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 Status
Claims 1-20 are pending and under examination.
Claims 1, 8, and 15 are independent.
Claims 1-2, 4-5, 8-9, 11-12, 15-16, and 18-19 are amended.
No claims are withdrawn, new, canceled, or allowed.
Claims 1-20 are rejected.
Office Action Outline
Rejections applied
Abbreviations
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Overview of Withdrawal/Revision of Objections/Rejections
In view of the amendment and remarks received 11/26/2025:
• The objection to the Specification is withdrawn.
• The claim objection is withdrawn.
• The 112(b) rejection is withdrawn. The clarity issue regarding the text representation has been resolved.
• The 101 rejection is maintained with revision.
• Note, no 103 rejection was applied in the previous Office action. (For details, see the 08/27/2025 FAOM, p.12-13, ¶ 42.)
Priority
As detailed in the 02/04/2022 filing receipt, this application was originally filed 01/26/2022, and no priority is claimed to any previous applications.
Claim Interpretation
Claims 3, 4, 10, 11, and 17, and 18 recite “training ECG”, which is being interpreted as including both “the sequence of diagnosis codes representing the diagnosis of the training ECG” (i.e., the text representation of an ECG diagnosis), and “the raw leads data of the training ECG”, after consideration of Specification [0045], which discloses “For each training ECG, the text encoder 145 may encode the sequence of diagnosis codes representing the diagnosis of the training ECG into a text embedding, while the ECG encoder 147 may encode the raw leads data of the training ECG into an ECG embedding.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
laws of nature and natural phenomena are naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1 analysis:
Claims 1-7 are directed to a 101 process, here a method. Claims 8-14 are directed to a 101 machine or manufacture, here a system including an ECG monitor and a cloud services system. Claims 15-20 are directed to a 101 machine or manufacture, here a non-transitory computer-readable medium (CRM). As such, claims 1-20 are directed to a related method, system, and CRM, which fall under categories of statutory subject matter. (Step 1: Yes.)
Step 2A, Prong One analysis:
The claims recite judicial exceptions in the form of abstract ideas as follows:
Independent claims 1, 8, and 15 recite mathematical concepts of:
• training a text machine learning (ML) model to generate a text embedding based on a text representation of an ECG diagnosis;
• training an ECG encoding ML model, using the text ML model (now considered to recite an abstract idea), to generate an ECG embedding based on received ECG leads data such that ECG embeddings generated from similar ECG leads data are proximate to each other in vector space;
• generating a query embedding, using the ECG ML model (now considered to recite an abstract idea), based upon a query ECG;
• determining a similarity score (also considered a mental process);
• ranking each of the ECG embeddings based on a similarity score (also considered a mental process).
Claims 3, 10, and 17 recite mathematical concepts of:
• generating a training text embedding;
• generating a training ECG embedding;
• projecting the plurality of training ECG embeddings and the plurality of training text
embeddings into a joint embedding space; and
• utilizing a loss function to train the ECG ML model to match each training ECG
embedding with a corresponding training text embedding.
Claims 4, 11, and 18 recite a mathematical concept of:
• determining a dot product of the training ECG embedding with each of the training text embeddings.
Claims 5, 12, and 19 further limit the text representation of claims 1, 8, and 15.
Claims 6, 13, and 20 recite mathematical concepts of:
• randomly removing a diagnosis code (also considered a mental process);
• training the text ML model to predict the removed diagnosis code .
Claims 7 and 14 recite a mathematical concept of:
• the text ML model is a bidirectional encoder representations from transformers (BERT) model.
Step 2A Prong One summary: The claims recite mental processes and mathematical concepts. Considering the broadest reasonable interpretation (BRI) of the claims, the limitations of training and using the ML models, generating embeddings, determining similarity scores, ranking embeddings, projecting embeddings, utilizing loss functions, determining dot products, etc., inherently recite mathematical concepts such as those disclosed in Specification [0030-31], [0043], [0045], [0047], [00601]. Additionally, the mental processes recited in the claims (determining a similarity score, ranking each of the plurality of ECG embeddings, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, as there are no details recited in the claims which would prevent mental performance of determining a similarity score and ranking each of the plurality of ECG embeddings. When considering the recited mathematical concepts and mental processes, such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two analysis:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
20. MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Claims 1, 8, and 15 recite an additional element of populating a database; claims 2, 9, and 16 recite an additional element of displaying data; these additional elements are considered data gathering steps, which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are insufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology [see MPEP § 2106.04(d)(I)].
