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 .
Claim Status
Claims 1-20 are pending. Claim 20 was amended in the preliminary amendment filed on December 23, 2024. Claims 1-20 are under examination in the instant office action.
Priority
The instant office action is a 371 national phase application of PCT/CN2021/11393, which was filed on September 9, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 6, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-2 and 13-14 are objected to because of the following informalities: (i) an indefinite article, “an” should be inserted before each of the words “ester” and “amide” on line 5 of claim 1; (ii) in claim 2 at line 2, the word “store” should be amended to read as “stored”; (iii) either “methylene chloride” or “dichloromethane” should be deleted from claim 13 at lines 5 and 6, respectively, because these terms are synonyms for the same compound, as evidenced by the Wikipedia article, entitled, “Dichloromethane” (accessed April 3, 2026 at en/Wikipedia.org/wiki/Dichloromethane, last edited on 30 March 2026 at 15:52 (UTC)). (and (iv) the indefinite article “a” should be inserted in claim 14, item (c) before “pharmaceutically”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is 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 13 recites the limitation "the carrier" in line 2. Claim 13 depends directly from independent claim 1 and neither dependent claim 13 before recitation of “the carrier” nor independent claim 1 recite “a carrier”. Thus, there is insufficient antecedent basis for this limitation in the claim.
It appears that “the carrier” was intended to refer to the “at least one pharmaceutically acceptable solvent vehicle” as recited in independent claim 1.
Claim 13 is also ambiguous because it recites in part at lines 1-2, “…further comprising a pharmaceutically acceptable solvent vehicle…”; however, independent claim 1, from which claim 13 depends directly, already recites at item (b) “at least one pharmaceutically acceptable solvent vehicle”. Thus, it is unclear if claim 13 is redundantly reciting a pharmaceutically acceptable solvent vehicle or is intending the composition to additionally comprise a different pharmaceutically acceptable solvent vehicle that is encompassed by the broad recitation of “at least one pharmaceutically acceptable solvent vehicle”.
It is respectfully suggested that Applicant amend claim 13 to replace “…further comprising a pharmaceutically acceptable solvent vehicle, wherein the carrier…” with “wherein the at least one pharmaceutically acceptable solvent vehicle” and that this amendment would overcome both aforementioned 112(b) issues in dependent claim 13.
Claim 13 is additionally ambiguous because the specification does not clearly redefine “pharmaceutically acceptable solvent vehicle” to include several solvents listed in claim 13 (i.e.: methylene chloride (also known as dichloromethane), chloroform, 1,4-dioxane, dimethylformamide (also known as N,N-dimethylformamide), and toluene) that are known to be class 2 solvents considered to be toxic, have low permitted daily exposure limits, and which would not be considered to be pharmaceutically acceptable solvents for a pharmaceutical formulation. See Table 2, Class 2 solvents on page 5 of Grodowska et al. “Organic Solvents in the Pharmaceutical Industry”, Acta Poloniae Pharmaceutica- Drug Research, Vol. 67, No. 1, pp. 3-12 (2010).
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.
Claims 1-3, 5, 7, 11-13, and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Inoo et al. US PG-PUB 2011/0160194 (“Inoo”; cited on the IDS filed December 6, 2024; Published on June 30, 2011 with a 371 filing date of March 2, 2011), as evidenced by the Wikipedia article entitled, “Oxybuprocaine” (last updated on 14 January 2025 at 03:20 (UTC)).
Applicant claims an anesthetic composition for topical application comprising (a) therapeutically effective amount of at least one pharmaceutically active agent; (b) at least one pharmaceutically acceptable solvent vehicle; (c) at least one clay; wherein the pharmaceutically active agent is ester type or amide type anesthetic agent (claim 1). Applicant also claims a method of use of the composition of claim 1 comprising (a) providing the composition of claim 1 and (b) contacting an area of skin with the anesthetic composition.
Inoo exemplifies the below composition on page 4 in Table 3 in paragraph [0061]:
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Inoo’s Table 3 composition is made by dissolving diclofenac sodium in N-methyl-2-pyrrolidone (i.e., a pharmaceutically acceptable solvent vehicle) and oxybuprocaine is separately dissolved in propylene glycol (i.e., a pharmaceutically acceptable solvent vehicle). The purified water of this composition also reads on a pharmaceutically acceptable solvent vehicle. The concentration of oxybuprocaine of 5% w/w meets the limitations of “the pharmaceutically active agent is ester type…anesthetic agent” and the limitations of dependent claims 3 and 5 for the amount of the ester-type anesthetic agent of “about 1 to 10%” w/w and “an amount of 5%” w/w, respectively. The “kaoline” (spelled as kaolin in Applicant’s dependent claim 11) of Inoo’s Table 3 composition reads on a clay. Applicant’s rejected claims use open “comprising” language and thus do not exclude additional components such as “diclofenac sodium”. The other components of Inoo’s Table 3 composition read on “the anesthetic composition of claim 1 further comprising at least one excipient”, as recited in rejected claim 12. With respect to the form of Inoo’s Table 3 composition, it is noted that in paragraph [0061] this composition is described as being a “drug-containing base” that was spread onto a woven fabric. Based on this description it is inferred that this composition is a semi-solid, such as a paste, which meets the limitations of rejected claim 2. Moreover, Inoo’s Table 3 composition has all the required elements of claim 1, so it follows that it would also be a semi-solid, absent evidence to the contrary.
