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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/27/2026 is acknowledged. Accordingly, claims 12-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 503, 504, 505, 507 (Fig 5). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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: Paragraph [0001] refers to US Patent Application No. 16/586,067; since this application was issued as US Patent No. 11,690,991 (on 7/4/2023), paragraph [0001] should be updated to indicate this. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “the device” on line 2 should be amended to recite “the port device” since this is how the “fully implantable port device” is referred to throughout the rest of the claims. Both occurrences of the phrase “one more light sources” on line 8 should be amended to recite “one or more light source” in order to be grammatically correct. The phrase “so the that the tapered seat” on line 9 should be amended to recite “so [[the]] that the tapered seat” in order to be grammatically correct. The phrase “the access tube tip” on line 10 should be amended to recite “the tip of the access tube [[tip]]” since this is how this feature is referred to throughout the rest of the claims. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: The phrase “one more light sources” on line 1 should be amended to recite “one or more light source” in order to be grammatically correct. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: The phrase “one more lights sources” on lines 2-3 should be amended to recite “one or more light[[s]] source” in order to be grammatically correct. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The phrase “the distal end of the access tube” lacks proper antecedent basis but it is clear that this should be amended to recite “the tip of the access tube” as in claim 1. 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.
Claim 5 is 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 5 requires the port device of claim 1 – which requires (1) “an interface surface” that is “configured to engage (i) the blood vessel of the patient or (ii) a vascular access device” and that has “an aperture in fluid communication with the distal portion of the tapered seal” and (2) a “tapered seat” that is “configured to create a mismatch fit with a diameter of the tip of the access tube when in use” – to also include “a valve mechanism having a spherical element”. Such a port device does not appear to be described in the Specification or shown in the Drawings. Because of this, it is unclear how to interpret claim 5 in light of the Specification and it is unclear how such a port device could operate as claimed.
The embodiments described in the Specification and shown in the Drawings that include an “interface surface […] having an aperture in fluid communication with the distal portion of the tapered seal” have the “interface surface” being directly in contact with the outside of the blood vessel or vascular access device (like in the embodiment of Fig 3,5). However, the embodiments described in the Specification and shown in the Drawings that include the “valve mechanism” of claim 5 have an “interface surface” that is the exterior surface of a nozzle (like 1463 in Fig 14A for example); such an “interface surface” does not have “an aperture in fluid communication with the distal portion of the tapered seal” because it is the outer surface of a tubular member. Because the configuration set forth in claim 5 is not described in the Specification or shown in the Drawings, it is unclear how to interpret claim 5 for the sake of examination. For the sake of examination, claim 1 is interpreted as referring to “an interface component” instead of “an interface surface”; this interpretation does not require that the “aperture” be possessed by a “surface” that engages the blood vessel or the vascular access catheter, but simply requires that the “aperture” be possessed by the component that also possesses the “surface”.
The embodiments described in the Specification and shown in the Drawings that include a “tapered seat” that “is configured to create a mismatch fit with a diameter of a tip of an access tube when in use” do not appear to allow the tip of the access tube to pass distally out of the tapered seat (as seen in Fig 4B). However, the embodiments described in the Specification and shown in the Drawings that include the “valve mechanism” of claim 5 require the tip of the access tube to pass distally out of the tapered seat and engage with the spherical element of the valve mechanism (as seen in Fig 14B). Because the configuration set forth in claim 5 is not described in the Specification or shown in the Drawings, it is unclear how to interpret claim 5 for the sake of examination. For the sake of examination, for claim 5 only, claim 1 is interpreted as not requiring the tapered seat to be “configured to create a mismatch fit with a diameter of the tip of the access tube in use, wherein the mismatch fit is adapted to cause an increase in flow during treatment”; this interpretation allows a port device having the valve mechanism of claim 5 to be operational.
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 1-4 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631) in view of McIntyre et al. (PG PUB 2009/0105688).
