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 .
Priority
This application was filed on 09/09/2020, which claims the benefit of the priority of People’s Republic of China Application No. CN201810198521.0 filed 03/09/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 10 is amended. Claims 1-2, 4-11, and 13-18 are being examined on the merits in this office action.
Claim Objections - Withdrawn
The objection to claim 10 is withdrawn in view of the claim amendment.
Claim Rejections - 35 USC § 103 - Maintained
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.
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.
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, 4-8, 10-11, and 13-17 remain rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0232754 A1 (hereinafter “the ‘754 publication”) as evidenced by USAID-Food and nutrition technical assistance – FANTA (https://www.fantaproject.org/sites/default/files/resources/FANTA-BMI-charts-Jan2013-ENG_0.pdf) references cited and enclosed in previous office action.
‘754 teaches a method of treating or preventing obesity the method comprising administering to an individual in need of such treatment a sufficient amount of a compound wherein the compound is a GLP-1 fragment or analogue including GLP-1(7-35), GLP-1(7-36) and GLP-1(7-37) (claims 1-13, 16, and 19). ‘754 teaches that the dosage will be in the range of from about 10 μg per kg body weight per day to about 5 mg per kg body weight per day [0050]. As evidenced by USAID, an adult that is 134-140 cm tall and with a weight of 57-60 kg is considered obese. The dose of 10 μg per kg body weight taught by ‘754 is therefore about 0.57-0.6 mg/day which falls within the instant claimed range. The administration dose of the peptide taught by the ‘754 would render the recited concentration or amount of the instant application prima facie obvious because the concentration is sufficiently close that the ordinary skilled artisan would infer that the concentration of polypeptides would possess the same or substantially similar properties. This is analogous to the facts in Titanium Metals Corp. of America v. Banner, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the prior art range did not overlap or touch a recited range, but was sufficiently similar in magnitude such that there was an expectation that the prior art range would pertain to a composition exhibiting the same or substantially similar properties; See MPEP § 2144.05. The ‘754 reference further teaches that the total daily dose may be administered in the form of two or more subdivisions thereof [0050]. Examiner notes this particular teaching reads on “…administered with the GLP-1 peptide two to three times a day.” ‘754 further teaches the GLP-1(7-36) is administered to human subjects [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat obesity comprising administering GLP-1(7-36) at a dose of about 10 μg per kg body weight per day as taught as by ‘754 to treat obesity [0050]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in administering the GLP-1 at the dose taught by ‘754 since ‘754 teaches that it was successful in treating obesity. The disclosures render obvious claim 1.
Regarding claim 2, ‘754 teaches that the GLP-1 peptides used according to the invention can be produced by chemical synthesis or—more conveniently-by a method which comprises culturing a host cell containing a DNA sequence encoding the peptide and capable of expressing the peptide in a suitable nutrient medium under conditions permitting the expression of the peptide, after which the resulting peptide is recovered from the culture [0027].
Regarding claims 4 and 6, ‘754 further teaches the GLP-1(7-36) is administered to human subjects [0052]. Examiner notes that since ‘754 teaches that the peptide is administered to human subjects, there is an expectation that this includes both male and female subjects.
Regarding claim 5, ‘754 teaches that the dosage will be in the range of from about 10 μg per kg body weight per day to about 5 mg per kg body weight per day [0050]. As evidenced by USAID, an adult that is 134-140 cm tall and with a weight of 57-60 kg is considered obese. The dose of 10 μg per kg body weight taught by ‘754 is therefore about 0.57-0.6 mg/day which falls within the instant claimed range.
Regarding claims 7 and 8, ‘754 teaches that the pharmaceutical compositions containing a GLP-1 peptide according to the present invention may be administered parenterally to patients in need of such a treatment and that parenteral administration may be performed by subcutaneous, intramuscular, intraperitoneal or intravenous injection by means of a syringe, optionally a pen-like syringe [0041].