With respect to rejected dependent claim 13, Inoo’s Table 3 composition contains propylene glycol (also known as propyl glycol) and water, which are recited in rejected claim 13. Moreover, rejected claim 13 uses “comprising” language and as a result does not exclude other pharmaceutically acceptable solvents, such as, N-methyl-2-pyrrolidone.
Inoo does not affirmatively describe oxybuprocaine as an ester-type anesthetic. The Wikipedia article entitled, “Oxybuprocaine” evidences that oxybuprocaine is an ester-type anesthetic, see below, and the ester functional group highlighted in the chemical structure of oxybuprocaine.
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Inoo discloses that the external preparations of the invention are not particularly limited as long as its dosage form allows for direct administration of an active agent to the surface of an affected skin area. See paragraph [0040]. Thus, application of the Table 3 composition spread onto a non-woven fabric with a polypropylene liner applied thereto, as described in paragraph [0061], permits the ordinary skilled artisan to clearly envisage providing the Table 3 Inoo composition and application of it (i.e., contacting) to an area of skin. This disclosure meets the limitations of the method of rejected claim 20.
Claims 1, 4, 6, 10-13, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ono et al. EP 0507160 A1 (“Ono”; Reference cited on the 12/6/2024 IDS; Published October 7, 1992).
Applicant’s claims have been generally described above and this description is incorporated herein by reference.
Ono discloses external preparations for application to the skin containing lidocaine (i.e., an amide-type anesthetic), which comprises a drug-retaining layer placed on a support, wherein the drug-retaining layer comprises an adhesive gel base and 1-10% w/w of lidocaine, said base comprising a water-soluble high molecular weight substance, water (i.e., a pharmaceutically acceptable solvent vehicle), and a water-retaining agent that can release the active lidocaine gradually and constantly so that the lidocaine is transdermally absorbed for a long period of time (abstract).
In Example 4 (bridging pages 5-6), Ono exemplifies the preparation of an aqueous base containing lidocaine (5 % w/w), propylene glycol (5% w/w; also known as propyl glycol), kaolin (1% w/w), water (q.s.), and additional components that each read on an excipient. Example 4 also indicates that the base is spread onto a non-woven fabric at 1000 g/m2 and to the base is adhered a liner made of polyethylene terephthalate processed with silicone. The effect rate of local anesthesis of the Example 4 lidocaine base is disclosed in Table 1 of Ono at page 9. It is the Examiner’s position that Ono’s disclosures set forth above permits the ordinary skilled artisan to clearly envisage providing the Example 4 lidocaine-containing base and apply it (i.e., contacting) to an area of skin. This disclosure meets the limitations of the method of rejected claim 20.
Although Ono does not explicitly refer to lidocaine as being an amide-type anesthetic, Applicant admits that lidocaine is an amide-type anesthetic (See paragraph [079] of the specification filed on January 29, 2024).
Claims 1-5, 7, 9-13, and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kanios et al. (“Kanios”; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995).
The rejected claims are as described generally above and incorporated herein by reference.
Kanios discloses compositions for topical application comprising a therapeutically effective amount of (i) a pharmaceutical agent(s), (ii) a pharmaceutically acceptable bio-adhesive carrier, (iii) a solvent for the pharmaceutical agent(s) in the carrier, and (iv) a clay and methods of administering the pharmaceutical agents to a mammal.(Abstract; col. 11, lines 11-29).
In claim 23, Kanios claims a method of administering one or more pharmaceutically active agents to a subject comprising (a) providing the composition as set forth in claim 1 and (b) contacting an area of skin or mucous membrane with the composition to administer the pharmaceutically active agent.
In claim 1, Kanios claims a flexible bio-adhesive composition for topical application comprising (a) a therapeutically effective amount of at least one pharmaceutically active agent; (b) a pharmaceutically acceptable solvent for the pharmaceutically active agent and a plasticizer; (c) in admixture with the pharmaceutically active agent in the solvent, a pharmaceutically acceptable bio-adhesive carrier in an amount from about 5-50% w/w and (d) a cohesive increasing amount of a clay, etc.
