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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 04/17/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 04/17/2026. As directed by the amendment: Claims 1, 3, 9, and 11 have been amended, claims 2, 4, 6-8, 10, 12-13, and 15-16 have been cancelled, and claims 17-22 have been added. Thus, claims 1, 3, 5, 9, 11, 14, and 17-22 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 9-10, regarding 35 U.S.C. 112(b) and claim objections, filed 04/17/2026, regarding claims 1-16 have been fully considered and are persuasive. The amendments obviate the rejection and objection of record. The rejections and objections have been withdrawn.
Applicant's arguments, pages 11-15, regarding 35 U.S.C. 112(a), filed 04/17/2026, regarding claims 1-16 have been fully considered but they are not persuasive. On page 12, Applicant asserts that “These amendments moot each of the PTAB's findings. The amended claims address PTAB finding (1) because the autoencoder architecture and the gradient descent step clarify the weights being adjusted, the optimization mechanism, and the purpose of the adjustments. The amended claims address PTAB finding (2) because the trained autoencoder's output is itself the noise-compensated cardiac signal. And PTAB finding (3) is addressed because the loss-function computation identifies both the comparand and the convergence criterion.”
Applicant then argues on page 12 that the amendments regarding the autoencoder “clarifies which weights are adjusted. The Specification describes the autoencoder architecture, including the encoder, the decoder, and the weights between the layers of the autoencoder, at page 23, lines 7-20 and Figure 6 [which] specify (i) which weights are adjusted (the weights of the autoencoder, between the layers of the encoder and decoder), (ii) the optimization mechanism by which they are adjusted (gradient descent), and (iii) what the weight adjustments are directed to (reducing the overall difference between the autoencoder outputs and the received first cardiac signal segments serving as the desired outputs of training).”
Examiner disagrees because the amendments remain rejected by the Board and is the “law of the case”. Because the Board upheld the rejection of record under 35 U.S.C. 112(a) to claims 1-16, “a Board decision …is thus controlling in that application and any subsequent, relate application. See MPEP § 1214.01 (where a new ground of rejection is entered by the Board pursuant to 37 CFR 41.50(b), argument without either amendment of the claims so rejected or the submission of showing of facts can result only in a final rejection of the claims, since the examiner is without authority to allow the claims unless amended or unless the rejection is overcome by a showing of facts not before the Board). As such, a submission containing arguments without either amendment of the rejected claims or the submission of a showing of facts will not be effective to remove such new grounds of rejection or any other rejection affirmed in such decision.” See MPEP 706.07(h)(XI)(A).
As noted in the Board Decision filed 02/25/2026, the PTAB noted that “the Examiner is correct in finding that the "[S]pecification describes adjusting weights within the encoder and the use of an Adam optimizer (page 25), but the instant [S]pecification fails to describe what these weight adjustments of the parameters would be changing, which specific weight parameters are being changed, and what exactly are these weights/parameters directed to." Ans. 5.” The instant specification fails to disclose the ways in amending the parameters or setting weights when the difference determination has been made. Instant specification describes adjusting weights within the encoder and the use of an Adam optimizer (page 25), but the instant specification fails to describe what these weight adjustments of the parameters would be changing, which specific weight parameters are being changed, and what exactly are these weights/parameters directed to.
Applicant then argues on page 13 that “The autoencoder is trained to map a noisy input (the noise-added cardiac signal segments) to a clean output (the received first cardiac signal segments serving as desired outputs), and the "applying" step applies that same trained autoencoder to the second cardiac signal to yield the second cardiac signal with noise-compensation.
There is no separate "noise compensation signal" that is generated, composed of any particular components, and then combined with the cardiac signal. The Examiner's questions of how the compensation is included into the cardiac signal and what the noise compensation signal is composed of therefore do not apply to the amended claims, because the architecture they recite does not separate noise compensation generation from signal output. See Decision at 9, citing Examiner's Answer at 5-6.”
Although amendments clarify where the noise compensation comes from, the claim and instant specification still fail to detail the training the model via comparing the noise-added cardiac signal and the received intracardiac signal or the ways in amending parameters and adjusting weights from the determination that a difference is not small enough, which is not defined in the instant specification. . For example, the specification does not disclose what is the “small difference” of Fig. 8 and page 25 between noise-added cardiac signal and the received intracardiac signal and how this calculation or decision is made. It is also noted that the specification does not disclose what within the signal would one skilled in the art look at to observe this small difference (e.g., is the small difference relating to peak values, SNR, zero crossings, or any other feature extraction technique). Examiner notes that the Board agrees with these finding (see page 9 of the Board Decision filed 02/25/2026).
