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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: “chitsosan” on pg. 24, line 20, should be corrected to “chitosan”.
Appropriate correction is required.
Claim Interpretation
Examiner notes several claims only recite functional language, which describe the invention by what it does rather by its specific structure or components. While functional language is not necessarily improper, Applicant is advised to ensure that the boundaries of the claims are clear and precise (MPEP § 2173.05(g)).
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.
In the instant application, “a molecular exchange means” in claim 12 is interpreted as a microdialysis probe, disclosed on page 8 of the Specification and equivalents thereof.
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: “analyte recovery system allowing for continuous, real-time propofol monitoring without the need for drawing blood in claim 11. This limitation is merely functional with no indication of the structural elements of the system that perform the analyte recovery and allow for monitoring without drawing blood. The analyte recovery system is interpreted as a microdialysis probe and equivalents thereof as indicated on page 8 of the Specification.
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 1-4, 6, 8-13, 15-16, and 18-24 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.
Claims 1, 6, and 8 recite “the sensor is based on” an enzyme. However, the enzyme is not positively recited, unlike in claim 24. It seems the sensor being “based on” an enzyme would necessarily require that the enzyme be part of the sensor; however, it is unclear if Applicant intends for the claim scope to encompass sensors that don’t necessarily include a cytochrome P450 enzyme. For example, a sensor that doesn’t have the enzyme immobilized on the sensor but interacts with reaction products from cytochrome P450 enzymes that are added to a test solution. To expedite prosecution, the enzyme will be interpreted as being part of the sensor, and accordingly the claim should be amended to positively claim the enzyme. Claims 2-4, 8-13, 15-16, 18-24 are rejected by virtue of dependency.
Claims 2, 4, 9, 16, 20, and 22 recite functional limitations or steps. It is unclear whether the claim scope includes the sensor only when it is performing the step. For example, does the claim scope encompass the sensor only when it is “providing” the measurement (claims 2, 4) or undergoing the electrochemical reaction (claims 9, 16, 20) or does it encompass the sensor at all times, including when it is not actively reacting? To expedite prosecution, the step limitations and electrochemical reactions will be interpreted as functions. It is recommended to amend the claim using phrasing such as “configured to” (i.e., amending claim 16 to “[[comprising]] wherein the sensor is configured to perform an electrochemical reaction with a redox step…).
Claim 3 recites “forming part of a blood-gas analyser,” however, the blood-gas analyser is not positively claimed. It is unclear what structure is implied in order for the sensor to form part of the blood-gas analyser or if this limitation is merely functional. To expedite prosecution, this limitation will be interpreted as merely functional, and the claim should be amended accordingly (i.e., “wherein the sensor is configured to form [[forming]] part of a blood-gas analyser”).
Claim 4 recites “direct electrochemical measurement of propofol.” It is unclear what is considered direct electrochemical measurement. The specification discloses that the oxidation of propofol may be directly detected electrochemically (pg. 3, lines 24-25), but claim 1 already indicates that the sensor uses an enzyme. The specification also discloses “direct electron transfer between the electrode and the CYP enzyme (pg. 7, lines 1-2) and “mediatorless” or direct biosensors that deliver electrons directly to the active site of the enzyme (pg. 7, lines 25-26). Thus, it is unclear whether direct electrochemical measurement of propofol in the claim refers to electron transfer between an electrode and an enzyme, and/or enzymatic biosensors without mediators. To expedite prosecution, direct electrochemical measurement of propofol will be interpreted as sensing occurring with direct electron transfer between an electrode and the CYP enzyme or sensing occurring without a mediator. Applicant should amend the claims or provide remarks for clarification.
