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 .
Drawings
The drawings were received on 2/15/2024. These drawings are accepted.
Claim Objections
Claims 2 and 12 are objected to because of the following informalities: Misspelling of 4-dimensional as 4-dimenstional. Appropriate correction is required.
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)(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, 3-4, 11 and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hoffman et al. (US20220254016, hereinafter “Hoffman”)
(Claims 1 and 3-4 are listed below Claims 11 and 13-14)
Claim 11. Hoffman teaches A system comprising:
data processing hardware; and
memory hardware in communication with the data processing hardware, ([0056] “The example computer system 700 includes a processor 702 (e.g., a central processing unit (CPU), … a main memory 704, and a static memory 706, which are configured to communicate with each other via a bus 708.”) the memory hardware storing instructions ([0057] “The instructions 724 (e.g., software) may also reside, completely or at least partially, within the main memory 704”) that when executed on the data processing hardware cause the data processing hardware to perform operations ([0059] “instructions 724 may be executable by the processor 702”) comprising:
defining lung segmentation of the lungs; ([0046] “ Lung segmentation is applied to TLC 12 and VNC images 22 to generate lung masks (18, 26).”)
performing deformable image registration on the segmented lungs; ([0046] “This registration 20 can be performed using any appropriate image registration method and one may assume registration to VNC here. The output of the registration 20 is the warped image 36” Warping an image for image registration is understood to be the same as the claimed deformable image registration as warping is a form of non-rigid image registration https://www.sciencedirect.com/science/article/pii/S2666555720300629)
performing ventilation estimation operations to determine a ventilation estimation; ([0042] “generate local ventilation maps… to assess regional ventilation”)
performing perfusion estimation operations to determine a perfusion estimation; ([0042] “derive a lung performance metric such as pulmonary…Perfusion maps.” And [0027] “Assessment of pulmonary perfusion”)
comparing the ventilation estimation to the perfusion estimation; ([0042] “generate local ventilation maps which are co-registered with blood perfusion in the lung.” And [0053] “The 3D map of the V/Q can be used directly by the radiologist to localize regions of VQ mismatch” Is understood to be the same as the claimed comparing the ventilation estimation to the perfusion estimation in light of instant specifications [0038])
and determining a pulmonary embolism risk score based on the comparison of the ventilation estimation to the perfusion estimation. ([0038] “Different colors may be used represent V/Q. For example, shades of blue may be used to represent higher than normal V/Q (i.e. low Q and/or high V) and shades of red may be used to represent lower than normal V/Q (i.e. low ventilation and/or high Q). Blue regions may be used represent areas of the lung where pulmonary emboli were restricting blood flow.” Is understood to be the same as the claimed pulmonary embolism (PE) risk score in light of instant specifications [0037] )
Claim 13. Hoffman teaches The system of claim 11, wherein the operations include receiving the images of the lungs. (Abstract “computed tomography (CT) scan of the lung to provide a total lung capacity (TLC) image” )
Claim 14. Hoffman teaches The system of claim 11, wherein the lungs are segmented into five regions. ( [0037] “FIG. 4 illustrates Lobar distribution of ventilation (V) and Perfusion (Q). LLL: left lower lobe; LUL: left upper lobe; RUL: right upper lobe; RML: right middle lobe; RLL: right lower lobe.” is understood to be the same as the claimed lungs are segmented into five regions in light of instant specifications [0030])
Claim 1. The method herein has been executed and performed by the system of claim 11 and is likewise rejected
Claim 3. The method herein has been executed and performed by the system of claim 13 and is likewise rejected
Claim 4. The method herein has been executed and performed by the system of claim 14 and is likewise rejected
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, 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.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US20220254016, hereinafter “Hoffman”)
Claim 15. Hoffman teaches The system of claim 14,
wherein the pulmonary embolism risk score is on a scale based on the number of lung regions that have ventilation/perfusion mismatch. ([0036] “Fig. 3 illustrates… percent of lung regions with a particular V/Q ratio.” The scale is shown in fig. 3 to be from 0 to 4 based on the percentage number of lung regions)
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Hoffman discloses the claimed invention except for wherein the PE risk score is on a scale of 0 to 5 instead Hoffman teaches a scale from 0 to 4. It would have been obvious for one of ordinary skill in the art to have a scale of 0 to 5 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum range involves only routine skill in the art. The scale is a results-effective variable and therefore it would have been obvious for an artisan of ordinary skill in the art to arrive at the same scale because it is not inventive to discover the optimum or workable ranges by routine experimentation according to MPEP 2144.05(II)(A)
Claim 5. The method herein has been executed and performed by the system of claim 15 and is likewise rejected
Claims 2, 9, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US20220254016, hereinafter “Hoffman”) and in view of Castillo et al (US20190183444, hereinafter “Castillo”)
(Claims 2 and 9 are listed below claims 12 and 19 )
Claim 12. Hoffman teaches The system of claim 11, wherein the images of the lungs are obtained using non-contrast computed tomography. ([0043] “CT scan of the lung may be processed to generate… a virtual non-contrast (VNC) image” is understood to be the same as the claimed non-contrast CT in light of instant specifications [0027])
Hoffman does not explicitly teach 4-dimenstional computed tomography
Castillo teaches 4-dimenstional computed tomography ([0030] “form four-dimensional (4D) CT image sets”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman to have 4-dimensional computed tomography as taught by Castillo to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been because (Castillo et al [0011]“accurate detection and treatment of PE is highly time sensitive.”)
Claim 19. Hoffman teaches The system of claim 11,
Hoffman does not explicitly teach wherein the pulmonary embolism risk score is determined using one or more of artificial intelligence, machine learning, and a neural network.
Castillo teaches wherein the pulmonary embolism risk score ([0062] “Referring again to FIG. 1E, brighter regions of the RIBMC image 234 indicate a relatively large amount of blood mass change (with respect to the 4D CT time points t.sub.1, t.sub.2), while the darker colors indicate very little or no blood mass change.”) is determined using one or more of artificial intelligence, machine learning, and a neural network. ([0043] “the segmenter 220 may execute other segmentation algorithms, such as those based on machine learning.”)
It would have been obvious to persons of ordinary skill in the art before the effective filing date of the claimed invention to modify Hoffman to have PE risk score determined using machine learning as taught by Castillo to arrive at the claimed invention discussed above. The motivation for the proposed modification would have been because (Castillo et al [0011]“accurate detection and treatment of PE is highly time sensitive.”)
Claim 2. The method herein has been executed and performed by the system of claim 12 and is likewise rejected
Claim 9. The method herein has been executed and performed by the system of claim 19 and is likewise rejected
Allowable Subject Matter
Claims 6-8, 10, 16-18 and 20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Zhang et al US8538111 teaches deformable image registration to calculate pulmonary ventilation
Samarage et al WO2018157191 teaches calculating V/Q ratio based on the extracted vessel region
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/OWAIS I MEMON/Examiner, Art Unit 2663