DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application was filed 02/18/2019. Acknowledgement is made of the present application as a proper National Stage (371)entry of PCT Application No. PCT/US2017/047445, filed 08/17/2017, which claims benefit to provisional application 62/378,538, filed 08/23/2016.
Status of the Claims
Claims 57-58, 62, 67-68, 72, 75, 78-79, 82, 84-87, and 89 are pending. Claims 57, 78, 87, and 89 are amended. Claims 1-56, 59-61, 63-66, 69-71, 73-74, 76-77, 80-81, 83, and 88 are cancelled. Claims 57-58, 62, 67-68, 72, 75, 78-79, 82, 84-87, and 89 are examined below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 57-58, 62, 67-68, 72, 75, 78-79, 82, 84-87, and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Espinosa et al., US9423399B2, 04/03/2014 (see PTO-892, 10/06/2023), in view of Anderberg et al., US20150293085A1, 10/15/2015 (see PTO-892, 07/16/2025).
Regarding claim 57, Espinosa teaches a method of determining whether an analyte is present in a sample using a competitive assay (Espinosa, ‘Abstract’, lines 1-2). Espinosa further teaches that the analyte can be a reporter gene (assessing reporter gene expression in a sample; Espinosa, column 16, lines 57-58). Espinosa further teaches generating an expression construct containing a reporter gene, culturing cells having the construct and testing a cellular supernatant or extract from said cells for the expressed reporter protein thus reading on a liquid sample suspected of containing a single protein product (a liquid contains, or is suspected of containing, a single reporter gene expression product; analyte is a single reporter gene expression product; Espinosa, column 16, lines 60- column 17, line 2). Espinosa further teaches applying a volume of a sample to a lateral flow device (contacting a liquid sample with a test device; Espinosa, column 4, lines 1-2). Espinosa further teaches that the device includes a bibulous member, examples of which include glass fiber, cellulose, various chromatographic papers and nitrocellulose (a porous matrix; Espinosa, column 5, line 64- column 6, line 7). Espinosa further teaches a capture probe region that includes an amount of an immobilized capture probe, i.e. a capture probe that is stably associated with the bibulous member in the capture probe region (a porous matrix that comprises a test location; Espinosa, column 6, lines 54-58). Espinosa further teaches the use of a competitor which is a molecule that competes with the analyte of interest for binding to a first capture probe and specifically binds to a detection capture probe (Espinosa, column 4, lines 32-35). Espinosa further teaches that in some cases the analyte and competitor include an identical binding pair member, e.g. an MBP tag, a GST tag, a histidine tag and the first capture probe specifically binds to the binding pair member (Espinosa, column 18, lines 45-47). Espinosa further teaches that following sample application, the sample is allowed to laterally flow through the bibulous member and detection region (liquid sample is applied to test device upstream of test location and transporting said analyte to said test location; Espinosa, column 14, lines 7-9). Espinosa further teaches that the detection region is then read to determine whether the analyte is present in the sample and that reading the detection region depends on the nature of the detectable product of the signal (assessing a detectable signal at said test location to determine presence of the single reporter gene product; Espinosa, column 14, lines 9-10). Espinosa further teaches that the detection region includes two or more distinct capture probe regions that include the same or different amounts of the same capture probe (single flow path; multiple test lines with different concentrations of said reagent; Espinosa, column 12, lines 40-43).
Espinosa fails to teach that the test location comprises a capture reagent that is an analyte or an analyte analog that competes with an analyte in the sample for specific binding to a labeled binding reagent and further fails to teach a labeled binding reagent. Espinosa further fails to teach that the method has a detection limit of 0.05 ng/µl for the analyte.
Anderberg teaches a method for quantitatively detecting multiple analytes in a sample (Anderberg, Abstract, lines 1-3). Anderberg further teaches contacting a liquid sample with a test device (Anderberg, page 1, paragraph [0007], lines 3-4), wherein the test device comprises a porous matrix with test locations comprising a test reagent that is an analyte or an analyte analog that binds to the binding reagent and the analyte or analyte analog competes with an analyte in said sample for binding to a binding reagent (Anderberg, page 1, paragraph [0006], lines 2-9). Anderberg further teaches that the liquid sample is applied to a site upstream of the test location, the method further comprising transporting the analytes, if present in the liquid sample, and a labeled binding reagent to the test locations and assessing a detectable signal at the test location to determine the amount of the analyte in the sample (Anderberg, page 1, paragraph [0007], lines 5-9). Anderberg further teaches that the term binding reagent refers to a substance that binds to an analyte with desired specificity (Anderberg, page 3, paragraph [0035], lines 1-3). Anderberg further teaches that the present test device can be applied to quantitatively detect analytes, wherein the analytes have a concentration ranging from about 1 pg/ml to about 1 μg/ml (Anderberg, page 11, paragraph [0084], lines 1-11). As such, the method of Anderberg is capable of detecting an analyte at a detection limit of 0.05 ng/μl (50 pg/µl). Anderberg further teaches that the assay can be used to determine amounts of analytes with desired or required precision (Anderberg, page 4, paragraph [0042], lines 1-3). Anderberg further teaches that the test device can also comprise an antibody as a capture reagent at the test location and an analyte or analyte analog having a detectable label will compete with an analyte in a sample to bind to the capture reagent at the test location (Anderberg, page 12, paragraph [0100], lines 1-7).
