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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 07/28/2026.
Claims 1-74 are pending.
Claims 3-4, 7-16, 22-23, 43, 49, 51-52, 64-65, and 68-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/28/2026.
Claims 1, 2, 5-6, 17-21, 24-32, 33-42, 44-48, 50, 53-63, and 66-67 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
a residence time of no less than 4 minutes;
an AUC of 0-10 minutes;
a polymeric matrix is polyvinylpyrrolidone;
an adrenergic receptor interactor is an oil extract of a clove plant;
an aromatic compound is benzyl alcohol;
a phenylpropanoid is oil extract of a clove plant;
a phytoextract is oil extract of a clove plant;
an oil component is an oil extract of a clove plant;
a polymer is a polysaccharide;
a stabilizer is silicon dioxide;
a branched polymer is a polysaccharide;
a prodrug is diisobutyryl epinephrine;
and a Tmax of 25 minutes or faster.
Upon further search and examination the species election over polymeric matrix is broadened to include polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide, pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide-propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, and chitosan. As well as the aromatic compound is broadened to include 8-hydroxy-p-cymene. As well as polymer is broadened to include polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone. As well as prodrug is broadened to dipifevrin.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/15/2024 has been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Specification
The disclosure is 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.
The use of the term ANAPHYLM®, AZONE® and LABRASOL®, which is a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 36 is objected to because of the following informalities: missing space between words. Claim 36 line 1 reads “componentis” should be corrected to “component is”. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: missing space between words. Claim 37 line 1 reads “componenthas” should be corrected to “component has”. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: missing space between words. Claim 38 line 1 reads “componenthas” should be corrected to “component has”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 5-6, 17-21, 24-32, 33-42, 44-48, 50, 53-63, and 66-67 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.
After administration of an oral film, claim 1, from which all other claims depend, requires “positioning the film in an oral mucosa for a residence time”. The use of “in” rather than “on” indicates more than simply placing the oral film in contact with the oral mucosa and implies are deeper insertion or integration of the oral film dosage form with the oral mucosa. That dosage form must be administered and a procedure such as creating an incision in the oral mucosa, such that the oral film could then be placed in rather than just on the oral mucosa, is not typically carried out by a subject on themselves even if the subject was a someone with medical training. Does claim 1 implicitly require an additional step such that the oral film can be placed in the oral mucosa? Would the claim then be met by the subject/patient themselves placing the oral dosage form in their own oral mucosa even if someone else created the opening in the oral mucosa? Or does administration require that all the necessary explicit and implicit steps be carried out by the subject themselves?
The dependent claims fall therewith.
Please clarify.
For the purpose of applying art, the administration and positioning steps are interpreted as being met when the subject places the oral film within their oral cavity bringing the oral film in contact with the mucosa and requiring insertion within the oral mucosa.
Claim 22 is 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 22 contains the trademark/trade name LABRASOL®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe caprylocaproyl macrogol-8 glyceride and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 17-21, 24-33, 41-48, 56-59,61, and 63 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schobel et al (US 20170290776 A1; as submitted on IDS of 03/15/2024).
Schobel discloses delivery of drugs or pharmaceuticals using film transdermally or transmucosally can require that the drug or pharmaceutical permeate or otherwise cross a biological membrane in an effective and efficient manner ([0003). Schobel teaches a pharmaceutical composition, comprising: a polymeric matrix; a pharmaceutically active component in the polymeric matrix; and an adrenergic receptor interacter, a pharmaceutically active component in the polymeric matrix; wherein the pharmaceutically active component is epinephrine (see entire document, for instance, claim 1,6,19).
Schobel teaches mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0069]). In particular, the buccal and sublingual tissues offer advantageous sites for drug delivery because they are highly permeable regions of the oral mucosa, allowing drugs diffusing from the oral mucosa to have direct access to systemic circulation ([0069]). This also offers increased convenience and therefore increased compliance in patients ([0069]). Absorption profiles and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0069]). Schobel discloses the residence time of the composition depends on the erosion rate of the water erodable polymers used in the formulation and their respective concentrations ([0146]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0146]). Generally, however, the residence time is modulated between about a few seconds to about a few days. Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0146]). More preferably, the residence time is adjusted from about 5 seconds to about 30 minutes ([0146]).
