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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/16/26 has been entered.
Status of Claims
Claims 1-20 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 3/16/26 have been fully considered but they are not persuasive.
Applicant asserts that amended claim 1 is not abstract based on the limitation “an output device for outputting electrophysical data regarding the first cardiac structure and an indication that the first cardiac structure is the cardiac structure of interest based on the determination that the first cardiac structure is the cardiac structure of interest.” However, the output device is recited at a high-level of generality and amounts to nothing more than a part of a generic computer. In addition, the outputting step amounts to post-solution activity.
Applicant asserts that the current invention makes it “possible to accurately detect cardiac structures” while preventing false positive identifications. (Present Application, ¶5-6, ¶51). However, the alleged improvement is directed to the abstract idea. An improvement to the abstract idea is still an abstract idea. MPEP 2106.05(a) states:
It is important to note, the judicial exception alone cannot provide the improvement.
Applicant cites to SRI Int’l, Inc. v. Cisco Sys., 918 F.3d 1368 (Fed. Cir. 2019). In SRI Int’l, Inc., the court found that “the representative claim improves the technical functioning of the computer and computer networks by reciting a specific technique for improving computer network security.” Id. at 1376. Applicant further asserts that like in SRI Int’l, Inc., the present specification that the claimed invention is directed to solving identified weaknesses of identifying cardiac structures of interest in a cardiac mapping environment. However, the Examiner disagrees. In SRI Int’l, Inc., the court found that the human mind is not equipped to detect suspicious activity by using network monitors and analyzing network packets as recited by the claims. Id. Whereas in the present application, the claim does not specify the size of the data. Under the broadest reasonable standard, a medical professional can perform a threshold comparison with the distance data and analyze print outs of electrophysiological data and distance/scalar data to make a determination if the cardiac structure is the cardiac structure of interest. The claims in the present application are not directed to improving the function of the computer in the field of computer technology.
Claim Objections
Claims 1, 8, and 15 are objected to because of the following informalities: “electrophysical” see claim 1, line 13 for example, should recite –electrophysiological—to match the specification. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the dash in line 5 should be removed. Appropriate correction is required.
Claim Interpretation
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:
output device 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.
For an output device in claim 1, the specification discloses “the output devices 310 include, without limitation, a display, a speaker, a printer, a haptic feedback device, one or more lights, an antenna, or a network connection (e.g., a wireless local area network card for transmission and/or reception of wireless IEEE 802 signals)” (¶82). Therefore, the Examiner is interpreting an output device to be a display, a speaker, a printer, a haptic feedback device, one or more lights, an antenna, or a network connection (e.g., a wireless local area network card for transmission and/or reception of wireless IEEE 802 signals), or equivalents thereof.
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 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 and 15-20 are 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.
In claim 1, the limitation of “receives distance data regarding a distance between a pair of the plurality of electrodes; operates on the received signal from the plurality of electrodes…” in lines 7-8 seems unclear. It remains unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. See MPEP 2173.05(h). Applicant is encouraged to change the limitation of “receives distance data regarding a distance between a pair of the plurality of electrodes; operates on the received signal from the plurality of electrodes…” to recite --receives distance data regarding a distance between a pair of the plurality of electrodes; and operates on the received signal from the plurality of electrodes…--. Dependent claims 2-7 are rejected for the same deficiency in independent claim 1.
In claim 15, the limitation of “applies a weight and a bias to the plurality of scalar values based on the distance being less than a threshold, applies an activation function to the weighted and biased distance to produce a second neural network output” in line 8-10 seems unclear. It remains unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. See MPEP 2173.05(h). Applicant is encouraged to change the limitation of “applies a weight and a bias to the plurality of scalar values based on the distance being less than a threshold, applies an activation function to the weighted and biased distance to produce a second neural network output” to recite --applies a weight and a bias to the plurality of scalar values based on the distance being less than a threshold, and applies an activation function to the weighted and biased distance to produce a second neural network output--. Dependent claims 16-20 are rejected for the same deficiency in independent claim 15.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 and 15-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1 and 15 include the limitation of “a plurality of electrodes positioned within a heart.” See claim 1, line 3 for example. As such, the limitation requires that a plurality of electrodes would encompass being in contact with a patient (human organism) under the broadest reasonable interpretation. Applicant should be recommended to change the claimed limitation to –a plurality of electrodes configured to be positioned within a heart-- in order to overcome this 101 rejection. Dependent claims 2-7 and 16-20 are rejected for the same deficiency in independent claims 1 and 15.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a system and method for automatically detecting a cardiac structure.
Step 2A, Prong One
Regarding claims 1, 8, and 15, the recited steps are directed to mathematical concepts and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
Regarding claims 1, 8, and 15, the limitations of “determine outputs by applying a weight and a bias to the distance and an activation function to the weighted and biased distance/applies a weight and a bias to the plurality of scalar values, applies an activation function to the weighted and biased distance; and multiply the determined outputs by the output of the activation function/combining the first neural network output and the second neural network output” are mathematical calculations of applying a mathematical function, multiplication, and summation in order to determine whether the first cardiac structure is the cardiac structure of interest.
