Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Application
Claims 1-16 and 18-20 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Claims filed on 10/14/2024.
Claims 1-16 and 18-20 are currently amended.
Claim 17 has been canceled and is not considered at this time.
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 1-2, 4-7, 10-11, 13-16, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-10, 13-14, and 16-19 of copending Application No. 18/856801 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite 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 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 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims recite “a memory or data storage unit having stored thereon software instructions, which when executed by a processing unit, configure a computer to”. The claim does not clearly define structure of the system or apparatus as a data storage unit storing software instructions can be interpreted as merely computer programs. Since a computer program is merely a set of instructions capable of being executed by a computer, the computer program itself is not a process or physical structural elements of the apparatus and the examiner therefore will treat a claim as software per se, without the non-transitory computer-readable medium needed to realize the computer program’s functionality, as non-statutory functional descriptive material.
Claims 1-16 and 18-20 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-15 fall within the statutory category of an apparatus or system. Claims 16 and 18 fall within the statutory category of a process. Claims 19-20 do not fall within a statutory category, as rejected above. For the purposes of compact prosecution, they will be included in the full analysis below.
Step 2A, Prong One
As per Claims 1 and 19, the limitations of generate a prescription comprising a recommendation that relates to an intake of a therapeutic substance by the user, wherein the prescription is generated based on one or more urine parameters , under its broadest reasonable interpretation, covers management of personal behaviors or personal interactions. The generation of a prescription with a recommendation for a person is activity that is performed by a physician in the care of a patient and as such it amounts to management of personal interactions. If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or personal interactions, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, Claim 1 recites the additional elements – 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 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 receive the one or more urine parameters of the user when provided by the user and to transmit the urine parameters 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; and a prescription unit configured to transmit to the user device a prescription. The server, user device comprising a user interface, processing unit operating on the user device, care provider device, and prescription unit in these steps is recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The elements including the server operates over a data network and is connected to a database, the user device communicates with the server via the data network, the processing unit transmitting urine parameters to the server, the care provider device communicating with the server via the data network, and the prescription unit transmitting data to the user device amount to mere instructions to apply the exception because they recite the idea of a solution similar to wireless delivery of content via a network without any details of how the delivery is accomplished, as per MPEP 2106.05(f)(1) and also involve the use of a computer in its ordinary capacity for tasks such as receiving, storing, or transmitting data, as per MPEP 2106.05(f)(2). The claims also recites the additional elements of entering one or more urine parameters of the user, receiving the one or more urine parameters of the user when provided by the user, and receiving the one or more urine parameters from the server which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of entering urine parameters and receiving urine parameters of the user are mere data gathering in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional elements of a server, user device comprising a user interface, processing unit operating on the user device, care provider device, and prescription unit to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The server is described as “not particularly limited” (Specification [0032]). The user device comprising a user interface is described as a mobile phone, smart phone, tablet, personal computer (specification [0011]). The processing unit is described as a microcontroller (Specification [0034]). The care provider device is described as personal computing devices or smart mobile devices (Specification [0036]). The prescription unit is described as a microcontroller (Specification [0037]). These additional elements do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The additional elements including the server operates over a data network and is connected to a database, the user device communicates with the server via the data network, the processing unit transmitting urine parameters to the server, the care provider device communicating with the server via the data network, and the prescription unit transmitting data to the user device also amount to mere instructions to apply the exception, as described above. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims also include the additional elements of entering one or more urine parameters of the user, receiving the one or more urine parameters of the user when provided by the user, and receiving the one or more urine parameters from the server which are elements that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which have been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 2-18 and 20 add further limitations which are also directed to an abstract idea. Claims 2-3, 5-6, 15-16, 18, and 20 further specify or limit the elements of the independent claims and are therefore directed to the same abstract idea. Claim 4 includes providing an alert when one or more of the urine parameter conditions are met which is also directed to certain methods of organizing human activity as this is an activity performed by a physician to communicate with a patient. The claim also includes an alarm unit which amounts to mere instructions to apply the exception similarly to the units of the independent claims. Claim 7 includes the additional element of a hydration fluid delivery article, which is described as any container, can, bottle, etc., and communicates with the user device such that this amounts to mere instructions to apply the exception as a general purpose device which is recited at a high level of generality. Claim 8 recites establishing a hydration fluid consumption plan that comprises a plurality of hydration fluid drinking events and comparing the hydration fluid intake with the specific hydration fluid intake target for each consumption event and to generate a further recommendation for the user before a next hydration fluid consumption event which is directed to certain methods of organizing human activity as this is activity performed in the treatment of a patient by a caregiver, similar to the independent claims. Claim 9 includes generating a revised prescription based on adherence of the intake of a user which is directed to certain methods of organizing human activity as this is activity performed in the treatment of a patient by a caregiver, similar to the independent claims. Claim 10 includes non-transitory computer-readable storage medium storing instructions which includes modules, which amounts to mere instructions to apply the exception because it is recited at a high-level of generality such that it amounts to general purpose computer executing the abstract idea. Claim 11 includes monitoring blood pressure, glycemia, or body composition which is directed to certain methods of organizing human activity for the same reasons as the independent claims. The claim also recites an additional connected device which is recited at a high-level of generality such that it amounts to mere instructions to apply the exception. Claims 12-14 include mere transmitting and receiving of data which amounts to mere instructions to apply the exception as it is the use of computers for their ordinary capacity. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
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 claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: prescription unit configured to generate in claims 1, 9, and 15 and an alarm unit configured to provide an alert in claim 4.
