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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “status signal indicator” and “detector” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Paragraph [0096] of the provided specification teaches an indicator light as a status indicator. Paragraph [0017] teaches that the detector may be a photocell.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claim(s) 1-4, 7-8, 11-24, 26-27, 29-32, 35-36, 39-52, and 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring (US 20180085003 A1).
In regards to claim 1 McCurdy teaches a biofluid monitoring apparatus, comprising:
a spectrometer ([0050] Spectrometer 36) disposed within a housing (Fig. 1 16a and 16d is housing), the spectrometer including:
a light source (Fig.1 light source 16b) to illuminate a sample within a catheter tubing ([0054] a fluid conduit 14 may comprise a catheter comprising tubing),
a detector to detect light returned from the sample (Fig.1 a detector 16g),
an indicator to provide results based on the sample in the catheter tubing ([0083] computer system display)
and a controller in communication with the light source, the detector, and the status signal indicator to collect and process data based on the light returned from the sample to determine test results and indicate the test result using the indicator ([0047] [0080] [0083] Computer/controller/processor 40),
wherein the housing is configured to attach at a low point in the catheter tubing such that the sample accumulates in the low point, and wherein the light source and the detector are directed towards the low point to obtain the data from the sample (Fig 2a catheter positioning device 30 is where the housing attaches, [0053] urine sample accumulates in measurement site “low point” using clamps on catheter).
McCurdy fails to teach a housing configured to receive a catheter tubing and hold the catheter tubing to form a low point in the catheter tubing such that a sample accumulates in the low point, but permits continued fluid flow through the catheter tubing.
Miller teaches a housing configured to receive a catheter tubing and hold the catheter tubing to form a low point in the catheter tubing such that a sample accumulates in the low point, but permits continued fluid flow through the catheter tubing ([0143] “Bend 960 may be created by a clamping or coupling mechanism to attach sensor body 912 to elongated body 12”, FIGs 13A-13B Element 710 is a light detector)). It would have been prima facie obvious to a person of ordinary skill in the art to modify the jaws of McCurdy so they do not clamp on the catheter, but merely bend it in a way that allows liquid to flow through like the device of Miller. Doing so would allow for the device to analyze the user’s urine without having to clamp and block the flow of the catheter while the user urinates and allow for urine flow analysis downstream of the device.
Modified McCurdy fails to teach determining and indicating a patient status based on the sample in the container. Goldring teaches determining a patient status using a spectrometer (Goldring [0398] [0406] Status is if the patient has a developing UTI). It would have been prima facie obvious to a person of ordinary skill in the art to modify the processor of modified McCurdy to determine if the user has a developing UTI like the system of Goldring and indicate that status on the indicator. Doing so would allow early UTI detection in order to prompt swift action to intercept a UTI before it gets worse (Goldring [0396-0398]).
In regards to claim 2 modified McCurdy teaches the apparatus of claim 1, wherein the spectrometer further comprises a power supply (McCurdy [0040] battery).
In regards to claim 3 modified McCurdy teaches the apparatus of claim 2, wherein the power supply comprises a battery (McCurdy [0040]).
In regards to claim 4 modified McCurdy teaches the apparatus of claim 1, wherein the housing comprises a slot into which the catheter tubing is inserted such that a portion of the catheter tubing is adjacent to the spectrometer (McCurdy [0049] Fig. 2A catheter positioning device 30).
In regards to claim 7 modified McCurdy teaches the apparatus of claim 1, wherein the spectrometer further comprises a monochromator to divide the light from the light source into a plurality of constituent wavelengths (McCurdy Fig.1 prism 16f).
In regards to claim 8 modified McCurdy teaches the apparatus of claim 7, wherein the monochromator comprises a prism (McCurdy Fig.1 prism 16f).
In regards to claim 11 modified McCurdy teaches the apparatus of claim 1, wherein the detector comprises a photocell to record one or more wavelengths of light returned from the sample based on the illumination of the sample (McCurdy [0039]).
In regards to claim 12 modified McCurdy teaches the apparatus of claim 11, wherein the light returned from the sample measured by the detector comprises absorbance information ([0039] light inherently comprises absorbance information).
In regards to claim 13 modified McCurdy teaches the apparatus of claim 1, wherein the spectrometer further comprises a communication module to transmit information from the spectrometer (McCurdy [0096]).
