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 .
Status of Application
The Preliminary Amendment filed on 02/07/24 is acknowledged.
Claims 1-18 were cancelled.
New claims 19-36 were added and are included in the prosecution.
Priority
This Application is a 371 of PCT/EP2022/063514 filed on 05/19/22. This Application also claims foreign priority to EP 21174941.1 filed on 05/20/21. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/17/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Objections
Claims 27-31, and 33 are objected to because of the following informalities:
In claim 27, line 1, the term “is” should be added before the term “defined.”
In claim 28, line 1, the term “is” should be added before the term “defined.”
In claim 28, line 1, the abbreviations “eos” and “hpf” should be replaced with “eosinophils” and “high power microscopic field” respectively, based on the instant specification (Substitute Specification Clean Copy filed on 11/17/23 on Page 1, line 20).
In claim 29, line 2, the abbreviation “NRS” should be replaced with “Numerical Rating Scale (NRS)” based on the instant specification (Substitute Specification Clean Copy filed on 11/17/23 on Page 8, line 27). An acronym/abbreviation in the first instance of claims should be expanded upon/spelled out with the acronym/abbreviation indicated in parentheses. The acronym/abbreviations can be used thereafter.
In claim 30, line 2, the term “musical” should be replaced with “mucosal.”
In claim 31, line 1, the phrase “ranges from span six weeks” should be corrected to recite “ranges from a span of six weeks.”
In claim 33, part (ii), the abbreviation “EREFS” should be replaced with “endoscopic reference score (EREFS)” based on the instant specification (Substitute Specification Clean Copy filed on 11/17/23 on Page 6, line 7).
Appropriate correction is required.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
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.
Claims 19-21, 23-24, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greinwald et al. (US 9,867,780 B2 – “Greinwald”).
The claimed invention is a method of treating eosinophilic esophagitis in a patient in need thereof, said method comprising the step of daily administering to said patient at least one orodispersible effervescent tablet comprising budesonide at least until complete mucosal healing is achieved.
Greinwald teaches a method of treating an inflammatory condition of the esophagus, comprising administering the orodispersible effervescent tablet containing 0.25 mg to 5 mg of budesonide to a patient in need thereof (Examples 4 and 7, claims 1 and 11), wherein the inflammatory condition of the esophagus being treated is eosinophilic esophagitis (claim 12). Greinwald teaches a daily dose (Col. 1, lines 36-39), and a twice-daily dose (FIG. 1, Col. 3, line 61 to Col. 4, line 2, Example 5 – Col. 11, lines 33-46). The first primary partial endpoint of the study was the rate of the histological remission, wherein the eosinophils (eos) of the patients in remission had to attain mean number of <16 eos/mm2 hpf (“high power field”, i.e. the visual field in the microscope at a magnitude of 400×) after 2 weeks of treatment (Col. 10, lines 2-8).
Regarding instant claim 19, the limitation of treating eosinophilic esophagitis in a patient in need thereof comprising administering to said patient at least one orodispersible effervescent tablet comprising budesonide is anticipated by the method of treating an inflammatory condition of the esophagus, comprising administering the orodispersible effervescent tablet containing 0.25 mg to 5 mg of budesonide to a patient in need thereof (Examples 4 and 7, claims 1 and 11), wherein the inflammatory condition of the esophagus being treated is eosinophilic esophagitis (claim 12), as taught by Greinwald. The limitation of daily administering is anticipated by the daily dose (Col. 1, lines 36-39), and the twice-daily dose (FIG. 1, Col. 3, line 61 to Col. 4, line 2, Example 5 – Col. 11, lines 33-46). The limitation of administering at least until complete mucosal healing is achieved is anticipated by the first primary partial endpoint of the study which was the rate of the histological remission, wherein the eosinophils (eos) of the patients in remission had to attain mean number of <16 eos/mm2 hpf (“high power field”, i.e. the visual field in the microscope at a magnitude of 400×) after 2 weeks of treatment (Col. 10, lines 2-8), as taught by Greinwald.
Regarding instant claim 20, the limitation of said orodispersible effervescent tablet comprising 0.5 mg budesonide which is administered twice daily is anticipated by the 0.5 mg of budesonide orodispersible effervescent tablet (TABLE 1) and the twice-daily administration (FIG. 1, Col. 3, line 61 to Col. 4, line 2, Example 5 – Col. 11, lines 33-46), as taught by Greinwald.
