DETAILED ACTION
Status of Claims
This is the first office action on the merits in response to the application filed on 21 February 2025.
Claim(s) 1-20 are currently pending and have been examined.
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 .
Priority
This application claims priority of US Provisional Application No. 63/566576 filed on 22 February 2024. Applicant’s claim for the benefit of this prior filed application is acknowledged.
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: clinical trial provider module, clinical trial participant module, clinical trial data module in claims 1, 2, and 4.
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(b)
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 1-20 are 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. Claims not listed below are rejected for dependency.
Claim 1 recites a “clinical trial provider module”, clinical trial participant module”, and “clinical trial data module.” Claim limitations “clinical trial provider module”, clinical trial participant module”, and “clinical trial data module” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed functions and to clearly link the structure, material, or acts to the function. Per MPEP 2181(II)(B), “[f]or a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b).” However, the present disclosure does not provide such algorithms for the identified modules. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 2 and 4 are similarly rejected.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites wherein the server and each of the clinical trial provider module, clinical trial participant module, and clinical trial data module are operatively associated with a corresponding one of the at least one clinical trial provider, the at least one clinical trial participant, and the at least one clinical trial investigator through a network computing system to perform for interacting with at least one user of the system programmed for providing access to at least one clinical trial participant participating in at least one clinical trial. The identified limitation cannot be parsed, making the meaning of the claim unclear. The limitation appears to be a splice of various sentiments, but one of ordinary skill in the art would not be able to determine the meaning of the phrase. As the limitation makes the scope of the claim unclear, the claim is indefinite.
Claims 2 and 4 are similarly rejected.
Claim 1 recites information associated with the clinical target disease of the at least one clinical trial participant. There is no antecedent basis for a clinical target disease, and the limitation makes it unclear whether the method requires clinical target disease or whether the participants are required to have a clinical target disease. As the limitation makes the scope of the claim unclear, the claim is indefinite.
Claims 2, 6, 11, 15, 16, and 20 are similarly rejected.
Claim Rejections - 35 USC § 112(d)
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 20 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 20 recites a software product comprising a non-transitory computer-readable medium in which computer program instructions are stored, said instructions, when executed by a computing system of Claim 4, cause the computing system to perform the acts. Thus claim 20 claims software that causes a computing system to perform certain acts, the computing system being defined by claim 4. This claim scope does not actually require the computing system of claim 4. Thus claim 20 does not include all the limitations of the claim upon which it depends.
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.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method of
assessment of clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria and exclusion criteria for the clinical trial;
(b) providing identification designating that the user is a clinical trial provider, clinical trial participant, or clinical trial investigator; and
(c) performing at least one of the steps of: (i) providing data comprising at least one of information from electronic health records associated with the at least one clinical trial participant, information associated with at least one treatment compliance program for the at least one clinical trial, and information associated with the clinical target disease of the at least one clinical trial participant; (ii) receiving an alert when a proposed medication or proposed medication dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the at least one clinical trial participant; (iii) receiving data for supporting clinical trial participant treatment compliance to clinical trial-specific treatment guidelines selected by at least one of the at least one clinical trial provider; (iv) providing data use of clinical trial participant-specific forms by the at least one clinical trial participant; (vi) tracking communication between each of the at least one clinical trial participant and at least one of another clinical trial participant, the clinical trial provider; (vii) generating inclusion criteria and exclusion criteria associated with at least one clinical trial eligibility decision for a clinical trial selected by at least one of the at least one clinical trial provider; (viii) analyzing clinical trial participant-specific data; and (xi) receiving data associated with at least one clinical trial.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of managing clinical trial data for providers, participants, and investigators. This concept plainly is an example of managing behavior and interactions between people. As such, the claims are determined to set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claims 1 and 2 recite the additional element of accessing a computer system comprising a server. Claim 4 recites the additional element of a computer system comprising a server. While the server is claimed as comprising various modules it remains extremely generally described and may be interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The claims further recite the additional elements of a network computing system and providing data through the network. This additional element only generally links the abstract idea to a technological environment of networked computing devices. As such, these additional elements do not integrate the abstract idea into a practical application. There are no further additional elements. When considered as a combination, the additional elements generally link the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not amount to significantly more.