In regards to claim 14 modified McCurdy teaches the apparatus of claim 13, wherein the communication module comprises a radio communication device including at least one of a Bluetooth device, a cellular service device, or a WiFi device for performing wireless transmission (McCurdy [0096]).
In regards to claim 15 modified McCurdy teaches the apparatus of claim 14, wherein the radio communication device including at least one of a Bluetooth device, cellular service device, or WiFi device performs wireless transmission to a computing platform comprising at least one of an electronic health record or a mobile computing device (McCurdy [0096]).
In regards to claim 16 modified McCurdy teaches the apparatus of claim 15, wherein the mobile computing device comprises at least one of a cell phone, a smart phone, a pager, or a telephone (McCurdy [0096]).
In regards to claim 17 modified McCurdy teaches the apparatus of claim 16, wherein the information from the spectrometer is transmitted as at least one of a text message, an audio message, an email, or a data file (McCurdy [0096]).
In regards to claim 18 modified McCurdy teaches the apparatus of claim 1, wherein the controller determines the patient status using one or more machine learning algorithms specifically trained for the apparatus (McCurdy [0061]).
In regards to claim 19 modified McCurdy teaches the apparatus of claim 18, wherein the one or more machine learning algorithms identify one or more biomarkers indicative of a functional status of a bodily system of the patient (McCurdy [0059] “ultimately bacteria, cellular DNA fragments, proteins, electrolytes”).
In regards to claim 20 modified McCurdy teaches the apparatus of claim 19, wherein the bodily system of the patient comprises at least one of a cardiac system, a respiratory system, a renal system, a neurologic system, an endocrine system, or an immune system (McCurdy [0059] can analyze “venous or arterial blood, urine, CSF, pleural fluid, peritoneal fluid”).
In regards to claim 21 modified McCurdy teaches the apparatus of claim 20. Modified McCurdy fails to teach an apparatus wherein the one or more machine learning algorithms identifies at least one condition comprising at least one of: a bacterial colony count, a bacterial colony type, or a bacterial infection by-product. Goldring teaches determining bacterial colony type using a spectrometer ([0398] “In some instances biofilm composition may identify bacteria type”). It would have been prima facie obvious to a person of ordinary skill in the art to modify the machine learning algorithm and processor of McCurdy to identify biofilm development and bacteria type like the system of Goldring in order to detect developing UTIs. Doing so would allow the device to alert the patient of a developing UTI (Goldring [0398]).
In regards to claim 22 modified McCurdy teaches the apparatus of claim 21, wherein the patient status is determined based on the identified at least one condition (Goldring [0398]).
In regards to claim 23 modified McCurdy teaches the apparatus of claim 1. Modified McCurdy fails to teach wherein the status indicator is configured to indicate at least one of a plurality of states of the patient status (Goldring [0398] indicates UTI).
In regards to claim 24 modified McCurdy teaches the apparatus of claim 23, wherein the states of the patient status comprises at least bacteria and infection in the sample (Goldring [0398] indicates UTI which means there is bacteria and infection in the sample).
In regards to claim 26 modified McCurdy teaches the apparatus of claim 1, wherein the low point in the catheter tubing comprises a bend in the catheter tubing (McCurdy Fig 2A Tubing 14 bends).
In regards to claim 27 modified McCurdy teaches claim 26, wherein the housing comprises a curved face, and wherein the bend in the catheter tubing is located adjacent to the curved face of the housing ([0049] Catheter positioning device 30 can be tube clips which inherently contain a curved face that wraps around the tube).
In regards to claim 29 McCurdy teaches a method for biofluid monitoring, comprising: providing a spectrometer ([0050] Spectrometer 36) disposed within a housing (Fig. 1 16a and 16d is housing), the spectrometer including:
a light source (Fig.1 light source 16b) to illuminate a sample within a catheter tubing ([0054] a fluid conduit 14 may comprise a catheter comprising tubing),
a detector to detect light returned from the sample (Fig.1 a detector 16g),
an indicator to provide results based on the sample in the catheter tubing ([0083] computer system display)
and a controller in communication with the light source, the detector, and the status signal indicator ([0047] [0080] [0083] Computer/controller/processor 40);
collecting and processing, using the controller, data based on the light returned from the sample ([0047] [0080] [0083] Computer/controller/processor 40 collects and processes the data);
and indicating, using the controller, the result using the status indicator (([0083] computer system display),
wherein the housing is configured to attach at a low point in the catheter tubing such that the sample accumulates in the low point (Fig 2a catheter positioning device 30 is where the housing attaches, [0053] urine sample accumulates in measurement site “low point” using clamps on catheter)., and wherein the light source and the detector are directed towards the low point to obtain the data from the sample (Fig 1. Light source 16b and detector 16g are directed towards tube 14).
