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The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Examiner’s Suggestion
The limitation “wearing 3D glasses to render the 2D map as 3D map to enhance visual accuracy of the heart chambers and their anatomy and the catheters used during mapping and ablation procedures and improve spatial awareness of the catheters during catheters movements and manipulation and the heart chambers anatomy during cardiac electrophysiology 3D cardiac chamber mapping and ablation procedures” recited in claim 1 may be in better form if rewritten as “ wearing 3D glasses to render the 2D map as 3D map to: i) enhance visual accuracy of the heart chambers, their anatomy, and the catheters used during mapping and ablation procedures and ii) improve spatial awareness of the catheters during catheters movements, manipulation, and the heart chambers anatomy during cardiac electrophysiology 3D cardiac chamber mapping and ablation procedures.” or “wearing 3D glasses to render the 2D map as 3D map to enhance visual accuracy of the heart chambers, their anatomy, and the catheters used during mapping and ablation procedures to improve spatial awareness of the catheters during catheters movements, manipulation, and the heart chambers anatomy during cardiac electrophysiology 3D cardiac chamber mapping and ablation procedures.”
Claim Objections
Claims 1 and 8 are objected to because of the following informalities: the limitation “project (or projecting) the 3D map into the 3D monitor” appears to be grammatically incorrect, and should be replaced with “project (or projecting) the 3D map onto the 3D monitor”. Additionally, in claim 8, delete the limitation chambers’ in line 5, and replace it with chambers. Appropriate correction is required.
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.
Claims 1 and 8 are 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 “converting electro-anatomical mapping inputs from any current or any existing mapping systems from a 2D map to a 3D map of the heart chambers and catheters used for 3D mapping and ablation of the heart chambers and catheters during cardiac electrophysiology procedures”. This feature would at least put the reader in doubt because it is unclear how the instant visual system is applied or adapted to any current or existing 3d mapping and ablation systems in order to create and view a three dimensional map of the heart chamber that is being displayed? For example, how is the claimed visual system compatible with any current or any existing system that has a built-in autostereoscopic 3D monitor that shows 3D images without wearing special (or 3D) glasses? A similar limitation also occurs in claim 8. Please clarify.
Since claims 2-7 and 9-14 depend on claims 1 and 8 respectively, they are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the same reason set forth above for claims 1 and 8.
Claim 1 recites a system for enhancing visual accuracy of the three dimensional (3D) map of the heart chambers and catheters comprising: a 3D monitor; a pair of 3D glasses; a processor unit; a memory unit. While it is clear that the converted 3D map is projected onto the 3D monitor, and viewed by the 3D glasses. It is unclear as to what happens between the processor unit and the memory unit. For example, it is unclear whether the memory unit contains a computer program, and the memory unit is accessible by the processor in order to execute the conversion, projection, and rendering. Please clarify.
Claims 4 and 11 recite the limitation "based on an operator’s viewpoint" in line 2. The operator’s viewpoint has not been established in the prior claim language. There is insufficient antecedent basis for this limitation in the claim.
Claims 4 and 5 recite the limitation "the treatment" in lines 7-8 and 5 respectively. There is insufficient antecedent basis for this limitation in the claims.
Prior Art
The closest prior art to Southworth, et al. (Performance Evaluation of Mixed Reality Display for Guidance During Transcatheter Cardiac Mapping and Ablation) disclose, among other things, Cardiac electrophysiology (EP) procedures are highly complex and require continuous assessment of multiple sources of information. Over the course of a procedure, electrophysiologists place multiple catheters within the heart, using electrical signals to induce, diagnose and ablate abnormal electrical foci that cause cardiac arrhythmias. These procedures
have been enhanced significantly by the development of electroanatomic mapping systems (EAMS) that provide a real-time display of all catheter locations within a cardiac geometry. EAMSs also construct a 3D map of the interior surface of the heart (endocardium) incorporating both anatomic location and local electrical signal. As in most minimally invasive procedures, the 3D information in maps is limited to display on conventional 2D screens that require the clinician
to reconstruct, interpret, and maintain a mental model of the 3D anatomy throughout the procedure. The Enhanced Electrophysiology Visualization and Interaction System ( ELVIS) system was developed to provide electrophysiologists with virtual 3D data placed within the
clinical work area in stereoscopic 3D display (Fig. 1). The system employs an optical see through (OST), near eye display (NED), head mounted device (HMD, Microsoft HoloLens) with custom HMD rendering software to provide a mixed reality system for the physician. The HMD
can be worn with or without prescription lenses (including leaded lenses) and is not tethered or cabled. The headset uses multiple sensors to continuously measure its position within the room such that displayed 3D images remain virtually anchored in the physical space. The HMD is integrated into the EP suite through an off the shelf wireless access point and medical computer and receives real-time, exported 3D data from the EAMS (See section I, paragraphs 4-5). Additionally, Southworth, et al. at section II(A), subsection 4 states: “In an EP procedure, as a catheter with one or more electrodes is moved throughout the heart anatomy, the EAMS records the 3D position, signal voltage magnitude and timing relative to a reference signal of the electrodes to build a 3D geometric representation with corresponding electrical data.”
