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.
Response to Arguments
Applicant’s arguments, see Pre-Appeal Brief Conference Request, filed
01/05/2026, with respect to the rejections of Claims 1-2, 4-5, 7-10, 13-16, and 21-23 under WO 2021/186182 (hereafter –Roberts--) in view of US 20170095372 A1 (hereafter –Aceti--) have been fully considered and are persuasive in part.
Regarding the arguments that Aceti and Roberts are intended for opposite purposes and therefore cannot be combined, the Examiner respectfully disagrees. Although Aceti does attenuate environmental sounds to a safe level, the main purpose of the device is to deliver minimally-distorted sounds (see paragraph [0036]), meaning that the user still hears the sound that is in the environment around them with the added benefit of sound protection in the case that the sound reaches dangerous levels (see paragraph [0035]). Aceti also discloses that the device comprises of an acoustic resonance channel tube, which allows sound to reach the tympanic membrane and maintain sound quality appropriate for listening to music and speech (see paragraph [0036]). Roberts additionally discloses that the device as disclosed also reduces sound distortion to the tympanic membrane (see page 10, lines 3-5). As both devices function to bring minimally-distorted sounds to the tympanic membrane (see page 9, lines 20-23 of Roberts, see paragraph [0036] of Aceti), and since the modification only involves increasing the length of the insertional portion, the rejection is sustained. There is no evidence that a change in length of the insertional portion would render the device of Roberts to not function as intended.
Regarding the argument that modification of the length would fundamentally change the principle of operation of Roberts, the Examiner respectfully disagrees. There is no evidence that the change of the length of the insertional portion of Roberts would reduce the conduction and amplification of sound within the ear canal as the Applicant suggests. The Applicant appears to have placed no criticality on the claimed range of from about 10 mm to 20 mm (see paragraph [0036] saying the range “can optionally” be from about 10 mm to about 20 mm). Additionally, the reference does not specifically say that the length is for “attenuating sound” specifically. It only lists the possible lengths of the device.
However, the argument surrounding the specific modification reasoning that was used in the previous rejection is persuasive, and therefore a new reasoning as to why modifying the length would be obvious to one of ordinary skill before the effective filing date of the invention has been added. The new reasoning of obviousness is that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the length of Robert’s insertional portion with the length taught by Aceti with a reasonable expectation for yielding an insertional portion having a suitable length for insertion into the ear canal as taught by Aceti.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 depends from itself. The Examiner suggests amending claim 22 to depend from claim 21. Appropriate correction is required. For purposes of expedited prosecution, the examiner is interpreting this claim to be dependent on claim 21.
Claim Rejections - 35 USC § 112
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.
Claim 22 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 contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Regarding .
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-2, 4-5, 7-8, 13-15, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/186182 (Roberts), in further view of US 20170095372 A1 (hereafter –Aceti--).
Regarding Claim 1, Roberts discloses an ear stent for insertion into an ear canal of a user (see page 3, lines 16-18), the ear stent having a longitudinal axis (see longitudinal axis in Figure 2 below) and comprising: an insertional portion that extends along the longitudinal axis between an insertional end and an outer end (see annotated insertional end, outer end, and insertional portion in Figures 2 and 1A below), wherein the insertional portion is configured to be inserted into the ear canal (see page 8, line 4-8), wherein the insertional portion defines a channel therethrough from the insertional end to the outer end (see channel 113 in Figure 2 below); and a flange portion that extends outwardly from the insertional portion at the outer end of the insertional portion (see annotated flange portion in Figure 1A), wherein the insertional portion and the flange portion are monolithically formed as a unitary body (see Figures 1A and 2 below), wherein the ear stent has an insertional length from the insertional end of the insertional portion to the flange portion (see below), wherein the insertional length is between 3.6 mm and 6.9 mm (see page 3, lines 29-31, see also measured L1 in Figure 2 below), wherein the ear stent does not comprise any electronic components (no electronic components are present in the reference).
