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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January6 has been entered.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
Information Disclosure Statement
The Information Disclosure Statements filed on January 30, 2026 have been considered. Applicant fails to provide copies of foreign patent documents and non-patent literature documents, as required by 37 C.F.R. 1.98(a)(2). Further, Examiner notes that the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with the Applicant's duty of disclosure. see MPEP § 2004. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972) (accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), stating that forcing the Examiner to find a needle in a haystack is probative of bad faith.). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Priority
Applicant’s arguments regarding priority of claims for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) has been considered. The priority date of the claims are determined as follows:
Regarding claims 12-14, Applicant argues US Provisional Application Serial No. 63/082,999, filed on September 24, 2020, discloses harmful solutes in paragraph [0015]. Paragraph [0015] discloses “Reservoir solution 134 likewise serves at least one of three purposes, including introducing at least one sensor enhancing sensor solute to sensor solution 132, or removing at least one harmful solute from sensor solution 132, or removing analyte from sensing solution 132 if analyte easily traverses through membrane 140 toward sensor solution 132 but not back into the sample solution 130 which is the case for example with an oil-membrane for protecting membrane 140” and “A harmful solute will have a slower rate of diffusion through membrane 140 than through 142 such that if enters the solution 132 it will be removed.” Examiner agrees that this disclosure would be supportive for claim 12 reciting “wherein the sensor fluid includes at least one solute harmful to the at least one sensing electrode, wherein the second element is adapted to allow the at least one solute harmful to the at least one sensing electrode to diffuse from the sensor fluid into the reservoir fluid” and claim 14 reciting “wherein the sample fluid includes at least one solute harmful to the at least one sensing electrode, wherein the harmful solute has a lower total mass transport through first element than through second element such that if it enters the sensor fluid it will be removed into the reservoir fluid.” However, there is no support for claim 13 reciting “wherein the first concentration is lower than the second concentration in an amount selected from the group consisting of greater than 2X, less than 10X, and less than 100X.” Thus, claims 12 and 14 have the benefit of priority date as of September 24, 2020, but claim 13 still does not have such benefit.
Regarding claims 15 and 29, Applicant argues US Provisional Application Serial No. 63/082,834, filed on September 24, 2020, discloses “concentration of analyte” in paragraph [0013]. Paragraph [0013] discloses the definitions of “continuous sensing” with a “continuous sensor” that has the capability of a device to provide multiple measurements of an analyte over time. This disclosure does not support the recited “wherein the target analyte in the sample fluid is at a first concentration, and the target analyte in the sensor fluid is at a second concentration, wherein the first concentration and second concentration differ by an amount chosen from less than 5%, less than 10%, and less than 50%” in claim 15 or “wherein a concentration of analyte in the sensor fluid will be within at least a percentage of a concentration of analyte in the sample fluid, wherein the percentage is chosen from 50%, 10%, 2%, and 0.4%.” Thus, claims 15 and 29 do not have the alleged benefit.
Regarding claim 20, Applicant argues US Provisional Application Serial No. 63/197,674, filed on June 7, 2021, discloses “polyethersulfone (PES)” in paragraph [0051]. Examiner agrees and thus claim 20 has the benefit of priority date as of June 7, 2021.
Regarding claim 21, Applicant argues US Provisional Application Serial No. 63/082,834 discloses “hydrogel” and “agar” in paragraphs [0017] and [0019]. Paragraphs [0017] and [0019] merely discloses “a hydrogel” but not “agar.” Applicant further argues US Provisional Application Serial No. 63/085, 484 discloses “hydrogel” and “agar” in paragraph [0026]. Paragraphs [0026] discloses “the space normally occupied by the sensor fluid also contains at least one hydrogel such as agar of acrylate, that wets, potentially expands, and displaces gas from the device” and “this same hydrogel could be used to create a spacer between the membrane and the substrate carrying the electrode, and the hydrogel and device alternately could be stored wet.” Thus, this disclosure is for a hydrogel is within the sensor volume containing the sensor fluid for wetting, not the recited second element between the sensor volume and the reservoir volume, and cannot be the support for claim 21. As a result, claim 21 does not have the alleged benefit based on these disclosures.
