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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/5/2026 has been entered.
Response to Arguments
A. Applicant’s arguments with respect to the rejection of claims 1-4 and 6-11 under 35 USC 101 have been fully considered but are not persuasive.
Applicant argues starting on page 8 of the response that the claims do not recite a judicial exception. Examiner respectfully disagrees.
Applicant first asserts that the element reciting “receiving, by the receiver system, encoded medical imaging data from the source system, wherein the encoded medical imaging data comprises the medical imaging data in a machine-readable format and validated based on a plurality of predefined standards; decoding, by the receiver system, the encoded medical imaging data using a decryption technique; and validating, by the receiver system, the decoded medical imaging data based on the plurality of predefined standards" does not recite a mental process on the basis that the operations “require secure data transmission protocols, cryptographic techniques, and automated validation mechanisms that cannot be practically performed in the human mind.” Examiner initially notes however, that the claims are construed as reciting a method of organizing human activity, not as reciting a mental process. Applicant’s assertions regarding “secure data transmission protocols” and “automated” validation lack nexus with the claim language itself, and a human is capable of receiving medical imaging data and validating it against predefined standards. As noted in the rejection, Applicant’s specification describes “machine-readable format as including formats such as Comma-Separated Values, JavaScript Object Notation, and Extensible Markup Language, which are also human-readable. Furthermore, the claims do not
Applicant next asserts that the element reciting "upon successful validation, mapping, by the receiver system, the decoded medical imaging data based on one or more business objects associated with the receiver system; and storing, by the receiver system, the decoded medical imaging data in a data store associated with the receiver system based on one or more configurations of the receiver system" does not recite a mental process, arguing that “These steps involve system-level data structuring and storage operations based on predefined configurations and business objects specific to the receiver system” and that the mapping “requires programmatic association of imaging data with structured system entities and subsequent storage in configured data repositories.” As noted above, the claims are not asserted as reciting a mental process. A human is capable of “mapping” image dating data based on “business objects,” i.e. categorizing and organizing the data, and storing it. Importantly, Examiner notes that the claimed medical imaging data is not limited to pixel data, and includes text and numerical as well (see e.g. specification paragraphs 27 describing mapping of the medical imaging data including mapping based on patient details and protocol parameters). A human is capable of organizing received data based on categories such as patient details. Computing elements such as the use of a “system” are not construed as falling within the scope of the abstract idea.
With respect to Applicant’s argument on page 12 that the claimed generation of reconstruction data based on the medical imaging data and input corresponding to a size parameter or orientation parameter, the assertion that such generation “involves algorithmic transformation of imaging datasets based on parameterized inputs and cannot be practically performed in the human mind” lacks nexus with the actual language of the claims. The claim does not define “reconstruction data” in such a way as to require algorithmic manipulation exclusive to computers. Additionally, the specification describes the reconstruction data as including human-readable information such as patient information. For example, paragraph 48 states “consider a scenario where the medical imaging data includes a name 'A' of a patient, and in the reconstruction data the name is changed to 'B'.” A human is capable of generating a data set of information such as patient details. With respect to the input information including a size parameter or orientation parameter, the current claim language encompasses simply including those pieces of information in the compiled information which will be used in the reconstruction.
Similar reasoning applies to Applicant’s argument that the step of validating the reconstruction data based on a plurality of predefined clinical rules and a set of constant fields involves a technical process that cannot be performed mentally. Paragraph 48 of the specification illustrates that validation encompasses checking the correctness of fields such as a patient’s name, which may be performed by a human. Elements in the specification such as the use of AI-based techniques are not imported into the claims.
Applicant argues starting on page 15 that the claims integrate any abstract idea into a practical application on the basis that the claims “recite a specific, end-to-end technical workflow for processing, reconstructing, and validating medical imaging data at a receiver system, which imposes meaningful limits on any alleged abstract idea.” Examiner respectfully disagrees.
Applicant disputes Examiner’s interpretation of the recited computing elements as encompassing generic computers, stating that “While paragraph [0061] of as filed specification indicates that the claimed invention system is implemented on a general-purpose computing device, the specification, for example paragraphs [0028]-[0032] and [0058] of the as filed specification, clearly describes a specialized processing architecture comprising a data generation module, a validation module, and an image generation module that together perform reconstruction-specific operations on medical imaging data.” However, paragraphs 28-32, as noted by Applicant, describe the computing elements themselves, as “modules.” Paragraphs 17 and 23 describe the modules as elements of source system 100 and receiver system 200, and paragraph 35 states that “the systems 100, 200 may be implemented in software for execution by various types of processors.” Claim 1 recites a receiver system as performing the various data processing tasks, and the disclosure expressly describes that system as implemented using generic computing elements. Assertions regarding a “specialized processing architecture” are not reflected in the claims or supported in the disclosure.
Examiner further respectfully disagrees with Applicant’s arguments on pages 17-19 regarding the mapping, generating reconstruction data, and validation. Applicant’s assertion that “mapping is performed based on one or more business objects associated with the receiver system, and storing is performed based on one or more configurations of the receiver system,” and that “These limitations impose a system-specific data organization framework that governs how decoded medical imaging data is structured and persisted within the receiver environment” does not support a conclusion that a human cannot “map” medical imaging data such as patient details and parameters to business objects and configurations.
Applicant cites paragraphs 28-34 of the specification in asserting that generating the reconstruction data “involves processing decoded imaging data in combination with user-defined parameters to generate reconstruction data that is subsequently used for image reconstruction” and that “this is not a mere relabelling or annotation of data, but a processing of stored imaging datasets to incorporate user-defined parameters for reconstruction purposes. Even if the claims do not explicitly recite a specific reconstruction algorithm, they clearly define a data processing pipeline that prepares imaging data for reconstruction based on user input, which is a practical and technical application.” However, the actual language of claim 1 simply recites generating reconstruction data “based on the stored decoded medical imaging data and an input received from a user, wherein the input comprises values corresponding to at least one of a size parameter and an orientation parameter of an image.” A broad recitation of generating “reconstruction data” used later to reconstruct images, or assertions regarding a data processing pipeline for preparing data for reconstruction, is not sufficient to amount to a practical application.
Similarly, the actual language of proposed claim 1, incorporating elements from previous claim 5, recites validating the reconstruction data “based on a plurality of predefined clinical rules and a set of constant fields.” This element falls within the scope of the abstract idea and could be performed by a human. Predicating reconstruction on a successful validation is not sufficient to integrate the abstract idea into a practical application.
