DETAILED ACTION
This office action is in response to applicant’s filing dated November 14, 2025.
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 Claims
Claims 1 and 5-7 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed November 14, 2025. Acknowledgement is made of Applicant's amendment of claim; cancelation of claims 2-4; and addition of new claims 5-7.
Priority
The present application is a Continuation of US Application No. 16/617,721 filed November 27, 2019, which is a 371 of PCT/US2017/035005 filed on May 30, 2017. The effective filing date of the instant application is May 30, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 14, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
New Objections and/or Rejections
Necessitated by Claim Amendment
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 and 5-7 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.
Claim 1 recites “orally administering to the patient, once daily, one or more tablets each comprising 50 mg of the compound…in an amount sufficient to provide 150 mg of the compound once daily.”
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, administering to the patient, once daily, one or more tablets each comprising 50 mg and the claim also recites an amount sufficient to provide 150 mg of the compound once daily which is the narrower statement of the range/limitation. The phrase “administering to the patient, once daily, one or more tablets each comprising 50 mg” reads on 50 mg or more. The claim(s) 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 claim, and therefore not required, or (b) a required feature of the claims.
Alternatively, it is unclear how one of ordinary skill in the art would administer 1 or 2 tablet comprising 50 mg once daily and simultaneously administer an amount sufficient to provide 150 mg of the compound once daily, as administering 1 or 2 tablets once daily would administer 50 or 100 mg of the compound respectively. It is unclear how one of ordinary skill in the art would administer 4 or more tablets comprising 50 mg once daily and simultaneously administer an amount sufficient to provide 150 mg of the compound once daily, as 4 or more tablets comprising 50 mg once daily would administer 200mg or more of the compound once daily.
Claims 5-7, which depend from claim 1, do not clarify the ambiguity of claim 1. Thus, the rejection also applies to claims 5-7.
Claim 5 recites the phrase “wherein the patient has been treated on a standard of care.” It is unclear what is meant by the phrase “standard of care.” By broadest reasonable interpretation, standard of care is defined as what a minimally competent physician in the same field would do in the same situation, with the same resources. Thus, any patient having a PDGFRα-mediated gastrointestinal stromal tumor receiving treatment from a board-certified oncologist for said PDGFRa-mediated gastrointestinal stromal tumor would read on a patient treated on a standard of care.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
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.
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.
Claim 1, 5, and 6 is rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al (WO 2013/184119 A1) in view of Chianelli et al (WO 2008/051757 A1).
Regarding claim 1 and 6, Flynn teaches a method of treating a disease caused by the kinase activity of c-KIT comprising administration of a compound of formula (Ia) (claim 1); wherein the compound is 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea (claims 5 and 9) wherein the disease is a gastrointestinal stromal tumor (claim 4). A tumor caused by the kinase of c-KIT reads on a PDGFR kinase-mediated tumor in view Reis et al (Cellular Oncology, 2005; 27:319-326). Reis teaches PDGFR-α and c-KIT belong to the PDGFR subfamily (page 320, left, 1st paragraph). Thus, c-KIT reads on a PDGFR kinase.
Flynn does not teach the gastrointestinal stromal tumor is a PDGFRα-mediated gastrointestinal stromal tumor.
However, Chianelli teaches compositions and methods for modulating C-KIT and PDGFR Receptors (Title); a method of treating a kinase-mediated condition or disease wherein said kinase-mediated condition or disease is mediated by c-kit, PDGFRα or PDGFRβ kinase comprising administering a compound of Formula (1) (claims 1, 18, 19), wherein the kinase- mediated disease or condition is a neoplastic disorder (claim 21); wherein the neoplastic disorder is gastrointestinal stromal tumor (claim 22), wherein the compound is F21 (claim 13):
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Chianelli teaches the compounds having the same core structure of F1 (see Table 6) are prepared following procedures described in Example 7 [0153-0155]:
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Compounds of Table 6 are structurally similar to the instantly claimed compound. In particular, Compound F1 differs from the instantly claimed compound in the substituents in the positions denoted by an arrow:
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Thus, Chianelli teaches a method of treating c-kit or PDGFRα-mediated gastrointestinal stromal tumor comprising administering structurally similar compounds.
As such, since Flynn teaches a method of treating gastrointestinal stromal tumor mediated by the PDGFR kinase, c-kit, comprising administering 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea, and since Chianelli teaches that compounds structurally similar to the instantly claimed compound are alternatively useful for treating gastrointestinal stromal tumor mediated by c-kit or PDGFRα kinase, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating gastrointestinal stromal tumor mediated by c-kit comprising administering 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea to treat gastrointestinal stromal tumor mediated by PDGFRα with an expectation of success, since the prior art establishes that structurally similar compounds are alternatively useful for treating gastrointestinal stromal tumor mediated by c-kit or PDGFRα kinase.
