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 .
Status of Claims
Claims 1-35 are pending and currently under consideration for patentability.
Claims 1 and 16 are newly amended.
Claims 36-38 are new.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
The applicant argues Hong fails to teach wherein the back plate is made of a material that prevents the needle from extending through the back plate. Gage teaches a cannulate assemble with a needle in which wherein the back plate is made of a material that prevents the needle from extending through the back plate (paragraph [0007]) and the back plate defining longitudinal edges and linear slots extending orthogonally from the longitudinal edges (annotated figure 4).
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Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannulation assembly of Hong so the material prevents the needle from extending through the backplate similar to Gage so that the needle penetrates at the intended area.
Claim Rejections - 35 USC § 103
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 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.
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 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(s) 1-10, 12-14, 16-26, 28-30, 32-33, and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong (US 20170304092 A1) in view of Gage (WO 2012125927 A2) in view of Butts (US 20060253076 A1).
Regarding Claim 1, Hong teaches a cannulation chamber (30) for use with an arteriovenous graft (paragraph 0042) including a flexible conduit (paragraph 0081), the cannulation chamber comprising:
an elongated body (12) having a first end (14a) and a second end (14b), an interior surface and an exterior surface (figures 1 and 2B), and an annular passageway defined by the interior surface (figures 1 and 2B) and having a longitudinal axis (paragraph 0043) extending between the first end (14a) and the second end (14b), the body adapted to receive and surround a least a portion of the conduit in the passageway (paragraph 0045)(figures 1 and 2B), the body comprising a flexible, nonporous elastomeric self-sealing material (paragraph 0046), and a cannulation port (30) that exposes the self-sealing material (cannulation region, 30) (paragraph 0042); and
a flexible resilient elongated back plate (reinforcement elements, 40) (paragraph 0046) having a first end and a second end, the back plate embedded in the body of the cannulation chamber (paragraph 0046) with the first end and the second end of the back plate adjacent the first end and the second end of the body (figure 2a), respectively, such that the back plate extends generally parallel with the passageway (figure 2a), wherein the back plate is formed of a substantially rigid material (paragraph 0046) such that when a needle is inserted through the cannulation port (30) and the self-sealing material the needle (paragraph 0042) is inhibited from extending through the back plate (paragraph 0073).
Hong fails to teach wherein the back plate is made of a material that prevents the needle from extending through the back plate. Gage teaches a cannulate assemble with a needle in which wherein the back plate is made of a material that prevents the needle from extending through the back plate (paragraph [0007]) and the back plate defining longitudinal edges and linear slots extending orthogonally from the longitudinal edges (annotated figure 4).
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Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannulation assembly of Hong so the material prevents the needle from extending through the backplate similar to Gage so that the needle penetrates at the intended area.
Hong and Gage fail to teach that the flexible resilient elongated back plate is positioned between the interior surface and the exterior surface of the elongated body. Butts teaches an insertable cannula assembly that the flexible resilient elongated back plate (102) is positioned between the interior surface and the exterior surface of the elongated body (paragraph [0106] FIG. 13). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the back plate of Hong so it is flexible so that it can move with the rest of the cannula.
Regarding Claim 2, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. Hong further teaches wherein the body (12) includes an outer layer surrounding the cannulation chamber (paragraph 0045) (figure 2a).
Regarding Claim 3, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 2. Hong further teaches wherein the outer layer comprises ePTFE (paragraph 0045) (figure 2a).
Regarding Claim 4, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. The primary embodiment of Hong fails to teach that the back plate is planar, however an alternative embodiment teaches wherein the back plate (patch, 430) is planar (paragraph 0081). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the back plate of Hong, with the alternative embodiment so the back plate is planar such that an inner surface of the patch 430 may be attached to a tissue or other body structure (paragraph [0081]).
Regarding Claim 5, Hong in view of Gage and Butt teaches the cannulation chamber as recited in in claim 1. Hong further teaches wherein a transverse cross-section of the back plate (reinforcement elements, 40) is c-shaped (paragraph 0047), the back plate (40) including a posterior wall and a pair of sidewalls (figure 2A) extending from the posterior wall partially surrounding the passageway (lumen, 16) and defining an open anterior portion facing the cannulation port (30) of the body (12) (paragraph 0073).
Regarding Claim 6, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim I. Hong further teaches wherein the back plate comprises a plurality of independent identically shaped pieces (40) being embedded in the body (12) unconnected to (paragraph 0047) and separate from adjacent pieces with spaces close enough between the pieces to prevent passage of a needle (paragraph 0046).