Schobel includes a mixture of two or three adrenergic receptor interacters such as benzyl alcohol (an aromatic compound per instant specification), phenylpropanoid, farnesol or Labrasol, essential oil extract of a clove plant (see entire document, for instance, [0013], claim 7, claim 22, claim 13-15). Schobel discloses the phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 8). Schobel teaches the phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 9). Schobel discloses the phenylpropanoid is chavicol (see entire document, for instance, claim 10). Schobel teaches the phenylpropanoid is safrole (see entire document, for instance, claim 11). Schobel discloses the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 12). Schobel discloses the phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 17). Schobel teaches the phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 13). Schobel discloses the adrenergic receptor interacter includes a terpenoid, a terpene, or a sesquiterpene (see entire document, for instance, claim 3). Schobel teaches the phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 18). Schobel discloses the polymer matrix includes a polymer (see entire document, for instance, claim 20). Schobel teaches the polymer includes a water-soluble polymer (see entire document, for instance, claim 21). Schobel discloses polymer includes a cellulosic polymer selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose (see entire document, for instance, claim 22). Schobel teaches the polymeric matrix comprises a polyethylene oxide, cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 24). Schobel discloses the polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide, propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 25). Schobel teaches a stabilizer (see entire document, for instance, claim 26). Schobel discloses the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 27). Schobel discloses absorbents ([0125]). Schobel teaches the additional components (such as absorbents and glidants) can range up to about 80%, desirably about 0.005% to 50% and more desirably within the range of 1% to 20% based on the weight of all composition components ([0135]). Schobel discloses various methods, including the use of chemical penetration enhancers, prodrugs, and physical methods may be employed to overcome the barrier properties of the buccal mucosa ([0079], [0105]).
Claim(s) 1, 17-21, 24-32, 41-48 ,56-59,61, and 63 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schobel et al (US 20170348251 A1 also available as US11191737B2; as submitted on IDS of 03/15/2024).
Schobel discloses delivery of drugs or pharmaceuticals using film transdermally or transmucosally can require that the drug or pharmaceutical permeate or otherwise cross a biological membrane in an effective and efficient manner ([0003). Schobel teaches pharmaceutical composition, comprising: a polymeric matrix; pharmaceutically active component including epinephrine in the polymeric matrix; and an adrenergic receptor interacter. (see entire document, for instance, [0004], claim 1).
Schobel teaches mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0054]). In particular, the buccal and sublingual tissues offer advantageous sites for drug delivery because they are highly permeable regions of the oral mucosa, allowing drugs diffusing from the oral mucosa to have direct access to systemic circulation ([0054]). This also offers increased convenience and therefore increased compliance in patients ([0054]). Absorption profiles and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0054]). Schobel discloses the residence time of the composition depends on the erosion rate of the water erodable polymers used in the formulation and their respective concentrations ([0129]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0129]). Generally, however, the residence time is modulated between about a few seconds to about a few days ([0129]). Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0129]). More preferably, the residence time is adjusted from about 5 seconds to about 30 minutes ([0129]).
Schobel includes a mixture of two or three adrenergic receptor interacters such as benzyl alcohol (an aromatic compound per instant specification), phenylpropanoid, farnesol or Labrasol, essential oil extract of a clove plant (see entire document, for instance, [0012], claim 4, claim 5, claim 14-15). Schobel discloses the phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 9). Schobel teaches the phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 10). Schobel discloses the phenylpropanoid is chavicol (see entire document, for instance, claim 11). Schobel teaches the phenylpropanoid is safrole (see entire document, for instance, claim 12). Schobel discloses the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 13). Schobel discloses the phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 18). Schobel teaches the phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 14). Schobel discloses the adrenergic receptor interacter includes a terpenoid, a terpene, or a sesquiterpene (see entire document, for instance, claim 20). Schobel teaches the phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 19). Schobel discloses the polymer matrix includes a polymer (see entire document, for instance, claim 21). Schobel teaches the polymer includes a water-soluble polymer (see entire document, for instance, claim 22). Schobel discloses polymer includes a cellulosic polymer selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose (see entire document, for instance, claim 24). Schobel teaches the polymeric matrix comprises a polyethylene oxide, cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 25). Schobel discloses the polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide, propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 26). Schobel teaches a stabilizer (see entire document, for instance, claim 27). Schobel discloses the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 28). Schobel discloses various methods, including the use of chemical penetration enhancers, prodrugs, and physical methods may be employed to overcome the barrier properties of the buccal mucosa ([0065], [0090]).
