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 .
DETAILED ACTION
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.
Claim 9 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Limitation “wherein the at least one three-dimensional model provides a visual illustration of a duration of peak strain as one or more of the strain measurements” is not disclose in the specification. What is duration of peak strain and where in the 3D model that provides a visual illustration of a duration of peak strain? Is duration of peak strain a time period in which the strain at its peak? “Duration of peak strain” is not a well-known term in the field and the specification does not define what “duration of peak strain” is.
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 9 is 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. Limitation “wherein the at least one three-dimensional model provides a visual illustration of a duration of peak strain as one or more of the strain measurements” is unclear. It is unclear what in the 3D model that provides a visual illustration of a duration of peak strain. It is unclear how a visual vector discloses a time period?
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.
Claims 1-2, 4-5, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Cupps et al. (US 2009/0281415 (provided in the IDS)) and in view of Osman et al. (US 2017/0311839).
Addressing claim 1, Cupps discloses a method of providing cardiac strain information of a patient, comprising:
generating at least one three-dimensional heart model visually showing MRI-derived strain measurements of cardiac tissue using visual vectors and/or color-coded strain values correlated to position in and/or on the at least one three-dimensional model (see [0019], [0059], [0061-0062], [0066-0067] and Figs. 7-10);
wherein the MRI-derived strain measurements comprise longitudinal and circumferential strain measurements from long and short axis slices of the heart respectively (see abstract and Fig. 3, elements 302 and 304; targets are acquired from long and short axis; longitudinal and circumferential strain are measure from acquire targets therefore longitudinal and circumferential strain measurements from long and short axis).
Cupp does not explicitly disclose with a direction of contraction orthogonal to a respective image plane and whereby short-axis image sequence provide longitudinal strain measurements and long-axis image sequences provide circumferential strain measurements. This specific limitation is not disclosed in the specification; however, specification paragraph [0176] discloses SENC strain is measured perpendicular to the image plane. Examiner interpreted the limitation according to paragraph [0176]. In the same field of endeavor, Osman disclose SENC strain measurement and whereby short-axis image sequence provide longitudinal strain measurements and long-axis image sequences provide circumferential strain measurements (see [0049], [0114], and [0119]; in SENC strain measurement short-axis image sequence provide longitudinal strain measurements and long-axis image sequences provide circumferential strain measurements; SENC strain measurement is perpendicular to the imaging plane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cupps to use SENC strain measurement and whereby short-axis image sequence provide longitudinal strain measurements and long-axis image sequences provide circumferential strain measurements as taught by Osman because it is an MRI technique for imaging regional deformation of tissue, such as the heart muscle. Producing multiple strain sequences along multiple acquisition planes allows global and/or regional assessment of circumferential and longitudinal strain that correlate to myocardial contraction and function (see [0014]). SENC imaging provide faster imaging, reduce post processing time, improved quantification and accuracy.
Addressing claims 2, 4-5, 11 and 13, Cupps discloses:
addressing claim 2, wherein the at least one three-dimensional heart model is provided as a cine of three-dimensional models of a cardiac cycle with the MRI-derived strain measurements, and wherein the visual vectors and/or color-coded strain values change in image frames of the cine and are correlated to times in a cardiac cycle (see [0044] and [0046], in a real-time view the viewer sees the frame changes of the cine to the current frame and the current change in strain (color change) of each part of the heart in a the cardiac cycle).
addressing claim 4, wherein the at least one three-dimensional heart model is a standardized heart model with different defined ranges of strain values shown in different colors as the color-coded strain values (see [0067])
addressing claim 5, wherein the different colors comprise first, second and third colors for different defined percentages of strain measurements, and wherein the first, second and third colors reflect different percentages of strain extending across and through volumes of the generated at least one three-dimensional heart model (see [0067]; “For example, locations where the subject's heart strain does not vary significantly from the reference heart model may be colored blue and locations of increasing variance may be color coded with successive colors of the spectrum”; many colors from the spectrum; each color represent a variance from the reference which is a percentage of variation).
addressing claim 11, wherein the strain measurements comprise endocardial or epicardial strain (see abstract, [0019] and [0059]; calculate strain for all points in the heart model; create strain map and the model include epicardial therefore epicardial strain is calculated).
addressing claim 13, an MRI workstation or module in communication with or configured with at least one processor and/or server configured to carry out the method of Claim 1 (see Fig. 1 and [0003]; the system acquires images, calculate strain and display result).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cupps et al. (US 2009/0281415 (provided in the IDS)) and in view of Razavi et al. (US 2015/0313480).
