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 .
This action is in response to the Applicant’s amendment filed on February 16, 2026.
Claims 1 and 6 are amended.
Claim 5 is cancelled.
Claims 1-4 and 6-20 are being examined within this office action.
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 8 and 9 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation about 1.15-1.75 mg/mL, and the claim also recites 1.15-1.75 mg/mL which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Similarly, claim 9 recites the broad recitation about 1.25-1.50 mg/mL, and the claim also recites 1.25-1.50 mg/mL which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 3, 4, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Demaria et al. (Pub. No. US 20190054233 A1, herein Demaria).
Regarding Claim 1, Demaria discloses an insulin delivery system (Fig. 1) comprising:
a reservoir configured to hold an insulin medication therein (112, Paragraph [0003]);
an infusion hub (130);
tubing fluidically connecting the insulin reservoir and the infusion hub (122);
a cannula configured to deliver the insulin medication to a patient (134); and
an absorbent element (240, Paragraph [0035]) positioned within the delivery system and in fluidic contact with the insulin medication (Fig. 2), the absorbent element configured to absorb and store a preservative from the insulin medication (Paragraph [0035]), wherein the absorbent element is further configured to selectively release the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication (Demaria discloses “a sorbent material configured to collect phenolic excipients … from the insulin formulation by sorption” and that “The sorbent material may be positioned along a fluid pathway specifically designed to increase and/or extend exposure between the insulin formulation and the sorbent material” – Paragraph [0007], examiner interprets that since the sorbent material is designed to increase and/or extend exposure between the insulin formulation and the sorbent material, after absorbing a concentration of m-cresol, for example, 80% as referenced in Paragraph [0036], the sorbent material would be able to continuously release preservatives back into the insulin medication to perform the same function).
Regarding Claim 3, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element comprises EVOH and nylon (Paragraph [0040]).
Regarding Claim 4, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element comprises a preservative capacity greater than a maximum concentration of preservative in the insulin medication (“sorbent material 240 may be capable of collecting over 5%, 10%, 15%, 20%, 25%, or 30% of the m-cresol initially present in the insulation formulation. In certain embodiments, sorbent material 240 may be capable of collecting over 60%, 65%, 70%, 75%, or 80% of the m-cresol after the 1-hour exposure time. The sorption may also increase as the surface area and/or volume of sorbent material 240 increases”).
For examination purposes, examiner interprets the maximum concentration of preservatives of the insulin medication to be less than 80%.
Regarding Claim 6, Demaria discloses the insulin delivery system of claim 1, wherein the absorbent element is configured to maintain a preservative concentration at the point of delivery to the patient (Paragraph [0043]) at a concentration that minimizes local toxicity (sorption is impacted by both surface area and volume, Paragraph [0064], in the first example the sorbent material is shown to collect roughly 0.63 mg/mL (19%) of m-cresol leaving about 2.67 mg/mL of m-cresol within the insulin formulation prior to delivery, Paragraph [0064], this is greater than 1.25 mg/mL as referenced in applicant’s specification) while maintaining insulin in a stable hexameric state (“This arrangement may preserve the integrity and stability of the insulin formulation and minimize risk of insulin precipitation and fluid path occlusion” – Paragraph [0043]).
Regarding Claim 7, Demaria discloses the insulin delivery system of claim 6, wherein the absorbent element is configured to maintain the preservative concentration at a concentration of greater than about 1.25 mg/mL (sorption is impacted by both surface area and volume, Paragraph [0064], in the first example the sorbent material is shown to collect roughly 0.63mg/mL (19%) of m-cresol leaving about 2.67 mg/mL of m-cresol within the insulin formulation prior to delivery, Paragraph [0064]).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demaria.
Regarding Claim 8, Demaria discloses insulin delivery system of claim 6.
Demaria does not expressly disclose wherein the absorbent element is configured to maintain the preservative concentration at a concentration of about 1.15-1.75 mg/mL. However, Paragraph [0065] shows examples that teach preservation concentrations in absorbent materials and Paragraph [0066] teaches that absorption results are impacted by both surface area and volume of the absorbent element.
