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 are objected to because Fig. 2 includes a step that comprises a plurality of reference numbers the last and second to last boxes. It is unclear what the order of operations are between these reference numbers, or if they are meant to be performed in parallel.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “140” has been used to designate both data connections, unidirectional data connections, and bidirectional data connections. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term BoneMRI, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 4, 6, and 9 are objected to because of the following informalities:
Claim 1 line 3 “data,” should read as “data” as the line that follows is a separate limitation according to its own list marker.
Claim 4 line 7 “…patient are generated which provided tissue…” should read as “…patient is generated which provides tissue…”
Claim 6 line 5 “system of” should read as “system of:” due to the introduction of list markers.
Claim 9 lines 5 and 8-9 describe two- or three-dimensional volumes. As it is impossible for a two-dimensional volume to exist, the term “two- or three-dimensional volume” should read as “two- or three-dimensional area”.
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 1-16 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 1-16 contain the trademark/trade name BoneMRI. See “BoneMRI®”, 1 page. This rejection is based on the assertion in that page that the trademark is registered and not an independent Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe data and a module that comprises the processing module and, accordingly, the identification/description is indefinite.
The term “preferably ” in claims 1-2 and 4-12 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Each instance of the term preferably introduces a range of possible options regarding the corresponding limitations it appears in front of. As such, it is unclear if any limitation preceded by the term “preferably” is actually required or not. Thus, any given limitation in the claim set that is preceded by “preferably” is ignored as not being required by the claims.
The limitation “and/or the like” in claims 2, 4, 8, and 15-16 is a relative limitation which renders the claim indefinite. The limitation “and/or the like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Each instance of “and/or the like” creates an unlimited range of potential options for the limitations it is connected to, however, they need to be “like” the other terms listed alongside “and/or the like”. There is no clear way to determine what makes a given term/limitation “like” another term/limitation, and as such it cannot be interpreted broadly, as there is some kind of linking aspect required by the limitation.
The term “Bone MRI data” in claims 1, 3-4, and 6-7 renders the claim indefinite. The term “Bone MRI data” is not defined by the claim and the specification does not provide a standard for ascertaining the what it particularly constitutes, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. [0028] of the instant application attempts to define Bone MRI data as being data generated by the Bone MRI module (which is only ever defined as a component of the processor module, such as in [0033]). However, [0028] further states that the data may be synthetic CT data, only suggesting that it is preferable to be said data type. As such, it is unclear what Bone MRI data is, and as such, renders the claims indefinite.
The term “Bone MRI data” will be interpreted as “data”. Each instance of “Bone MRI data” is followed with further narrowing of the data it comprises to be synthetic scan data from the Bone MRI data. As such, the interpretation retains the broader data category that synthetic scan data in particular is drawn from while not additionally conflicting with the other data types mentioned in the claims.
Claims 3, 4, 6, 7, and 15 each include the term “Bone MRI module” to further narrow their respective limitations related to the processor module. However, the Bone MRI module is introduced as a preferable component. Due to it being unclear if this is intended to be required by the claims, each claim is rendered as indefinite. It is unclear if these respective claims are to be performed due to them concerning a limitation that is, itself, not required.
As each instance of “Bone MRI module” is used to further narrow a non-indefinite component (being the processor module), the respective instances of “in particular of the Bone MRI module” will be ignored to preserve the definite relationship of the corresponding limitations to the processor module (including “…in particular of the Bone MRI module and/or the image transformation module…” from claim 15 line 3-4). Further claim 7 uses the term “Bone MRI module” in lines 10-11 and line 18. Line 10-11 “…training of the Bone MRI module…” will be read as “…training of the processor module…” Line 18 “…free transfer parameter of the Bone MRI module…” will be read as “…free transfer parameter of the processor module…”
Claim 5 includes primary and secondary data assessment; it is unclear if this is the same data assessment(s) from claim 1 or a new assessments(s); in addition the data assessments in claim 1 are recited in the alternative, so the antecedent basis problems are more pronounced.
