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 .
Status of the Claims
Applicant’s submission filed on December 2, 2025 has been entered and considered. Rejections and/or objections not reiterated from the previous office action mailed June 2, 2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The amended claims filed on December 2, 2025 are acknowledged. Claims 7, 14, 21, 28, and 32 have been amended.
Claims 1-4, 7, 13-18, 21, 27-28, 30-33, 36, and 38 are pending and are being examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application claims domestic benefit from U.S. provisional application 63/218,635 filed on July 6, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on July 6, 2022 is acknowledged and has been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Withdrawn Claim Objections
In light of Applicant’s amendments to claims 7 and 21 to correct spelling of chromatography and amendments to claims 18 and 28 to refer to a latent P. vivax infection, the objections to claims 7, 14, 21, and 28 are withdrawn.
Withdrawn Claim Rejections - 35 USC § 112(b)
In light of Applicant’s amendment to claim 32 such that it depends from claim 30, the antecedent basis rejection of claim 32 has been withdrawn.
Maintained Claim Rejections - 35 USC § 103
Claims 1-4, 7, 13-18, 21, 27-28, 30-33, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Gualdron-Lopez et al. (2018, Characterization of plasmodium vivax proteins in plasma-derived exosomes from malaria-infected liver-chimeric humanized mice, Fron. in Microbiology, 9, 1271); Roth et al. (2018, A comprehensive model for assessment of liver stage therapies targeting Plasmodium vivax and Plasmodium falciparum. Nat. Commun. 9, 1837); Gural et al. (2018, In vitro culture, drug sensitivity, and transcriptome of Plasmodium vivax hypnozoites. Cell, Host & Microbe, 23, 395-406); and Llanos-Cuentas et al. (2019, Tafenoquine versus primaquine to prevent relapse of Plasmodium vivax malaria. New England J. of Medicine, 380, 229-241).
With regard to claim 1, Gualdron-Lopez et al. teaches that P. vivax infection is characterized by the presence of hypnozoites, a dormant liver stage of infection, which can remain latent and asymptomatic prior to relapse of malaria. Further Gualdron-Lopez et al. teaches a method of analysis in which identified proteins from pre-erythrocytic liver stages of infection can be used as detection markers of P. vivax hypnozoite infection (Abstract). The method of Gualdron-Lopez et al. teaches use of extracellular vesicles (e.g. “exosomes”, Abstract) derived from hepatocytes and secreted in the bloodstream (Pg. 11, first col., second full para.) and includes collection of blood samples from subjects infected with P. vivax (Pg. 3, Blood Collection and Plasma Separation), isolation of exosomes via size exclusion chromatography (Pg. 3, Exosome Purification), and confirmation of presence of exosomes via exosomal marker CD5L (Pg. 3, Bead-Based Flow Cytometry). Additionally, Gualdron-Lopez et al. teaches use of antibody binding (Figs. 6D and E) in exosomes and use of protein digestion (Pg. 3, Exosome Solubilization and Protein Digestion for LC-MS/MS) followed by liquid chromatography and mass spectrometry (Pg. 3, Mass Spectrometry) in order to detect and identify P. vivax hypnozoite proteins present in EVs.
Although Gualdron-Lopez et al. does not teach detection of P. vivax hypnozoites in liver cell cultures, they do teach that EVs can be isolated from the culture supernatant of hepatocyte cultures in vitro (Pg. 6, second para.)
Roth et al. teach that presence of P. vivax hypnozoite stage in primary human hepatocyte cultures can be determined using antibody staining for proteins differentially expressed in latent hypnozoite stage when compared to replicating schizont stage (Fig. 4).
Therefore, it would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to combine the method of detection of P. vivax hypnozoites in a subject using EVs present in a biological sample and the knowledge that EVs can be isolated from hepatocyte cells in culture as taught by Gualdron-Lopez et al. with the knowledge that cultured primary human hepatocyte cells can be used to detect the hypnozoite stage of P. vivax as taught by Roth et al. One having ordinary skill in the art would have recognized that the methods of P. vivax detection taught by Gualdron-Lopez et al. could be combined with cultured hepatocyte cells as used by Roth et al. by known methods with each element performing the same function as it would separately. One having ordinary skill in the art would have had a reasonable expectation of success as both Gualdron-Lopez et al. and Roth et al. teach methods of identification of P. vivax hypnozoites.
