DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 14 January 2026 in which claim 9 was amended to change the scope and breadth of the claims.
Claims 1-18 are pending in the current application and are examined on the merits herein.
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 .
Withdrawn Rejections
Applicant’s amendment, filed 14 January 2026, with respect to the objection of claim 6, has been fully considered and is persuasive because the claim has been amended to correct the typographical error of “herein” to “wherein”. The objection is hereby withdrawn.
Applicant’s amendment, filed 14 January 2026, with respect to the rejection of claim 9 under 35 U.S.C. § 112(b), has been fully considered and is persuasive because claim 9 has been amended to delete the recitation “insoluble”. The rejection is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 14 January 2026 have been fully considered but they are not persuasive.
Applicant contends none of the prior art suggests a dry product that is resoluble. Applicant argues that while Jamas teaches dried glucan can be “reconstituted” prior to use, it does not teach that the dried beta-glucans are “resoluble”. Applicant argues Jamas et al. teach reconstituting the dried glucan by adding an alkali solution and reprocessing the dried product immediately following the organic acid contact steps. Applicant contends this is different from a product that is resoluble.
The above arguments have been carefully considered but are not found persuasive. The resolubility of the beta-glucan is a property of the product when prepared according to the method of claim 5, and the steps of claim 5 are obvious for the reasons of record. The ‘853 Publication teaches performing all of the steps recited in claim 5 (and only differs from the concentration by a small amount), and suggests drying. There is no evidence to show this concentration is critical.
Applicant continues to argue there would not have been a reasonable expectation of success in arriving at a dried resoluble product as claimed following the method of the prior art. To overcome the rejection, Applicant could provide data comparing a dried product of the ‘853 Publication compared to the present Application to show whether the claimed method steps are critical.
The following response to arguments was submitted in the Advisory Action mailed 28 August 2025 and is repeated below:
With respect to the rejection under §103(a), the term “soluble” means a compound is capable of being dissolved in a liquid. The ‘853 Publication is concerned with taking native insoluble beta-glucan, treating it with a strong base to obtain short-chain length beta-glucan by unwinding crystalline beta glucan in paramylon derived from Euglena, cleaving the molecule (enzymatically, ultrasonication, catalyst, heat, energy-transfer), and separating/purifying to obtain a soluble homogenous product.
At paragraphs [0049]-[0055], the ‘853 Publication discusses disrupting the three-dimensional structure of native beta glucan. “The triple-helix structure is stable over a broad range of temperatures at a neutral pH, resulting in a polymer that is water insoluble. Solubilization of beta-1,3-glucan results in disruption and unwinding of the triple-helix structure of particulate beta-1,3-glucan. Soluble beta-1,3-glucan comprises unwound, free, individual chains of beta-1,3-glucan in solution. Moreover, different immunological effects can be obtained that are related to the beta-1,3-glucan conformation, be it the native state, denatured, or denatured and re-natured. Specifically, the compositions provided herein comprise solubilized beta-1,3-glucans that are in a conformation that makes them especially effective for enhancing an immune response compared to, for example, beta glucans in a particulate form. The conformation of the beta glucan and its resulting solubility may also affect how it is delivered.”
Para [0052] “As described herein, solubilized beta-1,3-glucan refers to beta-1,3-glucan that has been exposed, at one point in time, to a solubilizing agent, such as base, heat, or detergent, which causes the beta-1,3-glucan to unwind and facilitates solubilization in a solution, such as an aqueous or organic solvent. In this way, the solubilizing agent is effectively a denaturing agent. Although subsequent exposure of the solubilized beta-1,3-glucan to certain conditions, for example, neutral pH, may afford a semi-solid, colloidal, or gel-like preparation, solubilized beta-1,3-glucan as referred to herein may also describe semi-solid, colloidal, or gel-like preparations that are derived from fully or partially beta-1,3-glucan that has been solubilized in a solution”.
In fact, the very teaching that “solubilized beta-1,3-glucan can be formulated as a liquid or a gel” in para [0090] makes it clear that solubilized beta-1,3-glucan is not inherently or necessarily in a solution state. The reference goes on to say “the solubilized beta 1,3-glucan may be dissolved…”, which also clearly demonstrates solubilized beta-1,3-glucan is not inherently or necessarily in a solution state.
It’s not clear how drying would reverse the denaturation process of treating beta-glucan with sodium hydroxide. Sodium hydroxide is a strong base that breaks beta-glucan into small chains. There is no reason to expect drying would anneal the chains back into a longer-chain. The rejection is hereby maintained.