McCurdy fails to teach a housing configured to receive a catheter tubing and hold the catheter tubing to form a low point in the catheter tubing such that a sample accumulates in the low point, but permits continued fluid flow through the catheter tubing. Miller teaches a housing configured to receive a catheter tubing and hold the catheter tubing to form a low point in the catheter tubing such that a sample accumulates in the low point, but permits continued fluid flow through the catheter tubing ([0143] “Bend 960 may be created by a clamping or coupling mechanism to attach sensor body 912 to elongated body 12”, FIGs 13A-13B Element 710 is a light detector)). It would have been prima facie obvious to a person of ordinary skill in the art to modify the jaws of McCurdy so they do not clamp on the catheter, but merely bend it in a way that allows liquid to flow through like the device of Miller. Doing so would allow for the device to analyze the user’s urine without having to clamp and block the flow of the catheter while the user urinates and allow for urine flow analysis downstream of the device.
Modified McCurdy fails to teach determining and indicating a patient status based on the sample in the container. Goldring teaches determining a patient status using a spectrometer (Goldring [0398] [0406] Status is if the patient has a developing UTI). It would have been prima facie obvious to a person of ordinary skill in the art to modify the processor of modified McCurdy to determine if the user has a developing UTI like the system of Goldring and indicate that status on the indicator. Doing so would allow early UTI detection in order to prompt swift action to intercept a UTI before it gets worse (Goldring [0396-0398])
In regards to claim 30 modified McCurdy teaches the method of claim 29, wherein the spectrometer further comprises a power supply (McCurdy [0040] battery).
In regards to claim 31 modified McCurdy teaches the method of claim 30, wherein the power supply comprises a battery (McCurdy [0040]).
In regards to claim 32 modified McCurdy teaches the method of claim 29, wherein the housing comprises a slot into which the catheter tubing is inserted such that a portion of the catheter tubing is adjacent to the spectrometer (McCurdy [0049] Fig. 2A catheter positioning device 30).
In regards to claim 35 modified McCurdy teaches the method of claim 29, wherein the spectrometer further comprises a monochromator, the method further comprising: dividing the light from the light source into a plurality of constituent wavelengths using the monochromator (McCurdy Fig.1 prism 16f divides light into wavelengths).
In regards to claim 36 modified McCurdy teaches the method of claim 35, wherein the monochromator comprises a prism (McCurdy Fig.1 prism 16f).
In regards to claim 39 modified McCurdy teaches the method of claim 29, wherein the detector comprises a photocell, the method further comprising: recording one or more wavelengths of light returned from the sample based on the illumination of the sample using the photocell (McCurdy [0039]).
In regards to claim 40 modified McCurdy teaches the method of claim 39, wherein the light returned from the sample measured by the detector comprises absorbance information ([0039] light inherently comprises absorbance information). .
In regards to claim 41 modified McCurdy teaches the method of claim 29, wherein the spectrometer further comprises a communication module, the method further comprising: transmitting information from the spectrometer using the communication module (McCurdy [0096]).
In regards to claim 42 modified McCurdy teaches the method of claim 41, wherein the communication module comprises a radio communication device including at least one of a Bluetooth device, a cellular service device, or a WiFi device, wherein transmitting information from the spectrometer using the communication module further comprises: transmitting information wirelessly from the spectrometer using the radio communication device including at least one of a Bluetooth device, cellular service device, or WiFi device (McCurdy [0096]).
In regards to claim 43 modified McCurdy teaches the method of claim 42, wherein the radio communication device including at least one of a Bluetooth device, cellular service device, or WiFi device performs wireless transmission to a computing platform comprising at least one of an electronic health record or a mobile computing device (McCurdy [0096]).
