DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the application filed on 2/11/26. Claims 18-36 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 18-36 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 18-24 are drawn to a method; claims 25-30 are drawn to a system; and claims 31-36 is drawn to an article of manufacture (storing computer instructions to perform a method)
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 18-36 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method, system, and article of manufacture are drawn to distributing and verifying/certifying the accuracy of electronic clinical trial source documents
In particular, claims 18, 25, and 31 recite a method and system for:
Linking… an electronic copy of a clinical trial source document to a tracking location in the clinical trial protocol, wherein the clinical trial source document relates to a clinical procedure performed with respect to a subject of the clinical trial, and the linking comprises:
updating the at least one programmatic element in the memory to generate a first link, in the encoding of the clinical trial protocol, between the electronic copy of the clinical trial source document and the tracking location in the clinical trial protocol;
in response to receiving the input of the clinical trial information via the second portion of the GUI, linking, in the memory of the electronic clinical trial protocol management system, the clinical trial information to the tracking location in the clinical trial protocol, the linking comprising:
updating the at least one programmatic element in the memory to generate a second link, in the encoding of the clinical trial protocol, between the clinical trial information and the tracking location in the clinical trial protocol.
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 18, 25, and 31 additionally recite:
generating a graphical user interface (GUI) including a first portion and a second portion;
displaying…at least a portion of the electronic copy of the clinical trial source document;
displaying… one or more GUI elements for receiving input of clinical trial information related to the portion of the electronic copy displayed in the first portion and/or the tracking location to which the electronic copy is linked
These additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. In the instant case the additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 18, 25, and 31 have been amended to further recite: accessing, from the memory, at least one of the programmatic elements of the encoding of the clinical trial protocol. This additional limitation is/are is a conventional computer activities that amount to no more than implementing the abstract idea with a computerized system.
Claims 18, 25, and 31 recite additional limitation(s), including: the electronic clinical trial protocol management system comprising: at least one processor; and at least one machine readable hardware storage medium containing machine executable instructions that when executed by the at least one processor, and a memory. The additional components is/are generic components performing well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “A machine-readable storage medium may be any medium that is capable of storing and/or encoding a sequence of instructions for execution by a machine (e.g., a computing device) and that causes the machine to perform any one of the methodologies and/or embodiments described herein. Examples of a machine-readable storage medium include, but are not limited to, a magnetic disk (e.g., a conventional floppy disk, a hard drive disk), an optical disk (e.g., a compact disk “CD”, such as a readable, writeable, and/or re-writable CD; a digital video disk “DVD”, such as a readable, writeable, and/or rewritable DVD), a magneto-optical disk, a read-only memory “ROM” device, a random access memory “RAM” device, a magnetic card, an optical card, a solid-state memory device (e.g., a flash memory), an EPROM, an EEPROM, and any combinations thereof. Such examples are hardware storage media. A machine-readable medium, as used herein, is intended to include a single medium as well as a collection of physically separate media, such as, for example, a collection of compact disks or one or more hard disk drives in combination with a computer memory." (par. 93 of PG-Pub)
The disclosure also states: “Examples of a computing device include, but are not limited to, an electronic book reading device, a computer workstation, a terminal computer, a server computer, a handheld device (e.g., a tablet computer, a personal digital assistant “PDA”, a mobile telephone, a Smartphone, etc.), a web appliance, a network router, a network switch, a network bridge, any machine capable of executing a sequence of instructions that specify an action to be taken by that machine, and any combinations thereof. In one example, a computing device may include and/or be included in, a kiosk.” (par. 96)
The application explains: “Examples of a storage device (e.g., storage device 1730) include, but are not limited to, a hard disk drive for reading from and/or writing to a hard disk, a magnetic disk drive for reading from and/or writing to a removable magnetic disk, an optical disk drive for reading from and/or writing to an optical media (e.g., a CD, a DVD, etc.), a solid-state memory device, and any combinations thereof. Storage device 1730 may be connected to bus 1715 by an appropriate interface (not shown). Example interfaces include, but are not limited to, SCSI, advanced technology attachment (ATA), serial ATA, universal serial bus (USB), IEEE 1794 (FIREWIRE), and any combinations thereof. In one example, storage device 1730 (or one or more components thereof) may be remotely interfaced with computer system 1700 (e.g., via an external port connector (not shown)). Particularly, storage device 1730 and an associated machine-readable medium 1735 may provide nonvolatile and/or volatile storage of machine-readable instructions, data structures, program modules, and/or other data for computer system 1700. In one example, software 1725 may reside, completely or partially, within machine-readable medium 1735. In another example, software 1725 may reside, completely or partially, within processor 1705.” (see par. 98) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are analogous to certain limitations recited in claims 18, 25, and 36:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
- Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
- A Web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Claims 19-24 are dependent from Claim 18 and include(s) all the limitations of claim(s) 18. However, the additional limitations of the claims 19-24 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 19-24 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 26-30 are dependent from Claim 25 and include(s) all the limitations of claim(s) 25. However, the additional limitations of the claims 26-30 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 26-30 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 32-36 are dependent from Claim 31 and include(s) all the limitations of claim(s) 25. However, the additional limitations of the claims 32-36 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 32-36 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 18-19, 25, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kahn et al (US 20140249845 A1) in view of Mitchel et al (US 20120022889 A1), and in further view of Kansara et al (US 20150286802 A1)
Claims 18, 25, and 31 Kahn discloses an electronic clinical trial protocol management system comprising:
at least one processor; (par. 87-89) and
at least one machine readable hardware storage medium containing machine executable instructions that when executed by the at least one processor cause the at least one processor (par. 87-89; claims 11 and 21) to implement a computer-implemented method of interacting with a clinical trial protocol via an electronic clinical trial protocol management system, the electronic clinical trial protocol management system being programmed with an encoding of a clinical trial protocol for a clinical trial having one or more treatment cycles, in the memory of the electronic clinical trial protocol management system, the encoding comprising including one or more programmatic elements that model a number of treatment cycle iterations for a subject progressing through the clinical trial, (Fig. 1; par. 75-77; par. 116) the method comprising:
linking the electronic copy of the clinical trial document to the tracking location via at least one programmatic element representing at least one of a visit, the clinical procedure, a treatment cycle, an iteration of a treatment cycle, and an interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial; (Fig. 1; par. 139- the iCPs are distributed to the clinical sites- the central authority maintains the iCP databases only on the central server and makes them available using a central application service provider (ASP) and thin-client model that supports multiple user devices including work stations, laptop computers and hand held devices. The availability of hand held devices allows the deployment of "intelligent" point of care data capture devices in which all protocol-specific, visit-specific and patient-specific required data elements, and their associated data validation rules, can be automatically created using information contained within the iCP)
generating a graphical user interface (GUI) including a first portion and a second portion; (Fig. 2-3; Fig. 11; par. 94-95)
displaying, via the first portion of the GUI, at least a portion of the electronic copy of the clinical trial document; (Fig. 11-12; fig. 16; par. 95-96; par. 99)
displaying, via the second portion of the GUI and simultaneously with the displaying of the portion of the electronic copy of the clinical trial document in the first portion, displaying, via the first portion of the GUI, at least a portion of the electronic copy of the clinical trial document; (Fig. 11-12; fig. 15-16; par. 95-96; par. 99) one or more GUI elements for receiving input of clinical trial information related to the portion of the electronic copy displayed in the first portion and/or the tracking location to which the electronic copy is associated within the electronic clinical trial protocol management system; (Fig. 16; Fig. 18-entering long/short description information; par.100-101; par. 103: the values that a protocol author places in the slot 1712 of a visit class 1128 object are themselves instances of VisitToVisitTransition class 2210 (FIG. 22) in the meta-model. The right-hand pane 2212 shows the slots which are available in an object of the VisitToVisitTransition class 2210. As can be seen, it includes a slot 2214 which points to the first visit object of the transition, another slot 2216 which points to a second visit object of the transition )
associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location to which the electronic copy is associated, wherein associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location comprises linking the clinical trial information to the tracking location via the at least one programmatic element representing at least one of the visit, the clinical procedure, the treatment cycle, the iteration of a treatment cycle, and the interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial. (Fig. 17-18: par. 101- FIG. 18 illustrates a particular instance of visit class 1128, which is included in the CALGB 9840 iCP. As can be seen, it includes a window 1810 containing the possible visit transitions, a window 1812 containing the patient management tasks, and a window 1812 showing the data management tasks for a particular visit referred to as "Arm A treatment visit;" par. 103- the values that a protocol author places in the slot 1712 of a visit class 1128 object are themselves instances of VisitToVisitTransition class 2210 (FIG. 22) in the meta-model. The right-hand pane 2212 shows the slots which are available in an object of the VisitToVisitTransition class 2210. As can be seen, it includes a slot 2214 which points to the first visit object of the transition, another slot 2216 which points to a second visit object of the transition, and three slots 2218, 2220 and 2222 in which the protocol author provides the minimum, maximum and preferred relative time of the transition.)