Claim(s) 1, 17-21, 24-33, 41-48, 50 ,54, 56-59,61, and 63 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schobel et al (US 20190022023 A1; as submitted on IDS of 03/15/2024).
Schobel discloses a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including epinephrine in the polymeric matrix, and an adrenergic receptor interacter. The epinephrine can be administered as a prodrug, such as dipifevrin ([0038]). Schobel teaches a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including dipifevrin in the polymeric matrix, and an adrenergic receptor ([0038]).
Schobel discloses mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0075]). Schobel teaches absorption profiles, and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0075]). As the composition rests on the mucosal surface, delivery of the drug occurs ([0157]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0157]). Generally, however, the residence time is modulated between about a few seconds to about a few days ([0157]). Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0157]).
Schobel discloses the adrenergic receptor interacter can be a terpenoid, terpene or a C3-C22 alcohol or acid ([0006]). The adrenergic receptor interacter can be a sesquiterpene ([0006]). In certain embodiments, the adrenergic receptor interacter can include farnesol ([0006]). Schobel teaches benzyl alcohol ([0015]). Schobel discloses farnesol or Labrasol (see entire document, for instance, claim 5).
Schobel discloses phenylpropanoid (see entire document, for instance, claim 4). The phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 9). The phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 10). The phenylpropanoid is chavicol (see entire document, for instance, claim 11). The phenylpropanoid is safrole (see entire document, for instance, claim 12). Schobel teaches that the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 13). The phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 18). The phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 14-15). The phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 19). The adrenergic receptor interacter includes a terpenoid, terpene or a sesquiterpene (see entire document, for instance, claim 20). Schobel discloses absorbents and glidants ([0140]).
Schobel teaches the polymer matrix includes a polymer (see entire document, for instance, claim 21). The polymer is a water soluble polymer (see entire document, for instance, claim 22). The polymer includes a polyethylene oxide (see entire document, for instance, claim 23). The polymer includes a cellulosic polymer is selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, methylcellulose and carboxymethyl cellulose (see entire document, for instance, claim 24). The polymeric matrix comprises a cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 25). The polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide-propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 26 ).Schobel discloses a stabilizer (see entire document, for instance, claim 27 ). Schobel teaches the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 28). Schobel teaches a pharmaceutical film, comprising: a polymeric matrix; pharmaceutically active component including epinephrine or its prodrug contained in the polymeric matrix and an adrenergic receptor, interacter, the pharmaceutical film having a Tmax of 5-60 minutes (see entire document, for instance, claim 47).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-2, 5-6, 17-21, 24-33,36, 41-48 ,50, 56-59, 61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al (US 20170290776 A1; as submitted on IDS of 03/15/2024).
Schobel discloses delivery of drugs or pharmaceuticals using film transdermally or transmucosally can require that the drug or pharmaceutical permeate or otherwise cross a biological membrane in an effective and efficient manner ([0003). Schobel teaches a pharmaceutical composition, comprising: a polymeric matrix; a pharmaceutically active component in the polymeric matrix; and an adrenergic receptor interacter, a pharmaceutically active component in the polymeric matrix; wherein the pharmaceutically active component is epinephrine (see entire document, for instance, claim 1,6,19).
Schobel teaches mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0069]). In particular, the buccal and sublingual tissues offer advantageous sites for drug delivery because they are highly permeable regions of the oral mucosa, allowing drugs diffusing from the oral mucosa to have direct access to systemic circulation ([0069]). This also offers increased convenience and therefore increased compliance in patients ([0069]). Absorption profiles and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0069]). Schobel discloses the residence time of the composition depends on the erosion rate of the water erodable polymers used in the formulation and their respective concentrations ([0146]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0146]). Generally, however, the residence time is modulated between about a few seconds to about a few days. Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0146]). More preferably, the residence time is adjusted from about 5 seconds to about 30 minutes ([0146]).
