DETAILED ACTION
This Office Action is in response to the election/restriction response, filed on December 1, 2025. Primary Examiner acknowledges Claims 1-5, 10-17, 19-22, 25, 28, 30-32, 34-43, 47, and 51 are pending in this application, with Claims 4, 5, 10-17, 19-22, 25, 28, 30-32, and 34-43 having been currently amended, and Claims 6-9, 18, 23, 24, 26, 27, 29, 33, 44-46, and 48-50 having been cancelled.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-5, 10-17, 19-22, 25, 28, 30-32, and 34-43, in the reply filed on December 1, 2025 is acknowledged.
Claims 47 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “1” has been used to designate “respiratory interface” (Para 0089) and “device” (Paras 0097 and 0099). Appropriate correction is required.
Reference character “10” has been used to designate “front portion”, “front” (Para 0094 – “front (10) walls”), “frame” (Para 0095). Appropriate correction is required.
Reference character “10b” has been used to designate “side walls” and “sidewalls” (Para 0095). Appropriate correction is required.
Reference character “10c” has been used to designate “side end” and “ends” (Para 0094). Appropriate correction is required.
Reference character “11” has been used to designate “support platform” (Para 0094) and “platform” (Para 0094 – multiple instances; and Para 0095). Appropriate correction is required.
Reference character “3” has been used to designate “frame” and “frames” (Para 0095 – in plurality). Appropriate correction is required.
Reference characters “10” and “3” have been used to designate “frame”. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “1” has been used to designate “respiratory interface” (Para 0089) and “device” (Paras 0097 and 0099). Appropriate correction is required.
Reference character “10” has been used to designate “front portion”, “front” (Para 0094 – “front (10) walls”), “frame” (Para 0095). Appropriate correction is required.
Reference character “10b” has been used to designate “side walls” and “sidewalls” (Para 0095). Appropriate correction is required.
Reference character “10c” has been used to designate “side end” and “ends” (Para 0094). Appropriate correction is required.
Reference character “11” has been used to designate “support platform” (Para 0094) and “platform” (Para 0094 – multiple instances; and Para 0095). Appropriate correction is required.
Reference character “3” has been used to designate “frame” and “frames” (Para 0095 – in plurality). Appropriate correction is required.
Reference characters “10” and “3” have been used to designate “frame”. Appropriate correction is required.
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 1-5, 10-17, 19-22, 25, 28, 30-32, and 34-43 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.
Specifically, Claim 1 recites the concept of “a front portion having a front wall” and later the orientation in which “a support platform extending rearwardly from said front wall”; however, Applicant has failed to claim the cartesian directionality of the terms “front” and “rear” with respect to the orientation of the respiratory interface device to the patient and/or ambient environment. Consequently, the breadth and scope of the terms “front” and “rear” appear to be unclear as these terms are relative and do not unequivocally recite a particular direction or orientation with respect to the respiratory interface device and the patient and/or the ambient environment. Dependent claims, Claims 2-5, 10-17, 19-22, 25, 28, 30-32, and 34-43, incorporate the indefinite subject matter form which they depend. Appropriate correction and clarification is required.
Specifically, Claim 4, Line 2-3; Claim 5, Line 2; Claim 39, Line 3; Claim 41, Line 2; Claim 42, Line 2; and Claim 43, Line 4 recite the term “platform”; however, this limitation lacks antecedent basis in the claims. Primary Examiner is unsure if the term “platform” is meant to refer back to the “support platform” as originally introduces in Claim 1, Line 4, or alternatively to some other feature of the claims. Appropriate correction and clarification is required.
Specifically, Claim 21, Line 4; and Claim 40, Line 3 (two instances) recites “the conduit”; however, this limitation appear to lack antecedent basis in the claims. Primary Examiner is unsure if this term “conduit” is meant to refer back to the “inlet conduit” of Claim 1, Lines 1 and 2, or alternatively to some other feature of the claims. Appropriate correction and clarification is required.