Regarding the claimed amounts, Flynn teaches a therapeutically effective amount is a dosage of the compound, or pharmaceutically acceptable salt thereof, or pharmaceutical composition containing an exemplified compound of Formula I, or pharmaceutically acceptable salt thereof, necessary to inhibit c-KIT signaling in a cancer patient, and either destroy the target cancer cells or slow or arrest the progression of the cancer in a patient; the exact dosage required to treat a patient and the length of treatment time will be determined by a physician in view of the stage and severity of the disease as well as the specific needs and response of the individual patient and the particular compound administered; although expressed as dosage on a per day basis, the dosing regimen may be adjusted to provide a more optimal therapeutic benefit to a patient. In addition to daily dosing, twice-a-day (BID) or thrice-a-day (TID) dosing may be appropriate; BID dosing is currently preferred [0081]. Thus, Flynn teaches administering the compound once daily.
Moreover, Chianelli teaches compounds of the invention will be administered in therapeutically effective amounts via any of the usual and acceptable modes known in the art, either singly or in combination with one or more therapeutic agents; a therapeutically effective amount may vary widely depending on the severity of the disease, the age and relative health of the subject, the potency of the compound used and other factors; in general, satisfactory results are indicated to be obtained systemically at daily dosages of from about 0.03 to 2.5 mg/kg per body weight; an indicated daily dosage in the larger mammal, e.g. humans, is in the range from about 0.5 mg to about 100 mg, conveniently administered, e.g. in divided doses up to four times a day or in retard form; and suitable unit dosage forms for oral administration comprise from ca. 1 to 50 mg active ingredient [0102]. The Examiner notes that a dose of 0.03 to 2.5 mg/kg per body weight is equivalent to a dose of 1.8 mg to 150 mg. Thus, the doses taught by Chianelli would suggest doses that would overlap the instantly claimed amount.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of Compounds of Formula (I) taught by Chianelli as a starting point for optimizing the amount of the claimed compound utilized to treat PDGFR-α mediated gastrointestinal stromal tumor since Chianelli teaches structurally similar compounds are useful for treating gastrointestinal stromal tumor and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claim 5, Flynn teaches the terms “treatment,” “treat,” and “treating” are meant to include the full spectrum of intervention for the cancer from which the patient is suffering, such as administration of the active compound to alleviate, slow or reverse one or more of the symptoms and to delay progression of the cancer even if the cancer is not actually eliminated [0082]. Treating the progression of gastrointestinal stromal tumor would read on treating progressive gastrointestinal stromal tumor.
Taken together, all this would result in the practice of the method of claims 1, 5, and 6 with a reasonable expectation of success.
New Objections and/or Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al (WO 2013/184119 A1) in view of Chianelli et al (WO 2008/051757 A1) as applied to claims 1, 5, and 6 above, and further in view of Arshad et al (Expert Rev Anticancer Ther. 2020; 20(4): 279-288).
Flynn and Chianelli teach all the limitations of claim 7 (see above 103), except wherein the patient is accessed utilizing RECIST 1.1.
However, Arshad teaches various criteria used for radiologic response assessment in GIST (gastrointestinal stromal tumor) include the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), Modified RECIST (mRECIST), WHO, PET Response Criteria in Solid Tumors (PERCIST) and Choi criteria; these criteria assess the changes on CT and/or FDG-PET/CT scan during treatment; the Choi response criteria were developed for tumor response manifesting as increased tumor size due to tumor necrosis and hemorrhage (i.e. pseudo-progression and incorporate measurements of tumor density (contrast enhancement) and intra-tumoral vascularity on CT scan, in addition to the size criteria that form the basis of RECIST 1.1; in the RECIST 1.1 criteria, a response entails a ≥30% decrease in the sum of the longest diameters (SLD) of target lesion whereas according to Choi response criteria, tumor response includes ≥ 10% decrease in tumor size or ≥ 15% decrease in tumor attenuation at CT scan.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method of treating PDGFR-α gastrointestinal stromal tumor comprising administering 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea taught by Flynn and Chianelli to further assess treatment response utilizing RECIST 1.1 criteria since the prior art teaches this is a criteria utilized to assess treatment response.
Moreover, with regard to claim 7, Flynn and Chiantelli teach the compound of the present invention is useful for treating PDGFR-α gastrointestinal stromal tumor and Arshad establishes that RECIST 1.1 is known criteria for assessing treatment response. Thus, it would have been obvious to one of ordinary skill in the art that administering the 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea taught by Flynn would be useful to treat symptoms of PDGFR-α gastrointestinal stromal tumor. Moreover, in performing the active step (i.e. administering an effective amount of the 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea taught by Flynn to a subject with s of PDGFR-α gastrointestinal stromal tumor and assessing treatment response with RECIST 1.1), the -(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea would necessarily result in the patient achieving stable disease according to RESCIST 1.1.
