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 .
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.
Response to Amendment
In the amendment dated 10/3/2025, the following has occurred: Claims 1 – 15 have been amended; Claim 16 – 19 have been added.
Claims 1 – 19 are pending.
The Applicant did not remark upon the previous 112 rejections. The amendment did not significantly change the rejection.
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 – 19 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claim 15), machine (claims 1 – 14 and 16 – 19) which recite the abstract idea steps of
a user that
qualifies a patient, at the point of prescriber for one or more of a plurality of vouchers for a respective plurality of different pharmaceutical products, available for the prescriber to prescribe for the patient at the point of prescriber, and
activates at least one of the plurality of vouchers, and fulfills one of the respective plurality of different pharmaceutical products;
obtain patient information from a patient source for a plurality of patients, wherein said patient source comprises first data that includes a patient record, and second data that includes qualifying data and relationship data;
rank qualifications said of the second data set to rank qualifications for patient vouchers to provide a highest ranked qualifier for one of the respective plurality of different pharmaceutical products,
wherein said highest ranked qualifier may include one or more data qualifiers for a patient from said patient record from said first data, and
wherein said second data qualifying data is associated with relationship data,
generate and rearrange ranking qualifications to improve the chances for patient qualification and medication adherence to one of the respective plurality of different pharmaceutical products, and to expedite the process of qualifying a patient at the point of prescriber and predict the likely continued adherence by the patient to the one of the respective plurality of different pharmaceutical products;
identify from the intelligently manipulated ranking qualifications one or more vouchers for the one or more of the respective plurality of different pharmaceutical products for the patient, and presenting the one or more vouchers to the physician prescriber.
These steps of claims 1 – 19, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the artificial engine language, identifying in the context of this claim encompasses a mental process of the user. Similarly, the limitation of obtaining, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the system language, providing a plurality of vouchers… in the context of this claim encompasses a mental process of the user. It should be emphasized that the vouchers do not have a destination. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
These steps of claims 1 – 19, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner is understanding the claimed invention, as a whole, in light of the Specification. From the Specification:
1. Field of the Invention
[0002] The present invention relates to the field of healthcare and more particularly to personal health via prescription management, and intelligently evaluating and analyzing the patient information to manage the prescriptions, offerings and monitoring of patient health, and providing digital health literacy to patients.
[0006] A need exists for a way to provide samples to patients that provides more options for discounts and eligibility programs that may be available to the patient, and which improves the potential for compatibility of a prescribed medication.
[0038] The system, method and device implement an intelligent system that reaches the physician prescriber at the point of providing the prescription. Referring to Fig. 1, a schematic diagram of a system is depicted to show some features of the inventive system. The intelligent patient sample system integrates a sample supply network with the physician and the patient to provide direct-ship-to-patient of the sample medicine that is prescribed by the patient's physician. The system, method and devices may include computers, computer systems, and data storage devices, and may operate using local, remote and/or cloud storage and applications, as well as networks. Software is provided and programmed with instructions to carry out the operations. Software also may be changed or re-programmed by the artificial intelligent (AI) functions of the system, method and devices, and databases may be generated, derived and/or revised in accordance with data received derived or generated by the AI functions of the system, method and devices.
From the claimed invention in light of the Specification, the invention the enumerated sub-grouping from MPEP 2106.04(a)(2)(II)
managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions).
Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings.
In sum, the invention represents an application of the abstract idea to technology. The result the invention is data that only has a potential usage and not a practical application. The invention also is not a technical or technological improvement.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 14 and 16 - 19, reciting particular aspects of how identifying vouchers may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do 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 An intelligent voucher qualifying system… comprising 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 intelligently obtaining amounts to mere data gathering, recitation of wherein said second data set amounts to selecting a particular data source or type of data to be manipulated, recitation of communication amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 14 and 16 - 19, additional limitations which amount to invoking computers as a tool to perform 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/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:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 19; engine configured to identify, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii))
Additional Elements
System – paragraph 33 general purpose computer
Engine/ Artificial intelligence – paragraph 54, Athey paragraph 8, neural network
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 2 – 14 and 16 - 19, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an engine in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Independent
claim 1 includes, “the engine intelligently manipulating …” and “the engine identifying from….”
claim 15 includes, “identifying with an artificial intelligence engine containing software configured to…”
The Specification describes the engine in paragraphs 66 and 67. However, per MPEP 2161.01(I)
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
The Specification does not disclose the required algorithm for performing the AI tasks. The AI engine is disclosed as a black box performing functions. For example, the Specification does not disclose which AI algorithm should be chosen and then how the unknown algorithm is trained.
