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 .
Acknowledgments
In the reply, filed on April 15, 2026, Applicant amended claims 1, 3-4, 8-9, 11-13, 16, and 21-23.
Applicant cancelled claims 2, 10, and 15.
Applicant added new claims 24-26.
In the non-final rejection of November 19, 2025, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 11, 13, and 21-22. Applicant amended claims 11, 13, and 21-22. Objection is withdrawn.
Examiner rejected claims 3-4, 8, and 12 under 35 U.S.C. 112(b). Applicant amended claims 3-4, 8, and 12; however, Applicant did not address all of the rejections. Rejection is maintained.
Currently, claims 1, 3-9, 11-14, and 16-26 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9, 11-14, and 16-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, lines 7-8 recite: a pressure sensor configured to measure “a level of” the pressure of the fluid within the cavity; however, such is new matter not described in the Specification. Claims 3-8 and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 12-13 recite: “wherein the amount of the light indicates the level of the pressure”; however, such is new matter not described in the Specification. Claims 3-8 and 24 are rejected by virtue of being dependent upon claim 1.
In regards to claim 9, lines 1-2 recite: A method of measuring “a level of” a pressure of a fluid within a disposable set of an automated peritoneal dialysis (APD) system; however, such is new matter not described in the Specification. Claims 11-14, 16-22, and 25 are rejected by virtue of being dependent upon claim 9.
In regards to claim 9, lines 8-9 recite: “wherein the amount of the light indicates the level of the pressure”; however, such is new matter not described in the Specification. Claims 11-14, 16-22, and 25 are rejected by virtue of being dependent upon claim 9.
In regards to claim 23, lines 9-10 recite: “wherein the amount of the light indicates a level of a pressure of the fluid within the cavity”; however, such is new matter not described in the Specification. Claim 26 is rejected by virtue of being dependent upon claim 23.
In regards to claim 24, lines 1-4 recite: “wherein the automated peritoneal dialysis (APD) system is configured such that the amount of the light is greater than zero when the diaphragm is undeflected, deflected toward the photosensor, and deflected away from the photosensor”; however, such is new matter not described in the Specification.
In regards to claim 25, lines 2-4 recite: “determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor”; however, such is new matter not described in the Specification.
In regards to claim 26, lines 3-5 recite: “determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor”; however, such is new matter not described in the Specification.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 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.
In regards to claim 3, line 5 recites “a first light”. Claim 3 depends upon claim 1. Claim 1, line 10 recites “light”. It is unclear whether the two recitations are the same component or different components.
Claim Rejections - 35 USC § 102
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, 3-4 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geipel et al (US 2014/0007694).
In regards to claim 1, Geipel et al teaches an automated peritoneal dialysis system (Figures 1a-1b)(Note: while Geipel et al explicitly discloses a medical fluid delivery system (paragraph [0002]), Geipel et al does not explicitly disclose that the medical fluid delivery system is “an automated peritoneal dialysis system”; however, the claim structurally requires an automated peritoneal dialysis system to comprise a disposable set including a diaphragm positioned over an opening in a cavity, and a pressure sensor including a light source and a photosensor, which are structural components disclosed by the medical fluid delivery system of Geipel et al; thus the medical fluid delivery system of Geipel et al is understood to disclose an automated peritoneal dialysis system, as claimed), comprising:
a disposable set (9)
wherein at least a portion of the disposable set includes a diaphragm (2) positioned over an opening in a cavity (1), the diaphragm is configured to deform in response to a force applied against the diaphragm due to pressure of fluid within the cavity (Figure 1b), and the diaphragm has an outer surface and an inner surface opposite the outer surface (Figures 1a-1b)
a pressure sensor (3/5) configured to measure a level of the pressure of the fluid within the cavity (paragraphs [0055][0056]), the pressure sensor including a light source (3) and a photosensor (5)
wherein, during operation the light source is configured to irradiate the outer surface of the diaphragm with light (4), and the photosensor is configured to measure an amount of the light that is reflected (6/6’) off of the outer surface of the diaphragm and directed toward the photosensor, wherein the amount of the light indicates the level of the pressure (Figures 1a-1b)
In regards to claim 3, Geipel et al teaches wherein:
the pressure sensor further includes a collimating element (7) positioned between the light source and the outer surface of the diaphragm
the light irradiating the outer surface of the diaphragm is collimated light (paragraph [0053]: parallelize the emitted light)
the collimating element is configured to collimate a first light emitted from the light source into the collimated light (Figures 1a-1b)
In regards to claim 4, Geipel et al teaches wherein:
the photosensor is a first photosensor (5a)
the amount of the light is a first amount of the light (6)
the pressure sensor further includes a second photosensor (5b) separate from the first photosensor
the second photosensor is directed toward the outer surface of the diaphragm and is configured to measure a second amount of the light that is reflected (6’) off of the outer surface of the diaphragm and is directed toward the second photosensor (Figure 1b)
In regards to claim 24, Geipel et al teaches wherein the automated peritoneal dialysis (APD) system is configured such that the amount of the light is greater than zero when the diaphragm is undeflected (Figure 1a), deflected toward the photosensor (Figure 1b), and deflected away from the photosensor (paragraph [0034]: pressure changes can be detected in respect to this reference state. In the case where the pressure within the fluidic chamber… decreases, the cover can be deformed due to the force of the pressure change).