Addressing claim 6, Cupps discloses all limitations, except wherein the visual vectors are provided in different sizes, including first, second and third sizes for different defined percentages of strain measurements, with the first and second sizes having lengths and/or widths that are different from the third size in/on 3d model/image. In the same field of endeavor, Razavi discloses visual vectors provided in different sizes for different defined percentages of strain measurement (see [0053], [0064], Figs. 6, 8 and 10; vector is magnitude (percentages of strain measurements) and direction; Razavi does not explicitly disclose 3 different sizes; Razavi discloses 604, 605, 1012 and 1014 are different sizes; smaller size is lower strain; vector is magnitude and direction; 604 is a vector that indicates magnitude and direction of strain; vector is not just direction by definition; vector: a quantity having direction as well as magnitude, especially as determining the position of one point in space relative to another; 604 is vector that shows on 3-d image as an arrow that indicate magnitude of strain and the direction the arrow pointed to; any size 2 or 3 or 4 is a designer choice that only require routine skill; as see in applicant’s specification [0166]; In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cupps to have visual vectors provided in different sizes for different defined percentages of strain measurement as taught by Razavi because this viewer visualizes the strength and direction of the strain.
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cupps et al. (US 2009/0281415 (provided in the IDS)), in view of Osman et al. (US 2017/0311839) and further in view of Friedman et al. (US 2007/0258631 (provided in the IDS)).
Addressing claims 7-8 and 12, Cupps does not disclose peak strain, systolic or diastolic strain rate and wherein the strain measurements are visually shown on the at least one three-dimensional model to visually illustrate a contraction profile. In the same field of endeavor, Friedman discloses peak strain and systolic or diastolic strain rate and wherein the strain measurements are visually shown on the at least one three-dimensional model to visually illustrate a contraction profile (see Fig. 5, [0004], [0019], [0031] and [0036]; show the measurement in Fig. 5; the measurement shows a direct and quantitative measure of the ability of the myocardium to contract and relax which is consider contraction profile; Friedman also disclose obtain and display multiple planes in 3d ultrasound; Cupps discloses 3d images/model; Osman discloses multiple image planes of the heart from the short and long axis in imaging sequence wherein each image plane provides a strain vector of contraction direction and magnitude of the MRI-derived strain measurements (see abstract, [0010], [0014] and Fig. 11B; SENC measurement of strain and heart contraction in short and long axis)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cupps to have peak strain and systolic or diastolic strain rate as taught by Friedman because this provides a direct and quantitative measure of the ability of the myocardium to contract and relax (see [0004]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Cupps et al. (US 2009/0281415 (provided in the IDS)), in view of Osman et al. (US 2017/0311839) and further in view of Tsadok et al. (US 2016/0098833).
Addressing claims 9-10, Cupps and Osman disclose wherein the at least one three-dimensional model provides a visual illustration of strain measurements as one or more of the strain measurements correlated to position in and/or on the at least one three-dimensional heart model (see Cupps’s abstract, Fig. 9 and [0033]; strain index is visually illustrated on 3d image by color coded; see Osman’s abstract, [0066] and [0070]; color coded strain measurement on heart model such as strain rate; this is visual illustration of strain measurements as one or more of the strain measurements correlated to position in and/or on the at least one three-dimensional heart model). It is unclear what duration of peak strain is. Cupps disclose determine strain index and provide visual illustration on 3d heart model, it would only require routine skill in the art to determine duration of peak strain as one of strain index and provide visual illustration on 3d heart model. However, Cupps does not disclose comprise midmyocardial strain. In the same field of endeavor, Tsadok discloses strain measurement of midmyocardial strain (see Figs. 16A-D, abstract, [0067] and claim 26; measure midmyocardial and myocardial strain; measure their strain rate and other strain metric). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cupps to have strain measurement of midmyocardial strain as taught by Tsadok because this would be useful in diagnosis and planning (see abstract).
