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
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/CN2021/112311, filed 08/12/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 202010860238.6, filed on 08/25/2020 in China.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed 03/22/2023 is considered, initialed and is attached hereto.
Claim Objections
Claims 1-8 and 11-16 are objected to because of the following informalities:
Claims 1 and 8 each recite “system for analytes detection”, the claim is objected for grammar because it appears “analytes” recited at the preamble should be singular, “analyte”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
See “Recognition module of detection area…configured to recognize an image on the reaction membrane collected by the optical imaging system, and then recognize the detection area on the reaction membrane by the detection area marker particles” in claim 1 (further claim 8 recites the system for analyte detection of claim 1).
The originally filed specification, at page 4, recites “the detection area recognition module can recognize an image on the reaction membrane recorded by the optical system, then recognize the detection area on the reaction membrane by means of the detection area marker particles”. Referring to this citation from the specification, the specification only further refers to what the recognition module does, not what it is. There is no structure indicated for performing the action indicated in the originally filed specification.
Claims 1 and further claim 7 (and claim 8, the system for analyte detection of claim 1, and claim 16) also recite “counting module” “configured to count the number of tracer nanoparticles specifically binding in the detection area”.
Following a review of the originally filed specification no description of structure for achieving the claimed function could be found. The specification indicates this structure by what it does rather than what it is.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 1-8 and 11-16 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 recites as part of the “lateral flow chromatographic assay system” a “binding pad”, the recited language refers to a bad by function (i.e., the word “binding”), however the claims and the specification fail to indicate any particular structure/structural feature, or indicate what “binding” is in reference to. For example, it is unclear what “binding” takes place at this pad, for example binding of a particular reagent (like the marker particles), or if this pad somehow facilitates/achieves some other binding event. Because the recited language is unclear, one cannot readily determine what is and is not encompassed by this language such to compare it to the closest prior art, and as such the language is indefinite.
Claim 1 also recites a fluorescence microscopy amplifications system and dark-field microscopy amplifications optical system, it is not clear what structure/structural feature the language “amplification” imparts on the claimed system. Put another way, it is not clear what the structure/structural difference is indicated by this language between a system that does not recite “amplification” and a system that does recite “amplification”.
Claim 2 recites “and the testing time is less than 20 minutes” recited as a further limitation of the ultra-sensitive digital rapid chromatographic assay system invention. The recited language is indefinite because it is open to two plausible, yet conflicting interpretations: (1) that the recited language is intended as functional language suggestive of/implying some additional structure. Which if this is the case, the claim language is indefinite because it is unclear what structure this language is referencing. Or (2) that the recited language is merely in reference to the intended use, i.e., that the claimed system is capable of achieving reaction time that is less than 20 minutes when applied for the use of detecting an analyte. Which if this is the case, the claim fails to further limit the invention which is a product invention (see in the interest of compact prosecution, this interpretation is further addressed below under 35 U.S.C. 112(d) as failing to further limit the claimed invention.
Claim limitations “recognition module” (claims 1 and 8) and “counting module” (claims 1, 7, 8 and 11) each invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. See as discussed in detail above under Claim Interpretation, the specification only further discusses what these modules do and not what they are in terms of any structure/structural components. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 6 recites “wherein the optical system….is configured to distinguish the single tracer nanoparticle”, the claim language is indefinite because the language “configured” appears to suggest or imply some action is taken to modify/impose on the optical system the ability to distinguish the tracer nanoparticles, rather than this merely being a capability the system naturally possesses as a result of being a fluorescent or dark-field microcopy system.
Regarding claim 8, the claim is indefinite because “certain volume” both implies a particular volume of sample to be added, yet fails to indicate any particular boundaries or standard of measure for what is or is not considered to be a “certain volume”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “the chromatography system is a lateral flow or vertical flow chromatographic reaction system, and the chromatography reaction time is less than 20 minutes”. However, see the independent claim 1 already recites that the system is either lateral or vertical flow, so this limitation adds no additional structural feature to the limitations of claim 1. Further, “the chromatography reaction time is less than 20 minutes”, is a limitation specific to the use of the claimed system, the limitation adding no additional structural feature/element to the invention (which the claimed invention is a product) itself. As a result, none of the limitations recited at claim 2 further limit the system of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lambert et al., US PG Pub No. 2008/0032420A1 in view of Boehringher eta l., US 6,924,153 B1 and Buechler et al., US 6,194,222B1.
Lambert et al. teach an ultra-sensitive (quantum dot based detection) digital rapid chromatography system for analytes, the system comprising a lateral flow chromatographic system (see Figure 1 para [0073]) comprising a sample pad, a binding pad (Lambert teaching a conjugate bad, which given broadest reasonable interpretation reads on “binding pad” as claimed), a reaction membrane (nitrocellulose membrane component) and an absorbent pad (wicking pad), the system comprising a detection area with immobilized capture biological ligands (capture antibodies). Lambert is teaching their system intended for detection of added (enriched) analytes at the detection area (analytes specifically recognized by labeled antibody conjugate (i.e., the detection biological ligands labeled with tracer nanoparticles, see e.g., paras [0028], [0031], [0032]).
