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 February 14, 2023, Applicant amended claims 1-9, 11-13, and 18-22.
Currently, claims 1-23 are under examination.
Specification
The abstract of the disclosure is objected to because:
In line 5, “a pressure” should be changed to “the pressure”
In line 5, “cavity” should be changed to “the cavity”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 11, 13, and 21-22 are objected to because of the following informalities:
In regards to claim 11, line 2, the first recitation of “irradiating” should be changed to “the irradiating”.
In regards to claim 11, line 5, “measuring” should be changed to “the measuring”.
In regards to claim 11, line 6, “determining” should be changed to “the determining”.
In regards to claim 11, line 6, “light” should be changed to “the light”.
In regards to claim 13, line 2, the first recitation of “irradiating” should be changed to “the irradiating”.
In regards to claim 13, line 5, the first recitation of “measuring” should be changed to “the measuring”.
In regards to claim 13, line 5, “light” should be changed to “the light”.
In regards to claim 21, line 3, “irradiating” should be changed to “the irradiating”.
In regards to claim 21, line 3, “collimated light” should be changed to “the light”.
In regards to claim 21, line 4, “first light” should be changed to “the light”.
In regards to claim 22, line 1, “measuring” should be changed to “the measuring”.
Appropriate correction is required.
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.
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.
Claims 3-4, 8, and 12 are 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 “first light”. Claim 3 depends upon claim 1. Claim 1, line 12 recites “light”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 4, line 6 recites “the diagram”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 4 depends upon claim 1. Claim 1, line 4 recites “a diaphragm”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 8, line 4 recites: “on” or more measurements. First, is unclear what “on… measurements” means. Second, it is unclear whether the term should be “one”.
In regards to claim 12, line 2 recites “amounts of light”. Claim 12 depends upon claim 9. Claim 9, line 7 recites “an amount of the light”. It is unclear whether the two recitations are related or different.
In regards to claim 12, line 3 recites “pressures”. Claim 12 depends upon claim 9. Claim 9, line 1 recites “pressure”. It is unclear whether the two recitations are related or different.
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 1-4 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 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 (Figures 1a-1b)
In regards to claim 2, Geipel et al teaches wherein the disposable set further includes a reflector disposed on the outer surface of the diaphragm and configured to reflect the light (paragraph [0008]).
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 is collimated light (paragraph [0053]: parallelize the emitted light)
the collimating element is configured to collimate 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 diagram 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)
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 on or more measurements of temperature of the photosensor. Shih teaches a system (Figure 9) wherein: a temperature sensor (995) is configured to capture on 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 on 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 9-16 and 20-22 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 pressure of 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 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 (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 pressure of 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 pressure of fluid within a disposable set “of an automated peritoneal dialysis system”. Hopping et al teaches a method of measuring pressure of 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 pressure of fluid within a disposable set, of Geipel et al, to be a method of measuring pressure of 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 10, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches aligning the outer surface of the diaphragm with the light source and the photosensor (Figures 1a-1b).
In regards to claim 11, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches wherein:
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)
measuring the amount of the light includes determining a zero-offset value (paragraph [0034]: reference measurement)
determining the zero-offset value includes measuring the amount of 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 amounts of light measured by the photosensor and deformation of the diaphragm in response to forces applied against the diaphragm due to pressures 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:
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)
measuring the amount of the light includes measuring the amount of 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 15, in the modified method of Geipel et al and Hopping et al, Geipel et al teaches further comprising comparing the pressure of the fluid to 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 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 the 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)
irradiating the outer surface of the diaphragm with collimated light includes collimating first 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 measuring the amount of the light includes compensating for effects due to temperature (paragraph [0062]).
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]).
Claim 23 is 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 a method (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 method 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. Geipel et al teaches a method (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 (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 method, 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, 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]).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783