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
The instant application, filed 04/14/2023, is a 371 filing of PCT/IB2020/059683, filed 10/15/2020.
Amendments and Claim Status
The following amendment filed on 05/21/2026 is acknowledged and entered.
Claims 1-16 are amended;
Claims 17 are added;
Claims 1-17 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/29/2026 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure is considered.
Response to arguments
Applicant’s arguments filed 05/21/2026 with respect to the objection to the specification, objections to the drawings, claim objections, and claim rejections under 35 U.S.C. §§ 112(b), 102 (a) (1), and 103 have been fully considered.
With respect to the objection to the specification, the amendment to remove “http://www.” from the hyperlinks on pages 2 and 3 is insufficient to overcome the objection. The text still continues to be browser-executable code. When the text is placed into a browser window, it leads to a webpage, which is impermissible according to MPEP § 608.01. Accordingly, the objection is maintained.
With respect to the objection to the drawings filed on 04/14/2023, the amendment to the drawings is insufficient to overcome the objection. The keys and symbols continue to be of low-resolution and difficult to read. The use of gray symbols, text, and images within the figures make it hard to read and understand the data. Accordingly, the objection is maintained.
With respect to the objection to claim 16, the deletion of “any of” is sufficient to overcome the objection. Accordingly, the objection is withdrawn.
With respect to the rejection of claims 2, 5, 7-14, and 16 under U.S.C. § 112(b), the amendments have been fully considered and are considered to be persuasive.
The removal of the broad limitations together with the narrow limitations from claims 2, 5, 8-12, and 14 from is sufficient to overcome the rejection.
The removal of the phrase “for example” from claims 2, 5, 7, 8-14, and 16, is sufficient to overcome the rejection.
The removal of the recitation “rate” from claims 16 is sufficient to overcome the rejection.
Accordingly, the rejections are hereby withdrawn.
With respect to the rejection of claims 1, 3, 4, 6-14, and 16 under 35 U.S.C. § 102(a)(1) as being anticipated by Khanna et al. (Ind J Pha Ed Res, Vol 54, Iss 2, published March 2020), hereinafter Khanna, the amendment to claim 1 to recite a weight percentage of nalbuphine from 2.5 to 20% w/w is sufficient to overcome the rejection. The amendment by applicant effectively has removed the disclosure by Khanna from consideration as a prior art rejection under the grounds of anticipation. The amendment to the claims is sufficient to overcome the rejection. Accordingly, the rejection is withdrawn.
However, the claim amendments made by Applicant have necessitated the inclusion of a new reference. Hariharan (U.S. 10,493,027 B2, published December 3, 2019) teaches a weight percentage by volume of nalbuphine salt which instant claims. Therefore, the rejection under 35 U.S.C. § 102 is hereby converted to a new grounds of rejection under 35 U.S.C. § 103, applying all the teachings of Khanna in combination with Hariharan.
Applicant argues that the pharmaceutical composition is novel over Khanna because the formulations disclosed by Khanna teaches nalbuphine at 0.5% w/w, lying outside the instantly claimed range of 2.5-20% w/w.
Applicant’s argument is unconvincing because the disclosure by Hariharan teaches the use of a nalbuphine hydrochloride salt covered by claims 1, 2, 17 at a weight percentage of 3.1% (column 11 lines 16-33, column 19, lines 29-39, column 52 table 24), which overlaps with that of the instant claims. Therefore, the claim limitation is considered obvious to a person of ordinary skill in the art.
Applicant argues that Khanna is silent on the pharmacokinetic properties of the nalbuphine formulation, and therefore provides no teaching for generating a composition with improved pharmacokinetic properties, in particular the importance of bioavailability as a property of the formulation.
Applicant’s argument is found unpersuasive because the absence of an express pharmacokinetic teaching of bioavailability does not overcome an obviousness rejection where the compositions are structurally similar, and the varied parameter (chitosan concentration) is a recognized result-effective variable. The role of chitosan as a nasal absorption/mucoadhesive enhancer is well-established in the art, according to the teachings of Khanna. The silence of a disclosure on a particular property does not preclude a finding that the property is either inherent, or the predictable result of routine optimization. Furthermore, Applicant has presented no evidence that the prior art composition is incapable of producing improved pharmacokinetic properties, as no comparison of the instantly claimed formulation to that of the prior art has been presented.
Applicant argues that increasing chitosan tenfold (as in composition 2 and 3) produced an unexpected 30% increase in absolute bioavailability and a 3.9-fold increase in Cmax. Applicants argue that the in vitro data of Khanna could not have predicted the results presented in the instant application.
