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 .
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) filed 7/23/26. Claims 1, 4, 6, 7, and 18-20 have been amended. Claim 3 is canceled. Claims 1, 2, and 4-20 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/20/26 has been entered.
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, 2, and 4-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1, 2, and 4-18 are directed to a method (i.e., a process), claim 19 is directed to a non-transitory computer-readable medium (i.e., a machine), and claim 20 is directed to a system (i.e., a machine). Accordingly, claims 1, 2, and 4-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A computer-implemented method for modifying one or more locked medical imaging protocol parameters, comprising:
receiving, via a user interface, one or more modified protocol parameters for an imaging protocol;
determining whether the one or more modified protocol parameters are acceptable based on at least one of: i) an acquired image acceptability check or ii) a parameter acceptability check; and
responsive to a determination that the one or more modified protocol parameters are acceptable, using the one or more modified protocol parameters for performing at least one of: image acquisition by a medical imaging apparatus or delivery of radiotherapy treatment by a radiotherapy device, wherein the acquired image acceptability check comprises:
acquiring an image of a subject using a protocol with the one or more modified protocol parameters;
determining a similarity metric value between the acquired image and a validated image; and
determining whether the one or more modified protocol parameters are acceptable based at least in part on the similarity metric value.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because receiving one or more modified protocol parameters for an imaging protocol; determining whether the one or more modified protocol parameters are acceptable based on at least one of: i) an acquired image acceptability check or ii) a parameter acceptability check; and responsive to a determination that the one or more modified protocol parameters are acceptable, using the one or more modified protocol parameters, wherein the acquired image acceptability check comprises: acquiring an image of a subject using a protocol with the one or more modified protocol parameters; determining a similarity metric value between the acquired image and a validated image; and determining whether the one or more modified protocol parameters are acceptable based at least in part on the similarity metric value amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or via pen and paper.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 19, and 20, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a user interface, a non-transitory computer-readable medium comprising computer-executable instructions, and a processor to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the user interface, non-transitory computer-readable medium, and a processor are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of receiving data, determining data, and acquiring data) such that it amounts no more than mere instructions to apply the exception using generic computer components. The claims recite the additional limitations of image acquisition by a medical imaging apparatus or delivery of radiotherapy treatment by a radiotherapy device. Such steps would be routinely used by those of ordinary skill in the art and are well-understood, routine and conventional activities specified at a high level of generality. Image acquisition is mere data gathering in conjunction with the abstract idea and therefore adds insignificant extrasolution activity to the judicial exception. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2 and 4-18 are ultimately dependent from Claim(s) 1 and include all the limitations of Claim(s) 1. Therefore, claim(s) 2 and 4-18 recite the same abstract idea. Claims 2 and 4-18 describe further limitations regarding updating one or more protocol parameters based on the one or more modified protocol parameters; performing an artefact detection on the acquired image, and wherein at least one of: i) performing the artefact detection comprises at least one of detecting, locating, or segmenting one or more artefacts in at least one of the acquired image and the validated image, or ii) performing the artefact detection comprises reporting an image quality of at least one of the acquired image and the validated image; outputting an alternative modified protocol parameter; wherein the similarity metric value is associated with a geometrical transformation between the acquired image and the validated image; wherein the geometrical transformation comprises a deformation vector field and determining i) at least one of an x, y, or z displacement component of the deformation vector field, and ii) a scalar length of the at least one of the x, y, or z displacement component; wherein the determining whether the one or more modified protocol parameters are acceptable is based at least in part on: i) the at least one of the x, y, or z displacement component of the deformation vector field or ii) the scalar length of the at least one of the x, y, or z displacement component; wherein the one or more modified protocol parameters are determined to be acceptable responsive to the scalar length of a threshold proportion of the at least one of the x, y, or z displacement component is less than or equal to a maximum scalar length, and wherein the threshold proportion lies within 60% to 100%; wherein the maximum scalar length lies within 0.5mm to 4mm; wherein the maximum scalar length is based on a resolution of the validated image; attempting to register the acquired image to the validated image; wherein when at least one of: i) an attempt to register the acquired image to the validated image is unsuccessful or ii) the geometrical transformation cannot be determined, the one or more modified protocol parameters are determined to be unacceptable; wherein the validated image is acquired using the imaging protocol with one or more unmodified or validated protocol parameters; wherein the similarity metric value is associated with at least one of: i) a structural similarity index metric or ii) a normalized cross correlation metric between the acquired image and the validated image; identifying whether a particular modified protocol parameter of the one or more modified protocol parameters is a critical parameter or a performance parameter; and checking the identified particular modified protocol parameter against a predetermined value; identifying whether the particular modified protocol parameter corresponds to at least one of: a bandwidth, a three-dimensional (3D) geometrical distortion, a field of view, a sound pressure level, or a specific absorption rate; identifying whether the particular modified protocol parameter corresponds to at least one of: a signal-to-noise ratio, a contrast, a view of a body, a time of acquisition, a resolution of acquisition, or a fat suppression. These are all just further describing the abstract idea recited in claim 1, without adding significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 19, and 20 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to a processor receiving one or more parameters via a user interface, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1, 2, and 4-20 are ineligible under 35 USC §101.