Kahn discloses the method substantially as claimed but does not expressly disclose that the electronic clinical trial document is a source document, and does not disclose associating/linking an electronic copy of the source documents.
Mitchel discloses: linking, in the memory of the electronic clinical trial protocol management system, an electronic copy of a clinical trial source document to a tracking location in the clinical trial protocol, wherein the clinical trial source document relates to a clinical procedure performed with respect to a subject of the clinical trial. (Mitchel: Source documents are electronically captured and associated with and stored with a particular clinical trial site: par. 10-Upon the collection of data at a clinical trial site, the data are transmitted to a central server where they are captured as an electronic source document(s) in human readable format. The system then transmits the captured electronic source document to a trusted third-party's electronic document repository. Then, the system uses the same captured data to populate the clinical study's electronic data capture database; par. 12-13: Upon receipt of the collected clinical data by the central data server (2), the data are immediately captures (7) in a human-readable file-format (e.g., JPEG, PDF, XML) which serves as the source document. Every submission over the course of the clinical trial, including modifications to existing data, are captured by the central server (2) in a human-readable file format which serves as the source document for the clinical trial. Once the source document has been captured by the central server, the source document is sent (3) to a source data storage server). At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the method/system of Kahn with the teaching of Mitchel to include linking an electronic source document with clinical trial location (i.e. tracking location), with the motivation of providing a system which will significantly enhance speed, efficiency and cost savings due to the elimination of transcription errors, source document verification and double-key data entry. (par. 6)
Claims 18, 25 and 31 have been further amended to recite:
accessing, from the memory, at least one of the programmatic elements of the encoding of the clinical trial protocol, wherein the at least one programmatic element comprises a scheduling representation associating the at least one programmatic element to a plurality of different tracking locations; and
updating the at least one programmatic element in the memory to generate a first link, in the encoding of the clinical trial protocol, between the electronic copy of the clinical trial source document and the tracking location in the clinical trial protocol;
in response to receiving the input of the clinical trial information via the second portion of the GUI, linking, in the memory of the electronic clinical trial protocol management system, the clinical trial information to the tracking location in the clinical trial protocol, the linking comprising:
updating the at least one programmatic element in the memory to generate a second link, in the encoding of the clinical trial protocol, between the clinical trial information and the tracking location in the clinical trial protocol.
