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 .
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.
Priority
This application is a U.S. National Stage (371) application of PCT/EP2020/063886 filed on 05/19/2020 which claims priority to Foreign Application No. FR1905358 filed on 05/22/2019.
Claim Status
Claims 1 and 14 are currently amended, and the Applicant notes that no new matter is added. Claims 2-3, 6-9, 15 and 18-19 are previously presented. Claims 4-5, 10-13, 16 are cancelled. Claim 20 is new, and the Applicant notes that no new matter is added.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/23/2025 and noted in in the office action of 10/28/2025.
Thus claims, 1-3, 6-9, 14-15 and 18-20 are under examination.
Withdrawn Objections/ Rejections
The previous rejection of claims 1-3, 6-9, 14-15 and 18-19 under 35 U.S.C. 112(a), regarding scope of enablement, is withdrawn in light of Applicant’s amendments of claims.
The previous rejection of claims 4 and 12-13 under 35 U.S.C. 112(a), regarding scope of enablement, is withdrawn in light of Applicant’s cancellation of claims.
The previous rejection of claim 4 under 35 U.S.C. 112(b), regarding indefiniteness, is withdrawn in light of Applicant’s cancellation of the claim.
The previous rejection of claims 4 and 12-13 under 35 U.S.C. 101, regarding the claims being directed to at least one judicial exception, is withdrawn in light of Applicant’s cancellation of the claims.
The previous rejection of claims 12-13 under 35 U.S.C. 103, regarding obviousness, is withdrawn in light of Applicant’s cancellation of the claims.
Maintained Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6-9, 14-15 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data from which the applicant or doctor will be able to diagnose, predict or prognose autoimmune hepatitis in a subject. Such an inference is not sufficient to transform the abstract idea of a mental process and a law of nature of natural correlations into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., a mental process (the presence or absence of a deviation of determined frequency of co-expression of PD-1 and CD38 from the reference value of the frequency of co-expression of PD-1 and CD38) and a law of nature (testing for the presence or absence of a deviation of the determined frequency of co-expression of PD-1 and CD38 from the reference value to make a diagnosis, prediction and/or prognosis of autoimmune hepatitis in a subject). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
Although there is a proposed initial treatment step in claim 1, it is conditional which means a doctor might not have to initiate treatment if the frequency of co-expression of PD-1 and CD38 is below the reference value. Furthermore, the treatment step of claim 1 is a general step that does not add significantly more to the judicial exceptions of the instant application.
Therefore, the judicial exceptions are not integrated into a practical application.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Example 43 of 2019 Revised Patent Subject Matter Eligibility Guidance (PEG) is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims (Subject matter eligibility | USPTO).
Regarding claim 1 of example 43 of the PEG and per Step 1 and claim 1 of the instant application, the claims are directed to a process, which is one of the statutory categories of invention. Specifically, claim 1 of example 43 recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
And similarly, claim 1 is also directed to a statutory class of a method as it recites “A method for diagnosis, prediction and/ or prognosis of an active autoimmune pathology in a subject, comprising detecting the co-expression of the proteins PD-1 (Programmed cell death 1) and CD38 at the surface of T lymphocytes in a biological sample of the subject; determining the frequency of co-expression of PD-1 and CD38; and testing for the presence or absence of a deviation of the frequency of co-expression of determined PD-1 and CD38 from a reference value of the frequency of co-expression of PD-1 and CD38.” (Step 1: YES).
(Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Claim 1 of example 43 of PEG recites judicial exceptions that are similar to claim 1 of the instant application. Specifically, and per Step 2A, prong 1, claim 1 of example 43 of PEG recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. And the grouping of “mathematical concepts” in PEG includes “mathematical calculations” as an exemplar of an abstract idea. PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) of claim 1 of PEG falls into the “mathematical concept” grouping of abstract ideas.
Similar to claim 1 of example 43, claim 1 of instant application also recites an abstract idea of a mental process without a mathematical calculation. Specifically claim 1 of the instant application recites a mental process (the presence or absence of a deviation of determined frequency of co-expression of PD-1 and CD38 from the reference value of the frequency of co-expression of PD-1 and CD38) as it recites “testing for the presence or absence of a deviation of the frequency of co-expression of PD-1 and CD3S determined in (i) from a reference value of the frequency of co-expression of PD-1 and CD3S”.
Also, limitation (a) of claim 1 of PEG describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus it recites a law of nature.