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Roberts fails to disclose wherein the insertional length is between 10 mm and 20 mm.
Aceti discloses an ear stent implant for insertion into an ear canal of a user, the ear stent having a longitudinal axis and comprising: an insertional portion that extends along the longitudinal axis between an insertional end and a flange end that extends outwardly from the insertional portion at the outer end, wherein the insertional portion and flange portion are monolithically forms as a unitary body (see annotated insertional end, insertional portion, flange portion, and longitudinal axis in Figure 2 below). Aceti teaches wherein the ear stent has an insertional length from the insertional end of the insertional portion to the flange portion (entirety of component 104), wherein the insertional length is between 10 mm and 15 mm (see paragraph [0045] talking about the possible length of component 104), a range that overlaps with the claimed range of about 10-20 mm. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the length of Robert’s insertional portion with the length taught by Aceti with a reasonable expectation for yielding an insertional portion having a suitable length for insertion into the ear canal as taught by Aceti. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Robert’s modified insertional portion from about 10 to 15 mm as taught by Aceti to about 10 to 20 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range of from about 10 mm to 20 mm (see paragraph [0036] saying the range “can optionally” be from about 10 mm to about 20 mm).
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Regarding Claim 2, Roberts as modified discloses the ear stent of claim 1, further comprising a protrusion that extends outwardly from the flange along the longitudinal axis a sufficient distance for a user to grip to pull the ear stent from the ear canal (see protrusion 122 in Figure 2 above).
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Regarding Claim 4, Roberts as modified discloses the ear stent of claim 2, wherein the protrusion is integrally formed with the flange portion as a unitary, monolithic structure (see Figure 1A above).
Regarding Claim 5, Roberts as modified discloses the ear stent of claim 2, wherein the insertional portion (see annotated insertional portion in Figures 1A and 2 above) has an outer surface that defines an oblong shape having a major dimension and a minor dimension (see page 7, lines 9-14 denoting that the opening 109 can have an oval shape, ovals always having a major and minor dimensions, see paragraph [0039] of Instant Application’s specification denoting the oblong shape can be an oval shape), wherein the protrusion is offset from the longitudinal axis along the transverse axis (see annotated protrusion in Figures 1A, 1B, and 2 above).
However, Roberts as modified fails to disclose wherein the insertional portion has an outer surface in a cross-sectional plane that is transverse to the longitudinal axis, wherein the major dimension extends along a transverse axis that is perpendicular to the longitudinal axis.
Nevertheless, the alternate embodiment of Figures 4-8 of Roberts discloses an ear stent having a longitudinal axis (see longitudinal axis 17 in Figures 4, 5, and 6 below) and comprises an insertional portion that extends along the longitudinal axis between an insertional end and an outer end (see annotated insertional end, outer end, and insertional portion in Figures 4, 5, and 6 below), wherein the insertional portion defines a channel therethrough from the insertional end to the outer end (see channel 16 in Figures 4, 5, and 6 below). The alternate embodiment of Figures 4-8 of Roberts teaches the insertional portion having an outer surface in a cross-sectional plane that is transverse to the longitudinal axis (see transverse axis/plane in Figures 4, 5, and 6 below), wherein the opening on the insertional end extends along a transverse axis that is perpendicular to the longitudinal axis (see Figures 4 and 6).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear stent of Figures 1-3 of Roberts such that the opening on the insertional end extends along a transverse axis that is perpendicular to the longitudinal axis (see transverse axis/plane in Figures 4, 5, and 6 below), as Roberts teaches that an ear stent that is straight along the longitudinal axis is an alternate shape that is recognized in the art as suitable for use in an ear canal. The modification would result in the major dimension of the oblong cross-sectional shape of the insertional portion being oriented transverse to the longitudinal axis, and the protrusion offset from the longitudinal axis along the transverse axis.
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Regarding Claim 7, Roberts as modified discloses the ear stent of claim 1, wherein the insertional length is from 12 mm to 18.5 mm (see claim 1 rejection above, wherein the range of 12 mm to 18.5 mm is within the range 10 mm to 20 mm).
