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 .
Applicants' arguments, filed March 19, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Specification
The disclosure was objected to because of the following informalities: trademarks or marks used in commerce are present and are not properly formatted each time they are used in the specification. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 19, 2025 and those set forth herein.
Applicants amended the specification but did not add generic terminology to each trade name or marks used in commerce. As indicated in the December 19, 2025 Office Actin, trade names or marks used in commerce should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term. As all of the conditions required for formatting of trade names or marks used in commerce have not been met, the specification remains objected to. Appropriate correction is still required.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, from which all other claims depend, contains the new limitation “by placing the pharmaceutical film can be placed under a subject’s tongue…” (emphasis added). “By placing” is affirmative language requiring the step(s) that follow to take place, “can be” is optional language that encompasses the step(s) that follow not being required. Therefore it cannot be determined if the pharmaceutical film must be placed under the tongue or positioned elsewhere on the oral mucosa for a residence time and if the subsequent steps after “can be placed” must take place.
Please clarify.
The dependent claims fall therewith.
For the purposes of applying art below, claim 1 is being interpreted as requiring all of the recited steps to take place.
Claim 22 was 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 19, 2025 and those set forth herein.
Claim 22 contains the trademark/trade name LABRASOL® and rejected as indefinite for clearly and distinctly reciting the actual materials used rather than the trademark/trade name which indicates the source of the goods and not the goods themselves.
Applicants responded by adding the “®” symbol to claim 22.
This does not address the issue as trademarks/trade names are not permitted in the claims and the trademark/trade name is still present. Therefore the rejection is maintained.
Claim Rejections - 35 USC § 112 – Written Description
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 2 – 18 were 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. This written description rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 19, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that the Examiner has contended that without details of the composition of ANAPHYLM®, it cannot be determined if the composition falls within the scope of the claims. The examples show the PD (pharmacodynamics) of self-administered epinephrine sublingual film (ANAPHYLM®) and compared to administration by a health care professional or intramuscular administration. As ANAPHYLM® is an embodiment of the claimed subject matter, the specification discussed the invention in sufficient detail to demonstrate possession of the claimed invention.
These arguments are unpersuasive. Arguments without factual support are mere allegations and are not found persuasive. The claims do not require just a sublingual film comprising epinephrine but epinephrine or a prodrug thereof present in a polymeric matrix and an adrenergic receptor interactor is also present in the film. The statement that ANAPHYLM® is an epinephrine sublingual film does not establish that this oral film falls within the scope of the claims. Even if it was established that ANAPHYLM® did fall within the scope of the claims, the rejection is based on the failure of the specification as filed to demonstrate the possession of a representative number of species of oral film as claimed that demonstrate the functions requires in claims 2 and 3 or comparable pharmacokinetic(s) parameters to any epinephrine containing formulation administered either by a health care professional or via intramuscular injection. Those films can contain any polymer matrix, any adrenergic receptor interactor that as discussed on p 9 of the December 19, 2025 Office Action and ¶ [0121] of the instant specification can modulate the absorption properties of the film and thus the pharmacokinetic parameters, and epinephrine or any prodrug thereof. This very large genus functionally defined genus would not be sufficiently supported by the ANAPHYLM® formulation tested in the specification even if it was demonstrated that this meets the structural limitation of instant claim 1. Therefore, possession of the full scope of the subject matter encompassed by the claims has not been demonstrated to fully satisfy the written description requirement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 - 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al. (US 11,191,737) in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
Schobel et al. discloses formulations that comprise a polymeric matrix, epinephrine in the polymeric matrix and an adrenergic receptor interacter (whole document, e.g., col 1, ln 27 – 29). Any desired polymeric matrix may be used, provided that it is orally dissolvable or erodible and can be moderate-dissolving in the oral cavity (col 17, ln 1 – 6). The composition can be a film such as shown in figure 1B (col 3, ln 57 – 61). Film formulations can have a size and thickness such that the film can be administered to a user, such as the oral cavity (col 12, ln 16 – 21). The compositions of epinephrine or its salts or esters can have a biodelivery profile similar to that administered by injection, such as an EPIPEN® (col 15, ln 62 – 65). Sublingual (under the tongue) or intramuscular were compared in example 14 (col 41, ln 63 – col 42, ln 16). The adrenergic receptor interacter can be a flavonoid or used in combination with a flavonoid, reading on a mixture and exemplified adrenergic receptor interacters/permeation enhancers include farnesol; linoleic acid; a phytoextract such as essential oils extracted from parts of the clove plant although it can also be synthetic; and phenylpropanoids, which are aromatic compounds, including eugenol, hydrocinnamic acid, chavicol and safrole (col 1, ln 35 – col 2, ln 11). The results shown in Figure 12 report epinephrine plasma concentration over time in male miniature swine so the film was positioned within the oral cavity in contact with the oral mucosae and was allowed to deliver the epinephrine. The formulations shown in columns 43 and 44 comprising epinephrine bitartrate are highly similar to the example formulations of the instant application comprising epinephrine bitartrate, with some amounts of the same ingredient only varying slightly in the amount present.
Self-administration of the dosage form to the subject is not disclosed as swine cannot place a film formulation in their mouths.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the epinephrine oral film dosages of Schobel et al. to a human subject who can place the oral film in their own mouth on the oral mucosa and allow the epinephrine to be delivered. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional. One of ordinary skill in the art is aware that the comparator EPIPEN® can be self-injected by a user when needed and the oral film formulation of Schobel et al. can be used in similar circumstances which often take place when not around a health care professional.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not disclosed.
Sayeed et al. discloses that following sublingual administration, the patient is advised to abstain from swallowing the tablet and avoid eating, drinking, or chewing to facilitate drug absorption through the oral mucosa and even swallowing saliva is to be avoided so that there is no ingestion through the gastrointestinal tract where drug absorption may be inefficient (p 12, ¶ 2).
NorthStar discloses that for sublingual strip administration, the strip is placed under the tongue (step 4 of the method bridging p 21 and 22). The tongue is compressed down on the strip, reading on holding the film under the tongue, and the mouth closed until the strip is completely dissolved and spitting, drinking water or consuming food should not take place for 5 minutes after the strip is dissolved (step 5 of the method bridging p 21 and 22).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of Schobel et al. to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
Regarding Schobel, Applicants argue that the amended claims render this rejection moot.
As set forth above, the claims as amended are rendered obvious by the new rejection set forth above with new references cited to teach the new claim limitations.
Applicants also argue that self-administration is not obvious because advantages like rapid dissolution, ease of swallowing and delivering drugs directly into systemic circulation by positioning the pharmaceutical film as claimed are not simple to adopt. The mode of delivery is often hindered by limitations in drug dosage, stability and the need for specialized production methods. More than merely identifying similarities between the claimed invention and the prior art is required to establish a prima facie case of obviousness.
These arguments are unpersuasive. Prior art is presumed to be enabled and Applicants’ arguments do not establish that Schobel, which discloses film formulations intended for administration to the oral cavity comprising a polymeric matrix, epinephrine in the polymer matrix and an adrenergic receptor interactor are not enabled for the disclosed administration sublingual administration route. There is no comparison of the effects of self-administration as claimed with the product of the prior art that was not self-administered to the pigs used in Schobel to demonstrate unexpected results from self-administration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Applicants state that the claims are distinct and since the rejections are provisional, the double patenting rejections will be addressed in full when the claims are allowable.
These arguments are unpersuasive. As set forth below, in view of the teachings of Sayeed et al. and NorthStar, the instant claims are not patentably distinguished over the claims of each of the patents or patent applications identified below. Contrary to Applicants’ statement, not all of the rejections are provisional nonstatutory double patenting rejections. Applicant's failure to argue the rejection on the grounds of non-statutory double patenting over US Patent Nos. 11,191,737; 12,023,309; and 12,433,850 is noncompliant with the regulations under 37 C.F.R. 1.111. Those rejections are not provisional rejections as the claims of US Patent Nos. 11,191,737; 12,023,309; and 12,433,850 have been issued. In the interest of compact prosecution, the Examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejections based on US Patent Nos. 11,191,737; 12,023,309; and 12,433,850. Because applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory double patenting rejections based on US Patent Nos. 11,191,737; 12,023,309; and 12,433,850 and no Terminal Disclaimer has been filed, the rejection is maintained.