It would have been prima facie obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to have modified the competitive lateral flow assay of Espinosa by immobilizing a test reagent that is an analyte or an analyte analog in the test location as taught by Anderberg as an obvious matter of a simple substitution of one art recognized competitive lateral flow assay method for another, both recognized as suitable for the same purpose, both suitable for a competitive lateral flow assay detecting an analyte in a liquid sample. The ordinarily skilled artisan would have been motivated to do so because the competitive assay of Anderberg performs the same function specified in the claim in substantially the same way and produces substantially the same results of detecting an analyte in a liquid sample, see Anderberg teaches both formats of a competitive lateral flow assay, either comprising an analyte or analyte analogue bound to the test location or a capture reagent that binds the analyte or analyte analogue bound to the test location. Substituting one type of competitive assay with the other would yield a predictable result.
Regarding the limitation that said method has a detection limit of 0.05 ng/µl, Anderberg teaches a method capable of detecting an analyte at a detection limit of 0.05 ng/μl and as such one of ordinary skill in the art would expect the method of Espinosa in view of Anderberg to be capable of detecting an analyte at the detection limit as claimed.
One of ordinary skill in the art would have a reasonable expectation of success in having modified the capture reagent of Espinosa with that of Anderberg because both Espinosa and Anderberg teach success detecting analytes in a liquid sample using a competitive lateral flow assay and Anderberg further teaches that the test location can comprise either the analyte or analyte analogue or a capture reagent that binds the analyte teaching success in the method of Espinosa and Anderberg for detection of an analyte in a competitive assay.
Regarding claim 58, the combination of Espinosa and Anderberg as applied to claim 57 also applies to claim 58.
Anderberg teaches that the liquid sample and the labeled reagent can be premixed to form a mixture and the mixture is applied to the test device (Anderberg, page 14, paragraph [0115], lines 1-3).
Regarding claim 62, the combination of Espinosa and Anderberg as applied to claim 57 also applies to claim 62.
Anderberg teaches that the test device comprises a dried labeled reagent before use and the dried labeled reagent can be solubilized or resuspended, and transported to the test location by the liquid sample (Anderberg, page 14, paragraph [0116], lines 1-4).
Regarding claims 67, Espinosa teaches generating a cellular supernatant or extract and determining presence, absence, or quantity of the expressed reporter protein (Espinosa, column 16, lines 60- column 17, line 2).
Regarding claim 68, Espinosa and the cited art above teach a competitive lateral flow device method substantially as claimed.
Espinosa does not teach that the detectable signal is assessed by a reader.
Anderberg teaches that even if a visual direct label is used, the detectable signal is often or typically assessed by a reader for quantitatively detecting analytes (Anderberg, page 14, paragraph [0118]).
It would have been prima facie obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to have used a reader as taught by Anderberg to analyze the results of the competitive lateral flow assay as taught by Espinosa in view of Anderberg because of the teaching of Anderberg that a reader is used to quantify the analytes.
One of ordinary skill in the art would have a reasonable expectation of success using the reader to analyze the results because Anderberg teaches success reading a visible label using a reader and both Espinosa and Anderberg teach a competitive lateral flow assay with visible test results.
Regarding claims 72 and 75, Espinosa teaches detecting an expressed reporter protein (Espinoza, column 16, line 60-column 17, line 2) or a tagged recombinant protein (Espinosa, column 15, line 34).
Regarding claim 78, Espinosa teaches that the analyte detection step can be used to determine the presence, absence, or quantity of the expressed reporter protein allowing the researcher to determine whether the transcription factor was active under stress conditions, whether to continue with subsequent steps of the protocol, etc. (Espinosa, column 16, 67- column 17, line 5). As such, Espinosa teaches using the assay to analyze different induction conditions for reporter protein expression allowing for optimization of the conditions.