Schobel includes a mixture of two or three adrenergic receptor interacters such as benzyl alcohol (an aromatic compound per instant specification), phenylpropanoid, farnesol or Labrasol, essential oil extract of a clove plant (see entire document, for instance, [0013], claim 7, claim 22, claim 13-15). Schobel discloses the phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 8). Schobel teaches the phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 9). Schobel discloses the phenylpropanoid is chavicol (see entire document, for instance, claim 10). Schobel teaches the phenylpropanoid is safrole (see entire document, for instance, claim 11). Schobel discloses the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 12). Schobel discloses the phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 17). Schobel teaches the phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 13). Schobel discloses the adrenergic receptor interacter includes a terpenoid, a terpene, or a sesquiterpene (see entire document, for instance, claim 3). Schobel teaches the phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 18). Schobel discloses the polymer matrix includes a polymer (see entire document, for instance, claim 20). Schobel teaches the polymer includes a water soluble polymer (see entire document, for instance, claim 21). Schobel discloses polymer includes a cellulosic polymer selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose (see entire document, for instance, claim 22).Schobel teaches the polymeric matrix comprises a polyethylene oxide, cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 24). Schobel discloses the polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide, propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 25). Schobel teaches a stabilizer (see entire document, for instance, claim 26). Schobel discloses the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 27). Schobel discloses absorbents ([0125]). Schobel teaches the additional components (such as absorbents and glidants) can range up to about 80%, desirably about 0.005% to 50% and more desirably within the range of 1% to 20% based on the weight of all composition components ([0135]). Schobel discloses various methods, including the use of chemical penetration enhancers, prodrugs, and physical methods may be employed to overcome the barrier properties of the buccal mucosa ([0079], [0105]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the components taught by Schobel in a manner taught by Schobel within the invention of Schobel. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would have been routine optimization to arrive at the claimed invention to a person of ordinary skill in the art before the effective filing date of claimed invention including amounts instantly claimed residence time, by routine experimentation, with a reasonable expectation of success.
It is noted that Schobel et al teaches the instantly claimed components, wherein it is further noted that anticipation is the greatest form of obviousness. Additionally, it would be obvious at the time the invention was filed to rearrange the components of Schobel and obtain additional embodiments of the invention as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, an absorbing component or adsorbent component), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Schobel et al., to include an example an absorbing component or adsorbent component, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Schobel et al., as cited above, and would yield predictable results.
Claims 5-8 and 50, recites pharmacokinetic parameters such as AUC and Tmax. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., page 2 lines [0007]- [0012], page 3 lines [0021]- [0023], page 4 lines [0029] - [0030]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition(s) are disclosed in the prior art, the recited limitation of claim 5-8 and 50, will also be considered to be met.
Claim (s) 1-2, 5-6, 17-21, 24-32, 41-48 ,50, 56-59,61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al (US 20170348251 A1 also available as US11191737B2; as submitted on IDS of 03/15/2024).
Schobel discloses delivery of drugs or pharmaceuticals using film transdermally or transmucosally can require that the drug or pharmaceutical permeate or otherwise cross a biological membrane in an effective and efficient manner ([0003). Schobel teaches pharmaceutical composition, comprising: a polymeric matrix; pharmaceutically active component including epinephrine in the polymeric matrix; and an adrenergic receptor interacter. (see entire document, for instance, [0004], claim 1).
Schobel teaches mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0054]). In particular, the buccal and sublingual tissues offer advantageous sites for drug delivery because they are highly permeable regions of the oral mucosa, allowing drugs diffusing from the oral mucosa to have direct access to systemic circulation ([0054]). This also offers increased convenience and therefore increased compliance in patients ([0054]). Absorption profiles and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0054]). Schobel discloses the residence time of the composition depends on the erosion rate of the water erodable polymers used in the formulation and their respective concentrations ([0129]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0129]). Generally, however, the residence time is modulated between about a few seconds to about a few days ([0129]). Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0129]). More preferably, the residence time is adjusted from about 5 seconds to about 30 minutes ([0129]).
