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 of Species A and Species X in the reply filed on 12/19/2025 is acknowledged. The election of Species A was made without traverse but the election of Species X was silent as to whether it was made with or without traverse. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement between Species X and Y, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 11 and 16-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (with claim 11 being directed to Species Y and claims 16-19 being directed to Species B), there being no allowable generic or linking claim.
Claim Objections
Claim 8 is objected to because of the following informalities: The phrase “proximal- and distal-end portions” on line 3 should be amended to recite “proximal-end and distal-end portions” in order to be more clear. 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 1-10, 12-15, and 20-28 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.
Claim 1 recites “a RICC including a catheter tube and a primary lumen therethrough” on line 3. It is unclear as to whether the term “therethrough” refers to the “catheter tube” or the “RICC”. For the sake of examination, the term “therethrough” is interpreted as referring to the “catheter tube”; accordingly, it is suggested to amend line 3 to recite “a RICC including a catheter tube and a primary lumen extending through the primary lumen”.
Claims 2-10, 12-15 and 20-28 are rejected due to their dependence on claim 1.
Claim 14 introduces to “a sheath opening” on line 3. It is unclear if this is intended to refer to an opening of the sheath or an opening through which the sheath extends. Based on the disclosure, the “sheath opening” is interpreted as being an opening of the sheath”; accordingly, it is suggested to amend line 3 to recite “an opening of the sheath”.
Claim 15 is rejected due to its dependence on claim 14.
Claim 25 recites “the secondary channel configured to guide the access guidewire split away from the splittable casing into the coupler and the needle sheath through the needle slot” on lines 4-5. The phrase “the guidewire split” lacks proper antecedent basis and it is unclear as to as to what this limitation is attempting to claim. Based on the disclosure – specifically Para 126 – it is believed that this limitation is intended to require the secondary channel to guide the access guidewire away from the splittable casing and into the coupler and the needle sheath through the needle slot as the splittable casing is split; accordingly, it is suggested to amend lines 4-5 to recite “the secondary channel configured to guide the access guidewire and into the coupler and the needle sheath through the needle slot as the splittable casing splits”.
Claim 26 is rejected due to its dependence on claim 25.
Claim 27 recites “wherein the RICC includes a set of three lumen including the primary lumen, a secondary lumen, and a tertiary lumen formed of fluidly connected portions of three catheter-tube lumens, three catheter-hub lumens, and three extension-leg lumens” on lines 1-4. This language renders it unclear as to whether the three “catheter-tube lumens” are lumens of the “catheter tube” introduced in claim 1 or are lumens found in other catheter tube(s) (and, if so, if all the lumens are in a single catheter or if each lumen resides in its own catheter), whether the three “catheter-hub lumens” are lumens in one catheter hub or are lumens found in three catheter hubs, and whether the three “extension-leg lumens” are lumens in one extension leg or are lumens found in three different extension legs. Based on the disclosure, it is believed that claim is intended to require a first lumen extending through the catheter tube of claim 1, a catheter hub connected to the catheter tube of claim 1, and a first extension leg connected to the catheter tube of claim 1, a second lumen extending through the catheter tube of claim 1, the same catheter hub as the first lumen, and a second extension leg connected to the catheter tube of claim 1, and a third lumen extending through the catheter tube of claim 1, the same catheter hub as the first and second lumen, and a third extension leg connected to the catheter tube of claim 1. Accordingly, it is suggested to amend claim 21 to recite “wherein the RICC includes a set of three lumen including the primary lumen, a secondary lumen, and a tertiary lumen wherein the primary lumen extends through a first extension leg, a catheter hub and the catheter tube, wherein the secondary lumen extends through a second extension leg, the catheter hub and the catheter tube, and wherein the tertiary lumen extends through a third extension leg, the catheter hub and the catheter tube” in order to clarify the scope of the claim.
Claim 28 is rejected due to its dependence on claim 27.
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 and 2are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Murphy (PG PUB 2022/0203075)1.
