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 .
Prosecution History Summary
Claims 7-8 and 15-16 are amended.
Claims 1-17 are pending.
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 1-17 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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 1-8), machine (claim 17), and article of manufacture (claims 9-16). Accordingly, claims 1-17 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 9 includes limitations that recite at least one abstract idea. Specifically, independent claim 9 recites:
A tangible non-transitory computer readable storage medium that stores a computer program, the computer program, when executed by a processor, causing a computer apparatus to implement a process comprising:
-identifying a prospect as a candidate and providing the candidate with a lab test based on identifying the prospect as the candidate;
-obtaining lab results from applying the lab test to a biometric sample from the candidate;
-determining whether the candidate is suitable for treatment as a patient based on the lab results;
-when the candidate is suitable for treatment, reviewing the lab test, patient medical history, and demographic characteristics of the candidate in a review;
-titrating a level of a customized drug or other therapy for the patient based on the review; and
-prescribing the customized drug or other therapy for the patient at the titrated level based on the review.
Examiner states submits that the foregoing underlined limitations constitute: “certain methods of organizing human activity” because analyzing biometric sample to determine suitable treatment and then prescribing the treatment is managing a user’s behavior.
Furthermore, the foregoing underlined limitation constitute: a “mental process” because analyzing biometric sample to determine suitable treatment can all be performed in the human mind.
Representative independent claim 17 includes limitations that recite at least one abstract idea. Specifically, independent claim 17 recites:
A system for touch-free medical treatment of a patient, the system comprising:
-a memory that stores instructions; and
-a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the system to:
-apply an artificial intelligence model to patient data for the patient; and
-identify treatment for disease states caused by menopause and perimenopause based on applying the artificial intelligence model to the patient data.
Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because identifying treatment based on analyzed information can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional
limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Claim 9
A tangible non-transitory computer readable storage medium that stores a computer program, the computer program, when executed by a processor (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 94-96), causing a computer apparatus to implement a process comprising:
-identifying a prospect as a candidate and providing the candidate with a lab test based on identifying the prospect as the candidate;
-obtaining lab results from applying the lab test to a biometric sample from the candidate;
-determining whether the candidate is suitable for treatment as a patient based on the lab results;
-when the candidate is suitable for treatment, reviewing the lab test, patient medical history, and demographic characteristics of the candidate in a review;
-titrating a level of a customized drug or other therapy for the patient based on the review; and
-prescribing the customized drug or other therapy for the patient at the titrated level based on the review (extra-solution activity, see MPEP 2106.05(g)).
Claim 17
A system for touch-free medical treatment of a patient, the system comprising:
-a memory that stores instructions (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 94-97); and
-a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the system (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 94-96) to:
-apply an artificial intelligence model to patient data for the patient (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 41); and
-identify treatment for disease states caused by menopause and perimenopause based on applying the artificial intelligence model to the patient data.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 9 do not recite additional elements that integrate the judicial exception into a practical
application. Accordingly, representative independent claim 1 and analogous independent claim 9 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 2, 10: The claim specifies the treatment, which further narrows the abstract idea.
Claim 3, 11: The claim specifies applying a trained AI model to lab results, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 4, 12: The claim specifies trained AI model trained with results of treating patient, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 5, 13: The claim specifies applying the trained AI model, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 6, 14: The claim specifies the trained AI model, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claim 7, 15: The claim specifies providing the lab test and obtaining a biometric sample for 2 rounds, which is an insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)).
Claim 8, 16: The claim specifies method performed without physical exam and using an application, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 1, 9, and 17 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Claim 9
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as obtaining lab results, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); reviewing lab results, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); titrating a level of a customized drug, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 3, 5, 7, 11, 13, 15, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 7, 15 (providing lab test), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 3, 5, 11, 13 (applying a trained AI model) e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)). 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.
Therefore, whether taken individually or as an ordered combination, claims 1-17
are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shtraizent et al. (U.S. Publication No. 2023/0015833).
