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 .
Claims 1, 3-6, 8-9, 17, 17, 19 and 21 have been amended. Claims 11, 12 and 15 are cancelled. Claims 20 and 22 were previously canceled. Claims 1-10, 13-14, 16-19 and 21 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 7-10, 13, 14, 16-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 10-11, 13-16 and 19-20 of copending Application No. 18/856,772 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite substantial similar or identical content in the above-identified claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a prescription unit configured to generate” in claims 1, 8-9, 12 and 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The “prescription unit is typically a microcomputer” or located on the server (Specification, Paragraph [0037]).” The prescription is determined through comparing the data to various thresholds to output a recommendation (Specification, Paragraph [0038]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10, 13, 14, 16-19 and 21 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 1-19 are drawn to a system for hydration fluid prescribing, which is within the four statutory categories (i.e. machine). Claim 21 is drawn to a microcomputer, which is within the four statutory categories (i.e. manufacture).
Claims 1-10, 13, 14, 16-19 (Group I) recites a system, comprising:
a server operational over a data network, and optionally connected to a database (MPEP §2106.05(g), apply it);
a user device configured to communicate with the server via the data network and comprising a user interface (MPEP §2106.05(g), apply it) configured to allow a user to enter one or more urine parameters of the user;
a processing unit configured to operate on the user device, wherein the processing unit is configured to (MPEP §2106.05(g), apply it) receive the one or more urine parameters about said of the user when provided by the user, and to transmit the urine parameters to the server (MPEP §2106.05(h), insignificant extra-solution activity);
a care provider device configured to communicate with the server via the data network and configured to (MPEP §2106.05(g), apply it) receive the one or more urine parameters from the server;
an additional connected device configured to: monitor one or more physiological parameters, communicate with the server via the data network, and communicate with the user device (MPEP §2106.05(g), apply it); and
a prescription unit configured to (MPEP §2106.05(g), apply it) generate and transmit, to the user device (MPEP §2106.05(g), apply it), a first prescription comprising a recommendation that relates to a first hydration fluid intake by the user, and a revised prescription based on adherence of the user to a hydration fluid consumption plan established by the prescription unit, wherein the first prescription is generated by the prescription unit (MPEP §2106.05(g), apply it) based on the user's one or more urine parameters and the one or more physiological parameters transmitted from the user device to the server,
wherein the hydration fluid consumption plan comprises a plurality of hydration fluid drinking events,
wherein each hydration fluid drinking event comprises a specific hydration fluid intake target,
wherein the processing unit (MPEP §2106.05(g), apply it) is configured to continuously and autonomously compare the first hydration fluid intake by the user with the specific hydration fluid intake target, and in response, to cause the prescription unit (MPEP §2106.05(g), apply it) to generate the revised prescription that relates to a second hydration fluid intake by the user if the first hydration fluid intake by the user during the hydration fluid consumption event is smaller than the specific hydration fluid intake target associated with that hydration fluid consumption event.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claim 21 is identical as the abstract idea for Claims 1-10, 13, 14 and 16-19 (Group I). Claim 21 further cites the additional elements of a “microcomputer comprising a processing unit and a memory or data storage unit having stored thereon software instructions which, when executed by a processing unit, configure a computer,” which are all recited at the “apply it” level.
Dependent Claims 2-10, 13, 14 and 16-19 include other limitations, for example Claim 2 recites wherein the one or more urine parameters are selected from the group consisting of: urine volume, urine pH, urinary specific gravity, urine color, a urine biomarkers biomarker of kidney injury, urine biomarker of infection, a urine biomarker of stress, a urine biomarker of inflammation, and any combination thereof, Claim 3 recites wherein the one or more urine parameters comprises a volume of urine of less than 2.5L in 24h, and wherein the revised prescription comprises a recommendation of an increase of water intake, Claim 4 recites wherein the one or more urine parameters comprises a volume of urine of greater than 2.5L in 24h, and wherein the revised prescription comprises a recommendation of no change in water intake, Claim 5 recites wherein the one or more user's urine parameters comprises a urine color of a score greater than 3 in an Armstrong scale, and wherein the revised prescription comprises a recommendation of an increase of water intake, Claim 6 recites wherein the one or more urine parameters comprises a urine color of a score less than 4 in an Armstrong scale, and wherein the revised prescription comprises a recommendation of no change of water intake, Claim 7 recites an alarm unit configured to provide an alert when one or more of the following urine parameter conditions are met: a daily urine volume is less than 3.0L I 24h, less than 2.8L / 24h, less than 2.6L / 24h, less than 2.5L I 24h, less than 2.4L / 24h, less than 2.2L / 24h, or less than 2.0L I 24h; a urinary specific gravity is greater than 1.010, or greater than 1.020 or greater than 1.030; a urine pH is outside the range from 5.0 to 7.0, or outside the range from 5.5 to 6.5; a urine color of a score greater than 3 in an Armstrong scale, Claim 8 recites wherein the revised prescription generated by the prescription unit further comprises a recommendation that relates to an intake of a therapeutic substance by the user, Claim 9 recites wherein the revised prescription generated by the prescription unit is communicated by the care provider device to the user device via the data network, Claim 10 recites a hydration fluid delivery article configured to communicate with the user device, Claim 13 recites comprising any of comprising a non-transitory computer-readable storage medium having stored