Regarding Claim 8, Roberts as modified discloses the ear stent of claim 1, wherein the insertional portion has an outer surface that defines an oblong shape having a major dimension and a minor dimension (see page 7, lines 9-14 denoting that the opening 109 can have an oval shape, ovals always having a major and minor dimension, see paragraph [0039] of Instant Application’s specification denoting the oblong shape can be an oval shape, see also page 4, line 3). However, Roberts fails to disclose wherein the outer surface of the insertional portion is in a cross-sectional plane that is transverse to the longitudinal axis.
Nevertheless, the alternate embodiment of Figures 4-8 of Roberts discloses an ear stent having a longitudinal axis (see longitudinal axis 17 in Figures 4, 5, and 6 above) and comprising: an insertional portion that extends along the longitudinal axis between an insertional end and an outer end (see annotated insertional end, outer end, and insertional portion in Figures 4, 5, and 6 above), wherein the insertional portion defines a channel therethrough from the insertional end to the outer end (see channel 16 in Figures 4, 5, and 6 above). The alternate embodiment of Figures 4-8 of Roberts teaches wherein the outer surface of the insertional portion is in a cross-sectional plane that is transverse to the longitudinal axis (see transverse axis/plane in Figures 4, 5, and 6 above).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear stent of Figures 1-3 of Roberts such that the opening on the insertional end extends along a transverse axis that is perpendicular to the longitudinal axis (see transverse axis/plane in Figures 4, 5, and 6 above), as Roberts teaches that an ear stent that is straight along the longitudinal axis is an alternate shape that is recognized in the art as suitable for use in an ear canal. The modification would result in the major dimension of the oblong cross-sectional shape of the insertional portion being oriented transverse to the longitudinal axis, and the protrusion offset from the longitudinal axis along the transverse axis.
Regarding Claim 13, Roberts as modified discloses the ear stent of claim 1, wherein the flange portion has an inner surface that defines a funnel that tapers along the longitudinal axis toward the channel (see Abstract, inner surface of flange portion is the start of the funnel wall leading to the channel).
Regarding Claim 14, Roberts as modified discloses the ear stent of claim 1, were in the ear stent consists essentially of silicone (see page 7, lines 26-27).
Regarding Claim 15, Roberts discloses a method comprising: inserting an ear stent into an ear canal of a user (see page 3, lines 16-18), the ear stent having a longitudinal axis (see longitudinal axis in Figure 2 above) and comprising: an insertional portion that extends along the longitudinal axis between an insertional end and an outer end (see annotated insertional end, outer end, and insertional portion in Figures 2 and 1A above), wherein the insertional portion is configured to be inserted into the ear canal (see page 8, line 4-8), wherein the insertional portion defines a channel therethrough from the insertional end to the outer end (see channel 113 in Figure 2 above); and a flange portion that extends outwardly from the insertional portion at the outer end of the insertional portion (see annotated flange portion in Figure 1A), wherein the insertional portion and the flange portion are monolithically formed as a unitary body (see Figures 1A and 2 above), wherein the ear stent has an insertional length from the insertional end of the insertional portion to the flange portion (see annotated insertional end and flange portion in Figures 1A and 2 above), wherein the ear stent does not comprise any electronic components (no electronic components are present in the reference).
Roberts fails to disclose wherein the insertional length is between 10 mm and 20 mm.
