DETAILED ACTION
Preliminary Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a 371 of PCT/EP2023/055072 filed 03/01/2023 which further claims priority to EPO 22161888.7 filed 03/14/2022.
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.
Claim(s) 1-4, 12 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matthews (U.S. Publication 2015/0003696).
In reference to claim 1, Matthews discloses a computer-implemented method of providing normalised medical images representing a region of interest in a subject (see paragraphs 1, 37, 49-50 and Figures 1 and 5-9 wherein Matthews discloses a medical image processing method for registering medical image data with a reference medical image dataset using a computer system comprising a processor for executing program instructions stored in a memory.), the method comprising:
receiving image data comprising a temporal series of 2D medical images including a region of interest in the subject (see paragraphs 48, 57-58 and Figures 3, 5-6, wherein Matthews discloses obtaining an x-ray scan of a region of a patient producing a series of 2D 512x512 image slices through the patient’s abdomen or body part of interest. Note, it is clear that the “series” of scans taken of at least a “body part of interest” in Matthews can be considered equivalent to Applicant’s “temporal series of 2D medical images including a region of interest in the subject.);
receiving a 2D atlas image representing the region of interest; and for each medical image in the temporal series (see paragraphs 48, 75-76, 87-88, 117 and Figures 7-8, #T1, U1 wherein Matthews discloses obtaining a reference dataset known as an atlas dataset that is a collection of actual medical image data for a particular portion of anatomy.):
warping the medical image to the atlas image to provide a normalised medical image having a warped region of interest for comparison with the region of interest in the atlas image (see paragraphs 77-81, 87, 98, 103 and Figures 7-9 wherein Matthews discloses determining variance data for an atlas dataset for use in segmenting a novel image dataset according to image registration (e.g. geometric normalization), the image registration being a mapping transform and more particularly a warping of novel image datasets using the atlas image datasets and computed variance data. Matthews discloses performing the registration using a warp field that sets magnitudes of warp for areas of higher atlas variance.); and
outputting the normalised medical images and a magnitude of a change in the warped region of interest between the normalised medical images (see paragraphs 98, 103 and Figure 9 wherein Matthews discloses producing a novel image dataset segmentation according to the warping processing which at least inherently produces the “warp field” that comprises magnitudes of warping, of which the Examiner interprets equivalent to Applicant’s “magnitude of a change in the warped region.”)
Although Matthews does disclose producing the atlas dataset either via medical imaging or by simply reading from computer storage (see paragraph 75), Matthews does not explicitly disclose the atlas dataset itself as 2D or two-dimensional. At the time the invention was filed, it would have been obvious to one of ordinary skill in the art to implement the medical image processing techniques of Matthews using atlas image datasets that are 2D. In the field of computer image processing, it is well-established that image operations span across various image dimensions. Applicant has not disclosed that explicitly requiring the atlas image data as 2D only provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the techniques as described by Matthews because the selection of 2D vs. 3D image data processing is a matter of engineering design choice as to which best suits the application at hand and/or to which best suits the inventor. Matthews further explicitly discusses collecting images in a multitude of different dimensions/modalities using a multitude of different imaging technologies of which include 2D image datasets (see at least paragraphs 2 & 55). Therefore, it would have been obvious to one of ordinary skill in this art to modify Matthews to obtain the invention as specified in claim 1.
In reference to claim 2, Matthews discloses all of the claim limitations of claim 1 above in addition. Although Matthews does not explicitly teach the aspect of the atlas image dataset representing a preferred perspective of the region of interest, Matthews discloses determining variance data for an atlas dataset for use in segmenting a novel image dataset according to image registration (e.g. geometric normalization), the image registration being a mapping transform and more particularly a warping of novel image datasets using the atlas image datasets and computed variance data (see at least paragraphs 87, 98, 103). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to modify the visual presentation of ROI medical image data techniques in Matthews to allow for a “preference” of such “visual representation” (via Matthew’s warping) in order to arrive at the invention. Motivation to perform such a modification would be to allow for a greater sense of customizability and flexibility in display output which would lead to an overall more “easy-to-use” user interface/device.
In reference to claim 3, Matthews discloses all of the claim limitations of claim 1 above in addition. Matthews discloses performing landmark information generation of novel medical images based on landmark information for that alas or reference dataset (see at least paragraph 36).
In reference to claim 4, Matthews discloses all of the claim limitations of claim 1 above in addition. Matthews further discloses the labeling of anatomical landmarks in both the atlas and novel image datasets and using such locations to measure the variance for offsets established between each landmark (see paragraphs 9, 106, 108 and Figure 9).
In reference to claim 12, Matthews discloses all of the claim limitations of claim 1 above in addition. Although Matthews does disclose focusing the image processing on a region of interest in the medical datasets, Matthews does not explicitly disclose suppressing one or more image features outside the region of image. It is well known in the art of image processing to only modify regions of image data that the user desires or is focused/interested in and disregarding, clipping or “suppressing” other regions of the image data. Allowing for the disregarding, clipping or “suppressing” of other regions of image data makes for a more memory efficient image processing system by only operating upon areas of an image that are desired (Official Notice). It would have been obvious to one of ordinary skill in the art for Matthews who already teaches image processing on a region of interest in medical datasets, because it is well known in the art that disregarding, clipping or “suppressing” of other regions of image data makes for a more memory efficient image processing system.