Regarding the recited language “method of claim 57, which is conducted for […] assessing [a…] time course […] optimizing induction” and “determining the fraction(s)”, MPEP in 2111.04 states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. In the present case, “which is conducted for” is directed to the intended use of the claimed method (the method of 57); the claim language does not clearly require steps 1-3 be actively performed/required of the claim. As a result, considering that claim 78, steps 1-3 do not present additional active steps, the cited art addresses the limitations of the claim for the reasons as discussed above (i.e., because the cited art further address the test device comprising multiple test lines/elements), it would be expected similarly capable of use, i.e. for conduct for, performing each of steps 1-3 on a sample.
Regarding claim 79¸ Espinosa teaches that following sample application the detection region may be read after a predetermined period of time which may range from 10 sec to 1 hour (Espinosa column 14, lines 7-13).
Regarding claims 82 and 84, the combination of Espinosa and Anderberg as applied to claim 57 also applies to claims 82 and 84.
Anderberg teaches a method comprising a test device comprising a porous matrix with test locations comprising a test reagent that is an analyte or an analyte analog that binds to the binding reagent and the analyte or analyte analog competes with an analyte in said sample for binding to a binding reagent (Anderberg, page 1, paragraph [0006], lines 2-9).
Regarding claim 85, Espinosa further teaches culturing cells having an expression construct and generating a cellular supernatant or extract and determining presence, absence, or quantity of the expressed reporter protein (Espinosa, column 16, lines 60- column 17, line 2).
Regarding claim 86, Espinosa and the cited art above teaches a method substantially as claimed.
Espinosa teaches detecting an analyte that is an expressed reporter protein (recombinant protein or reporter gene expression; Espinoza, column 16, line 60-column 17, line 2) using a lateral flow assay (Espinoza, column 13, lines 22-25). Espinosa further teaches a system in which a target analyte and a competitor molecule compete for binding to a capture probe (competitive assay; Espinosa, column 4, lines 25-29).
Espinosa fails to teach that the test location comprises the test reagent that is a reporter gene expression product or an analog of the reporter gene expression product.
Anderberg teaches a method comprising a test device (Anderberg, page 1, paragraph [0007], lines 3-4), wherein the test locations comprise a test reagent that is an analyte or an analyte analog that binds to the binding reagent and the analyte or analyte analog competes with an analyte in said sample for binding to a binding reagent (Anderberg, page 1, paragraph [0006], lines 2-9). Anderberg further teaches that the binding reagent is labeled (Anderberg, page 1, paragraph [0007], line 7).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Espinosa with the method of Anderberg to detect the reporter gene expression, for the reasons as discussed above, thereby resulting in test location comprising a test reagent (analyte/analog) that is a reporter gene expression product, further the reporter gene expression product in sample competing with that at the test location for the labeled reagent.
The ordinarily skilled artisan would have a reasonable expectation of success, because both teach a competitive lateral flow assay in order to detect an analyte in a sample, where the analyte competes with an unlabeled analyte for binding to a binding molecule.
Regarding claim 87, Espinosa and the cited art above teach a method substantially as claimed.
Regarding the recited language “method of claim 57, which is conducted for assessing a single recombinant protein expression or a single reporter gene expression time course”, MPEP in 2111.04 states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. In the present case, “which is conducted for” is directed to the intended use of the claimed method (the method of 57); the claim language does not clearly require steps 1-4 be actively performed/required of the claim. As a result, considering that claim 87 does not present additional active steps, the cited art addresses the limitations of the claim for the reasons as discussed above (i.e., because the cited art further address the test device comprising multiple test lines/elements), it would be expected similarly capable of use, i.e. for conduct for, performing each of steps 1-4 on a sample.
Regarding claim 89, Espinosa and the cited art above teaches a method of detecting a recombinant protein or reporter gene expression product in a sample substantially as claimed.
Regarding the recited language “method of claim 57, which is conducted for optimizing induction condition for a single recombinant protein expression or a single reporter gene expression”, MPEP in 2111.04 states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. In the present case, “which is conducted for” is directed to the intended use of the claimed method (the method of 57); Considering that claim 89 does not present additional active steps, the cited art addresses the limitations of the claim for the reasons as discussed above (i.e., because the cited art further address the test device detecting analytes), it would be expected similarly capable of use, i.e. for determine the presence, absence and/or amount of an analyte.
