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 .
Response to Arguments
Applicant's arguments filed 3/27/2026 have been fully considered but they are not persuasive. The Applicant argued that Baker does not disclose mathematically analyzing shapes to objectively rate them and administering an adaptive test in the same manner as the Applicant. The Examiner respectfully disagrees. The claims merely state “mathematically analyzing the at least one drawing characteristic to determine an objective rating for each shape”. Baker discloses a “draw a shape” test to assess motor function by adding pre-written alternating shapes with increasing complexity and make a score based on a multitude of characteristics using checkpoints and weighing factors (eg. Para. 219-251). The test can figure out the most complex shape the person can draw based on the scores and can be adapted to the right and left hands in daily alterations (eg. Para. 219-251 and 526-527). The claims do not specify how the tests are adapted. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). With regards to combining with Edwards, Baker already discloses a learning algorithm for estimating the probabilities for diseases (eg. Para. 61-64 and 87). Edwards random forest learning is a well-known type of learning algorithm that can be modified for Baker since both are in the realm of determining the probabilities of diseases based on physiological characteristics/scores. One of ordinary skill could apply the inputs of the drawing parameters in Baker into the random forest learning algorithm to output a probability of a disease. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all references. Rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art (see MPEP 2145). The rejection is maintained below.
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.
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.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2020/0258631 A1) in view of Edwards (US 2021/0353218 A1).
Regarding claim 1, Baker discloses A method of screening a patient for a degenerative neurological disorder (eg. Abstract, Para. 5, 56-64), comprising a. providing a tablet computer having a touchscreen to the patient (Eg. Para. 218-219 and 526-528); b. instructing the patient to draw a plurality of shapes, wherein each shape of the plurality of shapes is of varying complexity (eg. Para. 218-251 and 526); c. recording at least one drawing characteristic for each shape drawn by the patient; d. mathematically analyzing the at least one drawing characteristic to determine an objective rating for each shape (eg. Para. 218-251 and 526); and f. administering a treatment based upon the objective probability that the patient has a neurological deficit, wherein the treatment is specific to the neurological deficit (eg. Para. 383, 390, 402, 414, and 445) and a machine learning algorithm for estimating probabilities for diseases (Eg. Para. 61-64, and 87) but does not disclose e. analyzing the objective rating for each shape using a random forest comprising a plurality of decision trees to determine an objective probability that the patient has a neurological deficit, wherein the objective probability that the patient has a neurological deficit is a function of the percentage of the plurality of decision trees which indicate a disease state.
Edwards teaches using a random forest learning algorithm that uses pretrained features, fine tuning of pretrained modules, and training from scratch random forest deep learning to determine a likelihood of someone having Alzheimer’s (eg. Para. 24-26, and 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the machine learning algorithm of Baker with a random forest learning algorithm as taught by Edwards to have a known alternative type of learning algorithm in the art for determining likelihoods of diseases.
Regarding claim 2, the combined invention of Baker and Edwards discloses determining a severity of the neurological deficit if the objective probability that patient has a neurological deficit is greater than a cutoff value (eg. Baker, Para. 224-251, 348-349 performance scores and categories, Edwards, Para. 7).
Regarding claim 3, the combined invention of Baker and Edwards discloses at least one shape of the plurality of shapes is:a. a spiral; b. a spirograph; c. a rectangle; d. a circle; e. an infinity symbol; f. a rectangular prism;g. a three-dimensional object, wherein the three-dimensional object is generalized for projected surfaces and curved surfaces; h. a sinusoid; or i. a combination thereof (eg. Baker, Para. 218-251 and 526).
Regarding claim 4, the combined invention of Baker and Edwards discloses determining a most complex shape which the patient is able to draw by administering an adaptive test (eg. Baker, Para. 218-251 and 526).
Regarding claim 5, the combined invention of Baker and Edwards discloses instructing the patient to draw the most complex shape in a different manner (eg. Baker , Para. 218-251 and 526).
Regarding claim 6, the combined invention of Baker and Edwards discloses the drawing characteristics comprise at least one of: a. a set of coordinates of the drawing; b. a pressure applied to the touchscreen for a segment of the drawing or at a timestamp of the drawing; c. an azimuthal angle of a stylus or a finger used to create the drawing for a segment of the drawing or at a timestamp of the drawing; d. an altitude angle of the stylus or the finger used to create the drawing for a segment of the drawing or at a timestamp of the drawing; e. a timestamp associated with each point of the drawing; f. the status of whether stylus or the finger is touching the surface of the screen for a segment of the drawing or at a timestamp of the drawing; or g. the velocity of the stylus movement or the finger movement at a timestamp for a segment of the drawing or at a timestamp of the drawing. (eg. Baker, Para. 218-251 and 526-528).
Regarding claim 7, the combined invention of Baker and Edwards discloses comparing the probability that the patient has a neurological deficit to a previous probability that the patient has a neurological deficit (eg. Baker, Para. 382, 429-430, 449, 480).
Regarding claim 9, the combined invention of Baker and Edwards discloses the drawing characteristics are analyzed to determine at least one of: a. Radius vs. Theta Regression Sum of Residuals; b. Radius vs. Theta Regression R2;c. d2r/dt2 Standard Deviation; d. dr/dt Standard deviation e. Curvature vs. time Regression R2;f. Rate of Inversion of Pressure; g. Jerk standard deviation; or h. Max Jerk (eg. Baker, Para. 218-251).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2020/0258631 A1) in view of Edwards (US 2021/0353218 A1), further in view of Grunsten (US 2021/0113143 A1).
Regarding claim 8, the combined invention of Baker and Edwards discloses the invention of claim 1, but does not disclose tablet computer comprises a stylus.
Grunsten teaches a mobile device with a stylus (eg. Para. 30) to assess movement disorders (eg. Para. 2, 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Baker and Edwards with the stylus assessment as taught by Grunsten to provide the predictable result of having another drawing test for assessing Parkinson’s (eg. Para. 30).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LAU/Examiner, Art Unit 3796
Prosecution Insights