Claim 7 recites the limitations "the first transfer element" and "the fourth transfer element" in line 12 and 13 (respectively). There is insufficient antecedent basis for these limitations in the claim. There is no prior mention of a first or fourth transfer element. These transfer elements are only introduced in claim 3, but claim 7 only recites dependency to claim 1. As such it is unclear what these limitations are referring back to.
For Claim 7 lines 12 and 13 (respectively), the limitations "…the first transfer element…" and "…the fourth transfer element…" shall be read as "…a first transfer element…" and "…a fourth transfer element…"
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 1-6 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter, for the reasons as follows:
In re to claim 1, the claim is directed to a system, which falls within one of the four statutory categories.
Claim 1 recites: “A system for assessment of different kinds of bodily tissues and/or bodily fluids and/or air, in particular air being associated with a human body, the system comprising:
- at least one processor module for handling and processing of MRI patient scan data,
- at least one storage module for storing patient data, in particular MRI patient scan data and/or synthetic CT data and/or data associated therewith, of at least one first patient, wherein at least one data connection is provided between the processor module and the at least one storage module, in particular a bidirectional data connection, such that data are transferrable for processing and/or for storing, wherein the processor module is configured to receive and/or request the at least one set of MRI patient scan data from the storage module or from a MRI scanning device, wherein, for primary data assessment, the processor module, preferably comprising a Bone MRI module of the processor module, is configured to process and/or analyse at least the MRI patient scan data of the first patient such that at least one set of Bone MRI data, in particular synthetic CT data, of the first patient is provided, and/or wherein, for a secondary data assessment, the processor module, preferably comprising an image transformation module, is configured to process and/or analyse at least the MRI patient scan data of the first patient such that at least one set of synthetic T1-weighted image data of the first patient is provided.”
The limitations of claim 1, as drafted, are considered to fall under the category of an abstract concept.
For example, an individual (such as a medical doctor) may look at patient MRI and analyse it in relation to synthetic CT data in order to determine if it should be used for further determinations (thus providing said synthetic CT data according to an analysis of MRI patient scan data). This may similarly be performed using with respect to synthetic T1-weighted image data (as opposed to synthetic CT data).
Thus, the claim recites an abstract idea. Additionally, the judicial exception is not integrated into
a practical application. In particular, the claim recites the additional elements of “…one processor module…” and “…one storage module…”
The additional elements do not recite an improvement in the functioning of a computer or other technology or technical field, the claimed steps are not performed using a particular machine, the claimed steps do not effect a transformation, and the additional elements do not apply the judicial exception in any meaningful way beyond generically linking the use of the judicial exception to a particular technological environment (See MPEP 2106.04(d)). Therefore, the analysis under prong two of step 2A of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in
MPEP 2106).
Furthermore, the additional elements do not add significantly more to the judicial exception. A processor may be implemented by a generic computer that performs functions that are well- understood, routine and conventional. It is a computer element which performs generic computer functions/computations. Thus, this element does not amount to more than implementing the abstract idea with a computerized system.
Storage may be implemented by a generic memory components that performs functions that are well- understood, routine and conventional. Memory is a computer element which performs generic computer data storage. Thus, this element does not amount to more than implementing the abstract idea with a computerized system.
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. There is no
indication that the combination of elements improves the functioning of a computer or improves any
other technology. Their collective functions merely provide conventional computer implementation, and
mere implementation on a generic computer does not add significantly more to the claims. Accordingly,
the analysis under step 2B of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106). Similarly, claims 11 and 12 (which recite similar limitations) are rejected for the same reasons.
Further, the limitations “…wherein at least one data connection is provided between the processor module and the at least one storage module, in particular a bidirectional data connection, such that data are transferrable for processing and/or for storing, wherein the processor module is configured to receive and/or request the at least one set of MRI patient scan data from the storage module or from a MRI scanning device…” are regarded as insignificant extra-solution activity with respect to MPEP 2106.05 (g), being only related to the movement and storage of information.
