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 .
Status of Claims
The action is in reply to the application filed 2024 December 03.
Claims 1-18 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12/03/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of a certified copy of application PCT/US2023/024439.
Claim Objections
Claims 2, 5, 8-9, 14 are 17 are objected to due to a minor informality: sentence ending in a semicolon.
Appropriate correction is required
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1-9) and a machine (claims 10-18).
INDEPENDENT CLAIMS
Step 2A Prong 1
Claim 1 recites steps of
A computer implemented method for determining and optimizing an individualized treatment regimen for a patient, the method comprising:
receiving, from a testing facility, a first test result for a user;
collecting user input from one or more client devices, wherein the user input comprises a questionnaire;
determining a treatment regimen for the user based at least in part on the user input and the first test result, wherein the determining comprises:
generating, by a dosing module, a treatment formulation based at least in part on the first test result and the user input; and
determining, by the dosing module, a dosing schedule for the user based at least in part on the treatment formulation;
issuing, by a physician, a first prescription based on the treatment formulation and sending the first prescription to a first compounding pharmacy;
compounding, at the first compounding pharmacy, a first compounded treatment based on the first prescription;
shipping, from the first compounding pharmacy to the user, the first compounded treatment; and
starting, by the user, the treatment regimen using the first compounded treatment and wherein the first compounded treatment is administered based on the determined dosing schedule.
Claim 10 recites steps of
A platform for determining and optimizing an individualized treatment regimen for a patient, the platform comprising:
one or more servers;
one or more client devices;
one or more fulfillment centers;
one or more laboratory testing facilities;
one or more compounding pharmacies;
one or more physicians;
wherein the platform is further configured for:
receiving, at the one or more servers, a request from the patient, wherein the request comprises an order for a testing kit;
shipping, from a fulfillment center, a first testing kit;
creating a patient account, wherein the creating comprises:
receiving, at the one or more servers, patient information collected during a registration process, wherein the registration process includes collecting patient input from the patient, wherein the input comprises answers to a questionnaire or survey and a first testing kit ID; and
associating the first testing kit with the patient account based on the first testing kit ID;
establishing, through a telehealth system, a relationship between the patient and a physician;
collecting, by the first testing kit, a first specimen from the patient;
shipping, by the patient to a first laboratory testing facility, the first specimen;
receiving, by the one or more servers, first test results for the first specimen, wherein the first test results are determined by processing the first specimen at the first testing facility;
qualifying, by the one or more servers, an eligibility of the patient for sublingual immunotherapy treatment;
determining, by an analysis module operating on the one or more servers, a first treatment regimen for the patient;
initiating a consultation, for the patient, with the physician;
issuing, by the physician, a prescription, wherein the prescription is based on the determined first treatment regimen and wherein the prescription is sent to a first compounding pharmacy;
receiving, from the patient, a subscription registration, wherein the subscription comprises providing the patient with compounded treatments at regular intervals;
compounding, at the first compounding pharmacy, a first compounded treatment based on the prescription issued by the physician;
shipping, to the patient from the first compounding pharmacy, the first compounded treatment; and
administering, by the patient, the first compounded treatment based on the determined first treatment regimen.
These steps for a workflow for a treatment regimen involving a patient, a physician, and a pharmacy, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is, nothing in the claim element precludes the italicized portions from commercial or legal interactions and managing personal behavior or relationships or interactions between people through organizing the activity around logistical processes, business processes, and facilitating a physician-patient relationship for treatment administration; all of which have historically been performed by humans. This could be analogized to considering historical usage information while inputting data. If a claim limitation, under its broadest reasonable interpretation, covers performance as organizing human activity but for the recitation of generic computer components, then it falls within the “Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, the additional elements non-italicized portions identified above for claims 1 and 10, does not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as
recitation of [Claim 1] one or more client devices; by a dosing module; [Claim 10] one or more servers; one or more client devices; through a telehealth system; and, by an analysis module operating on the one or more servers amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of [Claim 1] receiving, from a testing facility, a first test result for a user; collecting user input; [Claim 10] receiving […] a request from the patient; receiving […] patient information collected during a registration process, wherein the registration process includes collecting patient input from the patient; receiving […] first test results for the first specimen; and, receiving, from the patient, a subscription registration amounts to mere data gathering since it does not add meaningful limitations to the receiving and collecting actions performed, see MPEP 2106.05(g))
Each of the above additional elements therefore only amounts to mere instructions to implement functions within the abstract idea using generic computer components or other machines within their ordinary capacity; and, add insignificant extra-solution activity to the abstract idea. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. These elements are therefore not sufficient to integrate the abstract idea into a practical application. Therefore, the above claims, as a whole, are directed to an abstract idea.
