-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 .
Applicant’s response dated October 21, 2025 is acknowledged.
Priority
This application is a 371 of PCT/JP2021/001027 filed on 01/14/2021, which claims foreign priority in Japanese application JP2020-005214 filed on 01/16/2020.
Claim Status
Claims 1-11 and 15 are pending and examined. Claims 1-6 and 15 were amended. Claims 12-14 were canceled.
Withdrawn Claim Rejections — 35 USC § 112
Rejections of claims 3-6 and 12-14 are withdrawn because rejections were obviated with claim amendments.
Modified Claim Rejections — 35 USC § 103
Necessitated by Amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
Claims 1-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moline (WO 2016/063995 Al Published April 28, 2016 – of record in PTO-892 dated July 30, 2025) and Gupta (WO 2011/045760 A2 Published April 21, 2011 – of record in PTO-892 dated July 30, 2025) as evidenced by Memorandum (Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, pages 1-26, Date October 28, 2019 – of record in PTO-892 dated July 30, 2025).
The claims encompass a lemborexant active pharmaceutical ingredient, which is a granular material having a 90% cumulative diameter of 64 microns or less, a pharmaceutical composition comprising said ingredient, and a method of producing said composition.
The teachings of Moline are related to compositions and methods for treating insomnia comprising compounds such as (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3- fluorophenyl)N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide (herein referred to as Compound A) (Abstract and paragraph 0002), which has the structure
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(paragraph 0003). Moline further teaches a pharmaceutical composition comprising Compound A in a therapeutically effective amount (paragraph 0007). In a method of treating insomnia, a dosage form with a therapeutically effective amount of Compound A is administered orally, wherein said therapeutically effective amount in single daily dose ranges from about 1 mg to about 15 mg, 2-15 mg, 2-10 mg, or specifically includes 2 mg, 2.5 mg, 4 mg, 5 mg, 8 mg, 10 mg, or 15 mg (paragraphs 0008-0011). In another embodiment, an oral dosage form is provided for treating insomnia comprising a therapeutically effective amount of compound A and at least one pharmaceutically acceptable excipient, wherein said therapeutically effective amount is single daily dose ranging from about 1 mg to about 15 mg (paragraph 0034). In certain embodiments, an oral pharmaceutical dosage form is provided comprising a pharmaceutically acceptable excipient and an effective amount of compound A for treating insomnia, the dosage form providing an dissolution rate of 85 % or more in dissolution medium (0. 1 mol/L hydrochloric acid, 900 mL, 37 + 0.5°C) within 15 minutes from the onset of dissolution study using the Apparatus 2 (Paddle Apparatus, paddle speed; 50 rpm) according to the procedure for immediate-release dosage form in 6.10 Dissolution test of JP16 or <71 1> Dissolution of USP37 (paragraph 0057). Fig.2 shows dissolution profiles of compound A 1 mg, 2.5 mg, 5 mg, 10 mg and 25 mg tablets (paragraph 0079). Solid dosage forms include capsules, granules, lozenges, pellets, pills, powders, suspensions, tablets, preferably capsules, granules, pellets, pills, and tablets (paragraph 0161).
The pharmaceutical composition for solid dosage form may be prepared, for example, powders is prepared by dry blending the components. For example, Compound A, one or more diluents, one or more optional excipients (e.g., binders and/or disintegrants, as well as other additional optional excipients) are blended together. The components of the blend prior to blending, or the blend itself, may be passed through a mesh screen, for example a 400-700 pill mesh screen. A lubricant, which may also be screened, is then added to the blend and blending is continued until a homogeneous mixture is obtained as granules. The mixture is then compressed into tablets. Alternatively, a wet granulation technique can be employed. For example, the active agent and excipient(s) are blended together, for example by using a granulator, and the powder blend is granulated with a small volume of purified water. The resultant wet granule is dried and passed through a mill to obtain as granules. Furthermore, a disintegrator and a lubricant are added to the milled granules and after blending the resultant homogeneous mixture is compressed into tablets (paragraph 0163).
Moline does not teach D90 diameter of the granules.
