DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant filed a response dated 8/19/2026 in which claims 1, 3, 8, and 17-20 have been amended, claims 2, 4, 6-7, and 9-16 have been canceled. Thus, the claims 1, 3, 5, 8, and 17-20 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/29/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The references that had been crossed out with a line have not been considered because they are either in foreign language or the English version was not submitted.
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, 3, 5, 8, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a medical information processing without significantly more.
Examiner has identified claim 8 as the claim that represents the claimed invention presented in independent claims 1, 3, 8, and 17-20.
Claim 1 is directed to an apparatus, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 is directed to a medical information processing apparatus comprising processing circuitry configured to: acquire information about a procedure performed on an examined subject so as to be kept in correspondence with time information; acquire, on a basis of the first information, second information about the procedure so as to be kept in correspondence with time information; as the first information, acquire, by using an optical camera, an optical camera image rendering a medical tool having a plurality of introduction ports and used for administering a drug for the examined subject; and as the second information, acquire information indicating a type of the drug by identifying, in the optical camera image, one of the introduction ports of the medical tool through which the drug is introduced, and determining the type of the drug based on a predetermined correspondence between the identified introduction port and drug types. These limitations (with the exception of italicized limitations) describe the abstract idea of a medical information processing, which correspond to a certain methods of organizing human activity. The additional limitations of a processing circuitry and an optical camera do not restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional element of a processing circuitry results in no more than simply applying the abstract idea using generic computer elements. The additional element of a processing circuitry is recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). The additional element of an optical camera is also recited at a high level of generality in that it amounts to an insignificant extra-solution activity (i.e., data gathering step) and does not transform the abstract idea into a practical application. Therefore, the recitation of additional elements does not meaningfully apply the abstract idea and hence does not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a processing circuitry is recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment. The additional element of an optical camera is also recited at a high level of generality in that it amounts to an insignificant extra-solution activity (i.e., data gathering step) and does not amount to add significantly more (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Claim 3 is directed to an apparatus, which is one of the statutory categories of invention (Step 1: YES).
The claim 3 is directed to a medical information processing apparatus comprising processing circuitry configured to: acquire information about a procedure performed on an examined subject so as to be kept in correspondence with time information; display the information on a display in accordance with the time information; display first output information that is a medical image and is kept in correspondence with the time information indicating a first point in time, and second output information that is biological information data related to the examined subject acquired in the procedure and is kept in correspondence with the time information indicating the first point in time, and at a time of displaying third output information, according to an instruction from a user, that is the medical image and is kept in correspondence with the time information indicating a second point in time different from the first point in time, in response to the instruction from the user and without receiving a separate user instruction for changing displayed biological information data, automatically display, in place of the second output information, fourth output information that is the biological information data related to the examined subject acquired in the procedure and is kept in correspondence with the time information indicating the second point in time.
These limitations (with the exception of italicized limitations) describe the abstract idea of a medical information processing, which correspond to a certain methods of organizing human activity. The additional limitations of a processing circuitry, a display, and automatically feature do not restrict the claim from reciting an abstract idea. Thus, the claim 3 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a processing circuitry, a display, and automatically feature result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a processing circuitry, a display, and automatically feature are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 3 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 3 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a processing circuitry, a display, and automatically feature are recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 3 is not patent eligible.
Similar arguments can be presented for other independent claims 17 and 19 and thus claims 17 and 19 are rejected on similar grounds as claim 3.
Claim 8 is directed to an apparatus, which is one of the statutory categories of invention (Step 1: YES).
