DETAILED ACTION
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.
Claims 1, 3, 4, 7, 10, 12, 20, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Application Publication No. WO 2018/226704 A1 (Sabetrasekh) in view of U.S. Patent Application Publication No. 2011/0130632 (McGrail), U.S. Patent Application Publication No. 2011/0028790 (Farr), and U.S. Patent Application Publication No. 2004/0122292 (Dey).
Regarding claim 1, Sabetrasekh discloses a laryngoscopy system (300) comprising: a laryngoscope body (302/310) having a handle portion (302) and a blade portion (310), the blade portion having a distal end (free end of blade 310, see Fig. 3) and a handle connection end (end of blade 310 coupled to housing 302, see Fig. 3 and paragraph [0038]) and a blade body extending therebetween (see Fig. 3), the laryngoscope body further comprising an imaging component (328) disposed on or housed by the blade portion (see paragraphs [0038]-[0041] and Fig. 3); and an image display module (304 or 1234, see paragraphs [0038], [0042], and [0095]) configured to receive image data from the imaging component; wherein the image display module comprises a sealed housing (303; housing of 304, see Fig. 3), a display screen (304), and an accelerometer (1254) for motion input control of the image display module (see paragraph [0095]).
Further regarding claim 1 and regarding claim 7, Sabetrasekh appears to disclose the image display module configured for pivotal mounting on the handle portion of the laryngoscope body (see Fig. 3; hinge pin between display 304 and handle 302). Alternatively, McGrail discloses an intubation instrument (10) in which an image display module (110) configured for pivotal mounting on a handle portion (108) via a pivot hinge (22), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Sabetrasekh to have the image display module configured for pivotal mounting on the handle portion in order to allow the user to pivot the display to a desired position for viewing during an intubation procedure (see McGrail, paragraph [0081]).
Further regarding claim 1, Sabetrasekh fails to disclose wherein the image display module comprises an integral power source, wherein the laryngoscope body is devoid of any power source and the imaging component and illuminating component of the laryngoscope body receives power only from the integral power source of the image display module. However, Farr discloses a laryngoscope system (300/200) including an image display module (210) that comprises an integral power source (power supply, see paragraph [0035]), wherein a laryngoscope body (302) is devoid of any power source (see Fig. 3A and paragraphs [0035], [0036], [0049], [0068]; display unit 210 contains the power supply while laryngoscope body 302 is devoid of a power source) and an imaging component (201) and illuminating component (202) of the laryngoscope body receives power only from the integral power source of the image display module (see Fig. 3A and paragraphs [0035], [0036], [0049], [0068]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Sabetrasekh to include an image display module that comprises an integral power source for powering imaging and illuminating components while the laryngoscope body is devoid of a power source as suggested by Farr in order to allow for more portable and disposable systems that still utilize digital visualization (see Farr, paragraphs [0010]-[0016]).
Further regarding claim 1 and regarding claim 4, as noted above, Sabetrasekh appears to disclose image display module comprises a sealed housing (303; housing of 304, see Fig. 3). Alternatively, Dey discloses a laryngoscope (40) having a power source that is a non-removable, rechargeable battery, which allows the laryngoscope to be sealed to prevent fluid ingress therein (See Dey, paragraph [0057]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the system of Sabetrasekh in view of Farr to have the image display module comprise a non-removable, rechargeable battery power source to allow for a housing of the image display module to be sealed (see Dey, paragraph [0057]), and thus, prevent ingress of fluids that could contaminate or disrupt the electronics of the image display module.
Regarding claim 3, Sabetrasekh discloses wherein the image display module and/or the laryngoscope body has no external buttons, switches or dials (see paragraph [0093]).
Regarding claim 10, Sabetrasekh discloses wherein the laryngoscope body comprises a light emitting component (light emitting diode, see paragraph [0044]) disposed on or housed by the blade portion.
Regarding claim 12, Sabetrasekh discloses wherein the imaging component is a camera (328) disposed within a housing section (320/322) of the blade portion of the laryngoscope body (see paragraphs [0038]-[0041] and Fig. 3).