Applicant argues starting on page 23 that the analysis provided under Step 2B “oversimplifies the claimed invention and analyzes the elements in isolation, rather than as an ordered combination that defines a specific and non-conventional technological solution in the field of medical imaging data processing.” Examiner respectfully disagrees. Applicant asserts that “The claims do not merely recite generic data handling operations, but instead define a structured and sequential processing pipeline in which encoded medical imaging data is first securely received and decoded, then validated against predefined standards, mapped to system-specific business objects, stored based on configuration logic, and subsequently used to generate reconstruction data based on user-defined parameters, followed by a further validation using clinical rules and constant fields.” However, the argued steps such as validating, mapping, storing, and generation of reconstruction data fall within the scope of the abstract idea itself. Claim 1 recites each of these elements as being performed “by the receiver system” which is expressly disclosed in the specification as encompassing a generic computer. Merely arguing that the data processing steps falling within the abstract idea itself “is not a routine or conventional data workflow, but a coordinated architecture tailored to address specific technical challenges in medical imaging systems” is not sufficient to establish that the claims as a whole amount to significantly more. Applicant’s arguments are not supported by the scope of the actual claim language, and elements from the specification are not imported into the claims.
Examiner respectfully disagrees with Applicant’s assertion on page 25 that Examiner’s assertion that the reconstruction, as presently claimed, encompasses basic operations such as displaying or orienting images “is overly broad and ignores the claimed requirement of generating reconstruction data based on stored decoded imaging data and user input, followed by validation using clinical rules.” Applicant is importing limitations and elements not required by actual scope of the claims. The claims do not recite a specific manner or scope of “reconstruction,” and recite the data used to perform such reconstruction as a specified orientation. The claim does not presently require more complex algorithmic functions as part of the recited reconstruction.
The rejection under 35 USC 101 is maintained.
B. Applicant's arguments with respect to the rejection of claims 1-4 and 6-11 under 35 USC 112(b) have been fully considered but they are not persuasive.
Applicant’s remarks starting on page 27 regarding the rejection under 35 USC 112(b) have been fully considered but are not persuasive.
Applicant argues that the recited element of “configurations of the receiver system” is not indefinite and that the scope of the term would be clear to one of ordinary skill in the art. Examiner respectfully disagrees.
Applicant cites paragraph 27 as providing that the mapping module "determines compatibility of the decoded medical imaging data with the receiver system configurations," and paragraphs 41 and 56 as clarifying that the mapping and storage occur after validation and that “compatibility is determined "based on the receiver system configurations.”” However, none of these portions clarify the subject matter actually being described by receiver system configurations. The receiver system itself is not defined in the claims beyond being used to perform the receiving, decoding, validating, mapping, storing, and generating functions, and is disclosed in the specification as encompassing any of a plurality of generic computers. The receiver system configurations being broadly tied to compatibility determination, mapping behavior, and storage behavior as asserted by Applicant does not provide clarification on what type of subject matter might fall within the scope of a configuration of the receiver system. Furthermore, Examiner has not required “an explicit enumeration of all possible configuration parameters.” Applicant’s assertion that a person of ordinary skill in the art “would understand that "receiver system configurations" refer to system-specific parameters that govern whether incoming decoded data can be accepted, mapped, and stored, and these configurations necessarily relate to: the receiver system's data handling requirements, and conditions under which decoded data is considered compatible for storage and downstream use” is not supported by the language of the disclosure. Applicant’s argument requires reading into the disclosure information not present, and one of ordinary skill in the art would not reach these conclusions based on the term appearing in the context of compatibility determination.
Examiner similarly respectfully disagrees with Applicant’s argument that the functions of the claim itself, i.e. “determining compatibility ... with the receiver system configurations", and "storing ... based on one or more configurations of the receiver system” provide clear boundaries. Applicant states that “If decoded data satisfies the receiver system's conditions, then it is mapped and stored” “If not, then it would not satisfy compatibility. Thus, the term is bounded by operational behavior of the system, not by an undefined abstraction.” However, this argument is conclusory, and the fact that the claims recite storing the medical imaging data “based on the receiver system configurations” and determining compatibility of the decoded medical imaging data with the receiver system configurations does not itself provide clear boundaries on what the receiver system configurations actually are. For example, it is not clear whether the recited functions are being performed using configurations specific to an imaging process, configurations related to a database schema, configurations related to software versioning, configurations related to preferences of one or more users, or any number of different conceivable forms of “configurations” of a computer system.
The rejection under 35 USC 112(b) is maintained.
C. Applicant's arguments with respect to the rejection of claims 1-4 and 6-11 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues starting on page 31 that the combination of Gendron and Omernick do not disclose or suggest the limitations reciting generating, by the receiver system, reconstruction data based on the stored decoded medical imaging data and an input received from a user, wherein the input comprises values corresponding to at least one of a size parameter and an orientation parameter of an image; and validating, by the receiver system, the reconstruction data based on a plurality of predefined clinical rules and a set of constant fields. Examine respectfully disagrees.
Applicant asserts that Gendron is limited by data access, routing, and communication, not data reconstruction, that “the "input received from a user'' in Gendron corresponds only to selection or retrieval of existing imaging assets, not input of reconstruction parameters such as image size or orientation,” that “Gendron does not disclose any processing of decoded pixel data to generate new data structures; instead, it merely retrieves and forwards already-existing data,” and that “There is no disclosure of any transformation in which stored decoded medical imaging data is combined with user-defined parameters to generate reconstruction data.”
However, Gendron is relied upon to teach the element of generating reconstruction data based on stored medical imaging data. The claim does not require any “processing of decoded pixel data to generate new data structures,” and Gendron is not relied upon to teach parameters such as image size or orientation or to teach the use of a user input. Examiner additionally notes that the claim does not require a “transformation in which stored decoded medical imaging data is combined with user-defined parameters to generate reconstruction data.” The claim, in relevant part, only recites generating reconstruction data based on stored medical imaging data.
As cited, Figure 5 and paragraphs 74, 75, 77, 78, and 81-84 describe retrieving and translating particular DICOM imaging data, construed as generating reconstruction data, based on stored study data. While Gendron is not relied upon to teach actually performing reconstruction of the medical imaging data, Examiner notes that paragraphs 85 and 86 describe presenting the data to an operator at a view station.
Omernick is then relied upon specifically to further teach generating reconstruction data based on a user input including an orientation parameter of an image. Omernick is not relied upon to teach decoding of image data, validation of reconstruction data, application of clinical rules, or other such elements argued by Applicant. Omernick expressly discloses a viewing system capable of reconstructing images using user-inputted parameters such as image orientation as well as access to and processing of image pixel data (see Omernic [18] and [42]-[44] as well as Figure 3 and [46]).
