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 .
Information Disclosure Statement
In the IDS submitted on 05/03/2022, U.S. Patents Reference 2 (4928694, Maxwell, et. al.) includes a likely incorrect date. It appears that the corresponding date for that patent number is 5/29/1990. The IDS date has been lined-out accordingly.
Drawings
Regarding the recited “the sensor holding portions are disposed in the inner diameter change portion” described in Claim 9, the location and extent of the “inner diameter change portion” is not clearly marked in a figure.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “inner diameter change portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 8 is objected for a likely typographical error between lines 8 and 9, of “portions.” This was likely intended to be a comma and not a period. Appropriate correction is required.
Claim 12 is objected for a typographical error in the term “configured to acquired data” in line 6. For readability, it is suggested to correct this term to “configure to acquire data”. Appropriate correction is required.
Claim 18 is objected for a typographical error in the term “wherein the measurement device is integrally with the measurement adapter.” It is likely that this was intended to be “wherein the measurement device is integral with the measurement adapter”. Appropriate correction is required.
Claim 20 is objected for the term “displaying information on a state of a urinary organ of a patient in which the bladder indwelling catheter is indwelled on the basis of the acquired data”. It is suggested to add commas for readability between the pairs “patient”/“in” and “indwelled”/”on”, such that the term becomes “displaying information on a state of a urinary organ of a patient, in which the bladder indwelling catheter is indwelled, on the basis of the acquired data”.
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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:
“Sensor holding portions” to “hold sensors” in Claims 1, 2, 4, 5, 7, 8, 9, 10, 11, 15, 16, 17, 19 (and their dependent claims)
The claim limitation is interpreted according to Applicant’s specification at [0007] “…sensor holding portions configured to hold sensors capable of detecting a state of urine flowing in the flow path”; [0072] “The through-hole provided in the first connection portion 211 and the through- hole provided in the second connection portion 212 are both examples of sensor holding portions....”; and [0143] “A portion of the measurement adapter 20 that holds the flow rate measurement unit 27 functions as a flow rate sensor holding portion that holds the flow rate sensor.”
“Display unit to “display information” in claims 10 and 19 (and their dependent claims)
The claim limitation is interpreted according to Applicant’s specification at [0081] “he display unit 35 can be, for example, a liquid crystal display panel, an organic electro-luminescence (EL) panel, or the like.” It is shown as “display unit 35” in Figure 1.
“Separation unit” to “optically separate the fluorescence” in claim 13
The claim limitation is interpreted according to Applicant’s specification at [0184] including “optical analyzer…second beam splitter 562…a separation unit that optically separates fluorescence emitted from the plurality of phosphors.“ and Figure 23.
“Data acquisition unit” to “acquire data” in claims10, 11, 12, and 13 (and their dependent claims).
The claim limitation is interpreted according to Applicant’s specification at [0101] “…control unit 31 implements a function of a data acquisition unit that acquires data from the sensors held in the sensor holding portions,” and [0231] “…data acquisition unit 92 that acquires data from the sensors…” The data acquisition unit is shown as “data acquisition unit 92” in figure 33.
“Index calculation unit” to ” to “calculate an index” in claim 19.
The claim limitation is interpreted according to Applicant’s specification at [0106] at “the control unit 31 implements a function of an index calculation unit that calculates an index representing the state of the urinary organ.” The “control unit 31” is shown in figure 23.
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.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 2 – 19 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.
Claim 2 (lines 1 – 2), Claim 4 (line 2), Claim 5 (line 2), Claim 7 (line 2), Claim 9 (line 5), Claim 10 (line 13), Claim 11 (line 2), Claim 16 (lines 4 and 5), Claim 17 (line 2), and Claim 19 (lines 2 and 5) recite the limitation "the sensor holding portions” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if each of these are intended to be the same as the “plurality of sensor holding portions” as in Claims 1 and 10, from which these claims depend, or if they are each different sensor holding portions. For the purpose of examination, the term "the sensor holding portions” is deemed to claim, "the plurality of sensor holding portions.” Claims 3, 6, 12 – 15, and 18 are similarly rejected due to their dependence on these claims.
Claim 8 recites the limitation "two of a plurality of the sensor holding portions” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same “plurality of sensor holding portions” as in Claim 1, from which this claim depends, or if they are different sensor holding portions. For the purpose of examination, the term "two of a plurality of the sensor holding portions” is deemed to claim, “two of the plurality of sensor holding portions”
Claim 8 recites the limitation "two of a plurality of the sensor holding portions” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same “plurality of sensor holding portions” as in Claim 1, from which this claim depends, or if they are different sensor holding portions. For the purpose of examination, the term "two of a plurality of the sensor holding portions” is deemed to claim, “two of the plurality of sensor holding portions”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 20, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Claim 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Claim 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, Claim 20 recites an abstract idea.
Specifically, Claim 20 recites (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 20
A measurement method comprising:
acquiring data acquired using sensors from a measurement adapter connected between a bladder indwelling catheter and a urine collection bag, the measurement adapter including a flow path through which urine flows from the bladder indwelling catheter to the urine collection bag and a plurality of sensor holding portions that hold the sensors that detect a state of the urine flowing in the flow path; and
displaying information on a state of a urinary organ of a patient in which the bladder indwelling catheter is indwelled on the basis of the acquired data.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claim 20, these limitations include:
Observation and judgement of data.
