DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3-9, 11, and 21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Saul et al. (US 2008/0160538 A1).
Regarding claim 1, Saul discloses a method of generating a definitive test result from an assay for detecting the presence or absence of an analyte when contacted with a sample (EXAMPLE 1; EXAMPLE 4; EXAMPLE 5), the method comprising:
incubating said assay in an incubation environment for at least a predetermined incubation time tailored to said analyte-specific assay (see: incubation at 40 °C; [0076], see: incubation for “8 minutes” and “10 minutes”, “incubation at room temperature for an additional 2 minutes”);
concurrently with said incubation, signaling an optical reader to perform continuous or periodic image detection, synchronized with incubation, of transmission of light on at least one control line and at least one test line site of said assay ([0067], see: results were read using a ROSA reader to read reflectance on the strip; [0029], see: test zone and control zone configured as lines; EXAMPLE 4, see: test area and control area; EXAMPLE 5, see: test area and control area) concurrently as incubating said assay and identifying a nondefinitive borderline test result, said nondefinitive borderline test result triggering further development in the test sequence for generating said definitive test result (EXAMPLE 4, see: 10 minute incubation result; EXAMPLE 5, see: 8 minute incubation results; [0076], see: “incubation at room temperature”);
in response to said nondefinitive borderline test result, initiating continued incubation of said assay and generating a subsequent image detection of said borderline test result to capture further signal development at said at least one control line and said at least one test line (EXAMPLE 4, see: 12 minute incubation results; EXAMPLE 5, see: 10 minute incubation results); and
synchronizing transmissions of light with imaging from said reader on said at least one control line and said at least one test line to monitor continued signal development at said at least one control line and said at least one test line ([0067], see: results were read using a ROSA reader to read reflectance on the strip; [0029], see: test zone and control zone configured as lines; EXAMPLE 4, see: test area and control area; EXAMPLE 5, see: test area and control area) and ending said incubation and image detection upon detection of sufficient signal development indicative of generating said definitive presence or absence test result from said borderline test result on said diagnostic test (EXAMPLE 4, see: 12 minute incubation time; EXAMPLE 5, see: 8 minute incubation time plus two minutes; [0076], see: “incubation at room temperature”; Regarding the intent of the method to end detection and incubation, the prior art method is directed towards maximizing accuracy and minimizing processing/incubation time of a single use assay, therefore it inherently is intended to end detection and incubation upon determining the assay is complete).
Regarding claim 3, Saul further discloses generating a definitive test result includes reading a predetermined difference between a reflectance value on a control line and a reflectance value on a test line ([0067], see: results were read using a ROSA reader to read reflectance on the strip; EXAMPLE 1; EXAMPLE 4; EXAMPLE 5).
Regarding claim 4, Saul further discloses generating a definitive test result includes reading a predetermined difference between a reflectance value of a control line and a reflectance value of a test line, and a predetermined reflectance value on said control line ([0067], see: results were read using a ROSA reader to read reflectance on the strip; EXAMPLE 1; EXAMPLE 4; EXAMPLE 5).
Regarding claims 5 and 6, the method and apparatus disclosed by Saul would inherently be deactivated upon completion of its use.
Regarding claim 7, Saul further discloses monitoring a pre-test analysis on said assay (EXAMPLE 1).
Regarding claim 8, Saul further discloses decoding a reference coding on said assay (EXAMPLE 1, see: formula for the calibration of the reader and conversion of reader results to a ppb value).
Regarding claim 9, Saul further discloses activating a corresponding channel in a multichannel reader ([0067], see: results were read using a ROSA reader to read reflectance on the strip).
Regarding claim 11, Saul further discloses monitoring a pre-flow development along said assay.
Regarding claim 21, Saul discloses a method of generating a definitive test result from an assay for an analyte when contacted with a sample and having an initial borderline rest result (EXAMPLE 1; EXAMPLE 4; EXAMPLE 5), the method comprising:
incubating said assay in an incubation environment (see: incubation at 40 °C; [0076], see: “incubation at room temperature”);
imaging a first transmission of light on at least one control line and at least one test line site of said assay ([0067], see: results were read using a ROSA reader to read reflectance on the strip; [0029], see: test zone and control zone configured as lines; EXAMPLE 4, see: test area and control area; EXAMPLE 5, see: test area and control area) as an incubator incubates said assay in said incubation environment and generating at least one initial nondefinitive borderline test result (EXAMPLE 4, see: 10 minute incubation result; EXAMPLE 5, see: 8 minute incubation results; [0076], see: “incubation at room temperature”);
imaging a subsequent transmission of light on said assay following said nondefinitive borderline test result (EXAMPLE 4, see: 12 minute incubation results; EXAMPLE 5, see: 10 minute incubation results); and
synchronizing imaging said subsequent transmission of light on said same at least one control line and said at least one test line site of said assay in said incubation environment ([0067], see: results were read using a ROSA reader to read reflectance on the strip; [0029], see: test zone and control zone configured as lines; EXAMPLE 4, see: test area and control area; EXAMPLE 5, see: test area and control area) and extending incubating of said assay, and ending imaging of transmission of light and incubating when generating said definitive test result following said initial nondefinitive borderline test result on said diagnostic test (EXAMPLE 4, see: 12 minute incubation time; EXAMPLE 5, see: 8 minute incubation time plus two minutes; [0076], see: “incubation at room temperature”; Regarding the intent of the method to end detection and incubation, the prior art method is directed towards maximizing accuracy and minimizing processing/incubation time of a single use assay, therefore it inherently is intended to end detection and incubation upon determining the assay is complete).
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saul et al. (US 2008/0160538 A1).
Regarding claim 2, Saul discloses all of the claim limitations set forth above, but the reference does not explicitly disclose the diagnostic reading period being one minute long. As the accuracy of assay results is a variable that can be modified, among others, by adjusting said diagnostic reading period, with said accuracy of assay results increasing as the timing of the diagnostic reading is increased, the precise diagnostic reading period would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed diagnostic reading period cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the diagnostic reading period in the method and apparatus of Saul to obtain the desired assay accuracy (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). It is further noted that the Applicants do not disclose or provide evidence for the criticality of the recited diagnostic reading period in the originally filed disclosure.
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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/ROBERT J EOM/Primary Examiner, Art Unit 1797
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