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 .
Election/Restrictions
Applicant’s election without traverse of group I (Claims 1-9 and 12-17) in the reply filed on 11/28/2025 is acknowledged.
Claims 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2025.
Claims 1-9 and 12-17 are examined on the merit.
Claim Objections
Claims 1, 12, 13 and 15 are objected to because of the following informalities:
Claim 1 line 8 recites “wherein at least one active pharmaceutical ingredient” which should read “wherein the at least one active pharmaceutical ingredient”
Claim 12 lines 2-3 recites “comprises one or more hydrophilic and/or hydrophobic polymers and/or gums” which should read “comprises one or more hydrophilic polymers, hydrophobic polymers, or gums”.
Claim 13 2-3 recites “the one or more hydrophilic and/or hydrophobic polymer and/or gum is/are” which should read “the one or more hydrophilic polymers, hydrophobic polymers, or gum is”
Claim 15 recites “whether prepared by synthesis or expression and/or extraction and biological material and particulate matter”, which should read “prepared by synthesis, expression, or extraction, biological material and particulate matter”
Claim 18 line 2 recites “an active pharmaceutical ingredient to a human or an animal” which should read “the at least one active pharmaceutical ingredient”
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 9, 12 and 13 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 9 recites the limitation “The dosage form according to claim 8, comprising:
An adhesive fiber layer;
A water-repelling backing layer; and
One solid foam intermediate layer comprising the at least one active pharmaceutical ingredient; or
b) An adhesive fiber layer
A water-repelling backing layer; and
Two or more solid foam intermediate layers each comprising the at least one active pharmaceutical ingredient; or
c) An adhesive fiber layer comprising the at least one active pharmaceutical ingredient;
A water-repelling backing layer; and
At least one solid foam intermediate layer”.
There is insufficient antecedent basis for this limitation in the claim, in an effort to compact prosecution the limitation is being interpreted as
“The dosage form according to claim 8, comprising:
a) the adhesive fiber layer;
the water-repelling backing layer; and
the at least one intermediate layer comprises one solid foam intermediate layer comprising the at least one active pharmaceutical ingredient; or
b) the adhesive fiber layer
the water-repelling backing layer; and
the at least one intermediate layer comprises two or more solid foam intermediate layers each comprising the at least one active pharmaceutical ingredient; or
c) the adhesive fiber layer comprising the at least one active pharmaceutical ingredient;
the water-repelling backing layer; and
the at least one intermediate layer comprises least one solid foam intermediate layer”.
Claim 12 recites “polysaccharides, such as xanthan, agar, guar gum, carrageenan agar, alginic acid, polymethacrylate, mixtures thereof, salts thereof, and derivatives thereof” which renders the claim indefinite. Claim uses exemplary phrase “such as” to list species of genus “polysaccharides” However, the list include “polymethacrylate” which is considered a synthetic polymer derived from methacrylate monomers and is not chemically classified as a polysaccharide. This creates ambiguity if the scope of the claim is limited to “polysaccharides” or “polymers”. In an effort to compact prosecution the limitation is being treated as “polymers comprising Xanthan, agar, guar gum, carrageenan agar, alginic acid, polymethacrylate, mixture thereof, salts thereof, or derivatives thereof”
Claim 13 is rejected for at least being rejected for being depends on claim 12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 20050118246 A1) in view of Masek (WO 2018033744 A1).
Regarding claim 1 and the claims dependent therefrom, Wong substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a dosage form for application on mucosae for release of at least one active pharmaceutical ingredient (figure 1 a-e and abstract, specifically an embodiment shown figure 1c, transdermal or transmucosal dosage form 2) comprising:
an adhesive layer (figure 1c [0023] and [0053], adhesive layer 6 configured to be adhered to mucosa) capable of adhering to a mucosae of a human body or an animal body;
a water-repelling backing layer (figure 1c and [0032], backing layer 4 impermeable to aqueous media); and
at least one intermediate layer (figure 1d, matrix layer 16 and drug layer 18) positioned between the adhesive layer and the water-repelling backing layer;
wherein at least one active pharmaceutical ingredient ([0023]-[0028] and [0046] drug dispersed in the matrix 16 and drug layer 18) is incorporated in the at least one intermediate layer and/or in the adhesive layer, wherein the at least one intermediate layer is a porous semi-solid or a solid material, and wherein the adhesive layer is made of fibers.
Wong does not teach wherein the at least one intermediate layer is a porous semi-solid or a solid material, and wherein the adhesive layer is made of fibers.