Observation and judgement to communicate information on a state of a urinary organ of a patient in which the bladder indwelling catheter is indwelled on the basis of the acquired data.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in Independent Claim 20 not integrated into a practical application under 2019 PEG because the additional elements (identified in Claim 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“measurement adapter”
“bladder indwelling catheter”
“urine collection bag”
“sensor-holding portions”
“sensors”
Additional elements recited include a “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” in Independent Claim 20. These components are recited at a high level of generality, , i.e., as generic sensors performing a generic function of acquiring data; and sensor-holding portions to hold sensors These generic hardware component limitations for “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claim 20 includes pre-solution activity limitations, such as:
acquired using sensors from a measurement adapter connected between a bladder indwelling catheter and a urine collection bag, the measurement adapter including a flow path through which urine flows from the bladder indwelling catheter to the urine collection bag and a plurality of sensor holding portions that hold the sensors that detect a state of the urine flowing in the flow path;
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” as recited in Independent Claim 20 are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claim 20 are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claim 20 is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claim 20 is directed to an abstract idea under 2019 PEG.
Step 2B –
Claim 20 does not include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” as recited in Independent Claim 20.
The additional elements of the “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” in Independent Claim 20, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “measurement adapter” is described generically in [0006] as “A measurement adapter includes a catheter connection portion connectable to a bladder indwelling catheter, a urine collection bag connection portion connectable to a urine collection bag, a flow path disposed between the catheter connection portion and the urine collection bag connecting portion, and a plurality of sensor holding portions configured to hold sensors capable of detecting a state of urine flowing in the flow path.” The “measurement adapter” is shown in figures 2, 4, 11, and 13.
Per Applicant’s specification, the “bladder indwelling catheter” is described generically in [0047], with “The bladder indwelling catheter 15 and the urine collection bag 17 of the present embodiment have been used in related art in a medical setting.” The “bladder indwelling catheter” is presented as “bladder indwelling catheter 15” in figure 1.
Per Applicant’s specification, the “urine collection bag” is described generically at [0047] as “The urine collection bag 17 can include a bag 171, a urine collection tube 172, and a connection tube 173…” and “The bladder indwelling catheter 15 and the urine collection bag 17 of the present embodiment have been used in related art in a medical setting.” The “urine collection bag” is presented as “bag 171” in Figure 1.
Per Applicant’s specification, the “sensor-holding portions” are described generically in [0006] as being configured to hold sensors that detect the state of urine flowing in the flow path, and as through-holes in [0070]. The “sensor-holding portions” are shown as through-holes 212 and 211 in Figure 2.
Per Applicant’s specification, the “sensors” are described generically in [0085] as “any sensor capable of measuring a temperature, such as a thermistor, a resistance temperature detector, or a phosphor“; [0006] “sensors capable of detecting a state of urine flowing in the flow path”; and [0089] “a measuring instrument such as a flow meter or a pressure gauge”. The “sensors” are likely presented as black box computing units “optical analyzer” and “temperature measuring instrument” in Figure 18.
Accordingly, in light of Applicant’s specification, the claimed terms “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “measurement adapter”, “bladder indwelling catheter”, “urine collection bag”, “sensor-holding portions”, and “sensors”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claim 20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, method of Claim 20 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. Claim 20 does not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claim 20 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claim 20 merely applies an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claim 20 amounts to significantly more than the abstract idea itself. Accordingly, Claim 20 is not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 6 and 10 - 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverton et. al., (US 2020/0205718 A1), hereinafter Silverton..
Regarding Claims 1 and 10, Silverton discloses
Claim 1:
A measurement adapter (Fig 1, Components between 128 and 126; [0036]) comprising:
Claim 10:
A measurement system (Fig 1, [Abstract]) comprising:
a measurement device (Fig 1, [Abstract]), the measurement device including:
a data acquisition unit ([0110] “when executed by the at least one processor…control system…”) configured to acquire data from the sensors held by the sensor holding portions ([0110] “when executed by the at least one processor, cause the control system to: receive a detected oxygen levels, a detected flowrate, and a detected temperature of the fluid flowing through the flow pathway”; [0079]; Fig 1); and
a display unit ([0062] “The user interface 154 may include…display (e.g. a display screen)”) configured to display information on a patient in which the bladder indwelling catheter is indwelled ([0035] “the urinary catheter 102…(e.g., inserted) through the urethra of the patient and into the bladder of the patient”); on the basis of the acquired data ([0099] “the user interface 154 is configured to display the mass flowrate of oxygen, the measured urine flowrate measured by the flowrate sensor 122, and the oxygen concentration or oxygen tension…”).
For the remainder of Claims 1 and 10:
a catheter connection portion ([0036] “oxygen-sensing assembly 104”, “inlet end 126 of the
housing 118 may be attachable to the outlet end 110 of the urinary catheter 102 via any connection methods known in the art.”) configured to be connected (connectable in Claim 10) to a bladder indwelling catheter ([0013] “..attaching an oxygen-sensing assembly to a urinary catheter”, Fig 1, “urinary catheter 102”; [0034] “oxygen sensing assembly 104 …incorporated with a urinary catheter 102 previously inserted into a patient…”);
a urine collection bag connection portion configured to be connected (connectable in Claim 10) to a urine collection bag (Fig 1, Left side at 128; [0036]; [0052] “the outlet end 128 of the oxygen sensing assembly 104 may be attachable to a fluid collection container ( e.g., a urine collection bag).”)
a flow path ([0014] “a flow pathway”; [0052] “flow pathway 130”) disposed between the catheter connection portion and the urine collection bag connection portion (Fig 1, “flow pathway 130” passing between “outlet end 128” “to collection container” and “inlet end 126” on the “catheter 110”); and
a plurality of sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include a housing 118, an oxygen sensor 120, a flowrate sensor 122, and a temperature sensor 124.”) configured to hold sensors (Claim 10: the sensors) ([0079] “ oxygen sensor 120, the flowrate sensor 122, and the temperature sensor 124”) 0079]) configured to detect a state of urine flowing in the flow path ([0036] “…measurements from the oxygen sensor 120, the flowrate sensor 122, and the temperature sensor 124.”; [0037] “detect and determine a flowrate of a fluid (e.g., urine) through the flow pathway”; [0079]) (Examiner notes that the state can be broadly interpretated as the urine being in a state of motion, or flowing at a certain rate that is measured.)
