DETAILED ACTION
The receipt is acknowledged of applicant’s amendment and request of continued examination (RCE) filed 04/19/2026.
The after final amendment filed 03/13/2026 had been entered by filing the RCE.
Claims 1-3 are pending and subject of this office 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/15/2026has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 14/32,561, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
There is not adequate support for multiple limitations recited in the instant claims in the previously filed applications. For example, application No. 14/32,561 does not disclose “epinephrine” instantly claimed by the present application, nor “delivery across at least two mucous membranes simultaneously inside said patient’s mouth”. Applicant first disclosed epinephrine and two dosages in application 15/818,056.
Thus, Applicant does not have sufficient support in the parent application 14/323,561 to earn the priority date of the instantly claimed epinephrine, and delivery across two mucous membranes simultaneously inside the patient’s mouth.
Accordingly, the filing date of the 15/818,056 application, which is 11/20/2017, will be considered for examining instant claimed method in terms of the drug is epinephrine and two sites of application of the dosage form in the mouth.
This application, which discloses and claims only subject matter disclosed in prior Application No. 15/818,056, filed 11/20/2017, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a divisional application, and not continuation application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment made to claim 1 to recite that “…., where a perimeter of the mucosa-facing surface is completely surrounded by a saliva blocking bioadhesive border,….”. Nowhere applicant disclosed that the perimeter of the mucosa facing surface is completely surrounded by bioadhesive as claimed. Applicant did not refer to where in disclosure such limitation is disclosed. Recourse to the specification, no support found to this amendment. To the contrary, applicant disclosed in paragraph [0059] of the published application that:
“…..FIG. 2 shows a cylindrical, bottom central tablet layer or drug product component containing the active pharmaceutical ingredient (e.g., epinephrine) portion of the drug product or formulation, surrounded by the thick bioadhesive, saliva-blocking border or housing.…”
This teaching does not implies that the perimeter of the mucosa facing surface is completely surrounded by bioadhesive, only portion of the product as a whole, and not only the perimeter of the mucosa facing surface is surrounded by the bioadhesive. This teaching also does not exclude covering of the mucosa facing surface with bioadhesive.
If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hill (US 2007/0293581, of record), Carver et al. (US 2010/00291160, of record), Tzannis et al. (US 2008/0166404, of record), Matson et al. (US 7,001,609, currently cited on PTO 892), and the article by Smart (“The basics and underlying mechanisms of mucoadhesion” of record) and/or the article by Shaikh et al. (“Mucoadhesive delivery systems” of record).
Applicant Claims
Claim is directed to a method of treating hypotension, anaphylaxis, or both in a patient, the method comprising:
dispensing, by a plunger-like applicator device, at least two dosages of at least one pharmaceutical formulation of epinephrine, the dosages in the form of a central active pharmaceutical ingredient portion having mucosa-facing surface, wherein a perimeter of the mucosa-facing surface is completely surrounded by a saliva blocking bioadhesive border, and the dosages including 2.5 mg to 80 mg of epinephrine in the active pharmaceutical ingredient portion and at least one pharmaceutically acceptable excipient;
holding the at least two dosages against at least one mucous membrane using the applicator device until the dosages are secured to the at least one mucous membrane by the bioadhesive border;
removing the applicator device; and
allowing non-gastrointestinal transmucosal delivery of the at least two dosages across at least two mucous membranes simultaneously inside said patient's mouth,
wherein said method avoids at least most first-pass metabolism by the liver by preventing more than 50% of said epinephrine from being ingested, and
wherein said method is associated with at least one of greater systemic bioavailability, lower dilution, lower side effects, or a combination thereof.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Hill teaches sublingual dosing regimen for administering a series of epinephrine doses for treatment of allergic emergencies such as anaphylaxis (abstract; ¶¶ 0070, 0081, 0082). Hill teaches treating an allergic emergency in a patient comprising the steps of (a) administering to the patient two or three doses of sublingual dosage form comprising epinephrine; and (b) administering to the patient a second and third dose of a sublingual dosage form comprising epinephrine (¶¶ 0011, 0025, 0030, 0036, 0108; claims; examples 4, 5). The dosage forms comprise epinephrine and excipient (¶ 0016). The sublingual dosage form comprises 1-100 mg of epinephrine, and preferably 15-60 mg (¶ 0014). The dosage form can be mucoadhesive formulation (¶ 0078). The dosage form is a tablet that is disintegrated and absorbed in the oral cavity (¶ 0084), not ingested. The dosage form comprises excipients (¶ 0104) and mucoadhesive film (¶ 0076). Example 4 teaches the dosage form is administered under the tongue and maintained there until fully dissolved.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Hill teaches two or more sublingual dosage form to deliver epinephrine and suggest administration at the same time, the reference however does not teach delivery of the dosage form across two mucous membranes simultaneously inside said patient's mouth as claimed by claim 1. Hill does not teach dosage in the form of central active ingredient portion of mucosa-facing surface that has perimeter completely surrounded by bioadhesive thick saliva blocking layer, and dispensed by plunger-like device, and does not teach holding the dosage form using the device as claimed by claim 1.