Regarding claim 20, Sabetrasekh discloses an image display module (304 or 1234, see paragraphs [0038], [0042], and [0095]) configured for engagement with a laryngoscope body (302/310) comprising an imaging component (328) to thereby form a laryngoscopy system (300); wherein the image display module is configured to receive image data from the imaging component of the laryngoscope body when engaged with the laryngoscope body (see paragraphs [0038]-[0042] and [0095]); and wherein the image display module comprises a sealed housing (303; housing of 304, see Fig. 3), a display screen (304), and an accelerometer (1254) for motion input control of the image display module screen (see paragraph [0095]); and wherein imaging data from the imaging component is delivered to the display module (see paragraph [0041]).
Further regarding claim 20, Sabetrasekh appears to disclose the image display module configured for pivotal mounting on the laryngoscope body (see Fig. 3; hinge pin between display 304 and handle 302). Alternatively, McGrail discloses an intubation instrument (10) in which an image display module (110) configured for pivotal mounting on a handle portion (108) via a hinge (22), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Sabetrasekh to have the image display module configured for pivotal mounting on the laryngoscope body in order to allow the user to pivot the display to a desired position for viewing during an intubation procedure (see McGrail, paragraph [0081]).
Further regarding claim 20, Sabetrasekh fails to disclose wherein the image display module comprises an integral power source, wherein power from the integral power source is delivered to the imaging component of the laryngoscope body. However, Farr discloses a laryngoscope system (300/200) including an image display module (210) that comprises an integral power source (power supply, see paragraph [0035]), wherein power from the integral power source is delivered to an imaging component (201) of the laryngoscope body (see Fig. 3A and paragraphs [0035], [0036], [0049], [0068]) and image data from the imaging component is delivered to the display module (see paragraphs [0034] and [0036]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the image display module of Sabetrasekh to include an integral power source for powering the imaging component and also receive imaging data from the imaging component as suggested by Farr in order to allow for more portable and disposable systems that still utilize digital visualization (see Farr, paragraphs [0010]-[0016]).
Further regarding claim 20 and regarding claim 23, as noted above, Sabetrasekh appears to disclose image display module comprises a sealed housing (303; housing of 304, see Fig. 3). Alternatively, Dey discloses a laryngoscope (40) having a power source that is a non-removable, rechargeable battery, which allows the laryngoscope to be sealed to prevent fluid ingress therein (See Dey, paragraph [0057]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the system of Sabetrasekh in view of Farr to have the image display module comprise a non-removable, rechargeable battery power source to allow for a housing of the image display module to be sealed (see Dey, paragraph [0057]), and thus, prevent ingress of fluids that could contaminate or disrupt the electronics of the image display module.
Regarding claim 21, Sabetrasekh discloses a kit (10, see Fig. 3) comprising an image display module (304 or 1234) according to claim 20 (as modified in claim 20, see analysis of claim 20 above) and at least one laryngoscope body (302/310), the laryngoscope body having a handle portion (302) and a blade portion (310), the blade portion having a distal end (free end of blade 310, see Fig. 3) and a handle connection end (end of blade 310 coupled to housing 302, see Fig. 3 and paragraph [0038]) and a blade body extending therebetween (see Fig. 3), the laryngoscope body further comprising an imaging component (328) and a light emitting component (light emitting diode, see paragraph [0044]) disposed on or housed by the blade portion.
Claims 1, 4, 7-10, 12, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0160261 (Miller) in view of Sabetrasekh, McGrail, and Dey.
Regarding claim 1, Miller discloses a laryngoscopy system (see Fig. 1) comprising: a laryngoscope body (30) having a handle portion (32) and a blade portion (36), the blade portion having a distal end (free end of blade portion 36, see Fig. 1) and a handle connection end (end of blade portion 36 coupled to handle portion 32, see Fig. 1 and paragraph [0030]) and a blade body extending therebetween (see Fig. 1), the laryngoscope body further comprising an imaging component (100) disposed on or housed by the blade portion (see paragraph [0030] and Fig. 1); and an image display module (4) configured to receive image data from the imaging component (see paragraph [0041]); wherein the image display module comprises a sealed housing (10/exterior housing of display 14); a display screen (14), and an integral power source (190), wherein the laryngoscope body is devoid of any power source (body 30 itself does not include a power source), and the imaging component and illuminating component of the laryngoscope body receives power only from the integral power source of the image display module (see paragraph [0041]).
