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 . Claims included in the prosecution are claims 1-25 and 30-37.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-25 and 30-37, drawn to a topical pharmaceutical composition, classified in A61K 47/38, A61K 47/36, A61K 31/222.
II. Claim 26, drawn to a method of making a topical pharmaceutical composition, classified in A61J 3/04.
III. Claim 27-29, drawn to a method of treating a medical condition, classified in A61P 17/02 and A61P 17/14.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process as claimed can be used to make another and materially different product. For example, the process as claimed can be used to make a non-topical composition, such as an injectable composition.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process. For example, the product can be used to treat a different medical condition, such as eczema.
Inventions II and III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different effect. For example, the effect of Invention II is the production of a product and the effect of Invention III is the treatment of a condition. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different
classification;
--the inventions have acquired a separate status in the art due to their recognized
divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different
classes/subclasses or electronic resources, or employing different search strategies or
search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Harold Fox on 08/28/2026 a provisional election was made without traverse to prosecute the invention of a topical pharmaceutical composition, claims 1-25 and 30-37. Affirmation of this election must be made by applicant in replying to this Office action. Claims 26-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Potential Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 13 objected to because of the following informalities: “is formed from” should be “in the form of.” Appropriate correction is required.
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 12, 14, 16, 19-23 and 30-37 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 12 recites “a permeation enhancer,” which renders the claim indefinite. It is unclear if a permeation enhancer is the same as the “skin permeability enhancer” in claim 1, or if it is referring to a different type of enhancer. The specification nor the claims elaborate on the difference between “permeation enhancer” and “skin permeability enhancer.” The Examiner will be interpreting these terms to mean the same thing and claim 12 is being interpreted as adding a second “skin permeability enhancer.”
Claim 14 recites the limitation "the spray,” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim because claim 14 is dependent on claim 1 which does not recite a spray. The Examiner is going to interpret “the spray” in claim 14 to be the spray referred to in claim 13. See MPEP 2173.05(e).
Regarding claim 16, the term "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 19 recites the limitation "the adrenergic receptor interactor,” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim because claim 19 is dependent on claim 8, which does not recite an adrenergic receptor interactor. The Examiner is going to interpret “the adrenergic receptor interactor” in claim 19 to be the adrenergic receptor interactor referred to in claim 18. See MPEP 2173.05(e).
Claim 20 recites the limitation "the adrenergic receptor interactor,” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim because claim 20 is dependent on claim 1, which does not recite an adrenergic receptor interactor. The Examiner is going to interpret “the adrenergic receptor interactor” in claim 20 to be the adrenergic receptor interactor referred to in claim 18. See MPEP 2173.05(e).
Claim 21 recites the limitation "the phytoextract,” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim because claim 21 is dependent on claim 10, which does not recite a phytoextract. The Examiner is going to interpret “the phytoextract” in claim 21 to be the phytoextract referred to in claim 20. See MPEP 2173.05(e).
Also, even if claim 21 depends from claim 20, the claim would still be indefinite since claim 21 recites wherein the phytoextract further includes an essential oil extract and claim 20 does not recite wherein the phytoextract comprises a particular compound. Thus, it is not clear whether claim 21 requires two different phytoextracts or just one.
Regarding claim 22, the term "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 23 recites the limitation "the mixed ester" in the first line. There is insufficient antecedent basis for this limitation in the claim. Claim 23 depends from claim 13, which does not recite a mixed ester. Therefore, the scope of mixed ester is unclear. For sake of compact prosecution, the examiner has interpreted claim 23 to depend from claim 22.
Regarding claim 30, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Clarification by amendment of claim 30 is required.
Claims 31-37 recite the limitation "epinephrine or its prodrug,” which renders the claim indefinite. There is insufficient antecedent basis for this limitation in the claim because claims 31-37 are dependent on claim 1, which does not recite “epinephrine or its prodrug.” Claims 1 recites at least one prodrug of epinephrine. See MPEP 2173.05(e).
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)(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.
1. Claim(s) 1-7, 9, 12-15, 18, 20-21, 24-25, and 30-37 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schobel et al. (US 2022/0160657 A1, May 26, 2022) (hereinafter Schobel), as evidenced by Nursal et al. (Formulation and Development of Grape Seed Oil (Vitis Vinifera L) Emulgel Peel-Off Mask using Gelling Agent Hydroxy Propyl Methyl Cellulose (HPMC), 2021) (hereinafter Nursal) and Kima Chemical (Hydroxypropyl Methylcellulose (HPMC) Manufacturer).
