DETAILED ACTION
Claims 1-20 are hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/07/2025 is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities:
Regarding claim 6, line 3 recites “a partial withdrawal”, however it appears it should read --the partial withdrawal-- (emphasis added).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 15: The claim limitation “a data processing unit … configured to … determine a current ratio … compare the current ratio … determine that the transcutaneous sensor has been at least partially withdrawn …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “configured to … determine a current ratio … compare the current ratio … determine that the transcutaneous sensor has been at least partially withdrawn …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 15 and Claim 17: The claim limitation “a primary receiver unit coupled to the data processing unit” (claim 15) and “the primary receive unit is configured to transmit data to the data processing terminal” (claim 17) has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “coupled to the data processing unit … configured to transmit data to the data processing terminal” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 16: The claim limitation “a secondary receiver unit coupled to the data processing unit” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “coupled to the data processing unit” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 17: The claim limitation “a data processing terminal … primary receiver unit is configured to transmit data to the data processing terminal” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “terminal” coupled with functional language “configured to transmit data to the data processing terminal” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “terminal”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“one or more application-specific integrated circuits (ASIC) may be used to implement one or more functions or routines associated with the operations of the data processing unit (and/or receiver unit) …”, or equivalents thereof, as described in para. [0071] of the disclosure filed on 03/07/2025;
“primary receiver unit 404 includes one or more of: a test strip interface 601, an RF receiver 602, a user input 603, an optional temperature detection section 604, and a clock 605, each of which is operatively coupled to a processing and storage section 607. The primary receiver unit 404 also includes a power supply 606 operatively coupled to a power conversion and monitoring section 608. Further, the power conversion and monitoring section 608 is also coupled to the processing and storage section 607. Moreover, also shown are a receiver serial communication section 609, and an output 610, each operatively coupled to the processing and storage section 607. The primary receiver unit 404 may include user input and/or interface components or may be free of user input and/or interface components”, or equivalents thereof, as described in para. [0073] of the disclosure filed on 03/07/2025;
“secondary receiver unit 406 may include a smaller (in one or more, including all, dimensions), compact housing or embodied in a device including a wrist watch, arm band, PDA, mp3 player, cell phone …”, or equivalents thereof, as described in para. [0062] of the disclosure filed on 03/07/2025; and
“data processing terminal 405 may include a personal computer, a portable computer including a laptop or a handheld device (e.g., a personal digital assistant (PDA), a telephone including a cellular phone (e.g., a multimedia and Internet-enabled mobile phone including an iPhoneTM, a Blackberry®, or similar phone), an mp3 player (e.g., an iPODTM, etc.), a pager, and the like), and/or a drug delivery device (e.g., an infusion device), each of which may be configured for data communication with the receiver via a wired or a wireless connection …”, or equivalents thereof, as described in para. [0068] of the disclosure filed on 03/07/2025.
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.
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.
Analysis in view of US 11,357,428 B2
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,357,428 B2, hereinafter referred to as ‘428 in view of Hayter et al. (US 20100081906 A1), hereinafter referred to as Hayter.
Regarding claim 1, ‘428 discloses a method of detecting a partial withdrawal of a transcutaneous sensor from a patient, the method comprising (claim 1, “A method of detecting withdrawal of a transcutaneous sensor from a patient, the method comprising”):
generating a first current output from an analyte of the patient utilizing a first working electrode having a first active sensing area (Claim 1, “transducing, with a first working electrode and a second working electrode of the transcutaneous sensor, an analyte in the patient into a first current output and a second current output” and “a first active sensing area …”);
generating a second current output from the analyte of the patient utilizing a second working electrode having a second active sensing area (Claim 1, “transducing, with a first working electrode and a second working electrode of the transcutaneous sensor, an analyte in the patient into a first current output and a second current output” and “a second active sensing area …”); and
determining that the transcutaneous sensor has at least partially withdrawn from the patient based on a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area (Claim 1, “determining a current ratio of the first current output by the first working electrode of the transcutaneous sensor to the second current output by the second working electrode of the transcutaneous sensor; comparing the current ratio to a size ratio defined by a first size of a first active sensing area of the first working electrode to a second size of a second active sensing area of the second working electrode; and determining that the transcutaneous sensor has at least partially withdrawn from the patient based on the current ratio being different than the size ratio”).
