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 Objections
Claim 7 is objected to because of the following informalities: the acronym application diffusion coefficient ADC is inconsistent with ADC as set forth in the original specification. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 11 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.
The scope of claim 11 is unclear. The claim recites a non-transitory computer-readable medium but fails to set forth any algorithm or instructions. The claim merely recites the intended use of the computing device to carry out a method.
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 therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of generating a synthetic contrast image based on mathematical operations or algorithms without significantly more. The claim(s) recite(s) the steps of obtaining a convolutional neural network (CNN) (step of using a mathematical operation/algorithm), obtaining at least one candidate pre-contrast image and a candidate contrast image (step of receiving data); and generating a synthetic contrast image by applying the CNN (step of using a mathematical operation/algorithm). This judicial exception is not integrated into a practical application because the claimed subject matter generally links the use of the judicial exception to a particular technological environment or field of use, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, and performing mathematical operations or algorithms. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the addition of general-purpose computer components alone to perform such steps is not sufficient to transform a judicial exception into a patentable invention. The computer components are recited at a high level of generality and perform the basic functions of a computer (in this case, performing a mathematical operation/algorithm and receiving data) that would be needed to apply the abstract idea via a computer. Merely using generic computer components to perform the above identified basic computer functions to practice or apply the judicial exception does not constitute a meaningful limitation that would amount to significantly more than the judicial exception.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of generating a synthetic contrast image based on mathematical operations or algorithms without significantly more. The claim(s) recite(s) the steps of obtaining a convolutional neural network (CNN) (step of using a mathematical operation/algorithm), obtaining at least one candidate pre-contrast image and a candidate contrast image (step of receiving data); and generating a synthetic contrast image by applying the CNN (step of using a mathematical operation/algorithm). This judicial exception is not integrated into a practical application because the claimed subject matter generally links the use of the judicial exception to a particular technological environment or field of use, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, and performing mathematical operations or algorithms. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the addition of general-purpose computer components alone to perform such steps is not sufficient to transform a judicial exception into a patentable invention. The computer components are recited at a high level of generality and perform the basic functions of a computer (in this case, performing a mathematical operation/algorithm and receiving data) that would be needed to apply the abstract idea via a computer. Merely using generic computer components to perform the above identified basic computer functions to practice or apply the judicial exception does not constitute a meaningful limitation that would amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-7 and 9 is/are rejected under 35 U.S.C. 103 as being obvious over Zaharchuk et al. (US 2019/0108634) in view of Valbusa et al. (US 2024/0290472).
Zaharchuk et al. discloses a method for medical imaging comprising of steps of obtaining a convolutional neural network ([0008]); trained from pre-contrast input image ([0007]; [0024]); post-contrast image ([0024]; [0026]); standard contrast dose ([0047]); and generating a synthetic contrast image ([0009]; [0024]). Zaharchuk et al. does not teach a super dose contrast image. However, Valbusa et al. teaches in the same field of endeavor simulation of a boosted dose higher than the standard dose ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Zaharchuk et al. with simulation of a super dose as taught by Valbusa et al. in order to provide a beneficial effect on the quality of the imaging procedure without affecting the standard of care and does not impact clinical workflows ([0036]).
With respect to claim 2, Zaharchuk et al. discloses wherein the low dose of contrast agent is between 10% and 50% of the standard dose of contrast agent ([0007]; [0012]).
With respect to claims 2-4, Zaharchuk et al. discloses the subject matter substantially as claimed except for the dose range of the contrast agent. However, an optimization of ranges is well within the skill level of one of ordinary skill in the art (MPEP 2144.05(II)(A)). Therefore, it would have been obvious to one of ordinary skill in the art to have modified Zaharchuk et al. as an optimization of range is well within the skill level of one of ordinary skill in the art with a finite number of possibilities with predictable results (MPEP 2144.05(II)(A)).
With respect to claim 5, Zaharchuk et al. discloses a MRI scanner ([0026]).
With respect to claims 6-7, Zaharchuk et al. discloses T1-weighted, T2-flair-weighted, and/or diffusion weighted imaging ([0050]).
With respect to claim 9, Zaharchuk et al. discloses training said CNN ([0009-0010]; [0024]).
Claim(s) 1 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2019/0122348) in view of Valbusa et al. (US 2024/0290472).
Jensen discloses a method for medical imaging comprising of steps of obtaining a convolutional neural network ([0048]; [0064]); trained from pre-contrast input image ([0038-0039]; [0044]); post-contrast image ([0048-0049]); and generating a synthetic contrast image ([0065]). Jensen does not teach a super dose contrast image. However, Valbusa et al. teaches in the same field of endeavor simulation of a boosted dose higher than the standard dose ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Jensen with simulation of a super dose as taught by Valbusa et al. in order to provide a beneficial effect on the quality of the imaging procedure without affecting the standard of care and does not impact clinical workflows ([0036]).
With respect to claim 5, Jensen discloses a MRI scanner ([0037]).
With respect to claims 6-7, Jensen discloses T1-weighted, T2-flair-weighted, and/or diffusion weighted imaging ([0021]; [0033]; [0044]).