Regarding claims 1, 8, and 15, the limitation of “the distance is determined to be less than a threshold and determine whether the first cardiac structure is the cardiac structure of interest based on the electrophysiological data and the distance data/scalar values” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional performing a threshold comparison with the distance data and analyzing print outs of electrophysiological data and distance/scalar data to make a determination if the cardiac structure is the cardiac structure of interest.
Step 2A, Prong Two
For claims 1, 8, and 15, the judicial exception is not integrated into a practical application. In particular, claims 1, 8, and 15 recite “a plurality of electrodes positioned within a heart to receive electrophysiological data regarding a first cardiac structure, a processor, and an output device for outputting electrophysical data regarding the first cardiac structure and an indication that the first cardiac structure is the cardiac structure of interest based on the determination that the first cardiac structure is the cardiac structure of interest.” The plurality of electrodes positioned within a heart to receive electrophysiological data regarding a first cardiac structure amount to nothing more than pre-solution activity of data gathering. The processor and output device are recited at a high-level of generality and amount to nothing more than parts of a generic computer. The “outputting electrophysical data regarding the first cardiac structure and an indication that the first cardiac structure is the cardiac structure of interest based on the determination that the first cardiac structure is the cardiac structure of interest” amounts to post-solution activity. Additionally, Applicant includes a neural network, a first neural network, and a second neural network which is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into 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 above with respect to integration of the abstract idea into
a practical application, the additional element of a plurality of electrodes positioned within a heart to receive electrophysiological data regarding a first cardiac structure amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the plurality of electrodes positioned within a heart to receive electrophysiological data regarding a first cardiac structure is a well-understood, routine, and conventional structure as evidenced by:
US 20150313501 (¶36-a conventional intracardial ECG signal path from a pair of ECG electrodes 10, 12 disposed on or in a cardiac catheter), US 20150133759 (¶26-a conventional method for mapping electropotentials of the heart, i.e., measuring intra-cardiac ECG signals, involves inserting a catheter with electrodes into the heart, and measuring potentials as the electrodes are moved to different locations within the heart), and (¶38-a conventional method for mapping electropotentials of the heart, i.e., measuring intracardiac ECG signals, involves inserting a catheter with electrodes into the heart, and measuring potentials as the electrodes are moved to different locations within the heart). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 2-7, 9-14, and 16-20, the limitations of claims 1, 8, and 15 further define the limitations already indicated as being directed to the abstract idea.
Claims 2, 9, and 16 further define the abstract idea.
Claims 3-4, 10-11, and 17-18 further define the data gathering.
Claims 5, 12, and 19 further define the abstract idea and data gathering. A mapping electrode amounts to pre-solution activity of data gathering and is a well-understood, routine, and conventional structure as evidenced by: US 20150272667 (¶42-mapping electrodes 40 may be provided for purpose of conventional electrophysiological mapping), US 20130253504 (¶2-a conventional method for mapping the electrical signals from conductive heart tissue is to percutaneously introduce an electrophysiology catheter (electrode catheter) having mapping electrodes mounted on its distal extremity), and US 20160008060 (¶6-in a conventional catheter as described in KR laid-open publication No. 10-2007-0027494, an ablation electrode to which high current is applied is disposed on the end of the distal portion of the catheter and a mapping electrode which performs a mapping on a lesion is disposed above the electrode to which high current is applied).
Claims 6-7, 13-14, and 20 further defines the neural network, which is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting.
Examiner’s Note
Claims 1-20 distinguish over the prior art but are still rejected under 35 USC § 101. Claims 1-7 and 15-20 are also rejected under 35 USC § 112.
The following is a statement of reasons for the indication of overcoming the prior art:
Regarding claims 1 and 8, the scope of determine whether the first cardiac structure is the cardiac structure of interest based on the electrophysiological data and the distance data and an output device for outputting electrophysical data regarding the first cardiac structure based on the determination that the first cardiac structure is the cardiac structure of interest were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. In the Remarks filed on 11/28/25, Applicant argues that Oren (WO 2020181006) does not teach the limitation of “determining whether the first cardiac structure is the cardiac structure of interest based on the electrophysiological data and the distance data,” which was found to be persuasive.
Regarding claim 15, the scope of receives a plurality of scalar values regarding at least a distance between a pair of the plurality of electrodes; determine whether the first cardiac structure is the cardiac structure of interest based on the electrophysiological data and the scalar values and outputting electrophysical data regarding the first cardiac structure were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is Oren (WO 2020181006); however it fails to recite determining whether the first cardiac structure is the cardiac structure of interest based on the electrophysiological data and the scalar values and outputting electrophysical data regarding the first cardiac structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11272887: relates to medical systems and methods for mapping an anatomical space of the body. More specifically, the disclosure relates to systems and methods for cardiac mapping (col. 1 and lines 14-17).
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/LAURA HODGE/Examiner, Art Unit 3792
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