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 7/29/2025 in which claims 1, 3, 8, 11,13, 18, and 21 have been amended, claims 22-39 have been canceled and new claims 40-42 have been added. Thus, the claims 1-21 and 40-42 are pending in the application.
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 1-21 and 40-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of transmitting patient-specific healthcare data without significantly more.
For 101 analysis, Examiner has identified claim 1 as the claim that represents the claimed invention described in independent claims 1, 11, 21, and 40.
Claim 1 is directed to a system, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 is directed to a system comprising: one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process providing patient-specific healthcare data from an implant, the process comprising: establishing a communicative contact with a patient-specific medical implant implanted in a body of a patient by a user device associated with a user using a proximity communication mode, wherein the patient-specific medical implant contains patient-specific healthcare data; receiving, by the user device, a request to access the patient-specific healthcare data in the patient-specific medical implant; determining at least one of a location of the user device or at least one vital metric of the patient; selecting, using a trained machine-learning module, a set of relevant patient data from the patient-specific healthcare data to provide to the user device, wherein the selection of the set of relevant patient data is based on the at least one of the location of the user device or the at least one vital metric of the patient, and reference similar patient data sets with reference patient pathology and acceptable outcomes used to produce the trained machine-learning module; and transmitting, to the user device of the user from the patient-specific medical implant, the set of relevant patient data from the patient-specific healthcare data. These limitations (with the exception of italicized limitations), under their broadest reasonable interpretation, describe the abstract idea of transmitting patient-specific healthcare data which may correspond to a Certain Methods of Organizing Human Activity. The additional elements of one or more processors, one or more memories, the system, an implant, a patient-specific medical implant, a user device, a proximity communication mode, and machine-learning module do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of one or more processors, one or more memories, the system, an implant, a patient-specific medical implant, a user device, a proximity communication mode, and machine-learning module result in no more than simply applying the abstract idea using generic computer elements. The additional elements of one or more processors, one or more memories, the system, an implant, a patient-specific medical implant, a user device, a proximity communication mode, and machine-learning module are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPEP 2106.05(f)). The additional limitations are no more than mere instructions to apply the exception using a generic computer element. Therefore, the recitation of additional elements of one or more processors, one or more memories, the system, an implant, a patient-specific medical implant, a user device, a proximity communication mode, and machine-learning module do not meaningfully apply the abstract idea and hence do 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 additional elements of one or more processors, one or more memories, the system, an implant, a patient-specific medical implant, a user device, a proximity communication mode, and machine-learning module 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 limitations provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 1 is not patent-eligible.
Similar arguments can be extended to other independent claims 11, 21 and 40 and hence rejected on similar grounds as claim 1.
Dependent claims 2-10, 12-20, and 41-42 further define the abstract idea that is present in their respective independent claims 1, 11, and 40 and hence corresponds to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims 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 2-10, 12-20, and 41-42 are directed to an abstract idea. Thus, the claims 1-21 and 40-42 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.
Claims 1, 6-7, 9, 11, 16-17, 19, 21 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling et al., WO2017/189187A1 in view of Ivan et al., US Patent Application No. 2025/0082411.
Regarding claim 1, Schilling discloses a system comprising:
one or more processors ([0013]); and
one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process providing patient-specific healthcare data from an implant, the process comprising ([0013], [0041], [0133]):
establishing a communicative contact with a patient-specific medical implant implanted in a body of a patient by a user device associated with a user using a proximity communication mode, wherein the patient-specific medical implant contains patient- specific healthcare data ([0006], [0008], [0038]-[0039], [0041]);
receiving, by the user device, a request to access the patient-specific healthcare data in the patient-specific medical implant ([0041], [0062]);
determining at least one of a location of the user device or at least one vital metric of the patient ([0036], biometric data, [0040], near the implanted device 104 (e.g., within a few feet or the same room);
selecting, using a trained machine-learning module, a set of relevant patient data from the patient-specific healthcare data to provide to the user device, wherein the selection of the set of relevant patient data is based on the at least one of the location of the user device or the at least one vital metric of the patient ([0036], diagnostic determination, therapy data, [0041], specific data associated with implanted device), and
reference similar patient data sets with reference patient pathology and acceptable outcomes used to produce the trained machine-learning module; and
transmitting, to the user device of the user from the patient-specific medical implant, the set of relevant patient data from the patient-specific healthcare data ([0041]).