Kahn discloses accessing, from the memory, at least one of the programmatic elements of the encoding of the clinical trial protocol, wherein the at least one programmatic element comprises a scheduling representation associating the at least one programmatic element to a plurality of different tracking locations (Fig. 1; par. 87-88; par. 135-139- accessing iCP from library, ICPs distributed to different clinical sites/tracking locations; par. 119-121: system includes object for tracking/scheduling patient follow-up; see also fig. 7)
Kahn does not disclose, but Mitchel teaches:
updating the at least one programmatic element in the memory to generate a first link, in the encoding of the clinical trial protocol, between the electronic copy of the clinical trial source document and the tracking location in the clinical trial protocol (linking the original data and creating new data elements to reflect corrections to data elements reads on updating programmatic elements: par. 5- When new data elements are added to an existing electronic CRF (eCRF), each new data element must be permanently linked to the electronic signature and/or digital certificate of its originator. This indicates the signing party's identity and approval of the document, and provides evidence of the document's integrity. Data elements in an eCRF can be corrected if found to be erroneous, but the original data element must remain present in the eCRF, and the correction must be accompanied by data element identifiers explaining the reason for the correction and the digital signature of the party making the correction.) ;
in response to receiving the input of the clinical trial information via the second portion of the GUI, linking, in the memory of the electronic clinical trial protocol management system, the clinical trial information to the tracking location in the clinical trial protocol (par. 5- Electronic source documents and CRFs include data elements. Each element represents an individual observation by an authorized data originator. Each data element includes data attributes…Data elements in an eCRF can be corrected if found to be erroneous, but the original data element must remain present in the eCRF, and the correction must be accompanied by data element identifiers explaining the reason for the correction and the digital signature of the party making the correction,) the linking comprising:
updating the at least one programmatic element in the memory to generate a second link, in the encoding of the clinical trial protocol, between the clinical trial information and the tracking location in the clinical trial protocol. (par. 5-7- creating links to electronic source documents as an audit trail (par. 5)… 21 CFR § 11 also mandates that a clinical trial records management system be capable of generating accurate and complete copies of records in both human readable and electronic form suitable for inspection, and protecting of records for accurate and ready retrieval throughout the records retention period (par. 6))
At the time of the applicant’s invention, it would have been obvious to one of ordinary skill in the art to further modify the system and method of Kahn with the teaching of Mitchel to include the additional features with the motivation of clinical trial documentation system to support compliance with federal regulations.
Claim 19 Kahn discloses a computer-implemented method, wherein the one or more programmatic elements are in a data format that includes at least one of an object-oriented data format, a tabular data format, a JavaScript Object Notation (JSON) format, an extensible markup language (XML) format. (object oriented data format: par. 76- The building blocks are represented as object classes, and an individual protocol database contains instances of the available classes.; par. 96- FIG. 12 is a screen shot of a particular instance of class "protocol" in FIG. 11, specifically a protocol object having identifier CALGB 9840. It can be seen that each of the slots defined for protocol class 1116 has been filled in with specific values in the protocol class object instance of FIG. 12)
Claim(s) 20-24; 26-30 and 32-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn et al (US 20140249845 A1) in view of Mitchel et al (US 20120022889 A1), as applied to claims 1, 25, and 31, and in further view of Mitchel et al (US 20180075410 A1- to Mitchel and Hays; referred to hereinafter as Hays)
Claims 20, 26, 32 Kahn and Mitchel in combination disclose the computer-implemented method of claim 18, as explained in the rejection of 18. Kahn and Mitchel do not disclose, but Hays teaches a method/system further comprising:
generating a certified electronic copy of the clinical trial source document, wherein generating the certified electronic copy comprises (Abstract; par. 11- electronic records management system for the collection, capture, processing, storage and tracking of data for both electronic source health records and for clinical trial purposes, including a certification module for creating a certified digital image copy of an original paper source document): associating an electronic signature data element representing a signature of a user of the electronic clinical trial protocol management system with the electronic copy, the electronic signature resulting from an action by the user in association with a verification of the electronic copy, (par. 11; par. 32- to create an unmodifiable digital image copy of a paper source document, with the unmodifiable digital image copy being permanently attached to an electronic signature certifying that the digital image copy is an exact copy having all of the same attributes and information as the original paper document ; par. 33- The certification interface 38 displays the digital image copy of a source document for comparison with the original paper source document. The certification interface 38 also transmits user commands to the copy processor 36 to permanently attach a digital signature to certify digital image copy) and generating a data structure, in the memory of the electronic clinical trial protocol management system, linking the electronic signature data element with the electronic copy of the clinical trial source document. (par. 33-34: The certification interface 38 displays the digital image copy of a source document for comparison with the original paper source document. The certification interface 38 also transmits user commands to the copy processor 36 to permanently attach a digital signature to certify digital image copy… the certification interface also runs software operable to create and populate a human-readable certification form including a history of data-related events associated with a source document, insert a user's digital signature upon the user's command, and permanently incorporate the human readable certification form into a digital image copy)