As per claim 1, Shtraizent teaches a method for touch-free medical treatment of a patient, comprising:
-identifying a prospect as a candidate and providing the candidate with a lab test based on identifying the prospect as the candidate (Shtraizent: para. 72-75; Gather a biological sample to measure hormones and then compare it to a population to determine if the user fits the profile or is an outlier.);
-obtaining lab results from applying the lab test to a biometric sample from the candidate (Shtraizent: para. 72; Determine hormone levels from blood sample of a user.);
-determining whether the candidate is suitable for treatment as a patient based on the lab results (Shtraizent: para. 72-76; Gather a biological sample to measure hormones and then compare it to a population to determine if the user fits the profile or is an outlier. Determine therapy based on the levels of hormones.);
-when the candidate is suitable for treatment as a patient, reviewing the lab results, candidate medical history, and demographic characteristics of the candidate in a review (Shtraizent: para. 72);
-titrating a level of a customized drug or other therapy for the patient based on the review (Shtraizent: para. 68; Analyzing the information to determine adjustment to therapy.); and
-prescribing the customized drug or other therapy for the patient at the titrated level based on the review (Shtraizent: para. 67; Transmit the information regarding therapy.).
As per claim 2, the method of claim 1 is as described. Shtraizent teaches wherein the treatment comprises hormone replacement therapy, and wherein the customized drug or other therapy is prescribed without face-to-face contact with a medical professional to obtain treatment via the customized drug or other therapy (Shtraizent: para. 135).
As per claim 3, the method of claim 1 is as described. Shtraizent teaches further comprising: applying a trained artificial intelligence model to the lab results to determine whether the candidate is suitable for treatment as the patient (Shtraizent: para. 68; Using AI to analyze the hormones in blood of the user.).
As per claim 4, the method of claim 3 is as described. Shtraizent teaches wherein the trained artificial intelligence model is trained based on results of treating a plurality of additional patients treated before the patient (Shtraizent: para. 83; Training using previous baseline datasets.).
As per claim 5, the method of claim 1 is as described. Shtraizent teaches further comprising: applying a trained artificial intelligence model to data from reviewing the lab results to titrate the level of the customized drug or other therapy (Shtraizent: para. 68; Analyzing the information to determine adjustment to therapy.).
As per claim 6, the method of claim 5 is as described. Shtraizent teaches wherein the trained artificial intelligence model is trained based on results of customizing the customized drug or other therapy for a plurality of additional patients treated before the patient (Shtraizent: para. 77).
As per claim 7, the method of claim 1 is as described. Shtraizent teaches wherein the lab test is provided to the patient and the biometric sample is obtained from the patient without consultation with a doctor (Shtraizent: para. 72) and the method further comprises again providing the patient with another lab test and again obtaining lab results from again applying the other lab test to a biometric sample from the patient without consultation with a doctor (Shtraizent: para. 139; Frequent measurements of hormones in blood of subjects.).
Claims 9-15 recite substantially similar limitations as those already addressed in claims 1-7, and, as such, are rejected for similar reasons as given above.
As per claim 17, Shtraizent teaches a system for touch-free medical treatment of a patient, the system comprising:
-a memory that stores instructions (Shtraizent: para. 9); and
-a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the system to (Shtraizent: para. 9):
-apply an artificial intelligence model to patient data for the patient (Shtraizent: para. 68; Analyzing the information using AI to determine therapy.); and
-identify treatment for disease states caused by menopause and perimenopause based on applying the artificial intelligence model to the patient data (Shtraizent: para. 68; Analyzing the information using AI to determine hormone therapy.).
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.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shtraizent et al. (U.S. Publication No. 2023/0015833) in view of DeOrchis (U.S. Publication No. 2021/0319893).
As per claim 8, the method of claim 1 is as described. Shtraizent teaches wherein the method is performed without a physical examination of the patient by a medical professional (Shtraizent: abstract).
Shtraizent does not explicitly teach the following, however, DeOrchis teaches using an application first provided to the candidate to guide the patient through the method (DeOrchis: para. 47).