Regarding claims 1, 13, 18 and 30, Schobel teaches a pharmaceutical composition that can include a polymeric matrix, epinephrine in the polymeric matrix, and an adrenergic receptor interactor. Epinephrine can be provided in the form of a prodrug, such as a lipophilic produg, for examples, dipivefrin. In certain embodiments, the pharmaceutical composition can further include a permeation enhancer ([0004]). The pharmaceutical composition can be used as a wound dressing (i.e., patch) in the form of a film for application to skin or a wound ([0167]).
Regarding claims 2 and 9, Schobel teaches example 24, which contains HPMC E15 (hydroxypropyl methylcellulose). As evidenced by Nursal, HPMC is a semi-synthetic gelling agent derived from cellulose (page 2, Introduction). Therefore, HPMC reads on the claimed “gelling polymer.” Furthermore, as evidenced by Kima Chemical, hydroxypropyl methylcellulose is a nonionic cellulosic polymer.
Regarding claim 3, a film of the composition can be produced by a combination of at least one polymer and a solvent, optionally including other components ([0134]). The solvent may be water, a polar organic solvent including, but not limited to, ethanol, isopropanol, acetone, or any combination thereof ([0134]).
Regarding claims 4-7 and 25, Schobel teaches additives may be included in the composition. For example, classes of additives include preservatives, lubricants, buffering agents, stabilizers, and mixtures thereof ([0141]). Stabilizers may also be classified as antioxidants ([0142]). It is noted that lubricants read on the claimed “spreadability agent.”
Regarding claim 12, Schobel teaches example 25, which comprises two permeation enhancers, clove oil and labrasol), as defined in the table of identified permeation enhancers in example 11 ([0224], [0247]).
Regarding claim 14, Schobel teaches in paragraph [0113] wherein the composition may be a spray. Regarding the claim limitation of “formed in an enclosure over a treatment area,” this is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. Thus, since the prior art discloses substantially the same spray as claimed, the claim is unpatentable even though the prior art does not disclose making the spray in an enclosure over a treatment area.
Regarding claim 15, Schobel teaches example 11, which identifies various permeation enhancers, including ethanol ([0224]). It is noted that ethanol reads on the claimed “solubilizer” and “solvent.”
Regarding claim 20-21, Schobel teaches wherein the adrenergic receptor interacter can be a phytoextract, and the phytoextract can be an essential oil extract of a clove plant ([0009], [0018]).
Regarding claims 24, Schobel teaches the polymer matrix can comprise a cellulosic polymer, such as hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, methylcellulose, carboxymethyl cellulose and/or sodium carboxymethylcellulose ([0022]).
Regarding claim 31, the instant application teaches Fig. 16B, which depicts 2.5% and 10% dipivefrin treatment increases histamine levels from baseline. Schobel teaches the epinephrine can be administered as a prodrug, such as dipivefrin ([0037]). In examples 23-27, dipivefrin is taught as the pharmaceutically active component ([0245-0258]). Therefore, because the prior art comprises the epinephrine prodrug, dipivefrin,, the prior art composition necessarily impacts mast cells or histamines like the claimed invention.
Regarding claim 32, the instant application specification teaches the prodrug, dipivefrin, and epinephrine both showed efficacy in inhibiting NK cells ([00348], [00395]). As discussed above, because the prior art comprises the epinephrine prodrug, dipivefrin, the prior art composition necessarily targets a disease in which natural killer cells are activated like the claimed invention.
Regarding claim 33, because the prior art comprises substantially the same epinephrine prodrug as claimed, the prior art composition necessarily acts as an immunosuppressant like the claimed invention.
Regarding claim 34, because the prior art comprises substantially the same epinephrine prodrug as claimed, the prior art composition necessarily acts as a melanogenic agent like the claimed invention.
Regarding claim 35, the instant application specification depicts epinephrine as a potent inhibitor of inflammatory cytokines in Fig. 15E ([00343]). As discussed above, because the prior art comprises an epinephrine, the prior art composition necessarily inhibits cytokine production like the claimed invention.
Regarding claim 36, because the prior art comprises substantially the same epinephrine as claimed, the prior art composition necessarily elevates TNF-α like the claimed invention.