Applicant lastly argues on pages 13-14 that the amendments “identifies the comparand directly: the autoencoder's outputs are compared to the received cardiac signal segments serving as the desired outputs, and the loss function computes the overall difference between them… suitable loss function, which computes the overall difference between all the outputs of the artificial neural network and all the desired outputs." Because the comparand is now identified in the claim as the loss-function difference between two specified signal sets, the Specification need not enumerate every possible signal feature (e.g., peak values, SNR, or zero crossings) on which a difference might otherwise be computed… Amended claim 1 also does not recite the "small difference" embodiment of Figure 8 at decision block 126. Rather, claim 1 recites that training proceeds "until the overall difference satisfies a convergence criterion," which is supported by the iterative training disclosure at page 24, lines 13-28 and Figure 8. The threshold-based check the PTAB identified is one species of convergence criterion, but amended claim 1 is not limited to that species. The written description requirement is satisfied with respect to amended claim 1 because the Specification conveys possession of the iterative training process now claimed, regardless of the particular convergence criterion used.
Selection of a particular convergence criterion or stopping value is, in any event, an engineering choice that depends on the specific application, the training data, and the desired noise- reduction performance. The written description requirement does not obligate Applicant to pre- specify every tunable hyperparameter of an iterative training process.”
Examiner disagrees. Such a limitation cannot be found in the instant specification. Therefore, the arguments are moot.
Therefore, the rejections of claims 1-16 are maintained.
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, 3, 5, 9, 11, 14, and 17-22 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.
Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Claims 1 and 9 fails to sufficiently describe the usage of the algorithm for the artificial neural network in enough detail for one skilled in the art to have sufficient written possession of the claimed invention. The independent claim recites “training an artificial neural network to at least partially compensate for electrical noise that will be added to cardiac signals in the cable responsively to the received first cardiac signal segments and the corresponding noise-added cardiac signal segments… applying the trained artificial neural network to the second cardiac signal yielding the second cardiac signal with noise-compensation”. The mere statement and recitation of the usage of Artificial Neural Networks for yielding noise-compensated cardiac signal (Pages 25-26) of the instant specification provides insufficient detail to the algorithm used in the artificial neural network to for noise decompensation. Specifically, there is insufficient disclosure of how the compensation is included into the noiseless cardiac signal, how the noise compensation is produced, and what is the noise compensation signal composed of. Further, there is insufficient disclosure in the instant specification detailing the training the model via comparing the noise-added cardiac signal and the received intracardiac signal or the ways in amending parameters and adjusting weights from the determination that a difference is not small enough, which is not defined in the instant specification. For example, regarding the training, the mere statement of comparing a difference between 150 and 152 of Fig. 7 fails to explain how the noisy signal and the normal cardiac signal are compared and what is used in the comparison to figure out the noise added. Further, how is the calculation to determine the compensation determined and how can this be added to the second cardiac signal. For example, the specification does not disclose what is the “small difference” of Fig. 8 and page 25 between noise-added cardiac signal and the received intracardiac signal and how this calculation or decision is made. It is also noted that the specification does not disclose what within the signal would one skilled in the art look at to observe this small difference (e.g., is the small difference relating to peak values, SNR, zero crossings, or any other feature extraction technique). Further, the instant specification fails to disclose the ways in amending the parameters or setting weights when the difference determination has been made. Instant specification describes adjusting weights within the encoder and the use of an Adam optimizer (page 25), but the instant specification fails to describe what these weight adjustments of the parameters would be changing, which specific weight parameters are being changed, and what exactly are these weights/parameters directed to.
The claims and instant specification recite the achieved result of an output of noise-compensation that is added onto the cardiac signal to cancel out the real noise and compensated [estimated] noise to obtain this original signal, but fails to describe how the noise compensation is added into the cardiac signal to yield the cardiac signal with noise compensation. It is also unknown what the benchmark of the convergence criterion for when the difference is satisfied, and what the threshold must be to satisfy the criterion.
Therefore, claims 1, 3, 5, 9, 11, 14, and 17-22 do not provide sufficient detail for one to replicate and understand the intended function that’s being performed.
Claims 1, 3, 5, 9, 11, 14, and 17-22 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 and 9 has been amended to include the limitation, " iteratively adjusting weights of the autoencoder using a gradient descent optimization algorithm to reduce the overall difference, until the overall difference satisfies a convergence criterion ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for “comparison is generally performed using a suitable loss function, which computes the overall difference between all the outputs of the artificial neural network 75 and all the desired outputs” (Pg. 25 lines 1-2). However, the specification does not provide support for a convergence criterion that is satisfied. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "iteratively adjusting weights of the autoencoder using a gradient descent optimization algorithm to reduce the overall difference, until the overall difference satisfies a convergence criterion”. Therefore, the new claim limitations introduce new matter.
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, 3, 5, 9, 11, 14, and 17-22 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 1 recites the limitation "the overall difference" in page 2 line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the overall difference " in page 5 line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 3, 5, 11, 14, and 17-22 are rejected for being dependent to the independent claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights