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 .
Response to Arguments
Applicant's arguments filed 07/29/2025 with respect to the obviousness rejection have been fully considered but they are not persuasive. The declaration filed 07/29/2025 has been considered but is not persuasive. The Examiner kindly requests that the supplemental drawing submitted 10/07/2024 in App. No. 18/099,319 also be submitted in the file wrapper of the instant application. The first figure in the declaration as filed is illegible. In the interest of compact prosecution however, the present Final Office Action is being mailed as the data appears to be identical to that submitted in the related application.
First, with respect to the declaration filed 07/29/2025, difficulties and unpredictability in the art are acknowledged. However, absolute predictability is not a requirement of obviousness and the level unpredictability in the art must be taken into account when determining obviousness. In the instant case, unpredictability in the pharmaceutical arts is known and routine experimentation of combinations of various excipients in various amounts such as in the present invention is employed in order to address these issues. The teachings of Heda that “appropriate amounts [of glidant and/or lubricant] need to be optimized based on the other physicochemical properties of the active and the excipients in relation to the primary function of the dosage form” indicates that a certain degree of unpredictability is expected and optimization of excipient choice and amount is necessary – this points to the instantly claimed invention being the result of routine optimization of dosage forms in view of the teachings cited drawn to the API, excipients and amounts thereof.
Applicant also asserts in multiple instances that because neither reference teaches the instantly claimed formulation and that neither Heda et al. or Chan et al. are applied to zanubrutinib formulations that the claims are non-obvious. This is not convincing because while the references are not drawn specifically to zanubrutinib, there is no evidence teaching away from combining the references. Absent a teaching away, it would have been prima facie obvious for a skilled artisan to combine the generic teachings of Heda et al. and Chan et al. of pharmaceutical dosages forms for API delivery to the API zanubrutinib taught by the primary ‘853 reference. This is further evidenced by the generic teachings for a capsule dosage form taught by the primary ‘853 patent reference.
Applicant alleges unexpected results with respect to particle size and that “while the 68-um capsule formulation had a dissolution rate faster than that of the 102-um capsule formulation, the 77-um capsule formulation had a dissolution rate slower than that of the 102-um capsule formulation. First, these alleged unexpected results are outside of the scope of the claims which is drawn to “a particle size that is less than or equal to 40 um”. Furthermore, the results discussed are only for the D90 value which cannot on its own be considered to represent the average particle size. Other values such as D50 and D[3,2] do not appear to support the alleged unexpected results. For example, the D-1611FP1788-03 and 1611FP1788-02 D[3,2] values appear to follow the expected dissolution trend (21.2 value of the former having a higher dissolution rate than 38.9). Lastly, the claims do not even specify the measure of particle size used. For example, if D10 is used, all samples have a particle size below 40 um. For at least these reasons the particle size/dissolution rate presented is insufficient to establish unexpected results commensurate with the scope of the claims.
Applicant alleges unexpected results regarding the use of two different types of MCC. First, the claims do not require a type of MCC or particle size thereof and therefore are not commensurate in scope. There also does not appear to be any support in the specification for any limitation drawn to MCC type or particle size, and the alleged unexpected results require a type/particle size of MCC. Furthermore, the addition of a glidant for improving fluidity is known and discussed in the prior art/rejection under 35 U.S.C. 103. It is accordingly not convincing that the addition of a glidant offsetting the poorer fluidity of a certain type of MCC is unexpected. There are also two different variables changed – MCC type and use of glidant – and accordingly the effect of the glidant independent of the effect of the MCC type/particle size is unable to be ascertained from the data.
In summary, while the claimed capsule may exhibit favorable dissolution properties, there is no evidence that said results are unexpected in view of the teachings of the prior art based on the data and explanations thereof provided in the declaration/arguments. The alleged unexpected results also do not appear to be commensurate in scope with the claims. Furthermore, they require limitations which are not in the present claims or supported by the specification and it is therefore unclear how, even if applicant were to successfully argue that there are unexpected results, the claims could be made commensurate.
With respect to applicant’s arguments filed 07/29/2025 for obtaining a capsule formulation with a relatively high concentration of Zanubrutinib. While each of these challenges are acknowledged, difficulties in translating an API to an acceptable dosage form are expected when formulating a dosage form and are the basis of formulation science. The teachings of the Wang et al. for a capsule dosage form comprising various excipients is an implicit acknowledgement of this. Wang et al. provides generic guidance for capsule dosage forms of zanubrutinib and both Heda et al. and Chan et al. provide more specific examples as to acceptable species of excipients and amounts thereof. An explicit teaching to apply said teachings to the generic teachings of Wang et al. for tablet dosage forms of Zanubrutinib is not necessary; a PHOSITA would recognize that the prior art teachings are analogous art.