Dependent claims
Claim 2 (dependent on claim 1) discloses the selection of a parameter. It does not add significantly more than the abstract idea, nor integrate into a practical application. As such, they are a part of the abstract idea.
3, 5, 6, 14, and 16 (dependent on claim 1) disclose further details regarding the process of providing data with regard to the independent claim. They do not add significantly more than the abstract idea, nor integrate into a practical application. As such, they are a part of the abstract idea.
Claim 4 (dependent on claim 1) introduces limitations that result in the generation of reduced patient data or perform a process of determining a bone volume parameter like bone mineral density. Thus, introducing a practical application.
Claim 7 (dependent on claim 1), describes a training of the system to generate synthetic CT data. Thus, introducing a practical application.
Claims 15 and 16 (dependent on claim 7 and 14, respectively) discloses the use of a computer readable medium. These limitations disclose transitory forms of signal transmission, and are as such not patent eligible subject matter. The computer readable medium should be “non-transitory computer-readable medium” according to MPEP 2106.3 (provided there is evidence within the original disclosure).
Claim Interpretation
Regarding claims 2, 5, and 8, they are each dependent on an alternative limitations from independent claim 1. Specifically, claims 2 and 8 require the use of synthetic T1-weighted image data, which is only generated in independent claim 1 when performing the alternate limitations of lines 15-18 (as indicated by the “and/or” that separates the primary and secondary data assessments into separate groups of limitations). Additionally, claim 5 requires the performance of both the primary and secondary data assessments. However, the secondary data assessment is an alternative set of limitations to the primary data assessment. As such, claims 2, 5, and 8 are not mapped due to them not being applicable to the alternate limitations of the primary data assessment.
The term “particular” is interpreted to mean that the corresponding limitation to it is a required limitation. As such, the various instances of “particular” are read to denote that said limitation is a further narrowing of the claim language. For example, claim 1 line 7 recites “…in particular a bidirectional data connection…” It is understood that the data connection described in claim 1 line 6 is, as such, required to be a bidirectional data connection.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 6 lines 3-4 are interpreted according to 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, due to the inclusion of a “…two- or three-dimensional display means…” in relation to a visualization device.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 6, 7, and 14-16 as best understood are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Han (US publication 20190362522 A1; hereinafter “Han”).
In re to claim 1, Han teaches wherein: a system for assessment of different kinds of bodily tissues and/or bodily fluids and/or air, in particular air being associated with a human body, the system comprising:
- at least one processor module for handling and processing of MRI patient scan data (Fig. 1A shows the radiotherapy system (corroborated by [0017]) which includes an image processor. Further, [0040] discloses use of the processor to process MRI image data. See also Fig. 4A-4B which includes an imaged subject’s head, thus showing processing of patient scan data (Fig. 4A and [0054] being specifically MRI data per [0071])), - at least one storage module for storing patient data (Memory and databases; Fig. 1A shows the memory and databases used by the system, understood to collectively be the storage module), in particular MRI patient scan data and/or synthetic CT data and/or data associated therewith (Fig. 1A shows that the memory may contain medical images, the category of “medical image” is further includes MRI image data per [0040]), of at least one first patient, wherein at least one data connection is provided between the processor module and the at least one storage module (Fig. 1 shows connection of the processor to the storage module (correspondent to the claims)), in particular a bidirectional data connection, such that data are transferrable ([0042] lines 1-5 discloses the sending and receiving of communication between the processor and memory, thus indicating a bidirectional data connection of medical image data) for processing and/or for storing , wherein the processor module is configured to receive and/or request the at least one set of MRI patient scan data from the storage module ([0042] lines 1-5 discloses the sending and receiving medical image data. Additionally, the category of “medical image” is includes MRI image data per [0040]) or from a MRI scanning device, wherein, for primary data assessment (processing to generate synthetic image; Fig. 5 shows the generation of a synthetic image), the processor module, preferably comprising a Bone MRI module of the processor module, is configured to process and/or analyse at least the MRI patient scan data of the first patient such that at least one set of Bone MRI data, in particular synthetic CT data, of the first patient is provided (Fig. 5 and [0093] discloses the generation of synthetic image data (which per [0086] lines 1-4 denotes generation of synthetic CT image data). See also [0084], which discloses the conversion of captured image data to synthetic data from image acquisition device 32 (which may be a MRI imaging device per [0046] lines 17-18). Thus providing an alternately possible processing method of captured MRI scan data (which is understood to include patient data such as is shown in Fig. 4A and described in [0054])), and/or wherein, for a secondary data assessment, the processor module, preferably comprising an image transformation module, is configured to process and/or analyse at least the MRI patient scan data of the first patient such that at least one set of synthetic T1-weighted image data of the first patient is provided.