However, ‘428 does not disclose the first active sensing area and the second active sensing area are at least partially embedded below a skin line of the patient.
Hayter teaches an analyte monitoring system comprising a transcutaneous sensor comprising multiple working electrodes (Fig. 1, Fig. 2, Fig. 3, Fig. 5A, Abstract, para. [0034], para. [0041-0042]). Hayter further teaches the working electrodes comprise active sensing areas at least partially embedded below the skin line of the patient (Fig. 5A, para. [0041], para. [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by ‘428 to additionally at least partially embed the working electrodes below the skin line of the patient, as taught by Hayer. This is because Hayter teaches embedding the working electrodes in the subcutaneous space of the users allows for the sensor to come into contact with the user’s interstitial fluid, allowing for continuous analyte monitoring (para. [0019], para. [0041]).
Regarding claim 2, ‘428 discloses the method of claim 1, further comprising compensating for a reduction in current output from one of the first and second working electrodes due to the partial withdrawal of the transcutaneous sensor using a difference between the current ratio and the size ratio (Claim 2, “compensating for a reduction in the current output from one of the first and second working electrodes due to the partial withdrawal of the transcutaneous sensor using a difference between the current ratio and the size ratio”).
Regarding claim 3, ‘428 discloses the method of claim 1, wherein the first size of the first active sensing area is different than the second size of the second active sensing area (Claim 3, “wherein the first active sensing area has a first size and wherein the second active sensing area has a second size different than the first size”).
Regarding claim 4, ‘428 discloses the method of claim 1, wherein the first size of the first active sensing area is substantially equal to the second size of the second active sensing area (Claim 4, “wherein the first active sensing area has a first size and wherein the second active sensing area has a second size substantially equal to the first size”).
Analysis in view of US 11,918,356 B2
Claims 5-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 20 of U.S. Patent No. 11,918,356 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application: 19/074,133 (claim set filed on 03/07/2025)
Reference Patent: US 11,918,356 B2 (claim set published on 03/05/2024)
5. A transcutaneous sensing system, comprising:
a transcutaneous sensor comprising:
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output; and
a processor configured to determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area.
1. A system for detecting partial withdrawal of a transcutaneous sensor from a patient, the system comprising:
the transcutaneous sensor, the transcutaneous sensor comprising:
a substrate;
a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in the patient into a first current output; and
a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output,
wherein the first active sensing area is longitudinally offset along the substrate from the second active sensing area; and
a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to:
determine a current ratio of the first current output to the second current output;
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area; and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio.
6. The transcutaneous sensing system of claim 5, wherein the processor is further configured to compensate for a reduction in the first current output or the second current output due to a partial withdrawal of the transcutaneous sensor utilizing a difference between the current ratio and the size ratio.
2. The system of claim 1, wherein the data processing unit is further configured to compensate for a reduction in the first current output or the second current output due to the partial withdrawal of the transcutaneous sensor utilizing a difference between the current ratio and the size ratio.
7. The transcutaneous sensing system of claim 5, wherein the first size of the first active sensing area is different than the second size of the second active sensing area.
3. The system of claim 1, wherein the first size of the first active sensing area is different than the second size of the second active sensing area.
8. The transcutaneous sensing system of claim 5, wherein the first size of the first active sensing area and the second size of the second active sensing area are substantially equal in size.
4. The system of claim 1, wherein the first size of the first active sensing area and the second size of the second active sensing area are substantially equal in size.