Claims 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Osman et al. (US 2017/0311839) and in view of Friedman et al. (US 2007/0258631 (provided in the IDS)).
Addressing claim 22, Osman discloses a method of providing cardiac information, comprising: electronically obtaining Magnetic Resonance Imaging (MRI) images of multiple image planes providing MRI-image strain data of a heart of a patient, wherein each image plane of the obtained multiple image planes comprises a strain vector of contraction direction and magnitude (see abstract, [0010], [0014] and Fig. 11B; SENC measurement of strain and heart contraction in short and long axis). However, he does not disclose electronically generating a three-dimensional model of a heart with a visual presentation of a contraction profile using the strain vectors that define three-dimensional information on contraction direction and magnitude of the heart of the patient. In the same field of endeavor, Friedman discloses electronically generating a three-dimensional model of a heart with a visual presentation of a contraction profile using the strain vectors that define three-dimensional information on contraction direction and magnitude of the heart of the patient (see Fig. 5, [0004], [0019], [0031] and [0036]; show the measurement in Fig. 5; the measurement shows a direct and quantitative measure of the ability of the myocardium to contract and relax which is consider contraction profile; vector is magnitude and direction; the arrow vector indicate strain direction and magnitude; strain is caused by contraction therefore the arrow vector also indicate contraction direction and magnitude of the heart). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Osman to have electronically generating a three-dimensional model of a heart with a visual presentation of a contraction profile using the strain vectors that define three-dimensional information on contraction direction and magnitude of the heart of the patient as taught by Friedman because this provides a direct and quantitative measure of the ability of the myocardium to contract and relax (see [0004]).
Addressing claims 23, Osman discloses:
Addressing claim 23, wherein the obtaining is carried out to obtain the MRI images in a single heartbeat per image plane of the multiple image planes thereby allowing detailed mapping of the contraction profile throughout the heart (see [0015]).
addressing claim 24. (New) The method of Claim 22, further comprising measuring strain perpendicular to a respective image plane of the multiple image planes to provide strain measurements of the contraction profile, wherein long-axis planes including one or more of 2-chamber, 3-chamber, and 4-chamber long axis planes provide circumferential strain and short axis planes including one or more of basal-, mid-, and apical-short axis planes provide longitudinal strain (see [0033], [0037], [0049], [0114], [0119] and [0178]; in SENC strain measurement short-axis image sequence provide longitudinal strain measurements and long-axis image sequences provide circumferential strain measurements; SENC strain measurement is perpendicular to imaging plane).
addressing claim 25, wherein the method is carried out by at least one processor in communication with an MRI system (see Figs. 2A-B and abstract).
Response to Arguments
Applicant's arguments filed 02/17/26 have been fully considered but they are not persuasive. Regarding 112 written description and indefinite rejection applicant argues Figs. 6A-C and paragraphs [0164-0171] discloses the claim limitation. Applicant’s argument is not persuasive because even thought the specification disclose duration of peak strain may be illustrated by visual vector, the specification lack sufficient detail disclose how can duration of peak strain could be illustrated by visual vector. Vector represent magnitude and direction for example contract by 17% is a magnitude and to the left is a direction. Examiner assume duration of peak strain would be a time period. There no clear definition of duration of peak strain discloses by the specification. It is unclear how a vector would illustrate a time period. What time would a small vector represent? What time would a large vector represent? For example, if the duration of peak strain is 10 seconds, how does an arrow in the 3d figures represent a 10 seconds time period. The Figures and paragraphs disclose a generic and general description of visual vector representing many strain metrics. It is unclear how each strain metrics is represented by visual vectors.
Regarding art rejection applicant’s arguments with respect to claim(s) 1-2, 4-13 and 22-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2010/0041992 (see [0006] and [0041]; visually illustrate strain information such as strain rate on 3d heart model by superimpose the information on the 3d image).
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.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797