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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on December 4th, 2025 is acknowledged. The traversal to the restriction between inventive groups is on the ground(s) that if the Examiner finds the invention of Group I, there is more than likely a disclosure of a method of using the apparatus as described in inventive Group II. This is not found persuasive because the apparatus of Group I can be used in a materially different process of using that product.
The requirement is still deemed proper and is therefore made FINAL.
It is noted that Applicant made changes to reflect proper claim numbering in the 12/4/2025 reply. Previous claims 8-15 have been corrected to be correctly numbered 7-14. Therefore, Group I pertains to claims 1-10 and Group II pertains to claims 11-14. Therefore, claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.84 because Figures 9B and 11 are black and white photographs. Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. The photos show mechanical devices where line drawings are practicable. Applicant is advised to replace the photographs with acceptable line drawings showing the claimed features with appropriate reference numerals, or explain why line drawings are not practicable. The objection to the drawings will not be held in abeyance.
The drawings are further objected to under 37 CFR 1.84 (p) because the text in Figure 9B is unclear to be legible upon reproduction. Corrected replacement drawings in compliance with 37 CFR 1.84 are required.
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. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim(s) 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 is/are objected to because of the following informalities:
In claim 1, line 4 introduces “at least one sensor” therefore lines 5 and 7 need to recite “the at least one sensor” for claim language consistency.
In claim 1, line 9, “the rate” should be changed to “a rate” because this is the first time this term is introduced.
In claim 2, line 4, should recite “the calculated infusion rate” to match the language of line 2.
In claim 3, line 2, “HTS delivery” should be corrected to “HTS administration” to match claim language consistency.
In claim 3, line 2, “patient’s” should be corrected to “the patent’s.
In claim 4, line 2 should recite “HTS administration” instead of “HTS delivery” to match the language of claims 2 and 3.
In claim 4, line 3 should include the term “the” in front of the phrases “cumulative administered volume” and “maximum safe dose” since these features were introduced in claim 3.
In claim 5, the term “predefined” should be removed from line 1 to match the language used in claims 3 and 4.
In claim 5, line 2, “the physician” should be corrected to “a physician” since this is the first time this term is introduced.
In claim 6, the term “an” should be inserted before the phrase “empty infusion reservoir” on lines 2-3 in order to be grammatically correct.
In claim 7, line 1-2, “maximum safe dose” should be corrected to “the maximum safe dose” as this term was previously introduced in claim 3.
In claim 8, line 2, the term “the” should be inserted before the phrase “proportional-integral-derivative (PID) equation” on line 2 since this was previously introduced in claim 2.
In claim 8, the term “the” should be inserted before the phrases “current error” on line 4, “difference” on line 5, “goal sodium concentration” on line 5, “current sodium concentration” on line 5, “sum” on line 6, “infusion” on line 6, and “difference” on line 7 should be replaced with the term “a”/”an” since it’s the first time these are being introduced.
In claim 8, line 4, “the hypertonic saline infusion rate” should be corrected to “the calculated infusion rate” for claim language consistency.
In claim 9, line 7, “connector fitting” should be corrected to “implantable connector fitting” for claim language consistency.
In claim 9, line 8, “fitting” and “sensor” should be corrected to “implantable connector fitting” and “implantable sodium sensor” for claim language consistency.
In claim 10, The phrase “at least one” should be inserted before the term “sensor” on lines 1 and 3 for claim language consistency.
In claim 10, line 3, “miscroneedle” should be corrected to “microneedle”.
In claim 10, line 2-3, the term “a” should be inserted before each of the phrases “ion selective electrode (ISE) optode”, “sodium-selective optode”, “near-infrared spectrometer” and “microneedle-based extended gate transister”.
The term “the” in the phrase “the range” on line 4 should be replaced with the term “a”.
The term “have” on line 4 should be replaced with the term “has” in order to be grammatically correct.
Claim(s) 9 is further objected to under MPEP 608.01(i) because the subparagraphs are not uniquely labeled (specifically, the letter “c” is used twice). Applicant is suggested to correct the lettering of the limitations so that each subparagraph has a unique letter.
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.
Claim(s) 1, 2, 3, 4, 5, 6 and 8 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (preAIA ), 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 1, line 9-10 recites “the real time measurement of the patient’s plasma sodium concentration”, but lines 5-6 introduce “measurements of plasma sodium concentration” and do not specify a single “measurement” (as in lines 9-10) or that these measurements are in “real time” (as in lines 9-10). Therefore, the Examiner is unsure if the measurement of lines 9-10 is intended to be one of the measurements of lines 5-6 or different therefrom. If the Applicant intended for the measurement of lines 9-10 to be different from lines 5-6, then Applicant is suggested to replace “the real time measurement of the patient’s plasma sodium concentration” with “a real time measurement of the patient’s plasma sodium concentration”. If the Applicant intended for the measurement of lines 9-10 to be same as the measurements of line 5-6, then it is unclear if the measurement of lines 9-10 is intended to refer to all of the measurements (vs a single measurement) of lines 5-6 and intended to require the measurements of lines 5-6 to be real time. Applicant is therefore suggested to amend claim 1 to overcome rejection.
