DETAILED ACTION
This communication is in response to application no. 19065436 filed 27 February 2025.
Claims 1-20 are currently pending and have been examined.
Claims 1-20 are rejected as shown in this 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 .
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, 3-17, 19, and 20 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.
Step 1
Claims 1 and 3-16 recite a series of steps and, therefore, is a process. Claims 17 and 19 recite a system and, therefore, is a machine or manufacture. Claim 20 recites a non-transitory computer-readable media and, therefore, is a machine or manufacture.
Step 2A-Prong One
(Claims 1, 17, and 20) The “generating, using an artificial intelligence (Al) engine, a plurality of variable vectors based on the plurality of variables, respectively; generating, using the Al engine, a free-text information vector based on the free-text information; aggregating the plurality of variable vectors with the free-text information vector to generate an examination order vector; determining, based on the examination order vector and using the Al engine, a set of medical indications corresponding to the examination order” steps, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “using an artificial intelligence engine” language, the claim encompasses a user manually utilizing known information to determine a medical indication. These claims fall into the mental processes grouping of abstract ideas and thus recite an abstract idea.
(Claims 3, 4, 5, and 19) These claims recite use of a neural network or a natural language processor to further carry out steps found in the independent claims. Use of these tools does not take the claims out of the above-identified abstract idea grouping. Thus, these claims recite an abstract idea.
(Claim 6) The “generating, by the one or more processors, a knowledge graph associating the plurality of variables with a plurality of medical indications” step, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the processor” language, the claim encompasses a user manually utilizing known information to generate a knowledge graph. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claim 7) The “assigning, by the one or more processors, the plurality of variables and the free-text information to nodes of an input layer of the neural network, respectively; and assigning, by the one or more processors, a plurality of medical indications to nodes of an output layer of the neural network, respectively” steps, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the processor” language, the claim encompasses a user manually assigning information to nodes. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claim 8) The “initializing, by the one or more processors, the nodes of the input layer of the neural network with the plurality of variable vectors and the free-text information vector; embedding, by the one or more processors, the plurality of medical indications to generate a plurality of medical indication vectors, respectively; and initializing, by the one or more processors, the nodes of the output layer of the neural network with the plurality of medical indication vectors, wherein determining the set of medical indications comprises: aggregating the plurality of medical indication vectors to generate an aggregated medical indication vector; and generating, using the neural network, a similarity score between the examination order vector and the aggregated medical indication vector” steps, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the one or more processors” language, the claim encompasses a user manually initializing nodes, generating vectors, aggregating vectors, and generating a similarity score. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claims 9 and 10) The “generating, using the neural network, a plurality of similarity scores between the examination order vector and the plurality of medical indication vectors, respectively” and “generating, using the neural network, a plurality of cosine similarity scores between the examination order vector and the plurality of medical indication vectors, respectively” steps, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “using the neural network” language, the claim encompasses a user manually generating scores using known information. These claims fall into the mental processes grouping of abstract ideas and thus recite an abstract idea.
(Claim 11) This claim indicates that “the set of medical indications corresponding to the examination order comprises one of the plurality of medical indications having a highest ranked similarity score associated therewith” This limitation does not take the claim out of the abstract idea grouping as it merely further limits the abstract idea.
(Claim 12) The “transmitting, by the one or more processors, to an examination order entry system for entry therein, without input from a provider, an automatic selection of the one of the plurality of medical indications having the highest ranked similarity score associated therewith in response to determining that a highest ranked cosine similarity score of the plurality of cosine similarity scores meets or exceeds a threshold score” step, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the one or more processors” language, the claim encompasses a user manually communicating information when a condition occurs. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claim 13) The “transmitting, by the one or more processors, to an examination order entry system the N of the plurality of medical indications having the N highest ranked cosine similarity scores associated therewith, respectively, in response to determining that a highest ranked cosine similarity score of the plurality of cosine similarity scores does not meet or exceed a threshold score; wherein N is one or more and less than a total number of the plurality of medical indications” step, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the one or more processors” language, the claim encompasses a user manually communicating information when a condition occurs. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claim 14) The “transmitting, by the one or more processors, to an examination order entry system an indication that none of the plurality of medical indications are applicable to the examination order in response to determining that a highest ranked cosine similarity score of the plurality of cosine similarity scores is less than a threshold score” step, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by the one or more processors” language, the claim encompasses a user manually communicating information when a condition occurs. This claim falls into the mental processes grouping of abstract ideas and thus recites an abstract idea.
(Claim 15) This claim indicates that “the plurality of variables comprises one or more variables associated with the patient including at least one of an age, a gender, a problem list, an encounter diagnosis, a patient class, or a medical center department; the plurality of variables comprises one or more variables associated with a provider including at least one of a provider identifier or a provider specialty; and the plurality of variables comprises at least one of an examination order name, an examination order identification, an examination order modality, an examination order contrast, or a body area identification.” This limitation does not take the claims out of the abstract idea grouping as it merely further limits the abstract idea.