In re to claim 3 [dependent on claim 1], Han teaches wherein: for the primary data assessment the processor module, in particular the Bone MRI module, is configured to apply a first transfer element on at least the MRI patient scan data (image conversion unit; it is understood that the first transfer element is the image conversion unit shown in Fig. 5, used to convert imaged data to synthetic CT data per [0093]), CT patient scan data, Bone MRI storage data, in particular synthetic CT storage data, synthetic T1-weighted image storage data and/or segmentation data of the first patient to provide at least one set of Bone MRI data, in particular at least one set of synthetic CT data (Fig. 5 and [0093] discloses the generation of synthetic image data (which per [0086] lines 1-4 denotes generation of synthetic CT data). See also [0084], which discloses the conversion of captured image data to synthetic data from image acquisition device 32 (which may be a MRI imaging device per [0046] lines 17-18). Thus disclosing patient scan data used to generate synthetic CT data. Additionally, the converted images are understood as a set of images due to [0093] indicating conversion of a plurality of images), and/or wherein for the secondary data assessment the processor module, in particular the image transformation module, is configured to apply a fourth transfer element on at least the MRI patient scan data, CT patient scan data, Bone MRI storage data, in particular synthetic CT storage data, synthetic T1-weighted image storage data and/or segmentation data of the first patient to provide at least one set of synthetic T1-weighted image data, wherein the Bone MRI data and the synthetic T1-weighted image data comprise different T1-weight factors.
In re to claim 6 [dependent on claim 3], Han teaches wherein: the system further comprises a visualization device, in particular a two- or three-dimensional display means, being configured to provide a human perceptible illustration for a first user of the system of - at least one set of Bone MRI data, in particular synthetic CT data, of the first patient (Fig. 5 and [0093] discloses the generation of synthetic image data (which per [0086] lines 1-4 denotes generation of synthetic CT data). See also [0084], which discloses conversion of captured image data to synthetic data from image acquisition device 32 (which may be a MRI imaging device per [0046] lines 17-18). Thus disclosing patient scan data used to generate synthetic CT data. Additionally, the converted images are understood as a set of images due to [0093] indicating conversion of a plurality of images) as provided by the processor module, in particular by the Bone MRI module, ([0094] discloses they use of a display to provide the synthetic images to a user. Thus providing a 2D display for a human perceptible image (the user being understood as a first user)) and/or - at least one set of synthetic T1-weighted image data as provided by the processor module, in particular by the image transformation module, preferably comprising at least one image property value being assigned to and/or determined for at least one image property parameter for at least one medium, in particular a bodily tissue and/or a bodily fluid and/or air, in particular air being associated to a human body.