Claim 2 recites “plasma sodium concentration measurement” in lines 2-3. Claim 2 is dependent on claim 1, however claim 1 recites the phrases “measurements of plasma sodium concentration” in lines 5-6 and “real time measurement of the patient’s plasma sodium concentration” in lines 9-10. Examiner is unsure if the Applicant intended for “plasma sodium concentration measurement” from claim 2 to refer to “measurements of plasma sodium concentration” or “real time measurement of the patient’s plasma sodium concentration” from claim 1. In light of the suggestions made regarding the interpretation of claim 1 and the suggested amendment, Applicant is suggested to amend claim 2 to overcome rejection.
Claim 2 recites “a treatment algorithm” in line 3. Claim 2 is dependent on claim 1, wherein claim 1 introduced “a treatment algorithm” in lines 10-11. The Examiner is unsure if the Applicant intended for the “treatment algorithm” of claim 2 to refer to claim 1, or introduce a new treatment algorithm in claim 2. Applicant is therefore suggested to amend claim 2 to overcome rejection.
Claim 3 recites “said goal sodium concentration”. Claim 3 is dependent on claim 2, however claim 2 does not recite “goal sodium concentration” and therefore there is insufficient antecedent basis for this limitation in the claim. The Examiner is unsure if the Applicant intended to refer to plasma sodium concentration in claim 2, or introduce a new term. Therefore, Applicant is suggested to amend claim 3 to overcome rejection.
Claim 4 recites “the goal sodium concentration” and therefore suffers the same issue as claim 3 due to its dependency on claim 2. Applicant is suggested to amend claim 4 to overcome rejection.
Claim 5 recites “the predefined goal sodium concentration” and therefore suffers the same issue as claim 3 due to its dependency on claim 2. Applicant is suggested to amend claim 4 to overcome rejection.
Claim 6 introduces the term “the infusion” in line 2. Claim 6 is dependent on claim 1, however claim 1 does not recite “the infusion” and therefore there is insufficient antecedent basis for this limitation in the claim. It is unclear if the Applicant intended to refer to the “HTS administration” line 9 of claim 1 or introduce a new term. Applicant is therefore suggested to amend claim 6 to overcome rejection.
Claim 8 recites “the goal sodium concentration” and therefore suffers the same issue as claim 3 due to its dependency on claim 2. Applicant is suggested to amend claim 4 to overcome rejection.
Claim 8, line 5-6, recites “IE” and “L’1E”. Claim 8 is dependent on claim 1 however claim 1 does not recite “IE” and “L’1E”. Furthermore, “IE” and “L’1E” is not previously introduced in claim 8. The Examiner is unsure if the Applicant intended to introduce “IE” and “L’1E” as new terms or refer to notations in line 3. Therefore, Applicant is suggested to amend claim 8 to overcome rejection.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), and further in view of Rovatti (US 10434236 B2, herein Rovatti).
Regarding claim 1, Gylland disclosed an infusion system for administering hypertonic saline (HTS) to a patient (infusion pump system 100 in FIG. 1A), the infusion system comprising:
an infusion device (infusion pump 130 [0025]) for delivering HTS to a patient (the infusion pump can deliver a first fluid from a first reservoir, then switch to delivering a second fluid from a second reservoir as per patient requirements; fluid as used herein can be any fluid suitable to be administered to a patient by infusion, including saline fluid [0023]);
Gylland fails to explicitly disclose at least one sensor for continuous monitoring of plasma sodium concentration of the patient, wherein the sensor takes measurements of plasma sodium concentration of the patient at a predetermined sampling frequency; and
a controller that sets the sampling frequency of said sensor, receives said measurements of the patient's plasma sodium concentration from the sensor, and automatically adjusts the rate of HTS administration of the infusion device based on the real time measurement of the patient's plasma sodium concentration using a treatment algorithm.