Response to Arguments
Applicant's arguments filed 09/08/2025 have been fully considered but they are not persuasive.
Applicant argues, starting on page 8, that the combination of the cited art does not teach or suggest every element of the present claim 57.
Applicant argues that regarding the element of the previous claim 89 that the examiner alleges that Anderberg and the cited art teach a method of detecting a recombinant protein or reporter gene expression product in a sample substantially as claimed and that Anderberg further teaches a labeled reagent that specifically binds one or more analytes in the sample and embodiments comprise multiple labeled reagents and that as such Anderberg teaches detecting one analyte.
Applicant has amended the claim to recite that “said analyte is a single recombinant protein expression product or a single reporter gene expression product” and that accordingly the present claim 57 is directed to a method for assessing a single recombinant protein and that in contrast Anderberg teaches a lateral flow test device for quantitatively detecting multiple analytes in a sample. Applicant argues that Anderberg does not teach or suggest any method for quantitatively detecting a single analyte in a sample and that Espinosa and Sharrock cannot be combined with Anderberg to fundamentally change the purpose of Anderberg’s invention to a lateral flow test device for detecting a single analyte in a sample.
This argument is not persuasive.
The rejection under 35 U.S.C. 103 has been amended in response to the amendment of the claims to a method for detecting a single recombinant protein or reporter gene expression product and no longer relies on Anderberg to teach the base method. Rather, Espinosa teaches the base method of detecting a single recombinant protein using a competitive lateral flow assay comprising multiple test lines comprising different concentrations of the same capture molecule. Anderberg is relied on to modify the competitive assay of Espinosa to comprise a competitive lateral flow assay wherein the capture molecule immobilized on the test line is the analyte or an analyte analogue.
Applicant further argues, starting on page 10, that claim 57 has been amended to include “contacting a liquid sample that contains […] a single reporter gene expression product” and as such contains an active step and is no longer directed to the intended use of the claimed method and that Anderberg only teaches a lateral flow test method for quantitatively detecting multiple analytes in a sample.
This argument is not persuasive.
As explained previously above, Anderberg is no longer relied on to teach the base method, rather Espinosa, directed to detecting a single reporter gene expression product, is relied on to teach the base method an Anderberg is relied on to teach a competitive lateral flow assay wherein the capture molecule immobilized on the test line is the analyte or an analyte analogue.
Applicant further argues (page 11) that amended claim 57 is directed to a “single recombinant protein expression product or a single reporter gene expression product” and that Anderberg does not teach or suggest any method for quantitatively detecting a single analyte in a sample.
This argument is not persuasive.
As explained previously above, Anderberg is no longer relied on to teach the base method, rather Espinosa, directed to detecting a single reporter gene expression product, is relied on to teach the base method an Anderberg is relied on to teach a competitive lateral flow assay wherein the capture molecule immobilized on the test line is the analyte or an analyte analogue.
Applicant further argues on pages 12-14 that Anderberg, Espinosa, and Sharrock, even combined, do not teach or suggest all elements of the present claim 57 and that there is no reason, suggestion, or motivation to combine the cited art.
Applicant argues that the claim recites “said test device comprises a single flow path only” and that Sharrock teaches an assay device comprising two or more assay flow-paths.
Sharrock is no longer relied on to reject claim 57 and therefore the argument is moot.
Applicant further argues on page 15 that Espinosa does not teach the assay format recited in the present claim 57 and that the competitive assay as claimed differs fundamentally from the competitive assay taught in Espinosa in various aspects. Applicant further argues that Anderberg teaches a competition assay wherein an analyte or analyte analog at the test location competes with an analyte in a sample (the method as claimed) and so the skilled artisan would not find a reason or motivation to combine the teachings of Ander berg and Espinosa.
This argument is not persuasive.
As discussed previously in detail above, in the rejection of claim 57 under 35 U.S.C. 103, both Espinosa and Anderberg teach a competitive lateral flow assay method and further Anderberg teaches that the competitive lateral flow assay can comprise an analyte or analyte analog immobilized as the capture agent at the capture zone (a competitive assay as claimed) or in another embodiment, a competitive lateral flow assay can comprise an antibody as a capture reagent at the test location (as taught by Espinosa). As such, Anderberg teaches that both assay formats are suitable for detecting an analyte in a sample and using an analyte or analyte analog as the capture reagent (as taught by Anderberg) instead of an antibody capturing the analyte or analyte analog (as taught by Espinosa and Anderberg) is an obvious matter of a simple substitution of one art recognized competitive lateral flow assay method for another, both recognized as suitable for the same purpose, both suitable for a competitive lateral flow assay detecting an analyte in a liquid sample.