Regarding Claim 7, Hong in view of Gage and Butt teaches the cannulation chamber as recited in in claim I, wherein the back plate (40) comprises a plurality of independent identically shaped pieces being embedded in the body unconnected to adjacent pieces such that the adjacent pieces partially overlap one another (figure 2e) (paragraph 0046).
Regarding Claim 8, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 6. Hong teaches wherein the plurality of pieces (40) are connected by a longitudinal spine extending parallel with the back plate (paragraph 0047). However, Hong fails to teach wherein the pieces are connected at a midpoint. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the connection point of the plurality of pieces disclosed by Hong to be connected at a midpoint, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, one having ordinary skill in the art would be motivated to modify the connection point of the plurality of pieces to be at a midpoint, in order to allow for increased flexibility, as suggested by Hong in paragraph [0047].
Regarding Claim 9, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 6, wherein the plurality of pieces are connected by a flexible material spanning the space between the pieces (paragraph 0081)(figure 12e).
Regarding Claim 10, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 5, wherein the back plate has a plurality of openings small enough to prevent passage of a needle (paragraph 0049).
Regarding Claim 12, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 5. Hong further teaches wherein the back plate (40) has opposed longitudinal side edges extending between the first end (14a) and the second end (14b) and spaced linear blind slots extending orthogonally inwardly from the edges defining a zigzag pattern that zigzags transversely relative to the longitudinal axis between the side edges of the back plate (paragraph 0046 and 0048).
Regarding Claim 13, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. Hong further teaches wherein the body is curved to have an arc angle (loop region, 20) formed by a longitudinal axis at the one end or another end of the curved chamber and an axis parallel to the longitudinal axis of a straight chamber (paragraph 0043)(figure 2a). Hong fails to teach that is between 10 and 30 degrees to accommodate placement in an extremity of the subject. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the axis to be between 10 and 30 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to modify the curved radius to 10-30 degrees would allow for more gradual curve, less likely to irritate the user with edges or sharp corners.
Regarding Claim 14, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. Hong further teaches wherein the body has an outer surface including a continuous raised perimeter portion (40) adjacent to the cannulation port (30) such that the cannulation port can be tactilely or visually identified (paragraph 0047-0048)
Regarding Claim 16, Hong teaches an arteriovenous access graft (graft, 10) configured to be subcutaneously implanted in a subject between a first blood vessel and a second blood vessel of the subject such that blood flows through the graft from the first blood vessel to the second blood vessel (Hong does not specify the use on a first a second blood vessel, but easily could be used in any portion of the body in two regions because on the loop allowing use in two regions, abstract), the arteriovenous graft comprising:
a flexible conduit (base material, 442) (paragraph 0081) having a first end and second end (figure 12e), an interior surface and an exterior surface (figures 1 and 2B), and a longitudinal flow passage defined by the interior surface (figures 1 and 2B), between the first end and the second end (paragraph 0043), wherein the first end is adapted to connect to an artery of the subject and the second end is adapted to connect to a vein of the subject such that blood flows through the flow passage of the conduit from the first end to the second end (Hong does not specify the use on a first a second blood vessel, but easily could be used in any portion of the body in two regions because on the loop allowing use in two regions, abstract);
a cannulation chamber (30) comprising an elongated body (12) having a first end (14a) and a second end (14b) and defining an annular passageway having a longitudinal axis (paragraph 0043) extending between the first end (14a) and the second end (14b), the body configured to receive and surround a least a portion of the conduit in the passageway (paragraph 0045)(figures 1 and 2B), the body comprising a flexible, nonporous elastomeric self-sealing material (paragraph 0046), and a cannulation port (30) that exposes the self-sealing material; and
a flexible resilient elongated back plate (reinforcement elements, 40) (paragraph 0046) having a first end and a second end, the back plate embedded in the body of the cannulation chamber (paragraph 0046) with the first end and the second end of the back plate adjacent the first end and the second end of the body (figure 2a), respectively, such that the back plate extends generally parallel with the passageway (figure 2a);
wherein the back plate is formed of a substantially rigid material (paragraph 0046); such that when a needle is inserted through the cannulation port (30) and the self-sealing material the needle (paragraph 0042) is inhibited or prevented from extending through the back plate (paragraph 0073).
