DETAILED ACTION
Claims 1-5, 7-8, 10-17, & 19-21 are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/29/2026 has been entered.
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 1-5, 7-8, 10-17, 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,449,284. Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to optimizing peritoneal dialysis using a patient hand-held scanning device. Application 18123498 includes claims directed to selecting containers for dialysis, determining dialysis dwell times, timing dialysis dwell times, determine which container to use for other cycles, and outputting an indication that the therapy is complete (see claims 1, 12, & 19). US Patent 10,449,284 includes claims also directed to selecting containers for dialysis, determining dialysis dwell times, timing dialysis dwell times, determine which container to use for other cycles, and outputting an indication that the therapy is complete (claims 17-19).
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 1-5, 7-8, 10-17, & 19-21 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-5, 7-8, 10-17, & 19-21 are directed to a system (i.e., a machine). Accordingly, claims 1-5, 7-8, 10-17, & 19-21 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A handheld personal communication apparatus for a peritoneal dialysis treatment, the apparatus comprising:
a reader configured to read markings displayed on at least two different dialysis fluid containers to acquire data concerning respective dialysis fluid types;
a processor communicatively coupled to the reader and configured to
determine from the markings that each of the dialysis fluid containers has a different dialysis fluid type,
determine, as a selected dialysis fluid container, which of the at least two different dialysis fluid containers is to be used for a first cycle of a peritoneal dialysis therapy for a patient,
provide a first container indication that specifies the selected dialysis fluid container should be used for the first cycle,
use the dialysis fluid type from the marking of the selected dialysis fluid container in conjunction with the patient weight value to determine a first dialysis dwell time for a first dialysis dwell of the first cycle of the peritoneal dialysis therapy, wherein the first dialysis dwell time corresponds to a time to achieve at least one of (a) a specified ultrafiltration removal level for the cycle, (b) a urea removal level for the cycle, or (c) a creatinine removal level for the cycle,
begin a timer upon receiving an indication of a start of the first dialysis dwell,
after the timer has reached the first dialysis dwell time, transmit a first output signal,
determine, as a second selected dialysis fluid container, which of the at least two different dialysis fluid containers is to be used for a second cycle of the peritoneal dialysis therapy,
provide a second container indication that specifies the second selected dialysis fluid container should be used for the second cycle,
use the dialysis fluid type from the marking of the second selected dialysis fluid container in conjunction with the patient weight value to determine a second dialysis dwell time for a second dialysis dwell of the second cycle of the peritoneal dialysis therapy, wherein the second dialysis dwell time corresponds to a time to achieve at least one of (a) a specified ultrafiltration removal level for the cycle, (b) a urea removal level for the cycle, or (c) a creatinine removal level for the cycle,
begin the timer upon receiving an indication of a start of the second dialysis dwell, and
after the timer has reached the second dialysis dwell time, transmit a second output signal; and
an output interface configured to, in response to the first output signal, provide a first indication to the patient of a completion of the first dialysis dwell time, and in response to the second output signal, provide a second indication to the patient of a completion of the second dialysis dwell time.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because selecting containers for dialysis, determining dialysis dwell times, timing dialysis dwell times, determine which container to use for other cycles, and outputting an indication that the therapy is complete are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access associated with dialysis, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 1 and analogous independent claims 12 & 19 recite at least one abstract idea.
Furthermore, dependent claims 2-5, 7-8, 10-11, 17, 20 further narrow the abstract idea described in the independent claims. Claims 2-3 & 13 outputting information to a user via an interface; Claims 4-5 & 16-17 recite tracking therapy progress of a patient; Claims 7-8 recites receiving patient input regarding dialysis. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1 and analogous independent claims 12 & 19, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. A handheld personal communication apparatus for a continuous ambulatory peritoneal dialysis (“CAPD”) treatment, the apparatus comprising:
a reader configured to read markings displayed on at least two different dialysis fluid containers to acquire data concerning respective dialysis fluid types;
a processor communicatively coupled to the reader and configured to
receive a patient weight value,
determine from the markings that each of the dialysis fluid containers has a different dialysis fluid type,
determine, as a selected dialysis fluid container, which of the at least two different dialysis fluid containers is to be used for a first cycle of a peritoneal dialysis therapy for a patient,
provide a first container indication that specifies the selected dialysis fluid container should be used for the first cycle,
use the dialysis fluid type from the marking of the selected dialysis fluid container in conjunction with the patient weight value to determine a first dialysis dwell time for a first dialysis dwell of the first cycle of the peritoneal dialysis therapy, wherein the first dialysis dwell time corresponds to a time to achieve at least one of (a) a specified ultrafiltration removal level for the cycle, (b) a urea removal level for the cycle, or (c) a creatinine removal level for the cycle,
begin a timer upon receiving an indication of a start of the first dialysis dwell,
after the timer has reached the first dialysis dwell time, transmit a first output signal,
determine, as a second selected dialysis fluid container, which of the at least two different dialysis fluid containers is to be used for a second cycle of the peritoneal dialysis therapy,
provide a second container indication that specifies the second selected dialysis fluid container should be used for the second cycle,
