DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 4-6, 8, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et al. ‘509 (US Pub No. 2010/0108509 – cited by Applicant) in view of Gardner et al. ‘382 (US Pub No. 2004/0167382 – cited by Applicant).
Regarding claim 1, Curry et al. ‘509 teaches an analyte monitoring system (Fig. 1 amperometric sensor 11 and [0090]), the system comprising:
a sensor (Fig. 1 flexible substrate 13 and [0090]) configured for at least partial placement in an interstitial fluid ([0006]; “in vivo analyte concentration measurement and monitoring”), the sensor comprising:
a first transducer that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the first transducer (Fig. 1 electrode 19 and [0090]; [0006]);
a first diffusion barrier arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the first diffusion barrier before reaching the first transducer (Fig. 3 membrane 3 and [0092]), wherein the first diffusion barrier is configured such that the analyte contained in the interstitial fluid diffuses through the first diffusion barrier at a first diffusion rate r1 (One of ordinary skill would understand that the analyte diffusing through membrane 25 would diffuse at a rate.); and
a second transducer that exhibits one or more detectable properties based on the amount or concentration of the analyte in proximity to the second transducer element (Fig. 1 electrode 17 and [0090]; [0048]).
Curry et al. ‘509 teaches all of the elements of the current invention as mentioned above except for a transceiver configured to:
receive first sensor data collected from the first transducer;
receive second sensor data collected from the second transducer;
calculate an interstitial fluid analyte level rate of change based on at least the first sensor data, the second sensor data, and the first diffusion rate r1.
Gardner et al. ‘382 teaches a transceiver (Fig. 1 spectrum analyzer 30 and [0061]) configured to:
receive first sensor data collected from the first transducer ([0084]; “X is the concentration of the analyte in one compartment”);
receive second sensor data collected from the second transducer ([0084]; “Y is the concentration in a second compartment”);
calculate an interstitial fluid analyte level rate of change based on at least the first sensor data, the second sensor data, and the first diffusion rate r1 ([0048]; “determine a rate and direction of change of concentration of one or more analytes” [0083]).
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 the system of Curry et al. ‘509 to include a transceiver as Gardner et al. ‘382 teaches that this will aid in measuring the value, rate of change, and direction of change of the analyte concentration by analyzing tissue ([0023]).
Regarding claim 4, Curry et al. ‘509 in view of Gardner et al. ‘382 teaches all of the elements of the current invention as mentioned above except for wherein the transceiver is configured to calculate the interstitial fluid analyte level rate of change using the following formula:
R
I
S
F
=
C
G
1
t
-
C
G
0
t
τ
1
-
τ
0
, wherein:
RISF is the interstitial fluid analyte level rate of change;
CG1(t) is the first sensor data collected by the first transducer at the time t;
CG0(t) is the second sensor data collected from the second transducer at the time t;
T1 is a delay associated with the first diffusion barrier and is inversely related to the first diffusion rate r1; and
T0 is (a) zero if no diffusion barrier is disposed over the second transducer such that, when the sensor is placed in the medium, the analyte contained in the medium need not diffuse through a diffusion barrier before reaching the second transducer or (b) if a second diffusion barrier is arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the first transducer, a delay associated with the second diffusion barrier.
Gardner et al. ‘382 teaches, in [0083], the relationship between the prediction rate of change and the analyte concentration in another compartment can be established using a known or experimentally determined equation. The equation for a first order diffusion system is:
d
Y
d
t
=
k
(
X
-
Y
)
[0084] of Gardner et al. ‘382 teaches that X is the concentration of the analyte in one compartment, Y is the concentration in a second compartment, k is the diffusion constant, and dY/dt is the rate of change of Y. It is noted that k, the diffusion constant, is used to teach T1 - T2. Claim 18 recites that T2 is (a) zero if no diffusion barrier is disposed over the second transducer such that, when the sensor is placed in the medium, the analyte contained in the medium need not diffuse through a diffusion barrier before reaching the second transducer or (b) if a second diffusion barrier is arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the first transducer, a delay associated with the second diffusion barrier (emphasis added). As such, Examiner interprets the T0 as (a). Regarding T1, claim 18 recites that T1 is inversely related to r1, or 1/r1. When replacing T1 with 1/r1, the RISF equation would be: RISF = r1(CG1(t) – CG0(t)). As such, the diffusion constant k is interpreted as the first diffusion rate r1.