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 specification provides the structure for the prescription unit by describing the prescription unit as typically a microcomputer which typically operates on the care provider device (Specification [0037]). However, the alarm unit is not described by a particular structure in the specification.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “alarm unit configured to provide an alert” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The specification is unclear what the structure which carries out the function of providing an alert. The specification describes the alarm unit as including visual alarms, audible alarms, sensory alarms, and any combinations thereof ([0040]) and the alarm unit is located in any of the user device, care provider device, and any combination ([0041]), but this does not provide the structure of the unit which performs the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims recites a hydration fluid delivery article configured to communicate with the user device. The specification describes exemplary hydration fluid delivery articles to include containers, cans, bottles, canisters, or boxes ([0044]). It is unclear to one of ordinary skill in the art how a container, can, bottle, canister, or box on its own is capable of communicating with the user device, which is described as having a built-in processing unit ([0044]) for devices such as a mobile phone, smart phone, tablets or personal computer ([0011]). Therefore the claim is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 9, 15-16, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peesapati et al. (US 2021/0074390 A1), hereinafter Peesapati.
As per Claim 1, Peesapati discloses a system comprising:
a server operational over a data network and optionally connected to a database ([0034] processing device is a remote server, [0035] the processing device includes a memory for storing processed urine data);
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 ([0055] urinalysis device and patient’s computer are in electronic communication with the server, [0087] urinalysis device connected to keypad, user manually enters urinalysis data);
a processing unit configured to operate on the user device, wherein the processing unit is configured to receive the one or more urine parameters of the user when provided by the user ([0055] urinalysis device analyzes urine, see Fig. 1 where 108 is the processor attached to the urinalysis device), and to transmit the urine parameters to the server ([0055] urinalysis device transmits the urine data to the server, [0066] server receives the raw urine data);
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 (Fig. 1, [0055] physician’s computer communicably connected with the server, receives processed data); and
a prescription unit configured to generate and transmit, to the user device, a prescription comprising a recommendation that relates to an intake of a therapeutic substance by the user, wherein the prescription is generated by the prescription unit based on the one or more urine parameters transmitted from the user device to the server ([0078] urine data is transmitted to the server, [0080] processor generates a report based on urine data where the report includes suggested adjustments to the patients treatment plan, [0082] report used to determine treatment prescription such as prescribing specific concentration of dialysate based on urine parameters).
As per Claim 2, Peesapati discloses the limitations of Claim 1. Peesapati also teaches the one or more urine parameters are selected form the group consisting of: urine volume, urine pH, urinary specific gravity, urine color, a urine biomarker of kidney injury, a urine biomarker of infection, a urine biomarker of stress, a urine biomarker of inflammation, and any combination thereof ([0021]/[0057] urine data includes specific gravity, urine pH, uric acid levels (which can indicate infection), protein/phosphate levels (indication of kidney injury and inflammation), and other levels, all of which indicate stress on the body, Examiner notes that only one parameter is required by the claim).
As per Claim 3, Peesapati discloses the limitations of Claim 1. Peesapati also teaches the one or more urine parameters comprises a pH value ([0021] urine data includes pH).
As per Claim 6, Peesapati discloses the limitations of Claim 1. Peesapati also teaches the prescription generated by the prescription unit is communicated by the care provider device to the user device via the data network ([0048] processed data transmitted from the patient’s medical staff to the patient/patient’s electronic device).
As per Claim 9, Peesapati discloses the limitations of Claim 1. Peesapati also teaches the prescription unit is further configured to generate a revised prescription based on an adherence of the intake of the therapeutic substance by the user ([0080-0081] determine patient adherence to recommended treatment plan/diet and recommend adjustments to the patient’s treatment plan/diet).