9. The transcutaneous sensing system of claim 5, wherein the first active sensing area comprises a first plurality of sensing spots and wherein the second active sensing area comprises a second plurality of sensing spots.
5. The system of claim 1, wherein the first active sensing area comprises a first plurality of sensing spots and wherein the second active sensing area comprises a second plurality of sensing spots.
10. The transcutaneous sensing system of claim 9, wherein a size of each first sensing spot of the first plurality of sensing spots is substantially equal to a size of each second sensing spot of the second plurality of sensing spots.
6. The system of claim 5, wherein a size of each sensing spot of the first plurality of sensing spots is substantially the same as a size of each sensing spot of the second plurality of sensing spots.
11. The transcutaneous sensing system of claim 10, wherein the first plurality of sensing spots comprises a greater number of sensing spots than the second plurality of sensing spots.
7. The system of claim 6, wherein the first plurality of sensing spots comprises a greater number of sensing spots than the second plurality of sensing spots.
12. The transcutaneous sensing system of claim 5, further comprising a substrate, wherein a proximalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a proximalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
8. The system of claim 1, wherein a proximalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a proximalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
13. The transcutaneous sensing system of claim 5, further comprising a substrate, wherein a distalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a distalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
9. The system of claim 1, wherein a distalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a distalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
14. The transcutaneous sensing system of claim 5, wherein a longitudinally centered portion of the first active sensing area is offset from a longitudinally centered portion of the second active sensing area.
10. The system of claim 1, wherein a longitudinally centered portion of the first active sensing area is offset from a longitudinally centered portion of the second active sensing area.
5. A transcutaneous sensing system, comprising:
a transcutaneous sensor comprising:
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output; and
a processor configured to determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area.
20. A transcutaneous sensing system, comprising:
a transcutaneous sensor comprising:
a substrate;
a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output,
wherein the first active sensing area is longitudinally offset along the substrate from the second active sensing area; and
a processor configured to:
determine a current ratio of the first current output to the second current output;
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area; and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio.
Claims 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, and 20 of U.S. Patent No. US 11,918,356 B2, hereinafter referred to as ‘356, in view of Hayter et al. (US 20100081906 A1), hereinafter referred to as Hayter.
Regarding claim 15, ‘356 discloses an analyte monitoring system comprising (claim 1, “A system for detecting partial withdrawal of a transcutaneous sensor from a patient”):
a transcutaneous sensor comprising (claim 1, “the transcutaneous sensor, the transcutaneous sensor comprising”):
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output (claim 1, “a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in the patient into a first current output”); and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output (claim 1, “a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output”),
wherein the first active sensing area is longitudinally offset from the second active sensing area (claim 1, “wherein the first active sensing area is longitudinally offset along the substrate from the second active sensing area”); and
a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to (claim 1, “a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to”):
determine a current ratio of the first current output to the second current output (claim 1, “determine a current ratio of the first current output to the second current output”);
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area (claim 1, “compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area”); and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio (claim 1, “determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio”).
However, ‘356 does not disclose a primary receiver unit coupled to the data processing unit.
Hayter discloses an analyte monitoring system comprising a transcutaneous sensor comprising a substrate and multiple working electrodes (Fig. 1, Fig. 2, Fig. 3, Fig. 5A, Abstract, para. [0034], para. [0041-0042]). Hayter discloses the analyte monitoring system comprises a data processing unit (Fig. 1, element 102, para. [0023]). Hayter further discloses a primary receiver unit coupled to the data processing unit (Fig. 1, element 104, para. [0023-0024], [0028-0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyte monitoring system disclosed by ‘356 to additionally include a primary receiver unit coupled to the data processing unit. Hayter teaches a primary receiver unit coupled to the data processing unit allows for data to be transmitted and received between the two components (para. [0023-0024]), thereby allowing processing to be performed in different locations reducing the size of the devices.
Regarding claim 16, ‘356 discloses the analyte monitoring system of claim 15.
However, ‘356 does not disclose a secondary receiver unit coupled to the data processing unit.