Re claim 1, Brugger discloses a fully implantable port device 41 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for establishing access to a blood vessel of a patient that is configured to be implanted entirely underneath the skin of the patient (the italicized text constitutes functional language; this limitation is met in view of Fig 3 and Col 6, Lines 6-8), the device comprising: a tapered seat 22 configured to receive a tip of an access tube (the italicized text constitutes functional language and, therefore, “an access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3), the tapered seat having a proximal portion (facing upward in Fig 2), a distal portion (facing downward in Fig 2), and a conical section extending between the proximal portion and the distal portion (as seen in Fig 2; Col 6, Line 30), wherein the proximal portion of the tapered seat is configured to receive the tip of the access tube therethrough (as set forth above, the “access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3); and an interface surface 34 configured to engage (i) the blood vessel of the patient or (ii) a vascular access catheter (the italicized text constitutes functional language; this limitation is met in view of Col 6, Lines 45-46), the interface surface having an aperture (at the left-most end of nipple 34 in Fig 3) in fluid communication with the distal portion of the tapered seat (as seen in Fig 3); wherein the tapered seat is configured to create a mismatch fit with a diameter of the tip of the access tube when in use, wherein the mismatch fit is adapted to cause an increase in flow during treatment (the italicized text constitutes functional language; this limitation is met in view of Col 6, Lines 28-34; Col 9, Lines 62-64). Brugger does not disclose a port guide including one more light sources, wherein the one more light sources are configured to illuminate a location of the tapered seat so the that the tapered seat is visible to a user to guide introduction of the access tube tip through the skin of the patient.
McIntyre, however, teaches a fully implantable port device 100 (Fig 1; Para 3) comprising a port guide 110 (Fig 1) including a seat (“opening sealed by the septum 104”, Para 11) and one or more light sources (“one or more light emitting diodes”, Para 14), wherein the light sources are configured to illuminate a location of the seat so that the seat is visible to a user to guide introduction of a tip of an access tube through the skin of a patient (Para 12) for the purpose of providing means for a practitioner to locate the seat (Para 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger to include a port guide including multiple light sources, as taught by McIntyre, for the purpose of providing means for a practitioner to locate the seat (Para 4).
Re claim 2, Brugger as modified by McIntyre in the rejection of claim 1 above discloses all the claimed features with McIntyre teaching that the one or more light sources comprise light emitting diodes (“one or more light emitting diodes”, Para 14). The motivation set forth in claim 1 above also applies to this claim.
Re claim 3, Brugger as modified by McIntyre in the rejection of claim 1 above discloses all the claimed features with McIntyre teaching that the light emitting diodes include a radiant material (Para 12 discloses that the light sources emit light and, therefore, the material of the light source is a radiant material). The motivation set forth in claim 1 above also applies to this claim.
Re claim 4, Brugger as modified by McIntyre in the rejection of claim 1 above discloses all the claimed features except that the light emitting diodes include ruby or sapphire. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify McIntyre to include the LEDs with ruby or sapphire since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Claim 4 has additionally been rejected with art below.
Re claim 7, Brugger as modified by McIntyre in the rejection of claim 1 above discloses all the claimed features with Cantlon teaching that the port guide further comprises a receiver coil 254 (Fig 3; “coil”, Para 17) for receiving an electrical current (Para 17), wherein the one or more light sources are configured to be illuminated when an electromagnetic inducer is positioned in proximity to the receiver coil (Para 17) for the purpose of providing non-contact control of when the light sources are illuminated (Para 17). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger to include the receiver coil of McIntyre for the purpose of providing non-contact control of when the light sources are illuminated (Para 17).
Re claim 8, Brugger discloses that the mismatch fit is further configured to decrease a cross-sectional sealing area (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the port device of Brugger only has to be structurally capable of creating a mismatch fit with a hypothetical tip of a hypothetical access tube that is configured to decrease a cross-sectional sealing area; this limitation is met because the conical section of the tapered seal would create a mismatch fit that decreases a cross-sectional sealing area with a cylindrically-shaped access tube having a diameter that is equal to a diameter along the conical section).
