DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/17/2025 and 2/16/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 2/16/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see pages 6-7, with respect to Applicant’s claim amendments made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant’s arguments, see page 8, with respect to previous interpretation of Kerr failing to include the base portion disposed towards a proximal end of the elongate member have been fully considered and are persuasive. Therefore, the previous prior art rejections made under Kerr have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in view of a new interpretation of Kerr, as set forth below (i.e., the elongate member comprising the tapered mount 30).
Applicant's arguments, see page 8, alleging Kerr failing to disclose the needle holder arms are not disposed on opposite sides of the capture area (34) of the needle trap mechanism (32) have been fully considered but they are not persuasive. It is the Examiner’s position that the disclosure of Kerr contradicts Applicant’s arguments as the wings of Kerr (24a/26a and 24b/26b) are expressly depicted on opposing left and right sides of the longitudinal axis (i.e., central axis positioned along rod 20), the opening (i.e., the opening/lumen having rod 20 disposed therein), the first groove (i.e., left groove about housing 34, see left vertical arrow in Fig. 6) and the second groove (i.e., right groove about housing 34, see right vertical arrow in Fig. 6). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see page 8, alleging McIntosh fails to disclose “two wings disposed opposite each other across the longitudinal axis and on opposite sides of the opening” have been fully considered but they are not persuasive. It is the Examiner’s position that the disclosure of McIntosh contradicts Applicant’s arguments as the two wings (65a and 65b) of McIntosh are disposed opposite each other across the longitudinal axis (i.e., central axis of the device/shaft 50) and on opposite sides (i.e., upper side and lower sides of the device in Fig. 5) of the opening (i.e., central opening/lumen housing wire 32, as shown in Figs. 2a and 5). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant’s arguments regarding calims 1 and 7, see page 8, with respect to previous interpretation of Gordon failing to include the base portion disposed towards a proximal end of the elongate member have been fully considered and are persuasive. Therefore, the previous prior art rejections made under Gordon have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in view of a new interpretation of Gordon, as set forth below (i.e., the elongate member comprising the distal portion of the device from the catch mechanism 16 to the distal end of housing 12, Fig. 1A).
Applicant's arguments regarding claim 11, see pages 8-9, alleging Gordon fails to disclose “two wings extending from the base portion, the two wings being opposite each other on opposite sides of the base portion, the two wings being configured to move in relation to a longitudinal axis to change the gap of the groove” have been fully considered but they are not persuasive. It is the Examiner’s position that the disclosure of Gordon contradicts Applicant’s arguments as the two wings (188a/188b) of Gordon extend from the base portion (i.e., the solid framed perimeter of catch 174) (as expressly shown in Fig. 19; wing 188a extends both downward and radially inward from the outer frame of catch 174, and wing 188b extends both upward and radially inward from the outer frame of catch 174). Further the two wings (188a/188b) are configured to move in relation to a longitudinal axis to change the gap of the groove (186) (as expressly shown in Fig. 19; col. 14, lines 12-21; spring leaves 188a/188b are expressly flexible and bend radially inward relative to the longitudinal axis and increase the gap size as needle 166 is captured therein). For at least these reasons, Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 102
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kerr (US 6,743,241).
Kerr discloses (see Figs. 1-8) a medical device comprising the following claim limitations:
(claim 1) an elongate member (30, Figs. 4-6) extending from a proximal end (i.e., lower edge of concave taper 30 as shown in Fig. 4) toward a distal end (i.e., upper edge of concave taper 30 as shown in Fig. 4), the elongate member (30) having a lumen with a longitudinal axis (as shown in Figs. 1-6; sub-components such as rod 20 expressly shown disposed within the central lumen of mount portion 30); a base portion (32/34, Figs. 1-7) disposed towards the proximal end of the elongate member (30) (as shown in Figs. 3-6), the base portion (32/34) comprising a first groove (i.e., left groove about housing 34, see left vertical arrow in Fig. 6) and a second groove (i.e., right groove about housing 34, see right vertical arrow in Fig. 6) wherein needle 26a/26b articulate towards and engage the respective groove portions; as shown in annotated Fig. 3 below) separated by an opening (i.e., central opening shown housing rod 20 in Figs. 1-7); two wings (24a/26a;24b/26b, Figs. 1-4) disposed opposite each other across the longitudinal axis (i.e., central axis positioned along rod 20) and on opposite sides of the opening (i.e., the opening/lumen having rod 20 disposed therein), the first groove (i.e., left groove about housing 34, see left vertical arrow in Fig. 6), and the second groove (i.e., right groove about housing 34, see right vertical arrow in Fig. 6) (as expressly shown in Figs. 1-6), wherein, the two wings are configured to (i.e., capable of) move in relation to the longitudinal axis and the opening (as expressly shown in Figs. 3-6);
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(claim 2) wherein each wing of the two wings comprises a first portion angularly orientated in relation to a second portion, the second portion extending to and forming a peripheral end (as expressly shown in annotated Fig. 6 below);
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(claim 3) wherein each of the two wings including an elongate slot, the elongate slot of each wing extends over at least a portion of each of the first portion and the second portion (as shown in annotated Fig. 6 above, the slot end expressly shown extending at east to and including the overlapping junction of both the first and second portions);
(claim 4) wherein each of the two wings include a textured surface (i.e., textured surface includes a plurality of ridges including at least the angular offset ridge, needle/holder interface ridges, needle tip ridge, and barbed reverse tip ridge);
(claim 5) wherein each of the two wings includes ridges (i.e., textured surface includes a plurality of ridges including at least the angular offset ridge, needle/holder interface ridges, needle tip ridge, and barbed reverse tip ridge); and
(claim 6) wherein the second groove and the first groove are parallel (as expressly shown in annotated Fig. 3 above).
