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 .
Restriction/Election
Applicant’s election of Group I (Claims 1-10 and 13-15), as well as Applicant’s election of Species 1C (antimicrobial peptides or proteins (Claims 1 and 8)), and Species 2B (beef cattle (Claims 13 and 15)), without traverse in the reply filed on 12 November 2025 are acknowledged.
Claims 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim. In addition, Claims 6-7, 9 and 14 are withdrawn as being drawn to nonelected species; therefore, all limitations relating to said nonelected species, are withdrawn from further consideration at this time. Election was made without traverse, in the reply filed on 12 November 2025 to the Restriction/Election Office Action mailed on 16 July 2025.
Status of Claims
Claims 6-7, 9, 11-12 and 14 show incorrect status identifiers. Applicant is reminded that claims 6-7, 9, 11-12 and 14 should be labeled: “(Withdrawn)”; remaining claims should be identified appropriately (MPEP 714 (II)(C)(A)) (See 37 CFR 1.121 (c)).
Appropriate correction is required.
Applicant is required to provide a new claim set showing correct status identifiers in the response to this Office Action.
Claims 1-15 are pending.
Claims 6-7, 9, 11-12 and 14 are withdrawn.
Claims 1-5, 8, 10 and 13 are rejected.
Claim 15 is objected to.
Priority
It is noted that Applicant has not claimed domestic or foreign priority in this application.
Therefore, claims 1-5, 8, 10 and 13 have the effective filing date of 15 May 2023, which is the filing date of the instant application.
Information Disclosure Statement
It is noted that Applicant has not submitted an information disclosure statement (IDS) with this application.
Drawings
The drawings were received on 15 May 2023. These drawings are accepted.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1), MPEP 608.01(o), MPEP 608.01(l) and MPEP 2173.03. See also MPEP 2163.06 (III). Correction of the following is required:
Claim 10 recites: "The method of any one of claims 1 to 9, further comprising evaluating the effectiveness of the Fusobacterium varium-targeted interventions by comparing the incidence of liver abscesses in treated and untreated cattle."
However, there is no explanation, description or definition in the specification of the evaluating step as cited in instant claim 10.
In order to provide proper antecedent basis, Applicant should indicate where in the specification this concept is explained, described or defined, or submit an appropriate amendment to the specification which provides clear antecedent basis for the concept appearing in the claimed subject matter, without introducing new matter (MPEP 608.01(o) and MPEP 2163.06 (III)) or the claim can either be deleted or amended to an 'evaluating' step that is supported by the specification.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 recites: "The method of claim 13, applied specifically in the beef cattle industry", which should read: "The method of claim 13, wherein the method is applied specifically in the beef cattle industry." Other language will be considered.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
35 U.S.C. § 112(a)
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.
35 U.S.C. §112(a) and pre-AIA 35 U.S.C. §112, first paragraph require that the specification include the following (MPEP 2161 (I)):
(A) A written description of the invention;
(B) The manner and process of making and using the invention (the enablement requirement); and
(C) The best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 fails to comply with the written description requirement because it does not adequately describe the manner and process of making and using the invention; and the claim text recites limitations which are not described in the specification and/or which encompass a claim breadth which is not supported by the specification.
Claim 8 recites: "...wherein the targeting further comprises implementing a dietary modification, probiotic supplementation, or administering antimicrobial peptides or proteins."
It is noted that 'administering antimicrobial peptides or proteins' is a species election made by Applicant.
The specification recites the term "antimicrobial peptides or proteins" three times, but does not describe, explain or define which antimicrobial peptides or proteins can be successfully incorporated into a method in which Fusobacterium varium is targeted (originally-filed specification, pg. 2, para. [0003]; pg. 4, para. [0007]; and pg. 10, cont. para. [0028]). The term is listed in a Markush group of potential targeting approaches, but there are no specific (working) examples showing the use of particular antimicrobial peptides or proteins to target F. varium.
Therefore, the practitioner of the method would not know which antimicrobial peptides or proteins could be used to target F. varium via their administration. Although antimicrobial peptides or proteins are known in the art for their use as antibacterial agents, the practitioner of the instantly-claimed method would not be able to identify which types of classes or individual antimicrobial peptides or proteins would successfully target F. varium without further guidance by Applicant.
MPEP 2163.03 (V) states: "The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. 'Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.' Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
MPEP 2163 (II)(A)(3)(a)(ii) states, in part: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above),…, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)”; and “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
To overcome this rejection, Applicant may attempt to demonstrate that the original disclosure establishes that he or she was in possession of the claimed subject matter or the recitation of ‘antimicrobial peptides or proteins’ in the claim can either be deleted or revised to a description of a targeting step that is supported by the specification.
35 U.S.C. § 112(b)
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 2-5, 10 and 15 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 pre-AIA the applicant regards as the invention.