Claim Objections
Claim 13 is objected to because of the following informalities: change “an attempt” to “the attempt.” 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.
Claims 4-15 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.
Claims 4-15 are rejected because it is unclear whether the limitations of claims 4 and 6 (and the limitations of claims 5 and 7-15 that depend on these claims) are required to be performed since the limitations regarding the “acquired image acceptability check” are optional in claim 1 due to the “at least one of” and “or” language in the “at least one of: i) an acquired image acceptability check or ii) a parameter acceptability check“ limitation. Note that claim 4 recites the optional “the acquired image” and “the validated image” and claim 6 recites the optional “the similarity metric value,” “the acquired image,” and “the validated image.” As such, these dependent claims are not required to be performed.
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, 2, 4-6 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. (US 2012/0010495 A1) in view of Ladenburger (US 2007/0162159 A1).
(A) Referring to claim 1, de Oliveira discloses A computer-implemented method for modifying one or more locked medical imaging protocol parameters, comprising (para. 3, 37, & 44 and Fig. 1 of de Oliveira):
receiving one or more modified protocol parameters for an imaging protocol (para. 37-44 of de Oliveira; One or more setting parameters for generating the MR images are automatically modified, depending on the failed quality inspection or quality inspections, such that an image quality of those MR images that are subsequently generated with the modified setting parameters is improved compared to the image quality of the MR image in which the quality inspection failed.);
determining whether the one or more modified protocol parameters are acceptable based on at least one of: i) an acquired image acceptability check or ii) a parameter acceptability check (para. 3, 31-37, 83-85 of de Oliveira; Quality inspection, during which the MR image to be inspected is compared to predefined MR images, for example by way of a cross correlation. Only if the results of this cross correlation lie within a predetermined bandwidth does this quality inspection count as passed. This quality inspection can automatically be improved evermore by way of machine learning. To this end, classification methods that classify the MR images to be inspected as acceptable or not acceptable can for example be learned with the aid of algorithms for machine learning. Quality inspection, in which an inspection is performed as to whether setting parameters for generating the MR images lie within predetermined regions. One or more setting parameters for generating the MR images are automatically modified, depending on the failed quality inspection or quality inspections, such that an image quality of those MR images that are subsequently generated with the modified setting parameters is improved compared to the image quality of the MR image in which the quality inspection failed.); and
responsive to a determination that the one or more modified protocol parameters are acceptable, using the one or more modified protocol parameters for performing at least one of: image acquisition by a medical imaging apparatus or delivery of radiotherapy treatment by a radiotherapy device (para. 3, 7-11, and 37 of de Oliverira; the image quality of MR images generated within the scope of an examination of a patient by way of a magnetic resonance scanner is inspected manually after the examination and appropriate modifications are subsequently undertaken if the image quality lies below an acceptable level. These modifications firstly comprise modifications in a protocol, in which appropriate parameters for acquiring the MR images are prescribed, and secondly comprise modifications in respect of the strategy (measurement method) by which the MR images are acquired. Parameters or procedures are modified during the generation of the further MR images such that the image quality of the further MR images is better than the image quality of the initially generated MR images.).
de Oliveira does not expressly disclose receiving, via a user interface, one or more modified protocol parameters for an imaging protocol.
Ladenburger discloses receiving, via a user interface, one or more modified protocol parameters for an imaging protocol (para. 14-18, 31, and 32 of Ladenburger; a first display module that is designated to display on a user interface control parameters that can be modified in the selected process control protocols; a parameter value detection module that is designated to detect parameter values according to which the control parameters are to be modified in the selected process control protocols).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Ladenburger within de Oliveira. The motivation for doing so would have been to enable modification in an easy manner (para. 80 of Ladenburger).
Insofar as the claim recites “at least one of” and “or,” the remaining steps of the claim regarding the “acquired image acceptability check” are not required to be performed.
(B) Referring to claim 2, de Oliveira discloses further comprising: updating one or more protocol parameters based on the one or more modified protocol parameters (para. 11 & 37-44 of de Oliveira).
(C) Referring to claim 4, de Oliveira discloses further comprising: performing an artefact detection on the acquired image, and wherein at least one of: i) performing the artefact detection comprises at least one of detecting, locating, or segmenting one or more artefacts in at least one of the acquired image and the validated image, or ii) performing the artefact detection comprises reporting an image quality of at least one of the acquired image and the validated image (para. 27-37 of de Oliveira).
(D) Referring to claim 5, de Oliveira discloses wherein a computer vision tool outputs an alternative modified protocol parameter based at least in part on at least one of: i) a reported image quality of the acquired image or ii) the validated image (para. 31-37 of de Oliveira).
(E) Referring to claim 6, de Oliveira discloses wherein the similarity metric value is associated with a geometrical transformation between the acquired image and the validated image (para. 29-37 of de Oliveira).