In re to claim 7 [dependent on claim 1], wherein the method comprises the steps of: - requesting and/or receiving MRI patient scan data, CT patient scan data, Bone MRI data, in particular synthetic CT data, synthetic T1-weighted image data and/or segmentation data of a plurality of patients ([0038] discloses the system receiving training data. Further, [0086] discloses the images used as training data may be MRI images (it is understood that the this is MRI patient scan data, the patient being the imaged subject)) as at least one set of training data comprising training input data and training output data ([0086] lines 10-12 discloses that the training data comprises MRI images and corresponding real CT images. It is understood that the MRI images are training input data and the real CT images are training output data), - applying the at least one set of training data to the processor module (Fig. 5 shows the use of training images data to in the training stage being used to train the system. Further, it is understood that a set of training data is an MRI image with a corresponding real CT image, as described in [0086] lines 10-12), preferably to the Bone MRI module and/or the image transformation module, for training of the Bone MRI module, in particular the first transfer element, and/or of the image transformation module, in particular the fourth transfer element, to be configured to generate at least one set of Bone MRI data, in particular synthetic CT data, by the processor module (Fig. 5 shows the use of the training step in order to train the system to produce a predictive image, and thus shows training of the a fourth transfer element, understood as the predictive model used to convert image data (as described in [0040]). See also [0084], which discloses the training operation of Fig. 5 is used to train the predictive model using training images, which is used to generate a synthetic image (as shown in Fig. 5)), preferably by the Bone MRI module, and/or at least one set of synthetic T1-weighted data by the processor module, preferably by the image transformation module, wherein training of the processor module is preferably achieved by optimizing at least one free transfer parameter of the Bone MRI module, in particular the first transfer element, and/or at least one free transfer parameter of the image transformation module, in particular of the fourth transfer element, and wherein training output data are preferably Bone MRI data and/or synthetic T1-weighted image data of the plurality of patients.
In re to claim 14 [dependent on claim 1], Han teaches wherein: a method for providing a primary data assessment (processing methodology to generate synthetic image; Fig. 5 shows the generation of a synthetic image through a series of steps outlining a methodology (as is shown in Fig. 9A))and/or a secondary data assessment by a system according to claim 1.
In re to claim 15 [dependent on claim 7], Han teaches wherein: a computer-readable medium comprising instructions which cause at least one computer, at least one processor ([0046] discloses the operation of the system using non-transitory computer readable storage mediums as memory that are accessed and used by the processor (correspondent to the claims). See also [0169]-[0170] use of software/instructions to perform operations of the system) and/or the like to execute the method for training of the processor module, in particular of the Bone MRI module and/or the image transformation module, according to claim 7.
In re to claim 16 [dependent on claim 14], Han teaches wherein: computer-readable medium comprising instructions which cause at least one computer, at least one processor and/or the like to execute the method according to claim 14 ([0046] discloses the operation of the system using non-transitory computer readable storage mediums as memory that are accessed and used by the processor (correspondent to the claims). See also [0169]-[0170] use of software/instructions to perform operations of the system).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Bojorquez et al. (non-patent literature titled “Automatic classification of tissues on pelvic MRI based on relaxation times and support vector machine”; hereinafter “Bojorquez”).
In re to claim 4 [dependent on claim 1], Han does not explicitly teach wherein: the processor module, in particular the Bone MRI module, for primary data assessment is further configured: - to apply a second transfer element on the at least one set of Bone MRI data, in particular synthetic CT data, and/or MRI patient scan data of the first patient such that reduced patient data of the first patient are generated which provide tissue volume information, in particular water and/or fat volume related information and/or the like, of the first patient (), and/or receiving tissue volume information, in particular water and/or fat volume related information and/or the like, from the MRI scanning device, - to apply a third transfer element on the reduced patient data and/or the MRI patient scan data of the first patient such that total bone volume information are achieved, wherein the processor module, in particular the Bone MRI module, is further configured to process and/or analyse the MRI patient scan data, the at least one set of synthetic CT data and/or the reduced patient data, preferably in combination with each other, such that at least one bone volume parameter, in particular bone mineral density, fat percentage, calcium concentration, total density trabecular space and/or the like, of the first patient is determined.