The teachings of Gupta are related to micronized olmesartan medoxomil compositions (Abstract). Olmesartan medoxomil is practically insoluble in water. This leads to a low rate of dissolution of olmesartan medoxomil in aqueous media (including gastrointestinal fluids), which results in inadequate bioavailability after oral ingestion. Two most common approaches employed in the prior art to increase the dissolution rate of a poorly soluble drug are either a reduction of the particle size of the drug or the addition of a surfactant. Reduction of particle size leads to increased surface area and addition of surfactant improves the surface properties of the drug particles, thereby improving the dissolution characteristics of a poorly soluble drug. For most of the drugs neither of the approaches used alone improve dissolution characteristics. The
reduction of the particle size of hydrophobic drugs also lead to increased surface charges resulting in the agglomeration of the particles, especially in an aqueous media because of thermodynamic repulsion. This results in significant decrease in the effective or exposed surface area available for dissolution. This tendency of micronized particles to agglomerate is generally reduced by the addition of a surfactant (from page 1 line 18 to page 2 line 2). Gupta teaches further reduction of the particle size of olmesartan medoxomil having D90 of less than 50 um, having a D90 of 2-25 micron, and having a D90 of 4-10 micron even without addition of a surfactant which leads to remarkably improved solubility characteristics and as a result, a pharmaceutical composition having an improved dissolution profile is obtained. The micronized particles of olmesartan medoxomil are present in an amount of about 2% to about 80% by weight of the composition. The pharmaceutical composition may further include one or more pharmaceutically acceptable excipients selected from a group comprising diluents, binders, disintegrants, lubricants, glidants, surfactants, coloring agents or flavoring agents. The pharmaceutical composition is in the form of a tablet, dispersible tablet or granules (page 2 lines 8-26).
The Memorandum is relied upon to show that lemborexant is practically insoluble in water (last paragraph on page 4).
The teachings of Moline and Gupta are related to drug formulations comprising drugs that are practically insoluble in water and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed a granular lemborexant composition, with a reasonable expectation of success because Moline teaches
lemborexant in the form of granules. Moline does not teach particle size of the granules. A person skilled in the art would have been motivated to look to the teachings of Gupta because Gupta is concerned with improving water solubility and bioavailability of practically insoluble drugs. It would have been obvious to have micronized the granules of Lemborexant to have a D90 of less than 50 microns, with a reasonable expectation of improving water solubility and bioavailability of lemborexant because Gupta teaches that reduction of particle size of poorly water soluble drugs to D90 of less than 50 microns leads to remarkably improved solubility characteristics and as a result, a pharmaceutical composition having an improved dissolution profile is obtained. It was known that particle size reduction or addition of surfactant are two of the most common approaches employed in order to increase the dissolution of poorly soluble drugs and Gupta teaches that reduction of particle size of D90 of less than 50 microns improves water solubility and dissolution even without addition of surfactant. The selection of a known particle size range based on its suitability for its intended purpose supports obviousness. Modifying Moline in view of Gupta would have improved Moline and the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In certain embodiments, Moline teaches an oral pharmaceutical dosage comprising a pharmaceutically acceptable excipient and an effective amount of compound A for treating insomnia, the dosage form providing a dissolution rate of 85 % or more in dissolution medium (0.1 mol/L hydrochloric acid, 900 mL, 37 + 0.5°C) within 15 minutes from the onset of dissolution study using the Apparatus 2 (Paddle Apparatus, paddle speed; 50 rpm) according to the procedure for immediate-release dosage form in 6.10 Dissolution test of JP16 or <71 1>
Dissolution of USP37 (paragraph 0057). Moline further teaches that the composition is an immediate release dosage form (paragraph 0158), where dissolution of an immediate release composition is described in paragraphs 0159-0160. Thus, the purpose of Moline is to form an immediate release dosage form of lemborexant and a person skilled in the art would have varied the D90 particle size in the range of less than 50 microns until a granular composition having desired immediate release, water solubility, and dissolution is obtained. One of skill would have had a reasonable expectation of success because it was known from Gupta that reduction of particle size of practically water insoluble drugs to D90 of less than 50 microns improves solubility and dissolution. The claimed particle size range D90 of 20-64 micron is obvious because it overlaps with D90 of less than 50 microns.
Regarding claim 2, it would have been obvious to have formed a pharmaceutical composition comprising lemborexant granular material having D90 of 50 microns and less and a pharmaceutically acceptable additive, with a reasonable expectation of success because Moline by Gupta teaches a pharmaceutical composition comprising Lemborexant having a D90 of less than 50 microns and at least one pharmaceutically acceptable excipient wherein the composition is in the form of granules. The claimed particle size range 20-64 microns is obvious because it overlaps with 50 microns and less.
Claims 3-6 describe dissolution properties of the composition of claim 2 under different dissolution test conditions. Moline does not teach the same dissolution conditions as claimed, however it would have been reasonable expect Moline’s composition modified by Gupta to have dissolution properties that overlap with the presently claimed dissolution properties when tested under identical conditions because Moline’s composition modified by Gupta meets all of the structural limitations of the claimed composition and a composition and its properties are inseparable.