Hong fails to teach wherein the back plate is continuous on a back side of the cannulation chamber. Gage teaches a cannulate assemble with a needle in which wherein the back plate is made of a material that prevents the needle from extending through the back plate (paragraph [0007]) Hong fails to teach wherein the back plate is made of a material that prevents the needle from extending through the back plate. Gage teaches a cannulate assemble with a needle in which wherein the back plate is made of a material that prevents the needle from extending through the back plate (paragraph [0007]) and the back plate defining longitudinal edges and linear slots extending orthogonally from the longitudinal edges (annotated figure 4).
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Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannulation assembly of Hong so the material prevents the needle from extending through the backplate similar to Gage so that the needle penetrates at the intended area.
. Hong and Gage fail to teach that the flexible resilient elongated back plate is positioned between the interior surface and the exterior surface of the elongated body. Butts teaches an insertable cannula assembly that the flexible resilient elongated back plate (102) is positioned between the interior surface and the exterior surface of the elongated body (paragraph [0106] FIG. 13). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the back plate of Hong so it is flexible so that it can move with the rest of the cannula.
Regarding Claim 17, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16, Hong further teaches comprising beading material (PTFE, paragraph 0043) disposed around a circumference of at least a portion of a length of the conduit (paragraph 0043) .
Regarding Claim 18, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16, Hong further teaches wherein the body (12) includes an outer layer surrounding the cannulation chamber (paragraph 0045) (figure 2a).
Regarding Claim 19, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 18, Hong further teaches wherein the outer layer comprises ePTFE (paragraph 0045) (figure 2a).
Regarding Claim 20, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16. The primary embodiment of Hong fails to teach that the back plate is planar, however an alternative embodiment teaches wherein the back plate (patch, 430) is planar (paragraph 0081). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the back plate of Hong, with the alternative embodiment so the back plate is planar such that an inner surface of the patch 430 may be attached to a tissue or other body structure (paragraph [0081]).
Regarding Claim 21, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16, Hong further teaches wherein a transverse cross-section of the back plate (reinforcement elements, 40) is c-shaped (paragraph 0047), the back plate (40) including a posterior wall and a pair of sidewalls (figure 2A) extending from the posterior wall partially surrounding the passageway (lumen, 16) and defining an open anterior portion facing the cannulation port (30) of the body (12) (paragraph 0073).
Regarding Claim 22, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16, Hong further teaches wherein the back plate comprises a plurality of independent identically shaped pieces (40) being embedded in the body (12) unconnected to (paragraph 0047) and separate from adjacent pieces with spaces close enough between the pieces to prevent passage of a needle (paragraph 0046).
Regarding Claim 23, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16. Hong further teaches wherein the back plate (40) comprises a plurality of independent identically shaped pieces being embedded in the body unconnected to adjacent pieces such that the adjacent pieces partially overlap one another (figure 2e) (paragraph 0046).
Regarding Claim 24, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 22, Hong teaches wherein the plurality of pieces (40) are connected by a longitudinal spine extending parallel with the back plate (paragraph 0047). However, Hong fails to teach wherein the pieces are connected at a midpoint. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of pieces so they are connected at a midpoint, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, one having ordinary skill in the art would be motivated to modify the pieces so they are attached at the midpoint would allow for increased flexibility (paragraph 0047).
Regarding Claim 25, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 22. Hong further teaches wherein the plurality of pieces are connected by a flexible material spanning the space between the pieces (paragraph 0081)(figure 12e).
Regarding Claim 26, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 21. Hong further teaches wherein the back plate has a plurality of openings small enough to prevent passage of a needle (paragraph 0049).
Regarding Claim 28, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 21, Hong further teaches wherein the back plate (40) has opposed longitudinal side edges extending between the first end (14a) and the second end (14b) and spaced linear blind slots extending orthogonally inwardly from the edges defining a zigzag pattern that zigzags transversely relative to the longitudinal axis between the side edges of the back plate (paragraph 0046 and 0048).
Regarding Claim 30, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16, Hong further teaches wherein the body has an outer surface including a continuous raised perimeter portion (40) adjacent to the cannulation port (30) such that the cannulation port can be tactilely or visually identified (paragraph 0047-0048).
Regarding Claim 29, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16. Hong further teaches wherein the body is curved to have an arc angle (loop region, 20) formed by a longitudinal axis at the one end or another end of the curved chamber and an axis parallel to the longitudinal axis of a straight chamber (paragraph 0043)(figure 2a). Hong fails to teach that is between 10 and 30 degrees to accommodate placement in an extremity of the subject. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the axis to be between 10 and 30 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to modify the curved radius to 10-30 degrees would allow for more gradual curve, less likely to irritate the user with edges or sharp corners.