Regarding Claim 20, Silverton discloses A measurement method ([Abstract]; Fig 3) comprising:
acquiring data (Fig 3, “Receive temperature and flow rate data” 312) acquired using sensors from a measurement adapter (Fig 1 components between 128 and 126, [0036] “oxygen-sensing assembly 104”, ;“…measurements from the oxygen sensor 120, the flowrate sensor 122, and the temperature sensor 124.”); connected between a bladder indwelling catheter and a urine collection bag (Fig 1, [0036] “inlet end 126 of the housing 118 …attachable to the outlet end 110 of the urinary catheter 102… ([0036] “oxygen-sensing assembly 104”, “inlet end 126 of the housing 118 may be attachable to the outlet end 110 of the urinary catheter 102 via any connection methods known in the art.”; [0052] “the outlet end 128 of the oxygen sensing assembly 104 may be attachable to a fluid collection container ( e.g., a urine collection bag).”), the measurement adapter (Fig 1, Components between 128 and 126; [0036]) including a flow path ([0014]; [0052] “flow pathway 130”) through which urine flows from the bladder indwelling catheter to the urine collection bag (Fig 1, “flow pathway 130” passing between “outlet end 128” “to collection container” and “inlet end 126” on the “catheter 110), and a plurality of sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include a housing 118, an oxygen sensor 120, a flowrate sensor 122, and a temperature sensor 124.”) that hold the sensors ([0079] “ oxygen sensor 120, the flowrate sensor 122, and the temperature sensor 124”)[0079]) that detect a state of the urine flowing in the flow path ([0036] “…measurements from the oxygen sensor 120, the flowrate sensor 122, and the temperature sensor 124.”; [0037] “detect and determine a flowrate of a fluid (e.g., urine) through the flow pathway”; [0079]) (Examiner notes that the state can be broadly interpretated as the urine being in a state of motion, or flowing at a certain rate that is measured.); and
displaying information on a state of a urinary organ of a patient in which the bladder indwelling catheter is indwelled ([0035] “the urinary catheter 102…(e.g., inserted) through the urethra of the patient and into the bladder of the patient”) on the basis of the acquired data ([0099] “the user interface 154 is configured to display the mass flowrate of oxygen, the measured urine flowrate measured by the flowrate sensor 122, and the oxygen concentration or oxygen tension…”).
Regarding Claims 2 and 11, Silverton discloses as described above, The measurement adapter according to claim 1, and The measurement system according to claim 10, respectively. For the remainder of Claims 2 and 9, Silverton discloses
Claim 2:
wherein the sensor holding portions include a light emitter holding portion configured to hold a light emitter (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”; [0039] “the sensing portion 134 of the oxygen sensor 120 may be secured to a distal end of the optical fiber 132.”; [0044])
Claim 11:
the sensor holding portions are configured to hold a light emitter (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”; [0039] “the sensing portion 134 of the oxygen sensor 120 may be secured to a distal end of the optical fiber 132.”; [0044]), and
the data acquisition unit ([0110] “when executed by the at least one processor…control system…”) is configured to acquire data related to a light emission state of the light emitter ([0048] “the oxygen sensor 120, in conjunction with the control system 106, may be used to detect and determine one or both
of a concentration of oxygen”; [0038]).
For the remainder of both Claims 2 and 11:
the light emitter configured to emit light upon coming into contact with a component to be measured in the urine flowing through the flow path ([0069] “sensing portion 234 may include a dye-impregnated polymer that includes and/or releases fluorescent dyes, which are excitable at selected wavelengths of light.”; [0069] “…fluorescent…Depending upon the partial pressure of oxygen molecules 266…”; [0068]; [0042])(Examiner notes that “upon coming into contact” is broadly interpreted that when there is light being emitted, it will come into contact with a component in the urine.”)
Regarding Claim 3, Silverton discloses as described above, The measurement adapter according to claim 2. For the remainder of Claim 3, Silverton discloses further comprising: the light emitter ([0069] “sensing portion 234”; [0068]) configured to be held by the light emitter holding portion (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”; [0039] “the sensing portion 134 of the oxygen sensor 120 may be secured to a distal end of the optical fiber 132.”; [0068])
Regarding Claim 4, Silverton discloses as described above, The measurement adapter according to claim 2. For the remainder of Claim 4, Silverton discloses wherein
the sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include a housing 118, an oxygen sensor 120, a flowrate sensor 122, and a temperature sensor 124.”) include an optical fiber holding portion (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”) configured to hold an optical fiber (Fig 1, “optical fiber 132”), the optical fiber configured to propagate irradiation light with which the light emitter is to be irradiated ([0040] “the optical fiber 132…may transmit light (e.g., excitation light)…through a distal end of the optical fiber 132 and at (i.e., toward) the sensing portion 134 of the oxygen sensor 120.”;) and radiation light emitted from the light emitter ([0040] “Additionally, the optical fiber 132 may transmit light (e.g., return light) emitted and/or reflected by (e.g., light originated at) the sensing portion 134 …”), the radiation light being fluorescence ([0038] “such as by fluorescence”; [0042] “ the sensing portion 134 …dye-impregnated polymer or silica impregnated with fluorescent dyes…fluorescence response…”); and
the optical fiber (Fig 1, “optical fiber 132”), held by the optical fiber holding portion (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”).
