DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 January 2026 has been entered.
Applicant’s arguments, filed 09 January 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
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 79, 105, 122, 124-125, and 127-132 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.
The term “derivative thereof” in claim 79 is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear to what At best, p. 16 lines 13-18 of the instant Specification discloses exemplary embodiments of what a pharmaceutically acceptable derivative of bedaquiline may be. However, it is not clear if such description serves as a definition of the term “derivatives,” or is merely descriptive.
Claim 79 and 132 recite the limitation “the physiologically acceptable pharmacologically inert excipient” in lines 5-6 of the claim. The claim is indefinite because the scope of the claim is unclear. Claim 79, lines 4-5 recite both a physiologically acceptable pharmacologically inert excipient, and a mixture of physiologically acceptable pharmacologically inert excipients. Therefore it is unclear whether “the physiologically acceptable pharmacologically inert excipient” refers to some or all of the inert excipients.
Claims 79, 105, and 132 recite a mass median diameter of about 50 µm. The term “about” in each claim is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. At best, p. 28 last paragraph of the instant Specification discloses wherein the solid carrier is provided in the form of coarse particles having a mass median diameter of between 50 µm and 500 µm. Thus it is not clear what sizes are encompassed by the term “about 50 µm,” such that one of ordinary skill in the art would know when a particle size infringes on the claimed invention.
Claims 79, 105, and 132 recite wherein the daily therapeutically effective dose of the pharmaceutical composition comprises 5 to 10 mg. The claims are indefinite because the scope of the claims is unclear. It is not clear whether the 5 to 10 mg refers to the total weight of the pharmaceutical composition (i.e. comprising bedaquiline and physiologically acceptable pharmaceutically inert excipient), or of the active ingredient (i.e. bedaquiline), since “daily therapeutically effective dose” implies a dose of the active agent, but pharmaceutical composition implies the active agent and the weight of said inert excipient(s). Clarification is requested.
Claims 122, 124-125, and 127-131 are rejected as they depend from claims 79, 105, or 132.
Claim 105 recites the limitation "the excipient " in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 105 recites one or more excipients. It is not clear whether “the excipient” refers to some or all of the one or more excipients. To obviate this issue, it is suggested for the claim to recite --- the one or more excipients ---.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 79, 105, 122, 124-125, and 127-132 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0028428 A1 (Hegyi et al., 02/04/2010) (hereinafter Hegyi) in view of WO 2015/179369 A1 (Palombella, 11/26/2015), as evidenced by “Bedaquiline” (PubChem, 06/24/2005) (hereinafter PubChem).
Hegyi discloses a pharmaceutical composition comprising a therapeutically effective amount of a fumarate salt of (αS, βR)-6-bromo-α-[2-(dimethylamino)ethyl]-2-methoxy-α-1-naphthalenyl-β-phenyl-3-quinolineethanol as active ingredient and a pharmaceutically acceptable carrier ([0016]). The particle size of the fumarate salt is preferably less than 200 µm ([0026]). The salt may be administered via inhalation or insufflation by means of methods and formulations employed in the art for administration via this way, such as in the form of a dry powder using any system developed for the delivery of dry powders via oral or nasal inhalation or insufflation ([0018]). The composition contains quantities of the fumarate salt equivalent to form about 1-1000mg of the corresponding free base ([0021]), and the effective daily amount may be lowered or increased depending on the response of the treated subject and/or depending on the evaluation of the physician ([0020]). The carrier for powder formulations includes diluents and sugars ([0017]) such as dextrose ([0080]). Suitable carrier particle sizes include those passing through a 200 mesh (i.e. < 75 µm) ([0080]). The pharmaceutical composition may further comprise phospholipids including phosphatidylcholine ([0048]). The chemical structure of the salt of the active ingredient is represented by the formula below ([0006]):
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PubChem evidences that the structure of the fumarate salt at paragraph 6 of Hegyi is the same as the structure known as bedaquiline, shown below:
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Hegyi does not explicitly disclose wherein the dry powder contains bedaquiline particles having a mass median diameter of 1 to 5 µm.
Palombella discloses compositions for administration by inhalation and kits comprising the same (abstract). Palombella further discloses that the bioavailability of an inhalation drug is optimum when the drug particles delivered to the respiratory tract are between 1 to 5 microns in size (¶ [0073]). Inhaled compositions may be administered via dry powder inhalers (DPIs), and controlled aliquots or doses of a compound may be pre-packaged in a blister pack (i.e. claimed container) (¶ [0074]). The dry powder may include carrier particles for carrying the particles of active material. The carrier particles may be composed of one or more crystalline sugars, including dextrose or lactose (i.e. claimed excipient) (¶ [0081]). The compositions may comprise other pharmaceutically acceptable additives or excipients such as phospholipids (¶ [0095]). The compositions may also include one or more force control additives (FCAs) in addition to the carrier particle, including leucine (¶ [0088]).
