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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 7 and 16-17 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 7 line 2 recites the limitation "the flattened 3D panoramic view". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “a computer program enabling a processor to carry out the method of claim 13”. The claim is indefinite as there is ambiguity regarding the limiting aspect of the claim language. Under one interpretation, a computer program that is capable of enabling a processor to carry out the method is required. However, a computer program/code is not eligible subject matter under 35 USC 101 as it is not drawn to a process, machine, manufacture, or composition of matter. (see MPEP 2106.03; see also Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible)). In another interpretation, the processor is required to execute the computer program to carry out the method. As currently written, the ambiguous nature of the claim language renders the claim indefinite. Claim 17 is rejected due to its dependence upon rejected claim 16.
Claim 17 line 1 recites “the program element”. This creates confusion as to the “elements” relationship to “a computer program” from claim 16, upon which claim 17 depends. If similar, the examiner recommends amending the claim with consistent terms. If different, there is insignificant antecedent basis for “the program element”.
Claim Rejections - 35 USC § 102
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 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 1-4, 7-10, and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Haim (WO 2018146613 A2).
Regarding claim 1, Ben-Haim teaches a device for providing three-dimensional data of a hollow organ, comprising:
a measurement input [page 38 ln. 34—page 39 lns. 1-2 “position service module”];
a data processor [page 6 ln. 26]; and
an output interface [page 14 ln. 18];
wherein the measurement input is configured to receive a plurality of local electric field measurements of at least one electrode on a catheter inserted in a lumen of a hollow organ of interest [page 26 lns. 27-28, see also page 38 ln. 34—page 39 lns. 1-2]; and to receive geometrical data representative of the location of the at least one electrode inside the lumen during the measurements [page 38 ln. 34—page 39 lns. 1-2];
wherein the data processor is configured to:
receive pre-set electric field characteristics associated with predetermined anatomical landmarks of the hollow organ expectable in the lumen in dependency of a type of the hollow organ [page 37 lns. 23-26];
compare at least one of the plurality of local electric field measurements with the pre-set electric field characteristics to determine matching electric field measurements [page 37 lns. 23-26];
based on the geometrical data, allocate local electric field measurements to matching electric field characteristics to identify anatomical landmarks of the hollow organ by identifying those local field measurements in the plurality of measurements that correspond to landmarks of the hollow organ [page 37 lns. 25-28];
generate a three-dimensional image data cloud by transforming the allocated electric field measurements into portions of the three-dimensional image data cloud based on the identified anatomical landmarks [Fig. 6, see also page 38 ln. 16]; and
wherein the output interface is configured to provide the three-dimensional image data cloud [Fig. 6, see also page 23 lns. 30-32].
Regarding claim 2, Ben-Haim teaches device according to claim 1, wherein he data processor is configured to achieve a number of measurements that have a counterpart in the pre-set characteristics by the matching operation [page 37 lns. 23-26]; and
as far as these represent a landmark, the data processor is configured to identify the matching measurements to correspond to the respective landmark of the organ [page 22 lns. 4-7].
Regarding claim 3, Ben-Haim teaches device according to claim 1, wherein the data processor is configured to project a representation of an inner surface enclosing the lumen as a 3D view based on the three- dimensional image data cloud [Fig. 6, see also page 32 lns. 9-19].
Regarding claim 4, Ben-Haim teaches device according to claim 1, wherein the data processor is configured to base an output image on the plurality of local electric field measurements [Fig. 6, see also page 23 lns. 30-32]; and
wherein the data processor is configured to determine the landmarks based on expected phenomena and to generate a panoramic view on the fly, wherein only what is measured is taken into account and other parts remain undetected until they are also measured [col. 32 lns. 27-31 “rolling ball method”].
Regarding claim 7, Ben-Haim teaches device according to claim 3, wherein a display is provided configured to display the 3D view [Fig. 6, see also page 14 ln. 18] and/or the flattened 3D panoramic view.
Regarding claim 8, Ben-Haim teaches device according to claim 1, wherein the pre- set electric field characteristics comprise at least one of the group of:
predefined gradients describing changes in the electric field; and
predefined patterns describing attributes of the electric field [page 37 lns. 26-28, “Euclidean distances” is being interpreted as an “attribute”]; and
wherein, for the comparison, the data processor is configured to match the measured electric field values with the pre-set electric field characteristics to identify measurements relating to a location of a landmark [page 37 lns. 22-28].
