DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/27/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 10/27/2025. As directed by the amendment: Claims 1, 9, 13, 16, and 21-22 have been amended, claim 23 has been cancelled, and claim 24 has been added. Thus, claims 1, 3-22, and 24 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 15-16 and 17, filed 10/27/2025, regarding the priority, have been fully considered but they are not persuasive.
Applicant argues on page 15 that “Paragraph [0027] of the '083 provisional application discloses identifying low- resolution impacts from electrode contributions in a sensing zone, stating: "by knowing the sensing zone for a selected R[OI], systems and methods disclosed wherein can readily determine if a bad channel exists outside of the sensing zone it will have little if any impact on ECM results. Thus, there may be no need to correct for such a bad channel. In contrast, if a bad channel or electrode is determined to exist within a sensing zone, an appropriate warning can be generated to prompt the user to take corrective action." This describes an area on the heart (e.g., low- resolution region) where contributions from electrodes in the sensing zone "fail to satisfy" usability criteria (e.g., due to bad channels impacting accuracy), with an indication (warning) and corrective action (adjustment).” Applicant also argues on page 17 that “Specifically, Il [0053] and FIG. 7 describe "erroneous reconstruction" in map 236 due to bad channels (electrodes) within the sensing zone, indicating a heart ROI with reduced mapping accuracy (i.e., low-resolution region). Similarly, I [0054] and FIG. 8 illustrate map 242 affected by "sixteen bad nodes" in the sensing zone, showing compromised accuracy. The transfer matrix A⁻¹ in I [0024] identifies electrodes with the "greatest contribution" to heart nodes, inherently establishing thresholds (e.g., coefficient values) for adequate VS. inadequate contributions. Statistical comparisons in IL [0049] quantify "significant differences" in maps when sensing zone electrodes are excluded, supporting failure thresholds.”
Examiner disagrees because the use of a criteria which is not specified. The bad channels may be compared to one another and not based on a criterion. The “significant differences”, may be between channels and not enough to prove that there is a threshold disclosed. Furthermore, ‘083 fails to mention the bad channels to be considered low-resolution.
Applicant then argues on pages 15-16 that “Paragraphs [0053]-[0057] and FIGS. 8-18 of the '083 provisional application provide enabling simulations and examples of identifying low-resolution regions based on electrode contributions, including graphical maps showing "the impact of having sixteen bad channels residing within the sensing zone" (I [0054]; FIG. 8) and comparisons where "removing electrodes from inside or outside of the sensing zone" results in distinct differences in resolution/accuracy (91 [0056]; FIGS. 9-18). These depict "threshold criteria" implicitly through visual/statistical evaluations of contribution impacts (e.g., "distinct difference" in maps when contributions fail). Thus, a PHOSITA would recognize that these disclosures, for example, evaluating electrode contributions via matrix coefficients (I [0030]; "relative contribution to identify the sensing zone via a corresponding transfer matrix A⁻¹"), generating warnings/corrective actions for failed contributions (I [0027]), and iterative map recomputation (FIG. 4), collectively describe identifying low-resolution regions where sensing zone electrode contributions fail threshold criteria (e.g., accuracy impacts from bad channels), providing indications, adjusting electrodes, and recomputing. This is not new matter, but rather is present in the '083 provisional application zone-based ECM with bad-channel analysis.”
Examiner disagrees because threshold criterions cannot be through a visual evaluation, and furthermore, there is no statistical evaluation. This threshold must surpass a level, which is not taught in ‘083. Therefore, the priority is maintained.
Applicant’s arguments, see pages 16-17 and 19, filed 10/27/2025, with respect to Double Patenting have been fully considered and are not persuasive. Since the applicant has failed to respond to the rejection of record, it appears that applicant acquiesces to the rejection of record. The rejection of the claims has been maintained.
Applicant’s arguments, see page 18, filed 10/27/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The amendments fail to clarify the rejection. It is unclear if the “electrodes” are the same electrodes used in “the set of electrodes” or different. The rejection of the claims has been maintained.