Examiner further respectfully disagrees with Applicant’s assertion that no motivation exists to combine the references and that such modifications require impermissible hindsight reasoning. With respect to Gendron, a rationale to combine the teachings of Gendron with those of Choudhury, Gazelle, and VanNostrand is provided based on those set out in KSR and enumerated in MPEP 2143. As provided, the combination Choudhury, Gazelle, and VanNostrand already teach storing DICOM files for display (see e.g. Choudhury [26]), and generating reconstruction data based on the stored data and a user input followed by validating the reconstruction data based on predefined clinical rules and constant fields as taught by Gendron would perform that same function in Choudhury, Gazelle, and VanNostrand. Likewise, a rationale for Omernick is provided under KSR and MPEP 2143, stating that the combination of Choudhury, Gazelle, VanNostrand, and Gendron already teaches generating reconstruction data based on the stored data, and further generating reconstruction data based on a user input including image orientation as taught by Omernick would perform that same function in Choudhury, Gazelle, VanNostrand, and Gendron.
The claim does not require elements argued by Applicant such as “processing of decoded pixel data,” “incorporat[ing] user-defined reconstruction parameters into reconstruction logic,” and “apply[ing] a clinical validation framework using constant fields.” Applicant’s remaining arguments rely on elements not required by the claims, and elements which the references are not relied upon to teach.
The rejection under 35 USC 103 is maintained.
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 1-4 and 6-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-4 and 6-8 are drawn to a method, while claims 9-11 are drawn to a system, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of:
receiving, by the receiver, encoded medical imaging data from the source, wherein the encoded medical imaging data comprises the medical imaging data in a machine-readable format and validated based on a plurality of predefined standards,
decoding, by the receiver, the encoded medical imaging data,
validating, by the receiver, the decoded medical imaging data based on the plurality of predefined standards,
upon successful validation, mapping, by the receiver, the decoded medical imaging data based on one or more business objects associated with the receiver,
storing, by the receiver, the decoded medical imaging data based on one or more configurations of the receiver,
generating, by the receiver, reconstruction data based on the stored decoded medical imaging data and an input received from a user, wherein the input comprises values corresponding to at least one of a size parameter and an orientation parameter of an image; and
validating, by the receiver, the reconstruction data based on a plurality of predefined clinical rules and a set of constant fields.
These steps amount to a form of managing personal behavior or relationships or interactions between people, and therefore fall within the scope of a certain method of organizing human activity. Fundamentally the process is that of receiving, decoding, and validating medical imaging data according to a standard, and then storing the imaging data after mapping it to information categories (see e.g. [27] of Applicant’s specification describing “business objects”). These functions could be performed as part of individuals sending and receiving medical imaging data and storing that information based on categories set by the receiver.
Examiner also notes paragraph 18 of Applicant’s specification describing “machine-readable format” as including formats such as Comma-Separated Values, JavaScript Object Notation, and Extensible Markup Language, which are also human-readable.
Independent claim 9 recites similar limitations and also recites an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) a receiver system recited as performing the functions of the receiver, b) a source system recited as performing the functions of the source, c) a decryption technique used to decode the medical imaging data, and d) a data store associated with the receiver used to store the medical imaging data.
Claim 9 recites the additional elements of a) a processor recited as executing stored instructions to perform the subsequently recited functions, b) a memory recited as storing the instructions, c) a source system recited as performing the functions of the source, d) a decryption technique used to decode the medical imaging data, and e) a data store associated with the receiver used to store the medical imaging data.
Paragraphs 17 and 23 describe source system 100 and receiver system 200, while paragraphs 35 and 36 state that source system 100 and receiver system 200 “may be implemented in programmable hardware devices such as programmable gate arrays, programmable array logic, programmable logic devices, or the like” or “implemented in software for execution by various types of processors” such as ASICs. Each of the receiver system, source system. Paragraphs 35 and 36 also describe the instructions as stored in memory devices and accessed by the processor.
Additionally, paragraphs 61-63 state that “[t]he disclosed methods and systems may be implemented on a conventional or a general-purpose computer system, such as a personal computer (PC) or server computer” such as desktops, laptops, mobile phones, or other general-purpose computers, and describe the computer system as employing microprocessors and various types of RAM, ROM, flash memory, and other memory types. The receiver system, source system, processor, and memory are each therefore construed as encompassing generic forms of computer processing and memory devices.
Paragraph 25 states that the decoder “may use a decryption technique…For example, the decryption technique may include, but is not limited to, an Advanced Encryption Standard (AES) technique, a Data Encryption Standard (DES) technique, a Triple-DES (TDES) technique, and a Rivest- Shamir-Adleman (RSA) technique.” Paragraph 39 of the specification lists the same encryption protocols. The decryption technique is therefore construed as encompassing generic forms of encryption/decryption protocols.
Paragraphs 27 and 41 describe a data store in the same terminology of the claims as used to store the decoded medical imaging data. No further disclosure of the data store itself is provided. The data store is construed accordingly as encompassing generic computer storage devices.
The above elements only amount to mere instructions to implement the functions of the abstract idea using computing elements as tools. For example, the receiver system and source system are each only recited at a high level of generality as used to perform functions such as receiving and validating the medical image data and are disclosed as encompassing generic computing elements, as are the recited processor and memory. The decryption technique is additionally only recited at a high level of generality as used to decode the imaging data and disclosed as encompassing any of a plurality of known encryption protocols. These elements are therefore not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 9 only recite the receiver system, source system, processor, and memory as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 2 recites generating, by the source, the medical imaging data in the machine-readable format by parsing medical imaging data, wherein the medical imaging data comprises a set of variable fields and the set of constant fields; validating, by the source, the medical imaging data based on the plurality of predefined standards; and transmitting, by the source, the medical imaging data to the receiver. These limitations fall within the scope of the abstract idea as set out above.
Claim 2 recites the additional elements of a) the source being a source system, b) the receiver being a receiver system, and c) an encryption technique used to encode the medical imaging data to generate encoded medical imaging data
As cited above, paragraphs 17 and 23 describe source system 100 and receiver system 200, while paragraphs 35 and 36 state that source system 100 and receiver system 200 “may be implemented in programmable hardware devices such as programmable gate arrays, programmable array logic, programmable logic devices, or the like” or “implemented in software for execution by various types of processors” such as ASICs. Paragraphs 35 and 36 also describe the instructions as stored in memory devices and accessed by the processor.
