DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The following is a non-final Office action on the merits in response to Application filed on 8/22/2024. Claims 1-12 are examined and pending.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on application filed in Canada (CA) on 2/22/2022, and the instant application is a cont. of PCT/CA2022/000058, filed 11/29/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/2024, follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Modifications made to [0001] to the original specification are acknowledged.
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 1-12 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.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
The claimed invention (Claims 1-12) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea “of itself”, which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Claim 1, Steps of,
providing a clinical trial information database, the clinical trial information database having stored therein clinical trial information of at least a clinical trial with the clinical trial information being indicative of clinical trial criteria of the at least a clinical trial and contact information of the at least a clinical trial's coordinator;
providing a server computer connected to the Internet and the clinical trial database;
the server computer executing computer-executable instructions stored in a non-transient memory thereof and performing:
generating data indicative of an interactive Internet website for facilitating clinical trial enrollment, the interactive Internet website enabling communication between the server computer and users of client computers connected to the Internet;
receiving from a user, via the Internet website executed on the user's client computer, a request for clinical trial information;
prompting and enabling the user to provide information indicative of patient characteristics; and,
comparing the received patient characteristics with the clinical trial criteria retrieved from the clinical trial information database and providing to the user's client computer information indicative of the patient's eligibility or ineligibility to a trial.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because the instant claims recite “providing a database/a compute, generating data, receiving a user request, prompting the user to provide information, comparing the collected information, providing eligibility information to the user“ which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer.
In addition, claim 1, steps mentioned above also falls within the abstract “Mental Processes” grouping of abstract ideas since these limitation covers performance of the limitations in the human mind or by paper and pen. For example, a human being can observe/receive/provide data/information, can observe/compare information, can observe/transmit/send data.
Further, steps of (“receiving ….”, “providing….”) are considered as “insignificant extra-solution activity” to the judicial exception since they are merely collecting/providing /sending data.
Independent claim1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application. The additional element (a database, a computer, a memory) that is not significant more than the abstract ideas described above. Other than reciting (a server computer), nothing in the claim element precludes the step from practically being performed in the mind or by paper and pens. There is no specificity regarding any technology, just broadly, executing the programming instructions, couple of databases to store data, to receive/obtain/transmit/send/display data over internet.
There is no specificity regarding any technology. The steps are mainly assessing a database to obtain data, generate data, compare data, and providing/transmitting data. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, there is neither improvement to another technology or technical field nor an improvement to the functioning of the computer itself, and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Independent claim 1 (step 2B):
Accordingly, the claim recites an abstract idea(s) as pointed out above. The claim includes additional elements (a database, a server computer) that are Not sufficient to amount to significantly more than the judicial exception and thus do not add something of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea.
In light of the specification, [0033--0035], the components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer/device components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/transmit/display information does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
According to MPEP 2106.05 (d), elements that the Courts have recognized as well-understood, routine, conventional activity in particular fields are e.g., "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); 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” (evidence required by Berkeimer memo). Further, according to Berkheimer memo 04/19/2018, section III.A.1, “A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)”.
Dependent claims 2-11, are merely add further details of the abstract steps/elements recited in claim 1, without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-11 are also non-statutory subject matter.
Independent claim 12: Alice Corp. also establishes that the same analysis should be used for all categories of claims. Therefore, independent system/apparatus claim 12 is also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim(s) 1.
Further, the components (i.e., a database, a computer, a memory) described in independent claims 12, add nothing of substance to the underlying abstract idea. Similarly, as it relates to the computer system claims, the limitations appear to be performed by a generic computing system/device. These components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/obtain/identify/update/transmit/display data/information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
Viewed as a whole, the claims (1-12) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Thus, the claimed invention, as a whole, does not provide 'significantly more' than the abstract idea, and is non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-8, 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Ozeran et al. (hereinafter, Ozeran, US 2020/0381087).
As per claim 1, 12, Ozeran discloses a method, a system, for facilitating clinical trial enrollment, comprising:
providing a clinical trial information database (Fig. 32, item 3264), the clinical trial information database having stored therein clinical trial information of at least a clinical trial with the clinical trial information being indicative of clinical trial criteria of the at least a clinical trial and contact information of the at least a clinical trial's coordinator (Fig. 9, Fig. 30, [0012, requirements for participation (eligibility criteria), locations where the trial is being conducted (sites) , and/or contact information for the sites, 0037, 0041, 0114, 0116, 0125—0126, 0143, 0146, 0195, 0232-0233, 0285, 0305]);
providing a server computer connected to the Internet and the clinical trial database (Fig. 1, [0110, 0126, 0203]);
the server computer (Fig. 1, [0110, 0126, 0203]) executing computer-executable instructions stored in a non-transient memory thereof and performing:
generating data indicative of an interactive Internet website for facilitating clinical trial enrollment (Fig. 2, Fig. 31G, item 3262, [0116—0118]), the interactive Internet website enabling communication between the server computer and users of client computers connected to the Internet (Fig. 5, Fig. 32, item 3262, [0143]);
receiving from a user, via the Internet website executed on the user's client computer, a request for clinical trial information ([0119, 0143—0145, 0285]);
prompting and enabling the user to provide information indicative of patient characteristics ([0135-0137, 0148, 0149, 0285]); and,
comparing the received patient characteristics with the clinical trial criteria retrieved from the clinical trial information database and providing to the user's client computer information indicative of the patient's eligibility or ineligibility to a trial (Fig. 49, item 4916, [0155, 0178-0179, 0183, 0235, 0320, 0325]).