As per Claim 15, Peesapati discloses the limitations of Claim 11. Peesapati also teaches the prescription unit is configured as a microcomputer as at least part of the care provider device ([0080] processor generates a report based on urine data where the report includes suggested adjustments to the patients treatment plan, [0082] report used to determine treatment prescription such as prescribing specific concentration of dialysate based on urine parameters).
As per Claim 16, Peesapati discloses a method for remotely monitoring a user’s intake of a therapeutic substance ([0046] monitor patient’s diet to track dietary information of the patient without manually logging data), the method comprising providing the system of claim 1 as disclosed by Peesapati above.
As per Claim 18, Peesapati discloses the limitations of Claim 11. Peesapati also teaches a pH value of a urine sample is entered by the user through the user interface of the user device ([0087] urinalysis device connected to keypad, user manually enters urinalysis data, [0021] where urine data includes pH), and wherein the prescription is based on the pH value ([0007] treatment plan and adjustments to the plan are based on the processed urine data, [0021] where urine data includes pH, [0071] report of the components measured in the urine are used to generate treatment plan/prescription).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (US 2021/0074390 A1), in view of Yolay et al. (WO 2019/066743 A1), hereinafter Yolay.
As per Claim 4, Peesapati discloses the limitations of Claim 2. Peesapati also teaches an alarm unit configured to provide an alert ([0065] status light to indicate an alert).
However, Peesapati may not explicitly disclose the following which is taught by Yolay:
alert is provided when one or more of the following urine parameter conditions are met (Page 9, lines 17-20 a warning is provided by the processor for display on the screen related to the color of the urine and status of dehydration): a daily urine volume is less than 3.OL/ 24h, less than 2.8L / 24h, less than 2.6L / 24h, less than 2.5L/ 24h, less than 2.4L / 24h, less than 2.2L / 24h, or less than 2.OL/ 24h; a urinary specific gravity is greater than 1.010, 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 (Page 4, lines 27-Page 5, lines 8-level Armstrong scale of urine color is used to determine dehydration where urine color score of greater than 3 is considered dehydration, Examiner notes that only one urine parameter condition is required by the claim).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of alerting the user when a urine parameter is outside of normal range from Yolay with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure proper hydration to avoid serious health problems (Yolay Page 2, lines 19-23).
Claims 5, 10, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (US 2021/0074390 A1), in view of McCord et al. (US 10,928,325 B1), hereinafter McCord.
As per Claim 5, Peesapati discloses the limitations of Claim 1. Peesapati also teaches the prescription generated by the prescription unit further comprises a recommendation ([0080] processor generates a report based on urine data where the report includes suggested adjustments to the patients treatment plan, [0082] report used to determine treatment prescription such as prescribing specific concentration of dialysate based on urine parameters)
However, Peesapati may not explicitly disclose the following which is taught by McCord: the recommendation relates to hydration fluid intake by the user (Abstract based on urine test results, recommend consumption of water or electrolytes based on hydration levels).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of recommending a hydration fluid from McCord with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure a person is hydrated to reduce health risks.
As per Claim 10, Peesapati discloses the limitations of Claim 1. Peesapati also teaches
a learning module, an educational module, a self-motivation module, a reward module, a quality-of-life assessment module, a diet recommendation module, or any combination thereof ([0071] controller generates a report including generating a treatment plan such as a recommended diet, i.e. diet recommendation module, Examiner notes that only one of the listed modules is required by the claim).
However, Peesapati may not explicitly disclose the following which is taught by McCord: non-transitory computer-readable 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 (Col. 18:lines 37-44 computer includes a processor which execute software instructions stored on a memory).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of computer-readable medium with instructions from McCord with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure a person is hydrated to reduce health risks.
As per Claim 19, Peesapati discloses generate a prescription that comprises a recommendation that relates to an intake of a therapeutic substance suitable for a user, and wherein the prescription is based on one or more urine parameters about the user ([0078] urine data is transmitted to the server, [0080] processor generates a report based on urine data where the report includes suggested adjustments to the patients treatment plan, [0082] report used to determine treatment prescription such as prescribing specific concentration of dialysate based on urine parameters).
Peesapati may not explicitly disclose the following which is taught by McCord: a memory or data storage unit having stored thereon software instructions which, when executed by a processing unit, configure a computer to execute the instructions (Col. 18:lines 37-44 computer includes a processor which execute software instructions stored on a memory).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of computer-readable medium with instructions from McCord with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure a person is hydrated to reduce health risks.