In the same field of endeavor, namely a mucoadhesive carrier or drug delivery systems, Masek teaches the at least one intermediate layer (figure 1, page 9 and page 12, (b) nanoscaffold overlapping with mucoadhesive layer, and nanoscaffold is formed of solid nanofibers and have a large interfibrous (pore) volume therein) is a porous semi-solid or a solid material, and wherein the adhesive layer is made of fibers (figure 1, page 9 and page 17, (d) mucoadhesive layer is made in the form of nanofibers ).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Masek and provide the intermediate layer and the adhesive layer as claimed for the purpose of promoting prolonged release of drug into submucosal tissue as taught by Masek (page 6).
Regarding claim 2, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination further teaches wherein the at least one intermediate layer comprises two or more intermediate layers (Wong; figure 1c, the intermediate layer as set forth in claim 1 comprises matrix layer and drug layer)
Regarding claim 3, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination further teaches wherein the porous semi-solid or the solid material of the at least one intermediate layer has been prepared by freeze-drying, vacuum drying, vacuum drying of an aqueous or organic polymer dispersion, or neat polymer (the phrase here is considered product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to shown an unobvious difference. In the instant case, despite the prior art above does not expressly teach the process as claimed, the combination teaches the at least one intermediate layer is porous sei-solid or a solid material, i.e., nanoscaffold formed by nanofiber mesh comprises pores, and therefore the prior art is considered to be processed with the claimed step above).
In the alternative, in the event that the interpretation is not envisaged by applicant, although the prior art does not expressly teach the claimed step, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, and prepare the at least one intermediate layer by claimed step to enable mass production of the product.
Regarding claim 4, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination does not teach wherein the adhesive layer comprises fibers produced by spinning
In the same field of endeavor, namely a mucoadhesive carrier or drug delivery systems, Masek teaches wherein the adhesive layer comprises fibers produced by spinning (page 7, mucoadhesive layer is made in the form of nanofibers, and the nanofibers made by electrospinning or are electrospun)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Masek and provide the adhesive layer as claimed to enable simple and efficient technique to produce nanofibers as taught by Masek (page 48)
Regarding claim 5, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination further teaches wherein the at least one active pharmaceutical ingredient is incorporated in the at least one intermediate layer (Wong; [0023]-[0028] drug layer and matrix layer contain drug).
Regarding claim 6, Wong as modified by Masek teaches the dosage form according to claim 2.
The combination further teaches wherein the at least one active pharmaceutical ingredient is incorporated in each of the two or more intermediate layer (Wong; [0023]-[0028] drug and matrix layers contains drug )
Regarding claim 12, Wong as modified by Masek, teaches the dosage form according to claim 1.
The combination does not expressly teach wherein the adhesive layer, intermediate layer(s), and backing layer comprise one or more hydrophilic polymers, hydrophobic polymers, or gums selected from the group consisting of polyethylene oxide, methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, methylhydroxyethylcellulose, hydroxypropyl methylcellulose, hydroxyethylcarboxymethyl-cellulose, carboxymethylhydroxyethylcellulose, polyvinylpyrrolidone, chitosan, polyacrylic acid, acacia, polylactic acid, poly(lactic-co-glycolic acid), ethylcellulose, gellan gum, gelatin and polymers comprising Xanthan, agar, guar gum, carrageenan agar, alginic acid, polymethacrylate, mixture thereof, salts thereof, or derivatives thereof.
In the same field of endeavor, namely a mucoadhesive carrier or drug delivery systems, Masek teaches adhesive layer, intermediate layer and backing layer is made of polyethylene oxide (figure 1, pages 9, 5 and 17, mucoadhesive, intermediate and cover layers are made of nanofibers and nanofibers comprises polyethylene oxide).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Masek and provide the adhesive layer, intermediate layer and backing layer as claimed for the purpose of provide the benefit of a biocompatible polymer as taught by Masek (pages 5-6)
Regarding claim 13, Wong as modified by Masek, teaches the dosage form according to claim 12.
The combination further teaches wherein the one or more hydrophilic polymers, hydrophobic polymers, or gums is in aqueous or organic dispersion, or as neat polymers with/before fabrication of layers by the process selected from the group consisting of spraying, lyophilisation, spinning, casting, and drying (the phrase “is in aqueous or organic dispersion, or as neat polymers with/before fabrication of layers by the process selected from the group consisting of spraying, lyophilisation, spinning, casting, and drying “ considered product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to shown an unobvious difference. In the instant case, despite the prior art above does not expressly teach the process as claimed, the polyethylene oxide of Masek is considered to be processed with the claimed step above).