Regarding Claim 5, Silverton discloses as described above, The measurement adapter according to claim 1. For the remainder of Claim 5, Silverton discloses wherein the sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include a housing 118, an oxygen sensor 120, a flowrate sensor 122, and a temperature sensor 124.”) include an optical sensor unit holding portion configured to hold an optical sensor unit (Fig 1, channel with “optical module 136”), and
the optical sensor unit (Fig 1, “optical module 136”), includes:
a light emitter ([0069] “…sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”) configured to emit light upon coming into contact with a component to be measured in the urine flowing through the flow path ([0069] “sensing portion 234 may include a dye-impregnated polymer that includes and/or releases fluorescent dyes, which are excitable at selected wavelengths of light.”; [0042] “For example, the dyes may be sensitive to oxygen such that the oxygen quenches a fluorescence response of the dyes.”)(Examiner notes that “upon coming into contact” is broadly interpreted that when there is light being emitted, the light emitter lights up when in contact with a component in the urine.) ;
a light source ([0068] “the optical fiber 232 may transmit excitation light…”) configured to irradiate the light emitter with light ([0068] “the optical fiber 232 may transmit excitation light in a first direction (e.g., toward…the sensing portion 234)”; [0069] “…sensing portion 234…include dye-impregnated polymer…excitable at selected wavelengths of light…”
a detector configured to detect radiation light emitted from the light emitter ([0068] “…and return light in a second opposite direction ( e.g., toward the optical module 136 of the control system 106 and from the sensing portion 234).”; [0069] “based on the fluorescence response…of the dye 264, the control system 106 may determine oxygen levels within the urine.”); and a light shielding layer configured to cover a portion not facing the flow path ([0068] “…optical fiber…”; [0041] “optical fiber 132 may include a core and a cladding…”)(Examiner notes that optical fiber has cladding such that the light primarily travels along the length of fiber to the tips and is shielded from travelling elsewhere.)
Regarding Claims 6 and 14, Silverton discloses as described above, The measurement adapter according to claim 2 and The measurement system according to claim 13, respectively. Silverton discloses
Claim 6: the light emitter includes a plurality of phosphors ([0042] “fluorescent dyes, which dyes are excitable at selected wavelength of light…the dyes may be oxygen sensitive and may be immobilized (e.g., impregnated) within a polymer matrix…”) configured to react with each of a plurality of components in urine to emit fluorescence ([0042] “…excitable at selected wavelength of light”; [0044] “the optical fiber 132 may transmit excitation light…to the sensing portion 134 of the oxygen sensor 120, which is exposed to urine and dissolved oxygen (e.g., any oxygen molecules) within the urine….depending on the amount of oxygen molecules that are (e.g. an oxygen concentration) present in the urine flowing through the flow pathway…the luminescence response (e.g., the return light) of the sensing portion 134 may vary.”)(Examiner notes that the phosphor dyes react with a plurality of components while they are in contact with urine. These include a particular component wavelength of the light spectrum shining into the sensing portion (and urine) that elicits a level of excitation fluorescence, and one or more components of oxygen that change that response, yielding a particular emitted fluorescence from interaction with these elements. The net emitted fluorescence can be measured to determine the oxygen concentration in the urine. This aligns with the use of the phosphor as described in paragraphs [0062] – [0064] of Applicant’s specification.) and
For the remainder of both Claims 6 and 14, Silverton discloses:
the fluorescence emitted from the phosphor configured to change according to an oxygen partial pressure in urine ([0042] “ the dyes may be oxygen sensitive and may be immobilized (e.g., impregnated) within a polymer matrix.”, “fluorescent dyes, which dyes are excitable at selected wavelength of light…”; [0044] “excitation light…depending on the amount of oxygen molecules that are (e.g. an oxygen concentration) present in the urine flowing through the flow pathway…the luminescence response (e.g., the return light) of the sensing portion 134 may vary.”) (Examiner again notes that the phosphor dyes react with a plurality of components while they are in contact with urine, including an excitation wavelength component of light and oxygen components. The net emitted fluorescence is measured to determine the oxygen concentration in the urine. This aligns with the use of the phosphor as described in paragraphs [0062] – [0064] of Applicant’s specification.)a carbon dioxide partial pressure in urine, a hydrogen ion index in urine, an ion concentration in urine, potassium ions in urine, sodium ions in urine, or a flow rate of urine.
Regarding Claim 12, Silverton discloses as described above, The measurement adapter according to claim 11. For the remainder of Claim 12, Silverton discloses wherein the light emitter ([0069] “sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”) includes a phosphor configured to react with a component in urine to emit fluorescence ([0042] “…excitable at selected wavelength of light”; [0044] “the optical fiber 132 may transmit excitation light…to the sensing portion 134 of the oxygen sensor 120, which is exposed to urine and dissolved oxygen (e.g., any oxygen molecules) within the urine….depending on the amount of oxygen molecules that are (e.g. an oxygen concentration) present in the urine flowing through the flow pathway…the luminescence response (e.g., the return light) of the sensing portion 134 may vary.”)(Examiner notes that the phosphor dyes react with a plurality of components while they are in contact with urine. These include a particular component wavelength of the light spectrum shining into the sensing portion (and urine) that elicits a level of excitation fluorescence, and one or more components of oxygen that change that response, yielding a particular emitted fluorescence from interaction with these elements. The net emitted fluorescence can be measured to determine the oxygen concentration in the urine. This aligns with the use of the phosphor as described in paragraphs [0062] – [0064] of Applicant’s specification.)the measurement device includes a light source ([0068] “the optical fiber 232 may transmit excitation light…”) configured to irradiate the light emitter with excitation light ([0068] “the optical fiber 232 may transmit excitation light in a first direction (e.g., toward…the sensing portion 234)”; and
the data acquisition unit ([0110] “when executed by the at least one processor…control system…”) is configured to acquired data related to the fluorescence emitted by the phosphor ([0110] “when executed by the at least one processor, cause the control system to: receive a detected oxygen levels…”; [0069]; Fig 1);.