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify further the method and system of Kahn and Mitchel in combination with the teaching of Hays to include signatures and certified electronic copies for clinical trial documents. One would have been motivated to include these features to ensure the archiving of original electronic source documents before they are exposed to a clinical trial database accessible to trial participants and other parties interested in the outcome of the clinical trial, and to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection in compliance with. 21 CFR § 11.10. (Hays: par. 6; par. 9)
Claims 21, 27, 33 Kahn, Mitchel, and Hays in combination disclose the computer-implemented method of claim 20 as explained. Hays further discloses further comprising: displaying, via the first portion of the GUI, at least a portion of the certified electronic copy of the clinical trial source document. (par.41-43; Fig.4- display and comparison of source and copy documents) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify further the method and system of Kahn and Mitchel in combination with the teaching of Hays with the motivation of ensuring the accurate archiving of original electronic source and generating accurate and complete copies of records in both human readable and electronic form suitable for inspection in compliance with. 21 CFR § 11.10. (Hays: par. 6; par. 9)
Claims 22, 28, 34 Kahn, Mitchel, and Hays in combination disclose the computer-implemented method of claim 20 as explained. Hays further discloses The computer-implemented method of claim 20, wherein the verification is related to a regulatory requirement. (par. 6; par. 9-10: e.g. FDA requirements, and compliance with 21 CFR section 11.10
Claims 23, 29, 35 Kahn, Mitchel, and Hays in combination disclose the computer-implemented method of claim 22 as explained. Hays further discloses wherein generating the certified electronic copy further comprises: associating a certification statement related to the regulatory requirement with the electronic signature data element and/or the electronic copy of the clinical trial source document. (par. 6; par. 9-10; par. 40-the certification interface 38 also runs software for creating the human-readable certification form and for commanding the copy processor 36 to incorporate the form into the digital image copy. The certification interface 38 also populates the certification form with required information such as the unique identifiers of the original document and of the copy, the date and time of certification, and a signed statement that the signer has certified the electronic image copy as an exact copy having all of the same attributes and information as the original document.)
Claims 24, 30, 36 Kahn, Mitchel, and Hays in combination disclose the computer-implemented method of claim 20 as explained. Hays discloses a method and system , further comprising: deconstructing the electronic copy of the clinical trial source document into one or more displayable pages; and associating the electronic signature data element representing the signature of the user of the electronic clinical trial protocol management system with each page of the one or more displayable pages. (Fig. 4; par. 39-42: par. 39- The certification interface 38 also includes a graphical user interface (GUI) (not shown) to enable a user to issue commands to the copy processor 36 to permanently affix the user's electronic signature to the digital image copy, render the digital image copy unmodifiable, and transmit the certified digital image copy to the central data server 14 for archiving at the source document storage server 20. Par. 42- at 418, the user next commands the certification interface 38 to permanently attach a digital signature certifying that the electronic image copy is an exact copy of the original source document, at 422. The user then commands the copy processor 36, to render the digital image copy unmodifiable, at 424…)
Response to Arguments
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive.
(A) Applicant argues the prior art does not disclose the features of the claims as amended.
In response, the examiner has provided additional citations to address the claims as amended.
(B) Applicant argues the rejection of the claims under 35 USC 101. In particular, applicant argues that any abstract idea is integrated into a practical application because the claimed invention recites an improvement in a technological field.
In response, the examiner disagrees. The abstract idea is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B).
Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019) Note, there is no requirement for the judicial exception to provide the improvement.
Applicant argues that the specification recites an improvement to clinical trial technology. However, the improvement argued by the applicant is an improvement to the abstract idea (i.e. a better process for distrubuting and verifying/certifying the accuracy of electronic clinical trial source documents).
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
The claim(s) must be evaluated to ensure the claim itself reflects the improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). The full scope of the claim under the broadest reasonable interpretation should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). (See MPEP 2106(a)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bargaje (Bargaje C., “Good Documentation Practice In Clinical Research.” Perspectives in Clinical Research. 2011 Apr;2(2):59-63. doi: 10.4103/2229-3485.80368. PMID: 21731856; PMCID: PMC3121265.) discusses the importance of source documentation and issues encountered during site visits when standard electronic documenting practices were lacking.
Kansara (US 20150286802 A1)- management of clinical trial data, generation and further use, and more particularly to a system and method using medical informatics primarily to plan, conduct and analyze clinical trials .
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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684
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