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McIntosh (US 2009/0048615).
McIntosh discloses (see Figs. 1-5) a medical device comprising the following claim limitations:
(claim 1) an elongate member (70, Fig. 1) extending from a proximal end (i.e., at foot housing 60) toward a distal end (i.e., at distally tapered tip), the elongate member (70) having a lumen with a longitudinal axis (i.e., lumen housing guidewire, with guidewire exit port shown at 63 in Fig. 1); a base portion (60, Figs. 1 and 5) disposed towards the proximal end of the elongate member (70) (as shown in Fig. 1), the base portion (60) comprising a first groove (i.e., upper groove 63 receiving needle 42, as shown in annotated Fig. 5 below) and a second groove (i.e., lower groove 63 receiving needle 42, as shown in annotated Fig. 5 below) separated by an opening (i.e., central opening/lumen expressly shown housing wire 32 in Figs. 2a and 5); two wings (65a/65b, Fig. 5) disposed opposite each other across the longitudinal axis (i.e., central axis of the device/shaft 50) and on opposite sides (i.e., upper side and lower sides of the device, as expressly shown in Fig. 5) of the opening (i.e., central opening/lumen housing wire 32, as shown in Figs. 2a and 5), the first groove (upper groove 63 in Fig. 5), and the second groove (lower groove 63 in Fig. 5) (as expressly shown in Fig. 5), wherein, the two wings (65a/65b) are configured to (i.e., capable of) move in relation to the longitudinal axis and the opening (as shown in positions of Figs. 1 and 5);
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(claim 2) wherein each wing of the two wings comprises a first portion angularly orientated in relation to a second portion, the second portion extending to and forming a peripheral end (as expressly shown in annotated Fig. 5 below);
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(claim 3) wherein each of the two wings (65a/65b) including an elongate slot (66, Fig. 5), the elongate slot (66) of each wing (65a/65b) extends over at least a portion of each of the first portion and the second portion (as shown in annotated Fig. 5 directly above, the slot/receptacle expressly shown extending at least to and including the overlapping junction of both the first and second portions);
(claim 4) wherein each of the two wings (65a/65b) include a textured surface (i.e. textured surface includes a plurality of ridges including at least the plurality of ridges shown in annotated Fig. 5 below);
(claim 5) wherein each of the two wings (65a/65b) includes ridges (i.e., the plurality of ridges expressly shown in annotated Fig. 5 below); and
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(claim 6) wherein the second groove and the first groove (i.e., respective upper and lower grooves 63 within the outer surface of shaft 50 for receiving needle 42) are parallel (as shown in Fig. 5, the grooves present within the outer surface of shaft 50 are shown parallel and diametrically opposed to each other).
Claim(s) 1-9, 11-12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon et al. (US 5,458,609).