However, Rovatti teaches at least one sensor for continuous monitoring of plasma sodium concentration of the patient, wherein the sensor takes measurements of plasma sodium concentration of the patient at a predetermined sampling frequency (sensor 11 may include a concentration sensor configured for measuring the concentration of at least one substance in the dialysate, such as sodium concentration [0204]); and
a controller (the apparatus may also comprise a user interface 22 and a control unit 12 [0181]) that sets the sampling frequency of said sensor, receives said measurements of the patient's plasma sodium concentration from the sensor (a control unit (12) connected to the regulating means 10 and programmed for receiving a value representative of a parameter of the blood [0056]; in particular the parameter value is the plasma sodium concentration [0065]), and automatically adjusts the rate of HTS administration (a dialysis apparatus able to provide an automated delivery and control of the dialysis prescription [0054]) of the infusion device based on the real time measurement of the patient's plasma sodium concentration using a treatment algorithm (the control unit is configured to calculate the adjustment contribution term as an algebraic sum of at least two components [0109]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the infusion system of Gylland with Rovatti to include at least one sensor for continuous monitoring of plasma sodium concentration of the patient, wherein the sensor takes measurements of plasma sodium concentration of the patient at a predetermined sampling frequency; and a controller that sets the sampling frequency of said sensor, receives said measurements of the patient's plasma sodium concentration from the sensor, and automatically adjusts the rate of HTS administration of the infusion device based on the real time measurement of the patient's plasma sodium concentration using a treatment algorithm since such a modification would enable the infusion device of Gylland to provide automated, feedback-controlled adjustment of HTS administration based on measured sodium concentration. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.B).
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), as modified by Rovatti (US 20180140761 A1, herein Rovatti) and in further view of Lindo et al. (US 12485221 B2, herein Lindo) and Chefitz (US 20210236772 A1, herein Chefitz).
Regarding claim 2, Gylland as modified by Rovatti, disclosed all limitations of claim 1. Gylland as modified by Rovatti further disclosed wherein the infusion device delivers HTS to the patient at a calculated infusion rate based on plasma sodium concentration measurement using a treatment algorithm which may include a proportion-integral-derivative (PID) equation (the control unit is configured to calculate the adjustment contribution term as an algebraic sum of at least two components[Col 10, line 35-37]), but failed to explicitly disclose wherein the calculated rate of HTS administration cannot exceed a maximum rate of 500 mL 3% saline (or equivalent) per hour.
However, Lindo teaches that Basic Therapy includes dose calculation, which allows dose rate programming based on volume to be infused (VTBI), drug amount, infusion time and drug concentration and simple rate programming that allows programming of volumetric rate (ml/hr) [Col 9, line 9-13].
Furthermore, Chevitz teaches that intravenous fluids include, but are not limited to dextrose solutions such as 2.5%, 5%, 20% and 50% dextrose, sodium chloride solutions such as 5% NaCl (hypertonic), 3% NaCl (hypertonic) [0136].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion device of Gylland as modified by Rovatti to deliver 3% NaCl at a volumetric rate with a maximum delivery limit, as taught by Lindo and Chevitz, because such modifications represent the predictable use of known infusion parameters and medicaments in programmable infusion systems to achieve controlled and safe delivery (See MPEP 2143.I.B)
Regarding claim 8, Gylland as modified by Rovatti and further modified by Lindo and Chefitz disclosed all limitations of claim 2. However, Gylland as modified by Rovatti and further modified by Lindo and Chefitz, failed to explicitly disclose wherein proportional-integral-derivative (PID) equation is: R = 0.002 x E1 + 0.001 x ∑E +0.05 x ΔE; where R is the hypertonic saline infusion rate, Ei is the current error as defined by the difference between the goal sodium concentration and the current sodium concentration, IE is the sum of the current error and all previous errors since starting the infusion, and L'. lE is the difference between the current error and the preceding error.
One of ordinary skill in the art would recognize that claim 2 recites the infusion device delivers HTS to the patient at a calculated infusion rate based on plasma sodium concentration measurement using a treatment algorithm which may include a proportion-integral-derivative (PID) equation, making the use of a proportion-integral-derivative (PID) equation optional. Claim 8 merely specifies a particular proportion-integral-derivative (PID) equation. Because claim 2 already permits using a differential equation, there is no inventive concept introduced by claim 8, and selecting a known or conventional proportion-integral-derivative (PID) equation would have been obvious to one of ordinary skill in the art (see MPEP 2143.I.B)
Claim(s) 3, 4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), as modified by Rovatti (US 20180140761 A1, herein Rovatti), Lindo et al. (US 12485221 B2, herein Lindo) and Chefitz (US 20210236772 A1, herein Chefitz) and in further view of Osawa et al (US 20230347048 A1, herein Osawa).