Claims 9, 16, and 20-21 recite limitations that seem to be inherent to the claimed sensor. A cytochrome P450 enzyme of the sensor reacting with propofol would presumably convert propofol into a quinone/quinol redox pair (claim 9; Figs. 2-3 show the conversion of propofol to a quinone/quinol pair in both direct and indirect detection methods), have an oxidation occurring before a reduction (claim 16; hydroxylation of propofol to 2,6-diisopropylquinone is an oxidation step prior to reduction of 2,6-diisopropylquinone, pg. 14, lines 31-32, and pg. 15, lines 35-38 of the Specification), and have a reduction occurring before an oxidation (claims 20-21; “it has been found that reduction must occur before the oxidation… reduction current of 2,6-diisopropylquinone.”,” pg. 15, lines 35-36). It is unclear whether the claim scope is being limited by these recitations. To expedite prosecution, prior art sensors comprising cytochrome P450 enzymes and sensing propofol will be interpreted as inherently performing these reactions.
Claim 10 recites “a propofol detection system…comprising the enzyme-based electrochemical sensor of claim 6.” A system suggests multiple components but only the electrochemical sensor of claim 6 is recited. It is unclear what other components are included within the system or if the system can be comprised only of the electrochemical sensor.
Claim 21 recites “a single sensor”. However, it is unclear whether this sensor refers to the electrochemical sensor recited in the preamble or a different sensor. To expedite prosecution, the single sensor will be interpreted as referring to the enzyme-based electrochemical sensor of the preamble. The following claim amendment is suggested: “The enzyme-based electrochemical sensor of claim 6, wherein the enzyme-based electrochemical sensor measures a reduction current of 2,6-diisopropylquinone.”
Claim 22 recites “two sensors in sequence”. However, it is unclear whether either sensor refers to the sensor recited in the preamble. In other words, does the enzyme-based electrochemical sensor of claim 6 make up one of the first or second sensor or do the two sensors in combination form the enzyme-based electrochemical sensor of claim 6 or are the two sensors different from the enzyme-based electrochemical sensor? To expedite prosecution, the claim will be interpreted as the two sensors in combination make up the enzyme-based electrochemical sensor, with at least one of the two sensors including the cytochrome P450 enzyme. Amendments are suggested to clarify the claim scope. For example, “comprising two sensors based on the one or more members of the cytochrome P450 group of enzymes in sequence…” shows that the two sensors are not different sensors from the enzyme-based electrochemical sensor. Claim 23 is rejected by virtue of dependency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9, 12, 16, and 20-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Under the 112(b) rejections above, claims 9, 16, and 20-21 are interpreted as only including inherent limitations, so they do not further limit the subject matter of the claims upon which they depend.
The analyte recovery system in claim 11 and the molecular exchange means in claim 12 are both interpreted as microdialysis probes and equivalents thereof following 35 U.S.C. 112(f) above (“the analyte recovery system may comprise a molecular exchange means such as a microdialysis probe,” pg. 8, line 37). As such, claim 12 does not further limit the subject matter of claim 11.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4, 6, 8-10, 15-16, 18, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Chaudhuri (WO 2017/125755, cited by Applicant) or, in the alternative, under 35 U.S.C. 103 as obvious over Chaudhuri in view of in view of Chaum (US 2018/0271413) and Blackburn (US 2014/0302492).
Regarding claims 1 and 6, Chaudhuri teaches a blood concentration electrochemical measurement sensor (“the sample is selected from…whole blood,” claim 12; “the concentration of the substrate in the solution can be determined,” pg. 11, lines 5-6), wherein the sensor is enzymatic, and wherein the sensor is based on one or more members of the cytochrome P450 group of enzymes (“Electrochemical biosensors employing recombinant yeast cells containing cytochrome P450 enzymes (CYPs) for biocatalysis,” Abstract).