Specifically, Claims 31, 32, and 34 recite the limitation “prong”; however, this term lacks antecedent basis in the claims. Primary Examiner is unsure if this term “prong” is meant to refer back to the “at least one nasal outlet” of Claim 1, to the “one or more nasal outlets (nasal prongs) of Claim 28, or to some other feature of the claims. Primary Examiner notes the parentage of Claims 31, 32, and 34 does not include Claim 28. Consequently, Applicant has not correlated the concept of the “at least one nasal outlet” as compared to the concept of “a pair of nasal prongs”. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claims 1-5, 10-16, 19-22, 25, 28, 30-32, and 34-40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hsiung et al. (11,413,419).
As to Claim 1, Hsiung discloses a respiratory interface device (best seen Figures 1-11) comprising a body (20, “a flexible nasal prong body 20” Column 2, Lines 60 thru Column 3, Lines 30), a frame (10, “a rigid sliding track frame 10” Column 2, Lines 60 thru Column 3, Lines 30), and an inlet conduit (30, “a rigid intake tube 30” Column 2, Lines 60 thru Column 3, Lines 30), wherein: the frame (10) comprises a front portion (best seen Figures 3-11) having a front wall (one of 14/15, “a first rib portion 14 of the sliding track frame 10, a second rib portion 15 of the sliding track frame 10” Column 3, Line 60 thru Column 4, Line 5) and two side walls (11/11, best seen Figures 4-6, “a rigid sliding track frame 10, two sides of the sliding track frame 10 respectively have a first positioning portion 11 and a track 12” Column 2, Lines 60 thru Column 3, Lines 30); side arms (16/16, “the sliding track frame 10 further has a pair of the guiding portions 16” Column 3, Lines 50-60); and a support platform (other of 15/14, “a first rib portion 14 of the sliding track frame 10, a second rib portion 15 of the sliding track frame 10” Column 3, Line 60 thru Column 4, Line 5) extending rearwardly from the front wall (one of 14/15), the support platform (other of 15/14) having an inlet opening (13, best seen Figures 2-5, “a through hole 13 is formed on the sliding track frame 10” Column 2, Lines 60 thru Column 3, Lines 30) formed therein; the body (20) comprising at least one nasal outlet (one of 22/22, “a pair of nasal prongs 22” Column 2, Lines 60 thru Column 3, Lines 30) for interfacing with a user’s nostril, in use, a base opening (25, “a sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30) in a base wall (21, “an elastic portion 21 of the nasal prong body 20” Column 2, Lines 60 thru Column 3, Lines 30) thereof, and at least one opening (via internal bounding perimeter of 26 that receives the frame 10, “a pair of lateral walls 26, each of the guiding portions 16 can be fixed between the lateral walls 26 and the elastic portion 21.” Column 3, Line 60 thru Column 4, Line 5) which the support platform (other of 15/14) extends (as best seen Figures 8, 10, and 11); and wherein the inlet conduit (30) comprises a connector (via engagement of 35/32/36, wherein 35 - “a flange 35 of the opening 34 can be pressed against the sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30; wherein 32 – “the flow guiding portion 31 has a pair of first convex portions 32 and a second positioning portion 33; wherein each of the first convex portions 32 can be inserted into each of the tracks 12” Column 2, Lines 60 thru Column 3, Lines 30; and wherein 36 – “the flow guiding portion 31 further has a pair of guiding surfaces 36; each of the guiding portions 16 can slide on each of the guiding surfaces 36 when the sliding track frame 10 is combined with the guiding portion 31” Column 3, Lines 50-60) at a first end (35, “a flange 35 of the opening 34 can be pressed against the sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30) extends through the base opening (25) and the inlet opening (13) of the support platform (other of 15/14) and clamps the base wall (21) of the body (20) and the support platform (other of 15/14) together, a chamber (defined by the passage of flow from 31 thru 13 to 22) being defined between the support platform other of 15/14) and the body (20), which chamber (defined by the passage of flow from 31 thru 13 to 22) provides fluid communication between the inlet conduit (30) and the one or more nasal outlets (one of 22/22).
As to Claim 2, Hsiung discloses the at least one opening (via internal bounding perimeter of 26 that receives the frame 10) through which the support platform (other of 15/14) extends is a front opening in a front wall (as best seen Figures 3-6) of the body (20).
As to Claim 3, Hsiung discloses the at least one opening (via internal bounding perimeter of 26 that receives the frame 10) through which the support platform (other of 15/14) extends is a pair of side openings (via engagement of 26 to 16, as shown in Figures 6-11) in side walls (26/26) of the body (20).