As previously noted, the claims recite the additional elements of a network computing system and providing data through the network. However, per MPEP 2106.05(d)(II), receiving or transmitting data over a network has been recognized by the courts as a well-understood, routine, and conventional computer functionality. As such, this additional element, both individually and in combination with the prior computing additional element, does not amount to significantly more. There are no further additional elements. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Dependent claims 3, 5, 6, and 8-20 continue to recite an abstract idea. Dependent claims 3, 5, 6, 8, and 10-18 recite no further additional elements. The previously identified additional elements, individually and in combination, do not integrate the abstract idea into a practical application for the same reasons articulated above. Therefore claims 3, 5, 6, 8, and 10-18 remain directed to an abstract idea. At Step 2B, the previously identified additional elements, individually and in combination, do not amount to significantly more than the abstract idea for the same reasons articulated above. Dependent claim 7 recite the additional element of a data storage means, wherein the at least one data storage means is adapted for storing data. This additional element only generally links the abstract idea to a computing environment. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore claim 7 remains directed to an abstract idea. At Step 2B, Examiner notes that per MPEP 2106.05(d)(2), storing data in a memory has been recognized by the courts as a well-understood, routine, and conventional computer functionality. As such, this additional element, both individually and in combination with the prior computing additional elements, does not amount to significantly more. Dependent claim 9 recites the additional element of the internet or a mobile electronic device network. This additional element only generally links the abstract idea to a networked computing environment. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore claim 9 remains directed to an abstract idea. At Step 2B, Examiner notes that Amendolagine et al. (US 2004/0189872 A1) demonstrates ([0015]) that the internet was conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. Therefore the combination of additional elements does not amount to significantly more than the abstract idea. Dependent claim 19 recites the additional element of a graphical user interface. This additional element amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore claim 19 remains directed to an abstract idea. At Step 2B, the additional element still amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not amount to significantly more than the abstract idea. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. Therefore the combination of additional elements does not amount to significantly more than the abstract idea. Dependent claim 20 recites the additional element of a software product comprising a non-transitory computer-readable medium. This additional element amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore claim 20 remains directed to an abstract idea. At Step 2B, the additional element still amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not amount to significantly more than the abstract idea. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. Therefore the combination of additional elements does not amount to significantly more than the abstract idea.
Thus as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
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.
Claim(s) 1-11, 13-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyce (US 2009/0313045 A1).
Regarding Claim 1, 2, and 4: Boyce discloses a method of using a computer system-programmed for providing access to at least one clinical trial participant participating in a clinical trial, comprising the steps of:
(a) accessing the computer system through a network, the computer system comprising a server (A method or a module may be installed on a server connected to the network. See at least [0146]. Also: A connection from a user device to a server that executes or performs instructions for a method may be a direct connection. See at least [0147]) comprising:
(i) a clinical trial provider module adapted for receiving, storing, and providing data in communication with at least one clinical trial provider at assessment of clinical trial eligibility, wherein the clinical trial provider module comprises an algorithm for generating at least one clinical trial eligibility decision for the at least one clinical trial participant at assessment of clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria and exclusion criteria for the clinical trial (FIG. 18 is a diagram of a log-in web page for a provider. See at least [0172]. Also: FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071])
(ii) a clinical trial participant module adapted for receiving, storing, and providing data in communication with the at least one clinical trial participant (FIG. 25 is a diagram of a log-in web page for a participant. See at least [0179]. Also: FIG. 26 is a diagram of a participant web site--home page. A participant may track her/his participation in projects in one page in a matrix 2600 and quickly and easily update, interact and communicate about information. See at least [0180]); and
(iii) a clinical trial data module adapted for receiving, storing, and providing data in communication with at least one clinical trial investigator, wherein the clinical trial data module is adapted for generating the inclusion criteria and exclusion criteria for the clinical trial (FIG. 10 shows in diagram an illustrative example of a sign-in or log-in web site screen for a network member. See at least [0157]. Also: FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200])