Carver teaches non-invasive drug delivery systems useful for the absorption of therapeutically active agents through the epithelial membrane (abstract). The dosage form is administered under the tongue and has top convex surface and concave underside to fit under the tongue and is prevented from easily dislodgment from the insertion area thereby allowing the delivery system to provide the intended therapeutic benefit to the patient (¶¶ 0107-0115). Sublingual-type formulations are more effective than simply chewing and swallowing because drug efficiently pass through the sublingual membrane and into the blood without irreversible modification (¶¶ 0009, 0061). Non-invasive sublingual delivery provides delivery of the active agents without passing through the gastrointestinal tract (GIT) without having the active ingredient pass through the liver via GIT, thus eliminating first pass detoxification. Eliminating first pass detoxification allows for a decreased dose of the therapeutic active agent, decreased toxicity from metabolic by-products of liver detoxification, and enhanced speed of delivery of the therapeutic active agent (¶ 0033). The reference teaches rapid absorption of the active agent which improves bioavailability with nearly immediate bioavailability of the active agent, which allows for decreased dosing and thus decreased level of associated toxicities (¶ 0027). Example of drugs to be delivered sublingually is epinephrine (¶¶ 0082, 0092). The reference teaches sublingual formulation should not be swallowed or chewed and patient instructed towards non-invasive sublingual delivery rather than ingestion of the formulation, and the formulation allowed to dissolve in the mouth (¶¶ 0110, 0111, 0128). Example 6 teaches epinephrine tablet is administered to a patient as a sublingual dose that is allowed to dissolve in the mouth over a period of 1 second to three minutes with a minimal residence time of 30 to 90 seconds under the tongue (¶ 0151). The formulation comprises excipients (abstract; ¶¶ 0012, 0013, 0029, 0099, 0124). The formulation can be protected and prevented from chewing and swallowing (¶¶ 0072, 0100, 0105, 0106, 0110, 0111). The formulation can be encapsulated or having protective coating (¶¶ 0123, 0127, 0150), i.e. barrier to protect the formulation from mixing with the saliva. The formulation is prevented from easily dislodging from its intended absorption area by including materials to enhance stickiness and bioadhesion of the formulation and may contain adhesive (¶¶ 0107-0109, 0118, 0124), i.e. adhered to the site of application. The reference teaches the immediate environment may allow for the formulation to interact directly with the membrane to allow the system to facilitate absorption. For example, the immediate environment may allow a dehydrated formulation applied to a site of administration to hydrate using moisture wicked from the site of administration. In another example, the immediate environment may allow a pH-adjusting agent to facilitate absorption by promoting the interaction of the acidic component with the basic component at the site of absorption. In some embodiments, the immediate environment is within about 0-5 cm or less of the administered system formulation (¶ 0043).
Tzannis teaches bioadhesive drug formulation that adheres to the oral mucosal membrane. The formulation is delivered by applicator to the oral mucosa, e.g. sublingual mucous membrane (abstract; ¶¶ 0065-0068). The formulation is in the form of desk of central drug containing area coated with bioadhesive to provide the designed delivery of drug, e.g. immediate, or sustained, while has improved bioadhesion and secured and adhered to the mucosa (¶¶ 0066-0068, 0071, 0093, 0116-0118). The applicator is disposable after dispensing the dosage form in the mouth (¶¶ 0033, 0264-0265). The reference teaches delivery of the formulation by single or multiple applicators provided as series of individual single doses (¶¶ 0270-0274). Applicators are capable of enabling accurate placement of dosage forms into the transmucosal cavity (¶¶ 0158, 0250, 0255). The applicator has a handle to help placing the dosage into the mucosal cavity (¶¶ 0262-0267; figure 15-16). The applicator and handle reads on the claimed plunger like applicator.
Matson teaches mucosal drug delivery device to deliver drugs across mucosal membrane to treat systemic conditions. The device comprises a central region comprising the drug surrounded by adhesive or bioadhesive region free of drug to seal the edge of the drug region. Example of the drugs include epinephrine. Examples of conditions treated by the mucosal device is hypotension. The mucosal device is sublingual (abstract; col.4, lines 9-19; col.7, lines 51-60; col.8, lines 20-25, 45-56; col.13, lines 43-57; col.15, lines 46-53; col.20, lines 27-45)
Smart teaches mucoadhesive dosage forms retain formulations in intimate contact with absorption sites to enhance localized drug delivery and deliver difficult molecules into systemic circulations. The mucoadhesive dosage forms initially contact the mucous membrane, and the mucoadhesive and the mucosa surfaces can be mechanically brought together by placing and holding a delivery system within the oral cavity. Factors affecting mucoadhesion include the force applied and length of contact time. (See the entire document, and in particular: abstract; paragraphs 4.3.1 and 6).