Furthermore, claim 1 of the instant application recites a judicial exception of a law of nature as it recites “wherein a frequency of co-expression of PD-1 and CD38 in said sample above a reference value indicates that the subject has the active autoimmune hepatitis or presents a risk of relapse of the active autoimmune hepatitis”.
Accordingly, limitation (a) of claim 1 of PEG recites three judicial exceptions (an abstract idea that falls within the mathematical concept, a mental process groupings in PEG, and a law of nature); whereas claim 1 of the instant application also recites two judicial exceptions of an abstract idea of a mental process and a law of nature, and the analysis must therefore proceed to Step 2A Prong Two.
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
Regarding claim 1 of example 43 of the PEG and per Step 2A, prong 2, the claim as a whole does not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, claim 1 of example 43 of PEG recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of the PEG fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of the PEG does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, claim 1 of the instant application does not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claims have steps of detecting the co-expression, at the surface of T lymphocytes of PD-1 and CD38 in a sample to determine the presence or absence of deviation of frequency of co-expression of PD-1 and CD38 from a reference value to diagnose, predict and /or prognose an active autoimmune pathology in a subject. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d). In the instant case, the doctor is not required to perform any further action if the frequency of co-expression of PD-1 and CD38 is not above the reference value. Moreover, and similar to claim 1 of example 43 of PEG, claim 1 of the instant application recites a treatment step “(iii) treating said subject with a treatment against autoimmune hepatitis”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to select a specific treatment based on the frequency of co-expression of PD-1 and CD38 when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Therefore, claim 1 of the instant application does not integrate the judicial exceptions into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
Regarding claim 1 of example 43 of the PEG and per Step 2B, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, claim 1 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as detecting the co-expression of the proteins PD-1 and CD38 at the surface of T lymphocytes by flow cytometry with any commercially available antibody (Specification, page 11, [0047]). Furthermore, the claim itself is recited at a high level of generality in which any assay can be used as the detection method for claim 1.
Thus, claim 1 is rejected under 35 USC 101.
Regarding claims 2-3, 6-9, 14-15 and 18-19, the claims do not integrate the judicial exceptions into a practical application, nor do they amount to significantly more.
Claim 20 is a new claim that is also rejected under 35 U.S.C. 101 because the claim does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Claim Rejections - 35 USC § 103
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 (PHOSITA) 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.
Claims 1-3, 6-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rehermann et al. (WO 2006/096800 A2) in view of Khleif et al. (US 2019/0336600 A1).
Regarding claim 1, Rehermann teaches a method for diagnosing and monitoring the progression or response to therapy to a subject with active autoimmune hepatitis (Abstract; page 3, lines 13-15; page 8, line 26; page 28, lines 24-26; page 39, lines 15-23).
Rehermann teaches detecting epitopes on the surface of T cells in a biological sample of the subject (Page 3, lines 13-14).
Rehermann teaches treating the subject with a treatment against autoimmune hepatitis (Page 10, lines 10-12).
Regarding claim 2, Rehermann teaches that the biological sample is a blood fraction or a whole blood sample, or a biopsy fraction, for example liver tissue (Page 58, lines 27-28; page 62, claim 16).
Regarding claim 6, Rehermann teaches detecting the expression of CD3 (Sheet 9/9, FIG. 9; page 6, lines 13-14).
Regarding claim 8, Rehermann teaches detecting only activated/memory T cells (Page 36, lines 12-14). A skilled artisan would have known that activated/ memory T cells express CD3 on its surface and not CD45RA because CD45RA is expressed by naïve T cells as evidenced by Dutton et al. (Abstract; page 203, second paragraph).
Regarding claim 9, Rehermann teaches that the detecting the biomarkers is performed by a method selected from flow cytometry, an immunoassay technology, such as ELISPOT technology and ELISA (Page 31, lines 16-21; page 42, lines 2-5).
Regarding claim 18, Rehermann teaches that the biological sample is a liver biopsy (Page 62, claim 16).
Regarding claim 19, Rehermann teaches that the immunoassay technology is ELISPOT technology and ELISA (Page 31, lines 16-21).
Regarding claim 1, Rehermann does not teach detecting the co-expression of the proteins PD-1 (programmed cell death 1) and CD38 at the surface of T lymphocytes in a biological sample of the subject.
Rehermann does not teach testing for the presence or absence of a deviation of the frequency of co-expression of determined PD-1 and CD38 from a reference value of the frequency of co-expression of PD-1 and CD38.
Rehermann does not teach that a frequency of co-expression of determined PD-1 and CD38 in the sample above a reference value indicates that the subject has the active autoimmune hepatitis or presents a risk of relapse of the active autoimmune hepatitis.