wherein the server and each of the clinical trial provider module, clinical trial participant module, and clinical trial data module are operatively associated with a corresponding one of the at least one clinical trial provider, the at least one clinical trial participant, and the at least one clinical trial investigator through a network computing system to perform for interacting with at least one user of the system programmed for providing access to at least one clinical trial participant participating in at least one clinical trial (See at least [0152] and Fig. 9)
(b) providing identification designating that the user is a clinical trial provider, clinical trial participant, or clinical trial investigator (See at least Fig. 10, Fig. 18, and Fig. 25); and
(c) performing at least one of the steps of: (i) providing data comprising at least one of information from electronic health records associated with the at least one clinical trial participant, information associated with at least one treatment compliance program for the at least one clinical trial, and information associated with the clinical target disease of the at least one clinical trial participant; (ii) receiving an alert when a proposed medication or proposed medication dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the at least one clinical trial participant; (iii) receiving data for supporting clinical trial participant treatment compliance to clinical trial-specific treatment guidelines selected by at least one of the at least one clinical trial provider; (iv) providing data through the network from at least one of a health monitoring device, mobile electronic device, and user computer; (v) tracking use of clinical trial participant-specific forms by the at least one clinical trial participant; (vi) tracking communication between each of the at least one clinical trial participant and at least one of another clinical trial participant, the clinical trial provider; (vii) generating inclusion criteria and exclusion criteria associated with at least one clinical trial eligibility decision for a clinical trial selected by at least one of the at least one clinical trial provider; (viii) analyzing clinical trial participant-specific data; and (xi) receiving data associated with at least one clinical trial (FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]).
Regarding Claim 3: Boyce discloses the above limitations. Boyce further discloses (d) generating at least one clinical trial eligibility decision for the at least one clinical trial participant with a clinical trial at assessment of clinical trial eligibility (FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]).
Regarding Claim 5: Boyce discloses the above limitations. Boyce further discloses wherein the algorithm is further based on at least one of clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways (FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200]).
Regarding Claim 6: Boyce discloses the above limitations. Boyce further discloses wherein the system is further programmed for performing at least one of the acts of: (a) providing data comprising at least one of information from electronic health records associated with the at least one clinical trial participant, information associated with at least one treatment compliance program for the at least one clinical trial, and information associated with the clinical target disease of the at least one clinical trial participant; (b) receiving an alert when a proposed medication or proposed medication dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant- specific medication plans, and clinical trial participant-specific care pathways associated with the at least one clinical trial participant; (c) receiving data for supporting clinical trial participant treatment compliance to clinical trial-specific treatment guidelines selected by at least one of the at least one clinical trial provider; (d) providing data through the network from at least one of a health monitoring device, mobile electronic device, and user computer; (e) tracking use of clinical trial participant-specific forms by the at least one clinical trial participant; (f) tracking communication between each of the at least one clinical trial participant and at least one of another clinical trial participant, the clinical trial provider; (g) generating inclusion criteria and exclusion criteria associated with at least one clinical trial eligibility decision selected by at least one of the at least one clinical trial provider; (h) analyzing clinical trial participant-specific data; and (i) receiving data associated with at least one clinical health trial (FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]).
Regarding Claim 7: Boyce discloses the above limitations. Boyce further discloses wherein each of the clinical investigation provider module, clinical investigation participant module, and clinical investigation data module is further operatively associated with at least one data storage means through the network, wherein the at least one data storage means is adapted for storing data saved by the at least one corresponding clinical investigation provider, at least one clinical investigation participant, and at least one clinical investigator (A diagram of a network is provided in FIG. 9 as an illustrative example. It is to be understood that different configurations may be possible. The system of FIG. 9 has at least 3 databases: a database 901 with data related to qualification of participants; a database 902 with data related to participants and a database 903 with data related to clinical information. The three database may reside on one server, they may also reside on 2 or 3 or more servers.. See at least [0148] and Fig. 9).
Regarding Claim 8: Boyce discloses the above limitations. The imitation wherein the at least one clinical investigation is concerned heart disease, diabetes, obesity, or asthma is considered intended use and as such may be given limited patentable weight. As such, Boyce continues to disclose the claimed invention.