Further regarding claim 1, Miller appears to disclose the image display module comprises an accelerometer for motion input control of the image display module (see paragraph [0042]). Alternatively, Sabetrasekh discloses a laryngoscope system comprising an image display module (304 or 1234, see paragraphs [0038], [0042], and [0095]) configured to receive image data from an imaging component; wherein the image display module includes an accelerometer (1254) for motion input control of the image display module (see paragraph [0095]). It would have been prima facie obvious to a person of ordinary skill in the art for the image display module to include an accelerometer in order to allow for module to use detected motion signals for further processing by a controller (see Sabetrasekh, paragraph [0095]), such as flipping video images as needed (see Miller, paragraph [0042]).
Further regarding claim 1 and regarding claim 7, Miller fails to disclose the image display module configured for pivotal mounting on the handle portion of the laryngoscope body. However, McGrail discloses an intubation instrument (10) in which an image display module (110) configured for pivotal mounting on a handle portion (108) via a pivot hinge (22), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Miller to have the image display module configured for pivotal mounting on the handle portion in order to allow the user to pivot the display to a desired position for viewing during an intubation procedure (see McGrail, paragraph [0081]).
Further regarding claim 1 and regarding claim 4, as noted above, Miller appears to disclose image display module comprises a sealed housing (10/exterior housing of display 14). Alternatively, Dey discloses a laryngoscope (40) having a power source that is a non-removable, rechargeable battery, which allows the laryngoscope to be sealed to prevent fluid ingress therein (see Dey, paragraph [0057]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the system of Miller to have the image display module comprise a non-removable, rechargeable battery power source to allow for a housing of the image display module to be sealed (see Dey, paragraph [0057]), and thus, prevent ingress of fluids that could contaminate or disrupt the electronics of the image display module.
Regarding claim 4, Miller discloses wherein the image display module comprises an integral power source (190), optionally wherein the integral power source is non-removable (as an optional feature, this feature does not limit the claim).
Regarding claim 8, Miller discloses wherein the image display module (4) is removably mountable on the handle portion of the laryngoscope body (see Fig. 1 and paragraph [0030]).
Regarding claim 9, Miller discloses wherein the image display module is mounted to the handle by corresponding male and female electrical connectors (194/22; see Figs. 1 and 9 and paragraph [0041]), optionally wherein the electrical connectors are corresponding male and female USB connectors (as an optional feature, this feature does not limit the claim).
Regarding claim 10, Miller discloses wherein the laryngoscope body comprises a light emitting component (LED, see paragraph [0035]) disposed on or housed by the blade portion.
Regarding claim 12, Miller discloses wherein the imaging component is a camera (100) disposed within a housing section (102; see also paragraph [0032] and [0033] and Figs. 3-5) of the blade portion of the laryngoscope body.
Regarding claim 19, Miller discloses wherein the image display module is configured to engage with the handle portion of the laryngoscope body such that a median plane of a screen portion of the image display intersects with a longitudinal central portion of the blade body of the laryngoscope (see marked-up Fig. 3 below).
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Regarding claim 20, Miller discloses an image display module (4) configured for engagement with a laryngoscope body (30) comprising an imaging component (100) to thereby form a laryngoscopy system (see Fig. 1); wherein the image display module is configured to receive image data from the imaging component of the laryngoscope body when engaged with the laryngoscope body (see paragraph [0041]); wherein the image display module comprises a sealed housing (10/exterior housing of display 14); a display screen (14), and an integral power source (190), wherein power from the integral power source is delivered to the imaging component of the laryngoscope body (see paragraph [0041]) and said image data from the imaging component is delivered to the display module (see paragraphs [0029], [0038], and [0043]).
Further regarding claim 20, Miller appears to disclose wherein the image display module comprises an accelerometer for motion input control of the image display module screen (see paragraph [0042]). Alternatively, Sabetrasekh discloses a laryngoscope system comprising an image display module (304 or 1234, see paragraphs [0038], [0042], and [0095]) configured to receive image data from an imaging component; wherein the image display module includes an accelerometer (1254) for motion input control of the image display module (see paragraph [0095]). It would have been prima facie obvious to a person of ordinary skill in the art for the image display module to include an accelerometer in order to allow for module to use detected motion signals for further processing by a controller (see Sabetrasekh, paragraph [0095]), such as flipping video images as needed (see Miller, paragraph [0042]).
Further regarding claim 20, Miller fails to disclose the image display module configured for pivotal mounting on the handle portion of the laryngoscope body. However, McGrail discloses an intubation instrument (10) in which an image display module (110) configured for pivotal mounting on a handle portion (108) via a hinge (22), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Miller to have the image display module configured for pivotal mounting on the handle portion in order to allow the user to pivot the display to a desired position for viewing during an intubation procedure (see McGrail, paragraph [0081]).
Further regarding claim 20 and regarding claim 23, as noted above, Miller appears to disclose image display module comprises a sealed housing (10/exterior housing of display 14). Alternatively, Dey discloses a laryngoscope (40) having a power source that is a non-removable, rechargeable battery, which allows the laryngoscope to be sealed to prevent fluid ingress therein (see Dey, paragraph [0057]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the system of Miller to have the image display module comprise a non-removable, rechargeable battery power source to allow for a housing of the image display module to be sealed (see Dey, paragraph [0057]), and thus, prevent ingress of fluids that could contaminate or disrupt the electronics of the image display module.
Regarding claim 21, Miller discloses a kit (see Fig. 1) comprising an image display module (4) according to claim 20 (as modified in claim 20, see analysis of claim 20 above) and at least one laryngoscope body (30), the laryngoscope body having a handle portion (32) and a blade portion (36), the blade portion having a distal end (free end of blade portion 36, see Fig. 1) and a handle connection end (end of blade portion 36 coupled to handle portion 32, see Fig. 1 and paragraph [0030]) and a blade body extending therebetween (see Fig. 1), the laryngoscope body further comprising an imaging component (100) and a light emitting component (LED, see paragraph [0035]) disposed on or housed by the blade portion (see paragraph [0030] and Fig. 1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sabetrasekh in view of McGrail, Farr, and Dey or Miller in view of Sabetrasekh, McGrail, and Dey, and further in view of U.S. Patent Application Publication No. 2013/0128223 (Wood).
Regarding claim 2, Sabetrasekh and Miller fail to explicitly disclose wherein the operational status of the image display module is controllable based on motion detection by the accelerometer. However, Wood discloses a digital-based medical device including an image display module (UI 1080) that has an operational status controllable based on motion detection by an accelerometer (see paragraph [0086]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system to have the image display module operational status controllable based on motion detection by the accelerometer as suggested by Wood so as to facilitate ease of use by having the module power on when the accelerometer detects motion (such as the device being picked up), and to conserve power by having the module power down when the accelerometer has not detected motion for a while (such as the device not being used) (see Wood, paragraph [0086]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sabetrasekh in view of McGrail, Farr, and Dey or Miller in view of Sabetrasekh, McGrail, and Dey, and further in view of European Patent EP 2,792,926 A1 (Germain).
Regarding claim 6, Sabetrasekh and Miller fails to disclose wherein the image display module has an ingress protection rating as defined in international standard IEC 60529 of IP64 or higher. However, Sabetrasekh discloses that the image display module should have water-tightness (see paragraph [0093]). Additionally, Germain discloses an image display module (1) used in medical settings that has an ingress protection rating as defined in international standard IEC 60529 of IP64 or higher (see paragraphs [0020] and [0021]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention for the image display module to have an ingress protection rating of IP64 of higher in order to have the module be waterproof yet easily cleaned as is often necessary in a medical environment (see Germain, paragraphs [0020] and [0021]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sabetrasekh in view of McGrail, Farr, and Dey or Miller in view of Sabetrasekh, McGrail, and Dey, and further in view of U.S. Patent Application Publication No. 2011/0077466 (Rosenthal).
Regarding claim 11, Sabetrasekh and Miller fails to disclose wherein the field of view of the imaging component includes part of the blade portion of the laryngoscope body. However, Rosenthal discloses a laryngoscope blade (10) with an imaging component (25) wherein a field of view of the imaging component includes part of the blade (see Figs. 2 and 6 and paragraphs [0033] and [0067]; tip 11 of blade 10 is visible in the field of view of an imaging component). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the imaging component field of view to include part of the blade portion in order to facilitate guiding of the laryngoscope blade into a patient to establish a desired field of view (see Rosenthal, paragraphs [0073], [0105], and [0115]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sabetrasekh in view of McGrail, Farr, and Dey or Miller in view of Sabetrasekh, McGrail, and Dey, and further in view of U.S. Patent No. 5,776,053 (Dragisic).