Regarding Claim 13, Silverton discloses as described above, The measurement adapter according to claim 12. For the remainder of Claim 13, Silverton discloses wherein the light emitter includes a plurality of the phosphors ([0042] “ the dyes may be oxygen sensitive and may be immobilized (e.g., impregnated) within a polymer matrix…”; Fig 2) configured to react with each of a plurality of components in urine to emit fluorescence ([0042] “…excitable at selected wavelength of light”; [0044] “the optical fiber 132 may transmit excitation light…to the sensing portion 134 of the oxygen sensor 120, which is exposed to urine and dissolved oxygen (e.g., any oxygen molecules) within the urine….depending on the amount of oxygen molecules that are (e.g. an oxygen concentration) present in the urine flowing through the flow pathway…the luminescence response (e.g., the return light) of the sensing portion 134 may vary.”)(Examiner notes that the phosphor dyes react with a plurality of components while they are in contact with urine. These include a particular component wavelength of the light spectrum shining into the sensing portion (and urine) that elicits a level of excitation fluorescence, and one or more components of oxygen that change that response, yielding a particular emitted fluorescence from interaction with these elements. The net emitted fluorescence can be measured to determine the oxygen concentration in the urine. This aligns with the use of the phosphor as described in paragraphs [0062] – [0064] of Applicant’s specification.);
the measurement device includes a separation unit configured to optically separate the fluorescence emitted from each of the phosphors (Fig 3A, “Compare return light to excitation light” Box 314 and “Determine oxygen level within fluid” box 318; [0074] “…excitable at selected wavelengths of light and may have a fluorescence response to the excitation light….optical module 136 of the control system 106 may receive the return light from the sensing portion 134…”; [0131] “transmitting light at a selected wavelength…; receiving light…emitted from the sensing portion of the oxygen sensor; analyzing the received light to determine a correlating fluorescence…” [0078] “the control system 106 may further determine additional markers such as, for example, pH, CO2 , bladder pressure, abdominal pressure, etc. utilizing the oxygen sensor 120…“)(Examiner notes that the control system separates the return light that is the target wavelength from each of the excited phosphors and separates that from the light not at that wavelength, yielding an oxygen level in the fluid ; and
the data acquisition unit ([0110] “when executed by the at least one processor…control system…”) is configured to acquire data related to each fluorescence separated by the separation unit ([0110] “when executed by the at least one processor, cause the control system to: receive a detected oxygen levels…”; [0069]; Fig 1);.
Regarding Claim 15, Silverton discloses as described above, The measurement adapter according to claim 12. For the remainder of Claim 15, Silverton discloses further comprising:
an optical fiber configured to propagate excitation light from the light source to the light emitter ([0072] “the optical module 136 may transmit the excitation light to the sensing portion 134 of the oxygen sensor 120 through an optical fiber 132; [0074] “..sensing portion 120 may include…fluorescent dyes 264…excitable at selected wavelength of light…fluorescence response to the excitation light”) and
wherein the sensor holding portions include an optical fiber holding portion configured to hold the optical fiber (Fig 1, channel in “oxygen sensor 120” holding “optical fiber 132”).
Regarding Claim 16, Silverton discloses as described above, The measurement adapter according to claim 15. For the remainder of Claim 16, Silverton discloses a fastener (Fig 1, “outlet end 128”) configured to fasten the optical fiber to a surface of the urine collection bag (Fig 1, “…the outlet end 128 of the oxygen-sensing assembly 104 may be attachable to a fluid collection container ( e.g., a urine collection bag).”)(Examiner notes that the optical fiber attached within the linked assembly between “outlet end 128” and “inlet end 126” is fastened to a fixed distance from the inside surface of the urine collection bag when the “outlet end 128” is inserted into via press-fit (to the surface) of the open orifice of the “collection chamber”), the fastener being configured to fasten a cable connected to the sensors disposed in the sensor holding portions to the surface of the urine collection bag (Fig 1, “…the outlet end 128 of the oxygen-sensing assembly 104 may be attachable to a fluid collection container (e.g., a urine collection bag).”)(Examiner notes that the optical fiber ‘s cable that is attached within the linked assembly between “outlet end 128” and “inlet end 126” is fastened to a fixed distance from the inside surface of the urine collection bag when the “outlet end 128” is inserted into via press-fit (to the surface) of the open orifice of the “collection chamber”);
wherein the light emitter ([0069] “sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”) is fixed to the sensor holding portions (Fig 1, [0053] “As a non-limiting example, the additional sensing portion 144 of the additional oxygen sensor 140 may be secured to the optical fiber 142 of the additional oxygen sensor 140…)(Examiner notes that the optical fiber 142 is fixed to the sensor holding portion slot (as in Fig 1) when it is in use for sensing. Since the “sensing portion 234” can be attached to it, it is thereby also fixed into the sensor holding portion slot in Fig 1 during sensing.) ;
the optical fiber is detachable from the optical fiber holding portion ([0103] “the catheter
assembly 100 is connected to the control system 106 via reusable cables…”); and
wherein the light emitter ([0069] “sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”) is fixed to an end portion of the optical fiber ([0039] “the sensing portion 134 of the oxygen sensor 120 may be secured to a distal end of the optical fiber 132.).