In regards to claim 44 modified McCurdy teaches the method of claim 43, wherein the mobile computing device comprises at least one of a cell phone, a smart phone, a pager, or a telephone (McCurdy [0096]).
In regards to claim 45 modified McCurdy teaches the method of claim 44, wherein the information from the spectrometer is transmitted as at least one of a text message, an audio message, an email, or a data file (McCurdy [0096]).
In regards to claim 46 modified McCurdy teaches the method of claim 29, wherein determining the patient status further comprises: determining the patient status using one or more machine learning algorithms specifically trained for the apparatus (McCurdy [0061]).
In regards to claim 47 modified McCurdy teaches the method of claim 46, wherein determining the patient status using one or more machine learning algorithms specifically trained for the apparatus farther comprises: identifying one or more biomarkers indicative of a functional status of a bodily system of the patient using the one or more machine learning algorithms (McCurdy [0059] “ultimately bacteria, cellular DNA fragments, proteins, electrolytes”).
In regards to claim 48 modified McCurdy teaches the method of claim 47, wherein the bodily system of the patient comprises at least one of a cardiac system, a respiratory system, a renal system, a neurologic system, an endocrine system, or an immune system (McCurdy [0059] can analyze “venous or arterial blood, urine, CSF, pleural fluid, peritoneal fluid”).
In regards to claim 49 modified McCurdy teaches the method of claim 48. Modified McCurdy fails to teach wherein the one or more machine learning algorithms identifies at least one condition comprising at least one of: a bacterial colony count, a bacterial colony type, or a bacterial infection by-product Goldring teaches determining bacterial colony type using a spectrometer ([0398] “In some instances biofilm composition may identify bacteria type”). It would have been prima facie obvious to a person of ordinary skill in the art to modify the machine learning algorithm and processor of McCurdy to identify biofilm development and bacteria type like the system of Goldring in order to detect developing UTIs. Doing so would allow the device to alert the patient of a developing UTI (Goldring [0398]).
In regards to claim 50 modified McCurdy teaches the method of claim 49, wherein determining the patient status using one or more machine learning algorithms further comprises: determining the patient status based on the identified at least one condition (Goldring [0398]).
In regards to claim 51 modified McCurdy teaches the method of claim 29, wherein indicating the patient status using the status indicator further comprises: indicating at least one of a plurality of states of the patient status (Goldring [0398] indicates UTI).
In regards to claim 52 modified McCurdy teaches the method of claim 51, wherein the states of the patient status comprises at least bacteria and infection in the sample (Goldring [0398] indicates UTI which means there is bacteria and infection in the sample).
In regards to claim 54 modified McCurdy teaches the method of claim 29, wherein the low point in the catheter tubing comprises a bend in the catheter tubing (McCurdy Fig 2A Tubing 14 bends).
In regards to claim 55 modified McCurdy teaches the method of claim 54, wherein the housing comprises a curved face, and wherein the bend in the catheter tubing is located adjacent to the curved face of the housing ([0049] Catheter positioning device 30 can be tube clips which inherently contain a curved face that wraps around the tube).
Claim(s) 5-6 and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring as applied to claims 1 and 8, further in view of Aryal (Spectrophotometer- Principle, Instrumentation, Applications).
In regards to claim 5 modified McCurdy teaches the apparatus of claim 1, wherein the spectrometer further comprises a collimator (McCurdy Fig. 1 Lens 16e), prism (McCurdy Fig. 1 prism 6f), and slit (McCurdy Fig. 1 slit 16h). McCurdy fails to teach the collimator being used to focus light from the light source into the sample. Aryal teaches a spectrometer setup that uses a lens, prism, and slit to focus selected light waves into a sample (Page 2 First Figure). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the spectrometer setup of modified McCurdy so that the lens, prism, and slit are between the light source and sample in order to direct specific wavelengths into the sample like the spectrometer taught by Aryal. Doing so would merely be a simple substitution of one known spectrometer setup for another to obtain predictable results.
In regards to claim 6 modified McCurdy in view of Aryal teaches the apparatus of claim 5, wherein the collimator comprises a lens (McCurdy Fig. 1 Lens 16e).
