Prosecution Insights
Last updated: April 19, 2026
Application No. 17/262,016

DEVICES AND METHOD FOR MEASURING AN ANALYTE CONCENTRATION IN A SAMPLE OF BODILY FLUID

Non-Final OA §103
Filed
Jan 21, 2021
Examiner
HUANG, MICKEY NMN
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Roche Diabetes Care Inc.
OA Round
4 (Non-Final)
63%
Grant Probability
Moderate
4-5
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
58 granted / 92 resolved
-2.0% vs TC avg
Strong +56% interview lift
Without
With
+55.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
38 currently pending
Career history
130
Total Applications
across all art units

Statute-Specific Performance

§101
7.1%
-32.9% vs TC avg
§103
37.4%
-2.6% vs TC avg
§102
21.7%
-18.3% vs TC avg
§112
26.0%
-14.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 92 resolved cases

Office Action

§103
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/24/25 has been entered. Response to Amendment Applicant’s amendment filed on 07/24/25 has been entered. Claims 1, 3-8, 10-14 and 16-17 remain pending. Claims 2,9, and 15 are cancelled. Claims 8 and 10-14 remain withdrawn. Claims 1, 3-7, and 16-17 are examined herein. Status of Rejection The amendment necessitates new ground of rejection. 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, and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak (U.S. Pub. No. 2017/0343480 A1; cited in previous OA) in view of Ismail (U.S. Pat. No. 5,116,729), as evidenced by Drozd (Pitfalls and capabilities of various hydrogen donors in evaluation of peroxidase-like activity of gold nanoparticles. 2016). Regarding claim 1 and 3, Kwak discloses an optical test strip for measuring the concentration of an analyte in a sample of blood (A method for measuring blood glucose levels by a portable terminal using a strip module is provided) (Abstract), comprising: a test strip carrier (cover case 500, Figure 5A) having at least one transparent area (hole for camera lens; see annotated Figure) (Figure 5A); a test field, wherein the test field: comprises at least one carrier foil); (transparent strip 220) (Figure 2), wherein the at least one carrier foil is applied to the test strip carrier and covers the at least one transparent area of the test strip carrier (Figure 7B); PNG media_image1.png 514 621 media_image1.png Greyscale comprises at least one test chemical (the chemical in the dye pad 210 that produces a color change) applied to the carrier foil, the at least one test chemical being configured for performing an optical detectable detection reaction with the analyte (The strip module includes a dye pad having a color that changes in response to a sample applied to the dye pad) (Abstract); and comprises at least one porous material for at least partially filtering out solid components contained in the sample (A mesh 240, which allows a blood sample pass through) (Paragraph 59; Figure 4B); wherein the at least one carrier foil has at least one wavelength filter component which is adapted to essentially block light having wavelengths λ b l c of 10 nm < λ b l c < WLlow, with 550 nm ≤ WLlow ≤ 650 nm (the transparent strip 220 can function as a filter through which light source of a red wave area can pass) (Paragraph 61) (Wavelength of color red is 645-650 nm) (also interpreted as the wavelength filter component located within the carrier foil). Kwak alone does not explicitly discloses the test chemical comprising glucose oxidase and/or glucose dehydrogenase and is further configured for at least partially absorbing light having at least one absorption wavelength λ a b s in the range 650 nm < λ a b s <1100 nm. In an analogous art, Ismail discloses a test strip for detecting glucose comprising: a reagent test pad and a reagent composition embedded in the reagent test pad, wherein the composition comprises glucose oxidase; 3,3',5,5'-tetramethylbenzidine indicator dye; a peroxidase; and a buffer (Claim 11). Furthermore, evidential reference Drozd discloses TMB products have a maximum absorption wavelength at 652 nm (Figure 4), and TMB oxidation product is typically measured at the absorption wavelength 652 nm (thus read on the limitation of “wavelength λ a b s in the range 650 nm < λ a b s <1100 nm”). As Kwak’s carrier foil already have the capability of selectively allowing wavelength of red (645-650 nm) to pass, it would have been obvious to one of ordinary skill in the art to have substituted the reagent composition of Ismail to the test field of the device of Kwak to derive the claimed invention. Ismail’s reagent composition prevents unwanted oxidation and mitigates adverse effect of atmospheric oxygen, moisture, and light, and enable the test strip to be stored for an extended period of time (Ismail, Col. 9, Line 59-Col. 10, Line 3) while also allowing for characterizing glucose concentration at absorption wavelength at 650 nm. Regarding claim 4, Kwak discloses the claimed invention as discussed above in claim 1. Kwak discloses the filter is a longpass filter (Kwak does not explicitly states the filter longpass filters but the filter only allows red light to pass). Kwak discloses the light source used can be fluorescent light (…and the light source 310 of the mobile terminal 300 can be embodied as a fluorescent light) (Paragraph 52). Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak in view of Ismail as discussed in claim 1 above, and evidenced by GlobalSpec (Long Pass Filters and Short Pass Filters Information, February 2018) cited in previous OA. Regarding claim 5, Kwak discloses the claimed invention as discussed above in claim 1. Kwak discloses the filter is a longpass filter (Kwak does not explicitly states the filter longpass filters but the filter only allows red light to pass). Kwak discloses the light source used can be fluorescent light (…and the light source 310 of the mobile terminal 300 can be embodied as a fluorescent light) (Paragraph 52). The limitation of “wherein the longpass filter has a transmission edge rising with wavelength of the light, wherein the long pass filter further has a characteristic wavelength…of a maximum transmission of the longpass filter” are interpreted to be functional limitation. In general, longpass filter has transmission edge rising with the wavelength of light and a specific characteristic wavelength. See Picture from GlobalSpec below. PNG media_image2.png 276 411 media_image2.png Greyscale Claim(s) 6, 7, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak in view of Ismail as discussed in claim 1 above, and further in view of Lundin (U.S. Pub. No. 2018/0246306 A1; as cited in previous OA). Regarding claims 6, 7, 16, and 17 Modified Kwak discloses the claimed invention as discussed above in claim 1. Neither Kwak nor Ismail discloses the wavelength filter component comprises an interference filter or the carrier foil comprises at least one further filter component wherein the at least one further filter component comprises a shortpass filter. In an analogous art, Lundin discloses a mobile microscopic device under fluorescent or LED light using a mobile phone (Paragraph 52-53). Lundin discloses a common/conventional problem relating to polymer lenses of the camera is auto fluorescence of polymer materials, which is disturbing at visible wavelengths (Paragraph 28). To correct the problem, Lundin discloses incorporating a low-pass (absorption) or an interference filter (LED used for excitation requires efficient low pass filters in order to block wave lengths at fluorescent emission spectrum. This excitation filter may be either based on dielectric interference filters or absorption filters) (Paragraph 85 and 87). It would have been obvious to one of ordinary skill in the art before the effective filing date to have alter the filter component to be an interference filter or including additional shortpass filter to account for auto fluorescence effect from polymeric camera lens of phone camera by blocking/eliminating undesired light transmission outside of the specified range as claimed. Regarding claim 16 and 17, Modified Kwak discloses the claimed invention as discussed above in claim 6 and 7 respectively. The modification of claim 6 and 7 was done within the wavelength filter component (which is a part of the carrier foil) and therefore would have satisfied the limitation, “interference filter is located on at least one surface of the carrier foil” or “the carrier foil comprises the at least one further filter component. Response to Arguments Applicant’s arguments, see Pages 10-12, filed on 07/24/25, with respect to the rejection(s) of claim(s) 1, 3-7, and 16-17 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kwak and Ismail. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M.H./Examiner, Art Unit 1758 /MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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Prosecution Timeline

Jan 21, 2021
Application Filed
Mar 15, 2024
Examiner Interview (Telephonic)
Apr 18, 2024
Non-Final Rejection — §103
Jul 17, 2024
Response Filed
Sep 19, 2024
Final Rejection — §103
Dec 23, 2024
Response after Non-Final Action
Jan 23, 2025
Request for Continued Examination
Jan 24, 2025
Response after Non-Final Action
Mar 19, 2025
Final Rejection — §103
Jun 24, 2025
Response after Non-Final Action
Jul 07, 2025
Applicant Interview (Telephonic)
Jul 24, 2025
Request for Continued Examination
Jul 26, 2025
Response after Non-Final Action
Nov 15, 2025
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

4-5
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+55.8%)
3y 4m
Median Time to Grant
High
PTA Risk
Based on 92 resolved cases by this examiner. Grant probability derived from career allow rate.

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