Regarding Claim 17, Silverton discloses as described above, The measurement adapter according to claim 11. For the remainder of Claim 17, Silverton discloses wherein the sensor holding portions include an optical sensor unit holding portion configured to hold an optical sensor unit (Fig 1, channel with “optical module 136” and “oxygen sensor 120”) and
the optical sensor unit (Fig 1, “optical module 136”), includes:
the light emitter ([0069] “sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”);
a light source ([0068] “the optical fiber 232 may transmit excitation light…”) configured to irradiate the light emitter with light ([0068] “the optical fiber 232 may transmit excitation light in a first direction (e.g., toward…the sensing portion 234)”; [0069] “…sensing portion 234…include dye-impregnated polymer…excitable at selected wavelengths of light…”
and a detector configured to detect radiation light emitted from the light emitter ([0068] “…and return light in a second opposite direction ( e.g., toward the optical module 136 of the control system 106 and from the sensing portion 234).”; [0069] “based on the fluorescence response…of the dye 264, the control system 106 may determine oxygen levels within the urine.”);
Regarding Claim 18, Silverton discloses as described above, The measurement adapter according to claim 17. For the remainder of Claim 18, Silverton discloses wherein
the optical sensor unit (Fig 1, “optical module 136”) includes a light shielding layer configured to cover a portion not facing the flow path ([0068] “…optical fiber…”; [0041] “optical fiber 132 may include a core and a cladding…”)(Examiner notes that optical fiber has cladding such that the light primarily travels along the length of fiber to the tips and is shielded for travelling elsewhere.)
the light emitter ([0069] “…sensing portion 234…dye-impregnated polymer that includes and/or releases fluorescent dyes…”) includes a phosphor ([0042] “ the dyes may be oxygen sensitive and may be immobilized (e.g., impregnated) within a polymer matrix…”) configured to react with a component in urine to emit fluorescence ([0042] “…excitable at selected wavelength of light”; [0044] “the optical fiber 132 may transmit excitation light…to the sensing portion 134 of the oxygen sensor 120, which is exposed to urine and dissolved oxygen (e.g., any oxygen molecules) within the urine….depending on the amount of oxygen molecules that are (e.g. an oxygen concentration) present in the urine flowing through the flow pathway…the luminescence response (e.g., the return light) of the sensing portion 134 may vary.”)(Examiner notes that the phosphor dyes react with a plurality of components while they are in contact with urine. These include a particular component wavelength of the light spectrum shining into the sensing portion (and urine) that elicits a level of excitation fluorescence, and one or more components of oxygen that change that response, yielding a particular emitted fluorescence from interaction with these elements. The net emitted fluorescence can be measured to determine the oxygen concentration in the urine. This aligns with the use of the phosphor as described in paragraphs [0062] – [0064] of Applicant’s specification.); the light source ([0068] “the optical fiber 232 may transmit excitation light…”) is configured to irradiate the light emitter with excitation light ([0068] “the optical fiber 232 may transmit excitation light in a first direction (e.g., toward…the sensing portion 234)”,
the detector ([0040] “optical module”) is configured to detect the fluorescence emitted from the phosphor [0040] “Additionally, the optical fiber 132 may transmit light (e.g., return light) emitted and/or reflected by (e.g., light originated at) the sensing portion 134 … transmit the return light back to the optical module 136”; [0042] “…dyes sensitive to oxygen…oxygen quenches a fluorescence response…”; [0110] “when executed by the at least one processor, cause the control system to: receive a detected oxygen levels…”)
the data acquisition unit ([0110] “when executed by the at least one processor…control system…”) is configured to acquire data from the detector via wireless communication ([0070] “signals between the oxygen-sensing assembly 104 and the control system 106 may be conveyed
wirelessly.”); and
wherein the measurement device is integrally with the measurement adapter (Fig 1).
Regarding Claim 19, Silverton discloses as described above, The measurement adapter according to claim 10. For the remainder of Claim 19, Silverton discloses a temperature sensor (Fig 1, [0036] “temperature sensor 124”), configured to be held by the sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include… a temperature sensor 124.”), the temperature sensor configured to measure a temperature of the urine flowing through the flow path ([0036] “…disposed along flow pathway 130”; [0037] “the measured temperature of the urine as measured by the temperature sensor 124”);
a flow rate sensor (Fig 1, [0036] “flowrate sensor”) configured to be held by the sensor holding portions (Fig 1 showing portion at 124 holding “temperature sensor” 124; [0036] “oxygen-sensing assembly 104… may include…a temperature sensor 124.”), the flow rate sensor configured to measure a flow rate of the urine flowing through the flow path ([0036] “…disposed along flow pathway 130”; [0038] “measured flowrate by the flowrate sensor 122”);
the display unit ([0062] “display ( e.g., a display screen),) configured to display information on a patient in time series ([0134] “displaying a real-time urine flowrate on a user interface of a control system.”);
the measurement device including an index calculation unit configured to calculate an index ([0059] “a derived parameter”) representing a state of kidney on the basis of data acquired by the data acquisition unit from each of a plurality of sensors ([0059] “processor 148 may be configured to determine the risk of developing acute kidney injury based on a derived parameter comprising a product of the flowrate and the oxygen concentration.”), and
the display unit ([0062] “display (e.g., a display screen),) is configured to display the index calculated by the index calculation unit (Fig 3A; [0101] “indication of the risk of developing future acute kidney injury and/or the patient's medullary oxygenation to be displayed on the user interface 154.”)