In regards to claim 33 modified McCurdy teaches the method of claim 29, wherein the spectrometer further comprises a collimator (McCurdy Fig. 1 Lens 16e), prism (McCurdy Fig. 1 prism 6f), and slit (McCurdy Fig. 1 slit 16h). McCurdy fails to teach focusing light from the light source into the sample using the collimator. Aryal teaches a spectrometer setup that uses a lens, prism, and slit to focus selected light waves into a sample (Page 2 First Figure). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the spectrometer setup of modified McCurdy so that the lens, prism, and slit are between the light source and sample in order to direct specific wavelengths into the sample like the spectrometer taught by Aryal. Doing so would merely be a simple substitution of one known spectrometer setup for another to obtain predictable results.
In regards to claim 34 modified McCurdy in view of Aryal teaches the method of claim 33, wherein the collimator comprises a lens (McCurdy Fig. 1 Lens 16e).
Claim(s) 9-10 and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring as applied to claim 8, in view of Aryal (Spectrophotometer- Principle, Instrumentation, Applications) further in view of Matlock (Analyzing Differences in Bacterial Optical Density Measurements Between Spectrometers).
In regards to claim 9 modified McCurdy teaches the apparatus of claim 8, wherein the spectrometer further comprises a wavelength selector to select a particular wavelength (McCurdy Fig. 1 slit 16h). Modified McCurdy fails to teach the slit directing the light to the sample, wherein the particular wavelength is selected based on at least one of a bacterial strain or a bacterial product to be identified. Aryal teaches a spectrometer setup that uses a lens, prism, and slit to focus selected light waves into a sample (Page 2 First Figure). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the spectrometer setup of modified McCurdy so that the lens, prism, and slit are between the light source and sample in order to direct specific wavelengths into the sample like the spectrometer taught by Aryal. Doing so would merely be a simple substitution of one known spectrometer setup for another to obtain predictable results. Modified McCurdy and Aryal fails to teach an apparatus where the particular wavelength is selected based on at least one of a bacterial strain or a bacterial product to be identified. Matlock teaches that bacteria is often measured using a 600nm wavelength when using a spectrometer (Matlock Introduction). It would have been prima facie obvious to one of ordinary skill in the art to modify the slit of modified McCurdy in view of Aryal to select 600nm as taught by Matlock in order to analyze a bacterial strain. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of analyzing bacteria using the proper wavelength.
In regards to claim 10 modified McCurdy in view of Aryal further in view of Matlock teaches the apparatus of claim 9, wherein the wavelength selector comprises a slit (McCurdy Fig. 1 slit 16h).
In regards to claim 37 modified McCurdy teaches the method of claim 29, wherein the spectrometer further comprises a wavelength selector to select a particular wavelength (McCurdy Fig. 1 slit 16h). Modified McCurdy fails to teach the slit directing the light to the sample, and selecting a particular wavelength to direct to the sample using the wavelength selector, wherein the particular wavelength is selected based on at least one of a bacterial strain or a bacterial product to be identified. Aryal teaches a spectrometer setup that uses a lens, prism, and slit to focus selected light waves into a sample (Page 2 First Figure). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the spectrometer setup of modified McCurdy so that the lens, prism, and slit are between the light source and sample in order to direct specific wavelengths into the sample like the spectrometer taught by Aryal. Doing so would merely be a simple substitution of one known spectrometer setup for another to obtain predictable results. Modified McCurdy and Aryal fails to teach an apparatus where the particular wavelength is selected based on at least one of a bacterial strain or a bacterial product to be identified. Matlock teaches that bacteria is often measured using a 600nm wavelength when using a spectrometer (Matlock Introduction). It would have been prima facie obvious to one of ordinary skill in the art to modify the method of modified McCurdy in view of Aryal to use the slit to select 600nm as taught by Matlock in order to analyze a bacterial strain. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of analyzing bacteria using the proper wavelength.
In regards to claim 38 modified McCurdy in view of Aryal further in view of Matlock teaches the method of claim 37, wherein the wavelength selector comprises a slit (McCurdy Fig. 1 slit 16h).
Claim(s) 25 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring as applied to claim 24, in view of Bechtold (US 20150238128 A1).
In regards to claim 25 modified McCurdy teaches apparatus of claim 24. Modified McCurdy fails to teach an apparatus wherein the status indicator indicates the patient status using at least one light coupled to the housing. Bechtold teaches an indicator light that lights up red if an infection is found and green if no infection is found (Bechtold [0038]). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the status indicator of modified McCurdy to include a status indicator light on the housing like the one of Bechtold. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of alerting the user of infection using light diodes on the housing.