Claims 2-5 and 15 are indefinite because the metes and bounds of the claimed subject matter are not clear.
(1) Claims 2, 3 and 15 recite the relative term "specifically".
Claim 2 recites: "..., wherein the antibacterial agent is specifically effective against Fusobacterium varium..."
Claim 3 recites: "..., wherein the bacteriophage is specifically lytic against Fusobacterium varium."
Claim 15 recite: "..., applied specifically in the beef cattle industry."
However, it is not clear, for example, what the difference is between an antibacterial agent that is specifically effective against Fusobacterium varium and an antibacterial agent that is effective against Fusobacterium varium. For the purpose of searching the prior art, it is not clear how an antibacterial agent or a bacteriophage which is effective or lytic against Fusobacterium varium is not also specific to F. varium.
For the purpose of compact prosecution, the claims will be interpreted to read: Claim 2: "..., wherein the antibacterial agent is effective against Fusobacterium varium..."; Claim 3: "..., wherein the bacteriophage is lytic against Fusobacterium varium"; and Claim 15: "..., applied in the beef cattle industry."
(2) Claims 4 and 5 recite the phrase: "antibacterial agent or bacteriophage".
However, it is not clear what the difference is between an antibacterial agent and a bacteriophage within the context of the claimed subject matter, because a bacteriophage would be considered to be an antibacterial agent. For the purpose of searching prior art, it is not clear what differentiates the 'antibacterial agent' from the 'bacteriophage', because the claimed subject matter does not describe what compounds or entities would be considered to be an antibacterial agent but not a bacteriophage.
For the purpose of compact prosecution, the claims 4 and 5 will be interpreted to read: Claim 4: "..., wherein the antibacterial agent is delivered..."; and Claim 5: "..., wherein the antibacterial agent is encapsulated..."
In addition, an antibacterial agent will be considered to include bacteriophage, as a genus/species relationship.
Claims 3-5 and 10 are indefinite, because they recite insufficient, improper or unclear antecedent basis for the limitations in the claim(s).
(3) Claim 3 recites: "The method of claim 1, wherein the bacteriophage..."
Claims 4 and 5 recite: "The method of claim 1, wherein the antibacterial agent or bacteriophage..."
(4) Claim 10 recites: "The method of any one of claims 1 to 9, further comprising evaluating the effectiveness of the Fusobacterium varium-targeted interventions..."
However, claim 1 does not recite the term "bacteriophage".
The claimed subject matter, preceding claim 10, does not cite a Fusobacterium varium-targeted intervention nor an at least one Fusobacterium varium-targeted intervention. It is not clear what parent claim claim 10 is referring to.
Claim Interpretations
Claims 1 and 13 recite intended uses in their preamble language.
Claim 1 recites: "A method for mitigating bovine liver abscesses, the method comprising targeting Fusobacterium varium in the gastrointestinal tract of cattle by administering an effective amount of an antibacterial agent."
Claim 13 recites: "A method for improving cattle health and productivity, and reducing the incidence of liver abscesses, comprising the steps of claim 1."
The phrases as intended uses merely state the purpose or intended uses of the invention, rather than any distinct definition of any of the claimed invention's limitations. Also, the intended use terminology does not limit the structure or method steps of the claimed invention. Therefore, the phrases as intended uses do not limit the scope of the claimed subject matter. (See MPEP 2111.02 (I)(II).) That is, the intended use recited in the preamble does not result in a structural or manipulative difference between the claimed invention and the prior art. Deletion of the preamble phrase does not affect the structure or steps of the claimed invention (MPEP 2111.02 (II)).
On the other hand, prior art which shows the mitigation or reduction of liver abscesses will be indicated at the discretion of the Examiner. In addition, prior art which shows the targeting of Fusobacterium varium will be considered to inherently mitigate bovine liver abscesses, improve cattle health, and reduce the incidence of liver abscesses.
Claim Rejections - 35 U.S.C. § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §102 and §103 (or as subject to pre-AIA 35 U.S.C. §102 and §103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 1 is rejected under 35 U.S.C. §102(a)(1)/(a)(2) as being anticipated by Allen-Vercoe et al. (Pub. No. WO 2012/045150 A1).
Regarding claim 1, pertaining to a method for mitigating bovine liver abscesses, the method comprising targeting Fusobacterium varium in the gastrointestinal tract of cattle,
[See Claim Interpretations section above.]
