DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 1-13, in the reply filed on 9/15/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite because it fails to clearly identify the attenuated bacteria in the strain. The claim recites the functional limitation of being prepared from: “an unattenuated Flavobacterium psychrophilum parent strain having a 40% or greater cumulative percent mortality (CPM) in fish weighing from 5-10 grams that are challenged intramuscularly with the parent strain at a dose of at least 1x10’ cfu/fish.” This leaves the structure of the bacteria in the strain unclear and ambiguous without a clear picture of which strains are within these parameters. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. It is noted that claims 2, 3, 11 and 12 are vague and indefinite for these same reasons. Appropriate clarification and/or correction is required.
Claim 4 is vague and confusing because claim 1 from which it depends already recites that the strain is an attenuated Flavobacterium psychrophilum strain, i.e., attenuated strains are alive, but weakened so it is unclear if the claim is intending to convey. The use of the term “formulated for fish” is unclear since it is not readily apparent what this encompasses. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim 5 is vague and indefinite due to the phrase “derived from US149, US063 (ST278).” The term “derived” does not provide the character or properties from the source that are to be retained in the final product, e.g., paper is derived from wood but is very different from wood. Appropriate clarification and/or correction is required.
Claims 9 and 13 are vague and indefinite because the mere recitation of a name, i.e., name “Fp063-np13.”, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties or the deposit number of the strain which would allow for one to identify the strain without ambiguity. The mere recitation of a name does not adequately define the claimed bacterial strain since it is unclear what is represented by the name. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 10-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
a bacterial cold-water disease (BCWD) vaccine for fish in the Salmonidae family comprising attenuated Flavobacterium psychrophilum strain Fp063-np13, deposited as NRRL Accession No. B-68156,
does not reasonably provide enablement for: .
A bacterial cold-water disease (BC WD) vaccine for fish in the Salmonidae family comprising an attenuated Flavobacterium psychrophilum strain prepared from an unattenuated Flavobacterium psychrophilum parent strain having a 40% or greater cumulative percent mortality (CPM) in fish weighing from 5-10 grams that are challenged intramuscularly with the parent strain at a dose of at least 1x10’ cfu/fish;
Or for the vaccines recited in claims 2-8 and 10-12.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The prior art teaches that vaccines to protect fish from bacterial cold-water disease (BCWD) are highly unpredictable. Takeuchi et al (Scientific Reports (2021), 11, Article 7518, pages 1-11) teach that bacterial cold-water disease (BCWD) is a globally distributed freshwater fish disease caused by Flavobacterium psychrophilum. In spite of its importance, an effective vaccine is not still available.
The present inventors therefore created a completely attenuated, rifampicin-resistant F. psychrophilum strain derived from highly virulent bacterial strains, as exemplified by the US149 and US063 (ST278) strains, to provide protection for fish species in Salmonidae family. It is noted that the instant claims do not recite a method for how the vaccines were prepared or that the strains are rifampicin-resistant. Additionally, the preparation and isolation of a strain with the recited functional abilities is completely unpredictable.
The specification teaches in EXAMPLE 1A, page 25:
The generation of Rifampicin Resistant Strains Two virulent F. psychrophilum strains (US149 and US063) were used as the parent strains to generate rifampicin resistant strains. Previously frozen glycerol stocks of the US149 and US063 strains were plated separately for isolation on tryptone yeast extract salts (TYES; 0.4% tryptone, 0.04% yeast extract, 0.05% MgSO4 - 7H20, 0.05% CaClo - 2H20, pH 7.2) agar and incubated at 15 °C for 5 days. A single colony was passed to TYES agar containing 2 ug/ml rifampicin (Sigma, St. Louis, MO, USA) and incubated at 15 °C for 6 days. For each strain, 3 of the resulting colonies were randomly selected, designated 149-mp17, 149-Anp16 and 149-np14 or 063-mp17, 063-Anp15 and Fp063-np13 (the number means passage number; p means passage; m or n means different initial colony/strain). The single colonies were then passed independently to TYES agar containing increasing concentrations of rifampicin. This process was repeated until the selected strains achieved growth at rifampicin concentrations of 260 ug/ml. Following initial virulence analysis, the Fp063-np13 strain was passaged two more times on TYES out to 280 pg/ml rifampicin. Following each passage, a portion of the growth was harvested, resuspended in sterile 20% glycerol, and frozen at -80 °C.