Additional elements of computer components and ECG monitors: Claim 8 recites additional elements of a system, an ECG monitor, and a cloud services system; claim 15 recites additional elements of a non-transitory computer readable medium and a processing device. The claims require only generic computer components and ECG monitors, which do not improve computer technology or ECG technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: Claims 1-20 have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: 1. an improvement, 2. a treatment, 3. a particular machine, or 4. a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of populating a database (claims 1, 8, 15), and displaying data (claims 2, 9, 16), do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network and storing and retrieving information in memory [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity, and as such, do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept.
Additional elements of computer components and ECG monitors: The additional elements of a system, an ECG monitor, and a cloud services system of claim 8, and non-transitory computer readable medium and a processing device of claim 15, do not cause the claims to rise to the level of significantly more than the judicial exception; these are conventional computer components and ECG monitors, which are claimed at a high level of generality and do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept.
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 8 and 15, which are interpreted to recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited cloud services system, ECG monitor, non-transitory computer readable medium, and processing device are used in training and using the ML models, generating query embeddings, determining similarity scores, gathering data, etc.; as such, these components act only as tools to perform the steps of data analysis or gather data, and do not integrate the exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The cloud services system, ECG monitor, non-transitory computer readable medium, and processing device of claims 8 and 15 used in gathering data and performing training, embedding, determining similarity scores, etc., do not impose meaningful limitations on the claims.
• The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, 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)). The populating of data, and displaying data, of claims 1, 2, 8, 9, 15, and 16 is recited in a generic manner.
All limitations of claims 1-20 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step 2B: NO.)
Therefore, summarizing the entire 101 analysis, claims 1-20, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Response to Applicant Arguments - 35 USC § 101
The Applicant's arguments filed 11/26/2025 have been fully considered but they are not yet persuasive.
Regarding Step 2A Prong One arguments:
The Applicant asserts (p.10-11):
• "...claim 1 does not recite a mathematical concept." (p.10, ¶ 2).
• "Similarly to the claim at issue in example 39 of the examples accompanying the 2019 Guidelines, claim 1 does not recite any abstract ideas...At most, claim 1 recites features that are based on or involve a mathematical concept." (p.11, ¶ 2).
• "...none of the...features of claim 1 correspond to a mental process." (p.11, ¶ 3).
The arguments are not persuasive because the claims recite mental processes and mathematical concepts. Considering the broadest reasonable interpretation (BRI) of the claims, the limitations of training ML models, generating embeddings, determining similarity scores, ranking embeddings, projecting embeddings, utilizing loss functions, determining dot products, etc., inherently recite mathematical concepts such as those disclosed in Specification [0030-31], [0043], [0045], [0047], [00601]. The mental processes recited in the claims (determining a similarity score, ranking each of the plurality of ECG embeddings, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, as there are no details recited in the claims which would prevent mental performance of determining a similarity score and ranking each of the plurality of ECG embeddings. Additionally, the fact pattern differs between Example 39 (method for training a neural network for facial detection) and the instant application (determining similarity scores between query embeddings generated by a ML model, and ECG embeddings, and ranking the ECG embeddings), and further because the judicial exceptions identified at Eligibility Step 2A: Prong One are not integrated into a practical application at Eligibility Step 2A: Prong Two. Still further, the claims do not recite additional elements that amount to significantly more than the judicial exceptions at Eligibility Step 2B when those additional elements are evaluated individually and in combination to determine whether they contribute an inventive concept.
Regarding Step 2A Prong Two arguments:
The Applicant asserts (p.11-12):
• "...claim 1 as a whole would integrate any recited judicial exception into a practical application of the exception..." (bridging p.11-12).
• "Claim 1 includes features directed to systems and methods for performing an ECG search based on a dual ECG and text embedding model...Thus, the features of claim 1 improve the technical field of ECG interpretation...Therefore, independent claim 1 is subject matter eligible." (p.12, ¶¶ 2-3).
The arguments are not yet persuasive because regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. Regarding showing an improvement to technology, a detailed explanation of a technical improvement may help to overcome a 101 rejection, (see MPEP 2106.04(d) and (d)(1), as well as MPEP 2106.05(a)). The explanation might include a concise statement of the improvement, including improvement over the previous state of the technology field; identification of the technology field; explanation of how the claims deliver the improvement and that reasonably all embodiments within the claim scope also will result in the asserted improvement, and extension of the explanation to persuasively demonstrate the nexus of integration of the judicial exceptions into a practical application. As further examples, argument may clearly and adequately explain cause and effect leading to improvement or, for example when such cause and effect explanation is not possible, then may include evidence (e.g. experimental data) comparing a claimed result to conventional results. Also, arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim. In the present invention, the nexus between the JEs and the improvement is vague, and the 11/26/2025 arguments do not persuasively explain the improvement.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686