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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
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 1-14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In Claim 1, the newly added phrase , “…performing ablation in the cardiac chamber based on the EA map, including the remapped one or more regions” in combination with the other steps and elements of the claims, fails to be supported by the disclosure as originally filed. The disclosure discloses the system has the option for a catheter both independent and integrated into the EA mapping catheter, that can be used for ablation, and further that ablation may be applied; however, the step of performing ablation “based on the EA map, including the remapped one or more regions” does not appear to be supported by the disclosure as originally filed. In addition, the disclosure does not seem to indicate that the processor is configured to perform the ablation process – rather it would appear that any ablation performed is done manually by a practitioner. In order to overcome the rejection, it is recommended applicant amend the claims to fall within the scope of the disclosure as originally filed, or specify where support lies for these claim amendments.
Claim 8 shares similar amended language and is rejected for the same rationale.
Claims 2-7 and 9-14 are rejected under the same rationale as being dependent upon claims 1 and 8 and their limitations.
Claim Rejections - 35 USC § 102
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harlev et al. (US 2012/0184863; hereinafter “Harlev”).
Regarding claim 1, Harlev teaches a method, comprising: receiving an electroanatomical (EA) map of at least a portion of a cardiac chamber (e.g. ¶¶ 4); scoring a quality of an EA analysis of the EA map, the scoring indicative of a reliability of the EA analysis (e.g. ¶¶ 313); based on the scoring, identifying one or more regions in the mapped portion as failing to meet a defined reliability criterion, indicating the one or more regions on the EA map to be displayed to a user, based on the indication, remapping the one or more regions to improve the EA analysis of the one or more regions (e.g. ¶¶ 359-365); and performing ablation in the cardiac chamber based on the EA map, including the remapped one or more regions (e.g. Claim 14).
Regarding claim 8, Harlev discloses a system, comprising: an interface configured to receive an electroanatomical (EA) map of at least a portion of a cardiac chamber (e.g. ¶¶ 4); and a processor (e.g. ¶¶ 49), which is configured to: score a quality of an EA analysis of the EA map, the scoring indicative of a reliability of the EA analysis (e.g. ¶¶ 313); based on the scoring, identify one or more regions in the mapped portion as failing to meet a defined reliability criterion, indicate the one or more regions on the EA map to be displayed to a user, based on the indication, remap the one or more regions to improve the EA analysis of the one or more regions (e.g. ¶¶ 359-365); and signal ablation in the cardiac chamber based on the EA map, including the remapped one or more regions (e.g. Claim 14).
Regarding claims 2 & 9, Harlev discloses the EA analysis is performed by at least one algorithm selected from a list of algorithms consisting of (i) Local Conduction Vectors (LCV), (ii) Coherent EA (CEA) propagation, (iii) Touch Indication Index (TPI), (iv) Late Activation times (LAT), and (v) Fractionation Score (e.g. ¶¶ 378, 412, etc.).
Regarding claims 3 & 10, Harlev discloses scoring the quality comprises calculating a weighted sum of scores of qualities of outputs from two or more algorithms from the list (e.g. ¶¶ 345-349).
Regarding claims 4 & 11, Harlev discloses indicating the one or more regions on the EA map comprises overlaying the EA map with a layer of transparency according to the scoring (e.g. ¶¶ 314 – overlaid on top of each other).
Regarding claims 5 & 12, Harlev discloses indicating the one or more regions on the EA map comprises overlaying the EA map with a layer of graphical symbols that vary in format according to the scoring (e.g. ¶¶ 456).
Regarding claims 6 & 13, Harlev discloses indicating the one or more regions on the EA map comprises (i) filtering outlier points based on the scoring, (ii) projecting the scoring onto a surface of the map, and (iii) applying Laplacian interpolation to the scoring (e.g. ¶¶ 405-408).
Regarding claims 7 &14, Harlev discloses displaying the EA map, including the identified one or more regions, to a user (e.g. ¶¶ 39, 243, etc.).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Altman et al. (US 2012/0327053).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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