Accordingly, it would have been obvious to one of ordinary skill in the art to select inhalation delivery of bedaquiline as the active where multiple delivery means are taught and then to adjust the size of the particles to between 1 to 5 microns (µm) in size for optimal delivery of drug containing particles to the respiratory tract, as taught by Palombella. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). The overlapping range applies both to the narrower instantly claimed ranges and the fact that the narrower range taught by Palombella as optimal falls within the broader range taught by the primary reference.
Regarding claims 79, 105, and 132 reciting a particle size range of one or more excipients, the claimed range (i.e. about 50 µm) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. <75 µm). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 79, 105, and 132 reciting a daily effective dose, it would have been obvious to one of ordinary skill in the art to have selected an amount of the fumarate salt (i.e. active ingredient) from the disclosed range of about 1-1000 mg free base equivalent, which appears to overlap the instantly claimed amounts in mg. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate milligram amounts would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in mg. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
With regard to claim 105, the preamble “for use in providing antibiotic activity when treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria” is merely a recitation of the intended use of the compound. Since the pharmaceutical composition of Hegyi comprises the same active ingredient as the claimed invention, the pharmaceutical composition of the prior art would inherently be capable of treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria, whether the prior art recognizes such use or not. MPEP 2112(II).
With regard to claim 105 reciting a dry powder inhaler, as discussed above, Hegyi discloses the use of any system developed for the delivery of dry powders via oral or nasal inhalation or insufflation for the administration of the compound. Since Hegyi teaches systems to allow inhaling the pharmaceutical composition as a dry powder, a dry powder inhaler would flow from such teaching.
Regarding claims 122 and 127, it would have been obvious to select any disclosed carrier, such as glucose or lactose as the sugars, as taught by Hegyi.
Regarding claims 128 and 129, Hegyi differs from the instant claims insofar as not explicitly disclosing the composition further comprises leucine.
As discussed above, Palombella discloses inhalation powder compositions may also include leucine as a force control additive, in addition to the carrier particles.
It would have been obvious to one of ordinary skill in the art to have formulated the pharmaceutical composition of Hegyi with leucine to impart force control benefits as taught by Palombella.
With regard to claims 130 and 131, it would have been obvious to include phosphatidylcholine as a phospholipid, as taught by Hegyi.
Response to Arguments
Applicant asserts para. [0018]-[0030] of the instant Specification provides objective evidence showing that the lower dosages required for inhalation versus oral administration reduce the likelihood of side effects commonly associated with bedaquiline.
Examiner disagrees. Regarding allegations of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). In this instant case, Applicant has referenced various statements in the Specification support their position (e.g., paragraphs [0018]-[0030] of the instant Specification alleged in p. 1-3 of the Remarks submitted 09 January 2026), but these cannot take the place of evidence of the record. Conclusory statements, unsupported by objective factual evidence, were not found to be of substantial evidentiary value. See MPEP § 716.01(c). Applicant has not presented objective factual evidence (e.g., experimental data) which shows inhalation has properties that are unexpected compared to the other delivery means, which could be considered to overcome the obviousness rejection.
Applicant further asserts because Palombella discloses bedaquiline only one time as an orally administered adjunct treatment, and Hegyi discloses a range of 1-1000 mg with an example containing over 120mg of the active ingredient, clearly suggesting dosages greater than those claimed, the cited art does not teach or suggest each element of the rejected claims.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. "Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations." See MPEP 2141(III). In this instant case, Applicant agrees that Hegyi explicitly states that one form of suitable delivery is an inhalation dry powder. As such, it would be obvious to select that from among the various forms taught, including dry powder inhalation, and one of skilled in the art need not rely on Palombella to teach bedaquiline. Once the inhalation dry powder form is selected, it would have been obvious to a skilled artisan to have selected an amount of bedaquiline from the disclosed range of about 1-1000 mg free base equivalent and arrived at an effective daily dose that is optimal for a inhalation dry powder, which would appear to overlap with those instantly claimed.
Finally, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Thus the teachings of Hegyi are not limited to its example and Applicant’s argument is unpersuasive.
Applicant asserts the cited teaching about inhalation particles size in Palombella is not directed to bedaquiline particles, thus one would not combine Hegyi and Palombella because the particle sizes of Hegyi are much larger than those of Palombella.