Re claim 9, Brugger discloses that the proximal portion of the tapered seat is distanced from the distal portion of the tapered seat (as seen in Fig 2) but Brugger/McIntyre do not explicitly disclose that the distance between these two portions is between about 1.0 mm and 5.0 mm. However, it would have been an obvious matter of design choice to include the tapered seat with a distance between about 1.0 mm and 5.0 mm between the proximal portion and the distal portion since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 10, Brugger discloses that the tip of the access tube is cylindrical and creates the mismatch fit along the conical section of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the conical section of the tapered seat of Brugger only has to be structurally capable of creating a mismatch fit with a hypothetical cylindrical tip of a hypothetical access tube; this limitation is met because the conical section of the tapered seal would create a mismatch fit with a cylindrically-shaped access tube having a diameter that is equal to a diameter along the conical section).
Re claim 11, Brugger discloses that the diameter of the distal end of the access tube is greater than a diameter of the distal portion of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the distal portion of the tapered seat of Brugger only has to be structurally capable of having a diameter that is less than a hypothetical diameter of a hypothetical distal end of a hypothetical access tube; this limitation is met because the port device of Brugger could be used with an access tube having a distal end with a diameter greater than a diameter of the distal portion of the tapered seat since the tapered seat has a larger diameter at its proximal end than at its distal end, as seen in Fig 3).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631)/McIntyre et al. (PG PUB 2009/0105688) in view of Hughes (PG PUB 2006/0092626).
Re claim 4, Brugger/McIntyre disclose all the claimed features except explicitly disclosing that the light emitting diodes include ruby or sapphire. Hughes, however, teaches using sapphire in light emitting diodes to achieve a generally blue light (Para 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger/McIntyre to include the LEDs with sapphire, as taught by Hughes, for the purpose of emitting generally blue light (Para 7).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631)/McIntyre et al. (PG PUB 2009/0105688) in view of Fischell et al. (US Pat 4,573,994) and Ellefson et al. (US Pat 3,892,974).
Re claim 5, Brugger discloses that the port device further includes a valve mechanism 42 (Fig 2,3; Col 7, Lines 10-12) and McIntyre teaches that the one or more light sources illuminate the seat and the interface for percutaneous access (Para 3); since the valve of Brugger is within the interface, the addition of McIntyre’s light sources would illuminate the valve for percutaneous access. Brugger/McIntyre, however, do not disclose that the valve mechanism has a spherical element made of synthetic sapphire. Fischell, however, teaches a port device 10 (Fig 1,2) comprising a valve mechanism 48 (Fig 3) that is to be actuated by fluid pressure (like in Brugger) and has a spherical element (“ball”, Col 5, Line 50) that precludes flow therepast until sufficient pressure builds up to cause the ball to move to open the valve and permit fluid to flow therepast (Col 5, Lines 48-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger/McIntyre to include the valve mechanism as one that has a spherical element, as taught by Fischell, for the purpose of precludes flow past the interface until sufficient pressure builds up to cause the ball to move to open the valve and permit fluid to flow therepast (Col 5, Lines 48-54). Fischell is silent to the material of the spherical element and, therefore, does not disclose that the spherical element is made of synthetic sapphire. Ellefson, however, teaches a spherical element 14 (Fig 1) made of synthetic sapphire (Col 1, Lines 24-28; col 2, Line 27) that, when illuminated by a light emitting diode 22 (Fig 1), delivers the focuses the light of the emitted by the diode (Col 3, Lines 63-65). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger/McIntyre/Fischell to include the spherical element (which is would be illuminated by McIntyre’s light emitting diodes as explained above) such that it is made of synthetic sapphire, as taught by Ellefson, for the purpose of focusing the light emitted by the diode (Col 3, Lines 63-65). One of ordinary skill in the art would recognize that focusing the light would provide the physician with a more precise location of the port device.
