DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-43, filed 7 March 2024, are pending in the present application.
Claim Objections
Claims 1, 11, 13, 26 and 38 are objected to because of the following informalities: claim 1 recites “TU”, but should recite “testosterone undecanoate (TU)” the first time it is used in the claims; claims 11, 26 and 38 recite “is substantially homogeneous” in subscript; and claim 13 repeats “glyceryl monolinoleate [in] an amount of about 50-70 w/w % of said pharmaceutical composition”. 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.
Claims 1-2, 5-8, 14, 20-23, 29, 35-37 and 41 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance,
claim 1 recites the broad recitation “about 112.5 ± 25 mg”, and the claim also recites “112.5 ± 20 mg, 112.5 ± 15 mg, 112.5 ± 10 mg, 112.5 ± 7.5 mg, and 112.5 ± 5 mg”, which is the narrower statement of the range/limitation;
claim 1 also recites the broad recitation “about 60.5 ± 5 °C”, and the claim also recites “about 60.5 ± 3.5 °C, about 60.5 ± 2.5 °C, about 60.5 ± 2.0 °C, about 60.5 ± 1.5 °C, and about 60.5 ± 1.0 °C”, which is the narrower statement of the range/limitation;
claim 1 also recites the broad recitation “about 10-20”, and the claim also recites “about 12-18, and about 14-16”, which is the narrower statement of the range/limitation;
claim 2 recites the broad recitation “about 40-80”, and the claim also recites “about 45-75, about 50-70, about 55-65, and about 57-63”, which is the narrower statement of the range/limitation;
claim 2 also recites the broad recitation “about 2-24”, and the claim also recites “about 5-30, about 8-25, about 10-20, about 12-18, and about 14-16”, which is the narrower statement of the range/limitation;
claims 5, 20 and 35 recite the broad recitation “more than… 10%”, and the claims also recite more than “15%, 25%, 50%, 75%, 100%, 125%, 150%, 200%, and 250%”, which is the narrower statement of the range/limitation;
claims 6, 21 and 36 recite the broad recitation “greater than… 2.5 years”, and the claims also recite greater than “3.0 years, 4.0 years, and 5.0 years”, which is the narrower statement of the range/limitation;
claims 7, 22 and 37 recite the broad recitation “about 200 ng/dL to about 800 ng/dL”, and the claims also recite “about 300 ng/dL to about 700 ng/dL, about 400 ng/dL to about 600 ng/dL, about 450 ng/dL to about 550 ng/dL, and about 475 ng/dL to about 525 ng/dL”, which is the narrower statement of the range/limitation;
claims 8 and 23 recite the broad recitation “less than… 200 hours”, and the claims also recite less than “150 hours, 140 hours, 130 hours, 125 hours, 120 hours, 115 hours, 110 hours, 105 hours, and 100 hours, 95 hours, 90 hours, 85 hours, 80 hours, 75 hours, 72 hours, 70 hours, 68 hours, and 65 hours”, which is the narrower statement of the range/limitation;
claims 14, 29 and 41 recite the broad recitation “less than… 5%”, and the claims also recite less than “4%, 3%, 2.75%, 2.5%, 2.25%, and 2.0%”, which is the narrower statement of the range/limitation; and
claims 14, 29 and 41 also recite the broad recitation “more than… 12,500”, and the claims also recite more than “15,000, 17,500, 20,000, 25,000, 30,000, 35,000, 40,000, 45,000, and 50,000”, which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claims, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15, 30 and 42 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding claims 15, 30 and 42, the claims recite a property of compositions that are outside the scope of the composition being prepared by the instantly claimed methods. The claims do not recite additional limitations regarding the compositions prepared by the methods of claims 1, 17 and 32. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
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 1-2, 7-11, 13-15, 17-18, 22-26, 28-30, 32-33, 37-38 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 2021/0169899 A1) as evidenced by Pharma IQ Glossary: Capsule Banding.
Patel et al. teach throughout oral pharmaceutical compositions for use in testosterone replacement therapy applications, wherein the compositions comprise testosterone undecanoate and a pharmaceutically acceptable carrier.
Regarding claims 1, 17 and 32, Patel et al. teach a unit dosage form comprising about 112.5 mg testosterone undecanoate, and a pharmaceutically acceptable carrier, wherein the unit dosage form is a capsule ([0045]-[0046], [0056], [0060], [0075], [0077], [0079], [0081], [0083]-[0087], [0089], [0103]-[0104], [0108]-[0113]; Claims 1, 3, 13-15, 18). Patel et al. teach a method of preparing unit dosage forms comprising disposing the mixture of API (testosterone undecanoate) and carrier into a capsule at a temperature of 50-70 °C ([0108]-[0113]).