Regarding claim 9, Ben-Haim teaches a system for measuring a hollow organ, the system comprising:
a catheter [Fig. 5 Item 9] with at least one electrode [Fig. 5 Item 3];
an electric field generator [Fig. 5 Item 10]; and
a device for providing three-dimensional data of a hollow organ according to claim 1 [see claim 1 rejection above];
wherein the catheter is configured to be partly inserted into the lumen and moved inside the lumen [page 26 lns. 27-28, see also Fig. 5]; and to conduct a plurality of local electric field measurements inside the lumen with the at least one electrode [page 26 lns. 19-21]; and to provide the local electric field measurements data to the measurement input of the device for providing three-dimensional data of a hollow organ [page 26 lns. 27-28, see also page 38 ln. 34—page 39 lns. 1-2]; and
wherein the electric field generator is configured to generate at least one electric field inside a lumen of a hollow organ, and to provide the geometrical data representative of the location of the at least one electrode inside the lumen during the measurements to the measurement input of the device for providing three-dimensional data of a hollow organ [page 31 lns. 10-17].
Regarding claim 10, Ben-Haim teaches system according to claim 9, wherein it is further provided at least one interventional device for insertion into a hollow organ [Fig. 5 Item 9];
wherein the interventional device comprises at least one tool for treatment inside the hollow organ [Fig. 5 “catheter probe 11”, see also page 26 ln. 1, “RF ablation” is interpreted as a treatment];
wherein the interventional device comprises the catheter Fig. 5 Item 9] having at least one electrode [Fig. 5 Item 3]; and
wherein the catheter is provided for guiding the at least one tool inside the hollow organ [page 26 lns. 27-28, see also Fig. 5].
Regarding claim 12, Ben-Haim teaches system according to claim 9, wherein the catheter is configured to be inserted into:
a heart comprising several chambers as the hollow organ, from which heart at least one chamber is to be imaged [page 26 lns. 27-28]; and/or
at least one of the group of bladder, uterus, stomach and colon.
Regarding claim 13, Ben-Haim teaches a method for providing three-dimensional data of a hollow organ, the method comprising the following steps:
receiving a plurality of local electric field measurements of at least one electrode on a catheter inserted in a lumen of a hollow organ of interest [page 26 lns. 27-28, see also page 38 ln. 34—page 39 lns. 1-2];
providing geometrical data representative of the location of the at least one electrode inside the lumen during the measurements [page 38 ln. 34—page 39 lns. 1-2];
providing pre-set electric field characteristics associated with predetermined anatomical landmarks of the hollow organ expectable in the lumen in dependency of a type of the hollow organ [page 37 lns. 23-26];
comparing at least one of the plurality of local electric field measurements with the pre-set electric field characteristics to determine matching electric field measurements [page 37 lns. 23-26];
allocating local electric field measurements to matching electric field characteristics based on the geometrical data to identify anatomical landmarks of the hollow organ by identifying those local field measurements in the plurality of measurements that correspond to landmarks of the hollow organ [page 37 lns. 25-28];
generating a three-dimensional image data cloud by transforming the allocated electric field measurements into portions of the three-dimensional image data cloud based on the identified anatomical landmarks [Fig. 6, see also page 38 ln. 16]; and
outputting the three-dimensional image data cloud [Fig. 6, see also page 23 lns. 30-32].
Regarding claim 14, Ben-Haim teaches method according to claim 13, further comprising:
inserting a catheter [Fig. 5 Item 9] with at least one electrode [Fig. 5 Item 3] in a lumen of a hollow organ and moving the at least one electrode inside the lumen [page 26 lns. 27-28, see also Fig. 5]; and
conducting a plurality of local electric field measurements inside the lumen with the at least one electrode for providing the local electric field measurements [page 26 lns. 19-21].
Regarding claim 15, Ben-Haim teaches method according to claim 12, wherein it is further provided:
projecting a representation of an inner surface enclosing the lumen as a 3D view based on the three-dimensional image data cloud [Fig. 6, see also page 14 ln. 18]; and/or
projecting a flattened 3D panoramic view of the inner surface enclosing the lumen based on the three-dimensional image data cloud, the flattened 3D panoramic view showing at least some surface parts of the inner surface; wherein a preset feature of interest is provided in a center region of the flattened 3D panoramic view.