Schobel includes a mixture of two or three adrenergic receptor interacters such as benzyl alcohol (an aromatic compound per instant specification), phenylpropanoid, farnesol or Labrasol, essential oil extract of a clove plant (see entire document, for instance, [0012], claim 4, claim 5, claim 14-15). Schobel discloses the phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 9). Schobel teaches the phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 10). Schobel discloses the phenylpropanoid is chavicol (see entire document, for instance, claim 11). Schobel teaches the phenylpropanoid is safrole (see entire document, for instance, claim 12). Schobel discloses the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 13). Schobel discloses the phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 18). Schobel teaches the phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 14). Schobel discloses the adrenergic receptor interacter includes a terpenoid, a terpene, or a sesquiterpene (see entire document, for instance, claim 20). Schobel teaches the phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 19). Schobel discloses the polymer matrix includes a polymer (see entire document, for instance, claim 21). Schobel teaches the polymer includes a water soluble polymer (see entire document, for instance, claim 22). Schobel discloses polymer includes a cellulosic polymer selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose (see entire document, for instance, claim 24).Schobel teaches the polymeric matrix comprises a polyethylene oxide, cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 25). Schobel discloses the polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide, propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 26). Schobel teaches a stabilizer (see entire document, for instance, claim 27). Schobel discloses the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 28). Schobel discloses various methods, including the use of chemical penetration enhancers, prodrugs, and physical methods may be employed to overcome the barrier properties of the buccal mucosa ([0065], [0090]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the components taught by Schobel in a manner taught by Schobel within the invention of Schobel. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would have been routine optimization to arrive at the claimed invention to a person of ordinary skill in the art before the effective filing date of claimed invention including amounts instantly claimed residence time, by routine experimentation, with a reasonable expectation of success.
It is noted that Schobel et al teaches the instantly claimed components, wherein it is further noted that anticipation is the greatest form of obviousness. Additionally, it would be obvious at the time the invention was filed to rearrange the components of Schobel and obtain additional embodiments of the invention as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference, but the reference does not disclose the specific combination of variables (for example, an absorbing component or adsorbent component), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Schobel et al., to include an example an absorbing component or adsorbent component, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Schobel et al., as cited above, and would yield predictable results.
Claims 5-8 and 50, recites pharmacokinetic parameters such as AUC and Tmax. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., page 2 lines [0007]- [0012], page 3 lines [0021]- [0023], page 4 lines [0029] - [0030]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition(s) are disclosed in the prior art, the recited limitation of claim 5-8 and 50, will also be considered to be met.
Claim(s) 1-2, 5-6, 17-21, 24-48 ,50, 56-59,61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al (US 20170290776 A1; as submitted on IDS of 03/15/2024). as applied to claim 1-2, 5-6, 17-21, 24-33,36, 41-48 ,50, 56-59,61, and 63 above, and further in view of Myers et al (US 20190328679 A1).
The teachings of Schobel et al have been set forth above. Schobel discloses absorbents and glidants ([0125]). However, they do not expressly disclose including adsorbant component or an amorphous silicon dioxide.
Myers discloses anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film (see entire document, for instance, abstract). Myers teach polymer selected from hydroxypropyl cellulose, hydroxypropylmethyl cellulose, polyethylene oxide (see entire document, for instance, [0020]). Myers discloses polyethylene oxide, pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin ([0063]). Myers teaches Cab-O-Sil (an amorphous silicon dioxide); syloid (an absorbant component per instant specification) ([0107]). Myers discloses silicon dioxide ([0115]).
It would have been obvious to utilize adsorbant component and an amorphous silicon dioxide as taught in Myers in the composition of Schobel. One would have been motivated to do so since Myers teaches that Cab-O-Sil and syloid are particularly useful for reducing sticking to the die in extrusion processes and reducing sticking to the roof of the mouth during administration of the dosage form in a composition. There would be a reasonable expectation of success since Schobel and Myers are both drawn to compositions for film compositions.
Myers discloses the uniformity in the mixture of components depends upon numerous variables ([0050]). Control of particle size and particle shape are further considerations ([0050]). Desirably, the size of the particle size of 150 microns or less, for example 100 microns or less. It would have been routine optimization to arrive at the claimed invention to a person of ordinary skill in the art before the effective filing date of claimed invention to optimize the particle size of the absorbant component taught by Myers to the compositions of Schobel et al (MPEP 2144.05). One would be motivated to do so with a reasonable expectation of success because Myers discloses the uniformity in the mixture depends on control of particle size.
Claim 37 recites that the absorbant component has an average surface area of 25-300 m2/g. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed absorbant compound discussed therein (see Spec., pg. [4], lines [27]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining the absorbant component is disclosed in the prior art, the recited limitation of claim 37, will also be considered to be met.
