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 Interpretation 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
As to claims 6-11, the “acquisition unit” is considered to read on a computer with a processor for operating an acquisition program (Specification as filed: Figure 3 and [0043]; PGPUB: Figure 3 and [0050]).
As to claims 6-11, the “extraction unit” is considered to read on a computer with a processor for operating an extraction program (Specification as filed: Figure 3 and [0043]; PGPUB: Figure 3 and [0050]).
As to claims 6-11, the “calculation unit” is considered to read on a computer with a processor for operating a calculation program (Specification as filed: Figure 3 and [0043]; PGPUB: Figure 3 and [0050]).
As to claims 6-11, the “adjustment unit” is considered to read on a computer with a processor for operating an adjustment program (Specification as filed: Figure 3 and [0043]; PGPUB: Figure 3 and [0050]).
As to claim 11, the “output unit” is considered to read on a computer with a processor for operating an evaluation output program (Specification as filed: Figure 3 and [0043]; PGPUB: Figure 3 and [0050]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al., US 10,453,224 B1 (Lin).
Regarding claim 1, Lin teaches an image standardization method for standardizing intensity values of multiple images (normalization of intensity values of multiple (set of) MRI images) (col. 3, lines 60-66) of a biological sample (region segmentation can include the region designations of bone region, soft region, and mixed region) (col. 2, lines 45-52), comprising the steps of:
a) extracting a region (all the intensity values of voxels in images from the multiple MRI scans are extracted for each region except for the excluded region) (col. 2, lines 54-56) corresponding to a whole or a part of the biological sample (region segmentation can include the region designations of bone region, soft region, and mixed region) (col. 2, lines 45-52) in each of the images, as an observation target region, for each of the multiple images (taking voxels for the same area from different training subjects) (col. 3, line 66 to col. 4, line 2);
b) calculating an aggregate value of intensity values (average MRI intensity value) (col. 4, lines 4-6) for each of the multiple observation target regions (calculating an average MRI intensity value for a given set of MRI scan images of voxels for the same area) (col. 3, line 66 to col. 4, line 10); and
c) adjusting intensity values of the multiple observation target regions so that a difference in the aggregate value becomes smaller (determine a training subject-specific correction factor to multiply the MRI intensity values of each subject for this set of MRI scan, so that the average intensity values from all training subjects are the same for this given set of MRI scan; thus the difference becomes zero) (col. 4, lines 7-10).
Although Lin does not explicitly teach that the biological sample includes multiple cells, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that since Lin teaches that the region can be tissue and/or bone (col. 2, lines 45-52) that tissue and bone are obviously made up of multiple cells.
Regarding claim 2, Lin teaches wherein the aggregate value is an average value of multiple intensity values included in the observation target region (calculating an average MRI intensity value for a given set of MRI scan images of voxels for the same area) (col. 3, line 66 to col. 4, line 10).
Regarding claim 4, Lin teaches wherein the region corresponding to the biological sample in each of the images includes multiple regions having different intensity values (region segmentation can include the region designations of bone region, soft region, and mixed region) (col. 2, lines 45-52), and
in the step a), one of the multiple regions is extracted as the observation target region (wherein the intensity values of voxels in images from the multiple MRI scans for each region, except for the excluded region; thus selecting the region that isn’t the excluded region) (col. 2, lines 54-56).
Claim(s) 3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al., US 10,453,224 B1 (Lin) and further in view of Oishi, US 2016/0317016 A1 (Oishi).
Regarding claim 3, Lin teaches calculating an average MRI intensity value for a given set of MRI scan images of voxels for the same area (col. 3, line 66 to col. 4, line 10).
However, Lin does not explicitly teach “wherein the aggregate value is a median value of multiple intensity values included in the observation target region”.
Oishi teaches an image generating apparatus includes an obtaining unit configured to obtain plural pieces of tomographic image data, in which each piece of tomographic image data indicates a cross section of substantially the same position of a subject (Abstract); and wherein the aggregate value is a median value of multiple intensity values (It should be noted that the signal intensity of the averaged image (average value of the signal intensities) is used as the comparison object with the threshold, but a representative value such as a highest value, a lowest value, or a median value of the signal intensities at the positions corresponding to the plurality of tomographic images may be used) ([0045]) included in the observation target region (generation unit extracts the intensity averaged image set as the processing target from among the intensity averaged images at the plurality of Y positions; wherein subsequently, the generation unit respectively applies a median filter) ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lin to include using a median value of the intensities since it allows for the target to be imaged at satisfactory accuracy (Oishi; [0121]).
