding to the biometric information of one patient in a range indicated by the image.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). For example, but for the noted computer elements, the claim encompasses a person following rules or instructions to assess and present data in the manner described in the abstract idea. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“circuitry”—is recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The “condition analysis device” is described in the specification as a generic computer component (e.g., see Fig. 1, [0010]) and similarly, merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application).
The claims only manipulate abstract data elements as part of performing the abstract idea. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. 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. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“circuitry”, “conditional analysis device”—see Specification Fig. 1, [0010] describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept that amounts to significantly more. See MPEP 2106.05(f).
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the function of a computer, technology, or technical field, and their collective functions merely provided conventional computer implementation. Accordingly, whether taken individually or as an ordered combination, the claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 2-6 merely recite the type of data utilized, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri et al. (USPPN: 2020/0178903; hereinafter Chaudhuri) in further view of Vadasz et al. (USPPN: 2015/0216929; hereinafter Vadasz).
As to claim 1, Chaudhuri teaches A condition analysis device (e.g., see Abstract, Fig. 2) comprising:
an acquisition circuitry that acquires rank information obtained by ranking a degree of self-support or magnitude of disorder of a patient and biometric information of the patient (e.g., see Fig. 1, [0018], [0048]-[0066] wherein the system receives patient measurement data and various stages for a particular medical condition, wherein the stages are associated with severity (i.e., ranking and/or magnitude));
a derivation circuitry that derives, for each rank, range information indicating a range in which the biometric information is distributed (e.g., see Fig. 1, [0035], [0049]-[0066] wherein for each stage of a disease, there are associated thresholds in which a patient parameter is deemed normal).
Chaudhuri teaches a superimposition display circuitry that displays an image for each rank, and superimposes and displays a predetermined image on the image at a position corresponding to the biometric information of one patient in a range indicated by the image (e.g., see Fig. 3, [0035] teaching a display that superimposes an image corresponding to the biometric information of the patient on information representing the upper and lower limits of each stage of the disease as indicated by color).
While Chaudhuri indicates the upper and lower limits of each stage (i.e., range) by a color, for the purposes of compact prosecution, and in the same field of endeavor of monitoring patient health, Vadasz teaches displays the range information as an image for each rank (e.g., see Fig. 4 wherein the severity of a disease is associated with range information).
Accordingly, it would have been obvious to modify Chaudhuri in view of Vadasz before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification in order to easily visualize the upper and lower bounds of each stage/severity of a disease.
As to claim 2, the rejection of claim 1 is incorporated. Chaudhuri further teaches comprising an outlier exclusion circuitry that excludes biometric information using a threshold according to a distribution of the biometric information (e.g., see [0046] wherein outlier data is removed).
As to claim 3, the rejection of claim 1 is incorporated. Chaudhuri further teaches a tendency display circuitry that detects one or more similar patients having the rank information and the biometric information similar to the rank information and the biometric information of the one patient in a period of time in a past, acquires the rank information of detected one or more similar patients after a lapse of a predetermined period from the period of time, and displays a tendency of a rank indicated by the acquired rank information (e.g., see Fig. 3, [0035], [0043]-[0045] teaching a machine learning model trained on longitudinal data of similar data such that a trend bar is displayed predicting the occurrence of an adverse event prior to the onset of severe changes in the patient’s physiological conditions).
As to claim 4, the rejection of claim 1 is incorporated. Chaudhuri further teaches a prediction circuitry that predicts the rank information and the biometric information after a lapse of a predetermined period from the period of time using the rank information and the biometric information in a period of time in a past and the rank information and the biometric information after the lapse of the predetermined period (e.g., see Fig. 3, [0035], [0043]-[0045] teaching a machine learning model trained on past longitudinal data of similar data such that a trend bar is displayed predicting the occurrence of an adverse event prior to the onset of severe changes in the patient’s physiological conditions).
As to claim 5, the rejection of claim 1 is incorporated. Chaudhuri further teaches a complement circuitry that complements the biometric information from the rank information or complements the rank information from the biometric information (e.g., see [0045]-[0048] teaching various types of data processing of the patient data to help identify trends improve classification into the various stages of a particular medical condition).
As to claim 7, the claim is directed to the method implemented on the device of claim 1 and is similarly rejected.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri and Vadasz, as applied above, and in further view of Sato et al. (USPPN: 2021/0217509; hereinafter Sato).
As to claim 6, the rejection of claim 1 is incorporated. Chaudhuri further teaches wherein the biometric information is information determined on a basis of a heart rate or body motion (e.g., see [0058] wherein the physiological parameter can include heart rate).
While Chaudhuri teaches the system/method can be utilized for any particular medical condition having different severity/stages, Chaudhuri fails to explicitly teach the rank information is information determined on a basis of functional independence measure (FIM) or stroke impairment assessment set (SIAS). Notably, the particular type of rank information being “functional independence measure (FIM) or stroke impairment assessment set (SIAS)” is interpreted as nonfunctional descriptive information as they are not functionally required in the claimed device. See MPEP 2111.05. The function described in the claimed device would be performed the same regardless of whether the claimed FIM of SIAS rank information was present. Therefore, Chaudhuri having taught any medical condition with various stages (i.e., rank), Chaudhuri teaches the claimed limitation. Furthermore, it would have been obvious to (substitute any particular type of rank for another. As such, it would have been obvious at the time of filing to substitute the generic stages of a non-descript medical condition of the prior art with any rank information because the results would have been predictable for easily identifying desired data). See KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007); and MPEP 2143.
Nonetheless, for the purposes of compact prosecution and in the same filed of endeavor of patient healthcare management, Sato teaches functional independence measure (FIM) or stroke impairment assessment set (SIAS) (e.g., see [0067], [0080]). Accordingly, it would have been obvious to modify Chaudhuri in view of Sato before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification in order to assess patient rehabilitation (e.g., see [0007] of Sato).
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STELLA HIGGS whose telephone number is (571)270-5891. The examiner can normally be reached Monday-Friday: 9-5PM.
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/STELLA HIGGS/Primary Examiner, Art Unit 3681
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