Regarding Claim 9: Boyce discloses the above limitations. Boyce further discloses wherein the network is at least one of the internet and a mobile electronic device network (wherein the network is an Internet. See at least [0017]).
Regarding Claim 10: Boyce discloses the above limitations. Boyce further discloses wherein the at least one clinical investigation provider is a physician, physician assistant, nurse, or nurse practitioner (Healthcare providers may be physicians. See at least [0202]).
Regarding Claim 11: Boyce discloses the above limitations. Boyce further discloses wherein the data received by at least one of the clinical investigation provider module comprises at least one of information from electronic health records associated with the at least one clinical investigation participant, information associated with treatment compliance programs for the at least one clinical investigation, and information associated with the clinical target disease of the at least one clinical investigation participant (FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]).
Regarding Claim 13: Boyce discloses the above limitations. Boyce further discloses wherein the data received by the clinical investigation participant module comprises information provided by the at least one clinical trial participant through the network from at least one of a health monitoring device, mobile electronic device, and user computer FIG. 25 is a diagram of a log-in web page for a participant. See at least [0179]. Also: A user may also connect via a computing device 921 to a Participant Web Site. See at least [0152]).
Regarding Claim 14: Boyce discloses the above limitations. The limitation wherein the at least one health monitoring device is a heart rate monitor, blood pressure meter, peak flow meter, pulse oximeter, pedometer, weighing scale, or glucometer further limits a claim limitation claimed in the alternative. As the reference discloses the alternative, it continues to disclose the claimed invention.
Regarding Claim 15: Boyce discloses the above limitations. Boyce further discloses wherein the data received by the clinical investigation participant module comprises at least one social determinant of the clinical target disease of the at least one clinical trial participant (Patient Portal: Scribe's Patient Portal provides HIPAA compliant access to medical records for a patient population and streamlines a registration process by collecting demographic, medical history, and billing information from patients. See at least [0137]. Also: patient demographics like age, sex, race, marital status, etc. See at least [0143]).
Regarding Claim 16: Boyce discloses the above limitations. Boyce further discloses wherein the at least one social determinant comprises at least one of racial, ethnic, religious, behavioral, linguistic, income and geography/location-related associated with the clinical target disease of the at least one clinical investigation participant (Patient Portal: Scribe's Patient Portal provides HIPAA compliant access to medical records for a patient population and streamlines a registration process by collecting demographic, medical history, and billing information from patients. See at least [0137]. Also: patient demographics like age, sex, race, marital status, etc. See at least [0143]).
Regarding Claim 18: Boyce discloses the above limitations. Boyce further discloses wherein the clinical investigation participant module is further adapted for tracking communication between the at least one clinical investigation participant and at least one of another clinical investigation participant, the at least one clinical investigation provider (it enables centralizing communications for all parties in one place. See at least [0173]).
Regarding Claim 19: Boyce discloses the above limitations. Boyce further discloses wherein each of the clinical investigation provider module, clinical investigation participant module, and clinical investigation data module is operatively associated with a graphical user interface comprising controls for selectively receiving, storing, and providing data in the system in response to an action by at least one of the at least one clinical investigation provider, the at least clinical investigation participant, and the at least one clinical investigator (See at least Figures 10-31).