The prior art to: Zaides, et al. (US 2024/0245467 A1) at paragraph 0048 states: “For instance, the system 10 can be part of a surgical system (e.g., CARTO® system sold by Biosense Webster) that is configured to obtain biometric data (e.g., anatomical and electrical measurements of a patient's organ, such as the heart 12 and as described herein) and perform a cardiac ablation procedure. More particularly, treatments for cardiac conditions such as cardiac arrhythmia often require obtaining a detailed mapping of cardiac tissue, chambers, veins, arteries and/or electrical pathways. For example, a prerequisite for performing a catheter ablation (as described herein) successfully is that the cause of the cardiac arrhythmia is accurately located in a chamber of the heart 12. Such locating may be done via an electrophysiological investigation during which electrical potentials are detected spatially resolved with a mapping catheter (e.g., the catheter 14) introduced into the chamber of the heart 12. This electrophysiological investigation, the so-called electro-anatomical mapping, thus provides 3D mapping data which can be displayed on the display device 27. In many cases, the mapping function and a treatment function (e.g., ablation) are provided by a single catheter or group of catheters such that the mapping catheter also operates as a treatment (e.g., ablation) catheter at the same time.”; Shuros, et al. (US 2025/0090077 A1) disclose A plurality of physiological signals are collected according to a collection parameter, the collection parameter based on the determined catheter context characteristic at 406. Also, a plurality of anatomical location signals corresponding to a measurement location associated with each of the plurality of physiological signals are collected at 408. For example, each physiological signal collected according to the catheter context characteristic at 406 is associated with an anatomical local signal corresponding to the measurement location of the physiological location. In one embodiment, the data collected based on the determine context characteristic are stored in memory as physiological information, location information pairs. A visualization of the electroanatomical map including the three dimensional representation of the anatomy is generated at 410 (See paragraph 0082); Fruci, et al. (US 2018/0042518 A1) The processor 32 may output data to a suitable device, for example display device 40, which may display relevant information for a user. For example, the display device 40 may provide to the user a three-dimensional electroanatomical map of the cardiac chamber in which the mapping probe 14 is deployed. In some examples, device 40 is a display (e.g. a CRT, LED), or other type of display, or a printer. In addition, the processor 32 may generate position-identifying output for display on device 40 that aids the user in guiding an ablation electrode or other therapeutic device into contact with tissue at the site identified for ablation (See paragraph 0021); and Fuimaono, et al. (US 9,668,704 B2) disclose a system for visually supporting an electrophysiology catheter application in the heart, particularly a catheter ablation, 3D image data of a body region containing the area to be treated are first recorded by way of a tomographical 3D imaging method before the catheter application is carried out. The area to be treated, or at least significant portions of it, is then extracted from the 3D image data. The resultant selected 3D image data and the electroanatomical 3D mapping data provided are finally correlated in the correct position and dimension and, preferably while the catheter application is being performed, are visualized next to one another at the same time in the correct position and dimension (See col. 2, line 58 – col. 3, line 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent Number 9,668,704; US Patent Application Publication Numbers: 2018/0042518, 2024/0245467, and 2025/0090077; and a publication to Southworth, et al. (Performance Evaluation of Mixed Reality Display for Guidance During Transcatheter Cardiac Mapping and Ablation).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL G MARIAM whose telephone number is (571)272-7394. The examiner can normally be reached M-F 7:30-5:00 EST.
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/DANIEL G MARIAM/Primary Examiner, Art Unit 2675