Hayter further discloses the analyte monitoring system comprises a secondary receiver unit coupled to the data processing unit (Fig. 1, element 106, para. [0023-0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyte monitoring system disclosed by ‘356 to additionally include a secondary receiver unit coupled to the data processing unit. Hayter teaches a secondary receiver unit coupled to the data processing unit allows for data to be transmitted and received between the two components, specifically with smaller housing devices (para. [0023-0024]).
Regarding claim 17, ‘356 discloses the analyte monitoring system of claim 15.
However, ‘356 does not disclose a data processing terminal, wherein the primary receiver unit is configured to transmit data to the data processing terminal.
Hayter further discloses a data processing terminal, wherein the primary receiver unit is configured to transmit data to the data processing terminal (Fig. 1, element 105, para. [0023-0024], [0030-0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyte monitoring system disclosed by ‘356 to additionally include a data processing terminal. Hayter discloses a data processing terminal configured to receive data from the data processing unit allows for further processing and may be used as a device for supplying treatment based on data from the data processing unit (para. [0030-0031]).
Regarding claim 18, ‘356 discloses the analyte monitoring system of claim 15, wherein the transcutaneous sensor further comprises a substrate and a reference electrode on the substrate (claim 11, “The system of claim 1, further comprising a reference electrode on the substrate”).
Regarding claim 19, ‘356 discloses the analyte monitoring system of claim 18, wherein the transcutaneous sensor further comprises a counter electrode on the substrate (claim 12, “The system of claim 11, further comprising a counter electrode on the substrate.”).
Regarding claim 20, ‘356 discloses the analyte monitoring system of claim 19, wherein the transcutaneous sensor further comprises a first dielectric insulator layer between the reference electrode and the substrate and a second dielectric insulator layer between the counter electrode and the substrate (claim 13, “The system of claim 12, further comprising a first dielectric insulator layer between the reference electrode and the substrate and a second dielectric insulator layer between the counter electrode and the substrate”).
Regarding claim 15, ‘356 discloses an analyte monitoring system comprising (claim 20, “A transcutaneous sensing system, comprising”):
a transcutaneous sensor comprising (claim 20, “a transcutaneous sensor comprising”):
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output (claim 20, “a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output”); and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output (claim 20, “a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output”),
wherein the first active sensing area is longitudinally offset from the second active sensing area (claim 20, “wherein the first active sensing area is longitudinally offset along the substrate from the second active sensing area”); and
a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to (claim 20, “a processor configured to”):
determine a current ratio of the first current output to the second current output (claim 20, “determine a current ratio of the first current output to the second current output”);
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area (claim 20, “compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area”); and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio (claim 20, “determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio”).
However, ‘356 does not disclose a primary receiver unit coupled to the data processing unit.
Hayter discloses an analyte monitoring system comprising a transcutaneous sensor comprising a substrate and multiple working electrodes (Fig. 1, Fig. 2, Fig. 3, Fig. 5A, Abstract, para. [0034], para. [0041-0042]). Hayter discloses the analyte monitoring system comprises a data processing unit (Fig. 1, element 102, para. [0023]). Hayter further discloses a primary receiver unit coupled to the data processing unit (Fig. 1, element 104, para. [0023-0024], [0028-0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyte monitoring system disclosed by ‘356 to additionally include a primary receiver unit coupled to the data processing unit. Hayter teaches a primary receiver unit coupled to the data processing unit allows for data to be transmitted and received between the two components (para. [0023-0024]), thereby allowing processing to be performed in different locations reducing the size of the devices.
Analysis in view of US 12,268,500 B2
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 12,268,500 B2, hereinafter referred to as ‘500 in view of Hayter et al. (US 20100081906 A1), hereinafter referred to as Hayter.