While Chaudhuri does not explicitly teach the measurement of propofol by the sensor, Chaudhuri does teach the sensor measures the concentration of a substrate of the cytochrome P450 enzymes including drugs (“Biosensors according to the present invention…for measuring the levels of exogenous molecules in a sample taken from a human or animal body such as by way of example only medicinal drugs, narcotics…for evaluating drug pharmacokinetics in vitro or in vivo; for monitoring drug metabolism in an individual prior to, during or after the administration,” pg. 5, lines 10-27 and pg. 6, lines 5-6). Chaudhuri also teaches the same components as Applicant for performing this function, such as CYP450 2B6 and CYP2C9 and direct electrochemical detection (see Chaudhuri claim 3 and pg. 10, lines 1-2). As such, absent an indication of unexpected results, Chaudhuri is expected to have the same function of measuring blood propofol concentration.
Alternatively, if Applicant does not consider the measurement of propofol to be an inherent function of Chaudhuri, then Chaum teaches an analogous electrochemical sensor for monitoring of drug concentrations in blood to provide closed-loop feedback on anesthetic concentration (“electrochemical monitoring of hydrophobic drugs, such as propofol, in aqueous electrolyte solutions, blood…closed-loop, feedback controlled infusion of propofol during anesthesia,” par. 21). Furthermore, it was known in the art that propofol is a substrate of cytochrome P450 enzymes (“It is well known that individual patients metabolise the majority of drug-like molecules (including anaesthetics) at widely varying rates due to inter-individual polymorphic variations present in for example the cytochrome P450 enzymes,” Blackburn par. 9)
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to apply the sensor of Chaudhuri for measurement of propofol. One would be motivated to do so because Chaudhuri, Chaum, and Blackburn indicate the need to monitor drug concentrations, such as propofol, to monitor drug metabolism and/or provide closed-loop drug delivery (Chaudhuri pg. 5, lines 10-27 and pg. 6, lines 5-6; “electrochemical monitoring of hydrophobic drugs, such as propofol, in aqueous electrolyte solutions, blood, serum, or plasma. This will allow for the construction of a closed-loop, feedback controlled infusion of propofol during anesthesia,” Chaum par. 21; “the ability to rapidly and accurately measure and monitor the individual patient's blood plasma concentration of compounds such as propofol in real time in the operating theatre would therefore be a major advance in anaesthesiology,” Blackburn par. 9). This modification should be successful since propofol is a substrate of cytochrome P450 enzymes.
Regarding claim 2, Chaudhuri in view of Chaum and Blackburn teach providing discrete measurement of propofol (“the detection of bioavailable drug concentration is preferably performed repeatedly…it is generally desirable to repeat the detection procedure at least every 5 minutes,” Chaum par. 245).
Regarding claim 4 (see interpretation under the 112(b) rejection above), providing direct electrochemical measurement of propofol (“In the CYP based biosensor of the invention instead of relying on NADH, NADPH, CPR and b5 for the transfer of electrons, an electrode acts as an electron donor,” pg. 10, lines 1-2).
Regarding claim 8, Chaudhuri teaches the sensor is based on the enzyme cytochrome P450 2B6 (claim 3).
Regarding claims 9, 16, and 20-21, since the claim limitations are interpreted as inherent (see rejections under 35 USC 112 above), then the claims are also considered to be taught or suggested by Chaudhuri alone or Chaudhuri in view of Chaum and Blackburn.
Regarding claim 10, Chaudhuri alone or Chaudhuri in view of Chaum and Blackburn teaches or suggests a propofol detection system for point-of-care measurement (Chaum Fig. 41) of blood propofol concentration during general anaesthesia (“closed-loop, feedback controlled infusion of propofol during anesthesia,” Chaum par. 21; the preamble limitations do not add limit the claim scope as they only describe a use environment, and since Chaudhuri teaches the components of the system, Chaudhuri can be interpreted as being able to function in the claimed environment), comprising the enzyme-based electrochemical sensor of claim 6 (see rejection of claim 6 and 112(b) rejection above).
Regarding claim 15, Chaudhuri teaches (Fig. 1) a working electrode (1), a counter electrode (2) and a reference electrode (3).
Regarding claim 18, Chaudhuri teaches the enzyme is expressed within deactivated yeast cells (“freeze-drying a small volume of CYP-enzyme containing yeast suspension…on the electrode,” pg. 16, lines 5-6).