Claim Rejections - 35 USC § 103
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al, as applied to claim 1 above, and further in view of Baxter et al (US 2017/0189231).
In regards to claim 5, Geipel et al teaches wherein:
the photosensor is a first photosensor (5a)
the pressure sensor further includes a second photosensor (5b) separate from the first photosensor
the second photosensor is configured to measure an amount of the light that is emitted from the light source (Figure 1b)
Geipel et al does not teach the second photosensor is configured to measure an amount of the light that is emitted from the light source “and is not reflected off of the outer surface of the diaphragm”, as Geipel et al instead teaches the second photosensor is configured to measure an amount of the light that is emitted from the light source and is reflected (6’) off of the outer surface of the diaphragm (Figure 1b). Baxter et al teaches a system (Figure 5B) wherein: a second photosensor (255) is configured to measure an amount of light (259) that is emitted from a light source (253) and is not reflected off of an outer surface of a diaphragm (310). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second photosensor, of the system of Geipel et al, to be configured to measure an amount of the light that is emitted from the light source and is not reflected off of the outer surface of the diaphragm, as taught by Baxter et al, as such will minimize the potential for inaccurate pressure measurement by isolating the pressure solely within the cavity, as the accuracy of pressure determination can be adversely impacted by unaccounted movement of the disposable part (paragraph [0038]).
In regards to claim 6, Geipel et al teaches wherein:
the light source is a first light source (paragraph [0065] states “light emitters 3”; thus it is understood that one of the light emitters 3 is a first light source)
the pressure sensor further includes a second light source (paragraph [0065] states “light emitters 3”; thus it is understood that a second one of the light emitters 3 is a second light source) separate from the first light source
the second light source is configured to project second light onto the photosensor (Figures 1a-1b)
Geipel et al does not teach the second light source is configured to project second light onto the photosensor “without the second light reflecting off of the outer surface of the diaphragm”, as Geipel et al instead teaches the second light source is configured to project second light onto the photosensor with the second light reflecting off of the outer surface of the diaphragm (Figures 1a-1b). Baxter et al teaches a system (Figure 5B) wherein: a second light source (253) is configured to project second light (259) onto a photosensor (255) without the second light reflecting off of an outer surface of a diaphragm (310). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second light source, of the system of Geipel et al, to be configured to project second light onto the photosensor without the second light reflecting off of the outer surface of the diaphragm, as taught by Baxter et al, as such will minimize the potential for inaccurate pressure measurement by isolating the pressure solely within the cavity, as the accuracy of pressure determination can be adversely impacted by unaccounted movement of the disposable part (paragraph [0038]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al, as applied to claim 1 above, and further in view of Aronowitz et al (US 7,577,469).