As per claim 2, Ozeran further discloses, wherein the information indicative of the patient's eligibility or ineligibility to a trial is indicative of the patient being eligible to a clinical trial and comprising:
the server computer retrieving the contact information of the clinical trial's coordinator from the clinical trial information database ([0012, requirements for participation (eligibility criteria), locations where the trial is being conducted (sites), and/or contact information for the sites, 0143, 0146, 0285]); and,
the server computer providing the contact information to the user's client computer (Fig. 49, [0027, 0118, 0292, 0296]).
As per claim 3, Ozeran further discloses, wherein the clinical trial information is indicative of clinical trial inclusion criteria (Abstract, Fig. 9, Fig. 10, Fig. 32, item 3272, Fig. 35, 38, [0012, 0023, 0041, 0235, 0256--0259]) and wherein the patient is determined to be ineligible to the trial if the patient characteristics do not meet all inclusion criteria of the respective trial (Fig. 32, item 3272, [0041, 0290, Table 10, 0325]).
As per claim 4, Ozeran further discloses, wherein the clinical trial information is indicative of clinical trial exclusion criteria (Fig. 32, item 3272, [0013, The trial has
fourteen inclusion criteria and twenty exclusion criteria …., 0117, 0118]) and wherein the patient is determined to be ineligible to the trial if the patient characteristics do meet one or more exclusion criteria of the respective trial (Fig. 32, item 3272, [0035, 0041, 0290, Table 10, 0325]).
As per claim 5, Ozeran further discloses,
wherein the clinical trial information is indicative of clinical trial inclusion criteria and clinical trial exclusion criteria (Fig. 9, Fig. 32, item 3272, [0013, The trial has fourteen inclusion criteria and twenty exclusion criteria …., 0117, 0118]), and
wherein the patient is determined to be ineligible to the trial if the patient characteristics do not meet all inclusion criteria of the respective trial (Fig. 32, item 3272, [0041, 0290, Table 10, 0325]), and
wherein the patient is determined to be ineligible to the trial if the patient characteristics do meet one or more exclusion criteria of the respective trial (Fig. 32, item 3272, [0041, 0290, Table 10, 0325]).
As per claim 6, Ozeran further discloses, wherein the interactive Internet website displays at least a drop-down menu for prompting and enabling the user to provide information indicative of patient characteristics (Fig. 31D, Fig. 34, [0136, 0146, 0149, drop down menu, 0203, 0299]).
As per claim 7, Ozeran further discloses, wherein the user is prompted to provide information indicative of patient characteristics that is directly related to the clinical trial criteria of the at least a clinical trial ([0148, 0149, 0235, 0287]).
As per claim 8, Ozeran further discloses, wherein the information indicative of patient characteristics is provided absent personal identifying information ([0134, 0235]).
As per claim 10, Ozeran further discloses, wherein the server computer further performs:
receiving clinical trial information of a clinical trial with the clinical trial information being indicative of clinical trial criteria of the clinical trial and contact information of the clinical trial's coordinator (Fig. 9, Fig. 30, [0012, requirements for participation (eligibility criteria), locations where the trial is being conducted (sites) , and/or contact information for the sites, 0037, 0041, 0114, 0116, 0125—0126, 0143, 0146, 0195, 0232-0233, 0285, 0305]); and,
storing the clinical trial information in the clinical trial information database (Fig. 32, item 3264, [0238, 0239, 0249]).
As per claim 11, Ozeran further discloses, wherein the server computer further performs:
enabling via the interactive Internet website communication between the server computer and a client computer of a clinical trial provider connected to the Internet (Fig. 10, 0146, 0148, 0149, 0167, 0176, 0287));
receiving from the clinical trial provider, via the Internet website executed on the clinical trial provider's client computer, a request for providing clinical trial information ([0119, 0143—0145, 0285]); and,
prompting and enabling the clinical trial provider to provide the clinical trial information ([0135-0137, 0148, 0149, 0285]).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ozeran et al. (hereinafter, Ozeran, US 2020/0381087), in view of Francois (US 2019/0244683).
As per claim 9, Ozeran further discloses, however, Ozeran does not explicitly disclose, wherein the contact information provided to the user's client computer comprises a hyperlink.
Francois teaches ([0433, Such information may include any one or more of the following, e.g., as appropriate for the experimental therapy: contact information for or
links to one or more physicians and/or sites that offer the experimental therapy, inclusion and/or exclusion criteria, a summary of the trial protocol, information about the intervention being studied, a copy of the informed consent form or a portion thereof (e.g., a portion explaining the intervention and what the patient may experience or be asked to undertake), sponsor name,….]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ozeran to include “links to contact information”, taught by the Francois. One would be motivated to do this in order to perform analysis to effectively conduct clinical trial for each patient.
The prior art made of record cited or referenced relied upon is considered pertinent to applicant’s disclosure.
Gravier et al. (US 2018/0046780),
Loew et al (US 2007/0214012),
Padmos (US 2022/0215908),
Kalathil (US 2015/0161336),
Pruit (US 2014/0316793).
Conclusion
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/SUN M LI/Primary Examiner, Art Unit 3685