Due to abandonment of Application No. 19/059,921 since the mailing of the previous Office Action, the provisional nonstatutory double patenting rejection over this application has been withdrawn.
Claims 1 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 28 of U.S. Patent No. 11,191,737 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’737 recite oral delivery films comprising a mucoadhesive polymeric matrix, a pharmaceutically active component including epinephrine, a pharmaceutically acceptable salt or ester thereof in the polymeric matrix; and an adrenergic receptor interacter that enhances permeation of the epinephrine and methods of making such films. The adrenergic receptor interacter of claims 3 – 16 contain the same elements as the adrenergic receptor interacters of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’737 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
Claims 1 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 33 of U.S. Patent No. 12,023,309 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’309 recite a pharmaceutical composition that can be a film (see claim 18) comprising a polymeric matrix, pharmaceutically active component including epinephrine, or a pharmaceutically acceptable salt or ester thereof in the polymeric matrix; and an adrenergic receptor interacter (claim 1). The exemplified adrenergic receptor interacters (claims 4 – 16) are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’309 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
Claims 1 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 39 of U.S. Patent No. 12,433,850 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’850 recite a film pharmaceutical composition for oral delivery comprising an oral mucoadhesive polymeric matrix; a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter with several required functions (claim 1). The claimed adrenergic receptor interacters (claims 3 – 9) are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’850 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 – 38, 33, 44, and 51 - 60 of copending Application No. 16/143,821 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’821 recite a film oral delivery pharmaceutical composition comprising an oral mucoadhesive polymeric matrix, a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter with some functional language (e.g., claim 33). The claimed adrenergic receptor interacters (claims 4 – 6 and 9 – 19) are the same as those claimed.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’821 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 50 of copending Application No. 17/549,219 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’219 recite a pharmaceutical composition comprising a polymeric matrix, a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter (claim 1) and can be in the form of a film (claim 3). The same ingredients as in the instant claims for the adrenergic receptor interacter can be present in the dosage form (claims 4 – 6 and 9 – 19). Pharmacokinetic parameters are recited in claims 47 – 50 for the claimed pharmaceutical film. Methods of use are also claimed (e.g., claim 36).
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’219 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 74 of copending Application No. 18/334,986 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’986 recite the administration of an oral film dosage form comprising a polymeric matrix; a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter; positioning the film in an oral mucosa for a residence time; and allowing the film to deliver the pharmaceutically active component. Pharmacokinetic parameters are claimed (e.g., AUC in claims 5 - 16 and the Tmax in claims 50 - 52). The claimed adrenergic receptor interacters (claims 18 – 31) are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’986 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 and 22 - 30 of copending Application No. 18/413,556 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’556 recite an oral transmucosal delivery pharmaceutical composition comprising a polymer and ester of epinephrine with a half-life of less than one minute (claim 1) that can further comprise an adrenergic receptor interacter or a permeation enhancer (claim 2). Those ingredients of claims 4 – 6 and 9 – 20 are the same as those of the instant claims. The composition can be in the form of a film (claim 3).