Aceti discloses an ear stent implant for insertion into an ear canal of a user, the ear stent having a longitudinal axis and comprising: an insertional portion that extends along the longitudinal axis between an insertional end and a flange end that extends outwardly from the insertional portion at the outer end, wherein the insertional portion and flange portion are monolithically forms as a unitary body (see annotated insertional end, insertional portion, flange portion, and longitudinal axis in Figure 2 of Aceti above). Aceti teaches wherein the ear stent has an insertional length from the insertional end of the insertional portion to the flange portion (entirety of component 104), wherein the insertional length is between 10 mm and 15 mm (see paragraph [0045] talking about the possible length of component 104), a range that overlaps with the claimed range of about 10-20 mm. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the length of Robert’s insertional portion with the length taught by Aceti with a reasonable expectation for yielding an insertional portion having a suitable length for insertion into the ear canal as taught by Aceti. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Robert’s modified insertional portion from about 10 to 15 mm as taught by Aceti to about 10 to 20 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range of from about 10 mm to 20 mm (see paragraph [0036] saying the range “can optionally” be from about 10 mm to about 20 mm).
Regarding Claim 21, Roberts as modified discloses the ear stent of claim 13, wherein the ear stent comprises at least one indicator (see annotated indicator in Figure 2 below), wherein each indicator of the at least one indicator is indicative of a respective dimension of the ear stent (see annotated indicator being a transitional marker between the insertional portion (L1 ends at the indicator) and the outer wider section of the ear stent, the “respective dimension” being L1), wherein each indicator of the at least one indicator comprises a surface that is offset from the inner surface of the flange portion that defines the funnel (see annotated indicator inner surface in Figure 2 below).
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Regarding Claim 23, Roberts as modified discloses the ear stent of claim 1, wherein the insertional portion has an outer surface that defines (see annotated insertional portion and outer surface in Figure 2 below), in a cross sectional plane that is perpendicular to the longitudinal axis (see annotated plane and axis in Figure 2 below), an oblong shape having a major dimension and a minor dimension (see major and minor dimensions in Figure 1F below), wherein the channel is radially offset from the outer surface by a consistent radial dimension (see annotated outer surface and channel in Figure 2 below), wherein the channel comprises: an open portion (see annotated open portion in Figure 2 below); and at least one filled portion corresponding to a region of increased wall thickness of the insertional portion (see annotated filled portion in Figure 2 below, that portion of the channel being filled more than the other section of the insertional portion, as the wall thickness increases in that region).
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Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/186182 (Roberts), in further view of US 20170095372 A1 (hereafter –Aceti--), as applied to claim 1 above, and even further view of US 7464786 B2 (hereafter –Falco--).
Regarding Claim 3, Roberts as modified discloses the ear stent of claim 2. However, Roberts fails to disclose wherein the sufficient distance is at least 5 mm.
Nevertheless, Falco discloses an ear insert (10) with an insertional portion (12), insertional end (16), an outer end (18), and a protrusion (14) along a longitudinal axis (A) that extends outwardly from the insert along the longitudinal axis (A) a sufficient distance for a user to grip to pull the ear stent from the ear canal (see Figure 1 of Falco). Falco teaches wherein the sufficient distance the protrusion extends is at least 5 mm, specifically within a range of 6.35 mm -12.7 mm. (see column 7, lines 11-14). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the ear stent of Figures 1-3 of Roberts to have the protrusion extend at least 5mm, as the dimension is suitable for facilitating insertion and removal of the ear insert in the ear canal as taught by Falco (see column 7, lines 23-27, see also column 3, lines 24-27)
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/186182 (Roberts), in further view of US 20170095372 A1 (hereafter –Aceti--), as applied to claim 8 above, in even further view of non-patent literature “Ear Canal Dimensions” (hereafter—Hearing--).
Regarding Claim 9, Roberts as modified discloses the ear stent of claim 8.
However, Roberts as modified fails to disclose wherein the major dimension is between 6 mm and 9 mm.