(Claim 16) This claim further limits where the information is stored (i.e., “in an electronic medical record system”) and does not take the claim out of the above-identified abstract idea grouping. Thus, the claim recites an abstract idea.
The mere nominal recitation of a generic computer component does not take the claim limitations out of the abstract idea grouping(s). Thus, the claims recite an abstract idea
Step 2A-Prong Two
This judicial exception is not integrated into a practical application. The claims recite the additional elements of one or more processors and an artificial intelligence engine (claims 1 and 3-16), a system comprising a processor, a memory and an artificial intelligence engine (claims 17 and 19), or one or more non-transitory computer readable media and an artificial intelligence engine (claim 20), and includes no more than mere instructions to apply the exception using these generic computer components. The one or more processors and an artificial intelligence engine (claims 1 and 3-16), a system comprising a processor, a memory and an artificial intelligence engine (claims 17 and 19), or one or more non-transitory computer readable media and an artificial intelligence engine (claim 20) does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Additionally, the step of “receiving input information associated with an examination order … ” (claims 1, 17, and 20) is mere data gathering. This step is considered insignificant extra-solution activity and does not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed previously with respect to Step 2A-Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in Step 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. See MPEP 2106.05(f). The claims do not provide an inventive concept (significantly more than the abstract idea). The claims are ineligible.
Regarding the “receiving” data gathering steps, the courts have determined that receiving or transmitting data over a network, e.g., using the Internet to gather data is considered routine, conventional, and well-understood. See MPEP 2106.05(d)(II).
Note: Claims 2 and 18 are not rejected under 35 USC § 101. These claims recite use of two different AI models to generate the plurality of variable vectors and the free-text information vectors which are then aggregated into the examination order vector. As indicated in the parent application (17/538273, now US patent 12,266,448), the Specification indicates that the use of these different models provides a technical solution to a technical problem (see current Specification at [0017]). These are the only claims that currently recite this technical solution.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448 (“Moon”) in view of US 6,915,254 (“Heinze”). Claim 1 of Moon does not recite “using a natural language processor” to generate the free-text vector. However, Heinze discloses the input of free text and use of natural language processing to generate vectors (See columns 3-4 “A physician note (or, simply, "note") is a physician generated record of a physician-patient encounter. Such notes may be handwritten, recorded by audio dictation systems, or directly input into a computer (e.g., by means of a general word processing program or a dedicated medical records program). … As shall be described in greater detail, each note is normalized to a format that meets the specifications of a medical provider and/or its transcription service. The normalized file is then typically processed by a central natural language processing (NLP) engine. … The matching of vectors to parsed data is performed at the phrase, clause, sentence, and adjacent sentence levels. … In addition to the vectors that define codes of which the NLP engine has complete knowledge, there are vectors that define codes for which knowledge is incomplete. (This is like a human coder who is able to recognize that the physician is describing a diagnosis, but who may not fully understand terms the physician is using). The NLP engine includes a set of knowledge vectors that broadly define the language of the entire set of diagnoses that can be coded. These vectors--termed "semi-knowledge vectors"--are not sufficiently detailed to permit accurate coding of specific diagnoses in all instances. Each semi-knowledge vector yields a range of possible diagnosis codes when matched to information in the normalized file. When a match to a semi-knowledge vector occurs, the NLP engine checks whether an acceptable standard vector is also matched.”). It would have been obvious to one having ordinary skill in the art at the time of filing to combine the teachings of Moon and Heinze to utilize natural language processing on the free-text information. The claimed invention is merely a combination of old elements, in the combination each element merely performs the same function as it does separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,266,448. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim under examination is anticipated by the patented claim.
Conclusion
The claims are not rejected under 35 USC § 102/103. The closest prior art found by Examiner is U.S. 2021/0304857 (“Johansson”). Johansson discloses “receiving first information associated with a patient, second information associated with a provider, and third information associated with an order; and determining, using a multi-layer neural network, a medical indication corresponding to the order responsive to receiving the first information, the second information, and the third information.” While Johansson discloses “receiving input information associated with an examination order for a patient, the input information comprising first information associated with a plurality of variables and second information associated with a free-text query for the examination order; embedding the plurality of variables to generate a plurality of input variable vectors, respectively; embedding the free-text query for the order to generate a free-text query vector” as claimed, Johansson does not disclose “aggregating, by the one or more processors, the plurality of variable vectors with the free-text information vector to generate an examination order vector; determining, by the one or more processors, based on the examination order vector, and using the Al engine, a set of medical indications corresponding to the examination order” as claimed. Johansson utilizes both a plurality of variables and a free-text query to determine a medical indication, but does not combine the plurality of variables and free-text query as claimed. Examiner was unable to find a secondary piece of prior art which makes up for the limitations not found in Johansson.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEREDITH A LONG whose telephone number is (571)272-3196. The examiner can normally be reached Mon - Fri 9:30 - 6.
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/MEREDITH A LONG/Primary Examiner, Art Unit 3622
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