The Examiner does not find the argument persuasive. Palombella was not relied upon for the particle sizes of bedaquiline specifically, but for teaching the optimal size of delivery for dry inhalation particles generally. Here, Hegyi teaches the particles should be smaller than 200 µm generally, so the skilled artisan would know that is a range for all dosage forms. When selecting a dry inhalation method, the skilled artisan would look to related dry powder inhalation art to find the general optimal size, such as taught by Palombella, and then to adjust from there. The range of particle sizes taught by Palombella falls within the broader range of particle sizes taught by Hegyi, which is what the skilled artisan would expect. The skilled artisan would then narrow the range of the particle’s sizes from 0-200 µm as taught by Hegyi to the optimized particle size range of 2-5 µm of Palombella for the reasons taught by Palombella.
Applicant asserts that hindsight reconstruction was used where the cited art teaches away from the instant claims given the size of particles in Hegyi are too large to navigate the bends in the airways.
The Examiner does not find the argument persuasive. As discussed above, the motivation to combine the references is not based on hindsight reconstruction, but a result of the skilled artisan picking an explicitly disclosed delivery method from Hegyi, i.e. dry inhalation powder, and then optimizing the size from the under 200µm to about 2.5µm based on the well-known teachings, as taught by Palombella, for dry powders. As such, the skilled artisan would expect the larger particle size taught by Hegyi would be expected to be suitable for other forms of delivery.
Applicant asserts the delivery route of dry powder results in an unexpectedly reduced dosage of 1/40th of the commercial dosage of orally administered bedaquiline, based on disclosed daily dosage of 5-10mg in para. [0124] of the instant Specification, compared to 400mg per day for Sirturo®, an oral bedaquiline, in para. [0013] and [0027] of the instant Specification. Applicant further asserts that although Hegyi broadly contemplates that dosages can be “1 mg to about 1000 mg” (Hegyi [0021]), it is superseded by the fact that the daily dose of Sirturo® is 400mg.
The Examiner is not persuaded by these statements. The dosages disclosed in Hegyi are not limited to Sirturo® dosages as asserted by Applicant. Applicant agrees that Hegyi discloses a dosage range of about 1mg to about 1000mg (Hegyi [0021]), and that Hegyi discloses one form of suitable delivery is an inhalation dry powder. Therefore it would appear that Hegyi teaches or at least suggests an inhalation dry powder of bedaquiline with dosage range as low as about 1mg. Additionally, para. [0124] of the instant Specification discloses wherein a device dose is 15-30mg in the case of M. abscessus infections. Thus it appears doses are adjusted based on the infections being treated, which Applicant agrees in para. [0125] of the Specification, stating that “it is understood that the person of skill in the art will routinely adjust the lung dose of bedaquiline to be administered based on the MIC of bedaquiline for the respective bacteria strain well established in the art.” Therefore doses of bedaquiline are not limited to Sirturo® doses. Finally, Applicant’s allegation about daily dose of oral Sirturo® being 400mg superseding Hegyi’s disclosed range of 1 mg to about 1000 mg, and that the instant Specification disclosing a daily dosage of 5-10mg is unexpectedly reduced over Sirturo® daily doses, are merely opinions with conclusory statements. Conclusory statements, unsupported by objective factual evidence, were not found to be of substantial evidentiary value. See MPEP § 716.01(c). In this instant case, para [0027] of the instant Specification discloses 400 mg as an oral loading dose, and further discloses wherein a maintenance dose of oral bedaquiline is 200 mg, and that the pulmonary dose will be 10 mg to 100 mg, depending on the particulars of inhaled administration. Thus it is unclear, in the absence of objective evidence (e.g. experimental data), how the various statements throughout the instant Specification support the alleged unexpected results compared to the other delivery means. Due to all the reasons above, Applicant’s argument is unpersuasive.
Finally, Applicant asserts there is a long felt but unresolved need to prevent or reduce the systematic side effects of bedaquiline, and such issue has not yet been solved in the two decades since bedaquiline was discovered. Specifically, Example 1 of the instant Specification demonstrates the significant inhibitory activity against mycobacteria ([0135] - [0141]), while showing minimal cytotoxic effect on pulmonary epithelial cell viability ([0155]). Thus, systematic side effects in hepatic and cardiac tissue can be reduced by use of the claimed compositions.
The Examiner does not find the assertion to be persuasive. The data as presented is insufficient in providing objective evidence of unexpected results. Example 1 of the instant Specification has not provided comparative data to supported the allegations of reduced side effects and significant inhibitory activity compared to existing formulations (e.g., oral administration). Moreover, the Examiner notes that the compositions of Example 1 of the instant Specification are not reasonably representative of the instantly claimed composition. For example, it is not clear how Example 1, comprising suspensions of bedaquiline, is reasonably representative of instant claims 79, 105 and 132, reciting dry powders for inhalation. Similarly, Example 1 does not demonstrate the alleged criticality of the excipient particle ranges as instantly claimed. Finally, Examiner notes Momin et al. (“Development and validation of a RP-HPLC method for simultaneous quantification of bedaquiline (TMC207), moxifloxacin and pyrazinamide in a pharmaceutical powder formulation for inhalation,” 3/2/2018), which demonstrates state of the art in developing bedaquiline dry inhalable powder. Due to all the considerations stated above, Applicant’s argument is unpersuasive.