Additionally, paragraphs 61-63 state that “[t]he disclosed methods and systems may be implemented on a conventional or a general-purpose computer system, such as a personal computer (PC) or server computer” such as desktops, laptops, mobile phones, or other general-purpose computers, and describe the computer system as employing microprocessors and various types of RAM, ROM, flash memory, and other memory types.
The receiver system and source system are each therefore construed as encompassing generic forms of computer processing and memory devices.
Paragraph 22 states that “[t]he encoder may use a decryption technique to generate the encoded medical imaging data 106…For example, the encryption technique may include, but is not limited to, an Advanced Encryption Standard (AES) technique, a Data Encryption Standard (DES) technique, a Triple-DES (TDES) technique, and a Rivest- Shamir-Adleman (RSA) technique.” Paragraph 45 of the specification lists the same encryption protocols. The encryption technique is therefore construed as encompassing generic forms of encryption protocols.
The above elements only amount to mere instructions to implement the functions of the abstract idea using computing elements as tools. Specifically, the receiver system and source system are each only recited at a high level of generality as used to perform functions such as validating and transmitting the medical image data and are disclosed as encompassing generic computing elements. The encryption technique is likewise only recited at a high level of generality as used to encode the imaging data and disclosed as encompassing any of a plurality of known encryption protocols These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 3 recites wherein the set of constant fields comprises at least one of text data and binary data corresponding to a patient, an imaging system, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 recites wherein the set of variable fields comprises at least one of text data and binary data corresponding to an examination parameter, a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, one or more examination rules and constraints, and additional examination data. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 recites generating a reconstructed image based on the validated reconstruction data, wherein the reconstructed image comprises information associated with the source system and the receiver system. These limitations fall within the scope of the abstract idea as set out above.
Examiner notes that the source system and receiver system are not recited in the above limitations as performing any function, and are only recited as being associated with information comprised in the reconstructed image.
Claim 7 recites rendering an error with a reason of failure to the user, for each failed validation corresponding to the medical imaging data, the decoded medical imaging data, and the reconstruction data. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 recites wherein storing the decoded medical imaging data comprises determining compatibility of the decoded medical imaging data with the receiver system configurations. These limitations fall within the scope of the abstract idea as set out above.
Examiner notes that the receiver system is not recited in the above limitations as performing any function, and is only recited as the object of the configurations used in determining compatibility.
Claim 10 recites generating the medical imaging data in the machine-readable format by parsing medical imaging data, wherein the medical imaging data comprises a set of variable fields and the set of constant fields, wherein the set of constant fields comprises at least one of text data and binary data corresponding to a patient, an imaging system, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician, and wherein the set of variable fields comprises at least one of text data and binary data corresponding to an examination parameter, a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, one or more examination rules and constraints, and additional examination data; validating the medical imaging data based on the plurality of predefined standards; upon successful validation, encoding the medical imaging data using an encryption technique to generate the encoded medical imaging data; and transmitting the encoded medical imaging data to the receiver. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 recites the additional elements of a) the processor executing instructions to perform the subsequent functions and b) the receiver being a receiver system.
As cited above, paragraphs 17 and 23 describe source system 100 and receiver system 200, while paragraphs 35 and 36 state that source system 100 and receiver system 200 “may be implemented in programmable hardware devices such as programmable gate arrays, programmable array logic, programmable logic devices, or the like” or “implemented in software for execution by various types of processors” such as ASICs. Paragraphs 35 and 36 also describe the instructions as stored in memory devices and accessed by the processor.
Additionally, paragraphs 61-63 state that “[t]he disclosed methods and systems may be implemented on a conventional or a general-purpose computer system, such as a personal computer (PC) or server computer” such as desktops, laptops, mobile phones, or other general-purpose computers, and describe the computer system as employing microprocessors and various types of RAM, ROM, flash memory, and other memory types.
The receiver system and processor are each therefore construed as encompassing generic forms of computer processing and memory devices.
The above elements only amount to mere instructions to implement the functions of the abstract idea using computing elements as tools. Specifically, the receiver system and processor are each only recited at a high level of generality as used to perform functions such as parsing and receiving the medical image data and are disclosed as encompassing generic computing elements. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 11 recites generating a reconstructed image based on the validated reconstruction data, wherein the reconstructed image comprises information associated with the source system and the receiver system. These limitations fall within the scope of the abstract idea as set out above.
Examiner notes that the source system and receiver system are not recited in the above limitations as performing any function, and are only recited as being associated with information comprised in the reconstructed image.
Claim 11 recites the additional element of the processor executing instructions to perform the subsequent functions.
As cited above, paragraphs 17 and 23 describe source system 100 and receiver system 200, while paragraphs 35 and 36 state that source system 100 and receiver system 200 “may be implemented in programmable hardware devices such as programmable gate arrays, programmable array logic, programmable logic devices, or the like” or “implemented in software for execution by various types of processors” such as ASICs. Paragraphs 35 and 36 also describe the instructions as stored in memory devices and accessed by the processor.
Additionally, paragraphs 61-63 state that “[t]he disclosed methods and systems may be implemented on a conventional or a general-purpose computer system, such as a personal computer (PC) or server computer” such as desktops, laptops, mobile phones, or other general-purpose computers, and describe the computer system as employing microprocessors and various types of RAM, ROM, flash memory, and other memory types. The processor is therefore construed as encompassing generic forms of computer processing devices.
The above element only amounts to mere instructions to implement the functions of the abstract idea using computing elements as tools. Specifically, the processor is only recited at a high level of generality as used to perform the subsequently recited data analysis function of generating reconstruction data and is disclosed as encompassing generic computing elements. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 1-4 and 6-11 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112(b)
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 1-4 and 6-11 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.
Claims 1 and 9 are indefinite because Examiner is unable to determine the metes and bounds of the respective claims based on the recitation of storing the medical imaging data “based on one or more configurations of the receiver system.” Specifically, it is not clear based on the context of the claims what is being described by “configurations of the receiver system” or what the metes and bounds of such configurations would be. While the specification uses the terminology “receiver system configurations” (see e.g. paragraph 27 of the specification as originally filed) it does not further describe or provide examples of such receiver system configurations. It is therefore not clear what subject matter is encompassed by “configurations of the receiver system.” It is therefore not clear what would fall within the scope of storing the medical imaging data specifically “based on one or more configurations of the receiver system” given that the claim is not merely reciting storing the imaging data, and it is unclear what types of information are being used to modify the storage of the imaging data.
Claims 2-4, 6-8, 10, and 11 inherit the deficiencies of claims 1 and 9 through dependency and are likewise rejected.
