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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 01/05/2026, the following occurred: Claims 1 and 5 have been amended. Claims 26, 34, 35 and 39-41 were amended. Claims 1-25 and 33 were canceled. Claim 46 is new.
Claims 26-32 and 34-46 are currently 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 26-32 and 34-46 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.
Claims 26, 35 and 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system, a method and a non-transitory computer-readable media (CRM) for providing clinical trial status information, which are within a statutory category.
Step 2A1
Regarding claims 26, 35 and 41, the limitation of (claim 26 being representative) storing a plurality of sets of code encoding eligibility criteria of a plurality of trials; obtain a plurality of data records; generate, using the plurality of data records, a plurality of namedtuples representing the plurality of data records, each namedtuple of the plurality of namedtuples encoding information from the plurality of data records associated with a respective patient as a number and a series of letters; identify, for the plurality of data records, a set of trials from the plurality of trials that match the plurality of data records, the identifying comprising: access the plurality of sets of codes encoding the eligibility criteria of the plurality of trials; evaluate the plurality of nametuples representing the plurality of data records against the eligibility criteria of the plurality of trials at least in part by executing the plurality of sets of code using the plurality of namedtuples to obtain output indicating whether the plurality of trials match the plurality of data records; and identify, from among the plurality of trials, using the output obtained from the evaluating, the set of trials that match the plurality of data records; and in response to the identification of the set of trials that match the plurality of data records, update the plurality of data records by writing, to the plurality of data records, data structures associating the plurality of data records with respective ones of the set of trials as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. That is other than reciting (claim 26) at least one computer hardware processor and at least one non-transitory computer-readable storage medium (claim 35) at least one computer hardware processor, or (claim 41) at least one computer hardware processor and a non-transitory computer-readable storage medium, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the recited computer components, the claims encompasses storing a plurality of sets of code, obtaining a plurality of data records, generating a plurality of namedtuples, identifying a set of trials that match the data record by accessing the plurality of sets of codes, evaluating the plurality of namedtuples against the eligibility criteria, identifying a set of trials that match the plurality of data records and updating the plurality of data records in the manner described in the identified abstract idea(s), supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claims 26 recites the additional elements of at least one computer hardware processor and at least one non-transitory computer-readable storage medium. Claim 35 recites the additional element of at least one computer hardware processor. Claim 41 recites the additional elements of at least one computer hardware processor and a non-transitory computer-readable storage medium. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computers or components thereof, see Spec. para. 0026) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, 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 claim is directed to an abstract idea.
Claims 26, 35 and 41 further recite the additional elements of an electronic data record database and a trial database. These additional elements represent a location to which data is stored, obtained and accessed. Each of these storing, obtaining and accessing steps are recited at a high level of generality (i.e. a general means to obtain/accessing/storing data) and amount to extra solution activity. MPEP 2106.04(d)(1) indicates that extra solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
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 at least one computer hardware processor, at least one non-transitory computer-readable storage medium, and a non-transitory computer-readable storage medium to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas do not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element of storing, obtaining and accessing data from the electronic data record database and the trial database were considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 27-32, 34, 26-40 and 42-46 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 27, 36 and 42 further merely describe(s) generating the plurality of namedtuples. Claim(s) 28, 37 and 43 further merely describe(s) evaluating the namedtuple . Claim(s) 29, 38 and 44 further merely describe(s) encoding the expression trees and evaluating the namedtuple against the expression trees. Claim(s) 30, 31 further merely describe(s) the output. Claim(s) 32 further merely describe(s) the plurality of sets of code. Claim(s) 32 include the additional element of “patient-trial matching algorithms” which as a mathematical concept and part of the identified abstract idea. Thus this cannot provide a practical application or Significantly more. Claim(s) 39 and 45 further merely describe(s) the set of one or more data records and generating a graphical user interface (GUI). Claim(s) 34 and 40 further merely describe(s) receiving an indication of an update, updating a first namedtuple, evaluating the updated first namedtuple against the eligibility criteria, determining an updated set of trials that match the data record and updating the GUI. Claim(s) 46 further merely describe(s) generating graphical user interfaces (GUIs) comprising first and second area to display information. Claim(s) 34, 39, 40, 45 and 46 also include the additional element of “a graphical user interface (GUI)” which merely represents saying “apply it” or equivalent to the abstract idea. MPEP 2106.04(d)(I) and MPEP2106.05(I)(A) indicate that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application or Significantly more.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 34 depends from a canceled claim and is of improper dependent form for failing to reference a claim previously set forth. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The Examiner suggests to amend the dependency of the claim to a base claim that logically supports the subject matter of claim 34. For purpose of examination, the Examiner considers dependency from claim 26.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claims 26, 35 and 41 and their dependent claims. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: each of the following conditions, using the corresponding method: a trial database storing a plurality of sets of code encoding eligibility criteria of a plurality of trials; at least one computer hardware processor; and at least one non-transitory computer-readable storage medium storing instructions that, when executed by the at least one computer hardware processor, cause the at least one computer hardware processor to: obtain, from the electronic data record database, a plurality of data records; generate, using the plurality of data records, a plurality of namedtuples representing the plurality of data records, each namedtuple of the plurality of namedtuples encoding information from the plurality of data records associated with a respective patient as a number and a series of letters; identify, for the plurality of data records, a set of trials from the plurality of trials that match the plurality of data records, the identifying comprising: access, from the trial database, the plurality of sets of codes encoding the eligibility criteria of the plurality of trials; evaluate the plurality of namedtuples representing the plurality of data records against the eligibility criteria of the plurality of trials at least in part by executing the plurality of sets of code using the plurality of namedtuples to obtain output indicating whether the plurality of trials match the plurality of data records; and identify, from among the plurality of trials, using the output obtained from the evaluating, the set of trials that match the plurality of data records; and in response to the identification of the set of trials that match the plurality of data records, update the plurality of data records by writing, to the plurality of data records, data structures associating the plurality of data records with respective ones of the set of trials.
