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 .
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 16 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention.
Claim 16 recites “the context weight”; however, claim 13, from which claim 16 depends, does not previously introduce or define a “context weight.” Claim 13 instead concerns calculating a wave score. Although claim 15 introduces a “context weight,” claim 16 does not depend from claim 15. Therefore, it is unclear what previously recited context weight is being further limited and whether claim was intended to depend from claim 13 or claim 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,974,854. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Present claims of U.S. Application 18/627,895
Claims of U.S. Pat. No. 11,974,854
A method for cardiac mapping…comprising:
A method for cardiac mapping…comprising:
positioning a two-dimensional electrode array at a location in a patient heart…arranged in an orthogonal close unipolar configuration…
positioning a two-dimensional electrode array at a location in a patient heart…arranged in a nonlinear configuration…
…simultaneously detecting at least one local activation signal and activation time at each electrode of the array…
…simultaneously detecting at least one local activation signal and activation time at each electrode of the array…
…calculating a conduction velocity (CV) vector for a first electrode of the array using the activation time of the first electrode, the activation of the second electrode…at least a third electrode…to construct a map of cardiac electrical activity…
…calculating a conduction velocity (CV) vector for a first electrode of the array using the activation time of the first electrode, the activation of the second electrode…at least a third electrode…to construct a map of cardiac electrical activity…
Although the instant claim recites the plurality of electrodes as being arranged in an “orthogonal close unipolar configuration,” whereas claim 1 of the ‘854 patent more broadly recites a non-linear configuration, the claimed orthogonal unipolar configuration arrangement constitutes a patentably indistinct implementation of the non-linear electrode configuration recited in the patented claim. Selection of the recited orthogonal arrangement would have been obvious configuration of the claimed electrode array for determining activation-time differences among spatially distributed electrodes and calculating a conduction-velocity vector. Accordingly, the instant claim does not define a patentably distinct invention from claim 1 of the ‘854 patent.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-11 & 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois et al. (US 2018/0325400) in view Desai (US 2002/0010392).
Claim 1.
Dubois teaches cardiac mapping by:
acquiring cardiac electrical-activity data using an electrode array;
reconstructing time-varying electrical potentials at respective spatial nodes; and
generating an electroanatomic map containing conductive-velocity information ([0020]-[0021], [0034], [0039] & [0085]).
Dubois does not expressly teach an intracardiac two-dimensional electrode array arranged in an orthogonal close unipolar configuration or calculating the CV vector using activation times from at least three electrodes of that array.
Desai teaches:
positioning a two-dimensional, five electrode array at an endocardial location in the heart ([0066]-[0071]).
four peripheral electrodes arranged orthogonally around a central electrode, forming a cross-shaped array having known locations and interelectrode distances of 0.5 cm and 0.7 cm ([0066]-[0069]).
Simultaneously detecting activation-wavefront arrival times at the five electrodes in real time ([0070]-[0076]);
detecting unipolar intracardiac electrograms using the orthogonal electrode array [0077].
defining triangular regions using first, second and third electrodes having respective activation times ([0072]-[0074]); and
calculating local velocity from known interelectrode spacing and arrival-time differentials to generate a cardiac map ([0030]-[0031] and [0071]-[0075]).
It would have been obvious to modify Dubois’s cardiac-mapping method to employ Desai’s orthogonal, closely spaced unipolar electrode array and activation-time calculations to obtain electrical measurements at known spatial locations along orthogonal directions, thereby facilitating rapid and accurate determination of cardiac propagation direction and conductive velocity.
Thus, Dubois in view of Desai teaches or suggests calculating a CV vector for a first electrode using the activation times of the first, second and at least third electrodes to construct a map of cardiac electrical activity, as claimed.
Claim 2
Dubois in view of Desai teaches the method of claim 1.
Desai further teaches:
determining respective activation times for at least three electrodes defining a triangular region ([0072]-[0074]).
determining activation-time differences between the electrodes;
using the known interelectrode distances and arrival-time differentials to calculate local velocity ([0031], [0068] and [0072]-[0074]); and
combining velocity components along orthogonal directions to obtain a velocity vector ([0031]; claim 1).
Claim 3.
Desai teaches determining a CV vector using a group of electrodes comprising a central/first electrode and at least two adjacent peripheral electrodes defining a triangular region ([0069], [0072]-[0074]).
Claim 4.
Desai teaches compiling a local isochronal activation map from activation times measured by the two-dimensional electrode array ([0071]-[0075]).
Desai further teaches calculating and displaying a velocity vector indicating cardiac propagation direction for the electrode group [0031].
Claim 5.