As to Claim 4, Hsiung discloses the side walls (11/11) of the front portion of the frame (10) are separated (via 12 and 13) from the support platform (other of 15/14).
As to Claim 5, Hsiung discloses the side walls (11/11) of the front portion of the frame (10) are joined (via 14/15) with the support platform (other of 15/14).
As to Claim 10, Hsiung discloses the support platform (other of 15/14) comprises a forward wall (defined by the region of other of 15/14), which the forward wall (defined by the region of other of 15/14) is spaced (via 12 and 13) from the front wall (one of 14/15) of the frame (10) such that a channel is formed between said forward wall (defined by the region of other of 15/14) and the front wall (one of 14/15).
As to Claim 11, Hsiung discloses the support platform (other of 15/14) comprises sidewalls (12/12, “a track 12” Column 2, Lines 60 thru Column 3, Lines 30).
As to Claim 12, Hsiung discloses the support platform (other of 15/14) comprises a rear wall (161, “an inside wall surface 161 of each guiding portion 16” Column 4, Lines 5-20).
As to Claim 13, Hsiung discloses a rear edge (defined by the region which abuts 24 of the body) of the support platform (other of 15/14) is shaped to correspond with the shape of a patient’s upper lip curving inwardly from its outer edges. As best shown in the Figures, the curvature of the body (20) is complementary to the curvature of the frame (10) to permit the fitment of the nasal prongs (22) about the face the user, in operation this fitment would be complementary to the curvature of the patient’s upper lip which anatomically provides the access upon which the nasal prongs are inserted to the patient’s nostrils.
As to Claim 14, Hsiung discloses the inlet opening (13) in the support platform (other of 15/14) is circular in shape. The term “circular” does not preclude shapes which are not an express circle with coincident foci, but rather includes various arcuate/annular shapes such as ovals which have offset foci.
As to Claim 15, Hsiung discloses the support platform (other of 15/14) comprises an annular wall extending upwardly around the inlet opening (13). As shown in the Figures, the shape of the support platform (other of 15/14) is arcuate/annular about the inlet opening (13).
As to Claim 16, Hsiung discloses the side arms (16/16) are contoured with the contours of a patient’s face. As best shown in the Figures, the curvature of the body (20) is complementary to the curvature of the frame (10) to permit the fitment of the nasal prongs (22) about the face the user, in operation this fitment would be complementary to support the side arms (16/16) of the frame (10) to correspond with the contours of the patient’s face to permit access upon which the nasal prongs are inserted to the patient’s nostrils.
As to Claims 19 and 20, Hsiung discloses a means (best seen Figures 8, 10, and 11) for holding the inlet conduit (30) in a fixed position on the front portion of the frame (10), wherein the means (best seen Figures 8, 10, and 11) includes a projection (32) on the inlet conduit (30) and a corresponding recess (12) on each side wall (11/11) of the front portion of the frame (10).
As to Claims 19 and 21, Hsiung discloses a means (best seen Figures 8, 10, and 11) for holding the inlet conduit (30) in a fixed position on the front portion of the frame (10), wherein the means (best seen Figures 8, 10, and 11) includes a recess (311, best seen Figure 9) in the inlet conduit (30) and a corresponding projection (16/16) on each side wall (11/11) of the front portion of the frame (10).
As to Claim 22, Hsiung discloses the frame (10) is made from a flexible plastics material (“Examples of the material of the sliding track frame 10, the nasal prong body 20 and the intake tube 30 will be illustrated below, the material of the nasal prong body 20 is, for example but not limited to Silicone, Thermo-Plastic-Rubber (TPR), Thermoplastic Elastomer (TPE), Thermoplastic Urethane (TPU); the material of the sliding track frame 10 and the intake tube 30 is, for example but not limited to plastic.” Column 3, Lines 40-55).
As to Claim 25, Hsiung discloses the support platform (other of 15/14) lacks a rear wall (defined by the region of 15 upon which insertion/removal of S1 occurs in Figures 7 and 9).