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 the transceiver of Curry et al. ‘509 in view of Gardner et al. ‘382 to include calculating the interstitial fluid analyte level rate of change using the recited formula as Garnder et al. ‘382 teaches that the determined equation is a known equation used to predict rate of change ([0083]).
Regarding claim 5, Curry et al. ‘509 in view of Gardner et al. ‘382 teaches all of the elements of the current invention as mentioned above except for wherein T1 is equal to 1/r1.
Gardner et al. ‘382 teaches, in [0083], the relationship between the prediction rate of change and the analyte concentration in another compartment can be established using a known or experimentally determined equation. The equation for a first order diffusion system is:
d
Y
d
t
=
k
(
X
-
Y
)
[0084] of Gardner et al. ‘382 teaches that X is the concentration of the analyte in one compartment, Y is the concentration in a second compartment, k is the diffusion constant, and dY/dt is the rate of change of Y. Regarding T1, claim 18 recites that T1 is inversely related to r1, or 1/r1. When replacing T1 with 1/r1, the RISF equation would be: RISF = r1(CG1(t) – CG0(t)). As such, the diffusion constant k is interpreted as the first diffusion rate r1.
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 T1 of Curry et al. ‘509 in view of Gardner et al. ‘382 to include being equal to 1/r1 as Garnder et al. ‘382 teaches that the determined equation is a known equation used to predict rate of change ([0083]).
Regarding claim 6, Curry et al. ‘509 teaches wherein the transceiver is configured to calculate an interstitial fluid analyte level based on at least (a) the first sensor data, (b) the second sensor data, or (c) the first sensor data and the second sensor data ([0040], [0090]).
Regarding claims 8 and 13-16, Curry et al. ‘509, as modified by Gardner et al. ‘382, teaches a method, as claimed, as claim 8 is analogous to claim 1 and claims 13-16 are analogous to claims 1 and 4-
Claims 2, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Joshi et al. ‘678 (US Pub No. 2009/0084678 – cited by Applicant) further in view of Liu et al. ‘647 (US Pub No. 2015/0148647 – cited by Applicant) further in view of Rebec et al. ‘869 (US Pub No. 2013/0303869 – cited by Applicant).
Regarding claims 2, 9, and 18, Curry et al. ‘509 in view of Gardner et al. ‘382 teaches all of the elements of the current invention as mentioned above except for a second diffusion barrier arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the second transducer, wherein the second diffusion barrier is further configured such that analyte contained in the interstitial fluid diffuses through the second diffusion barrier at a second diffusion rate r2, the second diffusion rate r2 being greater than the first diffusion rate r1;
wherein calculating the interstitial fluid analyte level rate of change is further based on the second diffusion rate r2.
Joshi et al. ‘678 teaches an inhibiting layer 8 that may cover electrodes 3a and 3b. An optional passivation, protective or inhibiting layer 8 may cover electrodes 3 and all or a portion of layers 2 and 7 (Fig. 4A and [0091]). One of ordinary skill would understand that the diffusion rate of the analyte through the second diffusion barrier before reaching the second transducer would diffuse at a rate.
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 the system of Curry et al. ‘509 in view of Gardner et al. ‘382 to include a second diffusion barrier arranged such that, when the sensor is placed in the interstitial fluid, the analyte contained in the interstitial fluid diffuses through the second diffusion barrier before reaching the second transducer, wherein the second diffusion barrier is further configured such that analyte contained in the interstitial fluid diffuses through the second diffusion barrier at a second diffusion rate r2 as Joshi et al. ‘678 teaches that including a diffusion barrier, or inhibiting layer, is optional.
Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Joshi et al. ‘678 teaches all of the elements of the current invention as mentioned above except for the second diffusion rate r1 being greater than the first diffusion rate r1.