Example I, page 30:
Shows Immunization Trial A protective immune response against F. psychrophilum was conferred to Atlantic salmon following immunization by IP injection with the Fp063-np13 strain (Table 6). Fish immunized with the Fp063-np13 strain exhibited a significantly decreased CPM, with 0% mortality in US063 challenged group and 2.67% (2/75) mortality in US149 challenged group. Conversely, naive fish sustained high mortality, specifically with 46.67%+ 0.15 mortality in the US149 challenged group, and 41.33% + 0.12 mortality in the USO063 challenged group at 28-day post challenge (FIG. 20). Relative percent survival values were 94.29%-100% (Table 6). There were no mortalities in the mock infected control groups. Challenge mortalities exhibited typical signs of F. psychrophilum infection. Yellow-pigmented bacteria phenotypically characteristic of F. psychrophilum were re-isolated from all mortalities.
Example 3, page 33: concerns immersion vaccination trials for Rainbow trout. A. Vaccination 180 Rainbow trout (1.46g/f) were vaccinated by standard immersion methods using a Fp063-np13 vaccine. For the immersion vaccination, Fp063-np13 vaccine bottles (previously stored at -80°C) were thawed at 15 °C overnight and diluted 1:10 in a total volume of 10 liters of clean rearing water immediately before vaccinating. Fish were immersion vaccinated for 30 minutes and all vaccinated fish were booster vaccinated two weeks after receiving the primary vaccination using the same immersion methodology. Control groups were immersed in a 1:10 dilution of TYES media in an identical manner as the vaccinated fish.
The results and disclosure do not enable the full breadth of the claims, but do enable the strain Fp063-np13 which produces the unexpected results. To identify any other strains with the functional abilities recited in claims 1-3, 10, 11, 12, etc. (the CPM in fish populations, from other strains, etc) would take an undue amount of experimentation, akin to invention.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
Claim Rejections - 35 USC § 112-Deposit Requirement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of the Fp063-np13 strain. Because it is not clear that the properties of this strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the strain, a suitable deposit for patent purposes is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6, 7, 8, 10 and 11 are is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cain et al (US Patent No. 7,740,864)
Cain et al teach a vaccine for protecting non-wounded fish against a disease caused by non-attenuated Flavobacterium psychrophilum comprising isolated, live attenuated, rifampicin-resistant Flavobacterium psychrophilum, wherein when the non-wounded fish are exposed by immersion to a sufficient amount of the live attenuated, rifampicin-resistant Flavobacterium psychrophilum in the vaccine, the vaccine provides protection against the disease in the non-wounded fish. Fish are immunized by a mass vaccination method, such as by immersion in water containing an attenuated strain of a pathogenic bacterium that does not effectively cause disease in fish when the non-attenuated pathogenic bacterium is exposed to the fish by immersion. An illustrative example of the method is for immunizing against cold-water disease caused by Flavobacterium psychrophilum, which may be attenuated by serial passage in media containing increasing amounts of an antibiotic, such as rifampicin. E.g., prepared from unattenuated F. psychrophilum strain (instant claim 1) Table 2 shows cumulative percent mortality (CPM).