Regarding claims 22-23, Applicant argues US Provisional Application Serial No. 63/122,071 discloses “volume” of the reservoir in paragraph [0023]. Paragraph [0023] discloses if the reservoir of aptamer had a volume of 200 µL, then it could lose 10% of its aptamer before sensor signal would be impacted by 10%.” Applicant further argues US Provisional Application Serial No. 63/085,484 discloses “volume” of the sensor fluid in paragraphs [0006], [0021], and [0024]. Paragraph [0006] discloses “the sensor fluid has a volume that is at least one of <500, <50, <5, <0.5 or <0.05 µL.” Paragraph [0021] discloses “the device would have a volume of … 50 µL of internal fluid volume.” Paragraph [0024] discloses “the sensor fluid is <500, <50, <5, <0.5 or <0.05 µL.” However, these disclosures are inadequate to support the recited “wherein the volume of the reservoir fluid in the second chamber is greater than the volume of sensor fluid in the first chamber” in claim 22 or “wherein the difference in volume of the reservoir fluid compared to the volume of the sensor fluid is chosen from at least 2X greater, at least l0X greater, at least 50X greater, and at least 250X greater” in claim 23 because US Provisional Application Serial No. 63/122,071 merely disclose the relationship between the volume of reservoir and the impact on the sensor signal, and the retaining time of the initial aptamer concentration, not the comparison on the volumes of the sensor fluid and sensor fluid. Thus, claims 22-23 does not have the alleged benefit based on these disclosures.
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 31are 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 pre-AIA the applicant regards as the invention.
Claim 31 is an improper dependent claim because it depends on claim 16 that has been canceled. 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.
For a compact prosecution, claim 31 will be examined as dependent on claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-9, 12-15, 18-19, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand (WO 2017/189122) in view of Lin (US 2020/0196925).
Regarding claim 1, Bertrand teaches a device for measuring the concentration of a target analyte in a sample fluid (Fig. 3; ¶37: sample concentration for a sweat sensing device with an EAB sensor 3) comprising:
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a. a housing (Fig. 3: the seat-impermeable substrate 370 and the cover 332 defining a housing for the EAB sensor) defining a plurality of chambers including at least a first chamber (Fig. 3: concentration channel 380) and a second chamber (Fig. 3: as annotated), the first chamber including a sensor fluid therein (Fig. 3: indicating the concentration channel 380 containing sensing fluid), and the second chamber including a reservoir fluid therein (Fig. 3: indicating the second chamber including a fluid passing through the post-sensor membrane 390);
b. a sample fluid area defined by the housing (Fig. 3: as annotated), the sample fluid area capable of receiving a sample fluid (Fig. 3: indicating the sample fluid area receiving sweat sample 14);
c. a first element (Fig. 3: pre-sensor membrane 394) that separates the first chamber from the sample fluid area (Fig. 3: indicating the pre-sensor membrane 394 separating the concentration channel 380 from the sample fluid area) and restricts diffusion of solutes between the sensor fluid and sample fluid (p. 9, para. 1: the pre-sensor membrane 394 used for the concentrator membrane, filters unwanted solutes);
d. a second element (Fig. 3: post-sensor membrane 392) that separates the first chamber from the second chamber (Fig. 3: indicating the post-sensor membrane 392 separating the concentration channel 380 from the annotated second chamber) and restricts diffusion of solutes between the sensor fluid and the reservoir fluid (here, this designation is functional limitation in apparatus claims, and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II). Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).); and
e. at least one sensing electrode positioned in the sensor fluid (Fig. 3: indicating sensors 322 and 324 in the sensor fluid within the concentration channel 380; ¶35: EAB sensor include an ion selective electrode sensor).
Bertrand does not disclose the plurality of aptamers free in the sensor fluid.
However, Lin teaches a microdevice for monitoring a target analyte, including a field effect transistor and a microfluidic channel including graphene ([Abstract]). The aptameric graphene nanosensing integrates aptamer-based selective analyte enrichment, and then the sample target was released into a free aptamer solution for binding of the free aptamer to the standard target on graphene via competitive binding, thus changing the graphene conductance (Fig. 38; ¶109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand by employing free aptamers in the sensor fluid for sensing as taught by Lin because it is a suitable detection method based on aptameric nanosensing due to specific binding between the aptamer and the analyte (Fig. 38; ¶109). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 3, Bertrand teaches a plurality of tags associated with the plurality of aptamers (Fig. 1; ¶33: a redox moiety 150 may be covalently bonded to the aptamer 140; ¶55: a plurality of aptamers may be chosen to cover the concentration range), the plurality of tags consisting of redox tags (¶33: redox moiety 150; here each aptamer is associated with a redox moiety, and thus a plurality of aptamers would be associated with the plurality of redox tags).