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Silverton in view of Miller, (United States Patent Application Publication US 2021/0330946 A1), hereinafter Miller.
Regarding Claim 7, Silverton discloses as described above, The measurement adapter according to claim 1. For the remainder of Claim 7, Silverton discloses wherein
the sensor holding portions include a temperature sensor holding portion (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include… a temperature sensor 124.”) configured to hold a temperature sensor (Fig 1, [0036] “temperature sensor 124”), the temperature sensor configured to measure a temperature of the urine flowing through the flow path ([0036] “…disposed along flow pathway 130”; [0037] “the measured temperature of the urine as measured by the temperature
sensor 124”); and
a flow rate sensor holding portion configured to hold a flow rate sensor (Fig 1 showing portion 122 holding a “flow rate sensor”, [0036] “flowrate sensor”), the flow rate sensor configured to measure a flow rate of the urine flowing through the flow path ([0036] “…disposed along flow pathway 130”; [0038] “measured flowrate by the flowrate sensor 122”),
the flow sensor (Fig 1, [0036] “flowrate sensor”)
Silverton does not specifically disclose and wherein the flow rate sensor is any of an optical flow rate sensor, an ultrasonic flow rate sensor, a thermal flow rate sensor, or a sensor configured to measure a urine flow rate on the basis of change in weight of urine that has been conducted. Silverton does broadly disclose at [0037] “Many such flowrate sensors are known in the art, and the flowrate sensor 122 may comprise any of the flow sensors known in the art.”
Miller teaches a medical device system incorporating an ultrasonic sensor that can be removably coupled to a tube with a foley catheter to measure urine flow rate. Specifically for Claim 7, Miller teaches wherein the flow rate sensor is any of an optical flow rate sensor, an ultrasonic flow rate sensor ([0053] “sensor 20…ultrasonic flow sensor”; Fig 1; Fig 9A; [0133] “Ultrasonic flow sensor 901 may be an example of sensor 20 of medical device 10...”; [0134] “…determine a flow rate of fluid…Ultrasonic sensor 901… include sensor body 912, first ultrasonic sensor 930, and second ultrasonic sensor 934.”; [0054] “…sensor 20 may be removably coupled to elongate body 12…may be removed from elongated body,”; [0043] “…Distal portion 1A…external to a patient’s body when in use…”), a thermal flow rate sensor, or a sensor configured to measure a urine flow rate on the basis of change in weight of urine that has been conducted.
Silverton and Miller both disclose flow rate sensors placed external to the body along the flow path for sensing urine flow rate, Silverton: “flow rate sensor” 122 and Miller: ultrasonic sensor 901 as “sensor 20” in Section “7A” that is external to the body in Miller’s Figure 1. Silverton provides a motivation to combine at [0037] with “Many such flowrate sensors are known in the art, and the flowrate sensor 122 may comprise any of the flow sensors known in the art.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a ultrasonic sensor is a flow sensor that is recognized in the art that is useful for measuring flow rate of urine flowing from an in-place catheter and it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the flow sensor broadly disclosed by Silverton with the ultrasonic urine flow rate sensor taught by Miller, creating a single urine analysis device that can determine flow rate of urine in a flow path using ultrasonic flow rate sensing.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Silverton in view of Miller, further in view of Huici, (United States Patent Application Publication US 2021/0060291 A1), hereinafter Huici, further in view of Suehara et. al., (United States Patent Application Publication US 2019/0150801 A1), hereinafter Suehara.
Regarding Claim 8, Silverton discloses as described above, The measurement adapter according to claim 1. For the remainder of Claim 8, Silverton discloses further comprising:
a plurality of the sensor holding portions arranged along a longitudinal direction of the flow path (Fig 1 showing portion at 124 holding “temperature sensor” 124, portion 122 holding a “flow rate sensor” 122”; [0036] “oxygen-sensing assembly 104… may include a housing 118, an oxygen sensor 120, a flowrate sensor 122, and a temperature sensor 124…” along “flow pathway 130”; [0036] “flow pathway 130 between the inlet end 126 and the outlet end 128.”);
a check valve ([0022] “an oxygen-sensing assembly having a check valve configuration”) configured to prevent backflow in the flow path ([0067] “including one or more valves for directing fluid flow through the flow pathway 130 of the oxygen-sensing assembly 104 may prevent backflow…”)
Silverton does not specifically disclose two of a plurality of the sensor holding portions are arranged to face each other across the flow path; is provided on a side closer to the catheter connection portion than any of a plurality of the sensor holding portions, a first material forming the catheter connection portion is a material different from a second material forming the urine collection bag connection portion; and the first material is softer than the second material, and the second material is elastomer or rubber.
Miller teaches two of a plurality of the sensor holding portions (Fig 9A, portions holding “ultrasonic sensor 930” and “second ultrasonic sensor 934”; [0134]) are arranged to face each other across the flow path (Fig 9A with “ultrasonic sensor 930” and “second ultrasonic sensor 934” facing each other on the left pictured and right pictured parts of “sensor body 912” housing; [0134] “…sensor body 912 houses and/or couples first ultrasonic sensor 930 and second ultrasonic sensor 934 to each other, e.g., in a fixed position…”; [0135])
Silverman does broadly disclose at [0037] “Many such flowrate sensors are known in the art, and the flowrate sensor 122 may comprise any of the flow sensors known in the art.” Miller provides a motivation to combine at [0134] with “Ultrasonic sensor 901 may be configured to determine a flow rate of fluid 504 utilizing, e.g., a transit time technique.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that facing ultrasonic sensors across from each other would allow for measuring the flow rate using a transit time technique.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the flow sensor broadly disclosed by Silverton with the ultrasonic urine flow rate sensor with Miller’s taught ultrasonic sensors held at positions facing each other across the flow path, creating a single urine analysis component that can determine flow rate of urine in a flow path using ultrasonic flow rate sensing.