Neither Gualdron-Lopez et al. nor Roth et al. teach detecting male gamete member fusion protein (HAP2) and/or proliferating cell nucleolar antigen P120 (PVP01_0930100) in extracellular vesicles.
Gural et al. teaches characterization of the P. vivax transcriptome in primary human hepatocyte co-cultured cells (Pg. 399, Hybrid Capture Reveals P. vivax Hypnozoite Transcriptome in the MPCCs) indicating that male gamete fusion protein (HAP2) and proliferating cell nucleolar antigen P120 (PVP01_0930100) are characteristic of in P. vivax hypnozoite-enriched primary human hepatocyte co-cultures compared to non-hypnozoite enriched primary human hepatocyte co-cultures (Table S1, found in Supplemental Information).
Therefore, it would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to combine the methods of detecting P. vivax hypnozoite protein expression using extracellular vesicles as taught in Gualdron-Lopez et al. with the known increases in HAP2 and proliferating cell nucleolar antigen P120 (PVP01_0930100) in P. vivax hypnozoite-enriched cells as taught by Gural et al. One having ordinary skill in the art would have been motivated to make this combination as they would have recognized a lack of known biomarkers for use in detecting presence of latent P. vivax hypnozoites and that Gural et al.’s teaching presented a finite number of potential biomarkers specific to P. vivax hypnozoite presence. One having ordinary skill in the art would have had a reasonable expectation of success as both Gualdron-Lopez et al. and Gural et al. teach methods of identifying biomarkers which are characteristic of latent stage P. vivax hypnozoites.
With regard to claims 2-3, Gualdron-Lopez et al. teaches use of size exclusion chromatography and detection of CD5L to confirm presence of exosomes (Pg. 5., Results, Isolation of Plasma-Derived Exosomes From Human Liver-Chimeric FRG huHEP Mice).
With regard to claims 4 and 7, Gualdron-Lopez et al. teaches that proteins present in EVs can be detected via use of antibody binding to EVs (Figs. 6 D and E) and via the use of protein digestion followed by liquid chromatography and mass spectrometry (Pg. 4, Exosome Solubilization and Protein Digestion for LC-MS/MS and Mass Spectrometry).
Gualdron-Lopez et al. does not teach detection techniques specific for detecting HAP2 protein or proliferating cell nucleolar antigen P120.
Gural et al. teaches that HAP2 and proliferating cell nucleolar antigen P120 exhibit increased expression in the P. vivax hypnozoite transcriptome (Table S1, found in Supplemental Information).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine the use of antibody binding and/or protein digestion followed by liquid chromatography and mass spectrometry as a method of detecting proteins in EVs as taught by Gualdron-Lopez et al. with Gural et al.’s teaching of HAP2 and proliferating cell nucleolar antigen P120 as potential biomarkers of P. vivax hypnozoites. One having ordinary skill in the art would have been motivated to make this combination as they would have recognized that biomarkers indicative of hypnozoite presence are currently unknown that that Gural et al.’s teachings indicate potential biomarkers which could be used to identify hypnozoite presence. One having ordinary skill in the art would have had a reasonable expectation of success as the teachings of both Gualdron-Lopez et al. and Gural et al. are geared toward identification of biomarkers which are characteristic of latent stage P. vivax hypnozoites.
With regard to claim 13, the limitations of this claim are addressed as in claim 1 by the combined teachings of Gualdron-Lopez et al. and Gural et al. which are detailed above and incorporated herein.
With regard to claim 14, Gualdron-Lopez et al. teaches that P. vivax infection is characterized by the presence of hypnozoites, a dormant liver stage of infection (Abstract).
With regard to claims 15-17, Gualdron-Lopez et al. teaches processing of plasma samples for isolation of exosomes using size exclusion chromatography and detection of CD5L as confirmation of exosome presence (Pg. 5., Results, Isolation of Plasma-Derived Exosomes From Human Liver-Chimeric FRG huHEP Mice).
With regard to claims 18 and 21, the limitations of these claims are addressed as above in claims 4 and 7.
With regard to claim 27, the method of obtaining biological samples comprising EVs and detecting the presence of HAP2 protein and/or proliferating cell nucleolar antigen P120 as indicators of latent state P. vivax infection has been detailed above in claim 13 and the combined teachings of Gualdron-Lopez et al. and Gural et al. are incorporated herein.
Although Gural et al. teaches that use of primaquine (an 8-aminoquinoline) is able to treat latent stage P. vivax hypnozoites in liver cells, neither Gualdron-Lopez et al. not Gural et al. teach use of administration of an 8-aminoquinoline compound for treatment in a subject.