Applicant’s argument is unconvincing, because the showing of unexpected results must be measured against the closest prior art, and must be commensurate in scope with the claimed range. Composition 2 has a nalbuphine:chitosan ratio of approximately 1:0.05 (178.6 g nalbuphine HCl : 8.9 g chitosan). This ratio lies outside of the claimed 1:0.1-1.1 range. Composition 3 has a nalbuphine:chitosan ratio of 1:0.5 (178.6 g nalbuphine HCl : 89.3 g chitosan), which lies inside the claimed range. A comparison between one out-of-range data point, and one in-range data point does not establish unexpected results over the full scope of the claimed range. Furthermore, this does not present evidence to rebut the prima facie case of obviousness against Khanna, who already teaches a composition of nalbuphine:chitosan ratio within the instantly claimed range. A modest increase in both bioavailability and Cmax constitutes an expected result following a tenfold increase in concentration of active ingredient. Therefore, the result is not shown to be unexpected, whatsoever. Further still, no additional data has been provided or discussed by Applicant to demonstrate any unexpected results. According to MPEP §716.02 (b) (I)
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c)
Thus, the burden is on Applicant to demonstrate that any asserted unexpected results are both significant and unexpected, and that they are directly attributable to the claimed invention. Importantly, the Applicant must provide a comparison with the closest prior art. Mere attorney argument or conclusory statements without adequate supporting evidence are insufficient to rebut a prima facie case of obviousness.
Applicant further argues that because Khanna identifies trial F5 (1:4 nalbuphine:chitosan) as optimal, and the ratio falls outside of the claimed range, Khanna teaches away from the claimed formulation.
Applicant’s argument is found unconvincing because Khanna discloses trials F1 (1:0.5 nalbuphine:chitosan) and F2 (1:1 nalbuphine:chitosan), both of which fall within the instantly claimed range. This provides direct motivation and direction to reproduce these ranges in an effort to optimize the parameters of the experiment. Furthermore, Khanna identifies F5 as optimal for different objectives (rapid CNS targeting), and not for systemic bioavailability, as in the instant case. According to MPEP 2125 II,
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)… Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Accordingly, a reference expressing a preference for one embodiment over another for different stated purpose is not constitute a teaching away from the known preferred embodiment. The embodiment disclosed by Khanna is within the instantly claimed range of nalbuphine:chitosan ratio. The only difference is the instantly claimed weight percentage, which is a teaching now supplied by Hariharan in the rejection included hereinafter.
Regarding newly added claim 17, the teachings of Hariharan address the use of the hydrochloric acid salt of nalbuphine, and the claim is rejected using the same references.
This. Accordingly, Applicant’s arguments are found insufficient to rebut the prima facie case of obviousness established by the combined teachings of the references, included hereinafter in a new grounds of rejection under 35 U.S.C. § 103.
With respect to the rejection of claims 1-16 under 35 U.S.C. § 103 as being unpatentable over Khanna (see earlier citation) as applied to claims 1, 3, 4, 6-14, and 16 above, and further in view of Hariharan (U.S. 10,493,027 B2, published December 3, 2019), the arguments made by Applicant are herein addressed as follows.
Applicant argues that Hariharan offers no teaching of chitosan to act as an excipient in combination with any intranasally administered drug.
Applicant’s argument is found unpersuasive because Hariharan expressly identifies chitosan in two separate excipient categories: both as a permeation enhancer useful for mucosally absorbable formulations (column 21, line 49) as well as a polymer viscosifier/gel former/mucoadhesive agents (column 23, line 5). Hariharan affirmatively teaches chitosan as a recognizable excipient class for formulations which include nalbuphine (Example 14). A reference need not reduce every listed component to a working example to render it available as known prior art which would produce a reasonable expectation of success. The disclosure of chitosan as a suitable permeation enhancer, combined with Khanna’s explicit teaching of specific nalbuphine: chitosan ratios for nasal delivery provides the motivation to combine required to establish a prima facie case of obviousness.
Applicant argues that Hariharan does not demonstrate a method of improving pharmacokinetic properties for intranasally administered compositions, and that Hariharan discusses the pharmacokinetic properties of only one intranasally administered nalbuphine composition.
Applicant’s argument is unconvincing because obviousness does not require the prior art itself to demonstrate a comparative improvement. It requires only a reasonable expectation of success in combining known elements according to their established functions. Example 14 of Hariharan establishes that nalbuphine is amenable to enhanced intranasal mucosal pharmacokinetic performance using permeation-enhancing excipients, Khanna establishes a specific, quantified relationship between chitosan and nalbuphine. The combination of these two teachings would have suggested to one of ordinary skill in the art that adjusting chitosan concentration relative to nalbuphine within the ranges informed by Khanna, would similarly affect the pharmacokinetic profiles as demonstrated by Hariharan—yielding a reasonable expectation of success.