Claims 79, 105, 122, 124-125, and 127-132 are rejected under 35 U.S.C. 103 as being unpatentable over Smyth et al. (WO 2019/070693 A1, priority 10/02/2018) (hereinafter Smyth).
Smyth discloses a dry powder composition for inhalation ([0006]), compatible with an inhaler ([0090]), comprising micronized particles of therapeutic agents including clofazimine and bedaquiline ([0099]). The therapeutic agents may be administered separately ([0100]). The therapeutic agents may be within a median particle diameter range of 0.5-10 µm, particularly less than 5 µm, as it is known that particles with a mass median aerodynamic diameter (MMAD) of < 3 µm would target infection site in peripheral lung ([0128], [0078], [0046]). The composition may comprise excipients including glucose, L-leucine, and dipalmitoyl phosphatidylcholine ([0081]). The composition may be in the form of a unit dosage form including a blister or capsule ([0017]).
Accordingly, Smyth discloses a dry powder composition suitable with an inhaler (i.e. instantly claimed container of claim 105) in the form of a blister, comprising bedaquiline, wherein suitable particle sizes include a diameter of < 3 µm, comprising inert excipients including glucose (i.e. instantly claimed sugar of claims 122 and 127), L-leucine (i.e. instantly claimed amino acid of claims 128 and 129), and/or dipalmitoyl phosphatidylcholine (i.e. instantly claimed DPPC of claims 130 and 131). Together these would provide a composition or combination as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 79, 105, and 132 reciting a particle size range of the one or more excipients, although Smyth does not explicitly disclose a particle size range of the excipients, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range (i.e. about 50 µm) through routine experimentation based on particle sizes desired to facilitate effective delivery of therapeutic agents. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
With regard to the bedaquiline particle sizes of claims 79, 124, 125, and 132, the claimed ranges (i.e. 1-5 µm, 1-3 µm, or 2.5 µm, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. <3 µm). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 79, 105, and 132 reciting a daily therapeutically effective dose, although Smyth does not explicitly disclose a specific therapeutic agent dose amount for bedaquiline, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range (i.e. 5 to 10 mg) through routine experimentation based on the amounts of actives desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
With regard to claim 105, Smyth further discloses wherein the composition treats or prevents a pulmonary infection, including a Mycobacterium infection ([0020], [0022]). Moreover, the preamble “for use in providing antibiotic activity when treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria” is merely a recitation of the intended use of the compound. Since the dry powder composition of Smyth comprises substantially the same active ingredient as the claimed invention, the dry powder composition of the prior art would inherently be capable of treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria, whether the prior art recognizes such use or not. MPEP 2112(II).
Claims 79, 105, 122, 124-125, and 127-132 are rejected under 35 U.S.C. 103 as being unpatentable over Smyth et al. (WO 2019/070693 A1, priority 10/02/2018) (hereinafter Smyth) in view of Hassan & Lau (“Inhalation performance of pollen-shape carrier in dry powder formulation,” 04/21/2011) (hereinafter Hassan).
The teachings of Smyth is discussed in detail above. While Smyth is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Smyth will be interpreted as though it does not explicitly disclose a particle size range of the one or more excipients.
However, Hassan discloses that dry powder inhalation requires drug particles to have an aerodynamic size range of 1-5 µm, and a common practice to improve the drug delivery efficiency is to blend the fine drug particles with larger carrier particles (p. 93, left col., ¶1). It has been commonly reported that the most efficient carrier particle sizes is 30-90 µm (p. 93, right col., ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art to have selected a particle size from the disclosed range of 30-90 µm since it is a known and effective particle size range for excipients including carrier particles as taught by Hassan. Such particle sizes selected would have equated to a mass median diameter that appears to overlap with the claimed particle diameters of the one or more excipients (i.e. about 50 µm), thus making the claimed mass median diameter ranges obvious.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Momin et al. (“Development and validation of a RP-HPLC method for simultaneous quantification of bedaquiline (TMC207), moxifloxacin and pyrazinamide in a pharmaceutical powder formulation for inhalation,” 3/2/2018), directed to bedaquiline as an inhalable powder.
Celik et al. (US 2017/0143626 A1, 05/25/2017), directed to dry powder formulations comprising active substance and carrier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612