Claim 8 is indefinite because Examiner is unable to determine the metes and bounds of the respective claims based on the recitation of “determining compatibility of the decoded medical imaging data with the receiver system configurations.” Specifically, and as set out above, it is not clear based on the context of the claims what is being described by “receiver system configurations” or what the metes and bounds of such configurations would be. While the specification uses the terminology “receiver system configurations” (see e.g. paragraph 27 of the specification as originally filed) it does not further describe or provide examples of such receiver system configurations. Given that the metes and bounds of the “receiver system configurations” are unclear, it is also unclear what functionality is encompassed by determining compatibility of the medical imaging data with such receiver system configurations.
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.
Claims 1, 2, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al (US Patent Application Publication 2024/0013893) in view of Gazelle X Validator Rule Editor (hereinafter Gazelle), VanNostrand (US Patent Application Publication 2007/0143342), Gendron et al (US Patent Application Publication 2002/0023172), and Omernick et al (US Patent Application Publication 2012/0002853).
With respect to claim 1, Choudhury discloses the claimed method of transmitting medical imaging data from a source system to a receiver system, the method comprising:
receiving, by the receiver system, encoded medical imaging data from the source system, wherein the encoded medical imaging data comprises the medical imaging data in a machine-readable format (Figures 1 and 9, [24], [25], [28], [33], [39], and [60] describe DPU 115 receiving encrypted medical image data in a format that does not conform to a medical image data protocol or in a format which does conform to the medical image data protocol);
decoding, by the receiver system, the encoded medical imaging data using a decryption technique (Figure 2, [25], [32], and [33] describe the DPU 115 decrypting the medical data);
mapping, by the receiver system, the decoded medical imaging data based on one or more business objects associated with the receiver system (Figure 9, [25], [37], [41], [43], and [44] describe converting the decrypted data from the format that does not conform to the medical imaging protocol to a first format which does conform to the medical imaging protocol);
storing, by the receiver system, the decoded medical imaging data in a data store associated with the receiver system based on one or more configurations of the receiver system (Figures 1, 4, and 5, [39], [41], and [43] describe storing the data based on rules configured at the receiving system);
but does not expressly disclose:
the received data having been validated based on a plurality of predefined standards;
validating, by the receiver system, the decoded medical imaging data based on the plurality of predefined standards;
mapping the imaging data upon successful validation;
generating, by the receiver system, reconstruction data based on the stored decoded medical imaging data and an input received from a user, wherein the input comprises values corresponding to at least one of a size parameter and an orientation parameter of an image; and
validating, by the receiver system, the reconstruction data based on a plurality of predefined clinical rules and the set of constant fields.
However, Gazelle teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to validate converted medical image data based on a plurality of predefined standards (Page 2 ¶1, page 7 ¶1, page 9 ¶3, and page 18 Illustration 21 describes a DICOM system which converts DICOM files into XML and validates the XML files).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the system of Choudhury to validate converted medical image data based on a plurality of predefined standards as taught by Gazelle since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Choudhury already discloses converting DICOM files into other predefined standards, and validating the files after conversion as taught by Gazelle would perform that same function in Choudhury, making the results predictable to one of ordinary skill in the art (MPEP 2143).
VanNostrand further teaches that it was old and well known in the art of medical image transfer before the effective filing date of the claimed invention to map, by a receiver system, imaging data which has been validated by the receiver system based on the plurality of predefined standards (Figures 1, 3A, 3B, 5, 7, and 8, [19]-[21], [30], [32], and [35] describe a receiver system validating medical imaging data based on predefined standards such as XML and mapping the result to a standard equivalent based on receiver capabilities).
Therefore it would have been obvious to one of ordinary skill in the art of medical image transfer before the effective filing date of the claimed invention to modify the system of Choudhury to map imaging data which has been validated, by a receiver system, based on the plurality of predefined standards as taught by VanNostrand since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Choudhury already discloses the receiver system receiving medical imaging data in a plurality of predefined standards and mapping the imaging data, and validating the received imaging data based on the standards and mapping the validated data as taught by VanNostrand would perform that same function in Choudhury, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Gendron further teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate reconstruction data based on stored medical imaging data (Figure 5, [74], [75], [77], [78], and [81]-[84] describe retrieving and translating particular DICOM imaging data, i.e. generating reconstruction data, based on stored study data), and to validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields (Figures 3 and 4, [61], [64]-[66], [151], and [152] describe the system validating the data based on the associated DICOM information and rules)
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, and VanNostrand to generate reconstruction data based on stored medical imaging data and validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields as taught by Gendron since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, and VanNostrand already teaches storing DICOM files for display (see e.g. Choudhury [26]), and generating reconstruction data based on the stored data followed by validating the reconstruction data based on predefined clinical rules and constant fields as taught by Gendron would perform that same function in Choudhury, Gazelle, and VanNostrand, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Omernick lastly teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate reconstruction data based on an orientation parameter of an image received from a user (Figure 3, [17], and [42]-[44] describe a user entering a value for image orientation which is then used to generate the reconstructed image based on the orientation).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, and Gendron to generate reconstruction data based on an orientation parameter of an image received from a user as taught by Omernick since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, and Gendron already teaches generating reconstruction data based on the stored data, and generating the reconstruction data by including image orientation as taught by Omernick would perform that same function in Choudhury, Gazelle, VanNostrand, and Gendron, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 2, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 1. Choudhury further discloses:
generating, by the source system, the medical imaging data in the machine-readable format by parsing medical imaging data, wherein the medical imaging data comprises the set of variable fields and a set of constant fields (Figure 8, [24], [31], [41], [42], [55], and [56] describe the system parsing medical imaging data of a first format and generating converted data in a second format prior to transmission, where the converted data includes a plurality of types of pixel and header data such as type of modality, study description, series description, and image type);
encoding, by the source system, the medical imaging data using an encryption technique to generate the encoded medical imaging data (Figure 2, [24], [28], [30], and [56] describe the system encrypting the data prior to transmission); and
transmitting, by the source system, the encoded medical imaging data to the receiver system (Figure 2, [28], [34], and [42] describe transmitting the encrypted imaging data from the source system to the receiver system);
but does not expressly disclose:
validating, by the source system, the medical imaging data based on the plurality of predefined standards.
However, Gazelle teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to validate converted medical image data based on a plurality of predefined standards (Page 2 ¶1, page 7 ¶1, page 9 ¶3, and page 18 Illustration 21 describes a DICOM system which converts DICOM files into XML and validates the XML files).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to validate converted medical image data based on a plurality of predefined standards as taught by Gazelle since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already discloses converting DICOM files into other predefined standards prior to transmission, and validating the files after that conversion as taught by Gazelle would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 7, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 1. Choudhury does not expressly disclose rendering an error with a reason of failure to the user, for each failed validation corresponding to the medical imaging data, the decoded medical imaging data, and the reconstruction data.
