DETAILED ACTION
The Examiner acknowledges the amendments received 27 July 2026. Claims 1-8 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
In view of the amendments received 27 July 2026, the Examiner withdraws the rejection of claims 1-8 under 35 USC 101.
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.
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: “interface” and “processor” in claim 5.
“interface” corresponds to “a processing interface unit (PIU) 24, e.g., such as that used by a CARTO™ system, produced by Biosense-Webster.” as in par. 0018 of the Published Application
“processor” corresponds to “a general-purpose computer with a suitable front end and interface circuits 38” or “an algorithm” as in par. 0022 of the Published Application
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.
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.
Response to Arguments
Applicant's arguments filed 27 July 2026 have been fully considered but they are not persuasive. The Applicant argues (page 5, “Remarks”):
The written description inquiry asks whether the specification demonstrates that the inventor possessed the claimed subject matter at the time of filing. Here, the specification directly describes location algorithms as a known class of tools existing in the art for estimating the source location of an arrhythmia based on non-invasive ECG data. The specification's reference to academic publications describing such algorithms serves to establish that location algorithms were well- known in the art, not to incorporate the specific details of those algorithms as essential material. The "location algorithm" is a known, conventional tool used within the claimed method rather than the point of novelty of the claims.
The Examiner respectfully disagrees, and notes that though the Applicant alleges that the articles establish the location algorithm as well-known and routine in the art, there is no evidence provided that this is the case. The Specification, the references relied upon, and the claims themselves, taken as evidence as a whole, do not provide concrete functional language as to what is meant by the phrase “location algorithm”, and as such without such evidence, the Examiner broadly interprets this phrase as a general software algorithm.
Applicant’s arguments, see “Remarks”, filed 27 July 2026, with respect to the rejection(s) of claim(s) 1-8 under Min have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Haeusser.
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 1-8 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.
MPEP 2161.01(I) states the following:
Similarly, 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.
Independent claims 1 and 5 recites computer-implemented limitation of “location algorithm” and the specification discloses the following for the limitation of “location algorithm”:
[0004] Some academic publications provide location algorithms for estimating the source location of an arrhythmia based on non-invasive ECG data, such as 12-lead ECG or Holter. For example, Muzakkir Amir et. al. describe “Park Algorithm as Predictor of in a paper titled, Premature Ventricular Contraction Origin in Three-Dimensional Mapping Electrophysiological Studies,” published in the International Journal of General Medicine Vol. 13, pp. 1083-1092 (2020), the validation of the Park algorithm accuracy in the prediction of the location of origin of PVC using a 12-lead ECG both in the case of PVC with and/or without structural heart disease. The researchers found the Park algorithm suitable to be used for determining the location of PVC origin in the right or left heart.
[0005] Park et. al. describe their location algorithm in a paper titled, “Using the surface electrocardiogram to localize the origin of idiopathic ventricular tachycardia,” which appeared in the journal Pacing Clinical Electrophysiology Vol. 35, Iss. 12, pp. 1516-1527 (2012).
It is noted that Muzakkir Amir et. al. and Park et al. references, which are both non-patent literature (NPL) references, are relied on for the support for the claimed limitation of ““location algorithm.” It is further noted that neither one of these NPL references are incorporated by reference. 37 CFR 1.57(d) requires that "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. As such, as-filed specification does not provide written description support for the claimed limitation of “location algorithm” in independent claims 1 and 5 and all dependent claims thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haeusser et al (U.S. 2022/0248956). Haeusser discloses acquiring a plurality of electrocardiogram (ECG) traces using a non-invasive ECG recorder (par. 0090-0091 and 0104); identifying, by a processor, a set of electrocardiograms (ECGs, from the plurality of ECG traces that belong to a given morphologic template indicative of a given type of arrhythmia (par. 0167-0168); using a location algorithm, calculating, by the processor, a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia (par. 0377); comparing, by the processor, the calculated percentage to a predefined threshold percentage; and if the percentage of ECGs is found to exceed the threshold percentage, reporting the source location to a user by rendering, by the processor, a highlighted region corresponding to the source location within a three-dimensional anatomical model of a heart on a display device (par. 0307).
Regarding claim 2, Haeusser discloses (par. 0090) the morphologic template is indicative of a Premature Ventricular Contraction (PVC) type of arrhythmia.
Regarding claim 3, Haeusser discloses (par. 0090) reporting an anatomical region within the heart, the anatomical region comprising a ventricular tissue source location.
Regarding claim 4, Haeusser discloses (par. 0027) the set of ECGs was acquired using non-invasive ECG Recorder comprises a 12-lead ECG recorder.
Regarding claim 5, Haeusser discloses (par. 0090-0091 and 0104) a non-invasive ECG recorder configured to acquire a plurality of ECG traces; an interface (par. 0094) configured to receive the plurality of ECG traces from the non-invasive ECG recorder; a display device (par. 0307); and processor (par. 0026), which is configured to: identify a set of electrocardiograms (ECG) from the plurality of ECG traces that belong to a given morphologic template indicative of a given type of arrhythmia (par. 0167-0168); a location algorithm, calculate a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia (par. 0377); the calculated percentage to a predefined threshold percentage; and if the percentage of ECGs is found to exceed the threshold percentage, report the source location to a user by rendering a highlighted region corresponding to the source location within a three- dimensional anatomical model of a heart on the display device.
Regarding claim 6, Haeusser discloses (par. 0090) the morphologic template is indicative of a Premature Ventricular Contraction (PVC) type of arrhythmia.
Regarding claim 7, Haeusser discloses (par. 0090) the processor is configured to report the source location by reporting an anatomical region within the hearts the anatomical region comprising a ventricular tissue source location.
Regarding claim 8, Haeusser discloses (par. 0027) the set of ECGs was acquired using non-invasive ECG recorder comprises a 12-lead ECG recorder.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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