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to find the specific surface area and volume wherein the absorbent element is configured to maintain the preservative concentration at a concentration of about 1.15-1.75 mg/mL, 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 within the art. In re Aller, 105 USPQ 233.
Regarding Claim 9, Demaria discloses the insulin delivery system of claim 6.
Demaria does not expressly disclose wherein the absorbent element is configured to maintain the preservative concentration at a concentration of about 1.25-1.50 mg/mL. However, Paragraph [0065] shows examples that teach preservation concentrations in absorbent materials and Paragraph [0066] teaches that absorption results are impacted by both surface area and volume of the absorbent element.
Therefore, it would have been obvious to one of ordinary skill within the art at the time of the invention to find the specific surface area and volume wherein the absorbent element is configured to maintain the preservative concentration at a concentration of about 1.25-1.50 mg/mL, 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 within the art. In re Aller, 105 USPQ 233.
Claims 2, 10-14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demaria in view of Yodfat et al. (Pub. No. US 20100174239 A1, herein Yodfat).
Regarding Claim 2, Demaria discloses the insulin delivery system of claim 1.
Demaria does not expressly disclose further comprising an impermeable backing layer adjacent to the absorbent element and configured to maintain the preservatives within the absorbent element.
Yodfat teaches an impermeable backing layer (31) adjacent to the absorbent element (Fig. 4) and configured to maintain the preservatives within the absorbent element (Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the absorbent element disclosed by Demaria to have an impermeable backing layer adjacent to the absorbent element and configured to maintain the preservatives within the absorbent element as taught by Yodfat in order to ensure the preservatives are maintained within the system (Yodfat, Paragraph [0046]).
Regarding Claim 10, Demaria discloses the insulin delivery system of claim 1.
Demaria does not expressly disclose wherein the absorbent element comprises an interior layer of the tubing.
Yodfat teaches that an absorbent element comprises an interior layer of tubing (Fig. 4, “an inner layer of polyolefin, such as for example polyethylene, polypropylene, or the like” – Paragraph [0033]). Polyolefin being an example of a low-density polymer used as the absorbent element.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria so that the absorbent element comprises an interior layer of the tubing as taught by Yodfat, so that the absorbent element is protected by a barrier layer (Yodfat, Paragraph [0047]).
Regarding Claim 11, Demaria discloses the insulin delivery system of claim 1.
Demaria does not expressly disclose wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservatives from the insulin medication.
Yodfat teaches wherein at least a portion of the insulin delivery system includes a barrier layer (“an outer layer of PVC” – Paragraph [0033]) configured to prevent migration of preservatives from the insulin medication (Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria to include wherein at least a portion of the insulin delivery system includes a barrier layer configured to prevent migration of preservatives from the insulin medication as taught by Yodfat so that the insulin delivery system is better able to prevent migration of preservatives (Yodfat, Paragraph [[0046]).
Regarding Claim 12, Demaria discloses the insulin delivery system as recited above.
Demaria does not expressly disclose wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of a layer of the multi-layer tubing.
Yodfat teaches wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of a layer of the multi-layer tubing (Fig. 4, Paragraph [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria wherein the tubing is a multi-layer tubing, and wherein the barrier layer is at least a portion of a layer of the multi-layer tubing as taught by Yodfat, the motivation being to coat the tubing with PVC (Yodfat, Paragraph [0033]) which can act as the barrier material in the multi-layered tubing.
Regarding Claim 13, Demaria discloses the insulin delivery system as recited above.
Demaria does not expressly disclose wherein the tubing is a multi-layered tubing, and wherein the barrier layer forms an entire layer of the multi-layer tubing.
Yodfat teaches wherein the tubing is a multi-layered tubing, and wherein the barrier layer forms an entire layer of the multi-layer tubing (Fig. 4, Paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria wherein the tubing is a multi-layered tubing, and wherein the barrier layer forms an entire layer of the multi-layer tubing as taught by Yodfat, the motivation being to coat the tubing with PVC (Yodfat, Paragraph [0033]) which can act as the barrier material in the multi-layered tubing.