Regarding claim 16, Ben-Haim teaches a computer program enabling a processor [page 16 lns. 12-19] to carry out the method of claim 13 [see claim 13 rejection above].
Regarding claim 17, Ben-Haim teaches a computer readable medium having stored the program element [page 13 ln. 34—page 14 lns. 1-4] of claim 16 [see claim 16 rejection above].
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.
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.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim as applied to claim 1 above, and further in view of Schwartz (WO 2019063161 A1).
Regarding claim 5, Ben-Haim teaches device according to claim 1, but fails to teach the data processor is configured to project a flattened 3D panoramic view of the inner surface enclosing the lumen based on the three-dimensional image data cloud, the flattened 3D panoramic view showing at least some surface parts of the inner surface; and wherein the data processor is configured to provide a preset feature of interest in a center region of the flattened 3D panoramic view.
Schwartz teaches the data processor is configured to project a flattened 3D panoramic view of the inner surface enclosing the lumen based on the three-dimensional image data cloud, the flattened 3D panoramic view showing at least some surface parts of the inner surface [Fig. 15D]; and
wherein the data processor is configured to provide a preset feature of interest in a center region of the flattened 3D panoramic view [Fig. 15C-D, “LIPV” as the “feature of interest”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Ben-Haim and incorporate the teachings of Schwartz to include the data processor is configured to project a flattened 3D panoramic view of the inner surface enclosing the lumen based on the three-dimensional image data cloud, the flattened 3D panoramic view showing at least some surface parts of the inner surface; and wherein the data processor is configured to provide a preset feature of interest in a center region of the flattened 3D panoramic view. Doing so configures the system to provide a means to "unfold" a curved, tubular structure like a blood vessel or airway into a single 2D plane, allowing clinicians to overcome the challenges of complex 3D geometry and more easily visualize key features.
Regarding claim 6, Ben-Haim and Schwartz teach device according claim 5, wherein the data processor is configured to generate the flattened 3D panoramic view based on user selected criteria [Schwartz page 62 lns. 6-9];
wherein the selected criteria comprises a type of operation or treatment of the hollow organ [Schwartz page 43 lns. 6-8]; and
wherein for finding a projection according to the user selected criteria, the data processor is configured to arrange a plurality of different landmark related criteria in different weighting orders depending on the user selected criteria and to check if these criteria are fulfilled according to the respective weighting order for variations of projections [page 52 lns. 14-17].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim as applied to claim 9 above, and further in view of Harlev (US 20070299352 A1).
Regarding claim 11, Ben-Haim teaches system according to claim 9, wherein the geometrical data comprises spatial tracking of the at least one electrode inside the organ during the measurements by the electric field generator [page 31 lns. 10-17]; but fails to teach wherein a tracker is provided configured to provide spatial information of a starting point for the moving of the catheter inside the hollow organ; and wherein the spatial tracking is based on the starting point.
Harlev teaches a tracker is provided configured to provide spatial information of a starting point for the moving of the catheter inside the hollow organ [0092 “The location of the catheter 110 inserted into the heart chamber can be determined using a conventional sensing and tracking system (not shown) that provide the 3D spatial coordinates of the catheter and/or its multiple electrodes with respect to the catheter's coordinate system as established by the sensing and tracking system”, the catheter described is “inserted” into the heart chamber and thus is obvious that the starting point is included in being tracked]; and wherein the spatial tracking is based on the starting point [0092, the catheter described is “inserted” into the heart chamber and thus is obvious that the starting point is included in being tracked].
It would have been obvious to one of ordinary skill in the art before the effective filiing date of the claimed invention to take the teachings of Ben-Haim and incorporate the teachings of Harlev to include a tracker is provided configured to provide spatial information of a starting point for the moving of the catheter inside the hollow organ; and wherein the spatial tracking is based on the starting point. Doing so configures the system for early detection of catheter malposition, which can prevent complications like infection, trauma, and medication errors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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, Alexander Valvis can be reached at (571)272-4233. 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.
/JONATHAN M HANEY/ Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791