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’556 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 75 of copending Application No. 18/778,562 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’562 recite the administration of an oral film dosage form comprising a polymeric matrix; a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter; positioning the film in an oral mucosa for a residence time; and allowing the film to deliver the pharmaceutically active component. Pharmacokinetic parameters are claimed (e.g., AUC in claims 5 - 16 and the Tmax in claims 50 - 52). The claimed adrenergic receptor interacters (claims 18 – 31) are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’562 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 34 of copending Application No. 18/940,570 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’570 recite providing an oral film dosage form comprising a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter (claim 1) that can further comprise a polymeric matric (claim 2) to a subject with angioedema. The claimed adrenergic receptor interacters (claims 3 – 12) are the same as in the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’570 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 50 of copending Application No. 19/319,020 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’020 recite a pharmaceutical composition comprising a polymeric matrix; pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter (claim 1) that can be in the form of a film (claim 7). The additional ingredients in the composition of claims 4 – 6 and 9 – 19 are the same as those of the instant claims. Pharmacokinetic parameters are recited in clams 47 – 50.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’020 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 19/347,120 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’120 recite a pharmaceutical composition comprising a polymeric matrix; pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter (claim 1) that can be in the form of a film (claim 7). The additional ingredients in the composition of claims 4 – 6 and 9 – 19 are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’120 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 34 of copending Application No. 19/350,454 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’454 recite a pharmaceutical composition comprising a polymeric matrix; pharmaceutically active component in the polymeric matrix; and an adrenergic receptor interacter (claim 1) that can be in the form of a film (claim 7). The pharmaceutically active ingredient can be epinephrine (claim 19). The additional ingredients in the composition of claims 4 – 6 and 9 – 18 are the same as those of the instant claims.
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’454 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 26 of copending Application No. 19/367,129 in view of Sayeed et al. (Pharm Tech, 2014) and Medication Management Services at NorthStar Regional Policy and Procedure Manual (“NorthStar”; January 28, 2022).
The claims of US’129 recite a method of treating an allergy symptom in a subject comprising: applying a pharmaceutical film to a subject, the pharmaceutical film comprising a polymeric matrix to an oral cavity, a pharmaceutically active component including epinephrine or a pharmaceutically acceptable salt or ester thereof contained in the polymeric matrix and an adrenergic receptor interacter contained in the polymeric matrix; and substantially resolving the allergy symptom earlier than reaching a Cmax of the pharmaceutically active component. The film can be applied to proximate to the allergy symptom site (claim 2) which can be oral (claim 12). The interacters of claims 16 – 20 are the same as those of the instant claims. Various pharmacokinetics parameters are claimed (e.g., claims 1 and 22 – 26).
Self-administration to a subject and pharmacokinetic parameters are not claimed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to self-administer the claimed epinephrine containing oral film to a human subject and that the subject would self-administer that formulation to their oral mucosa, resulting in delivery of the epinephrine. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because many dosage forms and oral dosage forms even more so are self-administered by the user and not by or with a health care professional and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
That the self-administration includes placement of the film under the tongue of a subject, closing the mouth and holding the film under the tongue, letting the film dissolve and avoiding swallowing, chewing or drinking for at least 4 minutes is not claimed.
Sayeed et al. and NorthStar are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have the person receiving the epinephrine oral film dosages of US’129 to place it under their tongue, close their mouth and compress the strip with their tongue and allowing the film to dissolve without swallowing, chewing or drinking for at least 5 minutes when self-administering the epinephrine oral film. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sayeed et al. and NorthStar discuss the steps that should or should not be taken with sublingual drug administration. Placement of the drug containing film on the oral mucosa allows for strip dissolution while avoiding swallowing, chewing or drinking for at least 5 minutes retains the therapeutic agent in the mouth for absorption across the mucosa membrane and avoids ingestion through the gastrointestinal tract where drug absorption may be inefficient and with different pharmacokinetics.
The pharmacokinetic parameters are determined by factors such as the formulation being administered and the administration route. The example formulations of Schobel et al. that comprise a polymeric matric, epinephrine bitartrate and at least one adrenergic receptor are highly similar between the examples of Schobel et al. and the example formulations of the instant application and both can be administered to the subject, either by someone else if the subject is a swine or unconscious human or by the person themselves if they are conscious and able to do so. Placing the formulation in the mouth against the mucosa results in delivery of the epinephrine to the subject. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). The formulations are highly similar in nature and there is no evidence of record that the self-administered formulations do not have comparable PK parameters as required by claims 2 – 18.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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