Regarding Claim 32, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. However Hong fails to teach wherein the flexible resilient elongated back plate (40) is positioned opposite the cannulation port (30). It would have been obvious to one having ordinary skill in the art at the time the invention was made to position the back plate opposite the cannulation port, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would also be advantageous to move the cannulation port so that the port is never obstructed by the back plate.
Regarding Claim 33, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 16. However Hong fails to teach wherein the flexible resilient elongated back plate (40) is positioned opposite the cannulation port (30). It would have been obvious to one having ordinary skill in the art at the time the invention was made to position the back plate opposite the cannulation port, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. It would also be advantageous to move the cannulation port so that the port is never obstructed by the back plate.
Regarding Claim 36, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 1. The combination further teaches, wherein the linear slots are blind (Gage, annotated figure 4).
Regarding Claim 37, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 36. The combination further teaches wherein the linear slots extend alternately from one of the longitudinal edges to an opposite edge of the longitudinal edges (Gage, annotated figure 4).
Regarding Claim 38, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 36. The combination further teaches wherein the back plate is curved such that the slots beginning at an outer curved edge (Gage, annotated figure 4).
Claim(s) 11 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong (US 20170304092 A1) in view of Gage (WO 2012125927 A2) as applied to claim 10 and 26 above, and further view of Michelson (US 5797909 A).
Regarding Claim 11, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 10. Hong fails to teach wherein the openings are hexagonal. Michelson teaches an apparatus and a method of inserting spinal implants (abstract) wherein the cap (374) has a hexagonal opening (394) for tightening the cap (374) (column 31, lines 53-55). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the openings of Hong so that they are horizontal similar to that disclosed by Michelson so that holes are compatible with tools (as motivated by Michelson, column 31, lines 53-55).
Regarding Claim 27, Hong in view of Gage and Butt teaches the cannulation chamber as recited in claim 26. Hong fails to teach wherein the openings are hexagonal. Michelson teaches an apparatus and a method of inserting spinal implants (abstract) wherein the cap (374) has a hexagonal opening (394) for tightening the cap (374) (column 31, lines 53-55). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the openings of Hong so that they are horizontal similar to that disclosed by Michelson so that holes are compatible with tools (as motivated by Michelson, column 31, lines 53-55).
Claim(s) 14 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong (US 20170304092 A1) in view of Gage (US 20200129749 A1) as applied to claim 1 and 16 above, and further view of Wilk (US 20020165479 A1).
Regarding Claim 15, Hong in view of Gage and Butt teaches the arteriovenous graft as recited in claim I. Hong fails to teach wherein the chamber body has an outer surface including a pair of spaced parallel flanges adjacent to the cannulation port such that the cannulation port can be tactilely or visually identified and the cannulation chamber can be manipulated follow implantation. Wilk teaches a cannula meant for insertion into a body cavity of the patient (paragraph 0120) wherein the chamber body (shunt, 28) has an outer surface including a pair of spaced parallel flanges (30 and 32) (figure 2) adjacent to the cannulation port such that the cannulation port can be tactilely or visually identified and the cannulation chamber can be manipulated follow implantation (paragraph 0122). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula body of Hong to include a pair of flanges similar to that disclosed by Wilk in order to facilitate attachment of the shunt to the body (as motivated by Wilk, paragraph 0122).
Regarding Claim 31, Hong in view of Gage and Butt teaches the arteriovenous graft as recited in claim 16. Hong fails to teach wherein the chamber body has an outer surface including a pair of spaced parallel flanges adjacent to the cannulation port such that the cannulation port can be tactilely or visually identified and the cannulation chamber can be manipulated follow implantation. Wilk teaches a cannula meant for insertion into a body cavity of the patient (paragraph 0120) wherein the chamber body (shunt, 28) has an outer surface including a pair of spaced parallel flanges (30 and 32) (figure 2) adjacent to the cannulation port such that the cannulation port can be tactilely or visually identified and the cannulation chamber can be manipulated follow implantation (paragraph 0122). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula body of Hong to include a pair of flanges similar to that disclosed by Wilk in order to facilitate attachment of the shunt to the body (as motivated by Wilk, paragraph 0122).
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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781