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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
The USPTO “Interim Guidelines for Examination of Patent Applications for Patent Subject Matter Eligibility” (Official Gazette notice of 22 November 2005), Annex IV, reads as follows (see also MPEP 2106):
In contrast, a claimed computer-readable medium encoded with a computer program is a computer element which defines structural and functional interrelationships between the computer program and the rest of the computer which permit the computer program's functionality to be realized, and is thus statutory. See Lowry, 32 F.3d at 1583-84, 32 USPQ2d at 1035.
Claims that recite nothing but the physical characteristics of a form of energy, such as a frequency, voltage, or the strength of a magnetic field, define energy or magnetism, per se, and as such are nonstatutory natural phenomena. O'Reilly, 56 U.S. (15 How.) at 112-14. Moreover, it does not appear that a claim reciting a signal encoded with functional descriptive material falls within any of the categories of patentable subject matter set forth in Sec. 101.
… a signal does not fall within one of the four statutory classes of Sec. 101.
… signal claims are ineligible for patent protection because they do not fall within any of the four
statutory classes of Sec. 101.
Claims 26 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows. Claim 26 is drawn to functional descriptive material recorded on a computer program product. The specification define that This computer program product may, for example, be provided on a data carrier or as a downloadable signal sequence. With broadest reasonable interpretation, computer program product includes non-statutory subject matter such as a “signal” or “carrier wave". Term “including, but not limited to” is open ended and does not exclude additional unrecited elements.
“A transitory, propagating signal … is not a “process, machine, manufacture, or composition of matter.” Those four categories define the explicit scope and reach of subject matter patentable under 35 U.S.C. § 101; thus, such a signal cannot be patentable subject matter.” (In re Nuijten, 84 USPQ2d 1495 (Fed. Cir. 2007)).
Because the full scope of the claim as properly read in light of the disclosure appears to encompass non-statutory subject matter (i.e., because the specification defines/exemplifies a computer readable medium as a non-statutory signal, carrier waver, etc.) the claim as a whole is non-statutory. The examiner suggests amending the claim to include the disclosed non-transitory tangible computer readable storage media, while at the same time excluding the transitory intangible transitory media such as signals, carrier waves, etc. Any amendment to the claim should be commensurate with its corresponding disclosure.
Claim Rejections - 35 USC § 102
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)(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 1-6, 8-10, 12-20, 22-24 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zaharchuk et al. (US 2019/0108634).
With respect to claim 1, Zaharchuk et al. teach input means for obtaining MRI images relating to at least one part of a patient's body without contrast agent administration (Fig. 1, 100, input image taken with zero contrast agent does; Fig. 4, 400 pre contrast )
input means for obtaining MRI images relating to at least the part of the patient's body with a first contrast agent administration (Fig. 1, 102, input image taken with low contrast agent does; Fig. 4, 402, 10% low does ),
means for image registration of the MRI images without contrast agent administration and the MRI images with contrast agent administration(Fig. 1, 106, multi-contrast image co-registration),
means for creating at least one subtraction image from the comparison of image- registered MRI images without contrast agent administration and image-registered MRI images with contrast agent administration (Fig. 4, 400-402),
means for contrast enhancement based on the subtraction image and the image- registered MRI images without contrast agent administration or the MRI image with low the first contrast agent administration, wherein the means for contrast enhancement on the basis of a trained neural network provide on the one hand an enhancement as well as an artifact reduction by means of a non-linear transformation (para [0032]), wherein the trained neural network has been trained at least partially using de-noised reference images as ground truth and wherein the means for contrast enhancement are set up to produce a de-noised contrast-enhanced difference image (Fig. 1, 116; Fig. 8, 806, synthesized image; para [0040], the method generates diagnostic quality contrast from the low-dose acquisition, also demonstrating improved noise suppression and contrast enhancement; Fig. 4 Deep learning).
With respect to claim 2, Zaharchuk et al. teach that the de-noised reference images have been produced at least partially from subtraction images containing noise and based on a probability of a contrast agent- related signal enhancement calculated by means of a machine learning model for each of the subtraction images (para [0031], predicting the enhancement signal).
With respect to claim 3, Zaharchuk et al. teach that the first contrast agent administration is reduced by at least 50 % relative to a second contrast agent administration, the second contrast agent administration corresponding to a conventional contrast agent administration allowed for an MRI image of the body part (para [0007], The low dose may be any fraction of the full dose, but is preferably 1/10 or less of the full dose).