Shaikh teaches mucoadhesive dosage forms designed to enable prolonged retention at the site of application, providing a controlled rate of drug release for improved therapeutic outcome. Drug delivery through the oral mucosa has proven particularly useful and offers several advantages over other drug delivery systems including bypassing hepatic first-pass metabolism, increasing the bioavailability of drugs, improved patient compliance, excellent accessibility, unidirectional drug flux, and improved barrier permeability. The mucoadhesive ability of a dosage form is dependent upon a variety of factors including initial force of application, and initial contact time between bioadhesive and mucosa. (See the entire document, and in particular: abstract; page 93, let column; page 95, left column).
Finding of Prima Facie Obviousness Rational and Motivation
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to treat anaphylaxis using first and second mucoadhesive sublingual epinephrine dosage forms as taught by Hill, and use a dosage form that comprises convex top and concave underside that dissolves under the tongue without swallowing or chewing as taught by Carver that also can be coated with bioadhesive coating to protect the dosage form from contacting the saliva. One would have motivated to do so because Carver teaches such a shape of sublingual dosage form fits under the tongue and is prevented from easily dislodgment from the insertion area thereby allowing the delivery system to provide the intended therapeutic benefit to the patient, and this method is non-invasive and more effective than simply chewing and swallowing because drug efficiently pass through the sublingual membrane and into the blood without irreversible modification and eliminates first pass detoxification which allows for a decreased dose of the therapeutic active agent, decreased toxicity from metabolic by-products of liver detoxification, and enhanced speed of delivery of the therapeutic active agent. one would coat the dosage form of Hill as coated with Carver to protect the dosage form from contacting the saliva. One would reasonably expect treating anaphylaxis using multiple mucoadhesive dosage forms comprising epinephrine that are coated and administered and fits easily sublingually and is prevented from dislodgment thereby allowing the delivery system to provide the intended therapeutic benefit to the patient, and expected to deliver epinephrine from both the top side contacting the sublingual mucosa and from the underside contacting the palate, meanwhile the dosage form provides decreased toxicity from metabolic by-products of liver detoxification, and speed of delivery of the therapeutic active agent from both sides of the dosage form that contact two mucosal surfaces is enhanced speeding the recovery from anaphylaxis while the dosage form is protected from the saliva.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to treat anaphylaxis using first and second mucoadhesive sublingual epinephrine dosage forms that contacts two mucosal surfaces and maintained under the tongue until completely dissolved as taught by Hill combined with Carver, and use disposable applicators to apply the dosage forms as taught by Tzannis. One would have been motivated to do so because Tzannis teaches disposable applicators can deliver single or multiple doses and enabling accurate placement of dosage forms into the transmucosal cavity. One would reasonably expect treating anaphylaxis using multiple mucoadhesive sublingual epinephrine dosage forms comprising the epinephrine to the sublingual mucosa wherein the dosage forms are delivered to the precise desired site.
Furthermore, one having ordinary skill in the art would have designed the mucoadhesive sublingual epinephrine dosage form taught by the combination of Hill, Carver and Tzannis to have central drug region surrounded by bioadhesive as taught by Matson because Matson teaches such a design seals the edge of the of the drug region, and therefore expected to prevent of mixing of the saliva with the drug in the device.
Additionally, it would have been obvious to one having ordinary skill in the art to hold the dosage forms delivered by plunger as taught by the combination of the above references in the mouth against the mucous membrane until the dosage forms are secured to the mucous membrane as taught by Smart and Shaikh because Smart teaches the force applied and length of contact time used to place and hold a dosage form within the oral cavity affect mucoadhesion, and because Shaikh teaches the mucoadhesive ability of a dosage form is dependent upon initial force of application, and initial contact time between bioadhesive and mucosa in order to provide the benefits of mucoadhesive delivery.
Regarding dosage form having mucosa facing surface comprising central portion and completely surrounded by mucoadhesive saliva blocking border as claimed by claim 1, this is taught by Tzannis. Carver also teaches bioadhesive coating.
Regarding the limitation of completely surrounding the dosage form with bioadhesive as claimed by claim 1, this is taught by Carver and Tzannis that do not teach partial coating.
Regarding saliva blocking layer as claimed by claim 1, Carver and Tzannis do not teach thin layer. In absence of claiming any thickness of the saliva blocking layer the prior art reads on the claimed thickness.
Regarding plunger like applicator claimed by claim 1, it is taught by Tzannis.