Step 2B
The claim(s) 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, and add insignificant extra-solution activity to the abstract idea. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to mere instructions to apply an exception in particular fields such as recitation of [Claim 1] one or more client devices; by a dosing module; [Claim 10] one or more servers; one or more client devices; through a telehealth system; and, by an analysis module operating on the one or more servers, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f).
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as recitation of [Claim 1] receiving, from a testing facility, a first test result for a user; collecting user input; [Claim 10] receiving […] a request from the patient; receiving […] patient information collected during a registration process, wherein the registration process includes collecting patient input from the patient; receiving […] first test results for the first specimen; and, receiving, from the patient, a subscription registration, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
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 generic computer implementation.
DEPENDENT CLAIMS
Step 2A Prong 1
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-9, and 11-18 reciting particular aspects for a workflow for a treatment regimen involving a patient, a physician, and a pharmacy such as
[Claims 2 & 11] retrieving, by a prescription logic module, one or more regional pollination schedules, one or more allergen extract mapping tables and one or more cross-reactive allergen tables, wherein the retrieving is based at least in part on the user input, the first test result and a location of the user;
[Claims 3 & 12] identifying, by an analysis module, one or more target allergens, the identifying comprising:
determining a correlation between the user input and the first test results, wherein the first test result comprises IgE levels of each allergen tested;
generating a list of allergies with a specific IgE value above a first predetermined threshold; and
generating a ranked list of one or more allergy triggers, wherein the allergy triggers and their ranking in the ranked list are determined based on the user input, a month of trigger for the allergy trigger and the one or more retrieved regional pollination schedules;
[Claims 4 & 13] selecting, from the ranked list of allergy triggers, a first target allergy trigger;
adding, to the treatment formulation, the first target allergy trigger;
selecting, from the ranked list of allergy triggers, a second target allergy trigger;
adding, to the treatment formulation, the second target allergy trigger;
mapping the target allergy triggers in the treatment formulation to one or more extracts;
selecting one or more extracts to be compounded into the treatment formulation; and
determining a concentration and volume of for each selected extract;
[Claims 5 & 14] wherein selecting the first target allergy trigger is based at least partly on a month of trigger for the allergy triggers, the IgE levels for corresponding allergens and regional allergens present during the month of trigger;
[Claims 6 & 15] determining, by the analysis module, a level of cross-reactivity between the allergy triggers in the ranked list of allergy triggers;
[Claims 7 & 16] wherein selecting the second target allergy trigger is based at least partly on the month of trigger for the allergy triggers, the IgE levels for corresponding allergens, regional allergens present during the month of trigger and the level of cross-reactivity between the first target allergy trigger and the second target allergy trigger;
[Claims 8 & 17] wherein second target allergy trigger is added to the treatment formulation if the cross-reactivity level between the first target allergy trigger and the second target allergy trigger is below a second predetermined threshold and the IgE value for the second target allergy trigger is above the first predetermined threshold;
[Claims 9 & 18] mapping the target allergy triggers in the treatment formulation to one or more extracts;
selecting one or more extracts to be added to the first prescription for the treatment formulation, wherein the selecting is based at least in part on the mapping and on availability of the extracts; and
determining a concentration and volume of for each selected extract, wherein the concentration and volume are based at least in part on the user input and IgE levels of the allergy triggers corresponding to the extracts;
these italicized portions are methods of organizing human activity since they merely describe types of data and determinations that can be performed by humans.
Step 2A Prong 2
Dependent claims 2-3, 6, 11-12, and 15 recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (the additional limitations in claims 2 & 11 (by a prescription logic module); claims 3 & 12 (by an analysis module); and, claims 6 & 15 (by the analysis module); amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f)); and, claims 2 & 11 (retrieving […] one or more regional pollination schedules, one or more allergen extract mapping tables and one or more cross-reactive allergen tables) amounts to mere data gathering since it does not add meaningful limitations to the retrieving action performed, see MPEP 2106.05(g))). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
Dependent claims 2-3, 6, 11-12, and 15 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, e.g., a commonplace business method or mathematical algorithm being applied on a general-purpose computer, Alice Corp. v. CLS Bank, MPEP 2106.05(f). Also, see [0069] which discloses off-the-shelf devices, [0131] which discloses off-the-shelf memory types, and [0132] which discloses off-the-shelf processors. Dependent claims 2 & 11 recite additional subject matter which amounts to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i). There is no indication that these additional elements improve the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation. Therefore, in consideration of all the facts, the present invention is not a patent-eligible invention under USC 101. Additionally, it is evident that the present claims cover all ways of performance of a diagnostic-testing-treatment cycle and thus monopolizes the underlying medical knowledge; “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied 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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Daines et al. (US20160026765A1) in view of Takatoku et al. (US20120065999A1).