Regarding claim 1, ‘500 discloses a method of detecting a partial withdrawal of a transcutaneous sensor from a patient, the method comprising (claim 1, “A method of detecting withdrawal of a transcutaneous sensor from a patient, the method comprising”):
generating a first current output from an analyte of the patient utilizing a first working electrode having a first active sensing area (Claim 1, “transducing, with a first working electrode having a first active sensing area and a second working electrode having a second active sensing area of the transcutaneous sensor, an analyte in the patient into a first current output and a second current output”);
generating a second current output from the analyte of the patient utilizing a second working electrode having a second active sensing area (Claim 1, “transducing, with a first working electrode having a first active sensing area and a second working electrode having a second active sensing area of the transcutaneous sensor, an analyte in the patient into a first current output and a second current output”); and
determining that the transcutaneous sensor has at least partially withdrawn from the patient based on a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area (Claim 1, “determining that the transcutaneous sensor has at least partially withdrawn from the patient based on a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area”).
However, ‘428 does not disclose the first active sensing area and the second active sensing area are at least partially embedded below a skin line of the patient.
Hayter teaches an analyte monitoring system comprising a transcutaneous sensor comprising multiple working electrodes (Fig. 1, Fig. 2, Fig. 3, Fig. 5A, Abstract, para. [0034], para. [0041-0042]). Hayter further teaches the working electrodes comprise active sensing areas at least partially embedded below the skin line of the patient (Fig. 5A, para. [0041], para. [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by ‘428 to additionally at least partially embed the working electrodes below the skin line of the patient, as taught by Hayer. This is because Hayter teaches embedding the working electrodes in the subcutaneous space of the users allows for the sensor to come into contact with the user’s interstitial fluid, allowing for continuous analyte monitoring (para. [0019], para. [0041]).
Regarding claim 2, ‘428 discloses the method of claim 1, further comprising compensating for a reduction in current output from one of the first and second working electrodes due to the partial withdrawal of the transcutaneous sensor using a difference between the current ratio and the size ratio (Claim 2, “compensating for a reduction in the current output from one of the first and second working electrodes due to the partial withdrawal of the transcutaneous sensor using a difference between the current ratio and the size ratio”).
Regarding claim 3, ‘428 discloses the method of claim 1, wherein the first size of the first active sensing area is different than the second size of the second active sensing area (Claim 3, “wherein the first size of the first active sensing area is different than the second size of the second active sensing area”).
Regarding claim 4, ‘428 discloses the method of claim 1, wherein the first size of the first active sensing area is substantially equal to the second size of the second active sensing area (Claim 4, “wherein the first size of the first active sensing area is substantially equal to the second size of the second active sensing area”).
Claims 5-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-20 of U.S. Patent No. US 12,268,500 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application: 19/074,133 (claim set filed on 03/07/2025)
Reference Patent: US 12,268,500 B2 (claim set published on 04/08/2025)
5. A transcutaneous sensing system, comprising:
a transcutaneous sensor comprising:
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output; and
a processor configured to determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area.
5. A transcutaneous sensing system, comprising:
a transcutaneous sensor comprising:
a substrate;
a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output; and
a processor configured to determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to a current ratio of the first current output to the second current output being different than a size ratio of a first size of the first active sensing area to a second size of the second active sensing area.
6. The transcutaneous sensing system of claim 5, wherein the processor is further configured to compensate for a reduction in the first current output or the second current output due to a partial withdrawal of the transcutaneous sensor utilizing a difference between the current ratio and the size ratio.
6. The system of claim 5, wherein the data processing unit is further configured to compensate for a reduction in the first current output or the second current output due to the partial withdrawal of the transcutaneous sensor utilizing a difference between the current ratio and the size ratio.
7. The transcutaneous sensing system of claim 5, wherein the first size of the first active sensing area is different than the second size of the second active sensing area.
7. The system of claim 5, wherein the first size of the first active sensing area is different than the second size of the second active sensing area.
8. The transcutaneous sensing system of claim 5, wherein the first size of the first active sensing area and the second size of the second active sensing area are substantially equal in size.