Applicant states that the combination of references does not provide a finite number of predictable solutions with anticipated success. Said rationale is only one of many possible rationales that may support a conclusion of obviousness and is not the rationale relied upon by the rejection of record.
That Wang fails to mention certain genre or species of excipients and amounts thereof is acknowledged. Nevertheless, a PHOSITA would recognize the teachings of Heda et al. and Chan et al. as applicable to oral capsule dosage forms and therefore applicable to the oral capsule dosage form taught by Wang et al. It would have therefore been prima facie obvious to apply said teachings in view of the reasons provided in the obviousness rejection.
Note that, as stated by applicant, Heda discloses a “typical” formulation. To arrive at a typical formulation for a known API, as is the result of the combination of references relied upon in the obviousness rejection, is prima facie obvious. The combination of references provides guidance for formulating capsule dosage forms, specific genre/species of excipients, and amounts thereof. To combine said teachings – even to select the five specific excipients and amounts thereof in the instant claims – is prima facie obvious in light of the fact that the art provides guidance for such. Said teachings for specific excipients and amounts thereof can be considered to disclose the general conditions of formulating a capsule dosage form, and arriving at the claimed invention therefore amounts to routine optimization.
Applicant cites the teachings of Heda et al. regarding selection of a soluble excipient for poorly soluble APIs and preference for wet-granulation with a soluble binder over inclusion of SLS in the formulation. With respect to the latter, Heda et al. does not provide guidance as to when such exclusion is preferable and the teaching can only be considered to make note of an exception and does not amount to a teaching away. Regarding Heda et al. suggesting the use of a soluble diluent/filler, it is acknowledged that Heda et al. suggests soluble diluents/fillers for poorly soluble drugs. First, it is not clear that zanubrutinib’s classification was disclosed in the prior art at the time of filing. Nevertheless, it is acknowledged that a PHOSITA may have surmised based upon the structure of the API and knowledge in the art that of similar APIs that it would have been a poorly soluble/BSC Class II drug. However, a suggestion to use a soluble diluent/filler is not necessarily a teaching away from using an insoluble filler such as MCC (note that MCC is not even necessarily taught as an insoluble filler by Heda et al.) and, even if it were a teaching away, rebuttal evidence is not evaluated for its “knockdown” value against the prima facie face. Furthermore, US 10688050 B1 to Nieto et al. teaches the compound ibrutinib (structurally and functionally similar to Zanubrutinib) as a BCS class II compound with low solubility and high permeability (Col. 1, lines 60-61) and the IMBRUVICA TM package insert discloses that MCC is used in a successfully marketed formulation of ibrutinib (p. 8). It is clear that a PHOSITA would not have been dissuaded from use of MCC in a zanubrutinib capsule formulation given these teachings, and the teachings of Heda et al. cannot be considered enough of a teaching away from using MCC in the instant formulation to support a conclusion of nonobviousness.
Applicant’s arguments (p. 10-11) regarding the fact that the combination of references do not teach specific guidance regarding Zanubrutinib are not convincing. The references are analogous art and would be considered relevant to the Wang reference when formulating a dosage form. Regarding the statement that applicant is not required to show superior results over any particular prior art Zanubrutinib capsule formulation, it is acknowledged that there are no specific capsule formulations taught by the prior art. However, the claimed formulation is obvious for reasons presented on record. Any formulation of routinely used excipients and amounts thereof would have been considered obvious absent sufficient evidence, i.e. teaching away, unexpected results, a combination thereof etc. to support a conclusion of nonobviousness. The data in the declaration filed 06/14/2024 cannot be considered to show unexpected results commensurate in scope with the claimed invention for reasons outlined in the Non-Final Rejection dated 02/05/2025. The arguments filed 07/03/2025 do not appear to address the arguments presented in the rejection and merely restate the assertions of the declaration and previous arguments.
Applicant is reminded that the standard used for deciding obviousness is the preponderance of the evidence, and the evidence of record in totality – while some arguments may be considered convincing in isolation – supports a conclusion of prima facie obviousness for reasons above. The Wang reference suggests capsule dosage forms of zanubrutinib comprising various excipients and it would have been prima facie obvious to select typical excipients in typical amounts as taught by the analogous Heda and Chan references. Arguments presented in opposition to this such as unpredictability in the art, teachings which may be interpreted to teach away, and alleged unexpected results are insufficient to support a conclusion of nonobviousness. Accordingly, the rejection of claims 1, 3-4, 6, 8, 10 and 19-23 is maintained.
Applicant requested that the provisional non-statutory double patenting rejection of claims 1-10 and 18-22 over claims 1-4, 6, 8, 10 and 19-23 of copending Application No. 18099319 (reference application) be held in abeyance. Modified obviousness and double patenting rejections are presented below in order to address amendments.