Gordon discloses (see Figs. 2-19) a medical device (30, Fig. 2) comprising the following claim limitations:
(claim 1) an elongate member (i.e., distal deployment housing 12, Figs. 1A) extending from a proximal end (i.e., adjacent bosses 62b in Fig. 7 (i.e., at the top edge of the lateral needle windows)) toward a distal end (i.e., at distal end defining recess 96 in Fig. 6), the elongate member (12) having a lumen with a longitudinal axis (i.e., axis of central lumen shown housing pushrod 42, needles 6, and other sub-components therein, as shown in Figs. 2, 4A, 6 and 15); a base portion (i.e., the catch mechanism region 16) disposed towards the proximal end of the elongate member, the base portion comprising a first groove (i.e., slot 186 (see Fig. 19) disposed at the left catch 78a of Fig. 6) and a second groove (i.e., slot 186 (see Fig. 19) disposed at the right catch 78b of Fig. 6) separated by an opening (i.e., central lumen/opening shown housing pushrod 42, needles 6, and other sub-components therein, as shown in Figs. 2, 4A, 6 and 15); two wings (i.e., two movable needle guide assemblies 58a/58b/84a/84b/88a/88b, Figs. 2-6 and 10-15) disposed opposite each other across the longitudinal axis and on opposite sides of the opening (i.e., central lumen/opening of the device), the first groove (i.e., slot 186 (see Fig. 19) disposed at the left catch 78a of Fig. 6), and the second groove (i.e., slot 186 (see Fig. 19) disposed at the right catch 78b of Fig. 6) (as shown in Figs. 4B and 10; the wings (see 58a/58b) are expressly shown on opposing left and right sides of the longitudinal axis, opening and two grooves), wherein, the two wings (at 58a/58b) are configured to (i.e., capable of) move in relation to the longitudinal axis and the opening (as expressly shown in Figs. 2-6 and 10; two wings expressly shown moving laterally in relation to the claimed structures);
(claim 2) wherein each wing (at 58a/58b) of the two wings comprises a first portion angularly orientated in relation to a second portion, the second portion extending to and forming the peripheral end (as expressly shown in annotated Fig. 4A below);
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(claim 3) wherein each of the two wings (at 58a/58b) including an elongate slot (94a/94b, Figs. 4A-4B), the elongate slot (94a/94b) of each wing (58a/58b) extends over at least a portion of each of the first portion and the second portion (as shown in annotated Fig. 4A directly above, the curved slot expressly shown extending through both the first and second portions);
(claim 4) wherein each of the two wings include a textured surface (i.e., ridges 190, as shown in Fig. 19);
(claim 5) wherein each of the two wings includes ridges (i.e., ridges 190, as shown in Fig. 19);
(claim 6) wherein the second groove (i.e., slot 186 (see Fig. 19) disposed at the right catch 78b of Fig. 6) and the first groove (i.e., slot 186 (see Fig. 19) disposed at the left catch 78a of Fig. 6) are parallel (as best shown in Figs. 6 and 19, diametrically opposed catches 78a/78b are expressly shown having parallel slots 186 on opposing sides of device shaft 32);
(claim 7) an elongate member (i.e., distal deployment housing 12, Figs. 1A) extending from a proximal end (i.e., adjacent bosses 62b in Fig. 7 (i.e., at the top edge of the lateral needle windows)) toward a distal end (i.e., at distal end defining recess 96 in Fig. 6), the elongate member (12) having a lumen with a longitudinal axis (i.e., axis of central lumen shown housing pushrod 42, needles 6, and other sub-components therein, as shown in Figs. 2, 4A, 6 and 15); a first proximal assembly (i.e., push rod 42, link pins 66/68a, and drive link 64a, as shown in Fig. 6) towards the proximal end of the elongate member (12) (as shown in Fig. 6); a second proximal assembly (16, Fig. 1B) cooperating with the first proximal assembly (as shown in Figs. 1A-1G and 11-15), the second proximal assembly comprising a base portion (i.e., the catch mechanism region 16) comprising a first groove (i.e., slot 186 (see Fig. 19) disposed at the left catch 78a of Fig. 6) having a first gap (i.e., opening/zoid space shown between leaves 188a/188b, as shown in Figs. 6 and 19), a second groove (i.e., slot 186 (see Fig. 19) disposed at the right catch 78b of Fig. 6) having a second gap (i.e., opening/zoid space shown between leaves 188a/188b, as shown in Figs. 6 and 19), and an opening (i.e., central lumen/opening shown housing pushrod 42, needles 6, and other sub-components therein, as shown in Figs. 2, 4A, 6 and 15), the base portion (16) being configured to (i.e., capable of) cooperate with a portion of the first proximal assembly (i.e., push rod 42, link pins 66/68a, and drive link 64a, as shown in Fig. 6) (as shown in Figs. 1A-1G and 11-15); and two wings (i.e., two movable needle guide assemblies 58a/58b/84a/84b/88a/88b, Figs. 2-6 and 10-15) being on opposite sides of the base portion (16) (as shown in at least Figs. 4B and 10-12), the two wings being configured to (i.e., capable of) move in relation to the longitudinal axis of the elongate member (12) (as expressly shown in Figs. 2-6 and 9-15) to change the first gap of the first groove (186, Fig. 19) and the second gap of the second groove (186, Fig. 19) on opposite sides of the opening (as shown in Fig. 6, advancement of each needle/wing further widens the gap formed by the slot 186 between the leaf springs 188a/188b), the two wings being disposed opposite each other across the longitudinal axis and on opposite sides of the opening (i.e., central lumen/opening of the device), the first groove (i.e., slot 186 (see Fig. 19) disposed at the left catch 78a of Fig. 6), and the second groove (i.e., slot 186 (see Fig. 19) disposed at the right catch 78b of Fig. 6) (as shown in Figs. 4B and 10; the wings (see 58a/58b) are expressly shown on opposing left and right sides of the longitudinal axis, opening and two grooves);