The original rejection under 35 U.S.C. § 103 has been combined with the aforementioned rejection that addressed the claims once rejected under 35 U.S.C. § 103. Regarding new claim 17, the teachings of Hariharan sufficiently Render obvious the claim limitations. Accordingly, claim 17 is included in the amended rejection under 35 U.S.C. § 103, presented hereinafter.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Drawings
The drawings filed on 05/21/2026 are objected to under 37 CFR § 1.83(a) for the following reasons:
Due to the low resolution and choice of gray text and symbols used in the images, the figure legends are very difficult to distinguish in Figures 1:
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and Figure 3:
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. The figures must be remade with a higher-quality representation of the key or the use of black symbols, thicker line weight, and/or darker letters denoting the symbol used to describe the data.
Due to the low resolution used in the images, the y-axis
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, as well as the numerical values on the plots
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are very difficult to read in Figure 2. The figure must be remade with higher resolution text that is readable.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 1-17 are rejected under 35 U.S.C. § 103 as being unpatentable over Khanna et al. (Ind J Pha Ed Res, Vol 54, Iss 2, published March 2020) in view of Hariharan (U.S. 10,493,027 B2, published December 3, 2019).
The instant claims are directed to a pharmaceutical composition for nasal administration comprising nalbuphine in combination with specific formulation excipients that enhance solubility, absorption, stability, viscosity, isotonicity, and preservation. The claims collectively define a mucoadhesive intranasal nalbuphine dosage form designed to achieve rapid systemic absorption and enhance bioavailability through the nasal mucosa. The instant are further drawn to a nasal nalbuphine formulation encompassing conventional excipients to enhance solubility, stability, isotonicity, preservation, viscosity, and organoleptic qualities beyond the base composition and teach specific formulation refinements and excipient selections applied to the composition.
Khanna discloses a pain relieving intranasal pharmaceutical composition comprising nalbuphine and chitosan as a mucoadhesive/absorption enhancer, formulated with PEG-400, ethanol, water, sodium chloride, and benzalkonium chloride, adjusted to pH ≈ 5.5-6.5, with an osmolarity of 288 ± 18 mom/L, for administration to animal models for rapid management (Abstract, Tables 1, 3-7).
Regarding claim 1, Khanna expressly teaches a pharmaceutical composition for nasal administration comprising nalbuphine base and chitosan (0.5-2.5% as a mucoadhesive/absorption enhancer, dissolved in a PEG-400, ethanol, water solvent system (page 312). The weight ratio of nalbuphine base in Formulations F1 and F2 (0.5%) to chitosan (0.25-0.5%) corresponds approximately to 1:0.5 to 1:1, which overlaps with the instantly claimed range of 1:0.1 through 1:1 (Table 1). With regard to overlapping of ranges, MPEP § 2131.03 (I),
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original)
As such, the specific example taught in the prior art falls within the claimed range, and renders obvious the range instantly claimed.
Regarding claim 3, Khanna reports that the intranasal nalbuphine formulation delivered nalbuphine to the brain within 10 minutes and remained localized up to 240 minutes (Abstract, page 319). Although the metric is not specifically disclosed within the prior art, such rapid and sustained absorption inherently results in bioavailability
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≥ 40%. According to MPEP § 2112 (III),
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims
Therefore, the instantly claimed property is deemed to be obvious when the prior art product seems to be identical, except in that the prior art is silent to an inherent characteristic. Thus, the composition as taught by Khanna, because it overlaps with the instantly claimed subject matter, is inherently capable of achieving bioavailability
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≥ 40%.
Regarding claim 4, Khanna discloses that the pH of the nasal formulation is adjusted between 5.5 and 6.5, which lies within the instantly claimed range of 4.0-7.0 (see rationale of overlapping ranges in MPEP § 2131.03 (I), as referenced earlier).
Regarding claims 6 and 7, Khanna teaches that the composition includes solubility enhancers in the form of PEG-400 (10-60%), which is a polyethylene alkyl ether (Table 1, page 312), and renders obvious the instantly claimed subject matter.
Regarding claims 8, 9, and 14, Khanna teaches the inclusion of benzalkonium chloride (0.01%), a cationic surfactant (Table 1, page 312), rendering obvious the instantly claimed surfactant, which is taught to be a microbiological preservative (page 320).
Regarding claim 10, the pharmaceutical composition comprises ethanol (5%) and propylene glycol (5-60%) (Table 1, page 312), rendering obvious the instantly claimed cosolvents.
Regarding claim 11, Khanna reports the viscosity of the nasal drop increases with increasing concentration of PEG and chitosan, demonstrating the presence of a viscosity regulator within the composition.
Regarding claim 12, Khanna includes sodium chloride (0.9%) to achieve isotonicity and to regulate osmolarity (Table 1, page 312), satisfying the limitation of claim 12.