Regarding claim 3, Gylland as modified by Rovatti and further modified by Lindo and Chefitz disclosed all limitations of claim 2. However, Gylland as modified by Rovatti and further modified by Lindo and Chefitz failed to explicitly disclose wherein the infusion device automatically suspends HTS delivery when patent's plasma sodium concentration is greater than or equal to said goal sodium concentration or when a cumulative administered volume is greater than or equal to a maximum safe dose.
However, Osawa teaches that the flow rate adjustment unit decreases the flow rate or stops supply of the fluid to be injected by the injection unit in a case where an oxygen concentration in the living body measured by the oxygen concentration measurement unit exceeds a predetermined upper limit value [0010].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion device of Gylland as modified by Rovatti and further modified by Lindo and Chefitz with Osawa to stop delivery when another routinely monitored physiological parameter, such as sodium concentration, exceeds a predetermined level, because the threshold-based shutoff control logic is independent of the specific parameter sensed and represents a predictable application of known safety controls (See MPEP 2143.I.B)
Regarding claim 4, Gylland, as modified by Rovatti, Lindo and Chefitz and further modified by Osawa disclosed all limitations claim 3, However, Gylland, as modified by Rovatti, Lindo and Chefitz and further modified by Osawa failed to explicitly disclose wherein the infusion device automatically resumes HTS delivery when measured plasma sodium concentration is below the goal sodium concentration and cumulative administered volume is below maximum safe dose.
However, Osawa teaches that the oxygen concentration in the vicinity of the cisterna magna first decreases to the lower limit value at time T3. In this case, the flow rate adjustment unit 45 restarts circulation of the fluid at a timing of time T3 [0036].
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion device of Gylland, as modified by Rovatti, Lindo and Chevitz and further modified by Osawa to automatically resume delivery when a physiological parameter, such as the sodium concentration falls below the predetermined level, as taught by Osawa, because this represents a substitution of one known measured physiological parameter for another to achieve the same predictable operation. (See MPEP 2143.I.B)
Regarding claim 7, Gylland, as modified by Rovatti, Lindo and Chefitz and further modified by Osawa disclosed all limitations of claim 3. However, Gylland, as modified by Rovatti, Lindo and Chefitz and further modified by Osawa failed to explicitly disclose maximum safe dose of cumulative administered volume is 500 mL 3% saline (or equivalent) in a 4-hour period.
However, Lindo teaches that Basic Therapy includes dose calculation, which allows dose rate programming based on volume to be infused (VTBI), drug amount, infusion time and drug concentration and simple rate programming that allows programming of volumetric rate (ml/hr) [Col 9, line 9-13].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the Gylland, as modified by Rovatti, Lindo and Chefitz and further modified by Osawa using the volumetric delivery rate taught by Lindo to include a maximum safe dose of cumulative administered volume is 500 mL 3% saline (or equivalent) in a 4-hour period, because limiting the total delivered volume over a specified time period is a predictable result of controlling the delivery rate once a calculated volume has been delivered. Therefore, applying a known volumetric rate-based control would have been an obvious modification (See MPEP 2143.I.B)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), as modified by Rovatti (US 20180140761 A1, herein Rovatti), Lindo et al. (US 12485221 B2, herein Lindo) and Chefitz (US 20210236772 A1, herein Chefitz) and in further view of Roth et al (US 20180289890 A1, herein Roth).
Regarding claim 5, Gylland as modified by Rovatti, and further modified by Lindo and Chefitz disclosed all limitations of claim 2. However, Gylland as modified by Rovatti, and further modified by Lindo and Chefitz fails to explicitly disclose wherein the predefined goal sodium concentration is set at approximately 140-160 mmol/liter by the physician based on individual patient need.
However, Roth teaches a target sodium concentration of 154 mmol/L in a patient for administration of 0.9% NaCl, disclosed in Table 1 as a non-limiting example of common infusion fluids.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion system of Gylland as modified by Rovatti, and further modified by Lindo and Chefitz with the target sodium concentration of 154 mmol/L taught by Roth to set the predetermined goal sodium concentration within the 140-160 mmol/L range. Using this known value would have been routine and obvious, because the target sodium concentrations are well-known and routinely applied in infusion systems to control patient blood sodium levels (See MPEP 2144.05.II.A).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), as modified by Rovatti (US 20180140761 A1, herein Rovatti) and in further view of Malloy et al. (US 20220387710 A1, herein Malloy).
Regarding claim 6, Gylland as modified by Rovatti disclosed all limitations of claim 1. However, Gylland as modified by Rovatti fails to explicitly disclose wherein the infusion system further includes one or more alarms to warn about bubbles in the infusion, and/or empty infusion reservoir.