Regarding claim 3, Rehermann does not teach that the proteins PD-1 and CD-38 are detected at the surface of CD3 and/ or CD8 T lymphocytes and/ or CD4 T lymphocytes.
Regarding claim 7, Rehermann does not teach detecting the co-expression of biomarker association of PD-1/CD38/CD3.
Regarding claim 8, Rehermann does not teach detecting lymphocytes that are PD-1 +CD38+.
Regarding claim 1, Khleif teaches detecting the co-expression of the proteins PD-1 (Programmed cell death 1) and CD38 at the surface of T lymphocytes in a biological sample (Abstract; page 2, [0013]).
And Khleif teaches testing for the presence or absence of a deviation of the frequency of co-expression of determined PD-1 and CD38 from a reference value of the frequency of co-expression of PD-1 and CD38 [0306-0307]. Khleif further teaches that a frequency of co-expression of determined PD-1 and CD38 in the sample above a reference value indicates that the subject presents a risk of relapse of the active autoimmune hepatitis [0309].
Regarding claim 3, Khleif teaches that the proteins PD-1 and CD-38 are detected at the surface of CD8 T lymphocytes (Page 2, [0013-0014] ). And regarding claim 7, Khleif teaches detecting the co-expression of biomarker association of PD-1/CD38/CD3 (Page 24, [0266]). Also, regarding claim 8, Khleif teaches detecting the lymphocyte population with the phenotype of PD-1 +CD38+ (Page 24, [0266]).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine Khleif’s teachings for detecting populations of T cells that has CD38 and PD-1 markers with Rehermann teachings for ex vivo identification and quantification of AIH-specific T cells because Khleif noted that T cells that has CD38 and PD-1 markers are associated with different diseases including autoimmune diseases (Page 1, [0004]; page 11, [0112]), and noted the dysfunctionality of cells that has CD38 and PD-1 markers (Page 6, [0057]). While Khleif noted that PD-1 prevents self-tissue destruction and consequent autoimmunity (Page 1, [0004]), the presence of PD-1 with CD38 on T cells is one of the hallmarks of dysfunctional T cells that fail to generate immune memory (Page 6, [0057]). Rehermann teaches using T cell epitopes that would permit the ex vivo identification and quantification of AIH-specific T cells (Page 1, lines 10-13). A skilled artisan would have been motivated to detect T cells with CD38 and PD-1 markers because it would have been helpful for monitoring treatment and the immune response in patients with autoimmune hepatitis (Page 1, [0008]). A PHOSITA would have had a reasonable expectation of success in combining the methods of Khleif and Rehermann because the methods are directed to detecting T cell populations.
It would have been obvious for a PHOSITA to detect T cells with CD38 and PD-1 in a patient with an autoimmune hepatitis to monitor the response of the patient to treatment.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rehermann et al. (WO 2006/096800 A2) and Khleif et al. (US 2019/0336600 A1) as applied to claims 1 and 13 above, and further in view of Maggiore et al. (Digestive and Liver Disease 48 (2016) 785–791).
Claim 20 is a new claim that is also rejected under 35 U.S.C. 103 as in the following discussion.
Regarding claims 14 and 20, the teachings of Rehermann and Khleif are previously discussed.
Regarding claims 14 and 20, Rehermann fails to teach that autoimmune hepatitis is an atypical form of autoimmune hepatitis, including a seronegative form and/or with little or no lymphocytic infiltrate of the liver tissue.
Regarding claims 14 and 20, Maggiore teaches that autoimmune hepatitis is an atypical form of autoimmune hepatitis, including a seronegative form (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the Maggiore’s management method of seronegative autoimmune hepatitis with the methods of Rehermann and Khleif’s to diagnose and treat seronegative autoimmune hepatitis (AIH) because Maggiore noted the inability to diagnose a seronegative AIH by a serum marker (Page 786, second paragraph) and Rehermann used agents that would permit the ex vivo identification and quantification of AIH-specific T cells irrespective of their function (Page 3, lines 7-10). Khleif further noted that T cells that has CD38 and PD-1 markers are associated with different diseases including autoimmune diseases (Page 1, [0004]; page 11, [0112]), and noted the dysfunctionality of cells that has CD38 and PD-1 markers (Page 6, [0057]). A skilled artisan would have been motivated to detect T cells with CD38 and PD-1 markers because it would have been helpful for monitoring treatment and predicting the immune response in a patient without serum markers such as with seronegative AIH. It would have been obvious for a PHOSITA to use T cells with CD38 and PD-1 in a patient with a seronegative AIH to provide an early diagnosis of the disease for a more specific treatment.