Regarding Claim 14, Demaria discloses the insulin delivery system as recited above.
Demaria does not expressly disclose wherein the tubing comprises the barrier layer.
Yodfat teaches wherein the tubing comprises the barrier layer (Paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria wherein the tubing comprises the barrier layer as taught by Yodfat so that the tubing prevents the migration of preservatives from the insulin medication (Yodfat, Paragraph [0046]).
Regarding Claim 17, Demaria discloses the insulin delivery system as recited above.
Demaria does not expressly disclose wherein the barrier layer comprises polyether block-amide, HDPE, polypropylene, PTFE, chloro- and fluorosilicones, hydrochloro-, hydrofluoro-, and perfluoro- polymers, chlorinated polymers (e.g. viton), metal-coated polymers (e.g., mylar), poly carbonate, organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides), vapor-deposited coatings (such as nitrides, titanium nitride, fluorocarbons, metals), Kapton, or parylene.
Yodfat teaches wherein the barrier layer comprises organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, Halogenated siloxanes, silicon suboxides) (Paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by Demaria wherein the barrier layer comprises organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, Halogenated siloxanes, silicon suboxides) as taught by Yodfat so that the barrier layer is better able to prevent migration of preservatives from the insulin medication (Yodfat, Paragraph [0046]).
Claim(s) 15, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demaria in view of Yodfat, further in view of Dillon et al. (Pub. No. US 2017/0224877 A1, herein Dillon).
Regarding Claim 15, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer comprises a coating on the tubing.
Dillon teaches wherein the barrier layer (“vapor deposition”- Paragraph [0014], “polyether block amide” – Paragraph [0013]) comprises a coating on the tubing (Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by modified Demaria in view of Yodfat wherein the barrier layer comprises a coating on the tubing as taught by Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 16, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer comprises an inner layer of the tubing.
Dillon teaches wherein the barrier layer comprises an inner layer of the tubing (Paragraph [0014]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by modified Demaria in view of Yodfat wherein the barrier layer comprises an inner layer of the tubing as taught by Dillon so that so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 18, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11, further comprising a barrel (Demaria, 251) connected to the cannula (Fig. 2).
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer is positioned on at least a portion of the barrel.
Dillon teaches a coating (104) of a barrier layer that is able to be positioned on at least a portion of the barrel (Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by modified Demaria in view of Yodfat wherein the barrier layer is positioned on at least a portion of the barrel as taught by Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 19, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11, comprising a connector (Demaria, 224, Fig. 2).
Modified Demaria in view of Yodfat does not expressly disclose a connector comprising the barrier layer.
Dillon teaches a coating (104) that can be applied to the connector comprising the barrier layer (Paragraph [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by modified Demaria in view of Yodfat comprising a connector comprising the barrier layer as taught by Dillon so that drug delivery effectiveness can be improved (Dillon, Paragraph [0009]).
Regarding Claim 20, modified Demaria in view of Yodfat discloses the insulin delivery system of claim 11.
Modified Demaria in view of Yodfat does not expressly disclose wherein the barrier layer extends through an entire fluid path of the system.
Dillon teaches wherein the barrier layer extends through an entire fluid path of the system (“the cannula 102 is at least partially coated on its exterior surface 102a with a coating 104 that comprises an anti-inflammatory agent. The cannula 102 is in fluid connection to the chamber, and the distal end of the cannula 102 extends into the patient” - Paragraph [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the insulin delivery system disclosed by modified Demaria in view of Yodfat wherein the barrier layer extends through an entire fluid path of the system as taught by Dillon to extend the wear time of the system (Dillon, Paragraph [0009]).
Response to Arguments
Applicant’s arguments filed February 16, 2026 have been fully considered.