Liu et al. ‘647 teaches thicker copolymer layers that covers an analyte sensor could reduce the rate, for a given concentration of the analyte in a fluid to which the sensor is exposed, at which the analyte diffused from the fluid to the analyte sensing component. A thinner thickness of the copolymer layer could be chosen to increase the rate, for a given concentration of the analyte in the fluid that the analyte diffuses to the analyte sensing component, thus increasing the sensitivity of the analyte sensor ([0039]).
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 the first diffusion barrier of Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Joshi et al. ‘678 to include the different copolymer layer thicknesses of Liu et al. ‘647 as it would reduce the rate at which the analyte diffused from the fluid to an analyte sensing component.
Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Joshi et al. ‘678 further in view of Liu et al. ‘647 teaches all of the elements of the current invention as mentioned above except for wherein calculating the interstitial fluid analyte level rate of change is further based on the second diffusion rate r2.
Rebec et al. ‘869 teaches that representative values are blood glucose value, that represents the determined concentration ([0023]) and tracking of representative values over time ([0075]), or rate of change of analyte level. Rebec et al. ‘869 teaches that some analysis/control regions may be used by a reader device to correct or determine representative values for a target analyte based on a local condition such as local blood/fluid flow, or changes/differences in analyte diffusion rates ([0108]).
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 the calculating of the interstitial fluid analyte level rate of change of Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Joshi et al. ‘678 further in view of Liu et al. ‘647 to include being based on the second diffusion rate r2 as Rebec et al. ‘869 teaches that this will aid in determining target analyte levels ([0108]).
Claims 3 and 12 rejected under 35 U.S.C. 103 as being unpatentable over Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of DeHennis ‘288 (US Pub No. 2015/0199288 – cited by Applicant).
Regarding claims 3 and 12, Curry et al. ‘509 in view of Gardner et al. ‘382 teaches all of the elements of the current invention as mentioned above except for wherein the first transducer comprises a first polymer graft and first indicator molecules, and the second transducer comprise a second polymer graft and second indicator molecules.
DeHennis ‘288 teaches sensors 100 include an analyte indicator element 106, such as, for example, a polymer graft coated, diffused, adhered, or embedded on or in at least a portion of the exterior surface of the system housing 104. The analyte indicator element 106 (e.g., polymer graft) of the sensor 100 may include indicator molecules (e.g., fluorescent indicator molecules) exhibiting one or more detectable properties (e.g., optical properties) based on the amount or concentration of the analyte in proximity to the analyte indicator element (Fig. 1 and [0022]).
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 the first and second transducers of Curry et al. ‘509 in view of Gardner et al. ‘382 to include a first/second polymer graft and first/second indicator molecules, respectively, as DeHennis ‘288 teaches that the polymer grafts and indicator molecules would aid in exhibiting one or more detectable properties based on the amount or concentration of the analyte in proximity to the analyte indicator element.
Claims 7, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et al. ‘509 in view of Gardner et al. ‘382 further in view of Rebec et al. ‘869.
Regarding claims 7, 10, and 17, Curry et al. ‘509 in view of Gardner et al. ‘382 teaches all of the elements of the current invention as mentioned above except for wherein the transceiver is further configured to calculate a blood analyte level based on the interstitial fluid analyte level and the interstitial fluid analyte level rate of change.
Rebec et al. ‘869 teaches that some analysis/control regions may be used by a reader device to correct or determine representative values for a target analyte based on a local condition such as local blood/fluid flow, or changes/differences in analyte diffusion rates ([0108]). Representative values may be a blood glucose value, that represents determined concentration ([0023]). Concentrations of target analytes in the interstitial fluid are also determined ([0077]).
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 the transceiver of Curry et al. ‘509 in view of Gardner et al. ‘382 to include calculating a blood analyte level based on the interstitial fluid analyte level and the interstitial fluid analyte level rate of change as Rebec et al. ‘869 teaches that this will aid in determining target analyte levels ([0108]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8, and 10-15 of U.S. Patent No. 12,303,265. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 4-8, and 10-15 of the US Patent is narrower in scope than claims 1-10 and 13-18 of the current invention, and encompasses all of the subject matter of claims 1-10 and 13-18. Therefore, any reference meeting the limitations set forth in claims 1, 2, 4-8, and 10-15 of the US Patent would also meet the limitations set forth in claims 1-10 and 13-18 of the current invention.
Conclusion
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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