However, Gendron teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to render an error with a reason of failure to a user for failed validations (Figures 11, 12, and 18, [151], [152], [154], and [155] describe the system validating imaging tags and providing reasons for any failures to a user).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to render an error with a reason of failure to a user for failed validations as taught by Gendron since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches performing validations corresponding to the medical imaging data, the decoded medical imaging data, and the reconstruction data, and rendering an error with a reason of failure to a user for any failed validations as taught by Gendron would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 8, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 1. Choudhury does not expressly disclose wherein storing the decoded medical imaging data comprises determining compatibility of the decoded medical imaging data with the receiver system configurations.
However, VanNostrand teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to determine compatibility of medical imaging data with receiver system configurations as part of storing medical imaging data ([20]-[23], [29], [31], and [34] describe determining portions of received medial imaging data based on the capabilities of the receiving system and sending compatible data to a data storage system).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to determine compatibility of medical imaging data with receiver system configurations as part of storing medical imaging data as taught by VanNostrand since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already discloses a receiving system decoding and storing received medical imaging data, and storing the medical imaging data by determining compatibility of the medical imaging data with receiver system configurations as taught by VanNostrand would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 9, Choudhury discloses the claimed system for transmitting medical imaging data from a source system to a receiver system, the system comprising:
a processor ([63]-[65] describe the system comprising processors); and
a memory communicatively coupled to the processor, wherein the memory stores processor-executable instructions ([63], [68], and [75] describe memory storing instructions executed by the processors), which, on execution, cause the processor to:
receive encoded medical imaging data from the source system, wherein the encoded medical imaging data comprises the medical imaging data in a machine-readable format (Figures 1 and 9, [24], [25], [28], [33], [39], and [60] describe DPU 115 receiving encrypted medical image data in a format that does not conform to a medical image data protocol or in a format which does conform to the medical image data protocol);
decode the encoded medical imaging data using a decryption technique (Figure 2, [25], [32], and [33] describe the DPU 115 decrypting the medical data);
map the decoded medical imaging data based on one or more business objects associated with the receiver system (Figure 9, [25], [37], [41], [43], and [44] describe converting the decrypted data from the format that does not conform to the medical imaging protocol to a first format which does conform to the medical imaging protocol); and
store the decoded medical imaging data in a data store associated with the receiver system based on one or more configurations of the receiver system (Figures 1, 4, and 5, [39], [41], and [43] describe storing the data based on rules configured at the receiving system);
but does not expressly disclose:
the received data having been validated based on a plurality of predefined standards;
validating, by the receiver system, the decoded medical imaging data based on the plurality of predefined standards;
mapping the imaging data upon successful validation;
generating reconstruction data based on the stored decoded medical imaging data and an input received from a user, wherein the input comprises values corresponding to at least one of a size parameter and an orientation parameter of an image; and
validating, by the receiver system, the reconstruction data based on a plurality of predefined clinical rules and the set of constant fields.
However, Gazelle teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to validate converted medical image data based on a plurality of predefined standards (Page 2 ¶1, page 7 ¶1, page 9 ¶3, and page 18 Illustration 21 describes a DICOM system which converts DICOM files into XML and validates the XML files).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the system of Choudhury to validate converted medical image data based on a plurality of predefined standards as taught by Gazelle since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Choudhury already discloses converting DICOM files into other predefined standards, and validating the files after conversion as taught by Gazelle would perform that same function in Choudhury, making the results predictable to one of ordinary skill in the art (MPEP 2143).
VanNostrand further teaches that it was old and well known in the art of medical image transfer before the effective filing date of the claimed invention to validate, by a receiver system, medical imaging data based on the plurality of predefined standards and subsequently map the imaging data (Figures 1, 3A, 3B, 5, 7, and 8, [19]-[21], [30], [32], and [35] describe a receiver system validating medical imaging data based on predefined standards such as XML and mapping the result to a standard equivalent based on receiver capabilities).
Therefore it would have been obvious to one of ordinary skill in the art of medical image transfer before the effective filing date of the claimed invention to modify the system of Choudhury to validate, by a receiver system, medical imaging data based on the plurality of predefined standards and subsequently map the imaging data as taught by VanNostrand since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Choudhury already discloses the receiver system receiving medical imaging data in a plurality of predefined standards and mapping the imaging data, and validating the received imaging data based on the standards and mapping the validated data as taught by VanNostrand would perform that same function in Choudhury, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Gendron further teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate reconstruction data based on stored medical imaging data (Figure 5, [74], [75], [77], [78], and [81]-[84] describe retrieving and translating particular DICOM imaging data, i.e. generating reconstruction data, based on stored study data), and to validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields (Figures 3 and 4, [61], [64]-[66], [151], and [152] describe the system validating the data based on the associated DICOM information and rules)
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, and VanNostrand to generate reconstruction data based on stored medical imaging data and validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields as taught by Gendron since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, and VanNostrand already teaches storing DICOM files for display (see e.g. Choudhury [26]), and generating reconstruction data based on the stored data followed by validating the reconstruction data based on predefined clinical rules and constant fields as taught by Gendron would perform that same function in Choudhury, Gazelle, and VanNostrand, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Omernick lastly teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate reconstruction data based on an orientation parameter of an image received from a user (Figure 3, [17], and [42]-[44] describe a user entering a value for image orientation which is then used to generate the reconstructed image based on the orientation).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, and Gendron to generate reconstruction data based on an orientation parameter of an image received from a user as taught by Omernick since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, and Gendron already teaches generating reconstruction data based on the stored data, and generating the reconstruction data by including image orientation as taught by Omernick would perform that same function in Choudhury, Gazelle, VanNostrand, and Gendron, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims 3, 4, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al (US Patent Application Publication 2024/0013893) in view of Gazelle X Validator Rule Editor (hereinafter Gazelle), VanNostrand (US Patent Application Publication 2007/0143342), Gendron et al (US Patent Application Publication 2002/0023172), and Omernick et al (US Patent Application Publication 2012/0002853) as applied to claims 2 and 9, and further in view of NEMA, DICOM PS3.6 2022d Registry of DICOM Data Elements (hereinafter DICOM Data Elements).
With respect to claim 3, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 2. Choudhury further discloses:
wherein the set of constant fields comprises at least one of text data and binary data corresponding to an imaging system ([41] describes the header data as including the imaging system used to acquire the images; [43] further describes the fields as including binary data fields);
but does not expressly disclose:
the set of constant fields corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician.