With respect to claim 4, Zaharchuk et al. teach that three-dimensional data is used throughout and the image registration means operate in three-dimensional space and provide rigid body registration in three dimensions (para [0033]).
With respect to claim 5, Zaharchuk et al. teach that the device further comprises means for interpolation, so that MRI images of different resolutions may be interpolated to a common resolution before further processing (para [0009], The method includes preprocessing to co-register and normalize between different images so they are directly comparable. This step is important since there are arbitrary different acquisition and scaling factor for each scan).
With respect to claim 6, Zaharchuk et al. teach that the means for interpolation have a standardization of the intensities (para [0024], normalization is used to match the intensity of each image/volume)
With respect to claim 8, Zaharchuk et al. that the neural network has three-dimensional convolutions (para [0044]).
With respect to claim 9, Zaharchuk et al. teach that that the neural network takes into account different sequences selected from T1-weighted acquisition without contrast agent administration, T1-weighted acquisition with reduced contrast agent administration, T2-weighted acquisition, and diffusion-weighted acquisition (para [0026]).
10. The device according to claim 1, characterized in that the contrast-enhanced subtraction image is added to the image-registered MRI images without contrast agent administration (Fig. 4, 410+400).
With respect to claim 12, claim 12 is rejected same reason as claim 1 above.
With respect to claim 13, claim 13 is rejected same reason as claim 2 above.
With respect to claim 14, claim 14 is rejected same reason as claim 3 above.
With respect to claim 15, claim 15 is rejected same reason as claim 4 above.
With respect to claim 16, Zaharchuk et al. teach that that it comprises an approved contrast agent administration of 0.1 mmol/kg (para [0012]).
With respect to claim 17, Zaharchuk et al. teach that that the first contrast agent administration is 50% to 1%, in particular 35% to 5%, in particular 35% to 30%, and in particular 20% to 5% compared to a second contrast agent administration corresponding to an approved contrast agent administration (para [0007], The low dose may be any fraction of the full dose, but is preferably 1/10 or less of the full dose).
With respect to claim 18, Zaharchuk et al. teach that the provision of a contrast enhancement is also provided on the basis of at least one metadatum (para [0027], patient weight)
With respect to claim 19, Zaharchuk et al. teach that the at least one metadatum is selected from the group comprising a device identification, field strength(s) used in the measurement, contrast agent used in the measurement, contrast agent administration used in the measurement (absolute and relative), weight of the patient, age of the patient, height of the patient, sex of the patient, status of the patient (e.g., pre-/post-operative) (para [0027], patient weight)
With respect to claim 20, claim 20 is rejected same reason as claim 6 above.
With respect to claim 22, claim 22 is rejected same reason as claim 8 above.
With respect to claim 23, claim 23 is rejected same reason as claim 9 above.
With respect to claim 24, claim 22 is rejected same reason as claim 8 above.
With respect to claim 26, claim 26 is rejected same reason as claim 1 above.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 7 and 21 are rejected under 35 USC 103 as being unpatentable over Zaharchuk et al. (US 2019/0108634) in view of Schmainda et al. (US 2022/0107377).
Zaharchuk et al. teach all the limitations of claim 6 as applied above from which claim 7 respectively depend.
Zaharchuk et al. do not teach expressly that means for interpolation have at least one of a Student t-standardization of the intensities and a Nyul standardization of the intensities. .
Schmainda et al. teach means for interpolation is Nyul standardization of the intensities. (para [0010])).
At the time of effective filing, it would have been obvious to a person of ordinary skill in the art to use Nyul standardization of the intensities to normalize image in the method of Zaharchuk et al..
The suggestion/motivation for doing so would have been that use well known method to normalize medical image so that makes comparison accurate.
Therefore, it would have been obvious to combine Schmainda et al. with Zaharchuk et al. to obtain the invention as specified in claim 7.
With respect to claim 21, claim 21 is rejected same reason as claim 7 above.
Allowable Subject Matter
1. Claims 11 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable of rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Randolph Chu whose telephone number is 571-270-1145. The examiner can normally be reached on Monday to Thursday from 7:30 am - 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached on (571) 272-7778.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDOLPH I CHU/
Primary Examiner, Art Unit 2667
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