Re claim 1, Murphy discloses a rapidly insertable central catheter ("RICC") insertion assembly 110 (Fig 5; it is noted that all reference characters cited below refer to Fig 5 unless otherwise noted), comprising: a RICC 100 (best seen in Fig 6J) including a catheter tube (labeled in Fig B below) and a primary lumen (through which dilator 102 and guidewire 24 extends in Fig 6A) therethrough (as seen in Fig 6A); an introducer needle (132 + 150 + the proximal portion of the “sealing-module insert” labeled in annotated Fig A below) including: a needle shaft 132 including a longitudinal needle slot (the lumen extending therethrough, through which the guidewire extends in Fig 6F); a needle hub 150 around a proximal-end portion of the needle shaft (as seen in Fig 6F); and a proximal portion of a sealing-module insert (labeled in annotated Fig A below) coupled to a distal portion of the needle hub (as seen in Fig 6F and Fig A below, all components of the introducer needle are coupled to each other either directly or indirectly); an access guidewire 24 including a proximal portion (to the right in Fig 5) disposed in the primary lumen of the RICC (Para 69) and a distal portion (to the left in Fig 5) disposed in the needle shaft through the needle slot (as seen in Fig 6F); and a coupler (labeled in Fig A below) coupling the RICC and the introducer needle together (as seen in Fig 6F, the coupler couples the RICC and the introducer needle together via the guidewire), the coupler including a coupler housing (the structure forming the coupler itself) including a sealing-module cavity (the opening that extends from the distal-most end of hub 150 through the proximal-most end of the coupler, as labeled in Fig A below); and a distal portion of the sealing-module insert disposed in the sealing-module cavity, the sealing-module cavity and the proximal and distal portions of the sealing-module insert forming a splittable sealing module of the RICC insertion assembly (as seen in Fig 6H) configured to separately seal around a proximal portion of the introducer needle and the distal portion of the access guidewire when the proximal and distal portions of the sealing-module insert are compressed in the sealing-module cavity (the language of due to the use of the term “separately”, the claim requires the cavity to seal around one of “a proximal portion of the introducer needle” and “the distal portion of the access guidewire” and the sealing-module insert to seal around the other of the “proximal portion of the introducer needle” and “the distal portion of the access guidewire”; as seen in Fig 6F, the cavity seals around the proximal portion of the introducer needle and the sealing-module insert seals around the distal portion of the access guidewire).
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Re claim 2, Murphy discloses that each portion of the proximal and distal portions of the sealing-module insert is formed of an elastomer (Para 46, “rubber”).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Okamura et al. (PG PUB 2013/0046241).
Re claim 10, Murphy discloses all the claimed features but is silent as to the sealing-module insert being radially compressed in the sealing-module cavity by the coupler housing. Okamura, however, teaches using a coupler housing 90 (Fig 6) to radially compress a sealing-module insert 40 (Fig 6) within a sealing-module cavity (Para 69) for the purpose of ensuring the sealing-module insert stays closed when no instrument is inserted therethrough (Para 69). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the sealing-module insert such that it is radially compressed in the sealing-module cavity by the coupler housing, as taught by Okamura, for the purpose of ensuring the sealing-module insert stays closed when the guidewire is not inserted therethrough (Para 69).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Kurth et al. (PG PUB 2009/0187147).
Re claims 13 and 20, Murphy discloses that the needle slot extends from the a proximal portion of the needle shaft through a distal needle tip (as seen in Fig 6F, the lumen/slot extends the entire length of the needle shaft), but is silent as to the introducer needle further including a sheath over the needle shaft sealing the needle slot thereunder (as required by claim 13) and wherein the sheath is formed of a polymeric material selected from polyethylene, polypropylene, polyurethane, and polytetrafluoroethylene (as required by claim 20). Kurth, however, teaches a needle shaft 16 (Fig 4,5) comprising a needle slot 20 (Fig 4) that extends through the needle shaft’s wall (as seen in Fig 4) and extends from a proximal portion of the needle shaft through a distal needle tip (Para 53) and a sheath 22 (Fig 4) over the needle shaft that seals the needle slot thereunder (Para 53, “the slot 20 is filled and/or coated so that it does not leak”) and is formed of polytetrafluoroethylene (Para 53) for the purpose of removing the needle shaft from the guidewire while the guidewire is still in use (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the needle shaft with a slot through its wall that is sealed by a polytetrafluoroethylene sheath, as taught by Kurth, for the purpose of removing the needle shaft from the guidewire while the guidewire is still in use (Para 50).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Heh et al. (PG PUB 2003/0036712).