The claim 8 is directed to a medical information processing apparatus comprising processing circuitry configured to: acquire information about a procedure performed on an examined subject so as to be kept in correspondence with time information; perform an analysis based on the information; display a result of the analysis on the display; as the information, acquire an optical camera image by using an optical camera or an audio by using an audio recorder, and acquire information indicating a type of a drug to be administered for the examined subject based on the optical image or the audio; and on a basis of the information indicating the type of the drug and examined subject information that is at least one of information about a disease which the examined subject is suffering from, records of the diseases which the examined subject suffered from and the treatment which the examined subject received in the part, and information about his/her constitution, analyze suitability of the drug for the examined subject, wherein the processing circuitry is configured to determine, as the analysis of the suitability, whether administration of the drug to the examined subject corresponds to a contraindication, and in response to determining that the administration of the drug corresponds to the contraindication, display, before the administration of the drug, a notification indicating that the drug corresponds to the contraindication. These limitations (with the exception of italicized limitations) describe the abstract idea of a medical information processing, which correspond to a certain methods of organizing human activity. The additional limitation of a processing circuitry, a display, an optical camera, and an audio recorder do not restrict the claim from reciting an abstract idea. Thus, the claim 8 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a processing circuitry and a display result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a processing circuitry and a display are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). The additional elements of an optical camera and an audio recorder are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application. Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 8 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 8 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a processing circuitry, and a display are recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment. The additional elements of an optical camera and an audio recorder are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application (Step 2B: NO). Thus, the claim 8 is not patent eligible.
Similar arguments can be presented for other independent claim 18, and thus the claim 18 is rejected on similar grounds as claim 8.
Claim 20 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 20 is directed to a medical information processing method comprising acquiring an optical camera image by using an optical camera or an audio by using an audio recorder, and acquiring information indicating a type of a drug to be administered for the examined subject, based on the optical camera image or the audio, as information about a procedure performed on an examined subject so as to be kept in correspondence with time information; on a basis of the information indicating the type of the drug and examined subject information that is at least one of information about a disease which the examined subject is suffering from, records of the disease which the examined subject suffered from and the treatment which the examined subject received in the past, and information about his/her constitution, analyzing suitability of the drug for the examined subject; and displaying a result of the analysis on a display, wherein the medical information processing method comprises determining, as the analysis of the suitability, whether administration of the drug to be examiner subject corresponds to a contraindication, and in response to determining that the administration of the drug corresponds to the contraindication, displaying, before the administration of the drug, a notification indicating that the drug corresponds to the contraindication. These limitations (with the exception of italicized limitations) describe the abstract idea of a medical information processing, which correspond to a certain methods of organizing human activity. The additional limitations of an optical camera, an audio recorder, and a display do not restrict the claim from reciting an abstract idea. Thus, the claim 20 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional element of a display results in no more than simply applying the abstract idea using generic computer elements. The additional element of a display is recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). The additional elements of an optical camera and an audio recorder are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application. Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 20 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 20 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a display is recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional element when considered separately and as an ordered combination does not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment. The additional elements of an optical camera and an audio recorder are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application (Step 2B: NO). Thus, the claim 20 is not patent eligible.
Dependent claim 5 further define the abstract idea that is present in their respective independent claim 3 thus correspond to a certain method of organizing human activity, and hence is abstract in nature for the reason presented above. Dependent claim do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 1, 3, 5, 8, and 17-20 are not patent-eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ueda, US Patent Application No. 2007/0225574 in view of Radojicic, US Patent No. 9,770,180 in view of Fine et al., US Patent Application No. 2021/0327567.
Regarding claim 1, Ueda discloses a medical information processing apparatus comprising processing circuitry configured to:
acquire first information about a procedure performed on an examined subject so as to be kept in correspondence with time information ([0084], surgical microscopes; [0089] time; [0120], surgical knife are used; [0121], brain surgery, [0152] time when a medical process is carried out, information about when medicines are administered, when “the surgeon A sprayed 50 mL of physiological saline around the incision site” is added to the medical movie as the index information; [0153] time information);
acquire, on a basis of the first information, second information about the procedure so as to be kept in correspondence with time information ([0084], surgical microscope; [0089] time; [0120], surgical knife are used; [0121], brain surgery, [0152] time when a medical process is carried out, information about when medicines are administered, when “the surgeon A sprayed 50 mL of physiological saline around the incision site” is added to the medical movie as the index information; [0152] time information);
as the first information, acquire, by using an optical camera, an optical camera image rendering a medical tool having a plurality of introduction ports and used for administering a drug for the examined subject; and
as the second information, acquire information indicating a type of the drug by identifying, in the optical camera image ([0152]-[0153], physiological saline serves as type of drug; [0154]-[0165]), one of the introduction ports of the medical tool through which the drug is introduced, and determining the type of the drug based on a predetermined correspondence between the identified introduction port and drug types.