Claims 1-4 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631) in view of Cantlon (PG PUB 2004/0199220).
Re claim 1, Brugger discloses a fully implantable port device 41 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for establishing access to a blood vessel of a patient that is configured to be implanted entirely underneath the skin of the patient (the italicized text constitutes functional language; this limitation is met in view of Fig 3 and Col 6, Lines 6-8), the device comprising: a tapered seat 22 configured to receive a tip of an access tube (the italicized text constitutes functional language and, therefore, “an access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3), the tapered seat having a proximal portion (facing upward in Fig 2), a distal portion (facing downward in Fig 2), and a conical section extending between the proximal portion and the distal portion (as seen in Fig 2; Col 6, Line 30), wherein the proximal portion of the tapered seat is configured to receive the tip of the access tube therethrough (as set forth above, the “access tube” and its “tip” are not a part of the claimed invention; this limitation is met in view of Fig 3); and an interface surface 34 configured to engage (i) the blood vessel of the patient or (ii) a vascular access catheter (the italicized text constitutes functional language; this limitation is met in view of Col 6, Lines 45-46), the interface surface having an aperture (at the left-most end of nipple 34 in Fig 3) in fluid communication with the distal portion of the tapered seat (as seen in Fig 3); wherein the tapered seat is configured to create a mismatch fit with a diameter of the tip of the access tube when in use, wherein the mismatch fit is adapted to cause an increase in flow during treatment (the italicized text constitutes functional language; this limitation is met in view of Col 6, Lines 28-34; Col 9, Lines 62-64). Brugger does not disclose a port guide including one more light sources, wherein the one more light sources are configured to illuminate a location of the tapered seat so the that the tapered seat is visible to a user to guide introduction of the access tube tip through the skin of the patient.
Cantlon, however, teaches a fully implantable port device 12 (Fig 1; wherein Fig 2 shows a substantially similar port device fully implanted) comprising a seat 16 (Fig 1) and a port guide including multiple light sources 18,18,18 (Fig 1; “LEDs”, Para 19), wherein the light sources are configured to illuminate a location of the seat so that the seat is visible to a user to guide introduction of a tip of an access tube through the skin of a patient (“indicating the location of the port 16”, Para 19) for the purpose of avoiding tissue damage, needle tip damage, and port device damage that can occur when the port device cannot be located under the skin (Para 3,4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger to include a port guide including multiple light sources, as taught by Cantlon, for the purpose of avoiding tissue damage, needle tip damage and port device damage that can occur when the port device cannot be located under the skin (Para 3,4).
Re claim 2, Brugger as modified by Cantlon in the rejection of claim 1 above discloses all the claimed features with Cantlon teaching that the one or more light sources comprise light emitting diodes (“LEDs”, Para 19). The motivation set forth in claim 1 above also applies to this claim.
Re claim 3, Brugger as modified by Cantlon in the rejection of claim 1 above discloses all the claimed features with Cantlon teaching that the light emitting diodes include a radiant material (Para 19 discloses that the light sources are LEDs; since the material of an LED glows, it is a radiant material). The motivation set forth in claim 1 above also applies to this claim.
Re claim 4, Brugger as modified by Cantlon in the rejection of claim 1 above discloses all the claimed features except that the light emitting diodes include ruby or sapphire. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Cantlon to include the LEDs with ruby or sapphire since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Claim 4 has additionally been rejected with art below.
Re claim 7, Brugger as modified by Cantlon in the rejection of claim 1 above discloses all the claimed features with Cantlon teaching that the port guide further comprises a receiver coil 92 (Fig 5) for receiving an electrical current (Para 28), wherein the one or more light sources are configured to be illuminated when an electromagnetic inducer 20 (Fig 1) is positioned in proximity to the receiver coil (Para 20,28) for the purpose of conserving electricity when the port is not actively being located (Para 9). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger to include the receiver coil of Cantlon for the purpose of conserving electricity when the port is not actively being located (Para 9).