As to Claim 28, Hsiung discloses the body (20) comprises a front, rear, base, side, and top walls (defined by the 3-Dimensional structure as seen in the Figures), the base wall (21) having a base opening (25), the top wall (defined by the region of 21 having the extension of 22) having one or more nasal outlets (nasal prongs)(22) for interfacing with the patient’s nostrils, and the base opening (25) being arranged so as to correspond got the inlet opening (13) of the support platform (other of 15/14), and wherein the front wall has a front opening therein (via internal bounding perimeter of 26 that receives the frame 10, in the S1 direction for insertion/removal as seen in Figures 7 and 9).
As to Claim 30, Hsiung discloses the body (20) comprises an annular exteriorly raised ring (251, best seen Figure 4, “a groove 251 of the nasal prong body 20, the groove 251 is adjacent to the elastic portion 21” Column 3, Line 60 thru Column 4, Line 5) around the base opening (25).
As to Claim 31, Hsiung discloses the body (20) comprises a pair of nasal prongs (22).
As to Claim 32, Hsiung discloses each nasal prongs (22) is curved in shape (as shown in Figures), curving rearwardly and inwardly from its base (via 21) with respect to the front and sides of the body (20).
As to Claim 34, Hsiung discloses the area around the base (via 21) of the prongs (22) is thinner than the rest of the body (20). As shown in the Figures, the thickness at the base (via 21) of the prongs (22) is thinner than the remainder of the body thickness to include the side walls (26) and side arms (28).
As to Claim 35, Hsiung discloses the rear wall (defined by the region which abuts 24) of the body (20) extends beyond the base (via 21) thereof, providing an increased area for contact (via 28/28) of the patient’s upper lip. As best shown in the Figures, the curvature of the body (20) is complementary to the curvature of the frame (10) to permit the fitment of the nasal prongs (22) about the face the user, in operation this fitment would be complementary to the curvature of the patient’s upper lip which anatomically provides the access upon which the nasal prongs are inserted to the patient’s nostrils.
As to Claim 36, Hsiung discloses the rear wall (defined by the region which abuts 24) of the body (20) is shaped to correspond with the shape of the patient’s upper lip, curving inwardly from its outer edges. As best shown in the Figures, the curvature of the body (20) is complementary to the curvature of the frame (10) to permit the fitment of the nasal prongs (22) about the face the user, in operation this fitment would be complementary to the curvature of the patient’s upper lip which anatomically provides the access upon which the nasal prongs are inserted to the patient’s nostrils.
As to Claims 37 and 38, Hsiung discloses the body (20) is made from a pliable material / silicone (“Examples of the material of the sliding track frame 10, the nasal prong body 20 and the intake tube 30 will be illustrated below, the material of the nasal prong body 20 is, for example but not limited to Silicone, Thermo-Plastic-Rubber (TPR), Thermoplastic Elastomer (TPE), Thermoplastic Urethane (TPU); the material of the sliding track frame 10 and the intake tube 30 is, for example but not limited to plastic.” Column 3, Lines 40-55).
As to Claim 39, Hsiung discloses the inlet conduit (30) has a connector (via engagement of 35/32/36, wherein 35 - “a flange 35 of the opening 34 can be pressed against the sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30; wherein 32 – “the flow guiding portion 31 has a pair of first convex portions 32 and a second positioning portion 33; wherein each of the first convex portions 32 can be inserted into each of the tracks 12” Column 2, Lines 60 thru Column 3, Lines 30; and wherein 36 – “the flow guiding portion 31 further has a pair of guiding surfaces 36; each of the guiding portions 16 can slide on each of the guiding surfaces 36 when the sliding track frame 10 is combined with the guiding portion 31” Column 3, Lines 50-60) at a first end (35, “a flange 35 of the opening 34 can be pressed against the sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30) for connecting to the support platform (other of 15/14) of the frame (10) and has a shape complementary to the shape of the inlet opening (13).
As to Claim 40, Hsiung discloses the inlet conduit (30) is in the form of an elbow, such that the connector (via engagement of 35/32/36) extends upwardly from the inlet conduit (30) at the first end (35) of the inlet conduit (30).
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hsiung et al. (11,413,419) in view of Stenzler et al. (2003/0200970).
As to Claim 17, Hsiung discloses the features of a frame (10) having side arms (16/16); yet, does not expressly disclose the configuration the side arms of the frame to support a means for attachment of headgear.