A PHOSITA would have had a reasonable expectation of success in combining the methods of Khleif, Maggiore and Rehermann because they are all methods directed to detecting lymphocyte populations and immune diseases.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rehermann et al. (WO 2006/096800 A2) and Khleif et al. (US 2019/0336600 A1) as applied to claims 1 and 13 above, and further in view of De Luca-Johnson et al. (Dig Dis Sci (2016) 61:2710–2720).
Regarding claim 15, the teachings of Rehermann and Khleif are previously discussed.
Regarding claim 15, Rehermann fails to teach that the diagnosis is a discrimination of patients with autoimmune hepatitis from patients with non-alcoholic steatohepatitis (NASH), or a demonstration of hepatic autoimmunity in patients with NASH.
Regarding claim 15, De Luca-Johnson teaches that the diagnosis is a demonstration of hepatic autoimmunity in patients with NASH (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine De Luca-Johnson’s demonstration of hepatic autoimmunity in NASH patients with the methods of Rehermann and Khleif to diagnose and treat patients presenting with autoimmune hepatitis (AIH) and coincident nonalcoholic fatty liver disease (NAFLD) because De Luca-Johnson noted that therapeutically, it is important to accurately recognize NAFLD in AIH because the standard treatment for AIH worsens NAFLD (Page 2711, left column, second paragraph). Furthermore, De Luca-Johnson noted that the portal inflammation in NASH is primarily lymphocytic (Page 2719, left column, second paragraph), and Rehermann used agents that would permit the ex vivo identification and quantification of AIH-specific T cells irrespective of their function (Page 3, lines 7-10). Khleif further noted that T cells that has CD38 and PD-1 markers are associate with different diseases including autoimmune diseases (Page 1, [0004]; page 11, [0112]), and noted the dysfunctionality of cells that has CD38 and PD-1 markers (Page 6, [0057]). A skilled artisan would have been motivated to detect T cells with CD38 and PD-1 markers because it would have been helpful for monitoring treatment and modifying the immune response in a patient who is presenting with AIH and NAFLD. It would have been obvious for a PHOSITA to use T cells with CD38 and PD-1 in a patient with AIH and NAFLD to provide an early diagnosis of the disease for a better treatment. A PHOSITA would have had a reasonable expectation of success in combining the methods of De Luca-Johnson, Khleif and Rehermann because the methods are directed to detecting lymphocyte populations and immune diseases.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive regarding the following rejections:
Rejection of claims 1-3, 6-9, 14-15 and 18-19 under 35 U.S.C. 101:
The Applicant argued that claim 1 has been amended to recite, inter alia, "treating said subject with a treatment against autoimmune hepatitis," thereby rendering the rejection moot.
This argument is not persuasive because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claim recites a mere collection of information in the form of data from which the applicant or doctor will be able to diagnose, predict or prognose autoimmune hepatitis in a subject. Such an inference is not sufficient to transform the abstract idea of a mental process and the law of nature of natural correlations into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., a mental process (the presence or absence of a deviation of determined frequency of co-expression of PD-1 and CD38 from the reference value of the frequency of co-expression of PD-1 and CD38) and a law of nature (testing for the presence or absence of a deviation of the determined frequency of co-expression of PD-1 and CD38 from the reference value to make a diagnosis, prediction and/ or prognosis of the subject's active autoimmune pathology). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
Although there is a proposed initial treatment step in claim 1, it is conditional which means a doctor might not have to initiate treatment if the frequency of co-expression of PD-1 and CD38 is below the reference value. Furthermore, the treatment step of claim 1 is a general step that does not add significantly more to the judicial exceptions of the instant application.
Therefore, the judicial exceptions are not integrated into a practical application, and claims 1-3, 6-9, 14-15 and 18-19 are still rejected under 35 U.S.C. 101.
Rejection of claims 1-3, 6-9 and 18-19 under 35 U.S.C. 103:
The Applicant argued that claim 1 has been amended to incorporate the subject matter of claim 4, which is not rejected over any combination of references, thereby rendering the rejection moot.
This argument is not persuasive because the combined references of Rehermann et al. (WO 2006/096800 A2) and Khleif et al. (US 2019/0336600 A1) teach all of the limitations of amended claim 1 as discussed above.
Therefore, the previous rejection of claims 1-3, 6-9 and 18-19 under 35 U.S.C. 103 is still maintained and is made final.
Conclusion
No claims are allowed.
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.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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