+-.standard error of the mean (SEM) and relative percent survival (RPS) among rainbow trout immunized by ip injection as described in Example 7A following challenge with the parent CSF-259-93 F. psychrophilum strain at 8 and 15 weeks post-immunization. Fish given mock immunizations with PBS sustained high CPM (nearly 100%) upon challenge with the parent CSF-259-93 strain, whereas fish immunized with the 259-93B.17 strain exhibited a significantly decreased CPM at both 8- and 15-weeks post-immunization (P<0.05). Relative percent survival values of up to 45% were observed, e.g., 40% or greater cumulative mortality. (88) Challenge mortalities exhibited typical signs of F. psychrophilum infection. Yellow-pigmented bacteria phenotypically characteristic of F. psychrophilum were reisolated from 98% (96/98) and 95% (52/55) of the mortalities examined at the 8- and 15-weeks post-immunization challenges, respectively. There were no mortalities in the mock-infected control groups. Example 6 teaches the challenge dose in the same amount as claim 1. Cain teach that (11) Fish that may be treated by the method of the invention include any fish that is susceptible to infection and disease caused by the particular organism. The fish may be a marine or salt-water fish. Examples of suitable fish for the method of invention include salmonids (Oncorhynchus sp. and Salmo sp.), American, European, and Japanese eels (Anguilla sp.), tilapia (Oreochromis sp.), striped bass and hybrid-striped bass (Morone chrysops. and M. saxatilis), flounders (Seriola sp.), seabream (Sparus sp.), sea perch (Lates calcarifer), the estuarine grouper (Epinephelus tawine), walleye (Stitzostedion vitreum), channel catfish (Ictalurus punctutus), centrachids (such as largemouth bass, Micropterus salmoides), brown bullheads (Nebulosus sp.), fat head minnows (Pimephales promelas), golden shiners (Netemigonus crysoleucas), goldfish (Carassius auratus), carp (Cyprinus carpio), and aquarium fish species such as black mollies (Poecilia sphenops) and platies (Xiphosphorus maculatus). Species affected specifically by CWD include all salmonids. The pathogen has also been reported in non-salmonid species, such as eel Anguilla sp., sea lamprey Petromyzon marinus, carp Cyprinus carpio, tench Tinca tinca, crucian carp Carassius carassius, goldfish C. auratus, ayu Plecoglossus altivelis, pale chub Zacco platypus, perch Perca fluviatilis, and roach Rutilus rutilus. The vaccine may be composed entirely of the attenuated live bacteria with or without culture medium in which the bacteria were grown. If desired, the vaccine may contain constituents in addition to the attenuated bacteria, such as a carrier or vehicle. Suitable carriers include water, physiological saline, mineral oil, vegetable oils, aqueous sodium carboxymethyl cellulose, or aqueous polyvinylpyrrolidone. Vaccine formulations may also contain optional adjuvants, antibacterial agents, or other pharmaceutically active agents as are conventional in the art. Suitable adjuvants include but are not limited to mineral oil, vegetable oils, alum, and Freund's incomplete adjuvant.
Prior art not presently relied upon:
Bruce et al Journal of Fish Diseases (2020), 43(8), 915-928
For salmonid producers, a common threat is Flavobacterium psychrophilum. Recent advancements in bacterial coldwater disease (BCWD) management include the development of a live-attenuated immersion vaccine that cross-protects against an array of F. psychrophilum strains. Emerging family Flavobacteriaceae cases associated with clinical disease have been increasing, including pathogenic isolates of Flavobacterium spp. and Chryseobacterium spp. The cross-protective ability of a live-attenuated F. psychrophilum vaccine was determined against three virulent Flavobacteriaceae isolates. Juvenile rainbow trout were vaccinated, developed high F. psychrophilum-specific antibody titres and were challenged with Chryseobacterium spp. isolates (S25 and T28), a Flavobacterium sp. (S21) isolate, a mixed combination of S21:S25:T28, and a standard virulent F. psychrophilum CSF259-93 strain. Results demonstrated strong protection in the CSF259-93 vaccinated group (relative per cent survival (RPS)=94.44%) when compared to the relevant CSF259-93 controls (p < .001). Protection was also observed for vaccinated fish challenged with the S21:S25:T28 mix (RPS = 85.18%; p < .001). However, protection was not observed with the S21, S25 or T28 isolates alone. Analysis of whole-cell lysates revealed differences in protein banding by SDS-PAGE, but conserved antigenic regions by Western blot in S25 and T28. Results demonstrate that this live-attenuated vaccine provided protection against mixed flavobacterial infection and suggest further benefits against flavobacteriosis.