Regarding claim 7, it would have been obvious to have formed the composition of Moline modified in view of Gupta as a tablet because Moline teaches tablet as a suitable form of the pharmaceutical composition.
Regarding claim 8-11, it would have been obvious to have formed the composition with Lemborexant in an amount of 1-15 mg and specifically 10 mg, 5 mg, and 2.5 mg, with a reasonable expectation of success because Moline teaches a single daily dose of Lemborexant in the range of 1-15 mg, and specifically 10 mg, 5 mg, and 2.5 mg. The claimed amounts of drug are obvious because they are the same as amounts suggested by Moline’s.
Regarding claim 15, it would have been obvious to have produced the pharmaceutical composition of Moline modified by Gupta by mixing lemborexant with the excipient, with a reasonable expectation of success because Moline teaches forming the pharmaceutical composition by mixing lemborexant with a pharmaceutically acceptable carrier (paragraph 0157).
Combining prior art elements according to known methods to produce predictable results supports obviousness.
Modified Double Patenting Rejections
Necessitated by Amendment
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 1-11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,188,652 B2 in view of Moline, Gupta, as evidenced by Memorandum.
The teachings of Moline, Gupta, and Memorandum are relied upon as summarized above.
Patented claims 1-13 are drawn to method of using a dosage form comprising a therapeutically effective amount of (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy )methyl)-2-(3- fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide, wherein said therapeutically effective amount is a single daily dose ranging from about 2.5 mg to about 10 mg, wherein said single daily dose achieves a mean Cmax of from about 3.0 ng/ml to about 7.2 ng/ml for each 1 mg of the drug. Patented claims 14 and 15 are drawn to an oral dosage form comprising a therapeutically effective amount of (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy )methyl)-2-(3- fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide, lactose and low-substituted hydroxypropyl cellulose, wherein said therapeutically effective amount is a single daily dose ranging from about 2.5 mg to about 10 mg; wherein said dosage form provides a dissolution rate of 85% or more in dissolution medium (0.1 mol/L hydrochloric acid containing 0.5% polysorbate 80, 900 mL, 37+0.5° C.) within 30 minutes from the onset of dissolution study using the Apparatus 2 (Paddle Apparatus, paddle speed; 75 rpm) according to the procedure for immediate-release dosage form in 6.10 Dissolution test of JP16 or <711> Dissolution of USP37.
Patented claims do not teach D90 of lemborexant.
Regarding claims 1 and 2, it would have been obvious to the skilled artisan to have micronized the drug to have a particle size of D90 of less than 50 microns, in order to obtain an immediate release dosage form having improved water solubility and dissolution, with a reasonable expectation of success because it was known from Gupta that water solubility and dissolution of practically water insoluble drugs may be improved by micronizing the drug to a particles size range of D90 of 50 microns or less. Lemborexant is a known poorly water soluble drug and the skilled artisan would have been motivated to rely on the teachings of Gupta in order to form the composition in patented claims.
Claims 3-6 describe dissolution properties of the composition of claim 2 under different dissolution test conditions. Patented claims do not teach the same dissolution conditions as claimed, however it would have been reasonable expect the composition of patented claims as modified by Moline and Gupta to have dissolution properties that overlap with the presently claimed dissolution properties when tested under identical conditions because modified patented composition meets all of the structural limitations of the instantly claimed composition and a composition and its properties are inseparable.
Regarding claim 7, it would have been obvious to have formed the patented composition as a tablet because Moline teaches tablet as a suitable form of the pharmaceutical composition.
Regarding claim 8-11, patented claim 1 teaches a single daily dose of the drug ranging from 2.5 mg to 10 mg. The claimed amounts are obvious because they are encompassed by 2.5- 10 mg.
Regarding claim 15, it would have been obvious to have produced the pharmaceutical composition of modified patented claims by mixing lemborexant with the excipient, with a
reasonable expectation of success because Moline teaches forming the pharmaceutical composition by mixing lemborexant with a pharmaceutically acceptable carrier (paragraph 0157).
Combining prior art elements according to known methods to produce predictable results supports obviousness.
Response to Arguments
Applicant’s arguments submitted in the remarks dated October 21, 2025 were fully considered but are not persuasive for the following reasons.