Patel et al. do not explicitly disclose a capsule comprising a body and cap. However, Patel et al. teach that the capsules are banded if required ([0110]). As evidenced by Pharma IQ Glossary, banding is a process wherein the joint between the capsule cap and body are sealed to ensure the filling of the capsule stays inside and remains usable all the way up until consumption. Thus, the capsule of Patel et al. will necessarily have a body and cap, wherein the seam can be banded to substantially seal the composition therein if required.
Regarding the insertion temperature, Patel et al. teach a method of preparing unit dosage forms comprising disposing the mixture of API (testosterone undecanoate) and carrier into a capsule at a temperature of 50-70 °C ([0108]-[0113]).
Regarding the testosterone undecanoate loading strength, Patel et al. teach that the percent loading of API can vary in compositions, e.g., the API loading can be 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49% or 50% ([0103]). Patel et al. teach that in one aspect, the pharmaceutical composition comprises from about 10% to 50%, from about 14% to about 40%, from about 14% to 18%, or from about 14% to 16% testosterone undecanoate ([0104]).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare the pharmaceutical product according to Patel et al. comprising disposing a composition comprising 112.5 mg testosterone undecanoate and a pharmaceutically acceptable carrier in a capsule body at a temperature of 50-70 °C, and a loading of 10-20%, followed by combining the capsule body and cap in order to seal the composition inside the capsule.
Regarding claims 2, 18 and 33, Patel et al. teach that the unit dosage form usually contains a lipophilic additive, a hydrophilic additive, a solidifying agent, or one or more other additives ([0061]). The lipophilic surfactants can comprise at least about 10, 20, 30, 40, 50, 60, 70, 80, or 90 wt % of the total pharmaceutically acceptable carrier ([0064], [0074]-[0084], [0088]-[0090]; Tables A-E).
Regarding claims 7, 22 and 37, Patel et al. teach that the unit dosage form provides a serum testosterone Cavg of 400-800 ng/dL when administered as 2, 3, or 4 unit dosage forms twice daily ([0056], [0060]; Claims 7-8).
Regarding claims 8 and 23, Patel et al. teach that the composition is prepared by weighing all of the components, except the API into a clean stainless steel container and mixed together at ambient temperature or at elevated temperatures e.g., at about 25 °C to about 30 °C, at about 30 °C to about 35 °C, at about 35 °C to about 40 °C, at about 40 °C to about 45 °C, at about 45 °C to about 45 °C, or 50 °C to about 70 °C, using a stirrer. The API is added and stirred into the mixture of other components until the API dissolves. A predetermined quantity of this “liquid fill material” is disposed into a capsule (for example, hard gelatin capsule) to get the required API dose per dosage unit. The capsules are allowed to cool at room temperature, banded (if required) and packaged in a HDPE bottle and tightly closed with an appropriate lid ([0110]). Therefore, Patel et al. teach a holding step wherein the API and the mixture of other components are combined before being disposed into a capsule. It is noted that a holding step of less than 200 hours includes any amount of time from 0 to 200 hours wherein the composition is held prior to the inserting step.
Regarding claims 9 and 24, Patel et al. teach that the capsules are banded if required ([0110]). As evidenced by Pharma IQ Glossary, banding is a process wherein the joint between the capsule cap and body are sealed to ensure the filling of the capsule stays inside and remains usable all the way up until consumption. Thus, the capsule of Patel et al. will necessarily have a body and cap, wherein the seam can be banded to substantially seal the composition therein if required.
Regarding claims 10 and 25, Patel et al. teach mixing the pharmaceutical composition prior to inserting into the capsule body ([0108]-[0113]).
Regarding claims 11, 26 and 38, Patel et al. teach that in one specific aspect, the carrier(s) and API are brought to or maintained at a temperature at which they are flowable (e.g., above 10 °C, 20 °C, 25 °C, 30 °C, 35 °C, or 40 °C). In one aspect, the mixture of carrier and API is a clear solution at a specified temperature (e.g., above 10 °C, 20 °C, 25 °C, 30 °C, 35 °C, or 40 °C) ([0109]). Patel et al. teach mixing the API (testosterone undecanoate) and carrier at a temperature of 50-70 °C ([0110], [0113]).
Regarding claims 13, 28 and 40, Patel et al. teach the pharmaceutically acceptable carrier comprising glyceryl monolinoleate (Claim 4). Patel et al. teach that various lipophilic surfactants can be used including, but not limited to mono-, di-glycerides of fatty acids like glyceryl monolinoleate (e.g., Maisine® 35-1) ([0063]-[0064], [0091], [0101]). Patel et al. teach that the lipophilic surfactants can comprise at least about 10, 20, 30, 40, 50, 60, 70, 80, or 90 wt % of the total pharmaceutically acceptable carrier ([0064]).
