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 .
Election/Restrictions
Claims 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 14-20 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim Election was made without traverse in the reply filed on 02/20/2026.
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.
Claim 7 is 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.
Regarding claim 7, the limitation “The food allergy treatment service provision method according to claim 3, wherein the oral immunotherapy guideline information comprises a message to visit a clinic since the oral food challenge is required in the maintenance step, in which a food antigen protein level of 4 grams has been reached” is indefinite. The manner in which the limitation is written renders the metes and bounds of the claim unclear. For sake of examination, the Examiner shall interpret the limitation as the oral immunotherapy guideline information comprising a message to visit a clinic.
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 1-13 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Representative claim 1 recites (additional elements crossed out):
A food allergy treatment service provision method using oral immunotherapy, the food allergy treatment service provision method comprising:
(a)
(b) generating oral immunotherapy guideline information based on the patient information received by the medical staff
(c)
(d) when symptom information about a symptom after protein intake is input to the patient terminal,
(e) analyzing the symptom information on the medical staff
(f) modifying the oral immunotherapy guideline information according to the adverse event grade and
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, and mental processes. That is, other than reciting the transmission of data through the use of “terminals” nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people, and mental processes. For example, but for the “terminals” language, the limitations describe a system for relaying information pertaining to oral immunotherapy. The limitations describe the management of personal behavior, as well as actions that can be performed mentally or with pen and paper. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of “terminals” to perform the steps. These additional element are recited at a high level of generality (see at least pages 16-23) such that it amounts to no more than mere instructions to apply the exception using generic computing components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. More specifically, the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) 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).
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 integration of the abstract idea into a practical application, the additional elements of using “terminals” to perform the steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claims 13 and 26 feature limitations similar to those of claim 1, and are therefore also found to be directed to an abstract idea without significantly more.
Claims 2-12 are dependent on claim 1, and include all the limitations of claim 1. Therefore, they are also directed to the same abstract idea. The remaining dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 2, 13, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evelyn (US 2022/0020467).
Regarding claim 1, Evelyn discloses A food allergy treatment service provision method using oral immunotherapy, the food allergy treatment service provision method comprising:
(a) transmitting patient information input to a patient terminal to a medical staff terminal connected to the patient terminal over a network;
(b) generating oral immunotherapy guideline information based on the patient information received by the medical staff terminal;
(c) transmitting the oral immunotherapy guideline information to the patient terminal for display;
(See at least Para. [0045] – “The system and method may collect patient data from the patient, manually and/or automatically, and utilize the patient data for scholarly treatment studies, to formulate individual medical guidelines for the patient, to modify existing clinical standard guidelines, present the information back to the patient to gamify the medical therapy, or any combination thereof.”, Para. [0046] – “The one or more patients may be any person undergoing medical therapy. The one or more patients may include any person with a food allergy. The medical therapy may involve the ingestion, injection, or absorption of a medication. The medical therapy may include immunotherapy, cancer treatments, autoimmune treatments, viral treatments, the like, or any combination thereof”, and Claim 1 – “wherein the patient device receives, from a patient and/or one or more caregivers, patient data including food journal data, quality of life data, medication data, or any combination thereof; wherein the patient device transmits the patient data to the one or more physician devices; and wherein the patient data is utilized by one or more physicians to adjust a dosage quantity and/or a dosage frequency of food allergy immunotherapy medication.”
Evelyn also discloses (d) when symptom information about a symptom after protein intake is input to the patient terminal, transmitting the symptom information to the medical staff terminal; (See Para. [0132] – “The patient data may include reaction data. The reaction data may be associated with instances of allergic reactions of the patient. The reaction data may be input into the treatment management system manually, autonomously, or both. The reaction data may be manually input into the treatment management system by one or more patients, caregivers, or both.”
Evelyn also discloses (e) analyzing the symptom information on the medical staff terminal to determine an adverse event grade; (See at least Para. [0132] – “The reaction data may include reaction entry, date, time, symptoms, duration of symptoms, severity of symptoms, reaction medication, reaction medication quantity, or any combination thereof.”
