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 communication dated 7/30/2025 in which claims 1-24 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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of managing a drug dose as a function of the physical activity without significantly more.
Examiner has identified claim 1 as the claim that represents the claimed invention presented in independent claims 1 and 24.
Claim 1 is directed to a system, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 describes a system comprising: a first electronic assembly for tracking the physical activity performed by the user; at least one first data processing unit operatively connected to the first electronic assembly for tracking the physical activity performed by the user; at least one first memory unit operatively connected to the at least one first data processing unit; the at least one first data processing unit is configured to: compare a value of the amount of physical exercise performed by the user, starting from a first time instant in which a drug dose is taken by the user, with a set reference value, the value of the amount of physical exercise performed by the user having been determined, starting from the first time instant in which a drug dose is taken by the user, as a function of data representative of the physical activity performed by the user tracked by said first electronic assembly for tracking the physical activity performed by the user; store in the at least one first memory unit the determined value of the amount of physical exercise performed by the user; if the determined value of the amount of physical exercise is greater than or equal to the set reference value: generate a first information representative of an authorization for the user to take the next drug dose; provide the user and/or personnel responsible for issuing an authorization to purchase the drug with the generated first information, representative of the authorization for the user to take the next drug dose; if the determined value of the amount of physical exercise is less than the set reference value: generate and provide the user and/or personnel responsible for issuing an authorization for the purchase of the drug with a second information representative of a non- authorization for the user to take the next drug dose or not to generate a first information representative of an authorization for the user to take the next drug dose. These limitations (with the exception of italicized limitations), under their broadest reasonable interpretation, describe the abstract idea of managing a drug dose as a function of the physical activity. Furthermore, if a claim limitation, under its broadest reasonable interpretation, covers interactions between people, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The additional elements of an electronic assembly, data processing unit, and memory 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 an electronic assembly, data processing unit, and memory result in no more than simply applying the abstract idea using generic computer elements. The additional elements of an electronic assembly, data processing unit, and memory 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 (MPRP 2106.05(f)). The additional elements of an electronic assembly, data processing unit, and memory are no more than mere instructions to apply the exception using a generic computer element. 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 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of an electronic assembly, data processing unit, and memory are recited at a high level of generality in that it result 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 1 is not patent eligible.
Similar arguments can be extended to other independent claim 24 and hence the claim 24 is rejected on similar grounds as claim 1.
Dependent claims 2-23 further define the abstract idea that is present in their respective independent claim 1 and thus correspond 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 2-23 are directed to an abstract idea. Thus, the claims 1-24 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 1-2, 8-12, 17-20, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Eustis, US Patent Application No. 2017/0177818.
Regarding claim 1, Eustis discloses a system for managing the authorization to proceed with an intake of a drug dose by a user as a function of the physical activity performed by the user, said system comprising:
- a first electronic assembly for tracking the physical activity performed by the user ([0018];
- at least one first data processing unit operatively connected to the first electronic assembly for tracking the physical activity performed by the user ([0018]);
- at least one first memory unit operatively connected to the at least one first data processing unit ([0018]);
the at least one first data processing unit is configured to ([0018]):
- compare a value of the amount of physical exercise performed by the user, starting from a first time instant in which a drug dose is taken by the user, with a set reference value, the value of the amount of physical exercise performed by the user having been determined, starting from the first time instant in which a drug dose is taken by the user, as a function of data representative of the physical activity performed by the user tracked by said first electronic assembly for tracking the physical activity performed by the user ([0027], comparing the vital data to patient medical data associated with the user profile; [0028]-[0031]);
- store in the at least one first memory unit the determined value of the amount of physical exercise performed by the user ([0027]-[0031]);
if the determined value of the amount of physical exercise is greater than or equal to the set reference value ([0018]-[0031]):
- generate a first information representative of an authorization for the user to take the next drug dose ([0018]-[0031]);
- provide the user and/or personnel responsible for issuing an authorization to purchase the drug with the generated first information, representative of the authorization for the user to take the next drug dose ([0018]-[0031]);
if the determined value of the amount of physical exercise is less than the set reference value ([0018]-[0031]):
- generate and provide the user and/or personnel responsible for issuing an authorization for the purchase of the drug with a second information representative of a non- authorization for the user to take the next drug dose or not to generate a first information representative of an authorization for the user to take the next drug dose ([0018]-[0031]).
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 different disclosure of Eustis in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 2, Eustis discloses wherein the at least one first data processing unit is configured to determine the value of the amount of physical exercise performed by the user [0018]).
Regarding claim 8, Eustis discloses at least one user's portable electronic device operatively connected to the at least one first data processing unit, said at least one user's portable electronic device comprising said first electronic assembly for tracking the physical activity performed by the user, the physical exercise for which the amount value is determined being at least partially performed by the user using the at least one user's portable electronic device ([0026]).
Regarding claim 9, Eustis discloses wherein the at least one user's portable electronic device comprises a respective first data processing block and a respective first data communication block operatively connected to the first data processing block, said first data processing block of the at least one user's portable electronic device being configured to communicate data by means of said first data communication block ([0026]).
Regarding claim 10, Eustis discloses wherein the first data processing block of the at least one user's portable electronic device comprises the at least one first data processing unit ([0026], continuous monitoring).
Regarding claim 11, Eustis discloses wherein the first data processing block of the at least one user's portable electronic device is configured to communicate data to the at least one first data processing unit by means of said first data communication block, the first data processing block of the at least one user's portable electronic device being configured to determine the value of the amount of physical exercise performed by the user, the first data processing block of the at least one user's portable electronic device being configured to transmit to the at least one first data processing unit, by means of said first data communication block, the determined value of the amount of physical exercise performed by the user ([0018]-[0031]).
