DETAILED ACTION
Continued Examination Under 37 CFR 1.114
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/19/2025 has been entered.
Notice to Applicant
This action is in reply to the filed on 8/19/2025.
Claims 1 have been amended.
Claims 2-89 have been cancelled.
Claim 1 and 90-108 currently pending and have been examined.
Response to Amendments
The Applicant’s amendments, and cancellation, of the claims as currently submitted have been noted by the Examiner. Said amendments, and cancellation(s), are not sufficient to overcome the rejections previously set forth under 35 U.S.C. §101. As such, said rejections are herein maintained for reasons set forth below.
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.
Certain Method of Organizing Human Activity
Applicant discloses (Applicant’s Specification, [0002]) the need to treat a patient for a food allergy by oral immunotherapy that include managing the distribution of a drug comprising a food allergen . So a need exists to organize these human interactions by/through managing the distribution of a drug comprising a food allergen using the steps of “receiving requests, generating statuses, generating patient enrollment status, sending setting enrollment statuses, providing patient statuses, providing doses of peanut protein,” etc. Applicant’s method is therefore a certain method of organizing the human activities as described and disclosed by Applicant.
Rejection
Claim(s) 1 and 90-108 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1 is/are directed to the abstract idea of “managing the distribution of a drug comprising a food allergen,” etc. (Applicant’s Specification, Abstract, paragraph(s) [0002]), etc., as explained in detail below, and thus grouped as a certain method of organizing human interactions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Accordingly, claims 1 and 90-108 recite an abstract idea.
Step 2A Prong 1 – The Judicial Exception
The claim(s) recite(s) in part, method for performing the steps of “receiving requests, generating statuses, generating patient enrollment status, sending setting enrollment statuses, providing patient statuses, providing doses of peanut protein,” etc., that is “managing the distribution of a drug comprising a food allergen,” etc. which is a method of managing personal behavior or relationships or interactions between people (social activities, teaching, following rules, instructions) and thus grouped as a certain method of organizing human interactions. Accordingly, claims 1 and 90-108 recite an abstract idea.
Step 2A Prong 2 – Integration of the Judicial Exception into a Practical Application
This judicial exception is not integrated into a practical application because the generically recited additional computer elements (i.e. networks, client computers, servers, microprocessor-based devices, handheld computing devices, processors, input devices, output devices, storage, memories, communication devices (Applicant’s Specification [0198]), etc.) to perform steps of “receiving requests, generating statuses, generating patient enrollment status, sending setting enrollment statuses, providing patient statuses, providing doses of peanut protein,” etc. do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and this is nothing more than an attempt to generally link the product of nature to a particular technological environment. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limit on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Insignificant extra-solution activity
Claim(s) 1 and 90-108 recites storing data steps, retrieving data steps, providing data steps, output steps (Bilski v. Kappos, 561 U.S. 593, 610-12 (2010), Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can., 771 F.Supp.2d 1054, 1066 (E.D. Mo. 2011), aff’d, 687 F.3d at 1266), and/or transmitting data step (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014), Apple, Inc. v. Ameranth, Inc., 842 F.3d 1299, 1241-42 (Fed. Cir. 2016)) that is/are insignificant extra-solution activity. Extra-solution activity limitations are insufficient to transform judicially excepted subject matter into a patent-eligible application (MPEP §2106.05(g)).
Step 2B – Search for an Inventive Concept/Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations (i.e. networks, client computers, servers, microprocessor-based devices, handheld computing devices, processors, input devices, output devices, storage, memories, communication devices, etc.) only store and retrieve information and perform repetitive calculations, and these are well-understood, routine, conventional computer functions as recognized by the Symantec, TLI, and OIP Techs. court decisions listed in MPEP § 2106.05(d)(II) (Berkheimer- Court Decisions). These court decisions indicate that mere collection or receipt of data over a network is a well-understood, routine and conventional function when it is claimed in a merely generic manner as it is here. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Accordingly, the claims are not patent eligible.
Individually and in Combination
The additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The additional elements amount to no more than generic computer components that serve to merely link the abstract idea to a particular technological environment (i.e., etc.). At paragraph(s) [0198], Applicant’s specification describes conventional computer hardware for implementing the above described functions including “networks, client computers, servers, microprocessor-based devices, handheld computing devices, processors, input devices, output devices, storage, memories, communication devices,” etc. to perform the functions of “receiving requests, generating statuses, generating patient enrollment status, sending setting enrollment statuses, providing patient statuses, providing doses of peanut protein,” etc. The recited “networks, client computers, servers, microprocessor-based devices, handheld computing devices, processors, input devices, output devices, storage, memories, communication devices,” etc. does/do not add meaningful limitations to the idea of beyond generally linking the system to a particular technological environment, that is, implementation via computers. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). 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, claims 1 and 90-108 do not amount to significantly more than the underlying abstract idea of “an idea of itself” (Alice).
Dependent Claims
Dependent claim(s) 90-108 include(s) all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein.
Although dependent claims 90-108 add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. Dependent claims 90-108 merely describe physical structures to implement the abstract idea. These information and physical characteristics do not change the fundamental analogy to the abstract idea grouping of certain method of organizing human interactions, and when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as independent claim 1.
Response to Arguments
Applicant’s arguments filed 8/19/2025 with respect to claims 1 and 90-108 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed 8/19/2025.
Applicant’s arguments filed on 8/19/2025 with respect to claims 1 and 90-108 have been fully considered but are moot in view of the new ground(s) of rejection.
Applicant argues that (A) the Applicant’s claimed invention is directed to statutory matter.
101 Responses
As per Applicant’s argument (A), Applicant’s remarks with regard to the statutory nature of Applicant’s claimed invention are addressed above in the Office Action.
Applicant’s Amendments
Applicant amended claims recite “(f) provisioning to the pharmacy, healthcare setting, healthcare provider, or patient one or more dose of the peanut protein.” To advance prosecution the Applicant is encouraged to identify and/or incorporate Applicant’s elements (e.g. networks, client computers, servers, microprocessor-based devices, handheld computing devices, processors, input devices, output devices, storage, memories, communication devices) and steps that demonstrate the active recitation/physical provision of Applicant’s “provisioning” step (e.g. manufacture, transportation, distribution, etc. See Fig 3A, 3B, Fig 4, Fig 5, Fig 6 606, Fig 7 706, Fig 8 806) Without further clarification, Applicant’s amended claims are information processing steps that are part of Applicant’s abstract idea and do not move Applicant’s invention into eligible subject matter. Applicant’s argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES P. COLEMAN whose telephone number is (571) 270-7788. The examiner can normally be reached on Monday through Thursday 7:30a-5:00p.
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, ROBERT W MORGAN can be reached on (571) 272-6773. 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.
/C. P. C./
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683