Claims 1 and 5 is/are rejected under 35 U.S.C. 103 as being obvious over Stancanello et al. (WO 2022/129634) in view of Valbusa et al. (US 2024/0290472).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Stancanello et al. discloses a method for medical imaging comprising the implementation by a data processor (11b; page 9, line 17) of an inference server (1b, page 9, line 18) of steps of obtaining a convolutional neural network (page 7, lines 13-20; page 8, line 26 to page 11, line 15); and generating a synthetic contrast image (page 11, lines 4-13). Stancanello et al. does not teach a super dose contrast image. However, Valbusa et al. teaches in the same field of endeavor simulation of a boosted dose higher than the standard dose ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Stancanello et al. with simulation of a super dose as taught by Valbusa et al. in order to provide a beneficial effect on the quality of the imaging procedure without affecting the standard of care and does not impact clinical workflows ([0036]).
With respect to claim 5, Stancanello et al. discloses a MRI scanner (page 7, line 5).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being obvious over Stancanello et al. (WO 2022/129634) in view of Valbusa et al. (US 2024/0290472) as applied to claim 1, further in view of Jensen (US 2019/0122348).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Stancanello et al. discloses the subject matter substantially as claimed except for T1-weighted, T2-flair-weighted, or ADC image. However, Jensen teaches in the same field of endeavor T1-weighted, T2-flair-weighted, and/or diffusion weighted imaging ([0021]; [0033]; [0044]) are known contrast MRi images. Therefore, it would have been obvious to one of ordinary skill in the art to have provided Stancanello et al. with the contrast images as taught by Jensen as they are well known contrast images.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 8 is/are rejected under 35 U.S.C. 103 as being obvious over Zaharchuk et al. (US 2019/0108634) in view of Valbusa et al. (US 2024/0290472) as applied to claim 1, further in view of Haghighi et al. (US 2021/0343014).
Zaharchuk et al. discloses the subject matter substantially as claimed except for wherein said CNN comprises an encoder branch followed by a decoder branch, with skip connections between the encoder branch and decoder branch. However, Haghighi et al. teaches in the same field of endeavor it is well known for CNN to comprise encoder-decoder with skip connects ([0037];[0131]; [0182]; Fig. 8B) to provide automated analysis to medical imaging with a high degree of accuracy so as to improve diagnosis capabilities, control medical costs, and to reduce workload burdens placed upon medical professionals ([0008]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Zaharchuk et al. with encoder-decoder skip connections as taught by Haghighi et al. to provide automated analysis to medical imaging with a high degree of accuracy so as to improve diagnosis capabilities, control medical costs, and to reduce workload burdens placed upon medical professionals ([0008]).
Claims 8 is/are rejected under 35 U.S.C. 103 as being obvious over Jensen (US 2019/0122348) in view of Valbusa et al. (US 2024/0290472) as applied to claim 1, further in view of Haghighi et al. (US 2021/0343014).
Jensen discloses the subject matter substantially as claimed except for wherein said CNN comprises an encoder branch followed by a decoder branch, with skip connections between the encoder branch and decoder branch. However, Haghighi et al. teaches in the same field of endeavor it is well known for CNN to comprise encoder-decoder with skip connects ([0037];[0131]; [0182]; Fig. 8B) to provide automated analysis to medical imaging with a high degree of accuracy so as to improve diagnosis capabilities, control medical costs, and to reduce workload burdens placed upon medical professionals ([0008]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Jensen with encoder-decoder skip connections as taught by Haghighi et al. to provide automated analysis to medical imaging with a high degree of accuracy so as to improve diagnosis capabilities, control medical costs, and to reduce workload burdens placed upon medical professionals ([0008]).
Claims 11 is/are rejected under 35 U.S.C. 103 as being obvious over Zaharchuk et al. (US 2019/0108634) in view of Valbusa et al. (US 2024/0290472) and Mazo (US 2018/0240235).
Zaharchuk et al. in view of Valbusa et al. (see above) discloses the subject matter substantially as claimed except for a computer readable storage medium. However, Mazo teaches in the same field of endeavor it is well known for computer readable storage medium to store instructions to execute by a processor ([0053-0054]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Zaharchuk et al. with a computer readable storage medium as taught by Mazo as it is well known in the art for computer readable storage medium to store instructions to be executed by a processor ([0053-0054]).
Claims 11 is/are rejected under 35 U.S.C. 103 as being obvious over Jensen (US 2019/0122348) in view of Mazo (US 2018/0240235).
Jensen discloses the subject matter substantially as claimed except for a computer readable storage medium. However, Mazo teaches in the same field of endeavor it is well known for computer readable storage medium to store instructions to execute by a processor ([0053-0054]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Jensen with a computer readable storage medium as taught by Mazo as it is well known in the art for computer readable storage medium to store instructions to be executed by a processor ([0053-0054]).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim rejections under 35 USC 101 have been considered but they are not persuasive. The claim recites the steps of “obtaining a CNN…” and “applying the CNN…”. The Examiner notes the subject matter directed to training the CNN is outside the scope of the claimed invention.
Applicant’s arguments with respect to claim(s) 1-9 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
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, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/Primary Examiner, Art Unit 3797
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