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 .
DETAILED ACTION
Response to Amendment
In the Amendment dated 30 October 2025, the following occurred:
Claims 1, 8, and 9 were amended.
Claim 10 was added.
Claims 1-4 and 6-10 are pending.
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 6-10 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 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a medical information system and a medical image diagnostic device, and therefore meet step 1.
Step 2A1
The limitations of (Claim 1 being representative) …acquir[ing] supplementary information as structured information associated with image data to be acquired…, the supplementary information being newly identified information, not included in patient information, of a subject to be imaged, wherein the supplementary information includes at least one of allergy information and implant information that affects the testing process, and the supplementary information is associated with an attribute for a corresponding DICOM tag, and notif[ying]…of the supplementary information in response to the acquisition of the supplementary information, the patient information being information unique to the subject to be imaged, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
That is, other than reciting a system and device implemented by processors (general-purpose computing devices), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional element of a processor (claims 1 and 8) that implements the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., a personal computer, see, e.g., Page 7, Para. 3) such that it amounts to no more than mere instructions to apply the exception using generic computer components. See MPEP 2106.05(f). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, acquiring information and notifying at least one server is considered insignificant extra solution activity such as pre-solution activity e.g., data gathering (performed by receiving/transmitting/etc.) See MPEP 2106.05(g).
The claims recite the additional elements of (1) at least one management server, (2) a network, and (3) a medical image diagnostic device / imaging unit. The (1) at least one management server and (2) network merely generally link the abstract idea to a particular technological environment or field of use. The (3) medical image diagnostic device / imaging unit represents a location from which data is received and merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) at least one management server, (2) a network, and (3) a medical image diagnostic device / imaging unit were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Claims 2-4, 6, 7, 9, and 10 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claims 2 and 7 merely describe the management server. Claim 2 further recites the additional element of a second processor, which is considered part of the server of claim 1 and thus part of the abstract idea. Claim 7 further recites the additional elements of a radiology management server and an image management and storage server, which are considered to further define the management server.
Claim 3 merely describes the first processor. Claim 4 merely describes the patient information. Claim 6 merely describes the supplementary information. Claim 9 merely describes the first processor and the supplemental information. Claim 10 merely describes setting imaging conditions based on supplementary information. Claim 10 further includes the additional element of controlling the medical image diagnostic device. The controlling of the medical image diagnostic device to use undescribed imagining setting based on undescribed supplementary information represents “apply it” under both 2A2 and 2B, which cannot provide a practical application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Backhaus (U.S. 2012/0323593) in view of Saffran (U.S. 2015/0324525).
REGARDING CLAIM 1
Backhaus teaches the claimed medical information system comprising:
a first processor on a side of a medical image diagnostic device, [The modality is a medical image diagnostic device, such as an X-ray, a CT, or an MRI device. Para. 0003 teaches generating medical images by an imaging modality, such as X-rays, CAT scans, and MRI’s. The medical images are transmitted from the modality to an image server (first processor), which is interpreted to be to the right side of the imaging device (see Fig. 1).]
and the supplementary information is associated with an attribute for a corresponding DICOM tag, [Para. 0197 teaches generating a heading tag and including information in the header. Para. 0211 teaches a DICOM header.]
and notify via a network at least one management server that manages the patient information of the supplementary information in response to the acquisition of the supplementary information, [Para. 0136 teaches notifying the medical facility (management server) in response to the acquisition of patient information. Para. 0034 teaches the image server component of the IO Management System and medical facilities are connected via a network.]
Backhaus may not explicitly teach
wherein the first processor is configured to during a testing process using the medical image diagnostic device, acquire supplementary information as structured information associated with image data to be acquired using the medical image diagnostic device, the supplementary information being newly identified information, not included in patient information, of a subject to be imaged, wherein the supplementary information includes at least one of allergy information and implant information that affects the testing process,
the patient information being information unique to the subject to be imaged.