In regards to claim 7, Geipel et al teaches wherein:
the pressure sensor further includes a temperature sensor (paragraph [0064]) disposed on or proximate the light source
Geipel et al states that the temperature sensor is configured to capture temperature changes, which can be located close to the interface between the disposable and reusable unit (paragraph [0064]); however, Geipel et al does not specifically disclose that the temperature sensor is configured to capture one or more measurements of temperature of the light source. Aronowitz et al teaches a system (Figure 52A) wherein: a temperature sensor (12800) is configured to capture one or more measurements of temperature of a light source (10000). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor, of the system of Geipel et al, to be configured to capture one or more measurements of temperature of the light source, as taught by Aronowitz et al, as such information is important to consider in situations where the brightness and intensity of the light emitted from the light source varies with changes in temperature, as any experienced brightness or intensity changes in the emitted light cause corresponding changes in an output signal, wherein with knowledge of temperature indicative information, appropriate actions can be taken during subsequent processing of the output signal in order to account for the temperature driven variations in emitted light and the corresponding variations in the output signal (column 33, lines 1-15).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al, as applied to claim 1 above, and further in view of Shih (US 2009/0194674).
In regards to claim 8, Geipel et al teaches wherein:
the pressure sensor further includes a temperature sensor (paragraph [0064]) disposed on or proximate the photosensor
Geipel et al states that the temperature sensor is configured to capture temperature changes, which can be located close to the interface between the disposable and reusable unit (paragraph [0064]); however, Geipel et al does not specifically disclose that the temperature sensor is configured to capture one or more measurements of temperature of the photosensor. Shih teaches a system (Figure 9) wherein: a temperature sensor (995) is configured to capture one or more measurements of temperature of a photosensor (980). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature sensor, of the system of Geipel et al, to be configured to capture one or more measurements of temperature of the photosensor, as taught by Shih, as such will allow for varying a drive voltage of the system to compensate for changes in gain or other photosensor parameters due at least in part to temperature changes (paragraph [0040]).
Claims 9, 11-14, 16, 20-22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al, and further in view of Hopping et al (US 2005/0209563).
In regards to claim 9, Geipel et al teaches a method of measuring a level of a pressure of a fluid within a disposable set (9) (paragraph [0013]), the method comprising:
irradiating an outer surface of a diaphragm (2) with light (4) using a light source (3) (paragraph [0013]: directing one or more incident light beams on the inflexion point area of the deformable cover), the diaphragm being positioned over an opening to a cavity (1) of the disposable set that is configured to contain the fluid (Figures 1a-1b)
measuring, using a photosensor (5), an amount of the light reflected (6)(6’) off of the outer surface of the diaphragm and directed toward the photosensor, wherein the amount of the light indicates the level of the pressure (Figures 1a-1b)(paragraph [0013]: detecting one or more reflected light beams reflected from the deformable cover in a non-pressurized state and a pressurized state)
Geipel et al teaches a method of measuring a level of a pressure of a fluid within a disposable set of a medical fluid delivery system (paragraph [0002]); however, Geipel et al does not specifically disclose a method of measuring a level of a pressure of a fluid within a disposable set “of an automated peritoneal dialysis system”. Hopping et al teaches a method of measuring a level of a pressure of a fluid within a disposable set (50) of an automated peritoneal dialysis system (10)(claim 58)(paragraph [0031]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of measuring the level of the pressure of the fluid within the disposable set, of Geipel et al, to be a method of measuring a level of a pressure of a fluid within a disposable set of an automated peritoneal dialysis system, as taught by Hopping et al, as such will allow for pressure at the patient to be controlled efficiently and safely within safe limits (paragraphs [0016][0017]) while waste, toxins and excess water pass from the patient's bloodstream, through the peritoneal membrane and into dialysate due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane, and the spent dialysate is drained from the patient, removing waste, toxins and excess water from the patient (paragraph [0006]).
In regards to claim 11, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the irradiating the outer surface of the diaphragm includes irradiating the outer surface of the diaphragm in an absence of a force applied against the diaphragm due to the pressure of the fluid within the disposable set (Figure 1a)
the measuring the amount of the light includes determining a zero-offset value (paragraph [0034]: reference measurement)
the determining the zero-offset value includes measuring the amount of the light in the absence of the force applied against the diaphragm due to the pressure of the fluid within the disposable set (Figure 1a)(paragraph [0034]: The non-pressurized state can be determined by a reference measurement with the optical detection system)
In regards to claim 12, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches determining a relationship between the amount of the light measured by the photosensor and deformation of the diaphragm in response to forces applied against the diaphragm due to the pressure of the fluid within the disposable set (paragraph [0058]: a linear mode of calculation, wherein the total shift s can be linear in relation to the pressure in the fluidic chamber 1 approximately).