Regarding claim 10, ‘754 teaches a method of treating or preventing obesity the method comprising administering to an individual in need of such treatment a sufficient amount of a compound wherein the compound is a GLP-1 fragment or analogue including GLP-1(7-35), GLP-1(7-36) and GLP-1(7-37) (claims 1-13, 16, and 19). ‘754 teaches that the dosage will be in the range of from about 10 μg per kg body weight per day to about 5 mg per kg body weight per day [0050]. As evidenced by USAID, an adult that is 134-140 cm tall and with a weight of 57-60 kg is considered obese. The dose of 10 μg per kg body weight taught by ‘754 is therefore about 0.57-0.6 mg/day which falls within the instant claimed range. The administration dose of the peptide taught by the ‘754 would render the recited concentration or amount of the instant application prima facie obvious because the concentration is sufficiently close that the ordinary skilled artisan would infer that the concentration of polypeptides would possess the same or substantially similar properties. This is analogous to the facts in Titanium Metals Corp. of America v. Banner, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the prior art range did not overlap or touch a recited range, but was sufficiently similar in magnitude such that there was an expectation that the prior art range would pertain to a composition exhibiting the same or substantially similar properties; See MPEP § 2144.05. The ‘754 reference further teaches that the total daily dose may be administered in the form of two or more subdivisions thereof [0050]. Examiner notes this particular teaching reads on “…administered with the GLP-1 peptide two to three times a day.” ‘754 further teaches the GLP-1(7-36) is administered to human subjects [0052]. The Examiner notes that the disclosure of ‘754 read on managing body weight because a treatment that prevents or treats obesity will necessarily manage body weight. The disclosures render obvious claim 10.
Regarding claim 11, ‘754 teaches that the GLP-1 peptides used according to the invention can be produced by chemical synthesis or—more conveniently—by a method which comprises culturing a host cell containing a DNA sequence encoding the peptide and capable of expressing the peptide in a suitable nutrient medium under conditions permitting the expression of the peptide, after which the resulting peptide is recovered from the culture [0027].
Regarding claims 13 and 15, ‘754 further teaches the GLP-1(7-36) is administered to human subjects [0052]. Examiner notes that since ‘754 teaches that the peptide is administered to human subjects, there is an expectation that this includes both male and female subjects.
Regarding claim 14, ‘754 teaches that the dosage will be in the range of from about 10 μg per kg body weight per day to about 5 mg per kg body weight per day [0050]. As evidenced by USAID, an adult that is 134-140 cm tall and with a weight of 57-60 kg is considered obese. The dose of 10 μg per kg body weight taught by ‘754 is therefore about 0.57-0.6 mg/day which falls within the instant claimed range.
Regarding claims 16 and 17, ‘754 teaches that the pharmaceutical compositions containing a GLP-1 peptide according to the present invention may be administered parenterally to patients in need of such a treatment and that parenteral administration may be performed by subcutaneous, intramuscular, intraperitoneal or intravenous injection by means of a syringe, optionally a pen-like syringe [0041].
Claims 9 and 18 remain rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0232754 A1 (hereinafter “the ‘754 publication”) as evidenced by USAID-Food and nutrition technical assistance – FANTA (https://www.fantaproject.org/sites/default/files/resources/FANTA-BMI-charts-Jan2013-ENG_0.pdf), as applied to claim 1 above and further in view of WO 2013003449 A2 (hereinafter “the ‘449 publication”) – references cited and enclosed in previous office action.
The teachings of ‘754 as evidenced by USAID are disclosed above and incorporated herein by reference.
‘754 does not teach the period of administration of GLP-1 as recited in claim 9.
‘449 teaches a method of treating obesity as well as methods for inducing weight loss, preventing weight gain, or controlling weight in a patient comprising administering an effective dose of a GLP-1 peptide (abstract) and that the GLP-1 peptide includes GLP-1 7-36 and GLP-1 7-37 (claim 23-24; page 2, line 27-29; page 7, line 16-20; ). ‘449 teaches that the method was successful for inducing weight loss, preventing weight gain, or controlling weight in a patient (abstract). ‘449 teaches the method of treating obesity wherein the subjects were both male and female and that the patient is overweight or obese and that HDL cholesterol < 40 mg/dL (1.03 mmol/L) in males, < 50 mg/dL (1.29 mmol/L) in females and an elevated waist circumference equal to or greater than 40 inches (102 cm) for men, or equal to or greater than 35 inches (88 cm) for women (claim 12). In addition, ‘449 further discloses that the subjects enrolled were males and females 18-75 years of age (page 20, line 14-15). ‘449 teaches the subcutaneous injection of GLP-1 is administered about weekly for a plurality of months (page 15, line 20-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of ‘754 and ‘449 and administer GLP-1 analogs for a period taught by ‘449 for weight management. One of ordinary skill in the art would have had a reasonable expectation of success in using the method of ‘754 and ‘449 because both references disclose that the instant GLP-1 analogs have been successfully used to treat obesity and ‘754 disclose dosages that encompass or are fairly close to the instant range hence it would have been obvious for one of ordinary skill in the art to experiment with similar dosages and at similar periods taught by ‘449.
Regarding claims 9 and 18, ‘449 teaches the subcutaneous injection of GLP-1 is administered about weekly for a plurality of months (page 15, line 20-25).