Regarding claim 12, Eustis discloses wherein the at least one user's portable electronic device comprises a respective first user interface module operatively connected to the first data processing block, the at least one first data processing unit being configured to send, based on the comparison of the determined value of the amount of physical exercise with the set reference value, a first notification message comprising the first information or the second information, the first data processing block being configured to provide the user with the first notification message by means of the first user interface module ([0118]-[0031]).
Regarding claim 17, Eustis discloses wherein, when providing the user and/or personnel responsible for issuing an authorization to purchase the drug with the generated first information representative of the user's authorization to take the next drug dose or when generating and providing the user and/or personnel responsible for issuing an authorization to take the drug with the second information representative of a non-authorization for the user to take the next drug dose, the at least one first data processing unit is configured to store the generated first information, representative of the authorization for the user to take the next drug dose, or the generated second information, representative of the non-authorization for the user to take the next drug dose, in the at least one first memory unit in a first reserved area for consultation by the user and/or personnel responsible for issuing an authorization to purchase the drug ([0018]-[0026]).
Regarding claim 18, Eustis discloses wherein the at least one first data processing unit is configured to determine and store, in the at least one first memory unit in the first reserved area for consultation by the user and/or personnel responsible for issuing an authorization to purchase the drug, information representative of the difference between the set reference value and the determined value of the amount of physical exercise performed by the user ([0018]-[0026]).
Regarding claim 19, Eustis discloses wherein the at least one first data processing unit is configured to store, in the at least one first memory unit in the first reserved area for consultation by the user and/or personnel responsible to issue an authorization to purchase the drug, additional information representative of target time period to reach the set reference value of the amount of physical exercise ([0018]-[0026]).
Regarding claim 20, Eustis discloses wherein said at least one first data processing unit is configured to monitor the provision of drug doses to be taken by the user based on a count of all generated information, representative of an authorization for the intake of a next drug dose by the user ([0018]-[0026]).
Regarding claim 22, it has been held that a wherein clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim (Texas Instruments Inc. v. International Trade Commission 26, USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (CAFC 2001)), therefore, wherein the determined value of the amount of physical exercise and the set reference value are expressed in METh will not differentiate the claims from the prior art.
Regarding claim 23, Eustis discloses wherein, if the determined value of the amount of physical exercise is greater than or equal to the set reference value, the at least one first data processing unit is configured to provide the user and/or personnel responsible for issuing an authorization to purchase the drug with the generated first information, representative of the authorization for the user to take the next drug dose only at the end of a set minimum time interval, elapsed from the first time instant in which the drug dose was taken by the user, in order to take the next drug dose ([0018]-[0026]).
Claim 24 is substantially similar to claim 1 and hence rejected on similar grounds.
Claims 3-7, 13-14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Eustis, US Patent Application No. 2017/0177818 in view of Holkkola, EP 1899023 B1.
Regarding claim 3, Holkkola discloses an exercise machine operatively connected to the at least one first data processing unit, the exercise machine comprising said first electronic assembly for tracking the physical activity performed by the user, the physical exercise for which the amount value is determined being at least partially performed by the user using the exercise machine (claim 1).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 4, Holkkola discloses wherein the exercise machine comprises a respective first data processing block and a respective first data communication block operatively connected to the first data processing block, said first data processing block being configured to communicate data by means of said first data communication block (claim 1).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 5, Holkkola discloses wherein the first data processing block of the exercise machine comprises the at least one first data processing unit (claim 1).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 6, Holkkola discloses wherein the first data processing block of the exercise machine is distinct from the at least one first data processing unit, the first data processing block of the exercise machine being operatively connected to the at least one first data processing unit, the first data processing block of the exercise machine being configured to communicate data to the at least one first data processing unit by means of said first data communication block, the first data processing block of the exercise machine being configured to determine the value of the amount of physical exercise performed by the user, the first data processing block of the exercise machine being configured to transmit to the at least one first data processing unit, by means of said first data communication block, the determined value of the amount of physical exercise performed by the user (claim 1).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 7, Holkkola discloses wherein the exercise machine comprises a respective first user interface module operatively connected to the first data processing block of the exercise machine, the at least one first data processing unit being configured to send, based on the comparison of the determined value of the amount of physical exercise with the set reference value, a first notification message comprising the first information or the second information, the first data processing block being configured to provide the user with the first notification message by means of the first user interface module of the exercise machine (claim 1).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 13, Holkkola discloses an exercise machine operatively connected to the at least one first data processing unit, the exercise machine comprising said first electronic assembly tracking the physical activity performed by the user, the physical exercise for which the amount value is determined comprising, at least partially, the physical exercise performed by the user using the exercise machine (claim 1);
Eustis discloses at least one user's portable electronic device operatively connected to the at least one first data processing unit, said at least one user's portable electronic device comprising a second electronic assembly tracking the physical activity performed by the user, the physical exercise for which the amount value is determined comprising, at least partially, the physical exercise performed by the user using the at least one user's portable electronic device ([0018]-[0031]).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 14, Holkkola discloses wherein: the exercise machine comprises a respective first data processing block and a respective first data communication block operatively connected to the first data processing block, the first data processing block being configured to communicate data by means of said first data communication block (claim 1).
Eustis discloses the at least one user's portable electronic device comprises a respective second data processing block and a respective second data communication block operatively connected to the second data processing block, said second data processing block being configured to communicate data by means of said second data communication block ([0018]-[0026]).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Regarding claim 21, Holkkola discloses wherein the exercise machine comprises an exercise machine usable by a user for performing strength exercises, an exercise machine for performing cardiovascular exercises, or an exercise machine for performing combined cardiovascular and strength exercises ([0002], [0026]).
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 Eustis with the above-noted disclosure of Holkkola in order to monitor the vitals data to generate an adjusted medical prescription.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
Prosecution Insights