Maintained Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Horst et al. (US 2017/0290853, hereinafter the ‘853 Publication, cited in previous Office Action) in view of Horst et al. (US 2018/0311271, hereinafter the ‘271 Publication, cited in previous Office Action) and Jamas et al. (US Patent No. 5,849,720, cited in previous Office Action).
The ‘853 Publication is directed towards the solubilization of beta-1,3-glucan with a base (hereinafter, beta glucan abstract; claim 2). Bases include sodium hydroxide, which are used at concentrations of 0.2-2M for 1-5 hours at room temperature or 30-95 °C (Table 2; para [0081]). The ‘853 Publication teaches suspending beta glucan in water (20 mg/mL, or 20 g/L, 2% weight by volume), (Example 1, para [0151]). The ‘853 Publication teaches the starting concentration of beta glucan can range from 0.1% to 10% by mass, which can be combined with boiling water or other aqueous solution for at least 10 minutes. To this, 2M NaOH was added to solubilize the beta glucan, for a final concentration of 1M NaOH. The pH was neutralized, and PBS was added to give beta glucan at a concentration of 4 mg/mL (or 4 g/L, or 0.4% weight by volume). The ‘853 Publication disclose beta glucan produced from Euglena is originally present as water-insoluble granules of about 0.5 to 2.0 microns in size, and easily isolated as particles (para [0054]). The viscosity of beta glucan can be optimized based on the chain length resulting from solubilization and/or the concentration of the polysaccharide in water (para [0062]). The solubilized beta glucan is expected to increase its bioactivity for enhancing immune function, blood sugar level, cholesterol level, infection, or inflammation (para [0057]; [0083]; claim 4). The ‘853 Publication discloses methods for obtaining short-chain length beta-glucan by unwinding crystalline beta glucan in paramylon derived from Euglena, cleaving the molecule (enzymatically, ultrasonication, catalyst, heat, energy-transfer), and separating/purifying to obtain a homogenous product (para [0073]; claim 10). Subsequent size selection methods include centrifugation, filtration, chromatography and electrophoresis (para [0074]-[0077]). The ‘853 Publication discloses administering solutions of beta-glucan intravenously (para [0084]). The solubilized beta glucan can be in the form of a liquid and dissolved in a beverage such as water (para [0090]; claim 28). The beta glucan can be stored under alkaline conditions to prevent microbial growth (para [0085]). Additional ingredients can be added to the solution for enhancing the immune response including pH buffers, minerals, gums, protein, lubricants, fillers, surfactants, carbohydrates, coloring agents, flavoring agents and vitamins (para [0089], [0146]; claim 23). The solubilized beta glucan can be combined into animal feed at various dosing levels including 1:10,000 and 1:500 by dry weight (para [0145]-[149]).
While the ‘853 Publication suggests a product in a dry form, it does not expressly disclose a composition with less than 10% moisture content (present claim 1). While the ‘853 Publication teaches the beta glucan can be in the form of a solution or administered in a feed, the ‘853 Publication does not expressly disclose drying the beta glucan (present claim 5). The ‘853 Publication does not expressly disclose forming a solution of beta-glucan having a concentration of at least 25 g/L in the solution (present claim 5). The ‘853 Publication does not expressly disclose “further comprising a step of dissolving the dried resoluble beta-glucan in water such that a concentration of beta-glucans is about 1 g/L (present claim 15), or “about 5-15 g/L” (present claim 16).
The ‘271 Publication teaches preparing a beta-glucan from paramylon and purified from Euglena (claims 19 and 21). The ‘271 Publication teaches obtaining crude polysaccharide materials and separating it from the biomass materials, washing it and optionally adjusting its pH with acid or base (para [0176]). The treated polysaccharide is then transferred to a dryer, such as a rotary drum dryer to obtain a product having less than 10% moisture content (para [0178]). The products can be dried to aid in consumption, and reformulated for oral administration (para [0109]-[0110]). The dried product is then milled to a particle size of less than 250 µm, packaged and labeled. The ‘271 Publication also teaches Euglena biomass can be dried (for example by freeze-drying, heat drying, drum dryer) to a moisture content of about 1% or less, pulverized to produce powder and processed to achieve an average particle size of about 100 microns or less, about 50 microns or less, about 25 microns or less, about 15 microns or less, about 10 microns or less, about 5 microns or less, about 3 microns or less, about 2 microns or less, about 1 micron or less or about 0.5 microns or less (para [0155]). The ‘271 Publication teaches particle size affects function and bioavailability of the beta glucan (para [0100]). The ‘271 Publication teaches these compositions comprise beta glucan in combination with the cellular components of the Euglena biomass (para [0156-0157]). The beta glucan can be mixed with an aqueous solution as a pharmaceutical composition, it may be further combined with a pharmaceutically acceptable excipient and administered intravenously (para [0157], [0349]).