Ueda does not specifically disclose
as the first information, acquire, by using an optical camera, an optical camera image rendering a medical tool having a plurality of introduction ports and used for administering a drug for the examined subject and
one of the introduction ports of the medical tool through which the drug is introduced, and determining the type of the drug based on a predetermined correspondence between the identified introduction port and drug types.
However, Radojicic discloses
as the first information, acquire, by using an optical camera, an optical camera image rendering a medical tool having a plurality of introduction ports and used for administering a drug for the examined subject (col. 5, lines 29-33) and
one of the introduction ports of the medical tool through which the drug is introduced (col. 5, lines 29-33), and determining the type of the drug based on a predetermined correspondence between the identified introduction port and drug types (col. 5, lines 29-33, multi-port catheter into the epidural, serves to define the type of drug that can be introduced through this multi-port catheter).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Ueda with the above-noted disclosure of Radojicic. The motivation for combining these references would have been to perform medical treatment on a patient.
Ueda and Radojicic do not specifically disclose
acquire, by using an optical camera, an optical camera image rendering a medical tool.
However, Fine discloses
acquire, by using an optical camera, an optical camera image rendering a medical tool (abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Ueda and Radojicic with the above-noted disclosure of Fine. The motivation for combining these references would have been to perform medical treatment on a patient.
Response to Arguments
Examiner withdraws 35 U.C.C. 103 rejection of claims 3, 5, 8, 17-20 in view of amendment/argument.
Applicant's arguments filed dated 8/19/2016 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claim 1 under 35 U.S.C. 101, Applicant states that the amended claim 1 does not merely involve organizing medical information. Instead, the claim defines special image processing for a medical drug administration tool that has multiple introduction ports visible in an optical camera image. This process identifies the active introduction port and determines the drug type using a predetermined correspondence between that port and specific drug types. The optical camera image is not merely used for data collection. Rather, the optical camera image is used to identify specific parts of a physical medical device and determine the type of drug, thereby improving the accuracy of drug administration information during procedures. Therefore, amended claim 1 does not implement an abstract idea using a general-purpose computer, but is integrated into a practical application that improves the accuracy of information acquisition in a medical procedure environment.
Examiner respectfully disagrees and notes that improving the accuracy of information acquisition in a medical procedure environment is an improvement to the abstract idea of collecting information (or data) with the use of an optical camera. There is no technical improvement to the optical camera or additional elements. In the absence of technical improvement, the claim limitations are merely used to apply the abstract idea with the use of additional elements. This is not sufficient to integrate the abstract idea into a practical application. Thus, these arguments are not persuasive.
With respect to the rejection of claims 3, 17, and 19 under 35 U.S.C. 101, Applicant states that claims 3, 17, and 19 do not merely describe the display of medical information. Rather, the claims define a specific display control that automatically changes the display of biological information in response to an instruction from a user to change the time point of medical images, without requiring a separate user instruction.
Examiner respectfully disagrees and notes that this is a mere automation of manual processes, and the courts have shown that mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100. 1108-09 (Fed. Cir. 2017) may not be sufficient to show an improvement in computer-functionality.
With respect to the rejection of claims 8, 18, and 20 under 35 U.S.C. 101, Applicant states that claims 8, 18, and 20 do not merely describe the evaluation of drug information. Rather the claims define a specific medical safety process that determined the contraindications based on the drug type obtained from images or audio and specific examined subject information, and displays a notification before the administering of the drug. This process is integrated into a practical application for preventing the inappropriate administration of drugs during actual medical procedures.
Examiner respectfully disagrees and notes that a specific medical safety process makes use of an optical camera that provides images in identifying which drugs are administered and makes a determination of contraindications and then displaying a notification. In this case, this is equivalent to a mental process (observation) or use of a device to capture an image (a certain method of organizing human activity). Thus, the use of a specific medical process that makes use of an optical camera is considered as applying the abstract idea with the use of an optical camera which does not integrate the abstract idea into a practical application or amounts to add significantly more. Thus, these arguments are not persuasive.
With respect to the rejection of claim 1 under 35 U.S.C. 103, Applicant states that Radojicic does not disclose “an optical camera image rendering a medical tool having a plurality of introduction ports and used for administering a drug to the examined subject.”
Examiner notes that these arguments are moot in view of the new grounds of rejection presented above in this office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
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