Stenzler teaches an alternative construction of a respiratory interface device (best seen Figures 1, 2, and 4) including the features of a body (24) attached to a frame (12), wherein the frame (12) includes side arms (38/38) to support the receipt of a strap (40) within the strap apertures (39) of the side arms (Para 0028). This orientation has the resultant effect of providing stabilization of the respiratory interface device upon the face of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the side arms of the frame of Hsiung to include the use of a means for attachment of headgear as taught by Stenzler to be a known consideration suitable for imparting stabilization of the respiratory interface upon the face of the patient.
Claims 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Hsiung et al. (11,413,419) in view of Howard et al. (2009/0223521).
As to Claim 41, Hsiung discloses the features of a frame (10), body (20), and inlet conduit (30) interconnected with a connector (via engagement of 35/32/36, wherein 35 - “a flange 35 of the opening 34 can be pressed against the sealing surface 25” Column 2, Lines 60 thru Column 3, Lines 30; wherein 32 – “the flow guiding portion 31 has a pair of first convex portions 32 and a second positioning portion 33; wherein each of the first convex portions 32 can be inserted into each of the tracks 12” Column 2, Lines 60 thru Column 3, Lines 30; and wherein 36 – “the flow guiding portion 31 further has a pair of guiding surfaces 36; each of the guiding portions 16 can slide on each of the guiding surfaces 36 when the sliding track frame 10 is combined with the guiding portion 31” Column 3, Lines 50-60) to provide a releasably engagement between separately machined component parts.
The benefit of this releasable engagement between separately machined component parts enable the ability of the device to be readily cleaned, sanitized, and damage parts to be replaced without complete disposal of the respiratory interface device when the device becomes dirty/clogged, no longer sanitary between uses of the same patient to prevent reinfection or uses between different patients to prevent infection, or damaged.
Although Hsiung does not expressly disclose the desire for a “permanent snap fit” connection, the decision to modify the releasable connection with a “permanent snap fit” connection is a well-known, routine, and conventional practice in order to obviate the efforts required to clean, sanitize, repair, and additional prevent unauthorized use of the patient interface device.
Howard teaches a patient interface device which considers the configuration of “permanently attached” separately machined component parts (Para 0095) as well as “temporarily or releasably attached” separately machined component parts manufactured by “mechanical connection, interference fit, snap fit, hook and loop.” (Para 0095).
Although Howard discloses the concept of “snap fit” to be distinct from a “permanent” attachment, the usage of mechanical/locking fitments with glue or other bonding means is well known routine and conventional practice to avoid unintentional separation of the components once attached.
In light of the teachings of Howard, the decision to modify a releasable engagement connection with a permanently engagement is a functionally equivalent alternative structure, and would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the patient to a have at least one use of the patient interface device before additional actions of cleaning, sanitizing, replacing/repairing, or disposing of the patient interface device is required for additional usage.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Hsiung, as the resultant effect would be a patient interface device suitable for at least one usage by the patient as the components are permanently affixed together.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of the modified Hsiung to include a permanent snap fit connection as taught by Howard to be a known result effective variable in order to achieve at least one usage of the patient interface device by the patient.
As to Claim 42, please see the rejection of Claim 41 for a discussion of the concept of “snap fit” connection. With respect to the further usage of “lugs”. Howard teaches “lugs” or locking fitments are well known, routine, and conventional structure suitable for imparting engagement between component parts. (Para 0080, 0086). Consequently, the decision to use a lug, protrusion, detent, or other locking shape fitment is obvious to one having ordinary skill in the art to impart a mechanical fitment between component parts.
As to Claim 43, please see the rejection of Claims 40 and 42, wherein Claim 40 addresses the features of the connector in the form of an elbow and Claim 42 addresses the concept of “lugs”. Howard teaches “lugs” or locking fitments are well known, routine, and conventional structure suitable for imparting engagement between component parts. (Para 0080, 0086). Consequently, the decision to use a lug, protrusion, detent, or other locking shape fitment is obvious to one having ordinary skill in the art to impart a mechanical fitment between component parts. With respect to the shape/thickness of the locking shape fitment, the thicker the locking shape fitment the more resistant the shape is to deflection as compared to thinner component parts.
Returning to the modified Hsiung, specifically Hsiung, Primary Examiner notes the second end (32) has a shape that is thicker than the shape of the first end (35) to provide a more resistant shape to deflection and thus retained engagement than the thinner first end (35).
Conclusion
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785