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.
Claims 1-16 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 is rejected because it is unclear if “the same first inter-beat phase” (line 14) is the same as phase as the first phase previously set forth in line 4. Claim 1 is rejected because “the heart rhythm” (line 19), “the same inter-beat phase” (Lines 19-20) lack proper antecedent basis. Claim 1 is also rejected because the limitations “on the one hand” and “on the other hand” are indefinite and lack proper antecedent basis. Claim 1 is also rejected because it is unclear if the non-rigid registration algorithm applied to subset of second images is the same non-rigid registration algorithm applied to subset of first images. Claim 16 inherits all of Claim 1’s rejections.
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) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S Publication No. 2017/0212195 to Rehwald et al. “Rehwald” in view of NPL “3D whole-heart phase sensitive inversion recovery CMR for simultaneous black-blood late gadolinium enhancement and bright blood coronary CMR angiography” to Ginami et al. “Ginami” and U.S. Publication No. 2021/0383537 to Chitiboi et al. “Chitiboi” or alternatively, U.S. Publication No. 2017/0076449 to Chow et al. “Chow”.
With respect to Claims 1-2, 11-12, 14 and 16, Rehwald discloses a method for reconstructing an image of a patient’s heart from a magnetic resonance imaging (MRI) device (Abstract; Fig. 1 and corresponding descriptions; Paragraph [0027]) comprising acquiring ECG triggered image data (Fig. 5 and corresponding descriptions). Rehwald explains the image acquisition can be 2D or 3D (Paragraph [0035]. Regarding the sequence, following the R-wave in each ECG cycle (e.g. phase), an inversion pulse is provided to invert magnetization (202 in Fig. 2 and corresponding descriptions) followed by the imaging sequence (Paragraphs [0032], [0035], [0050] and Fig. 5 and corresponding descriptions). Rehwald also discloses where the preparation may use a combination of a leading T2-preparation (T2-prep) with a trailering IR pulse or a leading magnetization transfer pulse, or the combination of any other suitable preparation with trailing or leading IR pulse (Paragraph [0038]) and where the preparation module comprises a series of at least one T1(rho), T2(rho), or spin-lock contrast imparting pulse being followed or preceding the inversion pulse (Claim 24). Thus, Rehwald is considered to read on the claimed limitations of a first phase image generation comprising acquiring electrical activity (ECG) of the patients heart, generating a first 180o inversion radio frequency signal to inverse a longitudinal magnetization of tissues of an imaged area, the inversion being between two QRS complexes; generating a first magnetization preparation including a set of pulses following the generation of the first inversion pulse in the same first inter-beat phase, acquiring a first image by a magnetization measurement of the imaged area after a first predefined duration following the preparation and synchronized with the ECG (e.g. heart rhythm) in its broadest reasonable interpretation.
Fig. 5 depicts a repeated image acquisition in a second inter-beat phase but with no inversion pulse. Thus, Rehwald is considered to read on the claimed limitations of generating a second magnetization preparation in a second inter-beat phase following the first inter-beat phase and acquiring a second image by a magnetization measurement of the second area in a second predefined duration synchronized with the ECT at the same time marker as the first image acquisitions in its broadest reasonable interpretations. Rehwald discloses the aforementioned steps can be accomplished in only two heartbeats, it may be repeated for any other suitable time period (Paragraph 0035]).
However, Rehwald does not expressly disclose applying a “non-rigid” registration algorithm to each subset of first images and second images to separately register them together and to combine the registered first and second images together as claimed.
Regarding combining images from different heart phases, Ginami teaches from within a similar field of endeavor with respect to cardiovascular MRI imaging systems and methods (Abstract) where black and bright blood images are collected separately, registered, and then combined to obtain complementary phase sensitive inversion recovery bright-blood and black-blood phase image (Page 2, “Methods”). While Ginami uses rigid registration, Ginami expressly suggests using non-rigid registration algorithms to improve the quality of the combined dataset (Page 12).
Chitiboi teaches from within a similar field of endeavor with respect to late gadolinium enhancement MRI systems and methods (Paragraphs [0019]-[0021]) where rigid or elastic registration techniques are used (Paragraph [0025]).
Alternatively, Chow teaches from within a similar filed of endeavor with respect to cardiac MRI imaging where images may be registered to one another with a non-rigid registration (Abstract; Paragraphs [0009] and [0018]).
Accordingly, one skilled in the art would have been motivated to have modified the cardiac MRI system and method described by Rehwald to register and combine image acquisitions as described by Ginami in order to provide accurate cardiac images with improved visualization of cardiac anatomy (Ginami-Abstract). Furthermore, one skilled in the art would have been motivated to have used elastic (e.g. non-rigid) registration techniques described by Chitiboi/Chow in order to compensate for residual mis-registration errors. Such modifications merely involve combining prior art techniques to yield predictable results (MPEP 2143).
Regarding Claim 3, Rehwald discloses averaging pixels within each portion (Paragraphs [0006] and [0055]). Accordingly, one skilled in the art would have been motivated to have averaged the registered images to produce the merged image in order to reduce errors and improve signal to noise ratio (Rehwald-Paragraph [0055]).
As for Claim 4, Rehwald teaches where the delay between the IR pulse and the readout can be set to achieve nulling (Paragraphs [0004], [0025] and [0033]).
With respect to Claim 5, Rehwald’s system calculates the optimal TI (Paragraph [0033]).
With respect to Claims 6-7 and 9-10, Ginami displays black blood, bright blood and combined images (Fig. 5 and corresponding descriptions) and determines scar tissue locations based on the acquired data, the combined images use color to indicate the scarring (Fig. 7 and corresponding descriptions). Ginami explains the combined images are “fused” which would read on overlaying the bright and black blood images together in its broadest reasonable interpretation.
As for Claim 8, Examiner notes repeating the modified imaging sequence as described above would read on the claimed steps in its broadest reasonable interpretation.
Regarding Claim 13, both Rehwald and Gianami disclose fat suppression techniques (Rehwald-Paragraph [0025]; Gianami-Fig. 1 and corresponding descriptions) which is considered tor read on filtering fatty areas in its broadest reasonable interpretation.
As for Claim 15, Rehwald depicts multiple acquisitions within each heart cycle (Fig. 5) and a plurality of images as a result (Fig. 6A). In addition, Chow explains that a plurality of images acquired inside heart cycles (Abstract; Figs. 4A; Paragraphs [0010], [0017] and [0062]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2017/0030990 to Janich et al. which discloses cardiac MRI late gadolinium imaging can be done in 2D or 3D (Paragraph [0026]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797