However, Malloy teaches the controller may then switch to reserve mode of operation. During the reserve mode, the device may output user notifications, such as haptic feedback (e.g., vibration), visual alerts (e.g. flashing screen or messages), and/or audio feedback (e.g., alarm chimes or other audio feedback). The user notifications may occur with increasing frequency and/or volume/intensity until a user changes the drug product container and/or clears the alarm. During reserve mode, the device may also decrease (e.g., “ramp down”) the drug dosage to extend the amount of time before the drug product container is empty [0036].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion system of Gylland as modified by Rovatti to include includes one or more alarms to warn about bubbles in the infusion, and/or empty infusion reservoir, using the alarm functionality taught by Malloy. Malloy describes triggering the alarm when the container is approaching empty, therefore adapting the alarm to indicate that the container is empty represents an obvious variation, because both conditions relate to notifying the user of container depletion, thus such a modification involves the substitution of one known operating condition for another and would have yielded predictable results (see MPEP 2143.I.B).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), and Goldsmith (US 20190374213 A1, herein Goldsmith).
Regarding claim 9 Gylland disclosed that the infusion system (infusion pump system 100 in FIG. 1A) for treating cerebral edema using HTS, comprising
a controller for generating a signal based on the monitored patient plasma sodium concentration using a treatment algorithm (the flow controller 235 can be any hardware processor, microprocessor, or the like responsive to the programming code to generate the control signal 231 [0032]); and
a pump (The fluid driver 232 can be any metered pump [0032]) for administering HTS stored therein (the infusion pump system can include a first reservoir that can hold a first fluid [0011]; Fluid as used herein can be any fluid suitable to be administered to a patient by infusion, including saline fluid [0023]) to the patient, said pump including means responsive to said signal from said controller to administer the HTS at adjusted rate (operable to drive fluid at a desired rate in response to the control signal 231 [0032])
However, Gylland fails to explicitly disclose an implantable sodium sensor for in vivo monitoring of a patient plasma sodium concentration;
an implantable connector fitting for supporting said implantable sodium sensor within the patient to permit transcutaneous access to said implantable sodium sensor for removal and replacement without removing said connector fitting from the patient.
However, Goldsmith teaches that an apparatus that uses the feedback from one or a combination of chemical, thermal, electrical, and mechanical implanted physiological diagnostic sensors (biosensors, microsensors, detectors), for example, to trigger adaptive drug dose computation, metering, and delivery through system conduits and unique junctions to ductus in response to a control program that is a prescription [0058]
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion system of Gylland with Goldsmith to include implantable sensor of Goldsmith, so that the controller receives physiological information from the implantable sensor in order to signal the pump to deliver. Sodium concentration is a physiological parameter; therefore, the physiological diagnostics sensor of Goldsmith reasonably includes a sodium concentration sensor. Thus using an implantable sensor to measure a physiological parameter was a known technique and would yield a predictable result (See 2143.I.B)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gylland et al. (US 20190282757 A1, herein Gylland), as modified by Rovatti (US 20180140761 A1) and in further view of Miller et al. (US 20190201675 A1, herein Miller).
Regarding claim 10, Gylland as modified by Rovatti, disclosed all limitations of claim 1. However, Gylland as modified by Rovatti failed to explicitly disclose wherein said sensor is ion selective electrode (ISE) optode, sodium-selective optode, near-infrared spectrometer or miscroneedle-based extended gate transister, wherein the sensor is accurate within 1 mmol/L in the range of 120-170 mmol/L and have a sampling rate of 60 seconds or less.
However, Miller teaches that the sensor can include one or more transducers, which can be any useful structure for detecting, sensing, and/or measuring a marker or target of interest. Exemplary transducers include one or more of the following: optical sensors (e.g., including measuring one or more of fluorescence spectroscopy, interferometry, reflectance, chemiluminescence, light scattering, surface plasmon resonance, or refractive index), piezoelectric sensors (e.g., including one or more quartz crystals or quartz crystal microbalance), electrochemical sensors (e.g., one or more of carbon nanotubes, electrodes, field-effect transistors, etc.), etc., as well as any selected from the group consisting of an ion selective electrode, an ion sensitive field effect transistor (e.g., a n-p-n type sensor), a light addressable potentiometric sensor, an amperometric sensor (e.g., having a two-electrode configuration (including reference and working electrodes) or a three-electrode configuration (including reference, working, and auxiliary electrodes)), and/or an impedimetric sensor [0043].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the infusion system of Gylland as modified by Rovatti with Miller to use the ion selective electrode taught by Miller, because selecting a known sensor type to implement the sensor function of the claimed invention represents a predictable choice that would yield a predictable result (see MPEP 2143.I.B)
Conclusion
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783