Re claim 8, Brugger discloses that the mismatch fit is further configured to decrease a cross-sectional sealing area (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the port device of Brugger only has to be structurally capable of creating a mismatch fit with a hypothetical tip of a hypothetical access tube that is configured to decrease a cross-sectional sealing area; this limitation is met because the conical section of the tapered seal would create a mismatch fit that decreases a cross-sectional sealing area with a cylindrically-shaped access tube having a diameter that is equal to a diameter along the conical section).
Re claim 9, Brugger discloses that the proximal portion of the tapered seat is distanced from the distal portion of the tapered seat (as seen in Fig 2) but Brugger/Cantlon do not explicitly disclose that the distance between these two portions is between about 1.0 mm and 5.0 mm. However, it would have been an obvious matter of design choice to include the tapered seat with a distance between about 1.0 mm and 5.0 mm between the proximal portion and the distal portion since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 10, Brugger discloses that the tip of the access tube is cylindrical and creates the mismatch fit along the conical section of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the conical section of the tapered seat of Brugger only has to be structurally capable of creating a mismatch fit with a hypothetical cylindrical tip of a hypothetical access tube; this limitation is met because the conical section of the tapered seal would create a mismatch fit with a cylindrically-shaped access tube having a diameter that is equal to a diameter along the conical section).
Re claim 11, Brugger discloses that the diameter of the distal end of the access tube is greater than a diameter of the distal portion of the tapered seat (as set forth in the rejection of claim 1 above, the “access tube” is not a part of the claimed invention; therefore, the distal portion of the tapered seat of Brugger only has to be structurally capable of having a diameter that is less than a hypothetical diameter of a hypothetical distal end of a hypothetical access tube; this limitation is met because the port device of Brugger could be used with an access tube having a distal end with a diameter greater than a diameter of the distal portion of the tapered seat since the tapered seat has a larger diameter at its proximal end than at its distal end, as seen in Fig 3).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631)/Cantlon (PG PUB 2004/0199220) in view of Hughes (PG PUB 2006/0092626).
Re claim 4, Brugger/Cantlon disclose all the claimed features except explicitly disclosing that the light emitting diodes include ruby or sapphire. Hughes, however, teaches using sapphire in light emitting diodes to achieve a generally blue light (Para 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger/Cantlon to include the LEDs with sapphire, as taught by Hughes, for the purpose of emitting generally blue light (Para 7).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Brugger et al. (US Pat 6,929,631)/Cantlon (PG PUB 2004/0199220) in view of Haase et al. (PG PUB 2007/0255234).
Re claim 6, Cantlon discloses that the light sources of the port guide are located on a top surface of the port device, surrounding the seat (as seen in Fig 1 and 2) but Brugger/Cantlon does not disclose that the port guide is configured to engage a proximal portion of the tip of the access tube and assist in directing the tip of the access tube toward the tapered seat. Haase, however, teaches a port guide 48 (Fig 3A,3B; “conical”, Para 35) located on a top surface of a port device and surrounding a tapered seat 64 (as seen in Fig 3A; like that of Cantlon), wherein the port guide is configured to engage a proximal portion of a tip of an access tube and assist in directing the tip toward the tapered seat (step 132 in Fig 4; via grooves 70, Para 30,40) for the purpose of ensuring quick and accurate percutaneous location of the tapered seat (Para 42). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brugger/Cantlon to include the port guide with a structure that is configured to engage a proximal portion of the tip of the access tube and assist in directing the tip toward the seat, as taught by Haase, for the purpose of ensuring quick and accurate percutaneous location of the tapered seat (Para 42).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wortley et al. (PG PUB 2007/0078391) and Meng et al. (PG PUB 2009/0192493) each disclose an implantable port device comprising a port guide including one or more light sources to indicate a position of the access opening of the port device.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783