DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-9, 11-16, 23, and 28-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
A computer-implemented method for pulmonary function testing, the method comprising, under the control of one or more processing devices:
identifying, based on a reference image received from a depth-sensing camera, reference locations of certain features of interest on a subject;
determining a chest region of interest comprising a chest area of the subject, based on the location of the features of interest;
receiving a plurality of images of the subject from the depth-sensing camera while the subject performs specified breathing maneuvers;
generating a three-dimensional representation of the chest region of interest based on the plurality of images of the subject;
computing changes in the volume of the chest region of interest based on the three- dimensional representation of the chest;
plotting the changes in volume of the chest region of interest on a graph, wherein the graph comprises volume of the chest region of interest over time and wherein certain chest movements are labeled on the graph;
filtering the data on the graph using one or more specified filters;
generate a flow volume curve based at least in part on rescaling the filtered graph and computing a gradient of the rescaled graph;
computing lung function parameters based at least in part on the flow volume curve; and
determining potential clinical interpretations of the pulmonary function of the subject based at least in part on the computed lung function parameters.
Independent Claim 31 recites:
A system for pulmonary function testing, the system comprising:
a first depth-sensing camera configured to generate depth-sensing images of a subject; and
a processor comprising memory operably coupled to the processor, wherein the memory comprises instructions stored thereon, which, when executed by the processor, cause the processor to:
identify, based on a reference image received from the depth-sensing camera, reference locations of certain features of interest on the subject;
determine a chest region of interest comprising a chest area of the subject, based on the location of the features of interest;
receive a plurality of images of the subject from the depth-sensing camera while the subject performs specified breathing maneuvers;
generate a three-dimensional representation of the chest region of interest based on the plurality of images of the subject;
compute changes in the volume of the chest region of interest based on the three-dimensional representation of the chest;
plot the changes in volume of the chest region of interest on a graph, wherein the graph comprises volume of the chest region of interest over time and wherein certain chest movements are labeled on the graph;
filter the data on the graph using one or more specified filters; generate a flow volume curve based at least in part on rescaling the filtered graph and computing a gradient of the rescaled graph;
compute lung function parameters based at least in part on the flow volume curve; and
determine potential clinical interpretations of the pulmonary function of the subject based at least in part on the computed lung function parameters; and
an operable connection between the depth-sensing camera and the processor.
Step 1:
The examiner finds claim 1 is drawn to a method and claim 31 is drawn to a machine.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of identifying, determining, and computing recite mental processes and/or mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “identifying...reference locations” in independent Claims 1 and 31 is an example of a mental process capable of being performed by the human mind. For example, the human mind is capable of identifying specific body parts when looking at body (i.e., hands, eyes, teeth). The steps of “determining a chest region of interest” and “determining potential clinical interpretations” in independent Claims 1 and 31 is a mental process capable of being performed in the human mind. For example, the human mind is capable of determining that a patient that is warm to the touch likely has a fever. The steps of “computing changes in the volume” and “computing lung function parameters” can be reasonably interpreted as both a mathematical calculation and/or a mental process. For example, calculating differences can be done with arithmetic operations (such as subtraction) and/or calculus (such as calculating rate of change). As a mental process, the human mind is capable of estimating that lung function is below normal by observing a patient taking shallow breaths.
The claimed steps of identifying, determining, and computing can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 2-5, 7-9, 11-16, 23, 28-30, and 32, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 1-5, 7-9, 11-16, 23, and 28-32 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for identifying, determining, and computing merely invoke a computer as a tool.
• The data-gathering step (receiving) and the data-output steps (generating and plotting) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for identifying, determining, and computing.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for identifying, determining, and computing. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: depth-sensing camera and processor.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. page 38 lines 13-16) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. collecting, aggregating, analyzing, and correlating) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
• Choi (US 20110305370 A1) which discloses the use of a depth camera is conventional to restore 3D images [0005];
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mestha (US 20150073281 A1) which discloses acquiring images from a subject during breathing activities [0029, Fig. 13];
Kiely (US 20190378329 A1) which discloses creating a point cloud of the surface of a patient’s chest using 3D imaging techniques [0017] and filtering the signal [0052].
However, the references fail to teach plotting the changes in volume of the chest region of interest on a graph, wherein the graph comprises volume of the chest region of interest over time and wherein certain chest movements are labeled on the graph, generate a flow volume curve based at least in part on rescaling the filtered graph and computing a gradient of the rescaled graph, computing lung function parameters based at least in part on the flow volume curve, and determining potential clinical interpretations of the pulmonary function of the subject based at least in part on the computed lung function parameters.
Therefore, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791