Response to Arguments
Claim Objections
Regarding the claim objection(s), the Applicant has amended claims 34 and 40 to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 26-32 and 34-46, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
… Namely, conventional systems evaluate patients against different trials individually based on a limited amount of information, making it challenging to match patients and trials efficiently computationally or otherwise-when a practice has many trials open (Id.). Computationally, conventional computer systems cannot read natural human language to parse through data in an electronic health record directly, further exacerbating the problem of computationally evaluating patients against different trials (Id.). Accordingly, the specification describes techniques that enable a computer to effectively and accurately computationally evaluate different patients against different potential clinical trials. The system encodes eligibility criteria as sets of code and encodes patient information as namedtuples associated with the patient (30-31). By encoding patient information as namedtuples, the information associated with a particular patient from across various records can be aggregated into a single unified data structure (e.g., that stores an encoding of information from the various records as alphanumeric data)… In particular, the computer system executes the sets of codes with the namedtuples to generate output indicating whether trials match the data records… The namedtuples transform plain, natural human language that a conventional computer system cannot parse into machine-readable data structures executable against the clinical trial eligibility encodings. Accordingly, the technology described in the application improves over conventional clinical trial support systems by providing these namedtuple data structures and eligibility criteria encodings that enable a computer to perform computational patient trial matching efficiently and accurately across a plurality of trials using data about patients from multiple data records… Further, the records associated with the patient can subsequently be updated to indicate whether that respective patient is matched with particular trials, enabling efficient storage and downstream use of the computation matching determination. Moreover, the claims do not simply recite certain methods of organizing human activity. Rather, the computer-executed steps recited in the claim recite the particular computer-specific data structures that enable computational patient trial matching. A human would not perform the above- recited steps of the independent claims. To the contrary, the steps are specific to a computer to allow it to efficiently computationally match patients with different trials. The recited steps are not simply a method of organizing human activity or even a mental process that is simply implemented on a computer. Rather, the claims recite specific data structures for a computer to encode data and use thereof to execute software application code for a computer to programmatically match data records to trials. This is not a method of organizing human activity, nor is it a mental process that can be performed in the mind or using pen and paper.
Regarding 1, The Examiner respectfully disagrees. The claims do not provide technical improvements nor improvements to a computer system. The Specification at para. [0003], [0048] and [0072] state improvements to trial recruitment and workflows between research coordinators and health care service providers, none of which are technical, but rather they are administrative/healthcare improvements.
Moreover, the claims use generic computer components (see Spec. para. 0026 that describe the at least one computer hardware processor, at least one non-transitory computer-readable storage medium, and a non-transitory computer-readable storage medium as generic computer components) for storing a plurality of sets of code, obtaining a plurality of data records, generating a plurality of nametuples, identifying a set of trials that match the data record by accessing the plurality of sets of codes, evaluating the plurality of namedtuples against the eligibility criteria, identifying a set of trials that match the plurality of data records and updating the plurality of data records. This amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). As a result, a person can follow a set of rules or instructions to store a plurality of sets of code, obtain a plurality of data records, generate a plurality of nametuples, identify a set of trials that match the data record by accessing the plurality of sets of codes, evaluate the plurality of namedtuples against the eligibility criteria, identify a set of trials that match the plurality of data records and update the plurality of data records. This, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, and falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Boru (US 2002/0077853) teaches system for selecting clinical trials. Yabloko (US 20040167862) teaches method and apparatus for mediated cooperation. Frankham (US 20120072232) teaches system and methods for using online resources to design a clinical study and recruit participants. Hoffman (US 2013/0332191) teaches identifying patient eligibility for clinical trials. Skocic (US 2013/0218594) teaches clinical trial health care data management. Pruit (US 2014/0316793) teaches systems and methods for recruiting and matching patients for clinical trials. Spetzler (US 2018/0045727) teaches molecular profiling for cancer. Zhang (US 2016/0196411) teaches systems and methods for matching patients with clinical trials. Rao (US 2003/0130871) teaches patient data mining for clinical trials.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683