Applicant's arguments, see page 18, filed 10/27/2025, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on page 18 that “amended claims 1 and 13 recite a practical application through application of CRT to a region of interest. Specifically, in amended claims 1 and 13 CRT is performed on a predetermined ROI based on a graphical map representing an estimated electrical activity for a predetermined ROI map. As such, amended claims 1 and 13 are directed to a specific medical treatment, which can be used to improve heart functionality in patients (Spec. I [0079), consequently reciting a practical application under the Alice framework.”
Examiner agrees because the claims are directed to a specific treatment because CRT is a specific subset of treatment applied to the heart, and therefore integrate the judicial exception into practical application. Examiner notes that claim 24 recites the types of stimulation treatment for the heart, including electrical stimulation therapy, a radiofrequency therapy, or a thermal therapy, which integrates the judicial exception into practical application for reciting a specific treatment to treat cardiac dyssynchrony. Therefore, the rejection of claims 1, 3-8 and 13-22 is withdrawn. Claim 24 is not rejected under 35 U.S.C. 101 for the reasons provided.
Applicant’s arguments, see pages 18-19, filed 10/27/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103(a) have been fully considered and are persuasive. The incorporation of cancelled claim 23 into all of the independent claims obviates the rejections of record. Therefore, the rejection has been withdrawn.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional App. 61/546,083, filed 10/12/2011, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The earliest disclosure of the claimed “at least one low resolution region of interest of the patient's heart corresponding to an area on the patient's heart where contribution from one or more electrodes within the identified respective sensing zone fail to satisfy threshold criteria” can be seen in US Application 13/650,678, filed 10/12/2012, and not in the US Provisional App. 61/546,083. Accordingly, the subject matter defined in claims 9-12 has an effective filing date of 10/12/2012. Should the Applicant disagree with the Examiner’s factual determination above, it is incumbent upon the Applicant to provide the serial number and specific page number(s) of any parent application filed prior to 10/12/2012, which specifically supports the particular claim limitation for each and every claim limitation in all the pending claims which applicant considers to have been in possession of and fully enabled for prior to 10/12/2012.
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.
Claim 1, 3-22, and 24 is 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 a “electrodes" in lines 27, 30 and 33 which is unclear if the electrodes are derived from the “set of electrodes” of line 7,“a group of electrodes of the set of electrodes” of lines 9-10, or if the “electrodes” are completely different electrodes from the “set of electrodes”. Examiner presumes that the “electrodes” are derived from the set of electrodes as both the “set of electrodes” and the “electrodes” are distributed on the outer body. If that is the case, Examiner suggests amending to clarify that the “electrodes” are from the set of electrodes. Dependent claims 3, 5-6, and 8 have the same problem.
Claim 9 recites the limitation a “electrodes" in lines 27, 30 and 33 which is unclear if the electrodes are derived from the “set of electrodes” of line 7, “a group of electrodes of the set of electrodes” of lines 9-10, or if the “electrodes” are completely different electrodes from the “set of electrodes”. Examiner presumes that the “electrodes” are derived from the set of electrodes as both the “set of electrodes” and the “electrodes” are distributed on the outer body. If that is the case, Examiner suggests amending to clarify that the “electrodes” are from the set of electrodes.
Claim 13 recites the limitation a “electrodes" in line 28, 31, and 34 which is unclear if the electrodes are derived from the “set of electrodes” of line 8, , “a group of electrodes of the set of electrodes” of lines 9-10, or if the “electrodes” are completely different electrodes from the “set of electrodes”. Examiner presumes that the “electrodes” are derived from the set of electrodes as both the “set of electrodes” and the “electrodes” are distributed on the outer body. If that is the case, Examiner suggests amending to clarify that the “electrodes” are from the set of electrodes.