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 24 is rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri alone or Chaudhuri in view of Chaum and Blackburn, as applied to claim 6 above.
Regarding claim 24, Chaudhuri teaches the sensor comprises a CYP enzyme (Abstract), in which sensing occurs in the absence of direct electron transfer between an electrode and the CYP enzyme, using an indirect method via NADPH and electrochemically detecting the reaction products (“the activity of CYP is strongly dependent on the close proximity of the cytochrome P450 oxidoreductase enzyme (CPR), and NADPH or NADH to act as electron donors,” pg. 9, lines 20-22).
While Chaudhuri teaches the CYP biosensors use direct electron transfer between an electrode and the CYP enzyme, Chaudhuri still indicates that the use of NADH or NADPH as electron donors was known in the prior art (“In the CYP based biosensor of the invention instead of relying on NADH, NADPH, CPR and b5 for the transfer of electrons, an electrode acts as an electron donor,” pg. 10, lines 1-2).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chaudhuri to comprise NADPH so that the sensor senses via an indirect method using NADPH as an electron donor. One would be motivated to do so because this sensing method was already known in the prior art, and one of ordinary skill in the art could have substituted one sensing method for another. Although this is not a preferred embodiment of Chaudhuri, patents are relevant as prior art for all they contain (MPEP § 2123).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri in view of Chaum and Blackburn, as applied to claim 6 above.
Regarding claim 22, Chaudhuri does not explicitly teach or suggest multiple sensors. Chaum teaches two sensors in sequence associated with the detection of propofol (“a plurality of sensor arrays, where each array includes the two or more electrodes required for the sensing format of choice, e.g., one or more working electrodes in combination with a reference electrode and a counter electrode,” par. 210; “a plurality of the electrochemical sensors 601 located at various positions along the body,” par. 226).
While Chaum does not explicitly teach that the two sensors are in sequence with respect to a flow of perfusate, Chaum’s Fig. 41 suggests there may be multiple openings along a catheter. Chaum Fig. 55 explicitly shows openings 5520 and 5520. It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to comprise multiple sensors in sequence to a flow of perfusate. One would be motivated to do so because Chaum teaches multiple sensors, which can be positioned along the body, and indicates an arrangement of openings along a catheter in the direction of flow (“a plurality of the electrochemical sensors 601 located at various positions along the body,” par. 226; Fig. 41). The arrangement of multiple sensors in a direction of flow would further be obvious to try. This would allow for sensing of a drug in vivo (par. 226).
While Chaum does not explicitly teach the first sensor measuring a reduction current of 2,6-diisopropylquinone and the second sensor measuring an oxidation current of 2,6-diisopropylquinol, since Applicant indicates that a reduction must occur before a oxidation current can be measured (“it has been found that reduction must occur before the oxidation,” pg. 15, line 35; “oxidation of the quinol only occurs after reduction of the quinone. Monitoring at -0.2V alone would provide no signal,” pg. 16, lines 30-31), this limitation would be inherent to Chaudhuri in view of Chaum and Blackburn with multiple sensors measuring propofol in a flow of perfusate. The downstream sensor would be able to measure an oxidation current of the quinol after an upstream sensor reduces the quinone.
Regarding claim 23, the two sensors in sequence are co-located on a single device or two separate devices in sequence (Chaum Figs. 24, 41).
Claims 3 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri alone or Chaudhuri in view of Chaum and Blackburn, as applied to claims 1 and 10 above, and further in view of Karlsson (US 2012/0289795).