Re claim 21, Murphy discloses that a distal portion of the guidewire is disposed in the needle shaft but does not disclose that the coupler further includes an access guidewire-connecting side arm including a connector configured to connect to an access-guidewire hub and a proximal-end portion of the access guidewire, the access-guidewire hub connected to the connector of the access guidewire-connecting side arm enforcing a loop in the access guidewire over which loop the RICC is disposed in at least a ready-to-operate state of the RICC insertion assembly. Heh, however, teaches a coupler 30 (Fig 1) comprising a housing 31 (Fig 1) through which a guidewire 100 (Fig 1) is received (as seen in Fig 2) and an guidewire-connecting side arm 32 (Fig 1) including a connector 35 (Fig 1) configured to connect to a hub of the guidewire and a proximal-end portion of the guidewire (as seen in Fig 2, wherein all components of the connector and the guidewire are either directly or indirectly connected), the guidewire hub connected to the connector enforcing a loop in the guidewire over which loop a catheter can be disposed in at least a ready-to-operate state of the guidewire and the catheter (as seen in Fig 2) for the purpose of providing an ergonomic design to provide the clinician with a proper feel of the assembly (Para 33). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the coupler with an access guidewire-connecting side arm that includes a connector configured to connect an access-guidewire hub and a proximal-end portion of the access guidewire, the access-guidewire hub connected to the connector enforcing a loop over which the RICC is disposed in at least a ready-to-operate state, as taught by Heh, for the purpose of providing an ergonomic design to provide the clinician with a proper feel of the assembly (Para 33).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Matsuno et al. (PG PUB 2014/0171833).
Re claim 22, Murphy discloses all the claimed features except a keeper including a splittable casing over both the catheter tube of the RICC and an extracatheteral portion of the access guidewire extending from a distal end of the RICC, the splittable casing configured to keep the catheter tube and the extracatheteral portion of the access guidewire sterile until deployed. Matsuno, however, teaches providing an entire assembly 1 (Fig 11) comprising a catheter 13 (Fig 11) and a guidewire W (Fig 11) including an extracatheteral portion (as seen in Fig 11) in a ready to use position (Para 76) within a keeper 60 (Fig 11) that includes a splittable casing (“pack”, Para 72) that is configured to keep the entire assembly sterile until deployed (Para 76) for the purpose of providing a means to compactly store the assembly (Para 89). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include a keeper including a splittable casing that is configured to keep the entire assembly sterile until deployed, as taught by Matsuno, for the purpose of compactly storing the assembly (Para 89).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075)/Matsuno et al. (PG PUB 2014/0171833) in view of Terzibashian (PG PUB 2014/0110296).