thereon instructions which, when executed by one or more processing units of the system, cause the one or more processing units to operate, wherein the instructions comprise: a learning module, an education module, a self-motivation module, a reward module, a quality-of-life, assessment module, a diet recommendation module, or any combination thereof, Claim 14 recites wherein the one or more physiological parameters are blood pressure, glycemia, body composition, or any combination thereof of the user, Claim 16 recites wherein the care provider device is configured to receive data provided by the additional connected device, Claim 17 recites wherein the revised prescription is based on data monitored and transmitted by the additional connected device, Claim 18 recites wherein the prescription unit is configured as a microcomputer as at least part of the care provider device, Claim 19 recites a method for remotely monitoring a user’s hydration state, the method comprising: providing the system of claim 1; prompting the user, from the user interface of the user device, to enter the one or more urine parameters; receiving the one or more urine parameters; generating, by the prescription unit, the first prescription; optionally wherein the user has a mineral metabolism disorder, kidney stones, nephrolithiasis, heart disease, chronic kidney disease (CKD), advanced stage kidney failure, advanced stage kidney failure post-extra-renal epuration or hemodialysis or peritoneal dialysis or translation, pregnancy or breastfeeding, or is a geriatric or pediatric patient, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 21.
Furthermore, Claims 1-19 and 21 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a server operational over a data network, and optionally connected to a database, a user device configured to communicate with the server via the data network and comprising a user interface, a processing unit configured to operate on the user device, a care provider device configured to communicate with the server via the data network, a prescription unit, a microcomputer, an additional connected device, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0012], [0024], [0032], [0034-0035], [0037-0038] of the present Specification, see MPEP 2106.05(f);
add insignificant extra-solution activity to the abstract idea – for example, the recitation of transmitting the urine parameters to the server, which amounts to an insignificant application, see MPEP 2106.05(g)
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h)).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0012], [0032], [0034-0035], [0037-0038] of the Specification discloses that the additional elements (i.e. a server, data network, database, user device, user interface, processing unit, a prescription unit) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. transmitting data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare and patient monitoring);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives hydration data, and transmits the data to the server over a network, for example the Internet.
Dependent Claims 2-10, 13, 14 and 16-19 include other limitations, but none of these functions are deemed significantly more than the abstract idea because they not contain any additional elements beyond those recited in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-10,13-14,16-19 and 21 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 1-2, 8-9, 13, 14, 16-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (U.S. Pub. No. 2021/0074390 A1) in view of Corso (U.S. Pub. No. 2023/0253119 A1).
Regarding claim 1, Peesapati discloses system, comprising:
a server operational over a data network, and optionally connected to a database (Paragraphs [0055] and [0079-0080] discuss Figure 1 which shows a server is in communication via a network and stores patient data in a memory.);
a user device configured to communicate with the server via the data network and comprising a user interface configured to allow a user to enter one or more urine parameters of the user (Paragraphs [0055] and [0079-0080] discuss Figure 1 which shows a server is in communication with a user device which can be used to enter urine parameters.);
a processing unit configured to operate on the user device, wherein the processing unit is configured to receive the one or more urine parameters about said of the user when provided by the user, and to transmit the urine parameters to the server (Paragraph [0055] discusses the patient’s device receiving the urine parameters and transmitting them to the server.);
a care provider device configured to communicate with the server via the data network and configured to receive the one or more urine parameters from the server (Paragraph [0055] discusses the provider’s computer being in communication with the server via the network and able to receive urine parameters from the server.); and
a prescription unit configured to generate and transmit, to the user device, a first prescription comprising a recommendation by the user, wherein the first prescription is generated by the prescription unit based on the user's one or more urine parameters and the one or more physiological parameters transmitted from the user device to the server (Paragraphs [0044] and [0080] discuss generating a report which is transmitted to the user based on the urine parameters that includes suggested adjustments for the patient based on physiological parameters and urine data.);
but Peesapati does not appear to explicitly disclose:
an additional connected device configured to: monitor one or more physiological parameters, communicate with the server via the data network, and communicate with the user device;
wherein the recommendation relates to a first hydration fluid intake and a revised prescription based on adherence of the user to a hydration fluid consumption plan established by the prescription unit;
wherein the hydration fluid consumption plan comprises a plurality of hydration fluid drinking events,
wherein each hydration fluid drinking event comprises a specific hydration fluid intake target,
wherein the processing unit is configured to continuously and autonomously compare the first hydration fluid intake by the user with the specific hydration fluid intake target, and in response, to cause the prescription unit to generate the revised prescription that relates to a second hydration fluid intake by the user if the first hydration fluid intake by the user during the hydration fluid consumption event is smaller than the specific hydration fluid intake target associated with that hydration fluid consumption event.