Regarding the amount of epinephrine of 2.5 mg to 80 mg as claimed by claim 1, Hill teaches 1-100 mg of epinephrine that embrace the claimed amount. 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 [R-5].
Regarding excipients claimed by claim 1, Hill and Carver both teach excipients.
Regarding the limitation of claim 1 of “holding the dosages against mucous membrane using the device until the dosages are secured to the at least one mucous membrane by the bioadhesive layer”, this is suggested by both Smart and Shaikh that teach increase the time of holding and contacting the dosage form will improve adherence of the mucoadhesive dosage form. Holding the dosage form to the application site as taught by Smart and Shaikh will inevitable secure the dosage form to the mucosa.
Regarding removing of the applicator as claimed by claim 1, Tzannis teaches disposable applicator that is removed after application of the dosage forms.
Regarding the limitation of claim 1 that “allowing non-gastrointestinal transmucosal delivery of dosages across two mucous membranes simultaneously inside said patient's mouth”, the dosage form of Carver is administered under the tongue and has top convex surface and concave underside to fit under the tongue and is prevented from easily dislodgment from the insertion area thereby allowing the delivery system to provide the intended therapeutic benefit to the patient. This teaching implies administration across two mucous membranes simultaneously inside said patient's mouth, the underside of the tongue and the mucous membrane of palate under the tongue.
Regarding the limitation of claim 1 that “the method avoids at least most first-pass metabolism by the liver by preventing more than 50% of said epinephrine from being ingested”, the cited references are directed to sublingual administration, and avoidance of ingesting the dosage form, and Hill teaches the dosage form is administered under the tongue and maintained there until fully dissolved, and Carver teaches to maintain the dosage form under the tongue and teaches the dosage form is dissolvable in the mouth in order not to be swallowed or chewed. Further, Carver teaches sublingual delivery provides delivery of the active agents without passing through the liver via gastrointestinal tract (GIT), thus eliminating first pass detoxification. Eliminating first pass detoxification allows for a decreased dose of the therapeutic active agent, decreased toxicity from metabolic by-products of liver detoxification, and enhanced speed of delivery of the therapeutic active agent. The teaching of Carver implies that more than half of epinephrine is not ingested. Shaikh teaches delivery through the oral mucosa has proven particularly useful and offers several advantages over other drug delivery systems including bypassing hepatic first-pass metabolism, increasing the bioavailability of drugs, improved patient compliance, excellent accessibility, unidirectional drug flux, and improved barrier permeability.
Regarding the limitation of claim 1 that “method is associated with at least one of greater systemic bioavailability, lower dilution, lower side effects”, the cited references teaches lower side effect more than side effects from ingested formulation, e.g. Carver and Shaikh teach delivery of the active agents without passing through the gastrointestinal tract (GIT) without having the active ingredient pass through the liver via GIT, thus eliminating first pass detoxification. Eliminating first pass detoxification allows for a decreased dose of the therapeutic active agent, decreased toxicity from metabolic by-products of liver detoxification, and enhanced speed of delivery of the therapeutic active agent.
Regarding claim 2 that the dosage forms are protecting with barrier, Tzannis and Carver teach barrier to protect the dosage form. Note that applicant disclosed protection is achieved by adhering the dosage form to the mucosa and by help of excipients, see page 5, lines 19-21 of the present specification as originally filed, and excipients disclosed by applicants at page 9, line 13, includes muco-adhesive, i.e. bioadhesives. Since combination of the cited references teaches adherence of the dosage form to the mucosa by adhesives, then protecting active pharmaceutical ingredient from mixing with saliva is expected from the prior art dosage form.
Regarding claim 3 that the barrier can be hydrophobic layer, hydrophobic surface, or physical barrier, the cited references teaches the bioadhesive claimed by applicants as barrier, Tzannis teaches coating that reads on barrier, and Carver teaches zein barrier that reads on hydrophobic and physical barrier.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive.
Priority
The examiner acknowledged applicant’s statement that: “Applicant does not acquiescence to or agree with the Examiner’s positions, but responds below to the Examiner’s rejections in order to advance prosecution of the present application”.
35 U.S.C. § 103
The focus of Applicant’s argument is that Figure 1 of Tzannis clearly teaches dosage form has no "mucosa facing surface" that can be bordered by bioadhesive. None of the cited references teach or suggest the recited arrangement of features as claimed by claim 1 that a saliva blocking bioadhesive border completely surrounds a perimeter of the mucosa facing surface.
This argument is moot in view of the newly cited reference to Matson that clearly teaches drug delivery device suitable for sublingual drug delivery to the mucosa, including epinephrine, the device comprises drug containing central region surrounded by non-drug containing adhesive/bioadhesive region to seal lateral edges of the drug containing region. This structure expected to prevent mixing of drug with saliva as applicant desired to achieve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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