Regarding claim 1, Daines discloses receiving, from a testing facility, a first test result for a user ([0083] “an allergy test is to be ordered […] location of the clinic” [0104] “received and/or stored numerical results from the allergy test”)
collecting user input from one or more client devices, wherein the user input comprises a questionnaire ([0081] “the patient diagnosis questionnaire includes a series of questions configured to achieve a diagnosis of a patient condition.”)
determining a treatment regimen for the user based at least in part on the user input and the first test result ([0057] “an allergy treatment recommendation module is configured to generate a specific treatment by programmatically deducing an immunotherapy treatment recommendation based on one or more of the patient's history, science factors, and results from the allergy test.”)
wherein the determining comprises:
generating, by a dosing module, a treatment formulation based at least in part on the first test result and the user input ([0057] “an allergy treatment recommendation module is configured to generate a specific treatment by programmatically deducing an immunotherapy treatment recommendation based on one or more of the patient's history, science factors, and results from the allergy test.”)
and determining, by the dosing module, a dosing schedule for the user based at least in part on the treatment formulation [0133] “The treatment schedule is an immunotherapy treatment dosage schedule based on the final treatment recommendation.”)
compounding, […] a first compounded treatment based on the first prescription ([0054] “In one embodiment, the treatment set includes various concentrations of allergens mixed together, e.g., 2 or more allergens in treatment delivery containers at various concentrations for administering.”)
starting, by the user, the treatment regimen using the first compounded treatment and wherein the first compounded treatment is administered based on the determined dosing schedule [0133] “The dosage schedule includes a ramping portion and a maintenance portion. The ramping portion includes increasing dosages or volumes over a predetermined time frame. […] In a preferred embodiment, the schedule is followed by a patient in home based immunotherapy.”)
Daines does not explicitly disclose however Takatoku teaches issuing, by a physician, a first prescription based on the treatment formulation and sending the first prescription to a first compounding pharmacy ([0150] “Thus, combinations of drugs which, when administered to an individual patient, may give rise to an increased likelihood of side effects, may be registered in a computer readable storage medium, and the patient's risk group assignment may be reflective of this increased risk. A physician is registered to prescribe at least one of the drugs for a patient and a pharmacy is registered to fill such prescription.”)
[…] at the first compounding pharmacy […] ([0150] “a pharmacy is registered to fill such prescription.”)
shipping, from the first compounding pharmacy to the user, the first compounded treatment ([0010] “monitoring the stocking and shipping of drugs” [0209] “The pharmacist or nurse will also verify the patient's shipping address” [0345] “pharmacy's stocking and shipping of the drug”)
Therefore, it would have obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include in the system of Daines issuing, by a physician, a first prescription based on the treatment formulation and sending the first prescription to a first compounding pharmacy; the first compounding pharmacy; and, shipping, from the first compounding pharmacy to the user, the first compounded treatment as taught by Takatoku since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art.
No Prior Rejection
For claims 2 to 9 no prior art rejection is being presented at this time. the references of record are understood to be the closest prior art. For claim 2, while the combination Daines et al. (US20160026765A1) in view of Takatoku et al. (US20120065999A1), Andersson (US20130203182A1), and further in view of ROMÁN-ESCUTIA et al. (US20220110983A1) teaches most of the limitations of the claim, the scope of the claims describe a particular manner by means of the retrieving is based at least in part on the user input, the first test result and a location of the user. This goes beyond any teachings or suggestions in the art.
For claims 10-18 no prior art rejection is being presented at this time. the references of record are understood to be the closest prior art. For claim 10, while the combination Daines et al. (US20160026765A1) in view of Takatoku et al. (US20120065999A1) and further in view of Luber et al. (US20220165423A1) teaches most of the limitations of the claim, the scope of the claims describe a particular manner by means that includes one or more laboratory testing facilities; a telehealth system; and, sublingual immunotherapy treatment. This goes beyond any teachings or suggestions in the art.
Prior Art Cited but Not Relied Upon
Batson, S., Mitchell, S. A., Lau, D., Canobbio, M., de Goede, A., Singh, I., & Loesch, U. (2020). Automated compounding technology and workflow solutions for the preparation of chemotherapy: a systematic review. European Journal of Hospital Pharmacy, 27(6), 330-336.
This reference is relevant because it discloses automating compounding technology & workflow for preparation of a treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINSTON FURTADO whose telephone number is (571)272-5349. The examiner can normally be reached Monday-Friday 8:00 AM to 4:00 PM EST.
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, Mamon Obeid can be reached at (571) 270-1813. 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.
/WINSTON R FURTADO/Examiner, Art Unit 3687