In regards to claim 53 modified McCurdy teaches method of claim 52. Modified McCurdy fails to teach a method wherein indicating the patient status using the status indicator further comprises: indicating the patient status using at least one light coupled to the housing.. Bechtold teaches an indicator light that lights up red if an infection is found and green if no infection is found (Bechtold [0038]). It would have been prima facie obvious to one of ordinary skill in the art to substitute modify the status indicator of modified McCurdy to include a status indicator light on the housing like the one of Bechtold. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of alerting the user of infection using light diodes on the housing.
Claim(s) 28 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring as applied to claim 1, in view of Holt (US 20190069830 A1).
In regards to claim 28 modified McCurdy teaches the apparatus of claim 1. Modified McCurdy fails to teach an apparatus further comprising a load cell sensor coupled to the housing, wherein the load cell sensor is coupled to a biofluid collection container fluidly coupled to the catheter tubing, wherein the controller is coupled to the load cell sensor and configured to: obtain data from the load cell sensor, calculate a weight change of the biofluid collection container based on the data obtained from the load cell sensor, and determine a flow rate of the sample into the biofluid collection contained based on the calculated weight change.
Holt teaches a load cell sensor ([0040] s-type load cell 16), wherein the load cell sensor is coupled to a biofluid collection container fluidly coupled to the catheter tubing ([0042] urine collection bag is hooked to load cell), wherein a controller is coupled to the load cell sensor and configured to ([0043] microprocessor); obtain data from the load cell sensor ([0041]), calculate a weight change of the biofluid collection container based on the data obtained from the load cell sensor, and determine a flow rate of the sample into the biofluid collection contained based on the calculated weight change ([0042]). It would have been prima facie obvious to one of ordinary skill in the art to modify the apparatus of McCurdy to include a collection bag and load cell device as described in Holt in order to determine flow rate. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of determining flow rate of the liquid in the catheter.
In regards to claim 56 modified McCurdy teaches the method of claim 29. Modified McCurdy fails to teach wherein the housing comprises a load cell sensor coupled thereto, wherein the load cell sensor is coupled to a biofluid collection container fluidly coupled to the catheter tubing, and wherein the method further comprises: obtaining data from the load cell sensor, calculating a weight change of the biofluid collection container based on obtaining the data from the load cell sensor, and determining a flow rate of the sample into the biofluid collection contained based on calculating the weight change.
Holt teaches a load cell sensor ([0040] s-type load cell 16), wherein the load cell sensor is coupled to a biofluid collection container fluidly coupled to the catheter tubing ([0042] urine collection bag is hooked to load cell), wherein a controller is coupled to the load cell sensor and configured to ([0043] microprocessor); obtaining data from the load cell sensor ([0041]), calculating a weight change of the biofluid collection container based on the data obtained from the load cell sensor, and determining a flow rate of the sample into the biofluid collection contained based on the calculated weight change ([0042]). It would have been prima facie obvious to one of ordinary skill in the art to modify the method of McCurdy to include a collection bag and load cell device as described in Holt in order to determine flow rate, and for the processor to carry out the method of Holt. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of determining flow rate of the liquid in the catheter.
Response to Arguments
Applicant’s arguments, see remarks, filed 01/27/2026, with respect to the 35 U.S.C. 101 rejection of claims 1-56 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 1-56 has been withdrawn.
Applicant’s arguments, see remarks, filed 01/27/2026, with respect to the 35 U.S.C. 112b rejections of claims 1-56 have been fully considered and are persuasive. The 35 U.S.C. 112b rejections of claims 1-56 have been withdrawn.
Applicant’s arguments, see remarks, filed 01/27/2026, with respect to the rejection(s) of claim(s) 1, 29, and their dependent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McCurdy (US 20210172864 A1) in view of Miller (US 20210330935 A1) in view of Goldring (US 20180085003 A1). The Applicant argues that McCurdy teaches away from continuous monitoring while a sample flows through a catheter because McCurdy states "[0053] The specimen should ideally not be moved along the conduit 14 while the device 10 is performing measurements". The examiner contends that “ideally” does not equate to “always” and that a non-moving specimen is merely a suggestion, not a requirement of McCurdy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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