In regards to claim 13, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the irradiating the outer surface of the diaphragm includes irradiating the outer surface of the diaphragm in a presence of a force applied against the diaphragm due to the pressure of the fluid within the disposable set (Figure 1b)
the measuring the amount of the light includes measuring the amount of the light in the presence of the force applied against the diaphragm due to the pressure of the fluid within the disposable set (Figure 1b)
In regards to claim 14, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches further comprising determining the pressure of the fluid within the disposable set based at least in part on the amount of the light reflected off of the outer surface of the diaphragm and directed toward the photosensor (paragraph [0013]: detecting one or more reflected light beams reflected from the deformable cover in a non-pressurized state and a pressurized state; and comparing detection data of the non-pressurized state and the pressurized state to extract the pressure change value).
In regards to claim 16, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches further comprising interrupting flow of the fluid through the disposable set when the pressure of the fluid is outside of a safe operating pressure range (paragraph [0049]: threshold pressure level can be defined and deposited in the controlling system at which the delivery system can be shut down or an alarm can be given to indicate a critical pressure value or malfunction of the system).
In regards to claim 20, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the photosensor is a first photosensor (5a)
the amount of the light is a first amount of the light (6) (Figure 1a)
the method further comprises measuring, using a second photosensor (5b) separate from the first photosensor, a second amount of the light (6’) reflected off of the outer surface of the diaphragm and directed toward the second photosensor (Figure 1b)
In regards to claim 21, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the light is collimated light (paragraph [0053]: parallelize the emitted light)
the irradiating the outer surface of the diaphragm with the light includes collimating the light emitted from the light source into the collimated light (paragraph [0053]: parallelize the emitted light)
In regards to claim 22, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein the measuring the amount of the light includes compensating for effects due to temperature (paragraph [0062]).
In regards to claim 25, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor (paragraph [0034]: pressure changes can be detected in respect to this reference state. In the case where the pressure within the fluidic chamber… decreases, the cover can be deformed due to the force of the pressure change).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al and Hopping et al, as applied to claim 9 above, and further in view of Aronowitz et al.
In regards to claim 17, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches further comprising capturing one or more temperature measurements to capture temperature changes, which can be located close to the interface between the disposable and reusable unit (paragraph [0064]); however, Geipel et al does not specifically disclose capturing one or more temperature measurements “of the light source or the photosensor”. Aronowitz et al teaches a method comprising capturing one or more temperature measurements of a light source (10000) (column 33, lines 3-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify capturing one or more temperature measurements, of the modified method of Geipel et al and Hopping et al, to be capturing one or more temperature measurements of the light source, as taught by Aronowitz et al, as such information is important to consider in situations where the brightness and intensity of the light emitted from the light source varies with changes in temperature, as any experienced brightness or intensity changes in the emitted light cause corresponding changes in an output signal, wherein with knowledge of temperature indicative information, appropriate actions can be taken during subsequent processing of the output signal in order to account for the temperature driven variations in emitted light and the corresponding variations in the output signal (column 33, lines 1-15).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Geipel et al and Hopping et al, as applied to claim 9 above, and further in view of Baxter et al.
In regards to claim 18, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the photosensor is a first photosensor (5a)
the method further comprises measuring, using a second photosensor (5b) separate from the first photosensor, an amount of the light that is emitted from the light source (Figure 1b)
Geipel et al does not teach measuring, using the second photosensor, an amount of the light that is emitted from the light source “and is not reflected off of the outer surface of the diaphragm”, as Geipel et al instead teaches measuring, using the second photosensor, an amount of the light that is emitted from the light source and is reflected (6’) off of the outer surface of the diaphragm (Figure 1b). Baxter et al teaches a method comprising measuring, using a second photosensor (255), an amount of light (259) that is emitted from a light source (253) and is not reflected off of an outer surface of a diaphragm (310) (Figure 5B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify measuring, using the second photosensor, of the modified method of Geipel et al and Hopping et al, to be measuring, using the second photosensor, an amount of the light that is emitted from the light source and is not reflected off of the outer surface of the diaphragm, as taught by Baxter et al, as such will minimize the potential for inaccurate pressure measurement by isolating the pressure solely within the cavity, as the accuracy of pressure determination can be adversely impacted by unaccounted movement of the disposable part (paragraph [0038]).
