DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are pending.
This action is Non-Final.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
It is noted for the record that the explanation of relevance for the two foreign patent documents cited in Chinese relevance statements are directly present in the specification as filed.
It is noted for the record that the only US PGPub on the IDS is incorrect, but the examiner corrected the citation; no correction/action is needed by applicant.
Drawings
The drawings are objected to because Figure 2 text is too small, placed directly on shading which is improper and the shading should be removed as it detracts from the figures. Figure 3 contains white text, which is improper, and the shading appears to be unnecessary; Figure 4 text is too small, uses white text, and text directly on shaded regions which is all improper; Figure 5 contains text directly on shaded regions which is improper. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings and specification are objected to for failure to comply with Rule 1.74 as Figure 3 is not referenced in the detailed description:
When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures and to the different parts by use of reference letters or numerals (preferably the latter).
Specification
The drawings and specification are objected to for failure to comply with Rule 1.74 as Figure 3 is not referenced in the detailed description:
When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures and to the different parts by use of reference letters or numerals (preferably the latter).
The use of the terms “Arduino” and “Raspberry Pi”, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Applicant please verify all other names in paragraph 35 are not also tradenames or marks registered with the USPTO.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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 1-6 are 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.
Claim 1 recites the limitation "the diagnosis" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the cloud" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the severity" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the limitations “feeding said patient characteristics and clinical features into a web application on a computing device; using an ensemble machine learning (ML) model residing on the cloud; and displaying the severity of COPD on said computing device” render the claim indefinite. It is not clear how any of these features are related based on the form of claims, but it seems that the features must be related. How are the steps completed on a computing device related to the functions completed on the cloud; to what data is that completed on; how is a severity determined and from what data/step? For these reasons, a provisional rejection is made to either confirm intention or to amend the claims; thus, the metes and bounds of the claim are unclear which renders the claim indefinite. For examination purposes, the claims are interpreted as being unrelated steps, i.e. feeding data, using ML on a cloud, and displaying data on a device.
Claim 2 recites the limitation "the age…of said patient". There is insufficient antecedent basis for this limitation in the claim. Claim 1 refers to “patients”, so claim 2 does not further limit that in addition to the issue with correct antecedent basis of the claimed terms.
Regarding claim 4, the limitations “wherein carbon monoxide is measured using a handheld CO analyzer” renders the claim indefinite. Claim 4 is a method step that states how data was measured. However, this does not further limit any active step of claims 1 or 3 methods as claim 3 merely lists data, and claim 1 merely has “obtaining” and “feeding” data. There is no step of measuring data to explain how the data was measured. Does applicant intend to limit a step here (measuring) or mere superfluous details of intended use (is measured)? This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 6, the limitations “wherein the diagnosis displayed on the computing device is transmitted to a receiver via an email or a text message” renders the claim indefinite. Claim 6 is a method step that states where data is displayed and how data was received. However, this does not further limit any active step of claim 1 as claim 1 merely was used for displaying a severity, and not “the diagnosis displayed”. Are these terms one in the same or are these in reference to different data that has not been claimed as actively displaying to be a positively recited step of the claimed method? Additionally, there is no step explaining how any data is “transmitted” in either claims 6 or 1 to afford any meaning and weight to “transmitted”. Is there a claimed method/process step missing that includes something like transmitting from the cloud and to the computer device the diagnosis of COPD (although, the claims do not actually ever determine the diagnosis, merely the severity and nothing links the severity to being the diagnosis present in the preamble. For these reasons, the metes and bounds of the claim are unclear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 101
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
using an ensemble machine learning (ML) model, wherein said ensemble ML is a combination of Decision Tree, Random Forest and Gradient Boosting models
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
obtaining patient characteristics and clinical features (data gathering; insignificant extra solution activities)
feeding said patient characteristics and clinical features into a web application on a computing device (steps related to data gathering, using a computer as a tool)
ML model residing on the cloud (using a computer as a tool)
displaying the severity of COPD on said computing device (insignificant extra solution activities, using computer as a tool)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using 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 - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the obtaining and feeding information are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further details of extra-solution details to the data gathered, data displayed. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Criner (US 2014/0365139) in view of Li (US 2019/0035505).
