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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-14) in the reply filed on February 5, 2026 is acknowledged.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,011,280 in view of (Blauer: Pub. No. 2017/0296084). Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are, except as indicated below, merely broader in scope than the patented claims. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
While the invention of ‘280 does not include the details of the catheter, the application of Blauer mirrors that presented below in the rejection of claims under §103 with regards to the use of the claimed catheter. The Blauer catheter is advantageous in that it allows mapping with standard basket catheter electrodes, while including a reference electrode configured to be immersed in blood, so as to allow the detection of injury currents typically induced in the mapping process. Those of ordinary skill would have therefore found it obvious to use the catheter of Blauer in the system of the ‘280 invention.
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.
Claims 7 and 11 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).
In claims 7 and 11, stating that the reference electrode is immersed in blood and the sensing electrode is in contact with tissue, is impermissible. Reference to the body must be made only in a functional sense (e.g., “electrode is adapted to be” or “electrode is configured for”).
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) the mentally performable feat of comparing one or more signals to a predefined threshold to detect the presence of an injury current.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a); there is no application or use of
a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b); there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the technological environment of intracardiac mapping using a basket catheter, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the catheter with an elongated shaft, an expandable assembly comprising a plurality of splines, a sensing electrode coupled to at least one spline, and a reference electrode, function in their usual capacity to collect intracardiac signals. The electrode catheter represents necessary data gathering activity that would be required in any system attempting to perform the abstract idea, and is thus insignificant. As disclosed, while the claimed invention specifically uses a basket catheter for cardiac mapping, other distal end assemblies may be used (par. 0042). The one or more processors are also generic and function merely as a tool upon which the abstract idea is performed. The combination of the one or more processors with the electrode catheter function in their usual manner of collecting data and processing data.
The recited electrode catheter, the one or more processors and the combination of the electrode catheter and the one or more processors is also WURC in the art. The applicant indicates that a variety of commercially available intracardiac electrode arrangements may be used (par. 0042) and that a general-purpose computer may be used to process the signals (par. 0036). The combination of a basket catheter and one or more processors is further WURC in the art of cardiac mapping, as they are the basic building blocks of any conventional computerized mapping system.
Regarding claim 8, the use of the recited first and second signals using a sensing and surface electrode, and a reference electrode and a surface electrode, respectively, is not considered WURC in the art. Such a feature enables one to obtain a unipolar signal where none of the electrodes are in contact with cardiac tissue, so as to identify injury currents caused by the sensing electrode being in contact with cardiac tissue.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blauer et al. (Blauer: Pub. No. 2017/0296084) in view of Deno et al. (Pub. No. 2016/0331471) and Govari et al. (Govari: Pub. No. 2020/0037924).
Regarding claim 1, Blauer discloses a system comprising: a catheter 10 comprising: an elongated shaft 14 extending along a longitudinal axis; an expandable assembly 40 disposed at a distal end of the elongated shaft and comprising a plurality of spines (see Fig. 1); a sensing electrode 44 coupled to at least one spine of the plurality of spines; and a reference electrode 48; and one or more processors (computational element of processing unit 34) configured to receive one or more signals from the sensing electrode and the reference electrode, for determining contact of the sensing electrode(s) with tissue (par. 0025).
Blauer does not explicitly state that the system compares the one or more signals to a predefined threshold to detect a presence of an injury current. The applicant states that an injury current is a well-known artifact and is typically caused during an EP signal acquisition procedure by the acquiring electrode pushing on cardiac cells (par. 0026).
Deno, in a related system, specifically teaches that unipolar EGMs such as disclosed by Blauer may be used to detect injury currents (par. 0093). Injury currents are those artifacts wherein the EGM shows a prominent positive deflection persisting for 60-80 or more milliseconds. Clearly it would have been obvious to one of ordinary skill in the art, given the known characteristics of injury currents, to have configured a processor to compare the received unipolar signals to a predefined threshold indicative of an injury current, so as to limit the effects of noise on the system. Govari, for example, discloses that such unipolar signals may be compared to a predefined threshold by the processor/ASIC (par. 0054).
Regarding claim 2, Deno (and Govari) teaches that unipolar signals can be used in the determination of injury currents (par. 0093). Unipolar signals are independent of catheter orientation and allow for consistent measurement of EGM amplitudes and morphologies (par. 0037). To use unipolar signals would have therefore been considered obvious to those of ordinary skill in the art.
Regarding claim 3, considering that Deno teaches that injury currents show up as prominent positive deflections and that Govari teaches that predefined thresholds may be used, comparison of peak signal levels (i.e., prominent deflections) to a predefined threshold would have been considered obvious to those of ordinary skill in the art.
The limitations of claims 5-7 are clearly shown by Blauer.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blauer, Deno and Govari as applied to claims 1-3 and 5-7 above, and further in view of Harlev et al. (Harlev. Pub. No. 2012/0184864).
Regarding claim 4, common sense dictates that any detected noise artifacts would be discarded so as not to negatively affect the mapping procedure. Harlev, for example, discloses that injury currents can be mis-annotated by the mapping system. To prevent this, injury currents are detected and the EGMs containing such currents are rejected (pars. 0381 and 0382). Those of ordinary skill in the art looking to reduce the effects of noise on the system –a common goal in the art—would have considered the feature of claim 4 to be obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. 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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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
March 20, 2026
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