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that given the well-known short half-life of GLP-1(7-36), a person of ordinary skill in the art would not have had reasonable expectation of success that "administration of GLP-1(7-36) two to three times a day" would have achieved similar appetite suppression effects, let alone sustained weight loss effect. Applicant argues that FANTA does not cure the deficiency of ‘754.
Examiner’s Response
The arguments presented above have been fully considered but are not persuasive. Examiner notes that the ‘754 teaches the instant invention because the reference teaches a method of treating or preventing obesity the method comprising administering to an individual in need of such treatment a sufficient amount of a compound wherein the compound is a GLP-1 fragment or analogue including GLP-1(7-36), that the analogue was administered at a dosage range of from about 10 μg per kg body weight per day to about 5 mg per kg body weight per day [0050]. As evidenced by USAID, an adult that is 134-140 cm tall and with a weight of 57-60 kg is considered obese. The dose of 10 μg per kg body weight taught by ‘754 is therefore about 0.57-0.6 mg/day which falls within the instant claimed range, and that the total daily dose may be administered in the form of two or more subdivisions thereof [0050]. Examiner notes this particular teaching reads on “…administered with the GLP-1 peptide two to three times a day.” ‘754 further teaches the GLP-1(7-36) is administered to human subjects [0052]. Examiner notes that all the limitation of the claimed invention are taught by the ‘754 reference. Applicant’s assertion about the short half-life of GLP-1(7-36), and that a person of ordinary skill in the art would not have had reasonable expectation of success that "administration of GLP-1(7-36) two to three times a day" would have achieved similar appetite suppression effects is unpersuasive since the instant method of treating obesity using the instant peptide, at the instant dosages in the instant patient population is known in the art and known to be successful.
Claims 1-2, 4-8, 10-11, 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bock et al. (US 20130165370 A1 - hereinafter “Bock”).
Bock teaches a method of treating obesity comprising administering GLP-1 agonist [0010, 0020-0022], wherein the GLP-1 agonist is selected from the group consisting of GLP-1(7-36)-amide, GLP-1(7-37), a GLP-1(7-36)-amide analogue, a GLP-1(7-37) analogue, or a derivative of any of these [0032], wherein the dosage of GLP-1 agonist to be administered to a patient in a method of the invention is from about 0.01 mg/day to about 5 mg/day [0080], and wherein the GLP-1 agonist are administered a different number of times per day [0030]. Examiner notes that this limitation would render obvious the limitation of administering GLP-1 peptide 2-3 times a day. Bock teaches that the subject is a human [0017]. Examiner notes that the dose taught by Bock, encompasses the instant dose range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat obesity comprising administering GLP-1(7-36) at a dose that encompasses the instant dose as taught by Bock so as to regulate the weight of the subject. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in administering the GLP-1 at the dose taught by Bock it was successful in treating obesity. Examiner notes that the dose of the peptide taught by Bock would render the recited dose range of the instant application prima facie obvious because the range is encompassed in the dose range taught by Bock that the ordinary skilled artisan would infer that dose would possess the same or substantially similar properties of reducing weight. It would have been obvious to administer the GLP-1 peptide 2-3 times a day since Bock teaches that the peptide can be administered a different number of times a day. The disclosures render obvious claims 1 and 10.
Regarding claims 2 and 11, Bock teaches that the GLP-1 compounds are produced by recombinant DNA technology or by peptide synthesis (e.g., Merrifield-type solid phase synthesis) as known in the art of peptide synthesis and peptide chemistry [0076].
Regarding claims 4, and 6, Bock teaches that the subject is a human [0017]. Examiner notes that this includes both male and female subjects thus rendering obvious the claim.
Regarding claim 5, Bock teaches wherein the dosage of GLP-1 agonist to be administered to a patient in a method of the invention is from about 0.01 mg/day to about 5 mg/day [0080], which encompasses the instant range.
Regarding claims 7-8, Bock teaches that the GLP-1 agonist is administered by parenteral administration may be performed by subcutaneous, intramuscular or intravenous injection by means of a syringe [0078].
Regarding claims 13 and 15, Bock teaches that the subject is a human [0017]. Examiner notes that this includes both male and female subjects thus rendering obvious the claim.
Regarding claim 14, Bock teaches wherein the dosage of GLP-1 agonist to be administered to a patient in a method of the invention is from about 0.01 mg/day to about 5 mg/day [0080], which encompasses the instant range.
