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 1-6, 9 and 12-21 are pending. Claims 7-8 and 10-11 are canceled. Claims 1 and 3-6 are amended. Claims 12-21 are withdrawn as being drawn to a non-elected invention or species, there being no allowable generic or linking claim.
Claims 1- 6 and 9 are examined on their merits.
Previous Rejections
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 103
Upon further consideration the rejection of claims 1-10 under 35 U.S.C. 103 as being unpatentable over Cohen et al. US 2018/251799 (9/6/2016)(1/18/2023 IDS) in view of Salmons et al. WO 2015/000972 (1/8/2015), Eckenhoff et al. CA 1278968 (1/15/1991) and Dhital et al. Inhibition of alpha-amylase activity by cellulose: Kinetic analysis and nutritional implications. Carbohydrate Polymers, Volume 123, (6/5/2015), 305-312 (2015) as evidenced by the specification is withdrawn.
New Rejections/Rejections Maintained
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The response filed 1/22/2026 added amendments to claim 1 with limitations that introduce NEW MATTER into the claims. The limitation “wherein an enzymatic activity of the one or more cellulase enzymes is fully inhibited.” does not have clear support in the specification and claims as originally filed.
There is no disclosure of this phrase in the specification or originally filed claims. Specifically, nowhere in the specification is the phrase “fully inhibited” disclosed, let alone disclosure of a fully inhibited cellulase enzyme. There is no indication from the specification that a fully inhibited cellulase enzyme was ever contemplated by the Applicants.
The originally filed claims do not recite or disclose any limitation wherein the cellulase is fully inhibited. Paragraph [0135] discloses that in some embodiments there is provided a method for inhibiting an activity of cellulose hydrolyzing enzymes in a medium wherein the method comprise contacting the hydrolyzing enzymes with the disclosed capsules. There is only discussion of inhibiting an activity but no discussion of fully inhibited in paragraph [0135].
In paragraph [0131] the hydrolyzing enzyme, upon adsorbing to the cellulosic layer of the disclosed capsule is characterized by enzymatic activity of less than 80%, less than 70%, less than 60%, less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, of the enzyme activity in a comparable situation lacking the attachment of the enzyme to the capsule in the same hydrophilic medium. There is no disclosure of fully inhibited and it is not clear from the disclosure in paragraph [0131] which range of percentages would be considered to be fully inhibited.
In paragraph [0132] the hydrolyzing enzyme upon adsorbing to the cellulosic layer of the disclosed capsule is characterized by enzymatic activity of 1 to 80%, 5 to 80%, 10 to 80%, 20 to 80%, 30 to 80%, 1 to 70%, 5 to 70%, 20 to 70%, 30 to 70%, 1 to 50%, 5 to 50%, 10 to 50%, 20 to 50%, 30 to 50%, 1 to 40%, 5 to 40%, 10 to 40%, 20 to 40%, 1 to 20%, 5 to 20%, 10 to 20%, 1 to 15%, 5 to 15% or 10 to 15% of the enzyme activity in a comparable situation lacking the attachment of the enzyme to the capsule in the same hydrophilic medium. There is no disclosure of fully inhibited and it is not clear from the disclosure in paragraph [0132] which range of percentages would be considered to be fully inhibited.
Thus, one skilled in the art would not understand that applicant was not in possession of the currently claimed invention.
Obviousness is not the standard for the addition new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977).
Claim 1 recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in claim 1, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 1 in the specification or claims, as-filed, or remove these limitations in response to this Office Action.
Claims 2-6 and 9 are rejected as depending from a dependent claim.
Claim Rejections - 35 USC §112(b)
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 2, 5-6 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.
Claim 2 recites the limitation “said one or more hydrolyzing enzymes” in lines 2-3 and 3-4 and depends from claim 1. Claim 2 also recites the limitation “the same non-adsorbed hydrolyzing enzyme” in lines 4-5 and depends from claim 1.
There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 1 as amended, now recites “one or more cellulase enzymes” in lines 7-8 and 9. There is no recitation of one or more hydrolyzing enzymes in claim 1.