Miller does not teach a check valve configured to prevent backflow in the flow path is provided on a side closer to the catheter connection portion than any of a plurality of the sensor holding portions; and a first material forming the catheter connection portion is a material different from a second material forming the urine collection bag connection portion; and the first material is softer than the second material, and the second material is elastomer or rubber.
Huici teaches a urinary catheter device with a check valve on the tubing close to the catheter. Specifically for Claim 8, Huici teaches a check valve configured to prevent backflow in the flow path is provided on a side closer to the catheter connection portion ([Fig 1, “check valve 50”; [0004]);
Silverman and Huici both provide check valves in the flow paths beyond the catheter. Huici teaches to put that check valve closer to the catheter exit, which for Silverman could be on a side closer to the catheter connection portion. Huici provides a motivation to combine at [0003-0004] with “…reverse flow can introduce bacteria into the bladder, which can in turn cause a painful bladder or urinary tract infection,”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including a check valve close to the catheter would be useful for preventing backflow and reduce associated infection risks.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the sensor attachments and check valve disclosed in Silverman with the check valve located closest to the catheter distal end, prior to sensors (along the direction of the urine flow path) taught by Huici, creating a single urine analysis device with advantageous flow control hardware to minimize backflow and reduce infection for users.
Huici does not teach a first material forming the catheter connection portion is a material different from a second material forming the urine collection bag connection portion; and the first material is softer than the second material, and the second material is elastomer or rubber.
Suehara teaches an oxygen measurement device with a urinary catheter, display, and collection bag. Specifically for Claim 8, Suehara teaches a first material forming the catheter connection portion is a material ([0209] “The hub 26 is integrally molded into the shape of a hollow, by the same material as that of the shaft 22…”; [0196] “the shaft material can include, for example…other elastomer”)(Examiner notes that elastomers can be softer than broadly rubber) different from a second material forming the urine collection bag connection portion ([0210] “..a urine collection bag 14 can be fabricated from…a resin material”); and the first material is softer than the second material, and the second material is elastomer or rubber ([0196] “The shaft 22a material can include…rubber such as silicone or latex, the other elastomer, vinyl chloride, polyurethane, a plastic tube, and the like.”; [0199])
Regarding the material choice, Suehara presents optional material that could be used for connection portions for a catheter/oxygen sensor/collection bag device. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “oxygen-sensing assembly 104” with its connectors to a collection bag and a catheter disclosed by Silverman with the different component component materials taught by Suehara, creating a single urine analysis device that integrates with different materials into a catheter and a urine collection bag.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Silverton in view of Arora et. al., (United States Patent Application Publication US 2015/0359996 A1), hereinafter Arora.
Regarding Claim 9, Silverton discloses as described above, The measurement adapter according to claim 1. For the remainder of Claim 9, Silverton does not specifically disclose the flow path includes an inner diameter change portion whose inner diameter decreases from the catheter connection portion side toward the urine collection bag connection portion side; and the sensor holding portions are disposed in the inner diameter change portion. Silverton broadly discloses a diameter change that decreases from the catheter connection portion side toward the urine collection bag portion side in Fig 1, in which the “outlet end 128” that tapers its diameter from larger to smaller from right to left in the figure, which is from the catheter connection portion side toward the urine collection bag portion side.)
Arora teaches a foley catheter device with sensors along a tapered transition portion to detect the concentration of an analyte. Specifically for Claim 9, Arora teaches the flow path includes an inner diameter change portion ([0091] “Tapered catheter 1701”; Fig 17) whose inner diameter decreases from the catheter connection portion side toward the urine collection bag connection portion side ([0091] “Tapered catheter 1701”; Fig 17; [0049] “…transition portion to distal end 322 or outside portion of the catheter that includes the urine collection bag)”); and the sensor holding portions are disposed in the inner diameter change portion ([0091] “Tapered catheter 1701…one or more sensors 1712 integrated on and/or within different components of the catheter body…at or near the transition portion of the catheter…”, Fig 17)
Arora provides a motivation to combine at [0091] with “a sensor 1712 can be located on an outside/external surface of the catheter body, on an internal surface of the catheter body, at or near the proximal end 1704 of the catheter, at or near the inner portion of the catheter, at or near the transition portion of the catheter, at or near the shaft of the catheter body, on or within the inner lumen, on or within the outer lumen”, suggesting that sensors can be aligned nearly anywhere along a tubular urine flow path, including on an incline. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the sensors could be rearranged to any section along a urine flow path, whether inclined or straight. It has previously been held that the mere rearrangement of parts without modifying the operation of a device is prima facie obvious. See, e.g., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); see also MPEP 2144.04(VI)(C). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the instrumented oxygen-sensing assembly 104 with a flow path tube between a catheter and a urine collection bag disclosed in Silverton with the sensors positioned on an inclined, changing-inner-diameter section in a flow path tube from a catheter to collection bag taught by Arora, creating a single urine analysis apparatus with sensors aligned at an angle in the urine flow path.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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