Claim 24 recites the limitation a “electrodes" in lines 27, 30 and 33 which is unclear if the electrodes are derived from the “set of electrodes” of line 7, “a group of electrodes of the set of electrodes” of lines 9-10, or if the “electrodes” are completely different electrodes from the “set of electrodes”. Examiner presumes that the “electrodes” are derived from the set of electrodes as both the “set of electrodes” and the “electrodes” are distributed on the outer body. If that is the case, Examiner suggests amending to clarify that the “electrodes” are from the set of electrodes.
Claims 2-8, 10-12, and 14-22 are rejected due to dependency onto the independent claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer
Claims 1, 3-8, 12-14, 16, 19, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 11, 15- 16, 18-19, 24-27 of U.S. Patent No. 9,549,683. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 1 recites measuring electrical activity from electrodes positioned on a region of interest, and determining an estimate for electrical activity of the region of interest, which renders obvious instant claims 1, 13, and 24. Patented claim 7 recites a plurality of sensing zones, which renders obvious instant claims 1, 13, and 24. Patented claims 11 and 15 recites the receiving of electrical measurements of a first and second mapping from the set of electrodes and comparing the first and second mapping, which renders obvious instant claims 1, 13, and 24. Patented claim 13 recites the providing therapy to the spatial region of the heart which would be based on the heart synchrony of patented claim 10, which renders obvious instant claims 1, 13, and 24. Patented claim 2 recites computing an inverse solution to reconstruct an image based on the measured electrical signals, rendering obvious instant claims 5 and 19. Patented claims 5, 7, 16, and 18-19 are directed to generating a graphical map to represent spatially relevant information for the region of interest for an anatomical structure, wherein different electrode data is gathered from predetermined areas correlated with spatial regions of interest of the heart, so that the predetermined areas show the electrodes were previously correlated with the predetermined region of interest, wherein estimates obtained from the measured electrode data provides application-specific benefits of delivering a therapy, rendering obvious instant claim 6. Providing the electrodes carried on a patch or patch-like means is a well-known feature in the art, and it would have been obvious to one having ordinary skill in the art to modify patented claim 1 to expressly provide the electrodes on the body surface by carrying the electrodes on a patch, rendering obvious instant claim 8. Patented claims 1 and 24-27 describe identifying a low resolution region based on determining how data sensed through a channel corresponds with the low resolution region, rendering obvious instant claims 9 and 14. The combination of patented claims 1 and 24-27 in view of patented claim 28 shows determining a contribution of an electrode location according to computing coefficients of a transformation matrix according to where the electrode data was sensed from, so that this process would identify the low resolution region based on determining how data sensed through a channel corresponds with the low resolution region, as identified by the computing coefficients of a transformation matrix, rendering obvious instant claim 11. Patented claims 1, 5, 7, 16, and 18-19 are directed to generating a graphical map to represent spatially relevant information for the region of interest for an anatomical structure, wherein different electrode data is gathered from predetermined areas correlated with spatial regions of interest of the heart, so that the predetermined areas show the electrodes were previously correlated with the predetermined region of interest, wherein estimates obtained from the measured electrode data provides application-specific benefits of delivering a therapy, and wherein providing the electrodes carried on a patch or patch-like means is a well-known feature in the art, so it would have been obvious to one having ordinary skill in the art to modify patented claim 1 to expressly provide the electrodes on the body surface by carrying the electrodes on a patch, said combination of features rendering obvious instant claim 16.
Conclusion
Claims 1, 3-8, and 12-22, and 24 overcome the prior art but are still rejected under Double Patenting and 35 U.S.C. 112(b).
Claims 9-11 overcome the prior art but are still rejected under 35 U.S.C. 112(b).
The comparing the second map data for each subset with the first map data to determine a degree of similarity between electrical activity represented in the second map data and the first map data, the respective sensing zone being selected based on the subset having a highest degree of similarity and displaying the first map data and the second map data for each subset on a display device as respective graphical maps representing electrical activity, the respective sensing zone being selected in response to user input based on the displayed respective graphical maps are not conventionally relied upon and obvious in the electrocardiographic imaging and are therefore allowable over the prior art.
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.
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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.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796