Lambert et al. teach a reader system comprising optical imaging system that performs fluorescence detection (see e.g., paras [0019], [0138] and [0140]-[1041] fluorescence spectrometer), and “recognition module” (e.g., para [141], and software program interprets the output data) that recognizes the obtained image signal and quantitatively interprets the detected fluorescence, Lambert et al. teach their invention as advantageously achieving independent agent detection (visualize down to the individual tracer).
However, Lambert et al. differs from that presently claimed in that Lambert fails to teach the detection area also having immobilized detection area marker particles.
Further, although Lambert teach a reader comprising and optical system and components to detect the number of tracer molecules (quantitatively determine bound conjugate) at the detection area (concentration proportional to amount of tracer captured), however fails to teach that the optical system is a fluorescence microscope system (fluorescence microscopy amplification system).
Buechler et al. teach independent assay controls (IACs) for optical communication between an assay device and an instrument (abstract), and IAC refer to a control measurement that is independent of an assay measurement (col. 2, lines 5-7). See at col. 12 starting at line 21-34, using IAC, detecting signal to determine if the device is inappropriately positioned in the signal detection apparatus (reader), or if manufactured inappropriately such that the detection zones are inaccurately positioned on the device. Particularly col. 13, lines 15-21, Buechler et al. teach measuring an optical signal in the diagnostic location generated by a label (signal producing particle), the location of the detection zone can be determined by the signal processor by a detection of the signal in the discreet zone. Buechler is teaching locating a detection zone based on the signal of the label that is not involved in the assay.
Alternative to a reader device (as in Lambert, cited above), Boehringer et al. teach a fluorescent microscope can be used as a means of simple fluorescent detection of accumulated label on a capture line of a test strip device (see for example, col. 20, lines 51-59).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Lambert such to provide at the detection area a marker labels (signal particles) as in Buechler as an independent assay control, one motivated to provide this modification in order to determine the test strip device is appropriately positioned in the reader and/or to determine the device is structurally manufactured properly, with the detection zone accurately positioned on the device (Buechler). One having ordinary skill in the art would have a reasonable expectation of success considering Lambert’s device requires input into a reader, as such it would benefit from detectable signal indicating appropriate placement/arrangement for detection.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Lambert to use a fluorescence microscope as the optical system in place of fluorescence spectrophotometer of the reader, as a simple substitution one known optical detection system for another, both recognized in the prior art for detecting the same type of signal (signal produced by capture reagent label), both recognized in the prior art as suitable for detection of captured labeled at the detection line of a lateral flow/immunochromatographic test strip structure. Since it was known in the art that either is suitable technique for optical detection(Boehringer et al.), one having ordinary skill in the art would have a reasonable expectation of success making the modification.
Regarding claim 2, Lambert is teaching a lateral flow assay that is able to be used for detection in less than 20 minutes, see e.g., para [0093], samples finished 5-10 minutes (and para [0100], read in minutes).
Regarding claim 3, the claim recites “are fluorescent nanoparticles or are particles of various shapes” recited in alternative. The combination of the cited art is teaching labels are include distinguishable fluorescent nanoparticles (e.g., col. 4, lines 12-13, fluorescent signal, also col. 5, lines 16-25, col. 12, lines 51-59, supporting fluorescent signal; see also col. 5, lines 5-15, solid support small diameter beads, the reference throughout referencing nm sized beads, see also col. 21, lines 10-18, nm sized particles).
Regarding claim 4, Lambert teach tracer nanoparticle having diameter selected to achieve emission (para [0007]), see further para [0114] referring to detection reagents, reporting sizes of particles (e.g., gold) 40 nm, diameters of 200-400 nm latex particles, para [0116] (quantum dogs), 1-10 nm radii exciton (2-20 nm diameter).
Regarding claim 5, see as cited above, Lambert teach ligand that are antibodies (cited above).
Regarding claim 7, Lambert et al. teach quantitative detection (detecting the amount of label, see for example paras [0011] and [0024], i.e., the system counting the amount of tracer at the detection area).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert et al. in view of Boehringer et al. and Buechler et al., as applied to claim 1 above, and further in view of Dukno et al., Time-dependent luminescence loss for individual upconversion nanoparticles upon dilution in aqueous solution, Nanoscale, 10, (2018), p. 15904-15910 (plus supplemental 22 pages).
Regarding claim 6, Lambert et al. and the cited art teach a system substantially as claimed, including for example, optical system comprising a fluorescent microscopy system, however the cited art is silent as to whether that system has a magnification of 100-1000X.
Although not specific to fluorescence microscopy, it was recognized in the prior art that a typical single-particle imaging setup has a 100x magnification objective (see Dukhno, supplemental information page 2, attached at end of document.