However, in a related field of endeavor, Borjorquez teaches wherein: the processor module, in particular the Bone MRI module, for primary data assessment is further configured: - to apply a second transfer element (tissue classifier; Fig. 1 shows an algorithm that performs the output of processed data, and is understood as a second transfer element) on the at least one set of Bone MRI data, in particular synthetic CT data, and/or MRI patient scan data of the first patient such that reduced patient data of the first patient are generated which provide tissue volume information, in particular water and/or fat volume related information and/or the like, of the first patient (Fig. 1 and Fig. 5 shows the generation of probabilistic maps From MRI scan data of subjects that have limited information indicating a particular tissue type, such as fat, based on MRI image data of a subject. It is understood that the probabilistic map is reduced patient data. Further, per the section titled evaluation, para. 1, this classification process was tested on a particular patient (understood as a first patient). Thus, it is understood that reduced patient data is generated for a first patient according to the pipeline of classification processing shown in Fig. 1)), and/or receiving tissue volume information, in particular water and/or fat volume related information and/or the like, from the MRI scanning device, - to apply a third transfer element on the reduced patient data and/or the MRI patient scan data of the first patient such that total bone volume information are achieved, wherein the processor module, in particular the Bone MRI module, is further configured to process and/or analyse the MRI patient scan data, the at least one set of synthetic CT data and/or the reduced patient data, preferably in combination with each other, such that at least one bone volume parameter, in particular bone mineral density, fat percentage, calcium concentration, total density trabecular space and/or the like, of the first patient is determined.
Borjorquez, like Han, discloses an MRI based image processing system that further generates a resultant output of processing MRI data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Han, to produce reduced patient data, as taught by Borjorquez. The motivation for the proposed modification would have been to provide a user additional information that breaks down the regions of a medical image as they relate to their tissue type, allowing the user to better understand the processed image data.
Allowable Subject Matter
Claims 9-13 would be allowable if rewritten to overcome the 112 (b) rejections above, and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance for claim 9. The claimed features of claim 9 are not anticipated nor obvious in view of prior art of record.
Han teaches a system that performs a data assessment of MRI input data in order to generate synthetic CT data (as is shown in Fig. 5). It further performs training of particular algorithms in order to facilitate the generation of synthetic CT data, as is described [0040]. The training data used is additionally comprised of two types of image data that may be considered input and output training data (due to representing input MRI data and the desired CT output data). However, it odes not indicate selection of region data from specifically the input training data. Nor does it further use the selected region data to transfer input training data to output training data to then generate synthetic T1-weighted image data.
Borjorquez discloses the use of training data in order to generate region information of bodily tissue, as is shown in Fig. 1 (which shows the segmentation of types of tissue, such as fat and muscle tissue). Additionally, the data used is comprised of two types of image data (being t1-weighted image data and T2-weighted image data). However, it does not explicitly indicate that this region selection is specifically from only one type of image data that comprises the training data. Nor does it indicate that the system transfers the training input data to the training output data as a part of a process for generating synthetic T1-weighte image data.
Sloan et al. (US patent 10346974 B2; hereinafter “Sloan”) discloses a system for the generation of synthetic images from medical image data. It further discloses training of its system in an iterative manner, as shown in Fig. 4. This is additionally performed in an adversarial fashion (as described in col. 5 lines 32-41). The system further includes different types of trained data represented of anatomical regions (as disclosed in col. 2 line 55-col. 3 line 2). However, it does not indicate that the training data used has input training data transferred to be training output data. Nor does it explicitly select regions from a particular type of training data to facilitate a transfer used to generate synthetic T1-weighted image data.
Additionally, the other known prior art or record do not address all the limitations of the independent claims without the use of impermissible hindsight bias. As such, claim 9’s limitations are neither anticipated nor rendered obvious in view of prior art of record.
Conclusion
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/KEVIN M COOMBER/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698
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