In regards to Applicant’s argument that
“Claims 6 stands rejected because the Office Action found the limitation "the preservative concentration" to lack antecedent basis and the limitation "wherein the absorbent element is configured to maintain the preservative concentration at the point of delivery to the patient at a concentration that minimizes local toxicity while maintaining insulin in a stable hexameric state" to be unclear as to what concentration minimizes local toxicity while still maintaining insulin in its stable hexameric state. With regard to the former issue, the claim has been amended to recite "a" preservative concentration. As to the latter, at least paragraph [0119] of the application gives express numerical examples of such concentrations. Given that definiteness is determined from the perspective of whether one skilled in the art would understand what is claimed when the claim is read in light of the specification, when the limitation is viewed in light of this disclosure in the specification giving these specific examples one skilled in the art would understand what is claimed. (MPEP 2173.02 (A decision on whether a claim is definite ... requires a determination of whether those skilled in the art would understand what is claimed when the claims is read in light of the specification."))”
This argument is persuasive and the 112(b) rejection of claim 6 has been withdrawn.
In regards to Applicant’s argument that
“The Office Action states with regard to claims 8 and 9 that "[a] broad range or limitation together with a narrow range or limitations that falls within the broad range or limitation (in the same claim) may be considered indefinite." (Office Action, p. 3.) The Office Action goes on to state that "claim 8 recites the broad recitation about 1.15 - 1.75 mg/mL, and the claim also recites 1.15 - 1.175 mg/mL which is the narrower statement of the range/limitation" and provides a similar argument with regard to "about 1.15-1.5 mg/mL" in claim 9. However, these claims each recite only a single range, namely "about 1.15 - 1.75 mg/mL" in claim 8 and "about 1.25 - 1.5 mg/mL" in claim 9. There is no second recitation of any other range that could be considered an additional, narrower range.”
This argument is not persuasive for the following reasons:
Claim 8, recites the broad range about 1.15-1.75 mg/mL and 1.15-1.75 mg/mL which is the narrower statement of the range/limitation. “About” imparts a slight range for the numerical value 1.15, for example, about 1.15-1.75 mg/mL can be interpreted to mean 1.14-1.75 mg/mL, 1.16-1.75 mg/mL, 1.19-1.75 mg/mL, etc. rendering the claim indefinite. Additionally, it appears a typographical error was made regarding claim 8 within the last paragraph of the page 5 of the arguments “about 1.15-1.175 mg/mL” is believed to say “about 1.15-1.75 mg/mL” as is stated in the rejection.
Claim 9 similarly, recites the broad range about 1.25-1.5 mg/mL and 1.25-1.5 mg/mL which is the narrower statement of the range/limitation. The rejection recited above is maintained.
With regards to Applicant’s argument that
“This paragraph describes use of a sorbent material to collect preservatives from the insulin formulation, but says nothing whatsoever about releasing preservatives back into the insulin as described above and now claimed in amended independent claim 1. The portion of the passage quoted in the Office Action of "designed to increase and/or extend exposure," quoted in full actually reads "[t]he sorbent material may be positioned along a fluid pathway specifically designed to increase and/or extend exposure between the insulin formulation and the sorbent material." The quoted language therefore describes prolonging exposure between the insulin and the sorbent material to increase the amount of preservatives absorbed, and has no relation to releasing preservatives back into the insulin as claimed. “
This argument is not persuasive for the following reasons:
Claim 1 does not require the absorbent material to release preservatives back into the insulin. The claim merely recites that the absorbent element is configured to selectively release the preservative into the insulin medication to maintain a concentration of the preservative in the insulin medication.
Examiner interprets that since the sorbent material in Demaria is designed to increase and/or extend exposure between the insulin formulation and the sorbent material, after absorbing a concentration of m-cresol, for example, 80% as referenced in Paragraph [0036], the sorbent material would be able to continuously release preservatives back into the insulin medication to perform the same function.
The claim language recites that the function of the absorbent element is to maintain a concentration of preservative in the insulin, similar to what the sorbent material of Demaria is doing, therefore being equivalent.
Examiner notes that claim 5 filed 05/23/2023 “The insulin delivery system of claim 1, wherein the absorbent element is further configured to release preservatives to the insulin medication after storing the preservatives.” In regards to Applicant’s argument filed 02/16/2026 appears to overcome the prior art of record, further search and consideration is required.
The rejection of the dependent claims is maintained as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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 Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri. off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783