(f) modifying the oral immunotherapy guideline information according to the adverse event grade and transmitting the modified oral immunotherapy guideline information to the patient terminal for display. (See at least Para. [0015] – “…and wherein the patient data is utilized by one or more physicians to adjust a dosage quantity and/or a dosage frequency of food allergy immunotherapy medication.”, and Para. [0132] – “The patient data may include reaction data. The reaction data may be associated with instances of allergic reactions of the patient. The reaction data may be input into the treatment management system manually, autonomously, or both. The reaction data may be manually input into the treatment management system by one or more patients, caregivers, or both” and “The reaction data may include reaction entry, date, time, symptoms, duration of symptoms, severity of symptoms, reaction medication, reaction medication quantity, or any combination thereof.”
Regarding claim 2, Evelyn discloses The food allergy treatment service provision method according to claim 1, wherein step (b) comprises determining a starting dose of oral immunotherapy with reference to a result of an oral food challenge (OFC) included in the patient information. (See at least Para. [0130] – “The food allergy immunotherapy may include oral immunotherapy ("OIT"), epicutaneous immunotherapy ("EPIT"), and sublingual immunotherapy ("SLIT"). The food allergy immunotherapy may involve exposing a patient to a quantity of allergen below a threshold (i.e., the threshold below which would not induce an adverse reaction by the patient) and incrementally increasing the quantity of the allergen with the goal of desensitizing the immune system of the patient. The medical therapy may be personalized to individual patients. The medical therapy may be personalized based on an individual's overall health profile, age, gender, genetics, treatment goals, progress throughout treatment, or any combination thereof. The medical therapy may be personalized before the start of therapy, during therapy, or both.”)
Claims 13 and 26 feature limitations similar to those of claim 1, and are therefore rejected using the same rationale.
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.
Claim(s) 3 and 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evelyn (US 2022/0020467) in view of “Oral Immunotherapy 101: Learning Module”1, available August 1, 2021, hereinafter referred to as OIT 101.
Regarding claim 3, Evelyn does not explicitly disclose:
the food allergy treatment service provision method according to claim 2, wherein step (b) is generating the oral immunotherapy guideline information comprising a start date of an oral immunotherapy step, which is divided into initial escalation, buildup, and maintenance and a food intake schedule comprising an amount of food corresponding to an amount of protein to be taken per day. (See OIT 101 – “Oral immunotherapy, or OIT, helps desensitize patients to the very foods they are allergic to by giving them small quantities of the food allergen to ingest every day and gradually building their body’s resistance to the food.”, “3. Initial OIT dosing at CHOP’s Main Campus, so the full OIT team of clinicians can monitor your child’s reaction. 4. Updosing at CHOP’s Main Campus or select CHOP Specialty Care sites as your child ingests increasingly larger controlled portions of their allergen. Specialty Care sites are an option based on your child’s progress in OIT. 5. Home dosing of oral immunotherapy every day between updosing appointments. 6. Maintenance dose visits to the Oral Immunotherapy Program every three months for a year after your child has reached maintenance dosing.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Evelyn to utilize the teachings of OIT 101 since both are in the same field of endeavor, and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Regarding claim 7, Evelyn does not explicitly disclose The food allergy treatment service provision method according to claim 3, wherein the oral immunotherapy guideline information comprises a message to visit a clinic since the oral food challenge is required in the maintenance step, in which a food antigen protein level of 4 grams has been reached. (In light of the 112 rejection above, OIT 101 teaches this. See OIT 101 – “To participate in OIT at CHOP, you must agree to the following: 1. An intake visit, to evaluate your child’s food allergy history and determine a care plan. 2. Food challenges, based on your child’s allergy history if not completed during the past year.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Evelyn to utilize the teachings of OIT 101 since both are in the same field of endeavor, and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Regarding claim 8, Evelyn discloses The food allergy treatment service provision method according to claim 7, wherein the oral immunotherapy guideline information is generated so as to repeat the oral food challenge after 2 grams to 4 grams of food antigen protein is taken every day for 2 months if an adverse event occurs as the result of the oral food challenge. (See at least Para. [0045] – “The system and method may collect patient data from the patient, manually and/or automatically, and utilize the patient data for scholarly treatment studies, to formulate individual medical guidelines for the patient, to modify existing clinical standard guidelines, present the information back to the patient to gamify the medical therapy, or any combination thereof.” The Examiner asserts that the language of “so as to repeat the oral food challenge after 2 grams to 4 grams of food antigen protein is taken every day for 2 months if an adverse event occurs as the result of the oral food challenge” is a statement of intended use and fails to result in a manipulative difference between the claimed invention and the prior art.)