Claim 39-40 recites one or more oil components of the composition can be adsorbed on the absorbant and amount adsorbed. Looking to Applicants’ instant specification, the limitation appears to be a functional limitation that is tethered to and definitive of the instantly encompassed absorbant compound discussed therein (see Spec., pg. [4], lines [27]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining absorbant compound is disclosed in the prior art, the recited limitation of claims 39-40, will also be considered to be met.
Claim(s) 1-2,5-6, 17-21, 24-33, 41-48, 50, 54, 56-59, 61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al (US 20190022023 A1; as submitted on IDS of 03/15/2024).
Schobel discloses a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including epinephrine in the polymeric matrix, and an adrenergic receptor interacter. The epinephrine can be administered as a prodrug, such as dipifevrin ([0038]). Schobel teaches a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including dipifevrin in the polymeric matrix, and an adrenergic receptor ([0038]).
Schobel discloses mucosal surfaces, such as the oral mucosa, are a convenient route for delivering drugs to the body due to the fact that they are highly vascularized and permeable, providing increased bioavailability and rapid onset of action because it does not pass through the digestive system and thereby avoids first pass metabolism ([0075]). Schobel teaches absorption profiles, and their rates can be controlled and modulated by a variety of parameters, such as but not limited to film size, drug loading, enhancer type/loading, polymer matrix release rate and mucosal residence time ([0075]). As the composition rests on the mucosal surface, delivery of the drug occurs ([0157]). Residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen pharmaceutical and the desired lifespan of the carrier ([0157]). Generally, however, the residence time is modulated between about a few seconds to about a few days ([0157]). Preferably, the residence time for most pharmaceuticals is adjusted from about 5 seconds to about 24 hours ([0157]).
Schobel discloses the adrenergic receptor interacter can be a terpenoid, terpene or a C3-C22 alcohol or acid ([0006]). The adrenergic receptor interacter can be a sesquiterpene ([0006]). In certain embodiments, the adrenergic receptor interacter can include farnesol ([0006]). Schobel teaches benzyl alcohol ([0015]). Schobel discloses farnesol or Labrasol (see entire document, for instance, claim 5).
Schobel discloses phenylpropanoid (see entire document, for instance, claim 4). The phenylpropanoid is eugenol or eugenol acetate (see entire document, for instance, claim 9). The phenylpropanoid is a cinnamic acid, cinnamic acid ester, cinnamic aldehyde or hydrocinnamic acid (see entire document, for instance, claim 10). The phenylpropanoid is chavicol (see entire document, for instance, claim 11). The phenylpropanoid is safrole (see entire document, for instance, claim 12). Schobel teaches that the adrenergic receptor interacter is a phytoextract (see entire document, for instance, claim 13). The phytoextract is synthetic or biosynthetic (see entire document, for instance, claim 18). The phytoextract further includes an essential oil extract of a clove plant (see entire document, for instance, claim 14-15). The phytoextract further includes 40-95% eugenol (see entire document, for instance, claim 19). The adrenergic receptor interacter includes a terpenoid, terpene or a sesquiterpene (see entire document, for instance, claim 20). Schobel discloses absorbents and glidants ([0140]).
Schobel teaches the polymer matrix includes a polymer (see entire document, for instance, claim 21). The polymer is a water soluble polymer (see entire document, for instance, claim 22). The polymer includes a polyethylene oxide (see entire document, for instance, claim 23). The polymer includes a cellulosic polymer is selected from the group of: hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, methylcellulose and carboxymethyl cellulose (see entire document, for instance, claim 24). The polymeric matrix comprises a cellulosic polymer, polyethylene oxide and polyvinyl pyrrolidone, polyethylene oxide and a polysaccharide, polyethylene oxide, hydroxypropyl methylcellulose and a polysaccharide, or polyethylene oxide, hydroxypropyl methylcellulose, polysaccharide and polyvinylpyrrolidone (see entire document, for instance, claim 25). The polymeric matrix comprises at least one polymer selected from the group of: pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, ethylene oxide-propylene oxide co-polymers, collagen, albumin, poly-amino acids, polyphosphazenes, polysaccharides, chitin, chitosan, and derivatives thereof (see entire document, for instance, claim 26 ).Schobel discloses a stabilizer (see entire document, for instance, claim 27 ). Schobel teaches the polymeric matrix comprises a dendritic polymer or a hyperbranched polymer (see entire document, for instance, claim 28). Schobel teaches a pharmaceutical film, comprising: a polymeric matrix; pharmaceutically active component including epinephrine or its prodrug contained in the polymeric matrix and an adrenergic receptor, interacter, the pharmaceutical film having a Tmax of 5-60 minutes (see entire document, for instance, claim 47).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the components taught by Schobel in a manner taught by Schobel within the invention of Schobel. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would have been routine optimization to arrive at the claimed invention to a person of ordinary skill in the art before the effective filing date of claimed invention including amounts instantly claimed residence time, by routine experimentation, with a reasonable expectation of success.