Regarding claim 1, Criner teaches a method for the diagnosis of chronic obstructive pulmonary disease (COPD) in patients with respiratory conditions comprising:
obtaining patient characteristics and clinical features (see [0026]-[0027], [0032] getting data and clinical features knowledge);
feeding said patient characteristics and clinical features into a web application on a computing device (see [0026]-[0027], [0032] inputting data and clinical features on computer program);
displaying the severity of COPD on said computing device (see [0038] scores from 1-5 for CPOD severity);
however, the limitations of using an ensemble machine learning (ML) model residing on the cloud; and said ensemble ML model is a combination of Decision Tree, Random Forest and Gradient Boosting models are not directly taught.
Li teaches a related system for analyzing medical data to determine disease status (see title and abstract), and teaches a process of server operated ML using ensemble machine learning to analyze data which reasonable teaches the claimed features of using an ensemble machine learning (ML) model residing on the cloud; and said ensemble ML model is a combination of Decision Tree, Random Forest and Gradient Boosting models (see Figures 1-2, [0038], [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using machine learning algorithms to identify patterns in multiple data in order to aid in diagnosing disease conditions.
Regarding claim 2, the limitations are met by Criner in view of Li, where Criner teaches wherein said patient characteristics comprise information about the age, gender, hypertension, smoking habits, and pack history of said patient (see [0032] age, gender, smoking use reads on pack history [0036] hypertension, current or past smoker reads on smoking habits).
Regarding claim 5, the limitations are met by Criner in view of Li, where Criner teaches wherein said severity of COPD is identified as “No COPD”, “mild”, “moderate”, “severe”, or “very severe” (see Figure 5, [0038] “As shown in FIG. 5, the score 32 has been determined to have a value of "2.5" based on the information entered by the patient, and categorized as "moderate". The score 32 can optionally be on a scale from 1 to 5 or any other suitable scale, and can be classified as mild, moderate or severe.”).
Regarding claim 6, the limitations are met by Criner in view of Li, where Criner teaches wherein the diagnosis displayed on the computing device is transmitted to a receiver via an email or a text message (the limitation is to an intended result and not an active method step of how displayed data may be received. The teaching of Criner are capable of such intended way the data is received as in [0039] calculations can be completed remotely, then data displayed on the computing device, where such transmissions could be by known mechanisms of text/email data transfers. For compact prosecution purposes, it is stated that text messages/emails are well-known means of communicating data- OFFICIAL NOTICE).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Criner (US 2014/0365139) in view of Li (US 2019/0035505) as applied to claim 1 above, and further in view of Hemnes et al. (Hemnes, US 2012/0302908) and Jameson et al. (Jameson, US 2021/0196148).
Regarding claim 3, the limitations are met by Criner in view of Li, where Criner teaches wherein said clinical features comprise Force Expiratory Volume (FEV) (see [0032], [0051]), but does not directly teach six-minute walking test (MWT), and percentage of carbon monoxide (CO) in exhaled breath of a patient.
Hemnes teaches a related system for analyzing parameters related to patient health (see title and abstract), and teaches using clinical factors for analyzing health including six minute walking test, and values of carbon monoxide of a patient (see [0016], [0053], [0081], [0096]). Jameson teaches a related system for measuring health parameters for determining health status (see title and abstract), and teaches clinical factors including percentage of carbon monoxide (CO) in exhaled breath of a patient (see [0047] “The measurement of eCO level has been known to serve as an immediate, non-invasive method of assessing a smoking status of an individual. The eCO levels for non-smokers can range between, e.g., 0 ppm to 6 ppm, or more particularly between, e.g., 3.61 ppm and 5.6 ppm.” Where ppm is another equivalent of representing components as a percentage in breath). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of utilizing different clinical factors to evaluate a patient’s health status to determine disease status from a combination of different parameters.
Regarding claim 4, the limitations are met by Criner in view of Li, Hemnes, and Jameson, where Hemnes teaches wherein carbon monoxide is measured using a handheld CO analyzer (see [0019], [0089], [0095]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791