In particularly preferred embodiments, the active agent is an anesthetic agent (col. 6, lines 1-2), including local anesthetic agents in free base form such as, lidocaine, procaine, prilocaine, etc. or local anesthetic agents in salt form, such as, prilocaine, tetracaine, bupivacaine, cyclonine, dibucaine, lidocaine, etc. Combination of local anesthetics with one in base form and another in salt form are contemplated (col. 8, lines 54-56).
Contemplated pharmaceutical carriers include liquids and solids, such as bio-adhesive (col. 8, line 56-60). Particular solid and semi-solid forms contemplated include gels, plaster, pastes (col. 8, lines 60-65)
Local anesthetic agents are specifically taught as being suitable pharmaceutically active agents and include amides, such as, lidocaine, prilocaine, mepivacaine, bupivacaine, etc. and esters, such as, procaine, tetracaine, propoxycaine, benzocaine, etc. (col. 3, lines 17-22; 42-48; claims 3, 6, 14-18, 19-22, and 24). The preferred local anesthetic base is lidocaine and the preferred local anesthetic salt is a salt of prilocaine, bupivacaine, dyclonine, mepivacaine, or tetracaine, preferably the HCl salt (col. 8, lines 17-20).
Generally, the concentration of solubilized pharmaceutically active agent can range on a weight basis between about 1 and about 50%, preferably about 2.5 and about 40%, and more preferably between about 5 and 30% of the composition. (col. 8, lines 1-9)
Various solvents are disclosed with polyhydric alcohols or combination thereof being preferred (col. 3, line 66 through col. 4, line 8; col. 4, lines 28-37; and claims 10-18, and 27), included in the preferred polyhydric alcohols are dipropylene glycol, glycerin, propylene glycol, butylene glycol, and sorbitol (col. 4, lines 33-37; col. 5, lines 24-36). Other contemplated solvents as being suitable include dimethylsulfoxide (i.e., DMSO) (col. 5, line 36).
Contemplated bio-adhesives include gums and celluloses, including cellulose derivatives (e.g., methyl cellulose, propyl cellulose, hydroxyethylcellulose, and the like, etc.) (col. 10, lines 13-18, 32-38, and 39-44; claims 8-9).
Suitable clays are disclosed at col. 4, lines 50-58 and include kaolinites, e.g., boalinite, anauxite, dickite, and nacrite; montmorillonites, such as, montmorillonite, bentonite, bordellite, and montronite; polygorshites, such as, attapulgite, galloysite; aluminum silicate clays, etc. Clays are used in amount of about 0.5 to about 20% w/w, preferably about 0.5 to about 10% w/w (col. 4, lines 62-63).
Typical, preferred, and optimal amounts by % weight of adhesive, solvent (with plasticizer), Drug(s), and clay are disclosed in the table at col. 11, lines 1-10, including adhesives in amounts of 15-60% w/w (typical), 20-50% w/w (preferred), and 20-35 % w/w (optimal).
Kanios exemplifies in Example 1 the following compositions and preparation thereof, wherein the compositions disclosed comprise in part lidocaine base (8% w/w), dipropylene glycol (5% w/w), 60% lecithin in propylene glycol (8% w/w), karaya gum (5% w/w), bentonite (2.0 % w/w), glycerin (6% w/w) etc.
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Applicant Claims
2. Determining the scope and contents of the prior art.
3. Ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-13 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kanios et al. (“Kanios”; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995).
Applicant Claims
Applicant claims an anesthetic composition and method of administering one or more pharmaceutical active agents, as generally described above, and incorporated herein by reference.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Kanios are set forth above and incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Kanios does not exemplify a formulation comprising an amide local anesthetic (e.g., lidocaine) in an amount of 5% or 7%, as in instant claim 6, and does not exemplify a formulation comprising claim within the range recited in dependent claim 8. Thus, Kanios does not anticipate claims 6 and 8. These deficiencies are nonetheless fairly suggested by the teachings of Kanios.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to obtain an anesthetic composition per the teachings of Kanios comprising 5% or 7% lidocaine, because the concentration of lidocaine exemplified by Kanios is very close in magnitude to the amount of lidocaine recited in dependent claim 6 and the person of ordinary skill in the art would have expected that formulations comprising 5%, 7%, and 8% lidocaine would exhibit the same or substantially similar properties. Moreover, Kanios teaches a suitable range for of pharmaceutically active agent, e.g., local anesthetics that encompasses the amounts recited in claim 6 of between about 1 and about 50%, preferably about 2.5 and about 40%, and more preferably between about 5 and 30% of the composition. It would have been prima facie obvious to optimize the amount of amide local anesthetic in Kanios’ exemplified formulations with a reasonable expectation of success and to arrive at formulations comprising an amide local anesthetic in an amount of 5% or 7%.