Regarding claim 37, the instant application specification analyzes the NK activation assay epinephrine and dipivefrin supernatants in an IFNγ TR Fret Assay ([00392-00393], [00396]). Although the values were not quantified, because the prior art comprises substantially the same epinephrine and dipivefrin as the claimed invention, the prior art composition necessarily has the same properties as the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
2. Claim(s) 8, 11, 19, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 2022/0160657 A1, May 26, 2022) (hereinafter Schobel).
The teachings of Schobel are discussed above. The prior art is not anticipatory insofar as Schobel does not specifically teach a composition comprising a viscosity agent, a mixed ester wherein the mixed ester is synthetic or biosynthetic, or gum arabic polymer.
Regarding claim 8, Shobel discloses in paragraph [0135] that for high dosages of epinephrine or its prodrug, it may be desirable to incorporate a polymer that provides a high level of viscosity. Accordingly, it would have been obvious for one of ordinary skill in the art to have incorporated a viscosity agent into the composition of Schobel to provide a high level of viscosity for high dosages of epinephrine or its prodrug.
Regarding claim 11, Schobel discloses in paragraph [0149] that the composition may comprise gum Arabic as an additive. The claim is not anticipatory since gum Arabic has to be selected from a list. It would have been obvious, however, to make the selection since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success supports a conclusion of obviousness. See MPEP 2143(I).
Regarding claim 19, Schobel discloses in certain embodiments, the adrenergic receptor interacter can be a phytoextract ([0009]). The phytoextract can include 20-95% eugenol, including 40-95% eugenol, and including 60-95% eugenol ([0019]). Claim 19 is not anticipatory since it depends from claim 8.
Regarding claims 22-23, Schobel discloses in paragraph [0149] a list of useful additives that include cellulose esters, such as cellulose acetate phthalate (CAP). The claim is not anticipatory since cellulose esters, such as cellulose acetate phthalate (CAP) has to be selected from a list. It would have been obvious, however, to make the selection since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success supports a conclusion of obviousness. See MPEP 2143(I).
3. Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 2022/0160657 A1, May 26, 2022) (hereinafter Schobel) in view of Bologna et al. (US 20170196896 A1, July 13, 2017) (hereinafter Bologna).
The teachings of Schobel are discussed above.
Schobel differs from the instant claims insofar as not teaching the pharmaceutical composition further comprising a gelling polymer, wherein the gelling polymer is a cross-linked polyacrylic acid.
However, Bologna teaches a gel composition comprising: (a) at least one active ingredient or a salt thereof; (b) at least one oleogel comprising at least one oily agent and at least one lipid soluble cellulose polymer ([0002]). The active ingredient can be a phenethylamine selected from the group consisting of dopamine, epinephrine, norepinephrine, phenylephrine, methylphenidate, amphetamine, a salt of any of these, and any combination thereof ([0009]). In some embodiments, the aqueous gel further can comprise at least one gelling agent ([0012]), and the gelling agent for the aqueous gel can be a carbomer, such as Carbopol 974 or Carbopol 980 ([0091]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Schobel teaches that the pharmaceutical composition can be a gel ([0113]). Accordingly, it would have been obvious for one of ordinary skill in the art to have incorporated Carbopol 974 into the composition of since it is a known and effective gelling agent to form a gel as taught by Bologna.
4. Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 20220160657 A1, May 26, 2022) (hereinafter Schobel) in view of Hartman et al. (US 2019/0254962 A1, August 22, 2019) (hereinafter Hartman).
The teachings of Schobel are discussed above.
Schobel does not teach wherein the skin permeability enhancer can be an ether, such as a monoethyl ether, or diethylene glycol monoethyl ether.
However, Hartman teaches epinephrine spray formulations, where in some embodiments, the spray further comprises a permeability enhancer. In some embodiment, the permeability enhancer is diethylene glycol monoethyl ether (Abstract, [0006]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As previously discussed, Schobel discloses wherein the composition comprises a permeation enhancer. Therefore, it would have been obvious for one of ordinary skill in the art to have incorporated diethylene glycol monoethyl ether into the composition of Schobel since it is a known and effective permeation enhancer as taught by Hartman.
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 1-2, 11-12, 18-21, 24-25, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-17, 21, 24, 27, and 39 of copending Application No. 17/549,219 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite an additional component of a polymer matrix) and thus read on the instant claims."
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-25 and 30-37 are rejected.
Claims 26-29 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L KRINOS whose telephone number is (571)270-1412. The examiner can normally be reached Monday -Thursday 9 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614