Plant et al Journal of fish diseases, (2012 Jul) Vol. 35, No. 7, pp. 529-39.
Flavobacterium psychrophilum is the aetiologic agent of bacterial coldwater disease and rainbow trout fry syndrome. In this study, we compared a wild-type strain (CSF 259-93) with a rifampicin-resistant strain and virulence-attenuated strain of F. psychrophilum (CSF 259-93B.17). The attenuated strain harboured a mutation in the rpoB gene consistent with resistance to rifampicin. Two-dimensional polyacrylamide gel electrophoresis (2D-PAGE) and mass spectrometry demonstrated an altered proteome with eight proteins characteristic for the parent strain and six that were unique to the attenuated strain. Immunoblotting with a diagnostic monoclonal antibody (FL-43) identified a putative antigen (FP1493) that was subsequently cloned, expressed as a recombinant protein and confirmed as recognized by FL-43. 2D-PAGE, immunoblotting with rainbow trout, Oncorhynchus mykiss (Walbaum), convalescent antisera and mass spectrometry of bacterial whole-cell lysates revealed several uniquely expressed immunoreactive proteins including FP1493. An FP1493 recombinant subunit vaccine was tested, but did not provide protection against challenge with the CSF259-93 strain. While the exact mechanism responsible for altered protein synthesis and attenuation of CSF 259-93B.17 is still unknown, the differentially expressed immunoreactive proteins are a valuable resource to develop subunit vaccines and to identify proteins that are potentially involved in disease.
Alvarez et al Microbiology (Reading, United Kingdom) (2008), 154(4), 1144-1151
Flavobacterium psychrophilum is a psychrotrophic fish-pathogenic bacterium that causes cold water disease (CWD) in salmonids. By means of Tn4351 mutagenesis a mutant named FP1033, deficient in growth on iron-depleted medium, was previously isolated. FP1033 recovered the parental phenotype in the presence of iron. The gene disrupted by the transposon in this mutant encoded a protein with similarity to ExbD proteins, which are members of the TonB complex system involved in iron uptake mediated by siderophores. Analysis of the DNA surrounding the transposon insertion showed the presence of a tonB cluster of genes composed of exbB, two exbD (exbD1 and exbD2) and tonB loci. RT-PCR analysis and complementation studies indicated that these genes are transcribed as an operon and that the exbD2 : : Tn4351 phenotype was caused by the lack of ExbD2. FP1033 showed decreased virulence and conferred a high level of protection in rainbow trout fry after vaccination. This is believed to be the first report of a F. psychrophilum attenuated strain that induces a protective immune response in rainbow trout against CWD. These results suggest that the exbD2 locus from this particular TonB system is a suitable target to generate a live attenuated vaccine.
Cain et al US 20130052228 A1 Date Published 2013-02-28
Teaches protection of fish from bacterial disease by vaccination with a live attenuated strain of the causative bacterium is enhanced when the attenuated strain has been grown in an iron-limited medium. [0014] The term "iron-limited" when referring to a bacterial growth medium means a medium that is essentially free of iron or, if iron is present in the medium, contains an iron chelator at a concentration that if sufficient to reduce the amount of free iron in the medium. 1. A vaccine for protecting fish against disease caused by a bacterium comprising a live attenuated strain of the bacterium which has been grown in or on an iron-limited medium, wherein the live attenuated strain of the bacterium which has been grown on or in a medium that is not iron-limited is effective in reducing morbidity and/or mortality due to disease caused by exposure of the fish to a live non-attenuated pathogenic strain of the bacterium. 2. The vaccine of claim 1 wherein the bacterium is Flavobacterium psychrophilum.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Thursday from 8:00 AM-6:30 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 10/10/25