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 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.
Claims 28-29 are 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. The Examiner is unable to find any apparatus to support the possession of an apparatus that is “at least one processing component arranged,” and “an interface component.”
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 1-2, 6-8, 10, 12-13, 15-23, 25 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.
In re claim 1, the acquired quantitative MRI scans lack antecedent basis even though “acquiring a plurality of quantitative non-contrast MRI scan images” are mentioned. That only refers to scan images, but not MRI scans.
It is unclear what the determined metrics are referring to. Is it referring the determined plurality of MRI metrics? Or something else.
It is unclear what the MRI image is referring to. Is that referring to “each MRI scan image” or “scan images”?
What is “the metric maps” referring to? Is it the plurality of MRI metric maps? The Examiner interprets so.
In re claim 2, what is “one or more MR metrics” referring to? Is that referring to “a plurality of MRI metrics” of claim 1?
In re claim 7, the density, the pixel, the MRI scan, the spatial distribution of a property, lack antecedent basis.
In re claim 10, it is unclear what the scopes of raw values are. How “raw” is raw”?
In re claim 15, the initial value lacks antecedent basis.
In re claims 18-21, the T1, T2*, T2, and ADC metric lacks antecedent basis. ADC is not mentioned in claim 1.
In re claim 22, the patient lacks antecedent basis.
In re claim 25, it is unclear which MRI images of claim 25 is from claim 1. Is it the scan images or just the one “the MRI image”?
Claims 28 and 30 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 pre-AIA the applicant regards as the invention.
Claim limitation:
“one processing component;” recited in claims 28-29 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “component” coupled with functional language “perform” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
“an interface component;” recited in claim 30 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “component” coupled with functional language “transmitting” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Claim elements a and b are limitations that invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to clearly link or associate the disclosed structure, material, or acts to the claimed function such that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function. It is unclear what the structure would be for each of the claim element above. It is unclear whether they are circuits, processor, software, etc. For the purpose of the examination, examiner interprets as processor circuits or the like.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim(s) 1, 7, 8, 10, 12, 13, 17-19, 22, 23, 28, 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeder et al. (US 2017/0181656, hereinafter Reeder ‘656).
In re claim 1, Reeder ‘656 teaches a method of analysing MRI data of breast tissue, comprising: acquiring a plurality of quantitative non-contrast MRI scan images of at least part of an area of the breast tissue using different MR pulse sequences for each MRI scan image (fig. 2, 202; 0043-0048, 0051); determining a plurality of MRI metrics from the acquired quantitative MRI scans; using the determined metrics to generate a plurality of MRI metric maps; calculating at least one of a breast composite map and a heterogeneity map from the metric maps to show tissue characteristics of fat and non-fat tissue in the MRI image (fig. 2, 206; 0051, 0053); determining breast tissue heterogeneity characteristics from at least one of the breast composite map and the heterogeneity map (fig. 2, 208, 0052-0066); and identifying clusters of data from at least one of the breast composite map, breast hetereogeneity map and the breast tissue hetereogeneity characteristics (0054-0067).
In re claim 7, Reeder ‘656 teaches wherein the determination of breast tissue heterogeneity characteristics comprises determining one or more of: mean of the density of the pixels or voxels in the MRI scan; a chloropleth map showing the spatial distribution of a property; and a texture map of the density (fig. 3, 0067, note that texture map is merely color map of a density, gray scale with percentage bar is a texture map; 0054-0058; 0078-0080).
In re claim 8, Reeder ‘656 teaches wherein determining breast tissue heterogeneity characteristics comprises determining one or more of: fat content and breast composition; breast inflammation; and alteration of breast tissue structure (fig. 2, 206).
In re claim 10, Reeder ‘656 teaches wherein at least two of the determined metrics are combined to generate a further metric map (fig. 2, 206 includes 1: water only and 2: fat only, 208 with 214, 216), and this further metric map is used in the calculation of the breast composite map, and wherein raw values for the at least two determined metrics are used to generate the further metric map (fig. 2, 206 includes 1: water only and 2: fat only, 208 with 214, 216).
In re claim 12, Reeder ‘656 teaches wherein the MRI metrics comprise one or more of T1, corrected T1, T2, T2*, PDFF and ADC (0034).
In re claim 13, Reeder ‘656 teaches wherein the MRI metric map is a PDFF map or a corrected T1 map (0034).
In re claim 17, Reeder ‘656 teaches further comprising: generating at least one of the following MRI metric maps: a T1 map, a T2 map, a T2* map (0064, image is a map), and an ADC map.