Jamas et al. is concerned with the preparation of soluble glucan from glucan particles (abstract). The method includes a step of alkaline treatment (col.2 to col.3, bridging para). Jamas et al. define “soluble” as a glucan that forms a visually clear solution in water, PBS, isotonic saline or a dextrose solution having a neutral pH at room temperature, and at a concentration of up to about 10 mg/mL (col.3:55-64). If desired, the soluble glucan can be dried by an appropriate drying method, such as lyophilization, and stored in dry form.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form a dried, resoluble beta-glucan comprising the steps of adding a strong base to insoluble beta-glucan, and drying the solution to form dried beta glucan.
Jamas et al. expressly provide motivation to dry solubilized beta-glucan. Jamas et al. expressly teach if desired, soluble glucan can be dried by an appropriate drying method, such as lyophilization, and stored in dry form. The ‘853 Publication teaches the beta-glucan can be combined in animal feed with dosing based on its dry weight and the ‘271 Publication teaches drying the products to aid in its consumption. Thus, the step of drying improves its ability to be consumed, and orally administered or reformulated as part of an oral edible product.
One of ordinary skill in the art would have been motivated to take insoluble beta glucan (paramylon) from Euglena gracilis, suspend it in water and add 2N NaOH to form a solution because the ‘853 Publication exemplifies these steps for obtaining soluble beta glucan having improved bioavailability. While the ‘853 Publication does not expressly disclose forming a solution having at least 2.5% wt./vol, one having ordinary skill in the art would have known paramylon granules can be treated with a base at a concentration ranging from 0.4-2% wt./vol., which is close to forming a solution having at least 2.5% wt./vol. One of ordinary skill in the art would have been motivated to optimize and increase the amount of paramylon subjected to basic conditions, as a means for obtaining higher amounts of solubilized beta-glucan.
Additionally, the ‘853 Publication teaches a range of reaction conditions for solubilizing the beta glucan, including a list of suitable base-solubilizing agents, concentrations, reaction times and temperatures. The skilled artisan would have expressly been motivated to modify any of these parameters to ensure solubilization of the beta glucan regardless of its starting concentration. The ordinary artisan would have had a reasonable expectation of success in optimizing the above parameters and obtaining a solubilized beta glucan if an initially higher concentration of beta glucan was used.
See MPEP 2144.05, sections I and II, including “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”.
While the ‘853 Publication does not define soluble beta-glucan in terms of concentration, one of ordinary skill in the art would have known from the additional teachings of Jamas et al. define “soluble” as a glucan that forms a visually clear solution in water, PBS, isotonic saline or a dextrose solution having a neutral pH at room temperature, and at a concentration of up to about 10 mg/mL. A concentration of 10 mg/mL is equivalent to 10 g/L, which lies in the range of present claims 15 and 16. Since the prior art is expressly concerned with preparing soluble beta glucan, one having ordinary skill in the art would have been motivated to optimize the reaction conditions to obtain a beta-glucan that is soluble at a concentration of up to about 10 g/L.
The ordinary artisan would have been motivated to grind/mill the beta glucan to a particle size of less than 100 microns because the prior art recognize smaller particles have improved bioavailability. While the ‘271 Publication teaches milling beta glucan to a particle size of less than 250 µm, they also teach milling E. gracilis biomass comprising beta glucan to a particle size about 100 microns or less, about 50 microns or less, about 25 microns or less, about 15 microns or less, about 10 microns or less, about 5 microns or less, about 3 microns or less, about 2 microns or less, about 1 micron or less or about 0.5 microns or less. Thus, the art teaches also decreasing the particle size of the beta glucan to a size of less than about 100 microns.
The ordinary artisan would have been motivated to dissolve the beta glucan in water to obtain a solution prior to use because the ‘853 Publication and ‘271 Publication teach beta glucan can be administered orally or intravenously in solution form. A solution of beta glucan dissolved in water is expected to be capable of passing through a 100-micron mesh because the particles are dissolved. If, they are somehow not dissolved, one of ordinary skill in the art would expect the beta glucan to be capable of passing through a 100-micron mesh because they were sized down to a particle size of less than 100 microns (0.5-100 microns). Additionally, beta glucan naturally found in Euglena is about 0.5-2 microns. Thus, there is a reasonable expectation of success the beta glucan dissolved in water would pass through a 100-micron mesh.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,744,847 in view of Horst-853 (cited above), Horst-271 (cited above), and Jamas et al. (cited above).