However, DICOM Data Elements teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to include a set of constant fields corresponding to a patient (Page 15 lists the DICOM tags including fields such as the patient’s name, ID, birth date, and other information), an institution where the source system is installed (Pages 3 and 9 list the DICOM tags as including the name and address of the institution as well as the relevant department within the institution), cardiac data (Page 40 lists the DICOM tags as including high and low R-R interval values as well as heart rate), pulmonary data (Pages 60, 84, and 85 list the DICOM tags as including information on respiratory cycle position as well as starting and ending respiratory amplitude and phase), injector data (Pages 35, 38, 43 list the DICOM tags as including injector data such as contrast administration route, contrast start/stop time, and syringe counts), a prescribed medicine (Pages 213, 249, and 258 list the DICOM tags as including prescription notes, dose, and sequence), and a certified technician (Pages 9 and 171 list the DICOM tags as including the operator’s name and content creator’s name).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to have a set of constant fields corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician as taught by DICOM Data Elements since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches the set of constant fields including DICOM header tags (see e.g. Choudhury [41] listing the StudyDescription 0008, SeriesDescription 0008, and other 0008 group tags), and having the set of constant fields include DICOM header tags corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician as taught by DICOM Data Elements would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 4, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 2. Choudhury further discloses:
wherein the set of variable fields comprises at least one of text data and binary data corresponding to an examination parameter and additional examination data ([41] describes the variable fields as including the Study Description and Series Description DICOM header tags; [43] further describes the fields as including binary data fields);
but does not expressly disclose:
the set of variable fields corresponding to a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints.
However, DICOM Data Elements teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to include a set of variable fields corresponding to a scan preference (Pages 49, 97, and 98 list the DICOM tags as including depth of scan field, scan pattern type, and scan cycle time/scan rate parameters), an image acquisition parameter (Pages 1, 2, 15, and 42 list the DICOM tags as including acquisition UID, acquisition date, acquisition contrast, and acquisition mode), a bolus tracking detail (Pages 34, 35, and 38 list the DICOM tags as including bolus agent, sequence, reflexivity, administration route, volume, start/stop time, and other information), collimation data (Pages 42 and 47 list the DICOM tags as including collimator grid, type, shape, and other information), a scan geometry (Pages 58, 63, 70, 74, and 81 list the DICOM tags as including geometry sequence, detector geometry, and image geometry type), scan coordinates (Pages 23, 88, 96, and 130 list the DICOM tags as including scan coordinate system data, reference coordinates, X and Y coordinates, and image center point coordinates), and one or more examination rules and constraints (Pages 126, 193, and 194 list the DICOM tags as including scheduled procedure step sequence, constraint type, and constraint violations).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to have a set of variable fields corresponding to a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints as taught by DICOM Data Elements since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches the set of constant fields including DICOM header tags (see e.g. Choudhury [41] listing the StudyDescription 0008, SeriesDescription 0008, and other 0008 group tags), and having the set of variable fields include DICOM header tags corresponding to scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints as taught by DICOM Data Elements would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 10, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the system of claim 9. Choudhury further discloses wherein the processor-executable instructions further cause the processor to:
generate the medical imaging data in the machine-readable format by parsing medical imaging data, wherein the medical imaging data comprises a set of variable fields and a set of constant fields (Figure 8, [24], [31], [41], [42], [55], and [56] describe the system parsing medical imaging data of a first format and generating converted data in a second format prior to transmission, where the converted data includes a plurality of types of pixel and header data such as type of modality, study description, series description, and image type),
wherein the set of constant fields comprises at least one of text data and binary data corresponding to an imaging system ([41] describes the header data as including the imaging system used to acquire the images; [43] further describes the fields as including binary data fields), and
wherein the set of variable fields comprises at least one of text data and binary data corresponding to an examination parameter and additional examination data ([41] describes the variable fields as including the Study Description and Series Description DICOM header tags; [43] further describes the fields as including binary data fields);
encode the medical imaging data using an encryption technique to generate the encoded medical imaging data (Figure 2, [24], [28], [30], and [56] describe the system encrypting the data prior to transmission); and
transmit the encoded medical imaging data to the receiver system (Figure 2, [28], [34], and [42] describe transmitting the encrypted imaging data from the source system to the receiver system);
but does not expressly disclose:
the set of constant fields corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician;
the set of variable fields corresponding to a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints
validating the medical imaging data based on the plurality of predefined standards.
However, DICOM Data Elements teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to include a set of constant fields corresponding to a patient (Page 15 lists the DICOM tags including fields such as the patient’s name, ID, birth date, and other information), an institution where the source system is installed (Pages 3 and 9 list the DICOM tags as including the name and address of the institution as well as the relevant department within the institution), cardiac data (Page 40 lists the DICOM tags as including high and low R-R interval values as well as heart rate), pulmonary data (Pages 60, 84, and 85 list the DICOM tags as including information on respiratory cycle position as well as starting and ending respiratory amplitude and phase), injector data (Pages 35, 38, 43 list the DICOM tags as including injector data such as contrast administration route, contrast start/stop time, and syringe counts), a prescribed medicine (Pages 213, 249, and 258 list the DICOM tags as including prescription notes, dose, and sequence), and a certified technician (Pages 9 and 171 list the DICOM tags as including the operator’s name and content creator’s name), and a set of variable fields corresponding to a scan preference (Pages 49, 97, and 98 list the DICOM tags as including depth of scan field, scan pattern type, and scan cycle time/scan rate parameters), an image acquisition parameter (Pages 1, 2, 15, and 42 list the DICOM tags as including acquisition UID, acquisition date, acquisition contrast, and acquisition mode), a bolus tracking detail (Pages 34, 35, and 38 list the DICOM tags as including bolus agent, sequence, reflexivity, administration route, volume, start/stop time, and other information), collimation data (Pages 42 and 47 list the DICOM tags as including collimator grid, type, shape, and other information), a scan geometry (Pages 58, 63, 70, 74, and 81 list the DICOM tags as including geometry sequence, detector geometry, and image geometry type), scan coordinates (Pages 23, 88, 96, and 130 list the DICOM tags as including scan coordinate system data, reference coordinates, X and Y coordinates, and image center point coordinates), and one or more examination rules and constraints (Pages 126, 193, and 194 list the DICOM tags as including scheduled procedure step sequence, constraint type, and constraint violations)
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to have a set of constant fields corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician, and a set of variable fields corresponding to a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints as taught by DICOM Data Elements since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches the set of constant fields including DICOM header tags (see e.g. Choudhury [41] listing the StudyDescription 0008, SeriesDescription 0008, and other 0008 group tags), and having the set of constant fields include DICOM header tags corresponding to a patient, an institution where the source system is installed, cardiac data, pulmonary data, injector data, a prescribed medicine, and a certified technician, and a set of variable fields corresponding to a scan preference, an image acquisition parameter, a bolus tracking detail, collimation data, a scan geometry, scan coordinates, and one or more examination rules and constraints as taught by DICOM Data Elements would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Gazelle lastly teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to validate converted medical image data based on a plurality of predefined standards (Page 2 ¶1, page 7 ¶1, page 9 ¶3, and page 18 Illustration 21 describes a DICOM system which converts DICOM files into XML and validates the XML files).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to validate converted medical image data based on a plurality of predefined standards as taught by Gazelle since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already discloses converting DICOM files into other predefined standards prior to transmission, and validating the files after that conversion as taught by Gazelle would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al (US Patent Application Publication 2024/0013893) in view of Gazelle X Validator Rule Editor (hereinafter Gazelle), VanNostrand (US Patent Application Publication 2007/0143342), Gendron et al (US Patent Application Publication 2002/0023172) and Omernick et al (US Patent Application Publication 2012/0002853) as applied to claim 1, and further in view of Kotula et al (US Patent Application Publication 2010/0211409).