8. The system of claim 5, wherein the first size of the first active sensing area and the second size of the second active sensing area are substantially equal in size.
9. The transcutaneous sensing system of claim 5, wherein the first active sensing area comprises a first plurality of sensing spots and wherein the second active sensing area comprises a second plurality of sensing spots.
9. The system of claim 5, wherein the first active sensing area comprises a first plurality of sensing spots and wherein the second active sensing area comprises a second plurality of sensing spots.
10. The transcutaneous sensing system of claim 9, wherein a size of each first sensing spot of the first plurality of sensing spots is substantially equal to a size of each second sensing spot of the second plurality of sensing spots.
10. The system of claim 9, wherein a size of each sensing spot of the first plurality of sensing spots is substantially the same as a size of each sensing spot of the second plurality of sensing spots.
11. The transcutaneous sensing system of claim 10, wherein the first plurality of sensing spots comprises a greater number of sensing spots than the second plurality of sensing spots.
11. The system of claim 10, wherein the first plurality of sensing spots comprises a greater number of sensing spots than the second plurality of sensing spots.
12. The transcutaneous sensing system of claim 5, further comprising a substrate, wherein a proximalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a proximalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
12. The system of claim 5, wherein a proximalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a proximalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
13. The transcutaneous sensing system of claim 5, further comprising a substrate, wherein a distalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a distalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
13. The system of claim 5, wherein a distalmost end of the first active sensing area is spaced apart from a distal end of the substrate by a first distance and a distalmost end of the second active sensing area is spaced apart from the distal end of the substrate by a second distance different than the first distance.
14. The transcutaneous sensing system of claim 5, wherein a longitudinally centered portion of the first active sensing area is offset from a longitudinally centered portion of the second active sensing area.
14. The system of claim 5, wherein a longitudinally centered portion of the first active sensing area is offset from a longitudinally centered portion of the second active sensing area.
15. An analyte monitoring system comprising:
a transcutaneous sensor comprising:
a first working electrode comprising a first active sensing area configured to transduce an analyte in a patient into a first current output; and
a second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output, wherein the first active sensing area is longitudinally offset from the second active sensing area; and
a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to:
determine a current ratio of the first current output to the second current output;
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area; and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio; and
a primary receiver unit coupled to the data processing unit.
15. An analyte monitoring system comprising:
a transcutaneous sensor comprising:
a substrate;
a first working electrode on the substrate, the first working electrode comprising a first active sensing area configured to transduce an analyte in the patient into a first current output; and
a second working electrode on the substrate, the second working electrode comprising a second active sensing area configured to transduce the analyte in the patient into a second current output, wherein the first active sensing area is longitudinally offset along the substrate from the second active sensing area; and
a data processing unit coupled to the transcutaneous sensor, wherein the data processing unit is configured to:
determine a current ratio of the first current output to the second current output;
compare the current ratio to a size ratio defined by a first size of the first active sensing area to a second size of the second active sensing area; and
determine that the transcutaneous sensor has been at least partially withdrawn from the patient in response to the current ratio being different than the size ratio; and
a primary receiver unit coupled to the data processing unit.
16. The analyte monitoring system of claim 15, further comprising a secondary receiver unit coupled to the data processing unit.
16. The analyte monitoring system of claim 15, further comprising a secondary receiver unit coupled to the data processing unit.
17. The analyte monitoring system of claim 15, further comprising a data processing terminal, wherein the primary receiver unit is configured to transmit data to the data processing terminal.
17. The analyte monitoring system of claim 15, further comprising a data processing terminal, wherein the primary receiver unit is configured to transmit data to the data processing terminal.
18. The analyte monitoring system of claim 15, wherein the transcutaneous sensor further comprises a substrate and a reference electrode on the substrate.
18. The analyte monitoring system of claim 15, wherein the transcutaneous sensor further comprises a reference electrode on the substrate.