Regarding instant claim 21, the limitation of said orodispersible effervescent tablet comprising 1 mg budesonide which is administered twice daily is anticipated by the 1 mg of budesonide orodispersible effervescent tablet (TABLE 1) and the twice-daily administration (FIG. 1, Col. 3, line 61 to Col. 4, line 2, Example 5 – Col. 11, lines 33-46), as taught by Greinwald.
Regarding instant claim 23, the limitation of said orodispersible effervescent tablet comprising 2 mg budesonide which is administered once daily is anticipated by the 2 mg of budesonide orodispersible effervescent tablet (TABLE 1) and daily dose (Col. 1, lines 36-39), as taught by Greinwald.
Regarding instant claim 24, the limitation of said complete mucosal healing achieved within 6-12 weeks of treatment is anticipated by the histological remission at 12 weeks (TABLE 4), as taught by Greinwald.
Regarding instant claims 35 and 36, the limitations of the dissolution of said orodispersible effervescent tablet which occurs by the action of saliva in the mouth within a time span of 2 to 20 minutes (instant claim 35) and 2 to 5 minutes (instant claim 36) are anticipated by the effervescent tablet which disintegrates completely, wherein the use of the tablet is completed after 1.5 to 2 minutes and allows a concentrated distribution of budesonide on the esophagus (Col. 2, line 65 to Col. 3, line 7), as taught by Greinwald. Since the prior art teaches a range touching the claimed range (i.e., 2 minutes) with sufficient specificity it anticipates the claimed range. Please see MPEP 2131.03(II).
Claims 19-21, 24, 26-31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Straumann et al. (Gastroenterology 2020;159:1672-1685 – “Straumann”).
Straumann teaches that budesonide orodispersible tablets (BOT) maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis (EoE) (Title). “In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated” (Page 1673, Col. 1, “CONCLUSIONS”). “After 48 weeks of treatment, 73.5% of patients treated with low-dose and 75% of patients treated with high dose budesonide remained in remission, compared with 4.4% of patients treated with placebo. Long-term treatment of EoE with an orodispersible budesonide tablet was highly superior to placebo for maintaining EoE in remission. Both dosages were equally effective and well tolerated. Neither systemic nor local corticosteroid side effects were a major problem” (Page 1673, Col. 2, “NEW FINDINGS”).
Regarding instant claim 19, the limitations of treating eosinophilic esophagitis in a patient in need thereof comprising daily administering to said patient at least one orodispersible effervescent tablet comprising budesonide is anticipated by the method of treating EoE comprising administering BOT containing 0.5 mg or 1.0 mg of budesonide to a patient in need thereof twice daily for 6 weeks (Pages 1673-1674 – “Study Population”). The limitation of administering at least until complete mucosal healing is achieved is anticipated by maintaining EoE in remission (Page 1673, Col. 1, “CONCLUSIONS” and Col. 2, “NEW FINDINGS”), as taught by Straumann.
Regarding instant claim 20, the limitation of said orodispersible effervescent tablet comprising 0.5 mg budesonide which is administered twice daily is anticipated by the 0.5 mg BOT administered twice daily (Page 1673, Col. 1, “CONCLUSIONS”), as taught by Straumann.
Regarding instant claim 21, the limitation of said orodispersible effervescent tablet comprising 1 mg budesonide which is administered twice daily is anticipated by the 1.0 mg BOT administered twice daily (Page 1673, Col. 1, “CONCLUSIONS”), as taught by Straumann.
Regarding instant claim 24, the limitation of said complete mucosal healing achieved within 6-12 weeks of treatment is anticipated by the results from a phase 3 trial which showed the effectiveness of a 6-week treatment with the BOT to induce clinicohistologic remission in 58% of adult patients with EoE, which increased to 85% when therapy was extended to 12 weeks in nonresponders (Page 1673, Col. 1, penultimate ¶, lines 8-13), as taught by Straumann.
Regarding instant claims 26-28, the limitation of deep endoscopic and deep histological remission is anticipated by the deep histologic remission (0 eos/mm2 hpf); and deep endoscopic remission (0 points total EREFS score) (¶ bridging Pages 1674 and 1675), as taught by Straumann.
Regarding instant claim 29, the limitation of deep clinical remission defined as an NRS for dysphagia of '0' and an NRS for pain during swallowing of '0' is anticipated by the dysphagia NRS of 0 and odynophagia NRS of 0 for BOT 0.5 mg and BOT 1.0 mg (Page 1678, continuation of Table 2), as taught by Straumann.
Regarding instant claim 30, the limitation of (i) a 6-12 week induction period, after which complete musical healing is achieved, and (ii) a maintenance period of up to 144 weeks is anticipated by the induction with BOT 1.0 mg twice daily for 6 weeks (¶ bridging Pages 1673 and 1647) and the disclosure that after 48 weeks of treatment, 73.5% of patients treated with low-dose and 75% of patients treated with high dose budesonide remained in remission, compared with 4.4% of patients treated with placebo (Page 1673, Col. 2, “NEW FINDINGS”), as taught by Straumann.
Regarding instant claim 31, the limitation of said maintenance period ranging from six weeks up to three years is anticipated by the disclosure that after 48 weeks of treatment, 73.5% of patients treated with low-dose and 75% of patients treated with high dose budesonide remained in remission, compared with 4.4% of patients treated with placebo (Page 1673, Col. 2, “NEW FINDINGS”), as taught by Straumann.
Regarding instant claim 33, the limitation of (i) deep clinical remission with dysphagia and odynophagia both rated as "0" on an NRS scale, wherein 0 point indicates "no symptoms at all", each day in a 7 day period is anticipated by the dysphagia NRS of 0 and odynophagia NRS of 0 for BOT 0.5 mg and BOT 1.0 mg (Page 1678, continuation of Table 2), as taught by Straumann. The limitation of (ii) deep endoscopic remission with EREFS=0 points is anticipated by deep endoscopic remission (0 points total EREFS score) (¶ bridging Pages 1674 and 1675), as taught by Straumann. The limitation of (iii) deep histological remission characterized by eos=0/hpf is anticipated by the deep histologic remission (0 eos/mm2 hpf) (¶ bridging Pages 1674 and 1675), as taught by Straumann.
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 of this title, 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 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 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 22 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Greinwald et al. (US 9,867,780 B2 – “Greinwald”), as applied to claims 19-21, 23-24, and 35-36 above, or alternatively over Straumann et al. (Gastroenterology 2020;159:1672-1685 – “Straumann) as applied to claims 19-21, 24, 26-31, and 33 above, each in view of Scottish Medicines Consortium (Falk Pharma, U.K. Budesonide 1 mg orodispersible tablets (Jorveza ®) – 12 October 2020, pp. 1-13 – “SMC”).
Instant claim 22 is drawn to the method of claim 21, wherein said twice daily administration comprises a first orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the morning and a second orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the evening.
The teachings of Greinwald and Straumann are discussed above.
Greinwald and Straumann do not expressly teach a first orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the morning and a second orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the evening.
SMC teaches that the recommended dose of the budesonide 1 mg orodispersible tablets (Jorveza ®) for the treatment of EoE is 2 mg budesonide as one 1 mg tablet in the morning and one in the evening (Page 2 – “Indication” and “Dosing Information”). SMC teaches that the usual duration of induction treatment is 6 weeks (Page 2 - “Dosing Information”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating EoE by administering an orodispersible effervescent tablet comprising 0.5 mg or 1.0 mg of budesonide daily to a patient in need thereof, as taught by Greinwald or alternatively by Straumann, in view of the recommended daily dose of 2 mg of budesonide as one 1 mg tablet in the morning and one in the evening, as taught by SMC, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to use the recommended dosing regimen taught by SMC because the same budesonide containing orodispersible effervescent tablet is taught for the treatment of the same disease, i.e., eosinophilic esophagitis.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 22 and 32, the limitation of the twice daily administration comprising a first orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the morning and a second orodispersible effervescent tablet comprising 1.0 mg budesonide administered in the evening would have been obvious over the recommended dose of the budesonide 1 mg orodispersible tablets (Jorveza ®) for the treatment of EoE which is 2 mg budesonide as one 1 mg tablet in the morning and one in the evening (Page 2 – “Indication” and “Dosing Information”), as taught by SMC.