The claims of the reference Patent are directed towards a method of administering a beta-1,3-glucan having no beta-1,6-glycosidic bonds, and dried to contain less than 10% moisture. The beta-glucan is in the form of paramylon.
The reference Patent do not expressly disclose whether the beta-glucan is resoluble in water (present claim 1), or the step of adding a strong base (present claim 5).
Horst-853, Horst-271 and Jamas et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form a dried, resoluble beta-glucan comprising the steps of adding a strong base to insoluble beta-glucan, and drying the solution to form dried beta glucan.
One of ordinary skill in the art would have been motivated to take insoluble beta glucan (paramylon) from Euglena gracilis, suspend it in water and add 2N NaOH to form a solution because the ‘853 Publication exemplifies these steps for obtaining solubilized beta glucan having improved bioavailability.
The ordinary artisan would have been motivated to grind/mill the beta glucan to a particle size of less than 100 microns because the prior art recognize smaller particles have improved bioavailability. While the ‘271 Publication teaches milling beta glucan to a particle size of less than 250 µm, they also teach milling E. gracilis biomass comprising beta glucan to a particle size about 100 microns or less, about 50 microns or less, about 25 microns or less, about 15 microns or less, about 10 microns or less, about 5 microns or less, about 3 microns or less, about 2 microns or less, about 1 micron or less or about 0.5 microns or less. Thus, the art teaches also decreasing the particle size of the beta glucan to a size of less than about 100 microns.
The ordinary artisan would have been motivated to reconstitute the beta glucan in water to obtain a solution because both references teach beta glucan can be administered orally or intravenously in solution form, and Jamas et al. teach soluble glucan can be dried by an appropriate drying method, such as lyophilization, and stored in dry form.
The ordinary artisan would have been motivated to dissolve the beta glucan in water to obtain a solution prior to use because the ‘853 Publication and ‘271 Publication teach beta glucan can be administered orally or intravenously in solution form.
Thus, the claimed invention as a whole is prima facie obvious over the ‘847 Patent and the combined teaching of the prior art.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,912,794 in view of Horst-853 (cited above), Horst-271 (cited above) and Jamas et al. (cited above).
The claims of the reference Patent are directed towards a method of administering a beta-1,3-glucan having no beta-1,6-glycosidic bonds, and dried to contain less than 10% moisture. The beta-glucan is in the form of paramylon.
The reference Patent do not expressly disclose whether the beta-glucan is resoluble in water (present claim 1), or the step of adding a strong base (present claim 5).
Horst-853, Horst-271 and Jamas et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form a dried, resoluble beta-glucan comprising the steps of adding a strong base to insoluble beta-glucan, and drying the solution to form dried beta glucan.
One of ordinary skill in the art would have been motivated to take insoluble beta glucan (paramylon) from Euglena gracilis, suspend it in water and add 2N NaOH to form a solution because the ‘853 Publication exemplifies these steps for obtaining solubilized beta glucan having improved bioavailability.
The ordinary artisan would have been motivated to grind/mill the beta glucan to a particle size of less than 100 microns because the prior art recognize smaller particles have improved bioavailability. While the ‘271 Publication teaches milling beta glucan to a particle size of less than 250 µm, they also teach milling E. gracilis biomass comprising beta glucan to a particle size about 100 microns or less, about 50 microns or less, about 25 microns or less, about 15 microns or less, about 10 microns or less, about 5 microns or less, about 3 microns or less, about 2 microns or less, about 1 micron or less or about 0.5 microns or less. Thus, the art teaches also decreasing the particle size of the beta glucan to a size of less than about 100 microns.
The ordinary artisan would have been motivated to reconstitute the beta glucan in water to obtain a solution because both references teach beta glucan can be administered orally or intravenously in solution form, and Jamas et al. teach soluble glucan can be dried by an appropriate drying method, such as lyophilization, and stored in dry form.
The ordinary artisan would have been motivated to dissolve the beta glucan in water to obtain a solution prior to use because the ‘853 Publication and ‘271 Publication teach beta glucan can be administered orally or intravenously in solution form.
Thus, the claimed invention as a whole is prima facie obvious over the ‘794 Patent and the combined teaching of the prior art.
Response to Arguments
Applicant's arguments filed 14 January 2026 have been fully considered but they are not persuasive.
Applicant contends neither the Patents nor references disclose whether the beta-glucan is resoluble in water.
The above arguments are not found persuasive, because resolubility is a property of the product obtained by performing the claimed method steps, which are obvious for the reasons of record.
The rejections are hereby maintained.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699