Regarding claims 13-15, Sabetrasekh and Miller fail to disclose wherein the blade body has a locally narrowed portion disposed adjacent the handle connection end of the blade (claim 13); wherein the locally narrowed portion is formed asymmetrically with respect to the longitudinal axis of the blade body (claim 14). However, Dragisic discloses a laryngoscope blade body (20) wherein a locally narrowed portion (42) of the body is disposed adjacent a handle connection end (26) of the blade, wherein the locally narrowed portion is formed asymmetrically with respect to the longitudinal axis of the blade body (see Figs. 1A, 2, and 8; narrowed portion 42 is formed asymmetrically with respect to the longitudinal axis of the blade body). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the blade body to have a locally narrowed portion as suggested by Dragisic in order to accommodate a patient’s teeth (see Dragisic, Fig. 9, Abstract, and col. 5, lines 51-67). Additionally, it would have been obvious to have the lateral extent of the locally narrowed portion be less than 60% of the maximum lateral extent of the blade body and the length of the locally narrowed portion be in a range from 1 cm to 5 cm in length, as “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would be obvious to optimize the lateral extend and length of the locally narrowed range in order to best accommodate a patient’s teeth during intubation with the laryngoscope.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sabetrasekh in view of McGrail, Farr, and Dey or Miller in view of Sabetrasekh, McGrail, and Dey, and further in view of U.S. Patent Application Publication No. 2018/0214013 (Casson).
Regarding claims 16 and 17, Sabetrasekh and Miller each disclose wherein an upper side of the blade body defines a generally longitudinally arcuate surface (see Figs. 1-3 of Sabetrasekh and Fig. 1 of Miller), but fail to disclose at least a portion of the surface subtending an angle of at least 30 degrees has a constant radius of curvature (claim 16); wherein the portion of constant radius of curvature is located towards the distal end of the blade (claim 17). However, Casson discloses a laryngoscope (10) blade (14) having a generally longitudinally arcuate surface (16a; see Fig. 1B) on an upper side of the blade, wherein at least a portion of the surface has a constant radius of curvature located towards the distal end of the blade (see Fig. 1B and paragraph [0046]; entire blade upper side surface has constant radius of curvature). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the blade upper side to have a constant radius of curvature as suggested by Casson as such a blade shape facilitates intubation and visualization of the airway of a patient (see Casson, paragraphs [0045] and [0046]). Additionally, it would have been obvious to have at least a portion of the upper surface subtend at an angle of at least 30 degrees, as “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would be obvious to optimize the subtended angle in order to provide the laryngoscope blade upper side with the best curved shape for facilitating intubation of a patient.
Response to Arguments
Applicant’s arguments with respect to claims 1-17, 19-21, and 23 have been considered but are moot in view of the new grounds of rejection.
Additionally, Applicant argues on page 10 of the Remarks that Sabetrasekh fails to disclose an accelerometer located in the display module. The examiner disagrees. Sabetrasekh discloses in paragraph [0041] that a user device can comprise the display 304, and discloses in paragraph [0095] that a user device may comprise an accelerometer. Thus, the user device display 304 can comprise an accelerometer. Alternatively, it would be obvious for the display 304 to include an accelerometer to allow for detecting and measuring motion of the device (see Sabetrasekh, paragraph [0095]).
Additionally, Applicant argues on page 13 of the Remarks that Miller fails to render obvious a power source that is located in the display module because other embodiments disclosed in Miller have batteries located in other parts of the device. This is not persuasive. The examiner is relying on the embodiment in Miller in which a power source integral to the display module provides power to the imaging and illuminating components; it is irrelevant if other embodiments of Miller disclose batteries located in other parts of a device.
Additionally, Applicant argues on pages 14-15 of the Remarks that Miller fails to disclose the illumination and imaging components solely powered by a power source in the display module. The examiner disagrees. Paragraph [0041] of Miller states that “[b]atteries 190 power the illumination device and camera 170”. Miller also shows in Fig. 9 and paragraph [0041] that batteries are integral to the display module 4. The display module 4 is a sealed housing including a display screen and the integral power source.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773