In regards to claim 19, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
the light source is a first light source paragraph [0065] states “light emitters 3”; thus it is understood that one of the light emitters 3 is a first light source); the light is first light (Figures 1a-1b); and the method further comprises projecting second light onto the photosensor (Figures 1a-1b)
Geipel et al does not teach projecting second light onto the photosensor “without reflecting the second light off of the outer surface of the diaphragm”, as Geipel et al instead teaches projecting second light onto the photosensor with reflecting the second light off of the outer surface of the diaphragm (Figures 1a-1b). Baxter et al teaches a method comprising projecting second light (259) onto a photosensor (255) without reflecting the second light off of an outer surface of a diaphragm (310). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify projecting second light onto the photosensor, of the modified method of Geipel et al and Hopping et al, to be projecting second light onto the photosensor without reflecting the second light off of the outer surface of the diaphragm, as taught by Baxter et al, as such will minimize the potential for inaccurate pressure measurement by isolating the pressure solely within the cavity, as the accuracy of pressure determination can be adversely impacted by unaccounted movement of the disposable part (paragraph [0038]).
Claims 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Egley (US 2017/0157311), and further in view of Geipel et al.
In regards to claim 23, Egley teaches a non-transitory computer-readable medium having instructions stored thereon that, when executed by one or more processors of an automated peritoneal dialysis (APD) system, cause the APD system to perform functions (paragraph [0047]: Implementations of the subject matter and the operations described in this specification can be implemented… via computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Implementations of the subject matter described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus)(paragraph [0048]: A computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal. The computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices))(paragraph [0005]: PD machines are designed to automatically infuse, dwell, and drain dialysate to and from the patient's peritoneal cavity). And while Egley teaches a diaphragm (paragraph [0034]: membrane) of a disposable set (112), the diaphragm positioned over an opening to a cavity (153) of the disposable set that is configured to contain fluid (paragraph [0034]); Egley et al is silent about the functions comprising: irradiating an outer surface of a diaphragm of a disposable set with light using a light source, the diaphragm positioned over an opening to a cavity of the disposable set that is configured to contain fluid; and measuring, using a photosensor, an amount of the light reflected off of the outer surface of the diaphragm and directed toward the photosensor, wherein the amount of the light indicates a level of a pressure of the fluid within the cavity. Geipel et al teaches functions (paragraph [0013]) comprising: irradiating an outer surface of a diaphragm (2) of a disposable set (9) with light (4) using a light source (3) (paragraph [0013]: directing one or more incident light beams on the inflexion point area of the deformable cover), the diaphragm positioned over an opening to a cavity (1) of the disposable set that is configured to contain the fluid (Figures 1a-1b); and measuring, using a photosensor (5), an amount of the light reflected (6)(6’) off of the outer surface of the diaphragm and directed toward the photosensor, wherein the amount of the light indicates a level of a pressure of the fluid within the cavity (Figures 1a-1b)(paragraph [0013]: detecting one or more reflected light beams reflected from the deformable cover in a non-pressurized state and a pressurized state). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the functions, of the non-transitory computer-readable medium of Egley, to comprise irradiating an outer surface of a diaphragm of a disposable set with light using a light source, the diaphragm positioned over an opening to a cavity of the disposable set that is configured to contain fluid; and measuring, using a photosensor, an amount of the light reflected off of the outer surface of the diaphragm and directed toward the photosensor, wherein the amount of the light indicates a level of a pressure of the fluid within the cavity, as taught by Geipel et al, as such will allow for monitoring pressure variations in a medical fluid delivery system, which is easy to install and indicates pressure changes or fluid path occlusion in a simple manner (paragraph [0011]), wherein a threshold pressure level can be defined and deposited in the controlling system at which the delivery system can be shut down or an alarm can be given to indicate a critical pressure value or malfunction of the system (paragraph [0049]).
