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 .
Priority
Acknowledgment is made of Applicant's claim for priority to the following application(s):
* 18380213 filed 16 October 2023
* 17380472 filed 20 July 2021
* 16147640 filed 29 September 2018
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on the following date(s) is/are entered and considered by Examiner:
* 05 March 2025
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-20 of U.S. Patent No. 11069447. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of application claims 1-20 may be found in patent claims 1-20.
It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A method for analysis and visualization of clinical data, the method comprising:
receiving vectors of outcomes of trial subjects;
generating, based on the vectors of outcomes, a plurality of metric graphs, a metric graph of the plurality of metric graphs including first nodes corresponding to the vectors of outcomes, the first nodes being selectively connected based on a first criterion;
selecting, from the plurality of metric graphs and based on a second criterion, an optimal graph;
generating, based on the optimal graph, a clustered graph including second nodes corresponding to groups of the first nodes, the second nodes being selectively connected based on a third criteria;
generating a first layout of the clustered graph, the first layout including a two - dimensional (2D) representation of the clustered graph;
generating, partially based on the first layout, a second layout of the optimal graph, the second layout including a 2D representation of the optimal graph; and
displaying the second layout.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mathematical concepts” because the claim recites various forms of graph theory and other mathematical calculations, i.e. mathematical relationships, mathematical formulas or equations, mathematical calculations. MPEP § 2106.04(a)(2)(I)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
The highlighted steps may be practically performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 2, 4-10 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
receiving vectors of outcomes of trial subjects;
displaying the second layout.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
The steps of receiving and displaying data merely add(s) insignificant extra-solution activity to the abstract idea (mere data gathering, selecting a particular data source or type of data to be manipulated, insignificant application). MPEP 2106.05(g))
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims (such as claim(s) 3 reciting a user interface, additional limitation(s) which amount(s) to invoking computers as a tool to perform the abstract idea).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
Regarding the step of receiving data, this limitation amount(s) to element(s) that have been recognized as well-understood, routine, and conventional (WURC) activity in particular fields (e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). MPEP 2106.05(d)(II)(ii))
Regarding the step of displaying data, Yamakawa (20140112562) discloses displaying graphs in a manner that would be WURC in the pertinent arts (Figure 4-11).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims). MPEP 2106.05(d)(II)(ii))
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
The claim is not patent eligible.
Claim(s) 11-20 recite(s) substantially similar limitations as those of claim(s) 1-10 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Subject Matter Free of Prior Art
Claim(s) 1-20 distinguish(es) over the prior art for the following reasons.
The following is a statement of reasons for the subject matter free of prior art:
Claim 1: the primary reason for the indication of subject matter free of prior art is the inclusion of the following limitations in the combination as recited in the abstract concept and not found in the closest available prior art of record:
generating, based on the vectors of outcomes, a plurality of metric graphs, a metric graph of the plurality of metric graphs including first nodes corresponding to the vectors of outcomes, the first nodes being selectively connected based on a first criterion;
selecting, from the plurality of metric graphs and based on a second criterion, an optimal graph;
generating, based on the optimal graph, a clustered graph including second nodes corresponding to groups of the first nodes, the second nodes being selectively connected based on a third criteria;
generating a first layout of the clustered graph, the first layout including a two - dimensional (2D) representation of the clustered graph;
generating, partially based on the first layout, a second layout of the optimal graph, the second layout including a 2D representation of the optimal graph.
The closest available prior art of record are as follows:
Carlsson (20150127650) discloses generating a plurality of graphs (Figure 5-6), but does not fairly disclose or suggest generating a plurality of metric graphs for a clinical trial, and selecting the optimal metric graph therefrom.
Based on the evidence presented above, none of the closest available prior art of record fairly discloses or suggests the claimed invention. For this reason, claim 1 would be found to be subject matter free of prior art.
Claim(s) 2-10: this/these claim(s) would also be found to be subject matter free of prior art for at least the same rationale as applied to parent claim 1 above, and incorporated herein.
Claim(s) 11-20: this/these claim(s) would also be found to be subject matter free of prior art for substantially similar rationale as applied to claim(s) 1-10 above, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pisner (20200167694) discloses generating a plurality of graphs with multiply connected nodes (Figure 1-2) (Abstract) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Singh (20110173189) discloses connecting a graph to another graph (Abstract, Figure 1-3) in a manner similar to those disclosed in the instant pending Specification as originally filed.
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/T.N.N./ Examiner, Art Unit 3685 /KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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