With respect to claim 6, Choudhury/Gazelle/VanNostrand/Gendron/Omernick teach the method of claim 1. Choudhury does not expressly disclose generating a reconstructed image based on the validated reconstruction data, wherein the reconstructed image comprises information associated with the source system and the receiver system.
However, Gendron teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate a reconstructed image based on validated reconstruction data (Figure 2 element 26, [26], [28], [74], and [86] describe generating a reconstructed image based on the validated data for viewing by a clinician).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to generate a reconstructed image based on validated reconstruction data as taught by Gendron since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches generating reconstruction data and validating the data, and generating a reconstructed image based on the validated data as taught by Gendron would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Kotula further teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate a reconstructed image comprising information associated with a source system and a receiver system (Figures 1A, 2, and 3, [14], [26], [49], [56], [63], and [68] show and describe a system receiving medical images, using image metadata to generate manifest information, and then generating reconstructed images having information associated with the transmitting facility such as the facility’s name and imaging modality, as well as information from the manifest file).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick to generate a reconstructed image comprising information associated with a source system and a receiver system as taught by Kotula since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, and Omernick already teaches a source system and receiving system as well as generating a reconstructed image, and generating a reconstructed image comprising information associated with a source system and a receiver system as taught by Kotula would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, and Omernick, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Choudhury et al (US Patent Application Publication 2024/0013893) in view of Gazelle X Validator Rule Editor (hereinafter Gazelle), VanNostrand (US Patent Application Publication 2007/0143342), Gendron et al (US Patent Application Publication 2002/0023172), Omernick et al (US Patent Application Publication 2012/0002853), and NEMA, DICOM PS3.6 2022d Registry of DICOM Data Elements (hereinafter DICOM Data Elements) as applied to claim 10, and further in view of Kotula et al (US Patent Application Publication 2010/0211409).
With respect to claim 11, Choudhury/Gazelle/VanNostrand/Gendron/Omernick/ DICOM Data Elements teach the system of claim 9. Choudhury does not expressly disclose wherein the processor-executable instructions further cause the processor to: validate the reconstruction data based on a plurality of predefined clinical rules and the set of constant fields; and generate a reconstructed image based on the validated reconstruction data, wherein the reconstructed image comprises information associated with the source system and the receiver system.
However, Gendron teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to (Figure 5, [74], [75], [77], [78], and [81]-[84] describe retrieving and translating particular DICOM imaging data, i.e. generating reconstruction data, based on stored study data and the inputted request from a user), validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields (Figures 3 and 4, [61], [64]-[66], [151], and [152] describe the system validating the data based on the associated DICOM information and rules), and generate a reconstructed image based on validated reconstruction data (Figure 2 element 26, [26], [28], [74], and [86] describe generating a reconstructed image based on the validated data for viewing by a clinician)
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements to validate the reconstruction data based on a plurality of predefined clinical rules and set of constant fields, and generate a reconstructed image based on validated reconstruction data as taught by Gendron since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements already teaches storing DICOM files for display (see e.g. Choudhury [26]), and generating reconstruction data based on the stored data and a user input followed by validating the reconstruction data based on predefined clinical rules and constant fields and generating the reconstruction image as taught by Gendron would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Omernick further teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate reconstruction data based on an orientation parameter of an image received from a user (Figure 3, [17], and [42]-[44] describe a user entering a value for image orientation which is then used to generate the reconstructed image based on the orientation).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements to generate reconstruction data based on an orientation parameter of an image received from a user as taught by Omernick since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements already teaches generating reconstruction data based on the stored data and a user input, and having the user input include image orientation as taught by Omernick would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Kotula lastly teaches that it was old and well known in the art of medical image processing before the effective filing date of the claimed invention to generate a reconstructed image comprising information associated with a source system and a receiver system (Figures 1A, 2, and 3, [14], [26], [49], [56], [63], and [68] show and describe a system receiving medical images, using image metadata to generate manifest information, and then generating reconstructed images having information associated with the transmitting facility such as the facility’s name and imaging modality, as well as information from the manifest file).
Therefore it would have been obvious to one of ordinary skill in the art of medical image processing before the effective filing date of the claimed invention to modify the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements to generate a reconstructed image comprising information associated with a source system and a receiver system as taught by Kotula since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements already teaches a source system and receiving system as well as generating a reconstructed image, and generating a reconstructed image comprising information associated with a source system and a receiver system as taught by Kotula would perform that same function in Choudhury, Gazelle, VanNostrand, Gendron, Omernick, and DICOM Data Elements, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Koutelakis et al, PACS through Web Compatible with DICOM Standard and WADO Service: Advantages and Implementation;
Yu et al, XML-Based DICOM Data Format;
Zhang et al, Implementation methods of medical image sharing for collaborative health care based on IHE XDS-I profile;
Silva et al, A community-driven validation service for standard medical imaging objects;
Hu et al (US Patent Application Publication 2010/0246981);
Oliveres (US Patent Application Publication 2023/0162837);
Westin et al (US Patent Application Publication 2019/0335096);
Liu et al (WO 2011/051103);
Kibble et al (US Patent Application Publication 2020/0312440).
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/Gregory Lultschik/Examiner, Art Unit 3682
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