Regarding claims 14, 29 and 41, Patel et al. teach in another embodiment, the unit dosage form has a release profile (e.g., single or multiple point) of TU using a USP type 2 apparatus in about 1000 mL 8% Triton X100 solution in water at a specific temperature (e.g., 20.0, 37.0 or 40.0° C. (±0.5)) at 100 rpm that releases at least 10, 20, 30, 40, 50, 60, 70, 75, 80, 85, 90, 95, 96, 97, 98, or 99% at 15, 20, 30, 40, 45, 50, 60, 90, 120, 180, 240, or 300 minutes. In a specific aspect, the unit dosage form having or made from solid releases greater than 85% at 4 hours; greater than 70% at 2 hours; or greater than 60% at 1 hour. In a specific aspect, the unit dosage form has a release profile that releases less than 100% (or 95%) at 15 minutes or less than 100% (or 95%) at 30 minutes. In a specific aspect, the unit dosage form releases less than 10, 20, 30, 40, 50, 60, 70, 75, 80, 85, 90, 95, 96, 97, 98, or 99% at 15, 20, 30, 40, 45, 50, 60, 90, 120, 180, 240, or 300 minutes ([0107]).
Regarding claims 15, 30 and 42, the claim recites a property of compositions that are outside the scope of the composition being prepared by the instantly claimed method. The claim does not recite additional limitations regarding the composition prepared by the method of claim 1.
Claims 1-4, 7-19, 22-34 and 37-43 are rejected under 35 U.S.C. 103 as being unpatentable over Giliyar et al. (US 2020/0360402 A1) as evidenced by Pharma IQ Glossary: Capsule Banding.
Giliyar et al. teach throughout pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate.
Regarding claims 1, 17 and 32, Giliyar et al. teach that the oral dosage capsules can include dosages of testosterone undecanoate of at least 50 mg, about 80 mg to about 400 mg, about 80 mg to about 140 mg, about 120 mg to about 300 mg, or about 150 mg to about 250 mg of testosterone undecanoate ([0068]; Tables X, XII).
Giliyar et al. do not explicitly disclose a capsule comprising a body and cap. However, Giliyar et al. teach that the capsules are banded if required ([0115]). As evidenced by Pharma IQ Glossary, banding is a process wherein the joint between the capsule cap and body are sealed to ensure the filling of the capsule stays inside and remains usable all the way up until consumption. Thus, the capsule of Giliyar et al. will necessarily have a body and cap, wherein the seam can be banded to substantially seal the composition therein if required.
Regarding the insertion temperature, Giliyar et al. teach a method of preparing unit dosage forms comprising disposing the mixture of API (testosterone undecanoate) and carrier into a capsule at a temperature of 50-70 °C ([0115], [0124], [0132], [0134]).
Regarding the testosterone undecanoate loading strength, Giliyar et al. teach that capsule fill compositions with a lower TU loading of less than 14% w/w are unsuitable for optimal activity due to inadequate bioavailability which also leads to larger dosage forms/doses for therapy in treatment of symptoms related to male hypogonadism. Consistent with the compositions of the present invention, higher loading dosage forms, i.e. those with >14% w/w of TU based on total capsule fill, resulted in a superior Cave per mg testosterone undecanoate administered, thus providing improved performance of oral testosterone undecanoate as a testosterone therapy ([0009]). Therefore, in one embodiment in order to facilitate improved activity, an oral capsule with TU loading in the range of about 14 wt% to about 18% is provided ([0010], [0067]; Tables I, II, XII, XIV, XV, XVI, XVIII, XIX).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare the pharmaceutical product according to Giliyar et al. comprising disposing a composition comprising at least 50 mg, such as 112.5 ± 25 mg, testosterone undecanoate in a capsule body at a temperature of 50-70 °C, and a loading of >14%, such as about 14 wt% to about 18 wt%, followed by combining the capsule body and cap in order to seal the composition inside the capsule.
Regarding claims 2, 18 and 33, Giliyar et al. teach that the dispersant of the current invention is at least one selected from the group of hydrophilic surfactant or lipophilic surfactant ([0019], [0074]). In another aspect of the invention, the pharmaceutical compositions and/or oral dosage capsules, namely the capsule fill, can include a solidifying agent ([0083]).
Regarding claims 3-4, 19 and 34, Giliyar et al. teach that “non-liquid” when used to refer to the state of a composition disclosed herein refers to the physical state of the composition as being a semi-solid or solid ([0031], [0083]).