Re claims 23 and 24, Murphy as modified by Matsuno in the rejection of claim 22 above discloses all the claimed features except that the keeper includes a catheter-hub holder to which a proximal end of the splittable casing is attached, the catheter-hub holder configured to hold a catheter hub of the RICC therein and keep the splittable casing in position over both the catheter tube and the extracatheteral portion of the access guidewire (as required by claim 23) and wherein the catheter-hub holder includes a perimetrical wall around at least a portion of a perimeter of the catheter-hub holder, the perimetrical wall defining a recess into which the catheter hub fits with an engineering fit (as required by claim 24). Terzibashian, however, teaches a keeper 20 (Fig 4) comprising a splittable casing 50+80 (Fig 4; Para 48, “removal of the lid 80”) and a catheter-hub holder 56+60+60 (Fig 4) to which a proximal end of the splittable casing is attached (it is noted that all components of the keeper are attached to each other either directly or indirectly), the catheter-hub holder configured to hold a catheter hub of a catheter therein (Para 44) and keep the splittable casing in position over an entire assembly (Para 44,45,51) and wherein the catheter-hub holder includes a perimetrical wall around at least a portion of a perimeter of the catheter-hub holder (as seen in Fig 4), the perimetrical wall defining a recess (as seen in Fig 4; Para 44, “pocket”) into which the catheter hub fits with an engineering fit (Para 44, “snap fit or press fit”) for the purpose of protecting the assembly while compactly storing the assembly (Para 22). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy/Matsuno to include the keeper with a catheter-hub holder including a perimetrical wall that defines a recess into which the catheter hub fits with an engineering fit, as taught by Terzibashian, for the purpose of protecting the assembly while compactly storing the assembly (Para 2).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Martin et al. (US Pat 5,195,962).
Re claims 27 and 28, Murphy discloses that the RICC includes a catheter hub (labeled in annotated Fig A above) and three extension legs (as seen in Fig 6J and Fig B above), each with a lumen therein (wherein the middle lumen receives dilator 102, Para 60, and the two outer lumen include ports that feed into the catheter, Para 69), wherein the middle lumen is the primary lumen and has a primary-lumen aperture in a distal end of the catheter tube (as seen in Fig 6A; Para 60) and the two outer lumen form secondary and tertiary lumen. Murphy is silent as to these three lumen extending through the catheter hub and through the catheter tube (as required by claim 27), wherein the secondary lumen has a secondary-lumen aperture in a side of the distal portion of catheter tube, and the tertiary lumen has a tertiary-lumen aperture in the side of the distal portion of the catheter tube proximal of the secondary-lumen aperture (as required by claim 28). Martin, however, teaches a RICC 20 (Fig 2) comprising three extension legs 32,34,35 (Fig 2), a catheter hub 30 (Fig 2) and a catheter tube 26 (Fig 2), wherein a primary lumen 54 (Fig 3-5) extends within a central leg 35 of the extension legs, the catheter hub and the catheter tube to a primary-lumen aperture 64 (Fig 3) in a distal end 28 (Fig 2,3) of the catheter tube (Col, 6, Lines 2-9 and 41-42), a secondary lumen 52 (Fig 3) extends within an outer leg 34 of the extension legs, the catheter hub and the catheter tube to a secondary-lumen aperture 45 (Fig 3) in a side of the distal portion of the catheter tube (as seen in Fig 3; Col 5, Lines 53-57), and a tertiary lumen 50 extends within the other outer leg 32 of the extension legs, the catheter hub and the catheter tube to a tertiary-lumen aperture 44 (Fig 3) in a side of the distal portion of the catheter tube proximal of the secondary-lumen aperture (as seen in Fig 3; Col 6, Lines 13-18) for the purpose of allowing the RICC to be used in procedures that require the removal and delivery of fluids without risk of cross flow (Col 5, Lines 57-52 and Col 6, Lines 28-31). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include each of the lumen within the extensions legs such that they extend through the catheter hub and the catheter tube so that the primary lumen extends to an aperture in the distal end of the catheter tube, the secondary lumen extends to an aperture in a side of the distal portion of the catheter tube, and the tertiary lumen extends to an aperture in a side of the distal portion of the catheter tube that is proximal to the aperture of the secondary lumen, as taught by Martin, for the purpose of allowing the RICC to be used in procedures that require the removal and delivery of fluids without risk of cross flow (Col 5, Lines 57-52 and Col 6, Lines 28-31).