Regarding claim 3, Chaudhuri teaches the sensor is connected to a potentiostat for measurement (pg. 17, lines 10-11). Chaudhuri does not teach the sensor forms part of a blood-gas analyser. Karlsson teaches an analogous probe for continuous measurement of blood (Fig. 1; “the present invention can be used when measuring substances that are indicators of pathological conditions,” par. 2). Karlsson teaches that in the prior art, sample fluid can be collected and analyzed with a blood gas analyzer (“according to prior art, blood samples are drawn from a patient before being analysed with a blood gas analyser,” par. 4).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chaudhuri or Chaudhuri in view of Chaum and Blackburn to configure the sensor for use in a blood gas analyzer. One would be motivated to do so because blood gas analyzers were known in the art to analyze various components in the blood (“it is known that certain substances which may be present in the body can function as indicators for various pathological conditions in the body… according to prior art, blood samples are drawn from a patient before being analysed with a blood gas analyser,” Karlsson par. 4). Integrating Chaudhuri’s sensor into a blood gas analyzer would allow sensing of propofol along with other indicators, which there is a need for (“Biosensors according to the present invention…for evaluating drug pharmacokinetics in vitro or in vivo; for monitoring drug metabolism in an individual prior to, during or after the administration,” Chaudhuri pg. 5, lines 10-27 and pg. 6, lines 5-6).
Regarding claims 11-13 (see interpretation under 112(f) and the 112(b) rejections above), Karlsson also teaches that microdialysis probes are known in the prior art for measuring drug pharmacokinetic data (“according to prior art, a microdialysis probe with a semi-permeable membrane…perfusate absorbs substances in the blood through the membrane…then flows through a sensor where the substances are measured,” par. 4; “a drug is administered to a rat and where a microdialysis probe is placed…Mass spectrometry is used to batchwise analyse the dialysate for obtaining pharmacokinetic data,” par. 5).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chaudhuri or Chaudhuri in view of Chaum and Blackburn to configure the sensor for use with a microdialysis probe. One would be motivated to do so because microdialysis probes were known in the art to analyze various components in the blood, including drugs (“a drug is administered to a rat and where a microdialysis probe is placed…analyse the dialysate for obtaining pharmacokinetic data,” Karlsson par. 5). Integrating Chaudhuri’s sensor into a blood gas analyzer would allow sensing of in vivo sensing propofol along with other indicators, which there is a need for (“Biosensors according to the present invention…for evaluating drug pharmacokinetics in vitro or in vivo; for monitoring drug metabolism in an individual prior to, during or after the administration,” Chaudhuri pg. 5, lines 10-27 and pg. 6, lines 5-6).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Chaudhuri alone or Chaudhuri in view of Chaum and Blackburn, as applied to claim 18 above, and further in view of Michelini (US 2012/0045835).
Chaudhuri teaches the yeast cells are in turn immobilized with gold nanoparticles (GNP) upon the surface of a screen-printed electrode (“screen-printed electrode (SPE)…modified with MWCNTs and GNPs…yeast cells immobilized at the CNT-GNP electrode,” pg. 8, lines 11-24). Chaudhuri does not explicitly teach or suggest immobilizing the yeast cells in chitosan. Michelini teaches an analogous analyte detection device for the screening of blood and drugs (“screening of clinical samples: serum; blood…(e.g., for anti-doping analysis)…Pre-screening of new drugs and pharmacologically active molecules,” pars. 159-161). Michelini teaches that prior art biosensors entrap cells in matrices such as chitosan (par. 23). Although this is not a preferred embodiment, patents are relevant as prior art for all they contain (MPEP § 2123).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chaudhuri or Chaudhuri in view of Chaum and Blackburn to immobilize the yeast cells in chitosan on the electrode. One would be motivated to do so because chitosan was a known component for immobilizing cells on a matrix to provide a more stable biosensor, as suggested by Michelini (“entrapment of viable cells in polymeric matrices for the manufacture of stable bioluminescent cell biosensors. For example, the microbial cells are entrapped in a matrix selected from…chitosan,” par. 23; “yeast cells are immobilized in the device by means of a new biocompatible matrix comprising a combination of synthetic and natural polymers functionalized with specific crosslinking agents,” par. 41).
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/ALICE LING ZOU/Examiner, Art Unit 3791