DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 11/10/2025; and IDS filed 07/31/2025.
Claims 1-3 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 .
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 § 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), Carver et al. (US 2010/00291160, of record), Tzannis et al. (US 2008/0166404), and the article by Smart (The basics and underlying mechanisms of mucoadhesion) and/or the article by Shaikh et al. (Mucoadhesive delivery systems), all references are 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 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 completely surrounded by bioadhesive thick saliva blocking layer dispensed by plunger-like device, and 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.
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 dosage form comprising central drug containing area surrounded/coated by the mucoadhesive coating and further use disposable applicators to apply the dosage forms as taught by Tzannis. One would have been motivated to do so because Tzannis teaches formulations in the form of central drug containing area coated with bioadhesive provide the designed delivery of drug, e.g. immediate, or sustained, while has improved bioadhesion and security to the mucosa, and teaches that 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 surrounded by mucoadhesive coating delivered to the sublingual mucosa wherein the dosage forms are delivered to the precise desired site and secured in the mouth.
Furthermore, 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 11/10/2025 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
Applicant argues that the PTO cites Hill for teaching a sublingual dosing regimen and cites each of Tzannis, Carver, Smart and Shaikh for allegedly teaching or suggesting assorted elements of the claimed pharmaceutical formulation. However, these references fail to teach or suggest the particular arrangement of features recited in amended claim 1. Tzannis teaches that a tablet can be coated with bioadhesive (para. [0117]) but does not teach or suggest a dosage form having a pharmaceutical ingredient mucosal contact surface bordered by a bioadhesive border. Carver, Shaikh and Smart fail to remedy this deficiency.
In response to this argument, it is argued that Hill is relied upon for teaching the sublingual dosing regimen. Both Carver and Tzannis teach coating the sublingual dosage form with bioadhesive layer. At paragraphs [0066-0068, 0071, 0093, 0116-0118], Tzannis teaches 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. Tzannis clearly teaches mucosa facing surface comprising central portion and completely surrounded by mucoadhesive saliva blocking border as claimed by claim 1. Carver, Shaikh and Smart satisfy the purpose for which the references applied as set forth in this office action.
Applicant maintains that the cited references fail to teach or suggest use of a plunger-like applicator device as specified in claim 1. Applicant disagrees with the PTO's characterization of Tzannis as teaching such a device. The PTO contends particularly that the applicator and handle in Tzannis Figures 15 and 16 "reads on the claimed plunger like applicator." Applicant argues that the broadest reasonable interpretation of a "plunger-like" device, at minimum, look like and/or functions like a plunger. The cited devices in Tzannis do neither. Plunger is "a piece with a motion like that of a ram or piston" where a piston is а sliding or reciprocating piece". In contrast, Figures 15 and 16 of Tzannis each show containers made for dropping a tablet onto a buccal surface. They do not evince a plunger-like function, particularly that would accomplish "holding the at least two dosages against at least one mucous membrane" as required by claim 1.
In response to this argument, it is argued that the handle as taught by Tzannis looks like a plunger and function like a plunger to dispense the dosage form into the mouth of the user. The handle of the prior art achieved the goal achieved by the claimed plunger-like. The claims are given the broadest interpretation during examination, and the handle taught by the reference meets the claimed term “plunger-like” absent claiming details of the plunger-like. The term “plunger-like” does not require any function or structure, only disposing the dosage form in the mouth of the patient that is fulfilled by Tzannis. Note, the claim broaden the scope of plunger by reciting “plunger-like”.
Applicant argues that the cited references further fail to teach sheathing the claimed dosage with a barrier to protect against mixing with saliva outside of the attachment zone as set forth in claim 2. The PTO alleges that Carver and Tzannis as allegedly teaching avoiding contact with saliva. Office Action p. 17. Both of these references (as well as Hill) describe coating formulations that rely on contact with saliva to release active agent, where the coating is designed merely to slow dissolution by saliva (Carver para. [0123] or to resist humid storage conditions but dissolve in the wet environment in the mouth (Tzannis para. [0118]). The other cited references fail to remedy this deficiency.
In response to this argument, it is argued that Tzannis clearly teaches coating of the sublingual dosage form with bioadhesive that implies central active pharmaceutical ingredient portion completely surrounded and sheathed by a bioadhesive layer as claimed. Tzannis teaching make it obvious that sublingual dosage form can be coated, i.e. completely surrounded and sheathed by bioadhesive layer, and can be applied sublingually using a removal applicator. Application of the dosage form sublingually implies adhesion to the lower surface of the tongue, as well as to the palate that is the floor of the mouth. The reference satisfies the purpose for which it was applied.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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