It is noted that Schobel et al teaches the instantly claimed components, wherein it is further noted that anticipation is the greatest form of obviousness. Additionally, it would be obvious at the time the invention was filed to rearrange the components of Schobel and obtain additional embodiments of the invention as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, an absorbing component or adsorbent component), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Schobel et al., to include an example an adsorbent component, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Schobel et al., as cited above, and would yield predictable results.
Claims 5-8, recites pharmacokinetic parameters such as AUC. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., page 2 lines [0007]- [0012], page 3 lines [0021]- [0023], page 4 lines [0029] - [0030]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition(s) are disclosed in the prior art, the recited limitation of claim 5-8, will also be considered to be met.
Claim(s) 1-2,5-6, 17-21, 24-33, 41-48, 50, and 53-63 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel et al (US 20190022023 A1; as submitted on IDS of 03/15/2024) as applied to claims ) 1-2,5-6, 17-21, 24-33, 41-48, 50, 54, 56-59,61, and 63 above, and further in view of Bernardo et al (US 20200016092 A1).
The teachings of Schobel et al have been set forth above. Schobel teaches administering an effective amount of a pharmaceutical composition comprising: a polymeric matrix; pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor. interacter. However, they do not expressly disclose a method of administering an oral film to a subject, comprising: administering a swallowable composition to the oral cavity of the subject to deliver through a digestive tract of the subject.
Bernardo discloses a method of delivering one or more active ingredients to a subject that include orally administering the oral dissolvable film (see entire document, for instance, abstract). Bernardo teaches oral dissolvable film (ODF) is a dosage form that uses a dissolving film or strip to administer drugs via absorption in the mouth (buccally or sublingually) and/or via the small intestines (enterically) ([0002). Especially for drugs which are metabolized extensively by the first-pass effect, oral dissolvable films provide an opportunity for a faster-acting and better absorption profile ([0056]).
Bernardo teaches a film is typically prepared using hydrophilic polymers that rapidly dissolve on the tongue or buccal cavity, delivering the drug to the systemic circulation via dissolution when contact with liquid (saliva) is made ([0002]).
Bernardo discloses ODFs can be administered without the use of water, fulfilling the need of target population seeking convenience in drug administration, along with rapid onset of action with increased bioavailability due to bypassing the hepatic metabolism, consequently, leading to improved therapeutic response ([0005]).
Bernardo teaches oral dissolvable films (alternatively known as ODFs, oral films, orally dissolving film strips, edible films, edible strips, oral film strips, oral drug strips, buccal films, sublingual films, oral soluble films, etc.) refer to a unit dosage form in which a film is administered in the oral cavity and disintegrates over a desired period of time ([0055]). Bernardo discloses adrenaline; epinephrine ([0258] - [0262]). Bernardo teaches polyvinyl alcohol, Silicon dioxide, desiccator, phenylpropanoids; terpene, sesquiterpene, Syzygium aromaticum (cloves), glidant, and stabilizer. ([0032], [0040], [0102], [0262], [0278], [0279], [0283], [0473]). Bernardo teaches residence times may be adjusted over a wide range depending upon the desired timing of the delivery of the chosen active ingredient and the desired lifespan of the carrier ([0107]). Generally, however, the residence time is modulated between about a few seconds to about a few hours ([0107]). Preferably, when the oral dissolvable film is an oral thin film, the residence time for is adjusted from about 5 seconds to about 3 minutes ([0107]). Bernardo discloses the orally dissolving film is then placed on top of the tongue where it dissolves and is swallowed, with or without water ([0064]).