(F) Referring to claim 12, de Oliveira discloses wherein determining the geometrical transformation between the acquired image and the validated image comprises attempting to register the acquired image to the validated image (para. 27-32 of de Oliveira).
(G) Referring to claim 13, de Oliveira discloses wherein when at least one of: i) an attempt to register the acquired image to the validated image is unsuccessful or ii) the geometrical transformation cannot be determined, the one or more modified protocol parameters are determined to be unacceptable (para. 3 & 32-37 of de Oliveira).
(H) Referring to claim 14, de Oliveira discloses wherein the validated image is acquired using the imaging protocol with one or more unmodified or validated protocol parameters (para. 44-48 of de Oliveira).
(I) Referring to claim 15, de Oliveira discloses wherein the similarity metric value is associated with at least one of: i) a structural similarity index metric or ii) a normalized cross correlation metric between the acquired image and the validated image (para. 29-31 of de Oliveira).
(J) Referring to claim 16, de Oliveira discloses wherein the parameter acceptability check comprises: identifying whether a particular modified protocol parameter of the one or more modified protocol parameters is a critical parameter or a performance parameter; and checking the identified particular modified protocol parameter against a predetermined value (para. 37-51 of de Oliveira).
(K) Referring to claim 17, de Oliveira discloses wherein identifying whether the particular modified protocol parameter is a critical parameter or a performance parameter comprises: identifying whether the particular modified protocol parameter corresponds to at least one of: a bandwidth, a three-dimensional (3D) geometrical distortion, a field of view, a sound pressure level, or a specific absorption rate (para. 32 & 40-43 of de Oliveira).
(L) Referring to claim 18, de Oliveira discloses wherein identifying whether the particular modified protocol parameter is a critical parameter or a performance parameter comprises: identifying whether the particular modified protocol parameter corresponds to at least one of: a signal-to-noise ratio, a contrast, a view of a body, a time of acquisition, a resolution of acquisition, or a fat suppression (para. 21-23 of de Oliveira).
(M) Claims 19 and 20 differ from claim 1 by reciting “A non-transitory computer-readable medium comprising computer-executable instructions which, when executed by a processor, cause the processor to…” (para. 103 of de Oliveira; The program may be stored on a tangible computer readable medium and is adapted to perform any one of the aforementioned methods when run on a computer device (a device including a processor). Thus, the tangible storage medium or tangible computer readable medium, is adapted to store information and is adapted to interact with a data processing facility or computer device to execute the program) and “A system for medical imaging, comprising: a medical imaging apparatus; a processor; and a non-transitory computer readable medium comprising computer-executable instructions which, when executed by the processor, cause the processor to…” (para. 72 & 103 of de Oliveira; FIG. 1 shows a schematic illustration of a magnetic resonance scanner 5 (a magnetic resonance imaging scanner or a nuclear magnetic resonance machine). The program may be stored on a tangible computer readable medium and is adapted to perform any one of the aforementioned methods when run on a computer device (a device including a processor). Thus, the tangible storage medium or tangible computer readable medium, is adapted to store information and is adapted to interact with a data processing facility or computer device to execute the program).
The remainder of claims 19 and 20 repeat substantially the same limitations as claim 1, and are therefore rejected for the same reasons given above.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Oliveira et al. (US 2012/0010495 A1) in view of Ladenburger (US 2007/0162159 A1), and further in view of Valadez (US 2006/0224363 A1).
(A) Referring to claims 7 and 8, de Oliveira and Ladenburger do not disclose wherein the geometrical transformation comprises a deformation vector field and determining i) at least one of an x, y, or z displacement component of the deformation vector field, and ii) a scalar length of the at least one of the x, y, or z displacement component and wherein the determining whether the one or more modified protocol parameters are acceptable is based at least in part on: i) the at least one of the x, y, or z displacement component of the deformation vector field or ii) the scalar length of the at least one of the x, y, or z displacement component.
Valadez discloses wherein the geometrical transformation comprises a deformation vector field and determining i) at least one of an x, y, or z displacement component of the deformation vector field, and ii) a scalar length of the at least one of the x, y, or z displacement component (para. 41 of Valadez) and wherein the determining whether the one or more modified protocol parameters are acceptable is based at least in part on: i) the at least one of the x, y, or z displacement component of the deformation vector field or ii) the scalar length of the at least one of the x, y, or z displacement component (para. 40-43 of Valadez).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Valadez within de Oliveira and Ladenburger. The motivation for doing so would have been to enable detection of potential problems at earlier and more treatable stages and to determine quality (para. 3 & 41 of Valadez).
Response to Arguments
Applicant's arguments filed 5/20/26 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 5/20/26.
(1) Applicant respectfully requests reconsideration and withdrawal of the §103 rejections.
(A) As per the first argument: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the acquired image acceptability check) are optional limitations due to the “at least one of” and “or” language.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine came directly from the reference. See modified 103 rejection of claim 1 above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches a method for acquiring magnetic resonance image data for image-guided radiotherapy (US 10,821,302 B2); and systems and methods for quality control in image-guided radiotherapy (US 2020/0038684 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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