Regarding claim 4, Bertrand teaches wherein the at least one sensing electrode contains a plurality of aptamers (Fig. 1; ¶33: indicating aptamer 140 having a first end covalently bonded to a thiol 120, which is in turn covalently bonded to a gold electrode base 130; ¶55: a plurality of aptamers may be chosen to cover the concentration range).
Regarding claim 5, Bertrand teaches a plurality of tags associated with the plurality of aptamers (Fig. 1; ¶33: a redox moiety 150 may be covalently bonded to the aptamer 140; ¶55: a plurality of aptamers may be chosen to cover the concentration range), the plurality of tags consisting of redox tags (¶33: redox moiety 150; here each aptamer is associated with a redox moiety, and thus a plurality of aptamers would be associated with the plurality of redox tags).
Regarding claims 6-7, Bertrand teaches wherein the reservoir fluid contains at least one enhancing solute (¶58: using the concentrating membrane 390 and pump 330 to maintain the sweat sample at a pH or salinity level while in contact with the EAB sensors) and wherein the at least one enhancing solute is a molecule (since the sweat sample is maintained at a pH or salinity level, the fluid surrounding the sensor 326 must contain an enhancing solute, such as a buffer or a salt, to buffer the solution or maintain the salinity).
Regarding claim 8, Bertrand discloses wherein any restriction on the diffusion of the at least one enhancing solute from the reservoir fluid to the sensor fluid provided by the second element is less than any restriction on the diffusion of the at least one enhancing solute from the sensor fluid to the sample fluid provided by the first element (¶39: the post-sensor membrane 392 is configured to pass fluid and solutes smaller than the target analyte, and causes the target analyte to further concentrate near the EAB sensor 322; thus the enhancing solute, i.e., the solutes smaller than the target analyte (e.g., buffer or salt), would encounter less restriction on their diffusion at the post-sensor membrane 392 compared to that at the pre-sensor membrane 394).
Regarding claim 9, Bertrand teaches wherein the at least one sensor enhancing solute is partially retained in a sensor solution (¶39: the post-sensor membrane 392 is configured to pass fluid and solutes smaller than the target analyte, and causes the target analyte to further concentrate near the EAB sensor 322; thus the enhancing solute, i.e., the solutes smaller than the target analyte (e.g., buffer or salt), would be only partially retained in the sensor fluid withing the concentration channel 380).
Regarding claim 12, Bertrand teaches wherein the sensor fluid includes at least one solute harmful to the at least one sensing electrode (¶50: the EAB’s capture signal must therefore be corrected for aptamer fouling caused by randomly bound small molecules and salting out).
The designation “wherein the second element is adapted to allow the at least one solute harmful to the at least one sensing electrode to diffuse from the sensor fluid into the reservoir fluid” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 13, Bertrand teaches wherein the harmful solute in the reservoir fluid is at a first concentration and the harmful solute in the sensor fluid is at a second concentration (the randomly bound small molecules and salting out molecules have two concentrations in the concentration channel 380 and the second chamber).
The designation “wherein the first concentration is lower than the second concentration in an amount selected from the group consisting of greater than 2X, less than 10X, and less than 100X” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 14, Bertrand teaches wherein the sample fluid includes at least one solute harmful to the at least one sensing electrode (the randomly bound small molecules must be contained in the sample that cause sensor fouling).
The designation “wherein the harmful solute has a lower total mass transport through first element than through second element such that if it enters the sensor fluid it will be removed into the reservoir fluid” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 15, Bertrand and Lin disclose all limitations of claim 1 as applied to claim 1. Bertrand further discloses wherein the target analyte in the sample fluid is at a first concentration, and the target analyte in the sensor fluid is at a second concentration (Fig. 3; ¶39).
Bertrand and Lin do not explicitly disclose wherein the first concentration and second concentration differ by an amount chosen from less than 5%, less than 10%, and less than 50%.
However, Bertrand teaches the post-sensor membrane 392 is configured to pass fluid and solutes smaller than the target analyte, and causes the target analyte to further concentrate near the EAB sensor 322 (¶39). The post-sensor membrane 392 may simply substantially slow the flow of the sweat sample through the channel to aid in sample concentration (¶39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by adjusting the analyte concentrations in the first and second chambers as claimed because analyte concentration is a result-effective variable for the degree of concentrating the analyte for measurement and can be optimized through routine experimentation to achieve optimal response time of the biosensor. MPEP 2144.05 (II)(B).
Regarding claim 18, Bertrand teaches wherein the first element is a membrane (Fig. 3: pre-sensor membrane 394).