Desai teaches determining the direction and location of a cardiac activation source from local velocity information, known electrode positions and activation-time differences, thereby mapping the trajectory of the activation wave relative to adjacent electrodes ([0031], [0071]-[0075]).
Claims 6-11
Dubois teaches the additional limitations of claims 6-11 concerning:
detecting conduction blocks and excluding associated propagation vectors;
applying activation-time thresholds to adjacent electrodes;
adjusting the threshold based on propagation direction;
calculating the spatial context of local activation signals;
connecting spatially adjacent activations having related activation times; and
identifying a contiguous cardiac activation wave from the related activations,
as previously mapped in the prior Office Action.
Desai is relied upon to cure Dubois’s deficiency regarding the intracardiac orthogonal close unipolar electrode arrangement and the calculation of CV vectors using activation times from groups of at least three electrodes ([0031], [0068] and [0072]-[0074]). Thus the combined teachings render claims 6-11 obvious for the reasons set forth for claim 1 and the prior office action.
Claims 17-18
Dubois teaches calculating the temporal context of each local activation signal and evaluating multiple activation signals at an electrode to determine whether the respective activation times occur within a common refractory period, as previously mapped in the prior Office Action.
Desai supplies the claimed intracardiac orthogonal electrode arrangement and simultaneous unipolar activation-time measurements ([0031], [0068] and [0072]-[0074])
Thus, the combination teaches the additional limitations of claims 17 and 18.
Claims 19-21.
Dubois teaches:
Calculating spatial and temporal context for local activation signals;
Collecting and aggregating data over multiple cardiac waves; and
Using the aggregated data to reveal substrate-mediated patterns of cardiac conduction, as previously mapped in the prior Office Action.
Desai teaches:
Supplying the intracardiac orthogonal close unipolar array and CV-vector calculation based on activation times from at least three electrodes ([0031], [0068] and [0072]-[0074]).
Thus, the combination teaches the additional limitations of claims 19-21.
Claim 22.
Regarding the limitations substantially corresponding to claim 1, Dubois and Desai teach the claimed cardiac-mapping method for the same reasons as set forth above for claim 1.
Desai additionally teaches obtaining activation times simultaneously from an intracardiac orthogonal electrode array having fixed, known interelectrode spacing and constructing a local map from the relative activation times and positions ([0068]-[0077]).
Because the electrodes move together with the cardiac tissue and the map is calculated from simultaneously acquired, array-relative measurements, cardiac or respiratory motion does not alter the relative electrode geometry resulting map characteristics.
Thus, Dubois in view of Desai teaches or suggests the method of claim 22.
Allowable Subject Matter
Claims 12-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The limitations are recited by claims 12-16 provide a mechanism for evaluating the reliability and spatial consistency of detected activation waves and filtering insufficiently supported activations. The prior art of record, Dubois in view of Desai teaches cardiac mapping, activation-time processing and conduction-velocity calculations, but does not tech or suggest the claimed wave-scoring and context-weighting analysis.
Accordingly, claims 12-15 would be allowable if rewritten in independent form to include all limitations of the base and intervening claims.
Claim 16 also contains allowable subject matter over the prior art but remains rejected under 112(b) because “the context weight” lacks antecedent basis in claim 13. Claim 16 would be allowable upon correction of that formal defect and incorporation of all intervening limitations.
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive as to patentability.
Applicant’s arguments regarding the 102 rejection over Dubois are persuasive to the extent that Dubois alone does not expressly disclose the claimed orthogonal close unipolar electrode configuration. Accordingly the 102 rejection is withdrawn.
However, the claims are not rejected under 103 over Dubois in view of Desai. Desai teaches an intracardiac orthogonal array having fixed interelectrode spacing, simultaneous activation-time measurements, unipolar electrograms and velocity calculations based on electrode spacing and arrival-time differences ([0031], [0066]-[0077]). Applicant’s arguments addressing Dubois individually do not rebut the, combined teachings of Dubois and Desai.
Applicant’s assertion that the dependent claims are patentable because the independent claims are novel is unpersuasive. Novelty over Dubois alone does not establish nonobviousness over the applied combination.
The statutory double-patenting rejection is withdrawn because amended claim 1 is no longer coextensive with claim of U.S. Patent No. 11,974,854. However, claim 1 remains subject to the newly presented non-statutory double patenting rejection. Although the applicant states that a terminal disclaimed was submitted, no terminal disclaimer appears in the record.
The indication of allowable subject matter in claims 12-16 is maintained, subject to correction of the 112(b) defect in claim 16 and incorporation of all base and intervening limitations.
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
Prosecution Insights