As per Claim 20, Peesapati and McCord disclose the limitations of Claim 19. McCord also teaches the prescription further comprises a recommendation that relates to a hydration fluid intake suitable for the user (Abstract based on urine test results, recommend consumption of water or electrolytes based on hydration levels).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of recommending a hydration fluid from McCord with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure a person is hydrated to reduce health risks.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (US 2021/0074390 A1), in view of Abbate et al. (US 2024/0000218 A1), hereinafter Abbate.
As per Claim 7, Peesapati discloses the limitations of Claim 1. Peesapati may not explicitly disclose the following which is taught by Abbate: a hydration fluid delivery article configured to communicate with the user device ([0011] drinking bottle with electronic components for monitoring drinking and sending signals to the user such as communicating with a mobile phone).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of a drinking bottle which communicates with a mobile device from Abbate with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to monitor the intake of a person over time (Abbate [0002]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (US 2021/0074390 A1), in view of McCord et al. (US 10,928,325 B1), hereinafter McCord, in view of Fieldberg (US 8,764,447 B2).
As per Claim 8, Peesapati discloses the limitations of Claim 1. Peesapati may not explicitly disclose the following which is taught by McCord: wherein the processing unit is further configured to compare the hydration fluid intake with the specific hydration fluid intake target for each hydration fluid consumption event and to configure the prescription unit to generate a further recommendation for the user to consume more hydration fluid, as part of the prescription, when the hydration fluid intake during the hydration fluid consumption event is less than the specific hydration fluid intake target associated with the hydration fluid consumption event, and wherein the prescription is provided before a next hydration fluid consumption event (Co. 14: lines 47-59 determine how well a patient is hydrated and recommend adjustments for the person, when user is under-hydrated, recommend drinking more fluids).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of recommending a hydration fluid adjustment based on comparison to target intake from McCord with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to ensure a person is hydrated to reduce health risks.
However, Peesapati and McCord may not disclose the following which is taught by Fieldberg: the processing unit is further configured to establish a hydration fluid consumption plan that comprises a plurality of hydration fluid drinking events scheduled at predetermined intervals, wherein each hydration fluid drinking event is associated with a specific hydration fluid intake target (Col. 13, lines 18-33 a lemon water program to provide an athlete with a plan of doses of lemon water to consume at particular intervals over a duration such as a day to replenish body fluids and hydration, see Fig. 9 lemon water consumption plan which includes plurality of drinking events at scheduled time with a target amount of fluid), and
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of generating a hydration fluid consumption plan from Fieldberg with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati and McCord in order to provide safe and healthy program to be used to monitor a person to balance ph and eliminate lactic acid (Fieldberg Col. 1:lines 20-23, Col. 2:lines 37-42).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Peesapati (US 2021/0074390 A1), in view of Wabel et al. (US 2022/0028523 A1), hereinafter Wabel.
As per Claim 11, Peesapati discloses the limitations of Claim 1. Peesapati may not explicitly disclose the following which is taught by Wabel: an additional connected device configured to monitor blood pressure, glycemia, composition, or any combination thereof of the user ([0038] additional device as a blood pressure cuff which take a blood pressure value which is output, Examiner notes that only one monitoring device is required by the claim).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of monitoring blood pressure from an additional device from Fieldberg with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to provide additional data used to provide recommendations for a dialysis patient (Fieldberg [0004]).
As per Claim 12, Peesapati and Wabel discloses the limitations of Claim 11. Wabel also teaches the additional connected device is in communication with the server ([0038] blood pressure cuff configured to communicate information to treatment apparatus/another device via wireless connection, [0087] the treatment apparatus incorporates a web server which interacts with the device).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of monitoring blood pressure from an additional device from Fieldberg with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to provide additional data used to provide recommendations for a dialysis patient (Fieldberg [0004]).
As per Claim 13, Peesapati and Wabel discloses the limitations of Claim 11. Wabel also teaches the care provider device is configured to receive data provided by the additional connected device ([0038] blood pressure cuff configured to communicate information to treatment apparatus/another device via wireless connection).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of monitoring blood pressure from an additional device from Fieldberg with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to provide additional data used to provide recommendations for a dialysis patient (Fieldberg [0004]).
As per Claim 14, Peesapati and Wabel discloses the limitations of Claim 11. Wabel also teaches the prescription is based on data monitored and transmitted by the additional connected device ([0006-0008] determining a dialysis treatment for a patient based on the input values which include the urine parameters (salinity) and the blood pressure of the patient).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of monitoring blood pressure from an additional device from Fieldberg with the known system of generating a recommendation for intake of a therapeutic substance for a user from Peesapati in order to provide additional data used to provide recommendations for a dialysis patient (Fieldberg [0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leveno et al. (US 2023/0007930 A1) teaches real time monitoring of a patient’s kidney function including monitoring a patient’s hydration status including determining if the patient is dehydrated.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682