In regard to "wherein” clauses, MPEP 2111.04 states:
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.
Taken together, all this would result in the practice of the method of claim 7 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Applicant asserts that the Office has not established a prima facie case of obviousness based on these references. Applicant asserts that the claimed 150 mg dosage, specifically administered across one or more tablets with 50 mg dose strengths, is not disclosed or suggested by Chianelli. Flynn does not disclose the claimed dosage. Applicant notes that the claimed dosage (150 mg) does not fall within the range. Chianelli's ranges cannot serve as a starting point for optimization to the claimed dose amounts.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As set forth above, Flynn teaches a method of treating gastrointestinal stromal tumor mediated by the PDGFR kinase, c-kit, comprising administering the claimed compound. The Examiner acknowledges that Flynn does not explicitly teach administering the claimed compounds in the claimed amounts. However, as set forth above, Chianelli teaches the use of structurally similar compounds for treating gastrointestinal stromal tumor mediated by c-kit or PDGFRα. Moreover, Chianelli teaches compounds of the invention will be administered in therapeutically effective amounts via any of the usual and acceptable modes known in the art, either singly or in combination with one or more therapeutic agents; a therapeutically effective amount may vary widely depending on the severity of the disease, the age and relative health of the subject, the potency of the compound used and other factors; in general, satisfactory results are indicated to be obtained systemically at daily dosages of from about 0.03 to 2.5 mg/kg per body weight; an indicated daily dosage in the larger mammal, e.g. humans, is in the range from about 0.5 mg to about 100 mg, conveniently administered, e.g. in divided doses up to four times a day or in retard form; and suitable unit dosage forms for oral administration comprise from ca. 1 to 50 mg active ingredient [0102]. The Examiner notes that assuming the average weight of an adult human is 60 kg, an amount of 2.5 mg/kg is equivalent to a dose of 150 mg.
As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of Compounds of Formula (I) taught by Chianelli as a starting point for optimizing the amount of the claimed compound utilized to treat PDGFR-α mediated gastrointestinal stromal tumor since Chianelli teaches structurally similar compounds are useful for treating gastrointestinal stromal tumor and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Attention is brought to the Patent Trial and Appeal Board Decision in US Application No. 17/845,278 dated July 3, 2025 in which the Examiner was affirmed. Application ‘278 is directed to a method of treating a progressive gastrointestinal stromal tumor in a patient that has previously received prior tyrosine kinase inhibitor treatment, comprising orally administering to the patient in need thereof 150 mg, once or twice daily, of the compound 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2- fluorophenyl]-3 -phenylurea, which is similar in scope to the instantly claimed method. The Board concluded that there was no error in the Examiner’s reliance on Chianelli to provide a starting point for optimizing the amount of ripretinib for the treatment of GIST, as disclosed by Flynn, that is inter alia commensurate with a benefit/risk ratio and does not exhibit excessive toxicity by utilizing methods known in the medical arts and sound judgement, e.g. using no more than routine experimentation. The Board further concluded that there was no error in Examiner’s finding that “the doses taught by Chianelli would suggest doses that overlap the instantly claimed amount.
Applicant argues:
The Chianelli reference discloses a vast number of possible disparate disorders (120+) with no guidance or suggestion on selecting or differentiating the disclosed dosage for indications as disparate as hair loss, blood sucking parasites, and neoplastic disorders. Chianelli does not teach a fixed, non-patient weight dependent dose for humans, or a dosing regimen such as the administration of one or more 50 mg tablets as recited in the claims as amended. There is no biological or other data in Chianelli that teaches that the cited Chianelli compounds are therapeutically active, and therefore there is no guidance to select a specific compound, specific dose, specific dosage form, nor specific division of the dose into several tablets, let alone any dose for treating a gastrointestinal stromal tumor (GIST) using a different compound, as claimed. Moreover, Chianelli does not provide specificity regarding a route of administration, or a specific route of administration in relation to GIST.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 2144.09 states:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). As set forth above, an amount of 0.03 to 2.5 mg/kg is equivalent to a dose of 1.8 mg to 150 mg. Moreover an amount of 100 mg four times daily would be equivalent to a total daily dose of 400 mg. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of Compounds of Formula (I) taught by Chianelli as a starting point for optimizing the amount of the claimed compound utilized to treat c-kit mediated gastrointestinal stromal tumor since Chianelli teaches structurally similar compounds are useful for treating gastrointestinal stromal tumor and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result.
Conclusion
Claims 1 and 5-7 are rejected.
No claim is allowed.
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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628