However, Saffran teaches the following:
wherein the first processor is configured to during a testing process using the medical image diagnostic device, acquire supplementary information as structured information associated with image data to be acquired using the medical image diagnostic device, the supplementary information being newly identified information, not included in patient information, of a subject to be imaged, wherein the supplementary information includes at least one of allergy information and implant information that affects the testing process, [Para. 0169 teaches the patient granting an MRI facility permission to access implant information, associated with image data to be acquired, that affects the testing process. Because the facility did not have access prior, the implant information is newly identified and not included in patient information.]
the patient information being information unique to the subject to be imaged. [Para. 0183 teaches a user name for the patient to be imaged.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the system of Backhaus to acquire newly identified information as taught by Saffran, with the motivation of improving the holistic health of the patient (see Saffran at Para. 0265).
REGARDING CLAIM 2
Backhaus in view of Saffran teaches the claimed medical information system according to claim 1.
Backhaus further teaches
wherein the at least one management server includes a second processor, and the second processor is configured to acquire the supplementary information via the network, store the patient information of the subject, [Para. 0059 teaches the medical facility (management server) contains an HIS (second processor) which stores patient information. A computing device is networked with the HIS and receives transmitted patient information.]
and update the stored patient information based on the acquired supplementary information. [Para. 0051 teaches updating the stored patient information.]
REGARDING CLAIM 3
Backhaus in view of Saffran teaches the claimed medical information system according to claim 1.
Backhaus further teaches
wherein the first processor is further configured to acquire the supplementary information as a DICOM tag of the image data. [Para. 0206 teaches the image server (first processor) extracting DICOM data from the images.]
REGARDING CLAIM 4
Backhaus in view of Saffran teaches the claimed medical information system according to claim 2.
Backhaus further teaches
wherein, when the patient information is updated, the […] processor is configured to output information notifying the update. [Para. 0051 teaches the medical facility transmitting an alert when patient information is updated.]
Backhaus may not explicitly teach that the patient information is updated on the HIS processor. However, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the updating feature of Backhaus with the HIS processor of Backhaus since the combination is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the HIS processor of Backhaus as the location which performs the updating of the patient information of Backhaus. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
REGARDING CLAIM 7
Backhaus in view of Saffran teaches the claimed medical information system according to claim 1.
Backhaus further teaches
wherein the management server includes a radiology management server and an image management and storage server. [Para. 0002 teaches a radiology image management system (server). Para. 0057 teaches the medical facility (management server) includes a storage system (server).]
The Examiner notes that this claim is considered nonfunctional descriptive information because the servers do not perform a function in the claim and thus the limitation would also be obvious in view of Backhaus.
REGARDING CLAIM 8
Claim 8 is analogous to Claim 1, thus Claim 8 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
REGARDING CLAIM 9
Backhaus in view of Saffran teaches the claimed medical information system of claim 1.
Backhaus further teaches
wherein the first processor is part of the medical image diagnostic device, [The modality is a medical image diagnostic device, such as an X-ray, a CT, or an MRI device. Para. 0003 teaches generating medical images by an imaging modality, such as X-rays, CAT scans, and MRI’s. The medical images are transmitted from the modality to an image server (first processor), which is interpreted to be to the right side of the imaging device (see Fig. 1).]
Saffran further teaches
the supplementary information is obtained from a console of the medical image diagnostic device at a time of the testing procedure, [Para. 0177 teaches information is obtained at the time of the testing procedure.]
and the first processor is configured to determine that information input to the console includes the supplemental information that is not currently included in the patient information. [Para. 0169 teaches the patient granting an MRI facility permission to access implant information, associated with image data to be acquired, that affects the testing process. Because the facility did not have access prior, the implant information is newly identified and not included in patient information.]
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Backhaus in view of Saffran and Eippert et al. (U.S. 2021/0391066), referred to hereinafter as Eippert.
REGARDING CLAIM 6
Backhaus in view of Saffran teaches the claimed medical information system according to claim 4.
Backhaus in view of Saffran may not explicitly teach
wherein the supplementary information includes an exit time when the subject leaves a test room.
However, Eippert teaches the following:
wherein the supplementary information includes an exit time when the subject leaves a test room. [Para. 0022 teaches the patient’s record includes an exit time when the subject leaves a surgical suite.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented system of Backhaus in view of Saffran to include an exit time as taught by Eippert, with the motivation of providing improved efficiencies in various aspects of medical procedures, including accurate time data records (see Eippert at Para. 0029).