In re claim 18, Reeder ‘656 teaches wherein the T1 metric is determined using a Modified Look Locker Inversion recovery sequence acquisition, shortened Modified Look Locker Inversion recovery sequence acquisition or a variable flip angle sequence acquisition (0049, 0072, note that flip angle can be selected, which is a variable flip angle sequence).
In re claim 19, Reeder ‘656 teaches wherein the T2* metric and/or the PDFF metric are determined using a multi echo gradient echo sequence acquisition (0049, 0052, low flip angle is normally a gradient echo).
In re claim 22, Reeder ‘656 teaches wherein the MRI scan is obtained with the patient in either the prone or supine position (0072).
In re claim 23, Reeder ‘656 teaches wherein the breast composite map and the breast tissue characteristics are used to provide a disease risk score (0035).
In re claim 28, Reeder ‘656 teaches an apparatus for analysing MRI data from breast tissue to determine breast tissue heterogeneity characteristics from a breast composite map, the apparatus comprising at least one processing component arranged to perform the method of claim 1 (0022).
In re claim 30, Reeder ‘656 teaches an apparatus as claimed in claim 28, wherein the apparatus further comprises at least one output component for outputting the breast composite map (0031, 0032), or determined breast tissue heterogeneity characteristics (0022), wherein the at least one output component comprising one or more of: a display device for displaying the breast composite map or determined breast tissue heterogeneity characteristics to a user (0031, 0032); a data storage device for storing the breast composite map or determined breast tissue heterogeneity characteristics (0022, 0031, 0032); and an interface component for transmitting the breast composite map or determined breast tissue heterogeneity characteristics to at least one external device (0022).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reeder ‘656 in view of Muradyan et al. (US 2007/0165927, hereinafter Muradyan ‘927).
In re claims 2, Reeder ‘656 fails to teach wherein the clusters of data are contiguous clusters identified across one or more MR metrics.
Muradyan ‘927 teaches wherein the clusters of data are contiguous clusters identified across one or more MR metrics (0030, 0038; 0106).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Reeder ‘656 to include the features of Muradyan ‘927 in order to implement pharmacokinetic and parametric analysis for dynamic contrast enhanced MRI scans.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reeder ‘656 in view of Reeder et al. (US 2018/0275235, hereinafter Reeder ‘235).
In re claim 15, Reeder ‘656 fails to teach wherein at least one MRI metric is combined with one or more other MRI metrics, before generation of an additional MRI metric map which provides an improved estimate of the initial value of at least one MRI metric; wherein the at least one metric is a T1 metric, and is combined with at least one of PDFF and T2*.
Reeder ‘235 teaches wherein at least one MRI metric is combined with one or more other MRI metrics (0028), before generation of an additional MRI metric map which provides an improved estimate of the initial value of at least one MRI metric (corrected T1, T2, etc. 0072); wherein the at least one metric is a T1 metric, and is combined with at least one of PDFF and T2* (0052, 0065, 0066, 0069, 0073, 0098).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Reeder ‘656 to include the features of Reeder ‘235 in order to estimate B1 inhomogeneities or generate a T1 map of the subject that is corrected for an influence of a presence of fat and a presence of iron in the subject.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reeder ‘656 in view of Setsompop et al. (US 2019/0369185, hereinafter Setsompop ‘185).
In re claim 20, Reeder ‘656 fails to teach wherein the T2 metric is determined using a multi-contrast spin echo sequence acquisition.
Setsompop ‘185 teaches wherein the T2 metric is determined using a multi-contrast spin echo sequence acquisition (0044, 0045, 0049).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Reeder ‘656 to include the features of Setsompop ‘185 in order to enable rapid simultaneous quantitative parameter estimation.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reeder ‘656 in view of Tymianski; Michael (US 2014/0248257, hereinafter Tymianski ‘257).
In re claim 21, Reeder ‘656 fails to teach wherein the ADC metric is determined using a single shot or multi-shot diffusion-weighted Echo Planar Imaging.
Tymianski ‘257 teaches wherein the ADC metric is determined using a single shot or multi-shot diffusion-weighted Echo Planar Imaging (0132, 0139).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Reeder ‘656 to include the features of Tymianski ‘257 in order to determine blood flow and ADC-derived lesion volume in the region of interest.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reeder ‘656.
In re claim 25, it would have been obvious of a conventional diagnostic of choices and decision for a doctor to rescan the patient after at least a week for comparison and better diagnoses and disease tracking, and such obvious method would lead to the reading on “wherein MRI images are acquired over a set time period to monitor changes in the breast composite map and the breast tissue characteristics, and wherein the set time period is a minimum of 1 week.”
Allowable Subject Matter
Claim 6 is 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 while resolving any 112 rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM 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, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
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