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 Interpretation
Examiner Note: for the purpose of advancing prosecution, citations are made for the function of device claims 1-7. However, the device of claims 1-7 does not comprise any processor, controller, or other computerized device that would claim the functional limitations as programmatic structure of the claimed device. Therefore, the functional limitations in claims 1-7 are considered an intended use, and not required. Applicant may consider amending the device claims to incorporate a processor, controller, or other type of computerized device (in accordance with the disclosure in order to avoid new matter) in order to explicitly require the claimed function.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: input unit in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Upon review of the originally filed disclosure, the only description of the structural elements comprising an input unit appear to be found in Fig. 2, which does not appear to disclose sufficient structure for performing the function of receiving an input of a single-lead ECG.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim limitation “input unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The only corresponding disclosure of any structural elements comprising the input unit appears to be found in Fig. 2. Fig. 2 is only a block diagram of a functional relationship between algorithmic structures and does not appear to comprise any specific structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “input unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The only corresponding disclosure of any structural elements comprising the input unit appears to be found in Fig. 2. Fig. 2 is only a block diagram of a functional relationship between algorithmic structures and does not appear to comprise any specific structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see this section of the MPEP for additional information.
Step 1 of the analysis is the question: “Is the claim to a process, machine, manufacture, or composition of matter?” and the answer is determined to be yes, as the claims as a whole are directed to a device, and/or method.
For Step 2, the preliminary question is whether the eligibility of the claim is self- evident. The answer is determined to be no, as the claim is not immediately self-evident as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., 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, 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.”
Using claim 1 as a representative claim, the claim recites the following limitations:
Generating an ECG reconstruction model based on a generative adversarial network
Generator configured to reconstruct a 12-lead ECG based on the single-lead ECG
Discriminator configured to use as an input value either a first input value that is a sum of the 12-lead ECG and the single-lead ECG or a second input value that is a sum of a ground-truth 12-lead ECG and the single-lead ECG and determine whether the input value is the reconstructed 12-lead ECG or the ground-truth 12-lead ECG.
This claim language is identified as an abstract idea, because in MPEP § 2106.04(a)(2) I B. this language is similar to concepts relating to mathematical relationships, mathematical formulas or equations, and mathematical calculations. For example, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first and second data by taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form. The court explained that such claims were directed to an abstract idea because they described a process of organizing information through mathematical correlations, like Flook's method of calculating using a mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721.
In the instant case, Applicant directs limitations to both an explicit recitation of an algorithm (GAN, e.g.) and a description of the structure of said algorithm (generator and discriminator). Therefore, the claims are both explicitly reciting and directed to these mathematical relationships/concepts. Similar to Digitech, the instant claims take existing information in the form of the single-lead ECG data, manipulate the data using mathematical functions (the generator, the discriminator, amounting to the GAN), and organizing this information into a new form, in the form of a machine learning model. Therefore, the claims are directed to an abstract idea because they described a process of organizing information through mathematical correlations.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the Claim Recite Additional Elements That Integrate the Judicial Exception Into a Practical Application?
First, the additional elements are identified:
Claim 1: input unit for receiving single-lead ECG data.
Claim 8, 10: receiving an input, the input is a single-lead ECG
In the case of the input unit, and receiving input as a single-lead ECG, the obtaining of data is considered insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be subsequently used, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g))
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claim 1: input unit for receiving single-lead ECG data.
Claim 8, 10: receiving an input, the input is a single-lead ECG
In the case of the input unit, and receiving input as a single-lead ECG, the obtaining of data is considered insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be subsequently used, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g))
The remaining dependent claims are directed to further specifying the desired algorithm by either explicitly naming or describing mathematical relationships and/or concepts but do not comprise any additional elements or do more than generally link the abstract idea to a technical field.
Claim Rejections - 35 USC § 103
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) 1, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (Korean Patent Publication No. KR102469984B1, machine translation included, citations are to machine translation); in view of Kwon et al. (Korean Patent Publication No. KR20220098600A, machine translation included, citations are to machine translation).
Regarding claim 1, Sun teaches a device for generating an electrocardiogram (ECG) reconstruction model, generating an ECG reconstruction model based on a generative adversarial network (GAN) (¶[0001]), comprising:
an input unit configured to receive an input of a single-lead ECG (¶[0039], ¶[0051] p. 58);
a generator (¶[0028]) configured to reconstruct a 6-lead ECG based on the single-lead ECG (¶[0009]); and
a discriminator configured to use as an input value either a first input value that is a sum of the 6-lead ECG and the single-lead ECG or a second input value that is a sum of a ground-truth 6-lead ECG and the single-lead ECG and determine whether the input value is the reconstructed 6-lead ECG or the ground-truth 6-lead ECG (¶[0028]).
Sun does not teach reconstructing a full 12-lead ECG.
Attention is drawn to the Kwon reference, which teaches reconstructing a full 12-lead ECG (¶[0042]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the reconstruction of Sun to include a full 12-lead reconstruction, as taught by Kwon, to match the diagnostic capability of clinical ECG monitoring (¶[0006-0010]).