Regarding claims 16-17, Bock teaches that the GLP-1 agonist is administered by parenteral administration may be performed by subcutaneous, intramuscular or intravenous injection by means of a syringe [0078].
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that Bock discloses various use of GLP-1 agonists at wide ranges of doses without a single example showing any specific regimen of any specific GLP-1 agonist effectively "treat obesity caused by the administration of an obesity-induced drug." Bock, Abstract. Accordingly, a person of ordinary skill in the art would not have had reasonable expectation of success that GLP-1 (7-36) at a dose range that has not been disclosed in Bock would have been effective in treating obesity or managing bodyweight, as recited in claims 1 and 10.
Examiner’s Response
The arguments presented above have been fully considered but are not persuasive. Examiner notes that Bock teaches a method of treating obesity comprising administering GLP-1 agonist [0010, 0020-0022], wherein the GLP-1 agonist includes GLP-1(7-36) or a derivative [0032], wherein the dosage of GLP-1 agonist to be administered to a patient in a method of the invention is from about 0.01 mg/day to about 5 mg/day [0080], and wherein the GLP-1 agonist are administered a different number of times per day [0030]. Examiner notes that this limitation would render obvious the limitation of administering GLP-1 peptide 2-3 times a day. All the limitations of the claimed invention are taught by Bock. The dosages of Bock include the instant dose range and one of ordinary skill in the art would be motivated to try dosages including those recited in the instant claims. Further, Examiner notes that Bock teaches that the method treated obesity caused by the administration of an obesity-inducing drug. However, the instant claims do not recite the cause of the obesity, whether the obesity was food related or caused by the administration of an obesity-inducing drug. The claims generally recite that the method treated obesity. Thus, the method of Bock reads on the instant invention. With regards to the argument that Bock contains no single example showing any specific regimen, Examiner notes that the use of GLP-1(7-36) is widely known in the art to treat obesity. Further, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation (See MPEP 2164.02). The arguments are unpersuasive and the rejection is maintained.
Double Patenting - Maintained
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, 5, 10, and 14 are still provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 8-9, 12, and 19 of copending Application No. 17/813,284 in view of Abdullah et al. (Diabetes Metab. Syndr. Obes. 2014; 7: 587–591).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method of treating a condition associated with elevated blood glucose in a subject comprising administering a first effective amount of one or more first active ingredients selected from the group consisting of GLP-1 and GLP-1 analogs and a second effective amount of one or more second active ingredients selected from the group consisting of insulin and insulin analogs to a subject to treat the condition (claim 1), wherein the subject has diabetes such as type 1 and type 2 diabetes (claim 2).
The instant claims recite a method of treating obesity or being overweight comprising administering to a human subject suffering from obesity or overweight a therapeutically effective amount of a composition comprising GLP-1 (7-36) wherein the therapeutically effective amount of GLP-1 (7-36) is from about 0.11 mg/day to about 0.60 mg/day, and the human subject is administered with GLP-1 (7-36) two to three times a day (claim 1).
The difference between the instant claims and he claims of the copending application is that the copending claims recite treating a condition associated with elevated blood glucose. However, it is known in the art that obesity is associated with elevated blood glucose as taught by Abdullah et al. Abdullah et al. teaches that both diabetes and obesity are correlated and specifically that the rising incidence of type 2 diabetes is related to the epidemic of obesity (Page 588, right col. 3rd paragraph). Abdullah teaches that Obesity is linked to many medical, psychological, and social conditions, the most devastating of which may be type 2 diabetes and that both type 2 diabetes and obesity are associated with insulin resistance (Page 589, left col. 2nd paragraph) and that the insulin resistance is caused by elevated glucose (Page 588, left col., 2nd paragraph, line 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the copending application and use the GLP-1 analogues to treat a disease that is correlated to diabetes and high blood glucose such as obesity thus rendering obvious the instant claims. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the method of the copending application and use the GLP-1 analogues to treat a disease that is correlated to diabetes and high blood glucose such as obesity because Abdullah teaches that Obesity is linked to many medical, psychological, and social conditions, the most devastating of which may be type 2 diabetes and that both type 2 diabetes and obesity are associated with insulin resistance (Page 589, left col. 2nd paragraph).
Regarding claims 5, 10 and 14, the claims of the copending application recite wherein the GLP-1 and/or GLP-1 analog(s) are administered at a daily dosage of about 0.01 mg/d to about 1 mg/d, about 0.06 mg/d to 0.6 mg/d, or about 0.12 mg/d to about 0.4 mg/d (claims 3, 6, 8-9).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request addressing the rejection after at least one claim is in allowable form. Since none of the claims are allowable, the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654