Regarding Claim 20: Boyce discloses a software product comprising a non-transitory computer-readable medium in which computer program instructions are stored (See at least [0145]), said instructions, when executed by a computing system of Claim 4, cause the computing system to perform the acts of:
(a) receiving, storing, and providing data in communication with at least one clinical trial provider (FIG. 18 is a diagram of a log-in web page for a provider. See at least [0172]. Also: FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]);
(b) receiving, storing, and providing data in communication with at least one clinical trial participant participating in a clinical trial (FIG. 25 is a diagram of a log-in web page for a participant. See at least [0179]. Also: FIG. 26 is a diagram of a participant web site--home page. A participant may track her/his participation in projects in one page in a matrix 2600 and quickly and easily update, interact and communicate about information. See at least [0180]);
(c) receiving, storing, and providing data in communication with at least one clinical trial investigator (FIG. 10 shows in diagram an illustrative example of a sign-in or log-in web site screen for a network member. See at least [0157]. Also: FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200]);
(d) facilitating interactions between each of the at least one clinical trial provider, the at least one clinical trial participant, and the at least one clinical trial investigator (it enables centralizing communications for all parties in one place. See at least [0173]); and
(e) providing access to the at least one clinical trial participant (it enables centralizing communications for all parties in one place. See at least [0173]),
wherein the software comprises an algorithm for generating at least one clinical trial eligibility decision for the clinical trial for the at least one clinical trial participant at assessment of clinical trial eligibility and at least one social determinant of the clinical target disease of the at least one clinical trial participant, wherein the algorithm is based at least in part on (1) inclusion criteria and exclusion criteria for the clinical trial and (2) at least one of clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways (FIG. 10 shows in diagram an illustrative example of a sign-in or log-in web site screen for a network member. See at least [0157]. Also: FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200]. Also: FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200]).
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.
The factual inquiries 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(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyce (US 2009/0313045 A1) in view of Bouhnik (US 2016/0147963 A1).
Regarding Claim 12: Boyce discloses the above limitations. Boyce does not appear to disclose wherein the clinical trial provider module is further adapted for providing an alert to the at least one clinical trial provider when a proposed medication or proposed medication dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the at least one clinical trial participant. However, Bouhnik teaches providing an alert to the at least one clinical trial provider when a proposed medication or proposed medication dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the at least one clinical trial participant (The primary care physician can validate that the proposed treatment remains compatible with the requirements of the Clinical Trial, thus limiting the risk of excluding a patient due to administration of a conflicting treatment. See at least [0144]).
Boyce provides a system which determines participant eligibility for providers, upon which the claimed invention’s issuing of alerts for treatments which could render a patient ineligible can be seen as an improvement. However, Bouhnik demonstrates that the prior art already knew of clinical trial management systems which would issue alerts for treatments incompatible with a clinical trial. One of ordinary skill could have easily incorporated the functionality of Bouhnik into the system of Boyce. Further, one of ordinary skill in the art would have recognized that such an application of Bouhnik would have resulted in an improved system which would help providers avoid disqualifying potential patients. As such, the application of Bouhnik and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosure of Boyce and the teaching of Bouhnik.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyce (US 2009/0313045 A1) in view of Jain et al. (US 11664099 B1).
Regarding Claim 17: Boyce discloses the above limitations. Boyce does not appear to disclose wherein the clinical investigation participant module is further adapted for tracking use of clinical investigation participant-specific clinical endpoints by the at least one clinical investigation participant. However, Jain teaches wherein the clinical investigation participant module is further adapted for tracking use of clinical investigation participant-specific clinical endpoints by the at least one clinical investigation participant (the application is configured to perform repeated interactions over time to monitor health of the user through (i) sensor measurements performed using sensors of one or more devices, and (ii) survey responses by the user to surveys presented by one or more devices. See at least Column 8, Lines 56-60).
Boyce provides a system which manages part of a clinical trial, upon which the claimed invention’s tracking of endpoint data can be seen as an improvement. However, Jain demonstrates that the prior art already knew of collecting endpoint data from participant facing software. One of ordinary skill could have easily incorporated the functionality of Jain into the system of Boyce. Further, one of ordinary skill in the art would have recognized that such an application of Jain would have resulted in an improved system which would help members collect data regarding their clinical trials. As such, the application of Jain and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosure of Boyce and the teaching of Jain.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 Notice of References Cited.
Bleicher et al. (US 6820235 B1), Boris et al. (US 2007/0067189 A1), Breigs et al. (US 2006/0143047 A1), Cerello et al. (US 2014/0222444 A1), Cunningham et al. (US 2021/0265049 A1), Kahn et al. (US 2009/0313048 A1), Kane et al. (US 2005/0038692 A1), Kansara (US 2015/0286802 A1), McAlindon et al. (US 7251609 B1), Meier et al. (US 2009/0063428 A1), and Thangaraj et al. (US 2003/0208378 A1) all describe various aspects of automating clinical trial operations with a computing device, and represent just a small fraction of the prior art on this subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-02-05