Regarding claims 8 and 14, the claims are directed to method comprising substantially the same subject matter as claim 1 and are rejected under substantially the same sections of Sun and Kwon.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun and Kwon as applied to claims 1, 8, and 14 above, and further in view of Sarkar et al. (U.S. Patent Application Publication No. 2023/0363655) hereinafter referred to as Sarkar; and Kamath et al. (Kamath, A., Willmann, J., Andratschke, N., Reyes, M. (2023). Do We Really Need that Skip-Connection? Understanding Its Interplay with Task Complexity. In: Greenspan, H., et al. Medical Image Computing and Computer Assisted Intervention – MICCAI 2023. MICCAI 2023. Lecture Notes in Computer Science, vol 14223. Springer, Cham.) hereinafter referred to as Kamath.
Regarding claim 2, Sun as modified teaches the device of claim 1.
Sun as modified does not teach wherein the generator comprises:
a label generator configured to receive the single-lead ECG as input and output a second latent vector for outputting a single-lead ECG identical to the single-lead ECG based on a U-Net-based encoder-decoder generation model without applying skip connections; and
an inference generator configured to perform preprocessing on the single-lead ECG based on a U-Net-based encoder-decoder generation model and reconstruct and output the 12-lead ECG based on a first latent vector and the second latent vector of the preprocessed single-lead ECG.
Attention is brought to the Kwon reference, which teaches a label generator configured to receive the single-lead ECG as input and output a second latent vector for outputting a single-lead ECG identical to the single-lead ECG based on a convolutional neural network without applying skip connections (¶[0049], ¶[0051]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the reconstruction model of Sun as modified to include a label generator, as taught by Kwon, to derive and provide diagnostic interpretation (Kwon ¶[0049]).
Sun as modified does not teach the label generator is a U-Net-based encoder-decoder generation model without skip connections, or an inference generator configured to perform preprocessing on the single-lead ECG based on a U-Net-based encoder-decoder generation model and reconstruct and output the 12-lead ECG based on a first latent vector and the second latent vector of the preprocessed single-lead ECG.
Attention is brought to the Kamath reference, which teaches U-net models without skip connections (Fig. 1, NoSkipU-Net).
It would have been obvious to one of ordinary skill in the art to modify the convolutional neural network of Sun as modified by Kwon to include a U-net model without skip connection, as taught by Kamath, because severing skip connections may lead to more robust models including robustness across variations (p. 304)
Attention is brought to the Sarkar reference, which teaches an inference generator configured to perform preprocessing on the single-lead ECG based on a U-Net-based encoder-decoder generation model and reconstruct and output the 12-lead ECG based on a first latent vector and the second latent vector of the preprocessed single-lead ECG (¶[0052]).
It would have been obvious to modify the reconstruction model of Sun as modified to include a U-net based generation model for preprocessing the ECG, as taught by Sarkar, because the U-net based model of Sarkar shows a benefit of improved performance (Sarkar ¶[0074]).
Regarding claim 3, Sun as modified teaches the device of claim 2.
Sarkar further teaches wherein the inference generator performs learning based on an adversarial loss function for the first input value and the second input value (¶[0053-0054]).
Claim(s) 4-7 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun, Kwon, Kamath, and Sarkar as applied to claims 3 above, and further in view of Edelberg et al. (U.S. Patent Application Publication No. 2025/0143622) hereinafter referred to as Edelberg.
Regarding claim 4, Sun as modified teaches the device of claim 3.
Sun as modified teaches performing learning based on a loss function that reflects a distance between the 12-lead ECG and the ground-truth 12-lead ECG (see above).
Sarkar further teaches a Frechet Distance (¶[0070]).
Sun as modified does not teach wherein the L1 loss function reflects the Manhattan Distance.
Attention is drawn to the Edelberg reference, which teaches LASSO regression (¶[0079], based on Manhattan distance calculation) for a GAN (¶[0075]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the loss function of Sun as modified to include LASSO, as Edelberg teaches improved training, predictive capacity, and accuracy (Edelberg ¶[0077], ¶[0079]).
Regarding claim 5, Sun as modified teaches the device of claim 4.
Sarkar further teaches wherein the inference generator performs learning based on a latent vector loss function for the first latent vector and the second latent vector (¶[0070]).
Regarding claim 6, Sun as modified teaches the device of claim 5.
Sarkar further teaches wherein the inference generator performs learning based on a total loss function that gives respective weights to the adversarial loss function, the L1 loss function, and the latent vector loss function (¶[0049], ¶[0051], ¶[0056]).
Regarding claim 7, Sun as modified teaches the device of claim 1.
Sarkar further teaches wherein the discriminator is a 1 D U-Net-based encoder-decoder generation model (¶[0052]).
Regarding claims 9-13, the claims are directed to methods comprising substantially the same subject matter as claims 2-7 and are rejected under substantially the same sections of Sun, Kwon, Kamath, Sarkar, and Edelberg.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chinese Patent Publication No. CN110353665B to Wang et al. teaches a 1 dimensional U-net model for ECG
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