Regarding instant claim 25, the limitation of complete mucosal healing evidenced by increased esophageal distensibility would have been obvious over the complete remission achieved by administering BOT 0.5 mg and BOT 1.0 mg (Page 1678 – Continuation of Table 2), as taught by Straumann.
Claims 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Straumann et al. (Gastroenterology 2020;159:1672-1685 – “Straumann”), as applied to claims 19-21, 24, 26-31, and 33 above.
Instant claim 25 is drawn to the method of claim 19, wherein said complete mucosal healing is evidenced by increased esophageal distensibility.
Instant claim 34 is drawn to the method of claim 33, wherein said deep disease remission is maintained over 3 years.
The teachings of Straumann are discussed above.
Straumann does not expressly teach increased esophageal distensibility or that said deep disease remission is maintained over 3 years.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating EoE by administering an orodispersible effervescent tablet comprising 0.5 mg or 1.0 mg of budesonide daily to a patient in need thereof, as taught by Straumann, in view of the EoE in remission over 1 year, also as taught by Straumann, and arrive at the instant invention.
One of ordinary skill in the art would have found the increased esophageal distensibility obvious over the complete remission taught by Straumann (Page 1678 – Continuation of Table 2), since increased esophageal distensibility is a measure of EoE disease severity.
One of ordinary skill in the art would have found the remission period obvious because EoE in remission over 1 year is taught by Straumann (Page 1682, Col. 1, “Discussion”). According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 25, the limitation of complete mucosal healing evidenced by increased esophageal distensibility would have been obvious over the complete remission achieved by administering BOT 0.5 mg and BOT 1.0 mg (Page 1678 – Continuation of Table 2), as taught by Straumann.
Regarding instant claim 34, the limitation of deep disease remission maintained over 3 years would have been obvious over the BOT 0.5 mg twice daily and BOT 1.0 mg twice daily that were effective and superior to placebo to keep adult patients with EoE in remission over 1 year with remission rates of up to 75% (Page 1682, Col. 1, “Discussion”), as taught by Straumann. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” One of ordinary skill in the art would have had a reasonable expectation of success in achieving deep disease remission for over 3 years given the guidance of Straumann, unless there is evidence of criticality or unexpected results.
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 19-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 12 of U.S. Patent No. 9,867,780 B2 (“the ‘780 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating eosinophilic esophagitis in a patient in need thereof, said method comprising the step of daily administering to said patient at least one orodispersible effervescent tablet comprising budesonide at least until complete mucosal healing is achieved, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘780 Patent recites (a) 0.25 mg to 5 mg of budesonide as well as components (b) – (d). However, instant claim 1 recites at least one orodispersible effervescent tablet comprising budesonide. The transitional phrase “comprising” is considered open language and allows the inclusion of additional components, such as components (b) – (d) recited in claim 1 of the ‘780 Patent.
Other differences regarding administering once daily, or twice daily recited in instant claims would have been obvious to one of ordinary skill in the art based on the desired clinical therapeutic efficacy. The limitations regarding remission parameters would have been obvious over the treatment of EoE recited in claim 12 of the ‘780 Patent since remission is a desired result of treatment.
Therefore, instant claims are obvious over claims of the ‘780 Patent and they are not patentably distinct over each other.
Claims 19-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, and 18 of U.S. Patent No. 10,369,100 B2 (“the ‘100 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating eosinophilic esophagitis in a patient in need thereof, said method comprising the step of daily administering to said patient at least one orodispersible effervescent tablet comprising budesonide at least until complete mucosal healing is achieved, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘100 Patent recites a. 0.25 mg to 5 mg of budesonide as well as components b – d. However, instant claim 1 recites at least one orodispersible effervescent tablet comprising budesonide. The transitional phrase “comprising” is considered open language and allows the inclusion of additional components, such as components b – d recited in claim 1 of the ‘100 Patent.
Other differences regarding administering once daily, or twice daily recited in instant claims would have been obvious to one of ordinary skill in the art based on the desired clinical therapeutic efficacy. The limitations regarding remission parameters would have been obvious over the treatment of EoE recited in claim 18 of the ‘100 Patent since remission is a desired result of treatment.
Therefore, instant claims are obvious over claims of the ‘100 Patent and they are not patentably distinct over each other.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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, Robert A. Wax can be reached on 571-272-6023. 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.
/ARADHANA SASAN/Primary Examiner, Art Unit 1615