The Examiner further notes that including an exit time constitutes nonfunctional descriptive information that is not functionally involved in the recited system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the supplementary information of the prior art with any other supplementary information because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). The Examiner notes that whether the supplementary information includes an exit time does not functionally affect the claim.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Backhaus in view of Saffran and Washburn et al. (U.S. 2009/0234218), referred to hereinafter as Washburn.
REGARDING CLAIM 10
Backhaus in view of Saffran teaches the claimed medical information system of claim 1.
Backhaus further teaches
further comprising the medical image diagnostic device, which is one of an X-ray computed tomography (CT) device, an ultrasonic diagnostic device, an X-ray diagnostic device, a magnetic resonance imaging (MRI) device, and a nuclear medicine diagnostic device, and [Para. 0026 teaches a computer tomography (CT) scanner.]
Backhaus in view of Saffran may not explicitly teach
the first processor is further configured to set imaging conditions of the subject to be imaged based on the supplementary information, and
control the medical image diagnostic device to image the subject using the set imaging conditions.
However, Washburn teaches the following:
the first processor is further configured to set imaging conditions of the subject to be imaged based on the supplementary information, and [Para. 0027 teaches the MRI system automatically selects (sets) the RF coils (imaging conditions). One skilled in the art would recognize that the presence of metallic implants (supplementary information) affects the selection of RF coils.]
control the medical image diagnostic device to image the subject using the set imaging conditions. [Para. 0028 teaches once the scan set up is complete, a control in the scan room may be used to start the scan. Alternatively, an automatic start mode may be selected and configured.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented system of Backhaus in view of Saffran to configure a processor to set imaging conditions and control the medical image diagnostic device as taught by Washburn, with the motivation of improving the efficiency (see Washburn at Para. 0004).
Response to Arguments
Claim Objections
Regarding the objection to Claim 9, the Applicant has amended the claim to overcome the basis of objection.
Rejections Under 35 U.S.C. § 102 and 35 U.S.C. § 103
Regarding the rejection of Claims 1-4 and 6-9, the Examiner has considered Applicant’s arguments; however, the arguments are not persuasive. The Applicant argues:
… “[t]his confirmation of MRI suitability can be done before a patient even leaves home or work for the facility, and, if the study needs to be cancelled, no travel time or facility time is wasted.” …the ‘525 application does not appear to describe a situation that is “during a testing process using the medical image diagnostic device” as required by Claim 1, but one that is before the testing process.
Regarding (a), the Examiner respectfully disagrees. The duration of the testing process has not been defined in the claim. Therefore, the Examiner interprets the confirmation of MRI suitability as part of the testing process.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-4 and 6-9, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
Claim 1 is directed to an improvement over existing medical technology…reduces the workload of a medical worker…suppressing leakage of information…
Regarding (a), the Examiner respectfully disagrees. Any improvement present is an improvement to the abstract idea.
Claim l is analogous to Example 42 of the Revised Guidance…
Regarding (b), the Examiner respectfully disagrees. MPEP 2106.04(d) states that one way in which a claimed abstract idea may be subject matter eligible under prong 2A2 is if the claimed invention solves a described technological problem. Example 42 is an illustration of this. The Specification of Example 42 describes a technical problem (i.e., a problem caused by the technology): the technological implementation of software formats made it difficult to share updated health information. The claimed invention then solved this problem (a technical solution) by providing a message and access to updated real-time data that has been converted to a standardized format, thus integrating the abstract idea into a practical application. Unlike Example 42 and/or the technical solution to a technical problem inquiry, Applicant has not identified nor can the Examiner locate any technical problem that the claimed invention is solving. At best, the problem(s) described in the as-filed disclosure are medical problems.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Reeves (U.S. 7295988) which discloses a system for optical scanning, storage, organization, authentication and electronic transmitting and receiving of medical records and patient information, and other sensitive legal documents.
Hough et al. (U.S. 2013/0173308) which discloses a system and method for analyzing the utilization of diagnostic imaging modality devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert W Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683