Nevertheless, Hearing discloses the dimensions of an ear canal, as the ear canal’s entrance and cross-sectional shape is of an oval throughout. The dimensions of the oval of the ear canal tapers and decreases from the entrance to the end of the ear canal as it approaches the tympanic membrane (see Figure below). Hearing teaches the major and minor dimensions of the oval cross section towards the inner ear canal, where the insertional portion of the ear stent with the major and minor dimensions would sit. The minor dimension of the inner ear canal is taught to be between 4.5 mm and 7 mm, and the major dimension is taught to be 6.25 mm to 10.1 mm (see “pre-TM” measurement in the Figure below to represent the inner ear canal oval cross-section dimensions prior to the ear drum). These dimensions of the oval cross-section of the ear canal overlap with the claimed range, as the claimed range 2 mm to 5mm overlaps with the minor dimensions of the ear canal of 4.5 and 7mm, and the claimed range 6mm to 9mm overlaps with the major dimensions of the ear canal of 6.25 mm to 10.1 mm.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the ear stent of the Figures 1-3 of Roberts to have an oval cross-section at the insertional end, the major dimension being between 6mm and 9mm and the minor dimension being between 2 and 5 mm, the exact measurement depending on the size of the ear canal of the user, so that the ear stent fits properly within the ear canal of a patient (see Figure below).
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Regarding Claim 10, Roberts as modified discloses the ear stent of claim 8, wherein the minor dimension is between 2 mm and 5 mm (see explanation above).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/186182 (Roberts), in further view of US 20170095372 A1 (hereafter –Aceti--), as applied to claim 15 above, and even further view of non-patent literature reference “A Composite Foley Catheter Stent Used to Successfully Manage Recurrent Canal Stenosis Caused by Fibrous Dysplasia of the Temporal Bone” (hereafter –Chao-Yin--).
Regarding Claim 16, Roberts as modified discloses the method of claim 15.
However, Roberts as modified fails to disclose wherein the user has a collapsed or collapsing ear canal, and wherein the ear stent supports the ear canal of the user in an at least partially open condition.
Nevertheless, Chao-Yin disclosed an ear stent (see Figure 2 in reference) with an outer end, insertional end, and insertional portion that tapers form the outer end to the insertional end. The ear stent is made out of Foley catheters, and is a hollow tube having a channel from the outer end to the insertional end (see text under Figure 2, see also the second paragraph of the discussion section on page 2 of the attached reference). Chao-Yin teaches the user has a collapsed or collapsing ear canal, and the ear stent supports the ear canal of the user in an at least partially open condition (see last paragraph of the reference denoting it’s a useful tool for preventing canal restenosis, see also first paragraph of the case presentation section).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use the ear stent of Roberts to treat the condition of a collapsed or collapsing ear canal, as Chao-Yin teaches that ear stents are useful for supporting an ear canal to prevent canal restenosis (see last paragraph of the Chao-Yin)).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/186182 (Roberts), in further view of US 20170095372 A1 (hereafter –Aceti--), as applied to claim 21 above, and even further view of US 20090095566 A1 (hereafter –Leong--).
Regarding Claim 22, Roberts as modified discloses the ear stent of claim 21.
Roberts as modified fails to disclose wherein each indicator of the at least one indicator comprises a boss that is integrally formed with the flange and projects outwardly from the inner surface of the flange portion that defines the funnel.
Leong discloses a device for insertion into an ear canal of a user, wherein the device has an insertional end and outer end (see annotated insertional and outer ends in Figure 40 below), wherein the insertional portion is configured to be inserted into the ear canal (see annotated insertional portion in Figure 40 below), and a flange portion that extends outwardly from the insertional portion at the outer end of the insertional portion (see annotated flange portion, insertional portion, and outer end in Figure 40 below), wherein the insertional portion and the flange portion are monolithically formed as a unitary body (see annotated insertional portion and flange portion in Figure 40 below), wherein the ear stent has an insertional length between the insertional end of the insertional portion and the flange portion (see annotated insertional length in Figure 40 below). Leong teaches a boss (486) that is integrally formed with the flange and projects outwardly from the inner surface of the flange portion (see annotated boss in Figure 47 below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the indicator of Roberts as modified have a boss that is integrally formed with the flange and projects outwardly from the inner surface of the flange portion, as by doing so would prevent the user from placing the replacement assembly in the wrong direction, and therefore support proper placement in the ear (see paragraph [0162]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774