Allowable Subject Matter
Claims 3-9, 12, 14, 15, 25 and 26 are objected to as being dependent upon a rejected base claim. Claims 3-9 and 12 would be allowable if (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims and (2) claim 1 were rewritten overcome the 112(b) rejection set forth above; claims 14 and 15 would be allowable if (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims and (2) claims 1 and 14 were rewritten to overcome the 112(b) rejections set forth above; and claims 25 and 26 would be allowable if (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims and (2) claims 1 and 25 were rewritten to overcome the 112(b) rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of each of dependent claims 3 (upon which claims 4-9 depend), 12, 14 (upon which claim 15 depends) and 25 (upon which claim 26 depends) could not be found nor was suggested in the prior art of record in combination with the subject matter of the claim(s) upon which each of claims 3, 12, 14 and 25 depend; that is, the combination of claims 1+3, the combination of claims 1+12, the combination of claims 1+13+14, and the combination of claims 1+22+25 could not be found nor was suggested in the prior art of record.
Dependent claim 3 requires the proximal and distal portions of the sealing-module insert to complete both an introducer-needle passageway and an access- guidewire passageway. As seen in Fig 6F, Murphy’s sealing-module insert completes an access guidewire passageway, but does not complete an introducer-needle passageway as the sealing-module insert resides completely proximal to the introducer-needle passageway. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the sealing-module insert such that it completes the introducer-needle passageway as doing so would affect the functionality of vacuum passageway 154 since the sealing-module insert would have to extend distally past the intersection point 160. It appears that such a modification would render the needle hub inoperable for its intended purpose. Additionally, the subject matter of dependent claim 3 in combination with the subject matter of claim 1 could not be found nor was suggested elsewhere in the prior art of record.
Dependent claim 12 requires the coupler housing to include a longitudinal coupler-housing slot configured to allow the access guidewire to escape from the coupler housing after the proximal portion of the sealing-module insert is removed from the sealing-module cavity with withdrawal of the introducer needle from the coupler. As seen in Fig A above, Murphy discloses that the coupler housing includes a longitudinal coupler-housing slot (the lumen extending longitudinally through the coupler housing) configured to allow the access guidewire to escape from the coupler housing (when the guidewire is retracted through the coupler housing); however, introducer needle is not disclosed as being able to be removed from the coupler and, therefore, the proximal portion of the sealing-module insert is not configured to be removed from the sealing-module cavity with withdrawal of the introducer needle from the coupler as claimed. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to allow the proximal-portion of the sealing module insert to be removed from the sealing-module cavity along with the introducer needle’s withdrawal from the coupler as doing so would require substantial redesign. Additionally, the subject matter of dependent claim 12 in combination with the subject matter of claim 1 could not be found nor was suggested elsewhere in the prior art of record.
Dependent claim 14 requires the coupler to include a blade extending into the splittable sealing module such that the blade is disposed in the needle slot under a distal end of an opening of the sheath, the blade including a distal-facing blade edge configured to cut the sheath away from the needle shaft as the introducer needle is withdrawn from the coupler, thereby allowing the access guidewire to escape from the needle shaft by way of the needle slot. Murphy and Kurth disclose that the sealing module, the needle and the sheath are splittable without the use of a blade. It would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy/Kurth to include a blade as doing so would be unnecessary and redundant while increasing the cost and manufacturing difficulty. Additionally, the introducer needle is not disclosed as being able to be withdrawn from the coupler and it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy/Kurth to sheath to be cut away from the needle shaft as the needle is withdrawn from the coupler as doing so would require substantial redesign. Additionally, the subject matter of dependent claim 14 in combination with the subject matter of claims 1 and 13 could not be found nor was suggested elsewhere in the prior art of record.
Dependent claim 25 requires the coupler to include a splittable casing-holding side arm including a primary channel configured to slidably hold the splittable casing therein and a secondary channel configured to guide the access guidewire away from the splittable casing and into the coupler and the needle shaft through the needle slot as the splittable casing splits. Murphy and Matsuno do not disclose that the coupler includes a side arm that holds the splittable casing in one channel and guides the guidewire away from the splittable casing through a secondary channel. Since Matsuno’s splittable casing is a pouch that fully encloses the entire assembly, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy/Matsuno to include such a side arm as doing so would require substantial redesign. Additionally, the subject matter of dependent claim 25 in combination with the subject matter of claims 1 and 22 could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Effective filing date of 12/15/2020.