Corso teaches:
an additional connected device configured to: monitor one or more physiological parameters, communicate with the server via the data network, and communicate with the user device (Paragraphs [0065-0067] discusses a blood pressure device connected to the system obtain the user’s blood pressure.);
wherein the recommendation relates to a first hydration fluid intake and a revised prescription based on adherence of the user to a hydration fluid consumption plan established by the prescription unit (Paragraphs [0280-0281] discuss the recommendations including actions for the user to take, including “drink water” or “stop consuming water.” Paragraphs [0310-0311] and [0323-0333] discuss adjusting the prescription based on the user’s hydration level, construed as including adherence to the hydration fluid consumption plan.);
wherein the hydration fluid consumption plan comprises a plurality of hydration fluid drinking events (Paragraph [0310] discusses a rehydration schedule with timing and amounts of water to be consumed.),
wherein each hydration fluid drinking event comprises a specific hydration fluid intake target (Paragraph [0310] discusses a rehydration schedule with timing and amounts of water to be consumed. Figure 11 shows an example where every 30 minutes the user should be drinking 300 mL of water.),
wherein the processing unit is configured to continuously and autonomously compare the first hydration fluid intake by the user with the specific hydration fluid intake target, and in response, to cause the prescription unit to generate the revised prescription that relates to a second hydration fluid intake by the user if the first hydration fluid intake by the user during the hydration fluid consumption event is smaller than the specific hydration fluid intake target associated with that hydration fluid consumption event (Paragraphs [0034-0035], [0112], [0164-0165], [0175], [0230], [0323-0333] and [0597] discuss reevaluating the hydration status continuously or at certain timepoints and alerting the user of any changes in recommendations, if necessary, including suggesting more water if the user did not drink enough.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the recommendation of Peesapati to relate to hydration fluid intake and a revised prescription, as taught by Corso, so that the “daily water intake by the user may be improved and the risk of dehydration decreased (Corso, Paragraph [0151]).”
Regarding claim 2, Peesapati wherein the one or more urine parameters are selected from the group consisting of: urine volume, urine pH, urinary specific gravity, urine color, a urine biomarkers biomarker of kidney injury, urine biomarker of infection, a urine biomarker of stress, a urine biomarker of inflammation, and any combination thereof (Paragraphs [0057] and [0060-0061] discuss the urine parameters including volume, pH, specific gravity, and various biomarkers including biomarkers of proteins of renal infections.).
Regarding claim 8, Peesapati discloses wherein the revised prescription generated by the prescription unit further comprises a recommendation that relates to an intake of a therapeutic substance by the user (Paragraphs [0071] and [0080] discuss the treatment plan can be modified by the device, including the patient’s prescribed medications, construed as a recommendation that relates to an intake of a therapeutic substance by the user.).
Regarding claim 9, Peesapati discloses wherein the revised prescription generated by the prescription unit is communicated by the care provider device to the user device via the data network (Paragraphs [0071] and [0080] discuss the treatment plan can be modified by the physician’s device, including the patient’s prescribed medications connected to the network and user device.).
Regarding claim 13, Peesapati does not appear to explicitly disclose comprising any of comprising a non-transitory computer-readable storage medium having stored thereon instructions which, when executed by one or more processing units of the system, cause the one or more processing units to operate, wherein the instructions comprise:
a learning module,
an education module,
a self-motivation module,
a reward module,
a quality-of-life assessment module,
a diet recommendation module, or any combination thereof.
Corso teaches wherein the instructions comprise (Examiner notes that the claim only requires one of the modules.)
a learning module (Paragraphs [0051] and [0472] discuss the system including a machine learning model.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration monitoring system of Peesapati to include a learning module, as taught by Corso, so that the “daily water intake by the user may be improved and the risk of dehydration decreased (Corso, Paragraph [0151]).”
Regarding claim 14, Peesapati does not appear to explicitly wherein the one or more physiological parameters are blood pressure, glycemia, body composition, or any combination thereof of the user.