use the dialysis fluid type from the marking of the second selected dialysis fluid container in conjunction with the patient weight value to determine a second dialysis dwell time for a second dialysis dwell of the second cycle of the peritoneal dialysis therapy, wherein the second dialysis dwell time corresponds to a time to achieve at least one of (a) a specified ultrafiltration removal level for the cycle, (b) a urea removal level for the cycle, or (c) a creatinine removal level for the cycle,
begin the timer upon receiving an indication of a start of the second dialysis dwell, and
after the timer has reached the second dialysis dwell time, transmit a second output signal; and
an output interface configured to, in response to the first output signal, provide a first indication to the patient of a completion of the first dialysis dwell time, and in response to the second output signal, provide a second indication to the patient of a completion of the second dialysis dwell time.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the handheld personal communication apparatus, processor, interface, display, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of a reader configuring to read markings, the Examiner submits that these additional limitations do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the steps of the at least one abstract idea are performed (see MPEP § 2106.05(h)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 12 & 19 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 2 and 13: These claims recite a display screen however the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claims 4-5 & 16-17: These claims recite a transceiver configured to transmit data to a remote computer however the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claims 7 recites a start dwell input device however the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claims 10-11, 14-15, & 20 recites a smartphone device however the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claim 21 recites using an output signal with an APD device to control at least one dwell cycle however the Examiner submits that these limitations attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result and is equivalent to the words “apply it” (see MPEP 2106.05(f)(1)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitation of a reader configuring to read markings, the Examiner submits that these additional limitations do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the steps of the at least one abstract idea are performed (see MPEP § 2106.05(h)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-5, 7-8, 10-17, & 19-21 are ineligible under 35 USC §101.
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: a reader configured to read markings displayed on at least two different dialysis fluid containers to acquire data concerning respective dialysis fluid types; a processor communicatively coupled to the reader and configured to determine from the markings that each of the dialysis fluid containers has a different dialysis fluid type, determine, as a selected dialysis fluid container, which of the at least two different dialysis fluid containers is to be used for a cycle of a peritoneal dialysis therapy for a patient, the cycle including a dialysis dwell time, use the dialysis fluid type from the marking of the selected dialysis fluid container to determine the dialysis dwell time for a dialysis dwell of the cycle of the peritoneal dialysis therapy, and provide a container indication that specifies the selected dialysis fluid container should be used for the cycle; and an output interface configured to display the container indication and provide an indication to the patient of a completion of the dialysis dwell time.
The most relevant prior art of record includes:
Krensky (US20030218623) teaches to dialysis therapy which can be performed according to the present invention includes an automatic dialysis fluid exchange of a patient fill, dwell and a patient drain. The dialysis system of the present invention can automatically perform dialysis therapy on a patient, for example, during nighttime while the patient sleeps.
Childers (US20040019320) teaches to provides systems and methods that can perform continuous flow dialysis therapy, such as during peritoneal dialysis.
Bello (US20050055242) teaches to a system and method is also disclosed for medical data tracking, analyzing and reporting within a healthcare system. The system can further integrate vital signs and infusion pump monitoring and reporting, and allow for enhanced provision of medical care through interface screens which combine this functionality.
Response to Arguments
Applicant’s arguments on pages 9-12 regarding claims 1-5, 7-8, 10-17, & 19-21 being rejected under 35 USC § 101 have been fully considered but they are not persuasive. Applicant claims that:
Similar to BASCOM and in light of Desjardins, the claims provide a technology-based solution regarding the optimal dwell time for dialysis treatment.
The Examiner, however, asserts that Desjardins decision cited to specific recitations of a technical problem and a technical solution where the Specification recited that the claimed improvement allows artificial intelligence (AI) systems to ‘us[e] less of their storage capacity’ and enables ‘reduced system complexity.’… The same cannot be said here. The instant application fails to provide any description of a technical problem and a technical solution. Applicant’s specification presents a non-technical problem – determining an optimal dwell time for dialysis therapy (see the instant Specification in para. 13). The solution to the problem is rooted in an improvement to the abstract idea itself and not a technical failure of a computer system. The additional elements can best be characterized as tools to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the ""Other examples., v."")."
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Busby (US20030220598) teaches to improved dialysis systems and improved methods of performing dialysis. More particularly, the present invention provides systems and methods for performing automated peritoneal dialysis (“APD”). The systems and methods of the present invention automatically provide dialysis therapy by providing dialysis fluid to the patient and draining spent dialysis fluid from the patient.
Biewer (US20090294339A1) teaches to a peritoneal dialysis machine includes an enclosure; dialysate pump located within the enclosure; a graphical user interface connected to the enclosure and configured to display a parameter associated with the dialysate pump; and a projector configured to project the parameter onto a surface external from the enclosure so as to allow a patient to readily view the parameter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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, Anita Coupe can be reached at 571-270-7949. 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.
/Jonathan Ng/ Primary Examiner, Art Unit 3619