It would have been obvious to utilize administering a swallowable composition to the oral cavity of the subject to deliver through a digestive tract of the subject as taught in Bernardo in the composition of Schobel. One would have been motivated to do so Bernardo teaches that Bernardo teaches oral dissolvable film (ODF) is a dosage form that uses a dissolving film or strip to administer drugs via absorption in the mouth (buccally or sublingually) and/or via the small intestines (enterically) ([0002). Especially for drugs which are metabolized extensively by the first-pass effect, oral dissolvable films provide an opportunity for a faster-acting and better absorption profile ([0056]). There would be a reasonable expectation of success since Schobel and Bernardo are both drawn to compositions for oral films.
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.
Claim 1,21-32, and 44-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. US 12433850 B2 in view of US 20190022023 A1.
The patented claims are directed to a pharmaceutical composition for oral delivery, comprising: an oral mucoadhesive polymeric matrix in a film that is orally dissolvable; a pharmaceutically active component including epinephrine or its prodrug in the polymeric matrix; and an adrenergic receptor interacter that creates increased blood flow or enables a flushing of the tissue to modify transmucosal uptake of the pharmaceutically active component thereof through a mucosal barrier by utilizing at least a paracellular transport route or mechanism, wherein the pharmaceutical composition is a film, the pharmaceutically active component being contained in the polymeric matrix of the film.
However, the patented claims do not explicitly use a method of administering a pharmaceutical composition.
Schobel discloses a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including epinephrine in the polymeric matrix, and an adrenergic receptor interacter.
It would have been obvious to one of ordinary skill in the art at the time of filing to administer the claimed epinephrine containing oral film resulting in delivery of the epinephrine. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Administration is a well-known route for oral formulations such as films. 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 administered by the user and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
Claim 1,21-32, and 44-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. US 11191737 B2 in view of US 20190022023 A1.
The patented claims are directed to a pharmaceutical composition for oral delivery, 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. As well as a method of making a pharmaceutical composition for oral delivery comprising combining an adrenergic receptor interacter with a pharmaceutically active component including epinephrine.
However, the patented claims do not explicitly use a method of administering a pharmaceutical composition.
Schobel discloses a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including epinephrine in the polymeric matrix, and an adrenergic receptor interacter.
It would have been obvious to one of ordinary skill in the art at the time of filing to administer the claimed epinephrine containing oral film resulting in delivery of the epinephrine. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Administration is a well-known route for oral formulations such as films. 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 administered by the user and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
Claims 1,21-32, and 44-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 17/549,219 in view of US 20190022023 A1. This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to a pharmaceutical composition, comprising: a polymeric matrix; pharmaceutically active component including epinephrine or its ester in the polymeric matrix, the ester having a half-life of less than one minute; and an adrenergic receptor interacter. As well as a method of making a pharmaceutical composition comprising: combining an adrenergic receptor interacter with a pharmaceutically active component including epinephrine or its ester, the ester having a half-life of less than one minute, and forming a pharmaceutical composition including the adrenergic receptor interacter and the pharmaceutically active component.
However, the copending claims do not explicitly use a method of administering a pharmaceutical composition.
Schobel discloses a method of treating a medical condition can include administering an effective amount of a pharmaceutical composition including a polymeric matrix, pharmaceutically active component including epinephrine in the polymeric matrix, and an adrenergic receptor interacter.
It would have been obvious to one of ordinary skill in the art at the time of filing to administer the claimed epinephrine containing oral film resulting in delivery of the epinephrine. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Administration is a well-known route for oral formulations such as films. 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 administered by the user and will result in the film against the oral mucosa of the user and allowing for delivery of the drug to the user.
Claims 1-2, 5-6, 17-21, 24-32, 33-42, 44-48, 50, 53-63, and 66-67 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8,10-12,14-75 of copending Application No. 18/778,562 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
While the copending claims teach all of the instantly claimed elements, the teaching does not rise to the level of statutory double patenting. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, by doing no more than following the guidance provided in the copending claims to arrive at the instantly claimed invention. One would have been motivated to do so since the copending claims expressly teach the instantly claimed elements and the instantly claimed orientation of said elements, wherein by simply following the guidance of the copending claims one would arrive at the instantly claimed invention.
Claims 1,21-32, and 44-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/277,509 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
While the copending claims teach all of the instantly claimed elements, the teaching does not rise to the level of statutory double patenting. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, by doing no more than following the guidance provided in the copending claims to arrive at the instantly claimed invention. One would have been motivated to do so since the copending claims expressly teach the instantly claimed elements and the instantly claimed orientation of said elements, wherein by simply following the guidance of the copending claims one would arrive at the instantly claimed invention.
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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