Corso teaches wherein the physiological parameter is the blood pressure of the user (Paragraph [0067] discusses a blood pressure device connected to the system obtain the user’s blood pressure.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration monitoring system of Peesapati to include blood pressure data, as taught by Corso, in order to include more clinically relevant information (Corso, Paragraph [0067]).
Regarding claim 16, Peesapati does not appear to explicitly disclose wherein the care provider device is configured to receive data provided by the additional connected device.
Corso teaches wherein the care provider device is configured to receive data provided by the additional connected device (Paragraphs [0048] and [0067] discuss the sensor data being continuously received by the device.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration monitoring system of Peesapati to have the care provider device configured to receive additional device data, as taught by Corso, in order to obtain the sensor data for monitoring purposes (Corso, Paragraph [0066]).
Regarding claim 17, Peesapati does not appear to explicitly disclose wherein the revised prescription is based on data monitored and transmitted by the additional connected device.
Corso teaches wherein the revised prescription is based on data monitored and transmitted by the additional connected device (Paragraph [0511] discusses using data obtained from other devices/sensors in making recommendations.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration monitoring system of Peesapati to have the prescription based on data monitored and transmitted by the additional connected device, as taught by Corso, in order to obtain the sensor data for monitoring purposes (Corso, Paragraph [0066]).
Regarding claim 18, Peesapati discloses wherein the prescription unit is configured as a microcomputer as at least part of the care provider device (Paragraph [0037] discusses the device being a mobile phone or tablet, construed as microcomputer.).
Regarding claim 19, Peesapati discloses a method for remotely monitoring a user’s hydration state, the method comprising:
providing the system of claim 1 (See above rejection of claim 1.);
prompting the user, from the user interface of the user device, to enter the one or more urine parameters (Paragraphs [0055] and [0079-0080] discuss Figure 1 which shows a server is in communication with a user device which can be used to enter urine parameters.);
receiving the one or more urine parameters (Paragraphs [0055] and [0079-0080] discuss Figure 1 which shows a server is in communication with a user device which can be used to enter urine parameters that are received by the system.);
generating, by the prescription unit, the first prescription (Paragraph [0080] discusses generating a report which is transmitted to the user based on the urine parameters that includes suggested adjustments for the patient.);
optionally wherein the user has a hemodialysis or peritoneal dialysis (Paragraphs [0002-0005] and [0055] discuss the system being used to treat hemodialysis or peritoneal dialysis patients.).
2025Attorney Docket No. 317EP.001US01
Claim 21 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above. Claim 21 further recites a “microcomputer comprising a processing unit and a memory or data storage unit having stored thereon software instructions which, when executed by a processing unit, configure a computer to…,” which is disclosed by Peesapati (Paragraph [0066] discusses a computer and a memory as part of the system that is used to store the instructions for the system.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Peesapati in view of Corso, and in further view of Radovcic (U.S. Pub. No. 2020/0075152 A1).
Regarding claim 10, Peesapati does not appear to explicitly disclose a hydration fluid delivery article configured to communicate with the user device.
However, Radovcic teaches a hydration fluid delivery article configured to communicate with the user device (Paragraphs [0097-0098] discuss a bottle with a smart electronic bottle cap that communicates with the client smart phone.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration system of Peesapati to include a hydration fluid delivery article, as taught by Radovcic, in order to “report volume of liquid that passes the cap portion of the bottle (Radovcic, Paragraph [0097]).”
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered.
Rejections under 35 U.S.C § 101
The Step 1 101 Rejection has been withdrawn in view of the amendments to claim 21.
Regarding the rejection of the claims as being abstract without significantly more, Applicant argues that “amended Claim 1 recites a system that provides improvements to the technology or technical field of hydration fluid prescribing systems, specifically ‘using personalized fluid intake prescribing systems and hydration efficacy estimation system by instant remote monitoring of a user’s hydration state assessed by urinary parameters and water intake’ to assist a user to ‘maintain an optimal water intake and most appropriate status of hydration (Remarks, page 11).’” Examiner maintains that this is not a technical problem, but rather a problem particular to healthcare and patient adherence/compliance. The systems/hardware used are not improved by the claimed invention. Furthermore, the claims do not recite a hydration efficacy estimation system. The claims recite generic computer components, which do not rise to the level of a practical application or significantly more than the abstract idea.
Therefore, the claims remain rejected as being directed towards an abstract idea without a practical application or significantly more.
Rejections under 35 U.S.C § 103
Applicant’s arguments with respect to the prior art rejection have been considered but are moot because the new ground of rejection necessitated by the amendments.
Examiner notes that there are multiple dependent claims not subject to a prior art rejection, and suggests amending future claims to include their subject matter in the independent claims.
Double Patenting Rejections
The double patenting rejection has been updated to reflect the amendments.
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 Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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, Jason Dunham can be reached at (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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