Schilling does not specifically disclose
reference similar patient data sets with reference patient pathology and acceptable outcomes used to produce the trained machine-learning module.
However, Ivan discloses
reference similar patient data sets with reference patient pathology and acceptable outcomes used to produce the trained machine-learning module ([0036], [0055]).
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 modify the above-noted disclosure of Schilling with the above-noted disclosure of Ivan. The motivation for modifying the disclosure would have been to aid in intraoperative decision-making during operation.
Regarding claim 6, Schilling discloses wherein the process further comprises:
encrypting the patient-specific healthcare data prior to transmission ([0085]).
Regarding claim 7, Schilling discloses wherein the process further comprises:
integrating input data sources of the patient-specific medical implant for the patient-specific healthcare data ([0076]).
Regarding claim 9, Schilling discloses wherein the patient-specific healthcare data is locked such that the user cannot initially access the patient-specific healthcare data, wherein the process further comprises ([0090]):
receiving authentication information from the user ([0128]);
authenticating the user based on the received authentication information ([0128]); and
in response to authenticating the user, unlocking a portion of the patient-specific healthcare data ([0016], [0041]).
Regarding claim 41, Ivan discloses
identify the reference similar patient data sets with reference patient pathology and acceptable post-operative outcomes ([0036], [0055]).
Regarding claim 42, Schilling discloses
determining an access level associated with the user based on at least one of the location of the user device relative to the patient-specific medical implant or the vital metric of the patient ([0036], [0040]); and
Ivan discloses
modifying, using the trained machine-learning module, a treatment plan for the patient based on the set of relevant patient data and the access level associated with the user ([0036], [0055], operation to aid in intraoperative decision-making).
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 modify the above-noted disclosure of Schilling with the above-noted disclosure of Ivan. The motivation for modifying the disclosure would have been to aid in intraoperative decision-making during operation.
Claims 11, 16-17, 19, 21 and 40 are substantially similar to claims 1, 6-7, and 9 and hence rejected on similar grounds.
Claims 2, 5, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling in view of Ivan in view of Viars, WO2008/157342A1.
Regarding claim 2, Schilling and Ivan disclose the invention as described above but fail to disclose the limitations of claim 2.
However, Viars discloses wherein the process further comprises:
identifying one or more linked accounts from at least one entity related to the patient-specific healthcare data and the patient-specific medical implant ([0048], [0060]);
determining whether the identified one or more linked accounts are authorized for receiving the patient-specific healthcare data ([0058]); and
in response to determining that the one or more linked accounts are authorized, transmitting the patient-specific healthcare data to the at least one entity ([0075]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Viars. The motivation for modifying the disclosure would have been to gain the advantage of setting different levels of access for different files to provide a multi-payer access to records particular to an individual as illustrated by Viars (abstract).
Regarding claim 5, Schilling and Ivan disclose wherein the process further comprises:
storing the patient-specific healthcare data in a healthcare digital filing cabinet ([0091]).
Viars discloses
linking accounts from multiple entities related to the patient-specific healthcare data into the healthcare digital filing cabinet ([0048], [0060], [0127]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Viars. The motivation for modifying the disclosure would have been to gain the advantage of setting different levels of access for different files to provide a multi-payer access to records particular to an individual as illustrated by Viars (abstract).
Claims 12 and 15 are substantially similar to claims 2 and 5 and hence rejected on similar grounds.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling in view of Ivan in view of Davison et al., US Patent Application No. 2020/0350082.