Llanos-Cuentas et al. teaches a method of “radical cure” of P. vivax infection, which is defined as elimination of latent P. vivax hypnozoites (Pg. 230, first para.), by administering a therapeutic dose of primaquine or tafenoquine, which are considered to read on 8-aminoquinoline compounds, followed by monitoring of treated patients for relapse infections (Abstract). Llanos-Cuentas et al. teaches that microscopic parasitemia was used for diagnosis and evaluation of P. vivax infection (Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine the combined teachings of Gualdron-Lopez et al. and Gural et al. wherein EVs isolated from a biological sample can be screened for presence of HAP2 protein and/or proliferating cell nucleolar antigen P120 for use as an indication of the presence of latent stage P. vivax hypnozoites with Llanos-Cuentas et al.’s teaching that administration of primaquine and tafenoquine can be used to treat latent stage P. vivax hypnozoites. One having ordinary skill in the art would have been motivated to combine these teaches as one would have recognized that use of the compounds taught by Llanos-Cuentas et al. would have eliminated latent infection characterized by presence of P. vivax hypnozoites in subjects as detected by the combined teachings of Gualdron-Lopez et al. and Gural et al. One having ordinary skill in the art would have a reasonable expectation of success as the teachings of Gualdron-Lopez et al., Gural et al. and Llanos-Cuentas et al. are all directed toward latent stage P. vivax infections characterized by presences of hypnozoites.
With regard to claim 28, the limitations of this claim are addressed above as in claim 14
With regard to claims 30-32, the limitations in these claims are addressed above as in claims 15-17.
With regard to claims 33 and 36, the limitations in these claims are addressed as above in claims 18 and 21.
With regard to claim 38, Llanos-Cuentas et al. teaches that primaquine and tafenoquine, both 8-aminoquinoline compounds, can be administered to subjects for use as a “radical cure” wherein the compounds are able to treat latent stage P. vivax hypnozoites and prevent relapsing infection (Abstract).
Response to Applicant’s Traversal
Applicant’s traversal filed on December 2, 2025 is acknowledged and has been fully considered but is not persuasive.
Applicant asserts on Pg. 9 that the Office’s conclusion of obviousness is based on impermissible hindsight reconstruction and alleges that the cited references do not teach or suggest the claimed methods nor provide a motivation to combine or reasonable expectation of success. Applicant asserts that the Office has applied discrete teachings from unrelated references which each address different scientific questions. Applicant asserts on Pg. 10 that the applied references do not teach or suggest that hypnozoite proteins (i.e., HAP2 and P120) are released into or are detectable in EVs, that EVs can function as a biomarker for hypnozoite stages of P. vivax, or that EV-based detection could be used in conjunction with therapeutic administration of 8-aminoquinoline compounds and that one having ordinary skill in the art would have had no reason to combine these references.
Applicant’s traversal related to impermissible hindsight reasoning has been fully considered, but is not found persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the methods of detection of P. vivax hypnozoite specific proteins in liver-derived EVs and the utility as a diagnostic marker was known in the art based on the teachings of Gualdron-Lopez, and HAP2 and proliferating cell nucleolar antigen P120 proteins were known to be P. vivax hypnozoite specific proteins based on the teachings of Gural. In this case, one having ordinary skill in the art could have reasonably chosen the known P. vivax hypnozoite markers HAP2 and proliferating cell nucleolar antigen P120 of Gural for use in the method of detecting hypnozoite-related proteins in EV for use as diagnostic markers of Gualdron-Lopez. Thus, it would have been predictably obvious to look for the presence of HAP2 and cell nucleolar antigen P120 in EVs as indicators of latent P. vivax hypnotize infection in patients.