In regards to claim 26, in the modified non-transitory computer-readable medium of Egley and Geipel et al, Egley is silent about the functions further comprising: determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor. Geipel et al teaches determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor (paragraph [0034]: pressure changes can be detected in respect to this reference state. In the case where the pressure within the fluidic chamber… decreases, the cover can be deformed due to the force of the pressure change). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the functions, of the modified non-transitory computer-readable medium of Egley and Geipel et al, to comprise determining the level of the pressure of the fluid based on the amount of the light detected by the photosensor that is affected by a deflection of the diaphragm away from the photosensor, as taught by Geipel et al, as such will allow for monitoring pressure variations in a medical fluid delivery system, which is easy to install and indicates pressure changes or fluid path occlusion in a simple manner (paragraph [0011]), wherein a threshold pressure level can be defined and deposited in the controlling system at which the delivery system can be shut down or an alarm can be given to indicate a critical pressure value or malfunction of the system (paragraph [0049]).
Response to Arguments
Applicant's arguments filed April 15, 2026, have been fully considered but they are not persuasive:
In regards to claims 1, 9, and 23, Applicant argued: The § 102 and § 103 rejections of claims 1, 3-9, 11-14, and 16-23 should be withdrawn for at least the reason that the cited art fails to teach or suggest the following feature of independent claim 1: "wherein the amount of the light [that is reflected off of the outer surface of the diaphragm] indicates the level of the pressure [of fluid within the cavity]." Independent claims 9 and 23 recite similar subject matter (Remarks, pages 10-11). Examiner disagrees. Geipel et al teaches wherein the amount of the light (6/6’) indicates the level of the pressure (Figures 1a-1b)(paragraphs [0055][0056]).
In regards to claim 1, Applicant argued: Geipel fails to teach or suggest such a system. First, as acknowledged by the Examiner Geipel, does not disclose an automated peritoneal dialysis system. Office Action at 5. Geipel does not suggest any use of its disclosure for peritoneal dialysis (Remarks, page 12). Examiner disagrees. While Geipel et al explicitly discloses a medical fluid delivery system (paragraph [0002]), Geipel et al does not explicitly disclose that the medical fluid delivery system is “an automated peritoneal dialysis system”; however, the claim structurally requires an automated peritoneal dialysis system to comprise a disposable set including a diaphragm positioned over an opening in a cavity, and a pressure sensor including a light source and a photosensor, which are structural components disclosed by the medical fluid delivery system of Geipel et al; thus the medical fluid delivery system of Geipel et al is understood to disclose an automated peritoneal dialysis system, as claimed.
In regards to claim 1, Applicant argued: Instead of the amount of light detected, Geipel is focused on the direction of the reflected light (i.e. deflected or not deflected, see [0055], [0056] of Geipel). This is in contrast to claim 1 which involves measuring an amount of the light that is reflected off of the outer surface of the diaphragm and directed toward the photosensor (Remarks, page 13). Examiner disagrees. Geipel et al teaches the photosensor (5) is configured to measure an amount of the light that is reflected (6/6’) off of the outer surface of the diaphragm (2) and directed toward the photosensor (Figures 1a-1b).
In regards to claim 1, Applicant argued: Claim 1 also specifies that "the amount of the light indicates the level of the pressure." Geipel fails to disclose that the amount of reflected light indicates the level of pressure within the cavity. Instead, Geipel teaches that an outward deflection of the deformable cover 2 can deflect reflected light from one sensor to another (Remarks, pages 13-14). Examiner disagrees. Geipel et al teaches wherein the amount of the light (6/6’) indicates the level of the pressure (Figures 1a-1b)(paragraphs [0055][0056]).
In regards to claims 1, 9, and 23, Applicant argued: Therefore, Geipel does not disclose or suggest the ADP system of claim 1. Geipel also fails to disclose or suggest the subject matter of claims 9 and 23 which recite features similar to that of claim 1, namely measuring the amount of light that is reflected as a proxy for the cavity fluid pressure (Remarks, page 14). Examiner disagrees. First, in regards to claim 1, Geipel et al teaches an automated peritoneal dialysis system (Figures 1a-1b), as in the rejection of claim 1 above. Second, in regards to claims 9 and 23, Geipel et al teaches measuring, using a photosensor (5), an amount of the light reflected (6)(6’) off of the outer surface of the diaphragm (2) and directed toward the photosensor (Figures 1a-1b)(paragraph [0013]: detecting one or more reflected light beams reflected from the deformable cover in a non-pressurized state and a pressurized state)
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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