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.
Claims 1 – 14 and 16 – 19 recites the limitation “a computer” in claim 1 first and 7th lines. There is insufficient antecedent basis for this limitation in the claim. The claim was amended to state:
1. (Currently amended) A computer comprising: a memory storing instructions and a processing device communicatively coupled to the memory device, wherein the processing device executes the instructions to:
execute a computer-implemented system configured to immediately qualify a patient at the point of prescriber in real time and to fulfill of a prescribed medicine for delivery to the patient, comprising:
a computer programmed with an engine that qualifies a patient, at the point of
The dependent claims are rejected for the same reasons.
Response to Arguments
Applicant's arguments filed 10/3/2025 have been fully considered but they are not persuasive.
2. The Section 101 Rejection is Traversed
The Applicant states, “Applicant's invention provides an intelligent system, computer and computer-implemented process that provides sample medications for patients and promotes medication adherence by intelligently relating not only patient data of the patient (to be qualified) but other data which may be de-identified data from other patients.” The Examiner believes that the Applicant is describing a method of organizing human behavior applied to technology. The technological benefits are achieved because of that application.
The Applicant states, “Applicant provides a technological advantage by using not only patient data to qualify the patient, but also additional data (second data) that is intelligently predictive of patient likelihood of continuing the medication.” As above.
The Applicant states, “The engine generates and rearranges ranking qualifications for the vouchers that a patient may be qualified to receive, so that the vouchers for a medication that the prescriber desires to prescribe for the patient are presented for that patient, not only based on the patient data for that patient, but other data that relates the medication to the patient data.” As above.
B. The claims are not directed to a judicial exception
The Applicant states, “Like the claims in Finjan and Core Wireless, Applicant's claims 1 -18 integrate any alleged recited abstract idea into a practical application because the claims recite specific steps that accomplish a result that realizes an improvement in a technology or technical field, namely patient sample management at the point of prescriber, which is in real time.” As a minor point, there are now 19 claims. Regardless, the Applicant’s specification does not describe the invention as a technological improvement as Finjan and Core Wireless. The invention is described, at a high level using functional terms, as using technology. Therefore, any comparisons Finjan and Core Wireless are moot.
The Applicant states, “Paragraphs [0004] and [0005] of the Applicant's as-filed specification clearly identify the shortcomings of existing technologies associated with pharmaceutical sample systems.” The cited paragraphs show the shortcomings of existing processes but do not discuss technology.
The Applicant states, “The invention not only can save costs (preventable medical costs), but can improve the patient well-being for patients receiving trial medications through the voucher system qualifying.” Please see above regarding the application of the abstract idea to technology.
The Applicant states, “For at least these reasons, Applicant respectfully submits that representative claim 1 as a whole is integrated into a practical application because the claim recites specific steps that accomplish a result that realizes an improvement in pharmaceutical sample distribution, in real time at the prescriber location.” The result of the invention is a recommendation that may or may not be performed. Therefore, there is a potential application and not a practical application.
The Applicant states, “A human would not be able to carry out what the computer is recited to perform, and the claim does not recite mental processes of a human. The Office Action contends that nothing in the claim element precludes the step from practically being performed in the mind. (See Office Action, at p. 3).” Please see MPEP 2106.04(a)(2)(III)(C) A Claim That Requires a Computer May Still Recite a Mental Process
In evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.
The Applicant states, “Accordingly, a human would not be able to carry out the invention of claim 1, and as pointed out above, the invention recited in the amended claims is not directed to a judicial exception, and are therefore is patent eligible.” As above.
The Applicant states, “This provides a further benefit of having effectiveness of medication adherence ranked from an actual patient response (preferably a number of patient responses of patients inputs).” As above regarding applying the instant invention to technology.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Athey et al. Pub. No.: US 2018/0330824 Then the model may be applied to data for new patients to predict their pharmacological phenotypes, and enable decision making in clinical and research contexts, including drug selection and dosage, changes in drug regimens, polypharmacy optimization, monitoring, etc., to benefit from additional predictive power, resulting in adverse event and substance abuse avoidance, improved drug response, better patient outcomes, lower treatment costs, public health benefits, and increases in the effectiveness of research in pharmacology and other biomedical fields.
Drenkard et al. Pub. No.: US 2018/0277252 Aspects of the disclosure relate to implementing and using a data processing system with a person engagement index to provide automated personalized healthcare functions.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626