First, Applicant asserts on Pgs. 10-11 that the cited references do not teach or suggest detection of hypnozoite-specific proteins (HAP2 or P120) in EVs, specifically that the prior art, including Gualdron-Lopez, does not identify hypnozoite specific proteins or biomarkers in EVs and that Gural does not suggest that HAP2 or P120 are secreted, exported, or packaged into EVs. Applicant traverses that the Office’s assumption transcriptome upregulation as taught by Gural would lead to protein detection in EVs is based on “mere speculation”. Applicant further asserts that there is no motivation to combine the cited references as each of the cited art addresses distinct problems. Applicant asserts that Gualdron-Lopez investigates EV proteomics in humanized mice and does not teach or suggest hypnozoite markers or hepatocyte cultures, Roth teaches detection of hypnozoites in liver cell culture but does not teach EVs or hypnozoite biomarkers, Gural teaches hypnozoite transcriptomics but does not teach EVs, and that Llanos-Cuentas teaches clinical treatment of hypnozoites with 8-aminoquinoline but does not teach EVs or hypnozoite biomarkers and thus Applicant asserts that the cited references do not address the same problem and do not suggest combining their teachings. Applicant further asserts that the prior art references each identify the long-standing problem of a lack of biomarkers for detection of latent hypnozoites the claimed invention fills a longstanding unmet need regarding the lack of biomarkers for detection of latent hypnozoites and therefore is not obvious.
Applicant’s traversal related to teaching, suggestion, and motivation to combine has been fully considered, but is not found persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding Applicant’s traversal that Gualdron-Lopez does not identify hypnozoite-specific proteins within EVs, Gualdron-Lopez teaches identification of P. vivax proteins present in EVs at various infection timepoints “with the objective of identifying parasite proteins secreted from infected cells that could be associated with a specific P. vivax liver stage” and further teaches that proteins identified as being present from day 16-21 post infection coincide with time points during which only non-replicating hypnozoites remain (Pg. 7, right col., 1st full para., Table 1). Further, Gualdron-Lopez teaches that the proteins in EVs 16-21 days after P. vivax infection suggests that these proteins originate from hypnozoites and are potential biomarkers of hypnozoite infection (Pg. 13, left col., 2nd para.). Thus, Gualdron-Lopez appears to teach identification of P. vivax hypnozoite-specific proteins in EVs and indicates use of these proteins as hypnozoite specific biomarkers. Regarding Applicant’s traversal that Gural does suggest that HAP2 or P120 are present in EVs, Applicant’s specification evidences and it was well known in the art that HAP2 is a membrane protein (i.e., a male gamete membrane fusion protein) and that proliferating cell nucleolar antigen P120 has predicted rRNA (cytosine-C(5))-methyltransferase enzymatic activity (Pg. 24), and Fig. 3 of the prior art of Gualdron-Lopez indicates that membrane proteins and nuclear proteins are packaged into EVs, thus a skilled artisan could reasonably assume that HAP2 and P120 as taught by Gural would be present in EVs. Applicant is reminded that absolute certainty is not a prerequisite for a case of obviousness, and that one of ordinary skill only need a reasonable expectation of success that the upregulated HAP2 membrane protein and P120 nuclear antigen could be in EVs.
Regarding motivation to combine, as Applicant has pointed out on Pg. 11, the cited prior art references identify the lack of biomarkers for detection of latent hypnozoites in P. vivax infection, thus providing to one having ordinary skill in the art the motivation to combine the prior art references, which address the subject of challenges in identification and treatment of hypnozoites, to arrive at the instantly claimed method. Similarly, one having ordinary skill in the art would be well aware of the challenges in identification and treatment of latent P. vivax infections based on lack of biomarkers for hypnozoite presence and would thus be motivated to combine the applied prior art references in search of a more reliable hypnozoite specific biomarker.
Applicant’s traversal related to long-felt need has been fully considered, but is not found persuasive.
MPEP 616.04 states
“Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967); Orthopedic Equipment Co., Inc. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 217 USPQ 1281 (Fed. Cir. 1983). Second, the long-felt need must not have been satisfied by another before the invention by applicant. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988).”
“Long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references. Texas Instruments Inc. v. Int’l Trade Comm’n, 988 F.2d 1165, 1179, 26 USPQ2d 1018, 1029 (Fed. Cir. 1993).”
Applicant asserts that the claimed subject matter solved a problem that was long standing in the art. However, there is no showing that others of ordinary skill in the art were working on the problem and if so, for how long. In addition, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the teachings of the above cited references, they would still be unable to solve the problem. See MPEP § 716.04.
Second, Applicant asserts on Pg. 12 that one having ordinary skill in the art would not have expected hypnozoite-specific proteins to be incorporated into EVs and that there is no reasonable expectation of success in identifying hypnozoite-specific proteins in EVs, let alone HAP2 of P120. Applicant traverses that there is no teaching that hypnozoites produce, secrete, or export proteins into EVs.
Applicant’s traversal related to reasonable expectation of success has been fully considered, but is not found persuasive.