19. The analyte monitoring system of claim 18, wherein the transcutaneous sensor further comprises a counter electrode on the substrate.
19. The analyte monitoring system of claim 18, wherein the transcutaneous sensor further comprises a counter electrode on the substrate.
20. The analyte monitoring system of claim 19, wherein the transcutaneous sensor further comprises a first dielectric insulator layer between the reference electrode and the substrate and a second dielectric insulator layer between the counter electrode and the substrate.
20. The analyte monitoring system of claim 19, wherein the transcutaneous sensor further comprises a first dielectric insulator layer between the reference electrode and the substrate and a second dielectric insulator layer between the counter electrode and the substrate.
Claim and Prior Art Analysis
Analysis regarding 35 USC § 101: Independent claims 1, 5, and 15, require the use of a particular machine (i.e., a transcutaneous sensor with a specific combination of working electrodes with different size ratios). Any judicial exceptions are applied through the use of the particular machine for detecting withdrawal of the transcutaneous sensor. Therefore, any judicial exceptions are integrated into a practical application, and the claims are not rejected in view of 35 USC § 101. Further, previous 35 USC § 101 rejections, arguments, and response to arguments are noted from the parent applications.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as recited above. However, the subject matter of claims 1-20 are allowable over the prior art made of record.
The closest prior art made of record includes Bohm et al. (Pub. No. US 2012/0078071), hereinafter referred to as Bohm, Hayter et al. (Pub. No. US 2010/0081906), hereinafter referred to as Hayter, Park et al. (Pub. No. US 2018/0042557), hereinafter referred to as Park, and Henry W. Oviatt Jr (Pub. No. US 2010/0219085), hereinafter referred to as Oviatt.
Bohm teaches a system and method for detecting insufficient depth and/or sensor pull out of a subcutaneous analyte sensor (para. [0296-0298]). Bohm teaches the insertion depth can be measured by sensing the surface area of an active electrode, and a measurement of the electrode surface area can be proportional to the depth of insertion (para. [0302]). While Bohm does teach multiple electrodes can be used to determine the depth of insertion (para. [0301]) and sensor insertion depth detection systems are known within the art, Bohm does not disclose, teach, or reasonably suggest determining a current ratio between a first current output from a first electrode and a second current output from a second electrode, and determining the sensor has at least partially withdrawn when the current ratio is different a size ratio of the first electrode and the second electrode.
Hayter teaches a method of detecting withdrawal of a transcutaneous sensor from a patient (Abstract and Fig. 6) by determining a current ratio between a first current output by a first working electrode and a second current output by a second working electrode (para. [0078] and [0080]). However, Hayter does not disclose, teach, or reasonably suggest further determining a size ratio between a first active sensing area of the first working electrode and a second active sensing area of the second working electrode, and determining partial withdrawal of the sensor based on the current ratio being different than the size ratio.
Park teaches a method of determining a bio-impedance ratio and determining the validity of the detected biometric information, based on the ratio (Abstract, Fig. 4, para. [0089-0090]). However, Park does not disclose, teach, or reasonably suggest further determining a size ratio between a first active sensing area of the first working electrode and a second active sensing area of the second working electrode. Further, Park does not explicitly suggest using the method to detect withdrawal of a sensor.
Oviatt teaches of a system for receiving current from a working electrode and current from a blank electrode, and determining a ratio corresponding to a ratio of surface areas of the working electrode and the blank electrode (Abstract, para. [0011], para. [0051]). However, Oviatt discloses the ratio of the current from the working electrode and the current from the blank electrode are used to determine a normalization ratio to correct and calibrate the working electrode (para. [0051]). Oviatt does not disclose, teach, or reasonably suggest the determining a size ratio of the first working electrode and the blank electrode, and using the ratios to determine the sensor has withdrawn based on the current ratio between different than the size ratio.
Conclusion
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/KYLE W. KRETZER/Examiner, Art Unit 3791