In reference to claim 16, Matthews discloses all of the claim limitations of claim 1 above in addition. Matthews discloses obtaining an x-ray scan of a region of a patient producing a series of 2D 512x512 image slices through the patient’s abdomen or body part of interest Matthews explicitly discloses (see paragraphs 48, 57-58 and Figures 3, 5-6). Further, the Examiner notes that the claim recites “or” type language requiring only a single teachings form the listing of limitations in the claim.
In reference to claim 17, Matthews discloses all of the claim limitations of claim 1 above in addition. Although Matthews does discuss the usage of specific CT scanner type devices (see at least paragraph 48 and Figure 3), Matthews does not explicitly disclose the obtaining of such x-ray images specifically generated via a “mobile X-ray imaging system.” At the time the invention was filed, it would have been obvious to one of ordinary skill in the art to utilize a number of different medical image scanner type devices to obtain the medical image datasets operating upon by Matthews. Applicant has not disclosed that the usage of an explicit “mobile X-ray imaging system” provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the teachings of Matthews because the exact type of device utilized to obtain the x-ray image dataset is a matter of engineering design choice as preferred by the inventor and/or to which best suits the application at hand. Therefore, it would have been obvious to one of ordinary skill in this art to modify Matthews to obtain the invention as specified in claim 17.
In reference to claim 18, Matthews discloses all of the claim limitations of claim 1 above in addition. Matthews explicitly discloses the usage of a CT scanner type device to obtain the medical image dataset (see at least paragraph 48 and Figure 3) of which the Examiner interprets as inherently providing a “longitudinal study on the subject” (patient).
In reference to claim 19, claim 19 is similar in scope to claim 1 and is therefore rejected under like rationale. In addition to the above rationale as applied to claim 1 above, claim 19 further recites, “A non-transitory computer-readable medium comprising executable instructions which, when executed by at least one processor, cause the at least one processor to perform a method for providing normalised medical images…” Matthews discloses a medical image processing method for registering medical image data with a reference medical image dataset using a computer system comprising a processor for executing program instructions stored in a memory (see paragraphs 1, 37, 49-50 and Figures 1 and 5-9).
In reference to claim 20, claim 20 is similar in scope to claim 1 and is therefore rejected under like rationale. In addition to the above rationale as applied to claim 1 above, claim 20 further recites, “A system for providing normalized medical images representing a region of interest in a subject, the system comprising one or more processors configure to…” Matthews discloses a medical image processing method for registering medical image data with a reference medical image dataset using a computer system comprising a processor for executing program instructions stored in a memory (see paragraphs 1, 37, 49-50 and Figures 1 and 5-9).
Allowable Subject Matter
Claims 5-11 and 13-15 are 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.
Response to Arguments
Applicant’s arguments, see page 8 of Applicant’s Remarks, filed 06/11/26, with respect to the objection of the abstract have been fully considered and are persuasive. The objection of the abstract has been withdrawn since amendments remedy the previous issues.
Applicant’s arguments, see page 8 of Applicant’s Remarks, filed 06/11/26, with respect to the objection of claims 19 and 20 have been fully considered and are persuasive. The objection of claims 19 and 20 has been withdrawn since amendments remedy the previous issues.
Applicant's arguments filed 06/11/26 have been fully considered but they are not persuasive.
In reference to claims 1, 19 and 20, Applicant argues that the cited prior art Matthews does not explicitly disclose the claimed limitations of, “a temporal series of 2D medical images” and “outputting the normalised medical images and magnitude of a change in the warped region of interest between the normalized medical images,” (see pages 8-9 of Applicant’s Remarks). In particular, Applicant argues that Matthews solely discloses the image slices representing a series of volume data and NOT temporal data (see page 9, 1st paragraph of Applicant’s Remarks). Further, Applicant argues that Matthews solely discloses that the magnitude discussed therein is a magnitude of a warp in a warp field used for registration mapping and NOT in representing a chance in a warped region of interest (see page 9, 2nd paragraph of Applicant’s Remarks).
In response, the Examiner disagrees. Firstly, Matthews explicitly discloses: “While the method has been primarily described with reference to CT medical image datasets collected by conventional CT scanners, the principles described herein are more generally applicable to other 2D and 3D datasets, and also so-called 4D datasets, i.e. time sequences of volume image datasets.” (see paragraph 117). In other words, Matthews explicitly refers to the volume datasets in a fourth dimension which is time therefore, the Examiner interprets such teachings of Matthews to disclose the limitations as argued by Applicant. Further, as per the “magnitude of change…” limitations of the claims, Matthews explicitly details in at least Figure 9 that the warping output utilizes a warp field that explicitly references “magnitude of warp” for “atlas variance” while further showing the warp field comprising vectors of different lengths which itself at least inherently defines “magnitudes.” Although Matthews maybe using such magnitudes in an image registration, the claims simply describe a “warped region of interest” of a “normalised medical image,” in other words, it does not rule out any interpretation by one of ordinary skill in the art that teachings of Matthews cannot be applied thereto. Perhaps Applicant desires the claim limitations to me more than that which is claimed however, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In view of the above, the Examiner deems the rejection of the claims based upon the Matthews prior art as just.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Antonio Caschera whose telephone number is (571) 272-7781. The examiner can normally be reached Monday-Friday between 6:30 AM and 2:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Said Broome, can be reached at (571) 272-2931.
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Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Technology Center 2600 Customer Service Office whose telephone number is (571) 272-2600.
/Antonio A Caschera/
Primary Examiner, Art Unit 2612
7/31/26
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