Allen-Vercoe et al. shows a method of treating a gastrointestinal cancer, by administering a compound or composition that induces an immunological response against a Fusobacterium sp. to a subject diagnosed with or suspected of having a gastrointestinal (GI) cancer (pg. 3, para. [0014]). In some embodiments, the methods and compounds described may pertain to a condition or a cancer that is "related" to a GI cancer. In alternative embodiments, conditions such as abscesses in other tissues, such as liver, are included (pg. 6, para. [0030]). By "Fusobacterium" is meant a genus of gram-negative, anaerobic, rod-shaped bacteria found as normal flora in the mouth and large bowel. Fusobacterium species include, minimally, F. varium (occurring in abscesses and other infections) (pg. 6, para. [0031]). A "subject" maybe a human, non-human primate, rat, mouse, cow, horse, pig, sheep, goat, dog, cat, etc. (pg. 11, para. [0041]).
Further regarding claim 1, pertaining to administering an effective amount of an antibacterial agent,
Allen-Vercoe et al. shows that, in alternative aspects, a GI cancer or related condition may be treated by administering an effective amount of a compound (e.g., an antibiotic) or a composition (e.g., a vaccine) effective against a Fusobacterium (pg. 11, para. [0043]).
Claims 1-5, 8 and 13 are rejected under 35 U.S.C. §102(a)(1)/(a)(2) as being anticipated by Mathieu et al. (Pub. No. US 2020/0390835 A1).
Regarding claims 1 and 13, pertaining to a method for mitigating bovine liver abscesses, the method comprising targeting Fusobacterium varium in the gastrointestinal tract of cattle [Claim 1]; and a method for improving cattle health and productivity, and reducing the incidence of liver abscesses [Claim 13],
[See Claim Interpretations section above.]
Mathieu et al. shows a safe, natural, and environmental-friendly method for controlling the growth of pathogens causing liver abscesses, such as Fusobacterium necrophorum, in cattle rumen and gut microbiomes (pg. 2, para. [0013]). Fusobacterium species level in cattle rumen comprises Fusobacterium varium in abundance (pg. 2, para. [0016]-[0017]). Bacteriophages present in described compositions may consist of narrow host range bacteriophages specific to one or more strains of Fusobacterium species (pg. 2, para. [0014]).
Further regarding claims 1 and 13, pertaining to administering an effective amount of an antibacterial agent,
Mathieu et al. shows an effective composition of one or more bacteriophage which is capable of infecting and inhibiting the growth of Fusobacterium species (pg. 3, para. [0027]).
Regarding claim 2, the conventional method of inhibiting the growth of Fusobacterium necrophorum by the use of antibiotics has a drawback of selecting microbial strains resistant to the antibiotics, thereby degrading the effect of antibiotics and, hence, increasing the proliferation of antibiotic-resistant bacteria. The described invention solves the problem of antibiotic resistance of microbial strains by utilizing bacteriophage as an alternative to the use of antibiotics (pg. 2, para. [0010]-[0011]).
Regarding claim 3, in one embodiment, the described invention is a composition for inhibiting the growth of pathogens causing liver abscesses in bovines comprising one or more bacteriophages capable of infecting and lysing one or more Fusobacterium species (pg. 2, para. [0013]). FIG. 6 illustrates Fusobacterium plaque assays. FIG. 6B illustrates phage ΦWL8-3 with F. varium 8501 as host (pg. 4, para. [0033]; and Fig. 6).
Regarding claim 4, the described composition comprising one or more bacteriophages is delivered to the bovine by an acceptable carrier which comprises a material selected from the group of water, a buffered solution, or feed (pg. 2, para. [0015]).
Regarding claim 5, pertaining to encapsulated and lyophilized,
Mathieu et al. shows that bacteriophage cocktails may be stabilized
by encapsulation, lyophilization, or any other method that protects the bacteriophages from degradation and maintains viability (pg. 6, cont. para. [0046]).
Regarding claim 8, pertaining to dietary modification,
Mathieu et al. shows that doses may be administered at any interval or time, but it is recommended to begin administration simultaneous with the transition from a forage-based diet to concentrated feed (pg. 6, cont. para. [0046]).
Claim Rejections - 35 U.S.C. § 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 of this title, 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.
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 1-5, 8, 10, 13 and 15 are rejected under 35 U.S.C. §103 as being unpatentable over Mathieu et al. (Pub. No. US 2020/0390835 A1) in view of Emery et al. (Pub. No. WO 2006/026373 A1).
Mathieu et al. addresses the limitations of claims 1-5, 8 and 13 in the 35 U.S.C. §102(a)(1)/(a)(2) rejection above.
Mathieu et al. further provides information from which one of ordinary skill in the art of mitigating bovine liver abscesses by targeting Fusobacterium varium, as shown by Mathieu et al., would have considered applying the targeting strategy to beef cattle, by way of addressing the limitations of claim 15.
Regarding claim 15, Mathieu et al. further teaches that in order to improve beef production efficiency, effectively utilize local agricultural byproducts, and meet consumer demand, feedlots were established that utilize high-energy, grain-based rations to maximize cattle growth. However, the feeding of grains to cattle can result in
a transient drop in ruminal pH that causes detrimental changes to the rumen microbial community. One such change is an increase in the abundance of the bacterial genus
Fusobacterium. Several different species of Fusobacterium are natural residents of the bovine rumen, including, minimally, Fusobacterium varium (pg. 1, para. [0002]).