One of ordinary skill in the art would have recognized that applying the known technique of DeOrchis would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of DeOrchis to the teachings of Shtraizent would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying usage of an application of a physical examination to Shtraizent teaching evaluation of a patient for therapy would have been recognized by those of ordinary skill in the art as resulting in an improved system that would provide a system that solved interaction and/or communication problems between patients and healthcare providers (DeOrchis: para. 3).
Claim 16 recites substantially similar limitations as those already addressed in claim 8, and, as such, are rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed for claims 1-17 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that the claims are not categorized as falling under “certain methods of organizing human activity.” Examiner states that the examples in MPEP 2106 are guidance and not the final listing of what is considered abstract idea under the category. Examiner interprets the claims to be categorized under this category because the claims are directed to interacting with a patient to determine therapy, which is managing personal behavior and interaction with a person.
Applicant argues that the claims are not categorized as falling under “mental process.” Examiner disagrees. A user is able to obtain lab results, analyze the lab results, determine therapy that needs to be prescribed in the human mind.
Applicant argues that the claims provide a technological solution to a technological problem. The present invention solves the problem associated with prescribing a customized drug, which is not a problem of technical nature, but an administrative problem solved by a scheme. The present application does not involve more than a generic utilization of well-known functions of a computer, including the particular arrangement/combination of functions, and therefore does not involve any invention or ingenuity in any program or operation of a computer, or implementation by a computer to operate the method.
As per claims 2 and 10, Applicant argues that the claims specify hormone replacement therapy and therefore a practical application. When considering if a particular treatment and prophylaxis is considered a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2).• Factor A. The treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Here, the treatment delivered is not specified. The determined treatment that is delivered is never a specific drug. • Factor B. The treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. As stated above, because the delivered treatment type is not defined, any possible treatment could not reasonably be considered known in the art as a treatment. • Factor C. The treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The titrating a customized drug according to a generated treatment plan is well known, nominally related to the inventive concept of creating the treatment plan, and amount to necessary data output similar to that of In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016). The step does not add a meaningful limitation to the process of determining a treatment plan for a patient.Therefore, the claims only recite the prophylactic step as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception. In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.
Applicant's arguments filed for claims 1-7, 9-15, and 17 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that Shtrazinet does not teach that obtaining the blood sample is “touch-free.” Examiner states that the preamble of the claim states it is a method for “touch-free medical treatment,” but fails to teach limitation of obtaining the blood sample “touch-free.” 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). Furthermore, Examiner is unable to determine how exactly would you obtain blood sample “touch-free.”
Applicant argues that Shtrazinet does not teach “identifying” “determining” steps. Examiner disagrees. Examiner states that the claimed limitations in its broadest reasonable interpretation maintains that Shtrazinet teaches the limitations. The limitation “identifying a prospect as a candidate” is simply identifying any user since no further clarification or limitation is provided in how the candidate is identified and Shrazinet teaches identifying a user to measure hormone levels. The limitation “determining whether the candidate is suitable for treatment” is so broad that Shrazinet comparing the hormone levels to the population to determine treatment teaches that limitation.
Applicant argues that Shtrazinet does not teach “titrating” step. Examiner disagrees. Shtrazinet teaches curating a customized treatment based on user’s test results, therefore determining the specific treatment is same as titrating a level of a customized therapy.
Applicant argues that Shtrazinet does not teach “prescribing” step. Examiner disagrees. Shtrazinet teches in para. 133 that adjustment to therapy is performed until the desired outcome, therefore, teaching “prescribing” since in its broadest reasonable interpretation it is a medical practitioner authorizing a use of treatment for someone. Shtrazinet teaches that therapy is constantly adjusted and therefore inherently patients are being prescribed the treatment.
Applicant’s arguments with respect to claims 8 and 16 under 35 U.S.C. 102 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Neumann – U.S. Publication No. 2024/0354660 – Teaches a method for generating dietary instruction using AI and biological data.
Nahavandi et al. – U.S. Publication No. 2024/0177860 – Teaches a system for recommending hormone therapy by employing biology and machine learning.
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 SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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, Marc Jimenez can be reached at (571) 272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681
Prosecution Insights