Regarding claim 13, Khanna reports an osmotic pressure of 288 ± 18 mOsm/L for the optimized formulation (Abstract, Table 3, page 317), which lies within the instantly claimed range of 300-700 mOsm/L (see rationale of overlapping ranges in MPEP § 2131.03 (I), as referenced earlier).
Regarding claim 16, Khanna discloses nasal administration of the composition to animals (pages 314 and 315), and reports dosing of 0.2-0.6mg/kg which corresponds to a human equivalent dose of approximately 12-36mg for a 60 kg subject—falling within the instantly claimed range of 3-20mg. Accordingly, the instant claims are rendered obvious by the teachings of Khanna, and thus, stand rejected.
Khanna fails to describe nalbuphine between a specific weight percentage of 2.5-20% w/w (claim 1). Khanna further fails to teach the use of pharmaceutically acceptable salts of nalbuphine to improve solubility (claim 1, 2, and 17); incorporation of defined pH regulators and buffers to maintain a nasal compatible pH range (claim 5); addition of solubility enhancers and surfactants to increase in drug dissolution and permeability (claims 6-8); inclusion of viscosity regulating polymers to control residence time and space performance (claim 11); addition of osmolarity regulating and stabilizing agents to maintain isotonicity and chemical stability (claim 12); use of broader set of antimicrobial preservatives to prevent microbial growth (claim 14); and finally, incorporation of taste, color, or order corrective additives for patient acceptability (claim 15).
The deficiencies of Khanna are remedied by Hariharan, who provides the full excipient system and stabilization strategy that Khanna’s intranasal nalbuphine formulation lacks. Hariharan teaches intranasal formulations of nalbuphine (see instant claim 1) (Table 22), which include nalbuphine hydrochloride in an amount of 3.1% (column 11 lines 16-33, column 19, lines 29-39, column 52 table 24, see instant claims 1, 2, and 17). Hariharan discloses that converting a drug into a salt through this process can increase its chemical stability, rendering the complex easier to administer, and allowing manipulation of the pharmaceutically active agent's equilibrium solubility and pharmacokinetic profile (column 3, lines 15-18). Hariharan teaches wherein the pharmaceutical composition containing nalbuphine hydrochloride has high bioavailability and is used for the treatment (relief) of pain. Specifically Hariharan teaches wherein the absolute bioavailability of the component is 200% (column 53, lines 9-50, column 7, lines 59-65, see instant claim 3). Khanna further teaches that the composition may contain chitosan (column 21, lines 45-49, see instant claim 1). Hariharan discloses wherein the pH regulator may be citric, lactic, and phosphoric acids (column 9, lines 34-45 , see instant claim 5). Hariharan further discloses that the composition can contain a solvent, such as diethylene glycol monoethyl ether (column 23 lines 53-58, see instant claims 6 and 7). Hariharan teaches wherein the composition may contain polysorbates as surfactants (column 21 lines 5-15), and that the composition may contain poloxamer (column 51 table 22, see instant claims 7 and 8). Hariharan teaches wherein the composition may contain a preservative of microbiological stability, such as methylparaben (column 18 lines 45-49, see instant claim 9). Hariharan teaches wherein the composition contains water as a solvent, hydroxypropyl cellulose, and disodium salt of ethylenediaminetetraacetic acid (EDTA) (column 52, table 24, see claims 10-12). Hariharan teaches wherein color, taste and odor correctors may be used in the composition (column 12 lines 37-40, column 24 lines 1-4, see instant claim 15) Finally, Hariharan teaches a method of using the pharmaceutical composition, wherein the dose for nasal use is 20 mg. (Table 23, see instant claim 16).
Both Hariharan and Khanna teach compositions related to nasal formulations of nalbuphine and share the same objective—to treat pain by rapid systemic absorption. Following the teachings of Hariharan, which states that converting a drug into a salt through this process can increase its chemical stability, rendering the complex easier to administer, and allowing manipulation of the pharmaceutically active agent's equilibrium solubility and pharmacokinetic profile (column 3, lines 15-18), a person of ordinary skill in the art prior to the filing date of the instant claims would have been directly motivated to incorporate nalbuphine at an explicitly taught weight percentage of 3.1% w/w nalbuphine HCl into the composition taught by Khanna, in order to achieve greater solubility and stability, yielding predictable results with a reasonable expectation of success. In addition, a person of ordinary skill in the art would have found it obvious to incorporate both buffering and surfactant systems as taught by Khanna, in order to improve drug permeability and shelf stability. Finally, a person of ordinary skill would have found it obvious to include taste and odor correctors in order to make the composition more palatable, arriving at the pharmaceutical composition of the instant claims. One of ordinary skill in the art would be directly motivated to do so in order to induce a pleasing aroma, or to mask flavors in the case of any product reaching the mouth, as taught by Hariharan (column 29 lines 63-65).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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