Similarly, with respect to the recited amount of clay in dependent claim 8, Kanios teachings an overlapping range of suitable amounts of clay of amount of about 0.5 to about 20% w/w. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. A prima facie case of obviousness also exists wherein the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985) (holding that a rejection of a claim directed to an alloy of titanium “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium was proper); MPEP § 2144.05.
The Examiner notes Applicant’s data present in various tables in the specification, however, this data is not presented with evidence of statistical significance and the rejected claims are not commensurate in scope with the compositions evaluated to obtain these data. Consequently, the rejected claims do not appear to have any secondary considerations present that could overcome the instant prima facie case of obviousness.
Claim 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kanios et al. (“Kanios”; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995) as applied to claims 1-13 and 20 above, and further in view of Kulichikhin et al. (US PG-PUB 2003/0225356; “Kulichikhin”; published December 4, 2003).
Applicant Claims
Applicant claims an anesthetic composition comprising (a) 1-10% w/w of anesthetic agent, (b) 5-60% of talc, (c) 20-90% of a pharmaceutically acceptable vehicle, and/or (d) 1-5% of hydroxypropylcellulose (HPC). The Examiner notes that HPC is not a required component of the claimed formulation of rejected claim 14.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Kanios are set forth above and incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Kanios does not teach the use of talc as the clay in his compositions. This deficiency is cured the teachings of Kulichikhin, who teaches skin-contacting adhesive compositions (abstract) wherein clay particles impart many of the beneficial aspects of the invention. For example, the clay particles: help to provide a wicking action to remove moisture from the skin surface and store it; reinforce the yield behavior that prevents the cold flow; help the composition maintain its adhesive nature as well as providing structural support to supply the high elastic recoil at application of skin-contacting adhesive (SCA) on the sole of foot, etc. (paragraph [0079]). Suitable clay minerals include kaolite (i.e., kaolin), montmorillonite , talc, etc. paragraph [0084]. Kulichikhin also claims a wound dressing comprising about 2-30 wt. % of reinforcing clay particles (claim 80).
In light of the teachings of Kulichikhin a person of ordinary skill in the art would have been motivated to use talc as a clay in Kanios’ formulations, because like other claims recognized by Kanios as being suitable, like kaolite (i.e., kaolin) and montmorillonite, talc is recognized as providing desirable properties to adhesive skin compositions. An ordinary skilled artisan would have been motivated to combine the teachings of Kanios and Kulichikhin with a reasonable expectation of success because both references are in the same field of endeavor of providing skin adhesive compositions comprising pharmaceutical agents for delivery to the skin. Moreover, the person of ordinary skill in the art would have been motivated to use talc in the amounts taught by Kanios as being suitable for clays such in an amount of 2-30% w/w. With respect to the selection tetracaine as the local anesthetic, the Examiner notes that Kanios teaches tetracaine as a suitable local anesthetic to use, thus, inclusion of tetracaine in Kanios formulations within the range taught as being suitable would have provided PHOSITA ample motivation and a reasonable expectation of success of obtaining an anesthetic composition such as in rejected claim 15. With respect to rejected claim 16, the Examiner notes that Kanios explicitly contemplates the combination of local anesthetics and explicitly highlights the combination of a local anesthetic in base form and another local anesthetic in salt form in ratios as taught at col. 8, lines 10-17. The Examiner notes Applicant’s data present in various tables in the specification, however, this data is not presented with evidence of statistical significance and the rejected claims are not commensurate in scope with the compositions evaluated to obtain these data. Consequently, the rejected claims do not appear to have any secondary considerations present that could overcome the instant prima facie case of obviousness.
Allowable Subject Matter
Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art references of record are Kanios and Kulichikhin which generally teach skin adhesive compositions comprising a pharmaceutically active agent (e.g., lidocaine or tetracaine) that also comprise clay, solvent, and an adhesive (e.g., a bio-adhesive). However, neither Kanios or Kulichikhin fairly teach such compositions comprising low amounts of hydroxypropylcellulose. For example, Kanios teaches bio-adhesives include cellulosic materials such as hydroxyethylcellulose and the like in a minimum amount of 15% w/w and Kulichikhin teaches HPC as a suitable material for use in skin adhesive compositions, however instant claims 17-19 recite small amounts of HPC of 1% w/w and there is no motivation for the ordinary skilled artisan to drastically reduce the amount of HPC taught/suggested by the prior art to the amounts recited in the claims.
Conclusion
Claims 1-16 and 20 are rejected. Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 1-2 and 13-14 are objected to for minor informalities.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES H. ALSTRUM-ACEVEDO whose telephone number is (571)272-5548. The examiner can normally be reached M-T/R-F 10 AM to 7:00 PM EDT; W 10 AM to 5 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer “Jenni” K. Michener can be reached at (571) 272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES HENRY ALSTRUM-ACEVEDO
Supervisory Patent Examiner
Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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