The designation “wherein… the membrane at least partially retains at least one sensor enhancing solute in the sensor solution” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Bertrand in view of Lin teaches all structural limitations of the presently claimed device including a first membrane, and thus is capable of partially retaining at least one sensor enhancing solute in the sensor solution.
Regarding claim 19, Bertrand teaches wherein the second element that separates the first chamber from the second chamber and restricts diffusion of solutes between the sensor fluid and the reservoir fluid is a membrane (Fig. 3: post-sensor membrane 390).
Further, the designation “restricts diffusion of solutes between the sensor fluid and the reservoir fluid” is functional limitation in apparatus claims, and does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. MPEP 2114 (II). Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 30, Bertrand teaches wherein the first element that separates the first chamber from the sample fluid area and restricts diffusion of solutes between the sensor fluid and sample fluid is a membrane (Fig. 3: pre-sensor membrane 394 separating the concentration channel 380 from the sample fluid area; p. 9, para. 1: the pre-sensor membrane 394 used for the concentrator membrane, filters unwanted solutes).
Regarding claim 31, Bertrand teaches wherein the first element is a membrane (Fig. 3: pre-sensor membrane 394) chose from a filtration membrane (p. 9, para. 1: the pre-sensor membrane 394 used for the concentrator membrane, filters unwanted solutes).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Sen (US 2008/0293160).
Regarding claims 10-11, Bertrand and Lin disclose all limitations of claim 1 as applied to claim 1. Bertrand and Lin do not explicitly disclose a passivating layer of molecules on the at least one sensing electrode (claim 10) or the passivating layer includes a monolayer of mercaptohexanol (claim 11).
However, Sen teaches a biosensor for electrically detecting the presence of analytes based on changes in DNA conformation induced by binding of a target analyte to a receptor site of the sensor (¶2). A plurality of sensors 10 is coupled to a gold chip 30 via a sulfur-gold linkage to form a robust DNA monolayer on the surface of chip 30 (Fig. 11(b); ¶100). The open surface of chip 30 may be passivated with 6-mercaptohexanol (MCH) to reduce nonspecific adsorption and current leakage (¶100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by passivating the sensing electrode surface with a monolayer of mercaptohexanol as taught by Sen because the MCH passivating layer would reduce nonspecific adsorption and current leakage (¶100) for the biosensor. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). Applying a known technique to a known device ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Peterson (US 2014/0234982).
Regarding claim 20, Bertrand and Lin disclose all limitations of claim 19 as applied to claim 19. Bertrand further discloses wherein the second element is a membrane (Fig. 3: post-sensor membrane 392). Bertrand and Lin do not disclose the membrane includes polyethersulfone (PES).
However, Peterson teaches dialysis membranes that are semi-permeable membranes that separate molecules by virtue of their size, shape, hydration and polarity, which are available in material of polyethersulphone (¶40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by substituting its dialysis membrane with one made of polyethersulphone as taught by Peterson. The suggestion for doing so would have been that polyethersulphone is a suitable material for dialysis membrane that separate molecules by their size and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Heikenfeld (US 2018/0199866).
Regarding claim 21, Bertrand and Lin disclose all limitations of claim 19 as applied to claim 19. Bertrand further discloses wherein the second element is a membrane (Fig. 3: post-sensor membrane 392). Bertrand and Lin do not disclose wherein the second element is a hydrogel, and the hydrogel includes agar.
However, Heikenfeld teaches a sweat sensing device 800 (Fig. 8; ¶60), including a material, such as a hydrogel, that protects sensor 820 (Fig. 8; ¶60). In another embodiment, a material 680 protecting a sensor 620 is a hydrophilic polymer with a coating of a hydrogel, such as agar (Fig. 6C, ¶55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by substituting its post-sensor membrane with one made of a polymer membrane coated with an agar layer as taught by Heikenfeld. The suggestion for doing so would have been that agar as a hydrogel is a suitable material for being a coating of a protective membrane of a sensor and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 22-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand in view of Lin, and further in view of Heikenfeld-1 (WO 2020/146002).
Regarding claims 22-23, Bertrand and Lin all limitations of claim 1 as applied to claim 1. Bertrand and Lin do not explicitly disclose wherein the volume of the reservoir fluid in the second chamber is greater than the volume of sensor fluid in the first chamber (claim 22) or wherein the difference in volume of the reservoir fluid compared to the volume of the sensor fluid is chosen from at least 2X greater, at least l0X greater, at least 50X greater, and at least 250X greater (claim 23).