Regarding claims 5-6, 20-21 and 35-36, Giliyar et al. teach that it was found that the pharmaceutical compositions and oral dosage capsules of the present invention have the ability to provide for increased stability of the testosterone undecanoate present in the formulation. In particular, the pharmaceutical compositions and oral dosage capsules of the present invention can provide for superior stability with respect to the degradation of the testosterone undecanoate that can occur during storage as compared to other formulation containing lower testosterone undecanoate concentration. In one embodiment, the pharmaceutical compositions and oral dosage capsules of the present invention can have increased stability such that, when stored for a period of at least three months there is at least 20% less degradation of the testosterone undecanoate as compared to testosterone undecanoate containing compositions having less than 14 wt % testosterone undecanoate. In another embodiment, the pharmaceutical compositions and oral dosage capsules of the present invention can have increased stability such that, when stored for a period of at least three months there is at least 20% less degradation of the testosterone undecanoate as compared to testosterone undecanoate containing compositions having less than 16 wt % testosterone undecanoate ([0064]; Example 38).
The Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Regarding claims 7, 22 and 37, Giliyar et al. teach that the oral dosage capsules of the present invention can be formulated such that, when administered to a human male they provide a serum total testosterone Cavg ranging about 300 ng/dL to about 1100 ng/dL. In another embodiment, the oral dosage capsules can be formulated such that, upon single administration to a human male, they provide a serum total testosterone Cavg ranging about 350 ng/dL to about 800 ng/dL. In another embodiment, the oral dosage capsules can be formulated such that, upon single administration to a human male, they provide a serum total testosterone Cavg ranging from about 400 ng/dL to about 600 ng/dL ([0090], [0092], [0112]; Claim 32).
Regarding claims 8 and 23, Giliyar et al. teach that the composition is prepared by weighing all of the components, except the testosterone undecanoate, into a clean stainless steel container and mixed together at about 50 °C to about 70 °C, using a stirrer. The testosterone undecanoate (TU) is added and stirred into the mixture of other components until the testosterone undecanoate dissolves. A predetermined quantity of this fill material is disposed into a capsule (for example, hard gelatin capsule) to get the required testosterone undecanoate dose per dosage unit. The capsules are allowed to cool at room temperature, banded (if required) and packaged in a HDPE bottle and tightly closed with an appropriate lid ([0115]). Therefore, Giliyar et al. teach a holding step wherein the API and the mixture of other components are combined before being disposed into a capsule. It is noted that a holding step of less than 200 hours includes any amount of time from 0 to 200 hours wherein the composition is held prior to the inserting step.
Regarding claims 9 and 24, Giliyar et al. teach that the capsules are banded if required ([0115]). As evidenced by Pharma IQ Glossary, banding is a process wherein the joint between the capsule cap and body are sealed to ensure the filling of the capsule stays inside and remains usable all the way up until consumption. Thus, the capsule of Patel et al. will necessarily have a body and cap, wherein the seam can be banded to substantially seal the composition therein if required.
Regarding claims 10 and 25, Giliyar et al. teach mixing the pharmaceutical composition prior to inserting into the capsule body ([0115], [0124], [0132], [0134]).
Regarding claims 11, 26 and 38, Giliyar et al. teach continuous mixing at about 50 °C to 70 °C ([0132]).
Regarding claims 12, 27 and 39, Giliyar et al. teach that the capsule size can be any size known in the art and can vary depending on the desired dosage amount. In one embodiment, the capsule can be a hard gelatin capsule having a fill volume of about 0.3 mL to about 1.1 mL. The capsule can have a ratio of the amount of testosterone undecanoate to the volume of the capsule fill can be about 80 mg/mL to about 750 g/mL. In another embodiment, the capsule can have a ratio of the amount of testosterone undecanoate to the volume of the capsule fill can be about 160 mg/mL to about 375 mg/mL ([0084]). It is noted that a known industry-standardized size of 00 capsule is approximately 0.95 ml/800 mg.
Regarding claims 13, 28 and 40, Giliyar et al. teach compositions comprising 50-70 wt.% Maisine® 35-1 (i.e., glyceryl monolinoleate) (Tables XVI, XVIII, XIX).
Regarding claims 14, 29 and 41, Giliyar et al. teach that the oral dosage capsules of the present invention can be formulated such that they have distinctive release profiles ([0084]-[0086], [0094]-[0096], [0127]-[0131]).
Regarding claims 15, 30 and 42, the claim recites a property of compositions that are outside the scope of the composition being prepared by the instantly claimed method. The claim does not recite additional limitations regarding the composition prepared by the method of claim 1.
Regarding claims 16, 31 and 43, Giliyar et al. teach that as used herein, the terms “solubilized” and “solubility,” when used to describe the state of testosterone undecanoate with respect to a composition and/or capsule fill, refer to the absence of testosterone undecanoate crystals in the composition or oral dosage form when observed under hot-stage microscope over a temperature of about 25 °C to about 65 °C, or the absence of crystalline testosterone undecanoate melting related peak (about 62 to about 65 °C) when the composition or oral dosage form is subjected to differential scanning calorimetry ([0021]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616