Applicant further argues on page 17 that requiring the assessment of a detectable signal of a “single reporter gene” defeats the purpose of Anderberg for quantitatively detecting multiple analytes and would render the prior art invention unsatisfactory for its intended purpose.
This argument is not persuasive.
As explained previously above, Anderberg is no longer relied on to teach the base method, rather Espinosa, directed to detecting a single reporter gene expression product, is relied on to teach the base method an Anderberg is relied on to teach a competitive lateral flow assay wherein the capture molecule immobilized on the test line is the analyte or an analyte analogue.
Applicant further argues on page 17 the combination of Anderberg and Sharrock.
Sharrock is no longer relied on in the rejection under 35 U.S.C. 103 and therefore the argument is moot.
Applicant further argues the combination of Anderberg and Espinosa on page 18. Applicant argues that, as discussed above, Anderberg and Espinosa teaching fundamentally different forms of competitive assay and given the incompatibility between the competitive assays the skilled artisans would not find a reasonable expectation of success combining Anderberg and Espinosa.
This argument is not persuasive for the reasons previously discussed above.
Applicant further argues that the assay of Espinosa shows a sensitivity of 1 ng/µl and that the assay as claimed shows superior assay sensitivity of 0.05 ng/ µl and that such superior and unexpected properties further rebut the obviousness allegation.
This argument is not persuasive.
Anderberg teaches a competitive lateral flow assay method wherein an analyte or analyte analog at the test location competes with an analyte in a sample and further teaches an assay sensitivity of 1 pg/ml to about 1 μg/ml and therefore the assay sensitivity as claimed of 0.05 ng/μl (50 pg/µl) is neither superior nor unexpected. The assay method of Espinosa in view of Anderberg teaches the competitive lateral flow assay method as claimed and as such one of ordinary skill in the art would have a reasonable expectation of being able to detect the single recombinant protein or single reporter gene expression product at the sensitivity as claimed, because the assay as taught by the combination of Espinosa in view of Anderberg would be expected to detect an analyte with a sensitivity of 1 pg/ml to about 1 μg/ml as taught by Anderberg.
Applicant further argues Examiner’s response to Applicant’s arguments, starting on page 19.
Regarding applicant’s arguments comprising the teachings of Sharrock pages 19-21, Sharrock is no longer relied on in the rejection of the claims and therefore the argument is moot.
Applicant further argues starting on page 21 that the examiner fails to present any evidence to show that the skilled artisan would look at Sharrock’s teachings on using an assay comprising an analyte and a competitor as required by Anderberg while ignoring Espinosa.
Sharrock is no longer relied on in the rejection under 35 U.S.C. 103 and therefore the argument is moot.
Applicant further argues, starting on page 22, that, contrary to examiner’s response to arguments, there is no evidence in Anderberg showing that its assay can be conducted to achieve “a detection limit of 0.05 ng/µl for said single recombinant protein or single reporter gene expression product”.
This argument is not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Espinosa in view of Anderberg teaches a competitive lateral flow assay method as claimed. The method of Anderberg teaches a detection limit comprising the sensitivity of 0.05 ng/µl as claimed and as such one of ordinary skill in the art would expect the combination of Espinosa in view of Anderberg to be capable of detecting a single analyte at the sensitivity as taught by Anderberg. Further, the combination of the cited art teaches a method as claimed and as such the method would be expected to be able to detect the analyte at the levels claimed.
Applicant further argues on page 23 that the rejection is based on improper hindsight and without any evidence of a specific reason for combining the cited art Examiner’s position is that the present claim 57 is obvious over the combination of the cited art because allegedly, the arbitrarily selected teachings of Sharrock and Espinosa could be used in Anderberg’s methods.
The amended claims are rejected over Espinosa in view of Anderberg and as such the argument is moot.
Applicant further argues (page 23) that the dependent claims are not obvious over the cited art at least for the same reasons that the present claim 57 is not obvious and that additionally, the present claims 78, 87, and 89 contain additional elements that are not taught or suggested by the cited art.
This argument is not persuasive.
As discussed previously in detail above, claim 57 is obvious over Espinosa in view of Anderberg and the additional limitation of a “single” analyte in claims 78, 87, and 89 does not overcome the present obviousness rejection.
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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE J KIRWIN whose telephone number is (571)272-6574. The examiner can normally be reached Monday - Friday 7.30 - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy 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.
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/STEFANIE J. KIRWIN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 March 2, 2026