As detailed above, the prior art of Gualdron-Lopez teaches identification of proteins in EVs that Gualdron-Lopez asserts are associated with hypnozoites and could be used as biomarkers for detection of hypnozoites (Pg. 7, right col., 1st full para., Table 1 and Pg. 13, left col., 2nd para.). Applicant’s specification evidences and it was well known in the art that HAP2 is a membrane protein (i.e., a male gamete membrane fusion protein) (Fig 3D) and that proliferating cell nucleolar antigen P120 has predicted rRNA (cytosine-C(5))-methyltransferase enzymatic activity (Pg. 24) and Fig. 3 of the prior art of Gualdron-Lopez indicates that membrane proteins and nuclear proteins are packaged into EVs, thus a skilled artisan could reasonably assume that HAP2 and proliferating cell nucleolar antigen P120 as taught by Gural would be present in EVs. Therefore, a skilled artisan has every reason to believe that hypnozoite proteins, including HAP2 and P120, would be produced and secreted by hypnozoites and exported into EVs. Further, although Gualdron-Lopez is silent to the presence of HAP2 and P120, the EVs of the instant invention appear to be obtained by the same methods as the EVs in the prior art.
Applicant’s disclosure investigates hypnozoite proteins in EVs present at a single timepoint of day 8 post infection and only during treatment with MMV048 to eliminate replicating schizonts (Pg. 19) and further indicates that P120 was only detected in a single sample (Pg. 24, 2nd para.). Gualdron-Lopez teaches that at day 8, the protein biomarkers from replicating schizonts “mute” the hypnozoite signal (Pg. 7, right col., 1st full para.). Thus, as Gualdron-Lopez did not investigate P. vivax proteins present in EVs during treatment to eliminate replicating schizonts, a skilled artisan would reasonably expect that hypnozoite-specific proteins present in EVs might not be detected, despite their inherent presence, based on the majority of P. vivax proteins detectable at day 8 being associated with schizonts. Additionally, Applicant’s specification indicates that their findings of the presence of HAP2 and P120 in EVs are supported by transcriptional analysis showing that these genes are upregulated in hypnozoite hepatocyte cultures (Pg. 23, last para. and Pg. 24, 2nd para.) as taught in Gural. Therefore, based on Applicant’s disclosure, a skilled artisan has every reason to believe that HAP2 and P120 were inherently present in the EVs as taught by Gualdron-Lopez.
Finally, Applicant asserts on Pg. 13 that the instantly claimed findings produce the alleged unexpected results of the presence of HAP2 and P120 in EVs which are detectable in biological samples and are correlated with presence of hypnozoites because the prior art does not suggest that hypnozoite-specific proteins would be secreted into EVs.
Applicant’s traversal related to alleged unexpected results has been fully considered, but is not found persuasive. As detailed above, the prior art of Gualdron-Lopez teaches that hypnozoite-specific proteins are secreted into EVs (Pg. 7, right col., 1st full para., Table 1 and Pg. 13, left col., 2nd para.) and are detectable in biological samples. HAP2 and P120 were known to be transcriptionally upregulated in hypnozoite-enriched cultures based on the teachings of Gural. Although Gualdron-Lopez is silent as to the presence of HAP2 and P120, it appears that these proteins are obvious to look for and/or inherently present in the EVs of Gualdron-Lopez and are likely to be present in EVs based on their upregulation and subcellular localization to the plasma membrane and nucleus, respectively. Therefore, based on the teachings of the prior art, a skilled artisan would have expected to detect HAP2 and P120, which are known to be associated with hypnozoites, in EVs from biological samples which can be used to detect hypnozoite-related biomarkers.
Additionally, Applicant has shown the presence of hypnozoite-associated proteins in EVs at a single timepoint of day 8 post infection and only in the presence of administration of a drug (MMV048) which eliminates replicating schizonts (Pg. 19). Further, P120 was detected only in a single sample (Pg. 24, 2nd para.). Based on the prior art of Gualdron-Lopez, absent treatment to eliminate replicating schizonts, proteins present in EVs at days 16-21 post infection are more likely to be indicative of biomarkers for hypnozoites and, at day 8, any biomarker indicative of hypnozoites is likely to be “muted” by schizont biomarkers. Applicant’s instant method has not claimed a particular time point for detection of HAP2 or P120 or recited the need for additional treatment to elimination schizonts, thus the alleged unexpected results are not commensurate in scope with the method as instantly claimed.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631