Although the combination of Lambert and the cited art is silent as to the magnification of their microscopic optical system, the combination of the cited art is teaching detection of nanoparticle sized conjugate at the detection line. Considering it was known that magnification of 100-1000X is suitable for detection of single particle imaging, and the conjugate immobilized at the capture line are individual nanoparticle conjugated antibodies, it would have been obvious that when using a microscope system such that of Boehringer, that one rely on a system having magnification 100-1000X as this would be expected suitable for detection of the nanoscale sized conjugate capture at the detection line of Lambert. One having ordinary skill in the art would have a reasonable expectation because it was already known that fluorescent microscopy could be used for test line visualization/detection, and because this magnification would be expected suitable for such means of detection (for the reasons discussed above).
Claim(s) 8, 11-14 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert et al. in view of Boehringer et al., Buechler et al. and Egan et al., US PG Pub No. 2010/0315644A1.
Lambert et al. and the cited art teach a method substantially as claimed (in addition to the device details cited above, see Lambert et al. teach adding sample droplet, i.e., dropwise addition of certain volume of sample, to a sample pad, see para [0073]), see as cited previously above Lambert is teaching allowing the sample to flow to achieve binding and detection (a testing action), obtaining microscope image of the detection area to count/quantitate the tracer nanoparticles in the detection area.
However, Lambert et al. fails to teach a step of calculating the concentration of the analytes to be detected in the sample through a fitting relationship.
See Egan also teaching diagnostic assay systems for detecting an analyte with a test device, Egan teach systems further comprising software that include curve fitting algorithms, such software optionally capable of compensating for ambient light and/or other background noise to determine the amount of an analyte (see paras [0068] and [0069]).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods using the device/system as taught by Lambert et al. and the cited prior art to further provide the system with software that includes curve fitting algorithms (calculating concentration by a fitting relationship) as an obvious matter of applying a known technique to a known method, one further motivated because such software was known capable of compensating for ambient light and background noise. As a result, the modification would be considered an obvious matter of applying a known technique to a known method, with the advantage of improving the determination of concentration (by accounting for background, for example). Further one having ordinary skill would have a reasonable expectation of success applying this technique as in Egan because Egan is evidence that such software is known and applicable to systems for detecting analyte using lateral flow test strip devices.
Regarding claim 11, Lambert is teaching a lateral flow assay that is able to be used for detection in less than 20 minutes, see e.g., para [0093], samples finished 5-10 minutes (and para [0100], read in minutes). Therefore, when used for detection as indicated above (the cited art teaching a method of detecting), it would have been further expected that the testing time occur in under 20 minutes.
Regarding claim 12, the claim recites “are fluorescent nanoparticles or are particles of various shapes” recited in alternative. The combination of the cited art is teaching labels are include distinguishable fluorescent nanoparticles (e.g., col. 4, lines 12-13, fluorescent signal, also col. 5, lines 16-25, col. 12, lines 51-59, supporting fluorescent signal; see also col. 5, lines 5-15, solid support small diameter beads, the reference throughout referencing nm sized beads, see also col. 21, lines 10-18, nm sized particles).
Regarding claim 13, Lambert teach tracer nanoparticle having diameter selected to achieve emission (para [0007]), see further para [0114] referring to detection reagents, reporting sizes of particles (e.g., gold) 40 nm, diameters of 200-400 nm latex particles, para [0116] (quantum dogs), 1-10 nm radii exciton (2-20 nm diameter).
Regarding claim 14, see as cited above, Lambert and the cited art teach ligand that is antibody.
Regarding claim 16, the system as taught by the combination of Lambert in view of Boehringer, Buechler and Egan, having magnification capability of 100-1000X, is considered to be “configured to” count the number of tracers, as this is single molecule resolution.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert et al. in view of Boehringer et al. and Buechler et al. and Egan et al., as applied to claim 8 above, and further in view of Dukno et al.
Regarding claim 15, Lambert et al. and the cited art teach a system substantially as claimed, including for example, optical system comprising a fluorescent microscopy system, however the cited art is silent as to whether that system has a magnification of 100-1000X.
It was recognized in the prior art that a typical single-particle imaging setup having a 100x magnification objective (see Dukhno, supplemental information page 2, attached at end of document.
Although the combination of Lambert and the cited art is silent as to the magnification of their microscopic optical system, the combination of the cited art is teaching detection of nanoparticle sized conjugate at the detection line. Considering it was known that magnification of 100-1000X is suitable for detection of single particle imaging, and the conjugate immobilized at the capture line are individual nanoparticle conjugated antibodies, it would have been obvious that when using a microscope system such that of Boehringer, that one rely on a system having magnification 100-1000X as this would be expected suitable for detection of the nanoscale sized conjugate capture at the detection line of Lambert. One having ordinary skill in the art would have a reasonable expectation because it was already known that fluorescent microscopy could be used for test line visualization/detection, and because this magnification would be expected suitable for such means of detection (for the reasons discussed above).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677