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 1-3, 5-6, 8-10 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO2018/033853A2 (Wang et al.) in view of Heda, Pavan, Vikas Agarwal, and Shailesh K. Singh. "8 Dry-Fill Formulation." Pharmaceutical Dosage Forms: Capsules (2017): 211. (Heda et al.); and Chan, Hak-Kim, and Nora YK Chew. "Excipients: powders and solid dosage forms." Encyclopedia of pharmaceutical technology, 3rd ed., Informa Healthcare USA, Inc, New York 3 (2007): 1646-1655. (Chan et al.).
Wang et al. teaches methods of treating B-cell proliferative diseases including chronic lymphocytic leukemia by administering crystalline Form A of zanubrutinib (Para. [0019]). Compositions may be in the form of an oral capsule (Para. [0087]) and may be produced using conventional methods, for example with excipients which include a filler such as starch, sucrose, etc., a binder such as cellulose derivatives, alginates, gelatin and polyvinylpyrrolidone (PVP); a wetting agent such as glycerol; a disintegrating agent such as agar, calcium carbonate and sodium bicarbonate; a lubricant such as talc, calcium stearate, magnesium stearate, polyethylene glycol, etc. (Para. [0088]). The pharmaceutical composition comprises 1 wt% to 99% of Form A; 1 wt% to 70 wt%; or 10 wt % to 30 wt% (Para. [0070]). The crystalline Form A is administered at a dose of 40 mg-320 mg/day (claim 41).
Wang et al. does not teach a single embodiment of a composition containing each of these components; wherein zanubrutinib has a particle size less than or equal to 40 um and wherein zanubrutinib is present in an amount from 20% to 50%, or wherein the capsule shell is a gelatin capsule shell; the specific excipients and amounts thereof as required by the instant claims; or wherein the compositions comprise 80 mg zanubrutinib.
Heda et al. teaches “formulation factors that can influence the bioavailability of drugs from hard gelatin capsules include the following: Surface area and particle size of the drug (particularly the effective surface area exhibited by the drug in the GI fluids)” (pp.214) and that “literature suggests a minimum particle size of 10 µm. If particle size is more than 60 µm, the fluidity of the powder starts to deteriorate, which leads to unwanted deviations of the filling weights. The size of particles should ideally measure between 10 and 150 µm. Excipients should be chosen in relation to the particle size of the drug active.” (pp. 218). Reducing particle size is obvious to one of ordinary skill in the art in order to increase the effective surface area exhibited by the drug in the GI fluids. With respect to the 20% to 70% limitation as in claim 3 and the 20% to 50% limitation as in claim 18, the claimed ranges overlap with those of the prior art making them prima facie obvious. See MPEP 2144.05. With respect to claim 10, Heda et al. teaches gelatin capsules/shells as standard in capsule formulation and therefore prima facie obvious to utilize in the oral capsule suggested by Wang et al.
Chan et al. generically teaches that “Except for diluents, which may be present in large quantity, the level of excipient is usually limited to only a few percent and some lubricants will be required at <1%.” (pp. 1646). These amounts overlap with the claimed amounts rendering them prima facie obvious. The following arguments are to address specific excipients selected and amounts thereof.
Microcrystalline cellulose as a filler is taught by both Heda et al. (Table 8.2, “Diluent/filler; Examples,” pp. 216) and Chan et al., (Table 1, “Diluent; Examples,” pp. 1647). While it is not explicitly taught that the filler is present in the composition for the oral capsule in an amount from 20% to 90% or 30% to 80% by mass relative to a total mass of the composition for the oral capsule, Heda et al. teaches that the optimal fill level for a full capsule is 90% (pp. 217). The skilled artisan would have found it obvious to use a filler, such as microcrystalline cellulose, in a sufficient amount, such as 20% to 90% or 30% to 80% by mass relative to a total mass of the composition for the oral capsule, in order to reach the optimal fill level for a full capsule of 90%. It is known to the skilled artisan that the active ingredient and other excipients would not be enough to reach this optimal fill level, and thus amounts of filler in the range disclosed would be necessary.