However, Heikenfeld-1 teaches a device (Fig. 1) including a first chamber and a second chamber (Fig. 1: two chambers containing buffer 140 and sensing solution 142), a first element (Fig. 1: sensor membrane 172) and a second element (Fig. 1: buffer membrane 170) and at least one sensing electrode positioned in the sensor fluid (Fig. 2: sensor 220). The buffer 140 could have a volume that is at least ten times greater than the volume of a portion of the microfluidic component 130 (Fig. 1; ¶20). The relatively large volume of buffer 140 is advantageous to extend the useful lifetime of the buffer 140 (¶20). Heikenfeld-1 further teaches the volumes of fluids, sizes of analytes (diffusion coefficients), concentration gradients for the analytes (diffusion velocity), membrane flow/diffusion resistance, and other factors would impact the response time of the device 100 in response to a change in the analyte concentration. Thus, the volume sizes of the reservoir fluid and the sensor fluid would be result-effective variables.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by adjusting the volume sizes of the reservoir fluid and the sensor fluid as claimed because their volume sizes are result-effective variables as taught by Heikenfeld-1 and can be optimized through routine experimentation to achieve optimal response time of the biosensor. MPEP 2144.05 (II)(B).
Regarding claim 24, Bertrand and Lin disclose all limitations of claim 22, including wherein the sensor fluid contains a plurality of aptamers (Lin, Fig. 38; ¶109).
Regarding claims 25-28, Bertrand and Lin disclose all limitations of claim 24 as applied to claim 24. Bertrand and Lin do not explicitly disclose wherein a first mass flow of the plurality of aptamers that occurs at the first element is less than a second mass flow of the plurality of aptamers that occurs at the second element (claim 25) or wherein the degree by which the first mass flow of the plurality of aptamers is less than the second mass flow of the plurality of aptamers is selected from the group consisting of at least 2X less, at least I0X less, at least 50X less, and at least 250X less (claim 26) or wherein a first mass flow of the analyte that occurs at the first element is greater than a second mass flow of the analyte that occurs at the second element (claim 27) or wherein the degree by which the first mass flow of analyte is greater than the second mass flow of analyte is selected from the group consisting of at least 2X greater, at least I0X greater, at least 50X greater, and at least 250X greater (claim 28).
However, Heikenfeld-1 teaches the buffer membrane 170 may be made of a dialysis membrane that allows transport of solute in a predetermined molecular weight range (¶20). The sensor membrane 172 may have a molecular weight cutoff above which analytes or solutes are unable to significantly traverse the membrane (¶23). For example, the buffer 140 could have a volume that is at least ten times greater than the volume of a portion of the microfluidic component 130 (¶20). The relatively large volume of buffer 140 is advantageous to extend the useful lifetime of the buffer 140 (¶20). Heikenfeld further teaches the volumes of fluids, sizes of analytes (diffusion coefficients), concentration gradients for the analytes (diffusion velocity), membrane flow/diffusion resistance, and other factors would impact the response time of the device 100 in response to a change in the analyte concentration. Thus, the mass flow, of the solutes, analytes, aptamers, etc., through the sensor membrane 172 or the buffer membrane based on their sizes, concentrations, membrane materials and/or structures, and chamber volumes of the reservoir fluid and the sensor fluid would be result-effective variables.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by adjusting the mass flows through the first and second elements (i.e., membranes) and their ratios as claimed because they are result-effective variables as taught by Heikenfeld-1 and can be optimized through routine experimentation to achieve optimal response time of the biosensor. MPEP 2144.05 (II)(B).
Regarding claim 29, Bertrand, Lin, and Heikenfeld-1 disclose all limitations of claim 27 as applied to claim 27. Bertrand, Lin, and Heikenfeld-1 do not explicitly disclose wherein a concentration of analyte in the sensor fluid will be within at least a percentage of a concentration of analyte in the sample fluid, wherein the percentage is chosen from 50%, 10%, 2%, and 0.4%.
However, Heikenfeld-1 teaches the volumes of fluids, sizes of analytes (diffusion coefficients), concentration gradients for the analytes (diffusion velocity), membrane flow/diffusion resistance, and other factors would impact the response time for the device 100 in response to a change in concentration of analyte ranging from seconds to hours, or even longer, with a preferable response time being on the order of minutes (¶27), and thus rendering the analyte concentration a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bertrand and Lin by adjusting the analyte concentrations in both sample fluid and the sensor fluid as claimed because analyte concentration is a result-effective variable as taught by Heikenfeld-1 and can be optimized through routine experimentation to achieve optimal response time of the biosensor. MPEP 2144.05 (II)(B).
Response to Arguments
Applicant’s arguments has/have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795