(claim 8) wherein each wing has an elongate slot (94a/94b, Figs. 4A-4B) having a closed first end at a location between the base portion and a peripheral end of the wing (as shown in annotated Fig. 4A below);
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(claim 9) wherein each of the two wings include a textured surface (i.e., ridges 190, as shown in Fig. 19);
(claim 11) providing a first medical device portion (i.e., proximal actuation end comprising pushrod 42, driver shaft 44, button 46, needle guides 58, needle carriers 84a, and needles 88/166, as shown in Figs. 2 and 6) comprising an elongate member (i.e., needle 166, Fig. 19); manipulating a second medical device portion (i.e., housing 32, catch mechanism 16 having catch 174) to change a frictional engagement between the second medical device portion (i.e., at catch 174, Fig. 19) and the first medical device portion (i.e., at needle 166, Fig. 19), the second medical device portion (32/16/174) comprising a base portion (i.e., outer frame portion of catch 174) with a groove (186, Fig. 19) having a gap (i.e., changeable gap size of slot 186, as shown in Fig. 19); and two wings (188a/188b, Fig 19) extending from the base portion (174) (as expressly shown in Fig. 19; wing 188a extends downward and radially inward from the outer frame of catch 174, and wing 188b extends upward and radially inward from the outer frame of catch 174), the two wings (188a/188b) being opposite each other on opposite sides of the base portion (as expressly shown in Fig. 19, wing 188a at top of base 174 and wing 188b at the opposing bottom of base 174), the two wings (188a/188b) being configured to (i.e., capable of) move in relation to a longitudinal axis to change the gap of the groove (186) (as expressly shown in Fig. 19; col. 14, lines 12-21; spring leaves 188a/188b are expressly flexible and bend radially inward relative to the longitudinal axis and increase the gap size as needle 166 is captured therein);
(claim 12) further comprising receiving the elongate member (166) within the second medical device portion (at 174) (as expressly shown in Fig. 19) and wherein manipulating the second medical device portion comprises changing a frictional engagement between the elongate member (166) and the second medical device portion (174) (as expressly shown in Fig. 19; col. 14, lines 12-21; frictional engagement/gripping force increases as leaves 188 further bend and also further engage ridges 190);
(claim 14) wherein each wing of the two wings (188a/188b) comprises a first portion angularly orientated in relation to a second portion, the second portion extending to and forming a peripheral end (as shown in annotated Fig. 19 below);
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(claim 15) wherein an elongate slot of each wing extends over at least a portion of each of the first portion and the second portion (as shown in annotated Fig. 19 above);
(claim 16) wherein each of the two wings (188a/188b) include a textured surface (col. 14, lines 12-21; the peripheral end of each wing 188a/188b has at least two shoulders/ridges to expressly engage with the ridges 190 on needle 166);
(claim 17) wherein each of the two wings (188a/188b) include ridges (col. 14, lines 12-21; the peripheral end of each wing 188a/188b has at least two shoulders/ridges to expressly engage with the ridges 190 on needle 166);
(claim 18) wherein the groove (186, Fig. 19) is a first groove (as shown in Fig. 6, two opposed grooves for capturing needles at 78a/78b) and the base portion (174) further comprises a second groove (i.e., as shown in annotated Fig. 19 above, annotated side slots are shown on each side of each respective leaves 188a/188b and are formed as grooves) disposed from the first groove (186) (as shown in Fig. 19, leaf springs 188a/188b each flex within an opening wherein the opening separates the first groove 186 from a second groove (e.g., side groove of each leaf springs 188a/188b));
(claim 19) wherein the two wings (188a/188b) are integral with the base portion (174) (as expressly shown in Fig. 19); and
(claim 20) wherein the second medical device portion comprises a stem (i.e., distal end tip of outer housing 32), the stem comprises a slot (96, Fig. 6).
Claim Rejections - 35 USC § 103
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gordon, as set forth above.
Gordon discloses the claimed invention except for the base portion is formed of a polymer (col. 14, lines 12-21; Gordon expressly discloses the base portion 174 being composed of flexible material such as spring steel). It would have been obvious to one having ordinary skill in the art at the time the invention was made to compose the base portion from another well-known flexible material such as a polymer, 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. In re Leshin, 125 USPQ 416.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,844,515. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,844,515
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Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that claim 10 remains subject to a double patenting rejection that must be resolved before claim 10 can be rewritten in independent form for allowance.
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771