It is suggested that amending claim 2 to recite “said one or more cellulase enzymes” such as is recited in claim 1 would overcome this lack of antecedent basis.
Claims 5-6 are rejected as depending from claim 2.
Claim 9 recites the limitation “said one or more hydrolyzing enzymes” in lines 1-2 and depends from claim 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 1 as amended, now recites “one or more cellulase enzymes” in lines 7-8 and 9. There is no recitation of one or more hydrolyzing enzymes in claim 1.
It is suggested that amending claim 9 to recite “said one or more cellulase enzymes” such as is recited in claim 1 would overcome this lack of antecedent basis.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The obviousness type double patenting rejection of claims 1-6 and 9 as being unpatentable over claims 1-12 of U.S. Patent No. 9786406 in view of Cohen et al. US 2018/251799 (9/6/2016) and Eckenhoff et al. CA 1278968 (1/15/1991) and Dhital et al. Inhibition of alpha-amylase activity by cellulose: Kinetic analysis and nutritional implications. Carbohydrate Polymers, Volume 123, (6/5/2015), 305-312 (2015) as evidenced by the specification is maintained.
Specifically, although the claims at issue are not identical, they are not patentably distinct from each other because in the instant case the claims are drawn to a composition comprising at least one capsule with a 5 to 50 nm thick cellulose shell and hydrophobic alkene core, wherein a median diameter of the capsule is less than about 3000 nm, and the shell has an average porosity of 85 to 99%. The capsule has a α-amylase cellulose hydrolyzing enzyme, and the adsorbed enzymatic activity of the α-amylase is less than 20% that of a non-adsorbed enzyme.
Claims 1-12 of US Patent No. 9786406 are drawn to a composition comprising an interior hydrophobic space comprising alkene hydrocarbons that is encapsulated by at least one non-derivatized amorphous cellulose layer wherein the cellulose is surrounded by a hydrophilic or hydrophobic medium. The composition comprises a cellulose hydrolyzing enzyme and the capsule is 50 -500 nm in diameter. Claims 1-12 differ from those of the instant application in that they do not teach a weight ratio of the cellulose shell to the hydrolyzing enzyme, they do not teach glycoside hydrolase, they do not teach a weight ratio between the hydrophobic core and the cellulose layer and they do not teach the porosity of the cellulose shell. They also do not teach that the adsorbed enzymatic activity of the α-amylase is less than 20% that of a non-adsorbed enzyme. These deficiencies are made up for with the teachings of Cohen, Eckenhoff and Dhital.
Cohen et al. (Cohen) teaches a method for the combined preparation of saccharides, alcohols and biodiesel using a composition comprising an interior hydrophobic or hydrophilic medium encapsulated by a layer comprising cellulose, cellulose derivative material, and/or starch surrounded by a hydrophilic or hydrophobic medium, respectively. (See Abstract). Cohen teaches that the hydrophobic core can comprise alkenes. (See [0133]). Cohen teaches that the capsules are characterized by a diameter that ranged from 10 nm to 1000 micrometers and have a core-shell structure. (See [0011], [0098], [0099]). The shell has a size that ranges from about 0.1% to about 500% of their inner (core) part, and can be less than 500 nm. (See [0011], [0098], [0099], [0121]).
Cohen thus discloses a composition comprising at least one capsule comprising a shell and a hydrophobic core as called for in claim 1, with a diameter that ranges from 10 nm to 1000 micrometers which overlaps with the median diameter of less than about 3000 nm as called for in claim 1. A median diameter of less than about 3000 nm overlaps with a cellulosic shell layer having a thickness of 5 to 50 nm as called for in claim 1. Cohen teaches a shell layer that comprises cellulose as called for in claim 1. A shell that ranges from about 0.1% to about 500% of the inner core part, this overlaps with the ratio between the hydrophobic core and cellulose shell ranging from 30:1 to 1.5:1 as called for in claim 4. Alkenes in the core is called for in claim 5.