Regarding claim 5, Lin teaches wherein the images are tomographic images or three-dimensional images (three-dimensional images through computed tomography (CT) and magnetic resonance imaging (MRI)) (col. 1, lines 16-18) of the biological sample (region segmentation can include the region designations of bone region, soft region, and mixed region) (col. 2, lines 45-52). Oishi teaches wherein the images are tomographic images or three-dimensional images (three-dimensional tomographic image data) ([0048]) of the biological sample (of a human eye) ([0029] and [0032]) that are acquired by optical coherence tomography (which are acquired by an image pickup apparatus, OCT apparatus, using optical coherence tomography) ([0028]).
Regarding claim 6, see the rejection made to claim 1, as well as prior art Oishi for an observation apparatus (OCT apparatus) (Fig. 1; [0028]) comprising an image acquisition unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), extraction unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), calculation unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), and adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), for they teach all the limitations within this claim.
Regarding claim 7, see the rejection made to claim 2, as well as prior art Oishi for an observation apparatus (OCT apparatus) (Fig. 1; [0028]) comprising an image acquisition unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), extraction unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), calculation unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), and adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), for they teach all the limitations within this claim.
Regarding claim 8, see the rejection made to claim 3, as well as prior art Oishi for an observation apparatus (OCT apparatus) (Fig. 1; [0028]) comprising an image acquisition unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), extraction unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), calculation unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), and adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), for they teach all the limitations within this claim.
Regarding claim 9, see the rejection made to claim 4, as well as prior art Oishi for an observation apparatus (OCT apparatus) (Fig. 1; [0028]) comprising an image acquisition unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), extraction unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), calculation unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), and adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), for they teach all the limitations within this claim.
Regarding claim 10, see the rejection made to claim 5, as well as prior art Oishi for an observation apparatus (OCT apparatus) (Fig. 1; [0028]) comprising an image acquisition unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), extraction unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), calculation unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), and adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]), for they teach all the limitations within this claim.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al., US 10,453,224 B1 (Lin), Oishi, US 2016/0317016 A1 (Oishi), and further in view of Richter et al., US 2020/0245960 A1 (Richter).
Regarding claim 11, Lin teaches an image having an intensity value having been adjusted (determine a training subject-specific correction factor to multiply the MRI intensity values of each subject for this set of MRI scan, so that the average intensity values from all training subjects are the same for this given set of MRI scan; thus the difference becomes zero) (col. 4, lines 7-10). Oishi teaches outputs an OCT angiography image as a result of the signal processing (Fig. 4; [0085]); and wherein intensity values/signals are adjusted ([0045]) using the intensity-value adjustment unit (computer apparatus that includes instructions for performing the functions) ([0029] and [0154]).
However, neither explicitly teaches “further comprising an evaluation-value output unit configured to output an evaluation value of the biological sample”.
Richter teaches systems and methods that provide for automated analysis of three-dimensional (3D) medical images of a subject in order to automatically identify specific 3D volumes within the 3D images that correspond to specific anatomical regions (Abstract); and wherein further comprising an evaluation-value output unit configured to output an evaluation value of the biological sample (evaluating and deriving meaning from intensity fluctuations in the functional image; it allows for regions of the functional image to be identified as corresponding to particular tissue regions of the subject) ([0203-0204]) on the basis of an image having an intensity value having been adjusted by the intensity-value adjustment unit (measures of intensity, such as a mean, peak, maximum, etc., within these reference volumes are then computed and used as reference points against which to evaluate intensities of individual detected hotspots and convert them to index values on the scale) ([0015-0016]) (adjusting intensities of voxels using a processor) ([0033-0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of prior arts to include using evaluation on the intensity values since it provides valuable context (Richter; [0203]), allows for more accurate diagnosis by evaluating in proper context (Richter; [0204]), and providing for consistent, efficient, and accurate detection of anatomical regions, including soft tissue organs, in the entire body (Richter; Abstract); and the accurate identification of one or more such volumes is used to automatically determine quantitative metrics that represent uptake of radiopharmaceuticals in particular organs and/or tissue regions (Richter; Abstract); wherein these uptake metrics can be used to assess disease state in a subject, determine a prognosis for a subject, and/or determine efficacy of a treatment modality (Richter; Abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J VANCHY JR whose telephone number is (571)270-1193. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/MICHAEL J VANCHY JR/Primary Examiner, Art Unit 2666 Michael.Vanchy@uspto.gov
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