Prosecution Insights
Last updated: August 06, 2026
Application No. 18/185,243

DIAGNOSTIC TEST KITS AND METHODS OF ANALYZING THE SAME

Non-Final OA §112§DP
Filed
Mar 16, 2023
Priority
Sep 17, 2020 — provisional 63/079,975 +1 more
Examiner
GIERE, REBECCA M
Art Unit
1677
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Scanwell Health Inc.
OA Round
3 (Non-Final)
74%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
375 granted / 509 resolved
+13.7% vs TC avg
Strong +32% interview lift
Without
With
+32.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
34 currently pending
Career history
543
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
44.4%
+4.4% vs TC avg
§102
15.4%
-24.6% vs TC avg
§112
23.9%
-16.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 509 resolved cases

Office Action

§112 §DP
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered. Status of Claims Claims 49-69 have been amended. Claims 49-69 are examined. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 49-69 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 49 is indefinite because the claim initially states that the control markings are representative of one or more predetermined test results for the diagnostic test and having different intensities while then proceeding to state that verifying detection of a faintest one of the control markings determines whether at least one of lighting, orientation and focus is adequate for analysis of the diagnostic test. It is unclear how the control markings are representative of both predetermined test results for the diagnostic test and also representative of conditions associated with the image analysis. For example, does the scan surface include X control markings for the diagnostic test result and then an additional amount of separate control markings for the image adequacy analysis or is there one set of markings that somehow indicate both test results and image adequacy analysis. Alternatively, is the “faintest one” merely a control line typically included on diagnostic reference charts in the prior art paired with a variety of line markings indicating the predetermined test results. Clarification is required to understand the functions of the computer-executable instructions of the application. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 50-56 and 57-62 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 50-62 recite “one or more control markings” and “one or more lines”, however claim 49 has already recited “a plurality of linear control markings” thus the rejected claims fail to further limit independent claim 49. 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. 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 49-55 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8 and 10 of U.S. Patent No. 11,996,183. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 49, Patent 183 recites a method for facilitating analysis of a diagnostic test, the method comprising: at one or more processors of a mobile computing device having at least one image sensor and a display: receiving an image captured at the at least one image sensor, the image depicting the diagnostic test, one or more static control markings on a scan surface, and a plurality of image region markers on the scan surface defining a boundary of an image region including the diagnostic test and the one or more static control markings, wherein the one or more static control markings comprise a control marking corresponding to a lower limit of optical detectability for analysis of the diagnostic test; prior to analyzing the diagnostic test, assessing an adequacy of at least one of lighting, orientation, and focus conditions associated with the image by verifying detection of the one or more static control markings in the image using at least one computer vision technique, wherein verifying detection of the one or more static control markings comprises: determining pixel values for multiple linear series of image pixels in the image, generating a 1D array of metrics, each metric in the 1D array of metrics comprising a value calculated based on the pixel values of an individual one of the multiple linear series of image pixels, and identifying one or more peaks in the 1D array of metrics; and when the one or more processors determine that the at least one of lighting, orientation, and focus conditions is adequate based on the identified one or more peaks in the 1D array of metrics: automatically analyzing the diagnostic test based on at least one computer vision technique to determine at least one test result; and causing the display to display the at least one test result (see patent claim 1). Additionally, patent claim 6 reads on instant claim 50, patent claim 7 reads on instant claims 51-54, patent claim 8 reads on instant claim 55, and patent claim 10 reads on instant claim 62. Response to Arguments Applicant's arguments filed 06/08/2026 have been fully considered and are found to be persuasive. While Polwart teaches software to analyze image quality, the reference fails to teach determining, based on verifying detection a faintest one of the plurality of linear control markings in the image, whether at least one of the lighting, orientation, and focus conditions associated with the image is adequate for analysis of the diagnostic test by the application. However, the claims remain unpatentable based on the issues described above. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30. 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, Bao-Thuy L Nguyen can be reached at 571-272-0824. 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. /REBECCA M GIERE/ Primary Examiner, Art Unit 1677
Read full office action

Prosecution Timeline

Mar 16, 2023
Application Filed
Oct 02, 2025
Non-Final Rejection mailed — §112, §DP
Jan 02, 2026
Response Filed
Mar 12, 2026
Final Rejection mailed — §112, §DP
Jun 08, 2026
Request for Continued Examination
Jun 09, 2026
Response after Non-Final Action
Jul 27, 2026
Non-Final Rejection mailed — §112, §DP (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

3-4
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+32.4%)
3y 0m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 509 resolved cases by this examiner. Grant probability derived from career allowance rate.

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