Mathieu et al. does not show: 1) the targeting further comprises administering antimicrobial peptides or proteins [Claim 8] [species election]); and 2) evaluating the
effectiveness of the Fusobacterium varium-targeted interventions by comparing
the incidence of liver abscesses in treated and untreated cattle [Claim 10].
Emery et al. addresses the limitations of claim 8 and 10.
Emery et al. shows methods for treating a condition caused by a Fusobacterium spp. In one aspect, the method includes administering an effective amount of a composition of the described invention to a subject having or at risk of having a condition caused by a Fusobacterium spp. The subject may be a mammal, such as an ungulate, or a human. Examples of ungulates include bovine, ovine, or caprine animals (pg. 5, lines 24-29 [nexus to Mathieu et al.- target Fusobacterium in cattle to mitigate a condition]).
Regarding claim 8, Emery et al. shows a composition including isolated polypeptides isolatable from a Fusobacterium spp. (pg. 5, lines 8-9). A composition can include polypeptides isolatable from 1 species of Fusobacterium, or can be isolatable from a combination of 2 or more species of Fusobacterium (pg. 12, lines 5-8). The polypeptides of the described invention are isolatable from a member of the family Bacteroidaceae, preferably the genus Fusobacterium, which includes F. varium (pg. 8, lines 23-29). A composition of the described invention is administered in an amount sufficient to provide an immunological response to polypeptides or whole cells of the described invention present in the composition (pg. 15, lines 20-23).
Regarding claim 10, when the condition is present in an animal such as, for instance, a sheep or cow, a controlled experimental trial can be run by vaccinating animals with varying levels of the composition and challenging vaccinated and unvaccinated animals with a Fusobacterium spp. (pg. 23, lines 17-20). Gross examination of each liver revealed a dramatic difference in the number of visible necrotic plaques between the Placebo and Vaccinated mice. It was clearly evident that mice given the vaccine rapidly reduced the number of bacteria able to proliferate successfully in the systemic circulation as indicated by the reduction in visible necrotic foci as compared to the placebo vaccinated mice (pg. 33, lines 21-22 [nexus to Mathieu et al.- mitigating bovine liver abscesses]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method for mitigating bovine liver abscesses, comprising targeting Fusobacterium varium by administering an effective amount of an antibacterial agent, as shown by Mathieu et al., by applying the method to the beef cattle industry [Claim 15], with a reasonable expectation of success, because Mathieu et al. teaches that an increase in the abundance of the bacterial genus Fusobacterium is negatively affecting the beef cattle industry (MPEP 2143 (I)(G)). Therefore, it would have been obvious to one of ordinary skill in the art of mitigating or reducing bovine liver abscesses to have administered an antibacterial agent, such as the bacteriophage, shown by Mathieu et al., to beef cattle with the reasonably predictable expectation that liver abscesses would have been mitigated or reduced in these animals (MPEP 2143 (I)(G)).
It would have been further obvious to have administered antimicrobial peptides or proteins to Fusobacterium varium-infected cattle [Claim 8] [species election]), as shown by Emery et al., with a reasonable expectation of success, because Emery et al. shows that peptides isolated from Fusobacterium sp bacteria (including F. varium) have an antimicrobial effect when administered in a composition, resulting in the reduction of liver abscesses (as necrotic foci), which is the desired therapeutic effect, as shown by Mathieu et al. (MPEP 2143 (I)(G)).
It would have been further obvious to have compared the incidence of liver abscesses in treated and untreated cattle in order to evaluate F. varium- targeted interventions (such as antimicrobial peptides or bacteriophage) [Claim 10], as shown by Emery et al., with a reasonable expectation of success, because Emery et al. shows that an experiment can be performed incorporating placebo- and composition- vaccinated mice in order to show the efficacy of the described antimicrobial peptides from Fusobacterium sp (MPEP 2143 (I)(G)).
Even in the absence of Emery et al., it would have been obvious to have conducted an experiment in which cattle were either treated with the bacteriophage shown by Mathieu et al. or left untreated, because it is well known in the therapeutic arts for scientists to conduct placebo-controlled studies in order to determine the efficacy and/or dosage of a drug treatment (MPEP 2144 (I)).
One of ordinary skill in the art would have been motivated to have made those modifications, because one of ordinary skill in the therapeutic arts would have preferred to have had a number of different antibacterial agents to choose from (e.g., the bacteriophage shown by Mathieu et al. and the antimicrobial peptides shown by Emery et al.) so as to optimize the mitigation of F. varium-induced bovine liver abscesses depending on the particular response of the subject to a particular therapeutic.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/SMP/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651