Applicant’s arguments that the skilled artisan would not have sought to modify the Lemborexant granules of Moline to have a 90% cumulative diameter of 20-64 microns, nor would there have been a reasonable expectation of success in doing so, based solely on Gupta’s characterization of improved solubility of micronized particles of an entirely different drug, are not persuasive because Gupta’s teachings about improved solubility are not limited to the olmesartan medoxomil. Gupta broadly teaches that two most common approaches employed in the prior art to increase the dissolution rate of a poorly soluble drug are either a reduction of the particle size of the drug or the addition of a surfactant. Reduction of particle size leads to increased surface area and addition of surfactant improves the surface properties of the drug particles, thereby improving the dissolution characteristics of a poorly soluble drug. For most of the drugs neither of the approaches used alone improve dissolution characteristics. The reduction of the particle size of hydrophobic drugs also lead to increased surface charges resulting in the agglomeration of the particles, especially in an aqueous media because of thermodynamic repulsion. This results in significant decrease in the effective or exposed surface area available for dissolution. This tendency of micronized particles to agglomerate is generally reduced by the addition of a surfactant (from page 1 line 18 to page 2 line 2). In view of Gupta’s teachings as a whole, a person skilled in the art would have had a reasonable expectation of improving dissolution and bioavailability of Lemborexant by micronizing the drug to a D90 particle size of 50 microns and less. The claimed D90 range is obvious because it overlaps with 50 microns and less.
Applicant argued that claimed D90 range resulted in a significant and unexpected increase in granule dissolution and referred to Tables 6, 7, 10, 11, 12, 16, and 17 of the specification for support.
The arguments and the data in the tables were considered, however they are not sufficient to obviate the grounds of rejection because applicant has not met the requirements set forth in MPEP 716.02. Data in the tables provides a dissolution rate for five particle sizes at five different time points. The data are not sufficient to establish that particles having a D90 in the 20-64 micron range provide statistically unexpected dissolution rates because each dissolution rate is reported as a single value without error or statistical analysis and the skilled artisan cannot determine whether or not the values for particle sizes 20-64 microns are statistically different from particles having a size of 79 and 98 microns. For example, in Table 6 at 5 min, the sample having D90 of 79 microns provided a dissolution rate of 79.4 and the sample having D90 of 64 microns provided a dissolution rate of 82.4. The skilled artisan cannot determine if two values are statistically different. Additionally, any differences in dissolution rates for different particle sizes are expected, the issue is whether the observed differences are in fact unexpected. In the present case it is not clear why the applicant considers the observed values for the range 20-64 microns unexpected. It was known from Gupta that dissolution and bioavailability of water insoluble drugs increases by decreasing particle size D90 at 50 microns and less. Applicant did not show that the claimed range of D90 is critical. The dissolution rates for the upper limit of the range (64 microns) and the lower limit of the range (20 microns) were reported without statistical analysis. Additionally, applicant did not report any dissolution rates for D90 that is less than 20 microns. In order to show criticality of a range, applicant is required to report data points within the claimed range and outside the claimed range in order to show that the claimed range in fact critical. A person skilled in the art cannot determine whether or not D90 of 20 microns is a critical lower limit because there are not data points obtained for particles below 20 microns for comparison.
The claims are not commensurate in scope with the composition that were tested and provided the asserted unexpected dissolution rates. For example, claim 1 is drawn to a Lemborexant active pharmaceutical ingredient having a D90 of 20-64 microns, whereas the tested compositions are described as tablets having 2.5 mg or 10 mg of the drug. Table 3 describes the contents and amounts of said contents in each of the tablets. Applicant did not show with evidence that the asserted unexpected results obtained for the specific tablet compositions would have occurred over the entire breadths of the claims. See MPEP 716.02 for the requirements applicant has to meet in order to rebut an obviousness rejection with unexpected results.
Applicant argued that the skilled artisan would have understood that particle size reduction of a drug does not necessarily lead to an improved dissolution profile thereof. Applicant cited US Patent 9,034,381 from column 2 line 5 to column 3 line 2, and argued that it was known reduction in particle size can lead to a wider particle size distribution, loss of uniformity, and poor manufacturability, which can negatively impact the properties of the API including its dissolution profile.
The argument and the reference were considered, however the reference does not support applicant’s conclusion that reduction in particle size negatively impacts dissolution profile of the API. In view of the teachings of Gupta, the skilled artisan would have had a reasonable expectation of success in obtaining Lemborexant having an improved bioavailability and dissolution rate by reducing the drug particle size to obtain a D90 of 50 microns and less.
Applicant’s statement that a terminal disclaimer was filed to overcome the double patenting rejections is not persuasive because applicant did not file a terminal disclaimer.
Conclusion
No claims are 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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/ALMA PIPIC/
Primary Examiner, Art Unit 1617