Cohen teaches that the cellulose can be amorphous non-derivatized cellulose in the form of a hydrogel as called for in claims 1 and 2. (See [0083] and [0115] and claim 6).
Cohen teaches a hydrolyzing enzyme that can be α-amylase as called for in claim 8. (See [0043-44]. This is a hydrolyzing enzyme as called for in claim 6. Cohen teaches at [0008] that the enzymes preferentially adsorb on the cellulose shell, specifically the hydrophobic glucan planes of the cellulose molecules. (See [0008]). Thus Cohen teaches the enzymes are adsorbed on the cellulose shell as called for in claim 6. Cohen teaches cellulose hydrogel capsules that comprise an enzyme that is adsorbed on the cellulose shell. (See [0127] and [0008]). Cohen even teaches exactly where the enzyme adsorbs on the cellulose (onto hydrophobic glucan planes of cellulose molecules). (See [0008]). The adsorption is reversible as called for in instant claim 2 in that adsorption is on the hydrophobic glucan planes of the cellulose molecules and can be released when the cellulose molecules disintegrate. (See [0008]).
With respect to claim 6, Cohen teaches a composition comprising at least one capsule comprising a cellulose shell, with a diameter that ranges from 10 nm to 1000 micrometers which overlaps with the median diameter of less than about 3000 nm. With a diameter ranging from 10 nm to 1000 micrometers and a shell size that ranges from about 0.1% to about 500% of the inner core part, this overlaps with the cellulosic shell layer having a thickness of 5 to 300 nm as called for in claim 6.
With respect to claims 9 and 10, Cohen teaches at [0119] that the amount of enzymes has an effect on the rate of enzymatic hydrolysis. Cohen thus teaches that the amount of enzymes is a results-effective variable and it would be no more than routine experimentation to experiment to arrive at the ideal ratio of enzyme to cellulose shell called for in claims 9 and 10.
It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786506 to have the hydrolyzing enzyme be α-amylase in light of Cohen’s teaching that it is a cellulose hydrolyzing enzyme and have it adsorb on the cellulose shell, since Cohen teaches that this is preferred. It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786506 to have the shell be from about 0.1% to about 500% of their inner (core) part, and the cellulose shell be less than 500 nm in light of Cohen’s teaching that this is effective for the production of biofuel. It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786506 to experiment to arrive at the ideal ratio of enzyme to cellulose shell in light of Cohen’s teaching that the amount of enzymes is a results-effective variable.
Eckenhoff et al. (Eckenhoff) teaches a delivery device that comprises a porous material in which the porosity is 95%. (See [0010] in Detailed Description). The porous material can be a wall that surrounds an inner space. (See [0001] and claim 1). The wall that surrounds and defines the internal compartment comprises a cellulose containing member. (See instant claims 2 and 3). A porosity of 95% falls within the 86 to 99% called for in instant claim 1. A porosity of 95% falls within the 94 to 96% called for in instant claim 3.
It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786506 to use a cellulose wall with a porosity of 95% as taught by Eckenhoff in light of Eckenhoff’s teaching that 95% porosity for a porous cellulose containing wall that surrounds an inner space is effective at releasing and delivering components.
Dhital et al. (Dhital) teaches that cellulose significantly inhibits alpha-amylase activity during starch hydrolysis through adsorption. (See Abstract). The degree of inhibition correlates positively to the cellulose concentration. (See Section 3.4) Dhital teaches that the inhibition is reversible, mixed-type and non-specific. (See Conclusion). Dhital teaches that cellulose can have a significant inhibitory effect on alpha-amylase that may have relevance during gastrointestinal digestion. (See Conclusion). Dhital also suggests dietary cellulose could slow starch digestion.
It would be prima facie obvious for a skilled artisan before the earliest effective filing date making the composition of US Patent No. 9786506 to use a cellulose concentration that would render the enzymatic activity of the adsorbed alpha-amylase to be less than 20% of a non-adsorbed alpha-amylase in light of Dhital’s teaching that cellulose significantly inhibits alpha-amylase activity during starch hydrolysis through adsorption and the degree of inhibition correlates positively to the cellulose concentration.