Heda et al. teaches croscarmellose sodium as an example of an excipient (Table 8.2, “Disintegrant; Examples” pp. 216) and “Today, such super-disintegrants as sodium starch glycolate and croscarmellose are preferred over starch to ensure that the powder mass inside the capsule is dispersed into the dissolution medium when the capsule disintegrates.” (Table 8.2, “Comments”, pp. 216). This indicates an advantage of croscarmellose in regards to bioavailability. Heda et al. teaches “Inclusion of a disintegrant, 4% croscarmellose sodium, tended to nullify the effects of number of tamps or tamping force regardless of the filler used.” (pp. 228). This indicates an advantage of croscarmellose sodium in the manufacturing process. In view of these advantages, the skilled artisan would have found it obvious to use croscarmellose sodium as the disintegrant. In addition to the teaching of 4% croscarmellose sodium, Heda et al. also teaches that “The requirement for a disintegrant should be accessed on a case-by-case basis. It also depends on the mechanism of the disintegrant … depending on the mechanism, higher concentrations may be needed. It is believed that for swelling to be effective in generating a disintegration action in the more porous capsule plugs, more disintegrant is needed. Botzolakis et al. reported that as much as 4-8% concentrations were needed. In some capsule formulations, it is known to require even higher amounts. In general, addition of a disintegrant may be prevalent for high-dose, hydrophobic API formulations.” (pp. 220). These amounts overlap with the claimed amounts rendering them prima facie obvious. Further, the language “as much as” used by Heda et al., indicates that the 4-8% range is on the high end, suggesting that lower amounts are more routine. Chan et al. supports this with the statement that “the level of excipient use is usually limited to only a few percent” (pp. 1646). The skilled artisan would accordingly have found the use of croscarmellose sodium obvious in view of its advantages as a disintegrant and in view of the advantages of disintegrants in general, and would have found the instantly disclosed range of 0.5% to 5% obvious given that “the level of excipient use is usually limited to only a few percent” and 4-8% is considered a high amount. The narrower range of claim 23 is obvious for the same reasons.
Heda et al. teaches “By far, the most commonly used wetting agent is sodium lauryl sulfate” (Table 8.2, “Disintegrant”; “Comments,” pp. 216). It is known in the art that sodium lauryl sulfate (SLS) and sodium dodecyl sulfate are equivalent. An example wherein amounts of 0%, 0.5% and 1% SLS are tested in a pharmaceutical composition is provided, indicating that 0%-1% SLS is an optimal starting range for SLS. These amounts overlap with the claimed amounts rendering them prima facie obvious. Chan et al. supports this with the statement that “the level of excipient use is usually limited to only a few percent” (pp. 1646). The skilled artisan would have found the instantly disclosed range of less than 5% sodium dodecyl sulfate obvious in view of SLS being “the most commonly used wetting agent” and the prior art’s teachings of 0% to 1% SLS and that “the level of excipient use is usually limited to only a few percent.”
Colloidal silica is the first glidant listed under Examples in Table 8.2 in Heda et al. (pp. 217). Heva et al. further teaches “Small quantities (up to 5% w/w) of highly active materials are used: glidants, which improve flow by reducing interparticulate friction (e.g., fumed silicon dioxide [colloidal silicon dioxide]) (pp.218) and “Glidant include the colloidal silicas [colloidal silicon dioxide], cornstarch, talc, and magnesium stearate. Usually, there is an optimum concentration for glow, generally less than 1% and typically 0.1-0.5% when colloidal silicas are used … the optimum concentration for Aerosil (colloidal silica) appears to be 1%.” (pp. 225). Colloidal silicon dioxide is clearly a first choice when a glidant is used in a pharmaceutical composition, and the instantly disclosed range overlaps with those (up to 5% w/w) taught in the prior art. These amounts overlap with the claimed amounts rendering them prima facie obvious.
Heda et al. teaches “Small quantities (up to 5% w/w) of highly active materials are used: … lubricants, which reduce powder to metal adhesion (e.g., magnesium stearate), thus enabling the dosing devices to function properly) (pp.218). A skilled artisan would have been motivated to include magnesium stearate for the purposes taught by Heda et al. These amounts overlap with the claimed amounts rendering them prima facie obvious.
Note that the quantities of claims 22 and 24 correspond to 22.2% Zanubritinib, 73.3% microcrystalline cellulose, 3% croscarmellose sodium, 0.5% colloidal silicon dioxide, 0.5% sodium dodecyl sulfate, 0.5% magnesium stearate. These quantities lie within the ranges previously discussed and are therefore obvious for the same reasons.
With respect to the 80 mg of zanubrutinib in claims 21-22 and 24, the amount lies within the 40 mg-320 mg/day dose of Wang et al. which renders an 80 mg capsule prima facie obvious.
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 1-3, 5-6, 8-10 and 19-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 6, 8, 10 and 19-23 of copending Application No. 18099319 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because according to MPEP 804(II)(B)(1), “it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.” In Sun Pharm. v. Lilly, the Court specifically affirms this kind of use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the specification of the copending application describes compositions to be useful for the treatment of B lymphocyte tumor, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL). Therefore, when construed according to the specification, copending claims 1-4, 6, 8, 10 and 19-23 describe essentially the same composition as that which is administered in the instant claims with the same utility as the methods of the instant claims. Accordingly, claims 1-3, 5-6, 8-10 and 19-24 are obvious in view of copending claims 1-4, 6, 8, 10 and 19-23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-3, 5-6, 8-10 and 19-24 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623