Regarding claim 3, Schilling and Ivan disclose wherein the process further comprises:
receiving the patient-specific healthcare data from at least one input data source ([0041]);
storing the patient-specific healthcare data in a healthcare digital filing cabinet ([0091]).
Davison discloses
receiving data sharing rules from a patient owner of the healthcare digital filing cabinet ([0004]); and
automatically transmitting the set of relevant patient data from the patient-specific healthcare data according to the received data sharing rules ([0004], [0036]), wherein the data sharing rules include at least one of a physician sharing rule, a hospital sharing rule, or an implant manufacture sharing rule ([0040]), wherein the data sharing rules include at least one a patient identifier setting, a data type sharing rule, or a meta data setting ([0052]-[0053]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Davison. The motivation for modifying the disclosure would have been to gain the advantage of rules-based inter-facility exchange of medical information between healthcare entities using dedicated communication channels per patient as illustrated by Davison ([0029]).
Claim 13 is substantially similar to claim 3 and hence rejected on similar grounds.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling in view of Ivan in view of Chace et al., US Patent Application No. 2015/0149190.
Regarding claim 10, Chace discloses wherein the process further comprises: notifying the user of locking of a healthcare digital filing cabinet that contains the patient-specific healthcare data ([0055]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Chace. The motivation for modifying the disclosure would have been to gain the advantage of notifying users of permissions required to locked medical information.
Claim 20 is substantially similar to claim 10 and hence rejected on similar grounds.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling in view of Ivan in view of Nycz et al., US Application No. 2006/0232408 in view of Chace et al., US Patent Application No. 2015/0149190.
Regarding claim 4, Nycz discloses wherein the process further comprises:
determining whether the patient-specific healthcare data is associated with the patient-specific medical implant ([0028]); and
in response to determining that the patient-specific healthcare data is associated with the patient-specific medical implant.
Schilling discloses transmitting at least a portion for the patient-specific healthcare data for a physician managing treatment involving the patient-specific medical implant ([0041]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Nycz. The motivation for modifying the disclosure would have been to sharing the healthcare data with others.
Chace discloses
wherein the patient-specific healthcare data includes one or more scans of the patient ([0034]).
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 modify the above-noted disclosure of Schilling, Ivan, and Nycz with the above-noted disclosure of Chace. The motivation for modifying the disclosure would have been to sharing the healthcare data with others.
Claim 14 is substantially similar to claim 4 and hence rejected on similar grounds.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schilling in view of Ivan in view of Lin, US Patent Application No. 2020/0021570 in view of Chace et al., US Patent Application No. 2015/0149190.
Regarding claim 8, Lin discloses wherein the patient-specific medical implant is a blockchain-enabled medical implant that is implanted in the body of a patient ([0018]),
wherein the process further comprises:
Schilling discloses
establishing the communicative contact using the proximity communication mode ([0038]).
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 modify the above-noted disclosure of Schilling and Ivan with the above-noted disclosure of Lin. The motivation for modifying the disclosure would have been to storing data in a secure manner.
Chace discloses
accessing, based on an authentication level associated with the user, a private key stored on the blockchain-enabled medical implant to access the patient-specific healthcare data in a healthcare digital filing cabinet ([0055]).
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 modify the above-noted disclosure of Schilling, Ivan, and Lin with the above-noted disclosure of Chace. The motivation for modifying the disclosure would have been to accessing the healthcare data in a secure manner.
Response to Arguments
Applicant's arguments filed dated 7/29/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-21 under 35 U.S.C. 101, Applicant states that the pending claims meet the requirements of Section 101.
Examiner respectfully disagrees and notes that the claims are directed to an abstract idea as per the 35 U.S.C. 101 rejection presented above.
With respect to the rejection of claims 1, 6-7, 9, 11, 16-17, 19, and 21 under 35 U.S.C. 103, Applicant’s arguments are moot in view of new grounds of rejection presented above in this office action.
With respect to the rejection of claims 2-5, 8, 10, 12-14, 15, 18, and 20 under 35 U.S.C. 103, Applicant’s arguments are moot in view of 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