Claims 1-10 are directed to an invention not patentably distinct from claims 1-12 of commonly assigned U.S. Patent No. 9786406 in view of Cohen, Eckenhoff and Dhital.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 9786406, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicants’ comments of January 22, 2026 and the accompanying Affidavit of Dmitry Rein have been fully reviewed and are found to be mostly persuasive for the reasons described below.
Applicants note the amendments to the claims and where support can be found for the amendments to the claims. The support for the amendment to claim 9 can be found in paragraph [0129] as well.
Applicants assert the criticality of the claimed capsule comprising a cellulosic shell and a hydrophobic core for the efficient entrapment of the cellulase and for inhibition of enzymatic activity thereof and point to the experimental evidence exemplifying this criticality in the Affidavit of Dmitry Rein. Applicants point to the conclusion reached in the Affidavit of Dmitry Rein that the cellulose/hydrophobic core capsule is essential for enzyme binding and retention because pure cellulose does not retain the enzyme, as it is fully hydrolyzed and releases all enzyme back into the liquid phase. Applicants also point to the conclusion reached in the Affidavit of Dmitry Rein that shell thickness of up to 300 nm is essential for enzyme deactivation. In sum, hydrophobic core/cellulose core-shell capsules (as opposed to pure cellulose) and a shell thickness up to 300 nm are essential for cellulase binding and deactivation. The obviousness rejections are withdrawn above in light of the prior art’s failure to teach the cellulose core/shell with a hydrophobic core with adsorbed cellulase enzymes adsorbed on the outer shell.
`Applicants reiterate their obviousness arguments with respect to the obviousness-type double patenting rejections.
Applicants’ arguments have been carefully reviewed and upon further consideration are found to be sufficiently persuasive with respect to the obviousness rejections over the prior art.
Applicants’ arguments with respect to the obviousness-type double patenting rejections are not found to be persuasive, however. The claims of US Patent No. 9786406 are drawn to the subject matter that Applicants are asserting to be critical to their invention. Namely, claims 1-12 of US Patent No. 9786406 recite a composition comprising an interior hydrophobic space comprising alkene hydrocarbons that is encapsulated by at least one non-derivatized amorphous cellulose layer wherein the cellulose is surrounded by a hydrophilic or hydrophobic medium. The composition comprises a cellulose hydrolyzing enzyme and the capsule is 50 -500 nm in diameter.
The ways in which claims 1-12 differ from those of the instant application are taught by the Cohen, Eckenhoff and Dhital prior art references. It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786406 to have the hydrolyzing enzyme be α-amylase in light of Cohen’s teaching that it is a cellulose hydrolyzing enzyme and have it adsorb on the cellulose shell, since Cohen teaches that this is preferred. It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786406 to have the shell be from about 0.1% to about 500% of their inner (core) part, and the cellulose shell be less than 500 nm in light of Cohen’s teaching that this is effective for the production of biofuel. It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786406 to experiment to arrive at the ideal ratio of enzyme to cellulose shell in light of Cohen’s teaching that the amount of enzymes is a results-effective variable.
It would be prima facie obvious for a skilled artisan making the composition of US Patent No. 9786406 to use a cellulose wall with a porosity of 95% as taught by Eckenhoff in light of Eckenhoff’s teaching that 95% porosity for a porous cellulose containing wall that surrounds an inner space is effective at releasing and delivering components.
It would be prima facie obvious for a skilled artisan before the earliest effective filing date making the composition of US Patent No. 9786406 to use a cellulose concentration that would render the enzymatic activity of the adsorbed alpha-amylase to be less than 20% of a non-adsorbed alpha-amylase in light of Dhital’s teaching that cellulose significantly inhibits alpha-amylase activity during starch hydrolysis through adsorption and the degree of inhibition correlates positively to the cellulose concentration.
Thus, the obviousness-type double patenting rejections have not been overcome by Applicants arguments and these rejections are maintained.
Conclusion
No claims are allowed.
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.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619