Regarding claim 9, Evelyn discloses The food allergy treatment service provision method according to claim 7, wherein the oral immunotherapy guideline information is generated so as to take 4 grams of food antigen protein at least four times every week if no adverse event occurs as the result of the oral food challenge. (See at least Para. [0045] – “The system and method may collect patient data from the patient, manually and/or automatically, and utilize the patient data for scholarly treatment studies, to formulate individual medical guidelines for the patient, to modify existing clinical standard guidelines, present the information back to the patient to gamify the medical therapy, or any combination thereof.” The Examiner asserts that the language of “so as to take 4 grams of food antigen protein at least four times every week if no adverse event occurs as the result of the oral food challenge” is a statement of intended use and fails to result in a manipulative difference between the claimed invention and the prior art.
Regarding claim 10, Evelyn discloses The food allergy treatment service provision method according to claim 1, wherein the patient information comprises at least one of patient's age, gender, underlying diseases, medication, allergenic foods, past medical history, and a result of an oral food challenge (OFC). (See at least Para. [0120] – “The patient data may include profile data. The profile data may include any suitable data identifying patients and general characteristics of the patients. The profile data may include name, age, weight, height, allergen, allergy severity, or any combination thereof.”)
Regarding claim 11, Evelyn does not explicitly disclose The food allergy treatment service provision method according to claim 10, wherein the oral immunotherapy guideline information is generated so as to comprise a food intake schedule including an amount of food corresponding to an amount of protein to be taken per day for each of the allergenic foods. (Evelyn discloses generating oral immunotherapy guideline information (See at least Para. [0045]). However, Evelyn does not disclose it being comprised of the claimed information. See OIT 101 – “Oral immunotherapy, or OIT, helps desensitize patients to the very foods they are allergic to by giving them small quantities of the food allergen to ingest every day and gradually building their body’s resistance to the food.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Evelyn to utilize the teachings of OIT 101 since both are in the same field of endeavor, and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evelyn (US 2022/0020467) in view of Anvari (US 2020/0286598)
Regarding claim 12, Evelyn does not explicitly disclose The food allergy treatment service provision method according to claim 1, wherein the symptom information comprises text information recorded on the patient terminal, image information of an area where the symptom occurs, and voice information of recorded patient's voice. (See at least Para. [0266] – “In one embodiment of PAR 1000, the patient uses application 1001 (210, 312, 412) to activate artificial intelligence 1002 (103) and to report patient's present medical problems and symptoms using text, graph, image, recorded audio and video or other means.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Evelyn to utilize the teachings of Anvari as it would provide a means of providing more details regarding symptoms.
Examiner Notes
None of the prior arts of record either individually or in combination teach or disclose the limitations of claims 4-6. While the overall concept of oral immunotherapy is well known in the art as indicated in the Applicant’s specification (See page 3 - “In order to address these issues, oral immunotherapy has been studied in recent years, especially in the West, but no uniform protocols have been established. In addition, various oral immunotherapy programs have been implemented, but they are heterogeneous, raising the need for unified standards for the rate of escalation of food antigens, the amount of food antigen protein taken during maintenance, and the evaluation of adverse events.”), the Examiner has not found prior art explicitly featuring a standardized protocol as featured in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://web.archive.org/web/20210801135333/https://www.chop.edu/centers-programs/oral-immunotherapy-program/oral-immunotherapy-101-learning-module
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