In the alternative, in the event that the interpretation is not envisaged by applicant, although the combination is still silent as to the claimed step, i.e., is in aqueous or organic dispersion, or as neat polymers with/before fabrication of layers by the process selected from the group consisting of spraying, lyophilisation, spinning, casting, and drying, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, and provide the claimed step for the purpose of effectively producing material as claimed.
Regarding claim 14, Wong as modified by Masek, teaches the dosage form according to claim 1.
The combination does not teach wherein the adhesive layer comprises a membrane comprising at least one adhesive polymer selected from the group consisting of chitosan, alginate, polyethylene oxide, salts thereof, and derivatives thereof.
In the same field of endeavor, namely a mucoadhesive carrier or drug delivery systems, Masek teaches adhesive layer is made of polyethylene oxide (figure 1, pages 9, 5 and 17, mucoadhesive, layer is made of nanofibers and nanofibers comprises polyethylene oxide).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Masek and provide the adhesive layer as claimed for the purpose of provide the benefit of a biocompatible polymer as taught by Masek (pages 5-6).
Regarding claim 15, Wong as modified by Masek, teaches the dosage form according to claim 1.
The combination does not expressly teach wherein the at least one active pharmaceutical ingredient is one or more of the group consisting of small molecular entities; peptides, proteins, oligonucleotides, prepared by synthesis, expression or extraction (biopharmaceuticals), and biological material, and particulate matter.
In the same field of endeavor, namely a mucoadhesive carrier or drug delivery systems, Masek teaches wherein the at least one active pharmaceutical ingredient is one or more of the group consisting of small molecular entities; peptides, proteins, oligonucleotides, prepared by synthesis, expression or extraction (biopharmaceuticals), and biological material, and particulate matter (page 1, active substances, e.g., therapeutic peptides and protein, are used. Examiner’s note: the phrase “prepared by synthesis or expression and/or extraction (biopharmaceuticals), and biological material, and particulate matter” considered product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to shown an unobvious difference. In the instant case, despite the prior art above does not expressly teach the process as claimed, the protein or peptides of Masek is considered to be processed with the claimed step above)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Masek and provides the at least one active pharmaceutical ingredient as claimed for the purpose of treating diseases in humans and animals as taught by Masek (page 1)
In the alternative, in the event that the interpretation is not envisaged by applicant, although the combination is silent as to the claimed step, i.e., extraction (biopharmaceuticals), and biological material, and particulate matter, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, and provide the claimed step for the purpose of effectively producing active pharmaceutical ingredient.
Regarding claim 16, Wong as modified by Masek, teaches the dosage form according to claim 1.
The combination further teaches wherein the at least one active pharmaceutical ingredient is selected from the group consisting of anti-inflammatory compounds, hormones, cannabinoids, opioids, immunosuppressive compounds, immune stimulating compounds, antibiotics, antivirals, antifungal, chemotherapeutics, probiotics, prebiotics, nutrients, vitamins, minerals, trace elements, and combinations hereof (Wong; [0020] drug include anti-inflammatory agent)
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 20050118246 A1) in view of Masek (WO 2018033744 A1), and in further view of alternate embodiment of Wang (US 20050118246 A1; [0030])
Regarding claim 7, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination further teaches wherein the at least one active pharmaceutical ingredient is incorporated in the adhesive layer
In the same field of endeavor, namely dosage forms, in the alternate embodiment of Wang teaches wherein the at least one active pharmaceutical ingredient is incorporated in the adhesive layer
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Wang and provide the adhesive layer as claimed for the purpose of achieving a desired drug release rate profile through the use of a continuous or stepwise concentration gradient throughout the dosage form, as taught by Wong ([0023]).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 20050118246 A1) in view of Masek (WO 2018033744 A1), and in further view of Bondi (US 4756710 A).
Regarding claim 8, Wong as modified by Masek teaches the dosage form according to claim 1.
The combination further teaches wherein each one of the at least one intermediate layer is a solid foam intermediate layer and wherein the adhesive layer is an adhesive fiber layer (Masek; figure 1, page 9 and page 17, (d) mucoadhesive layer is made in the form of nanofibers)
The combination does not teach wherein each one of the at least one intermediate layer is a solid foam intermediate layer.
In the same field of endeavor, namely a controlled drug delivery system, Bondi teaches wherein each one of the at least one intermediate layer is a solid foam intermediate layer (col 3 lines 35-40 “buffered solutions of drug may migrate or solid open foam matrixes”).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, as modified by Masek, to incorporate the teachings of Bondi and provide the intermediate layer as claimed for the purpose of providing transdermal delivery system capable of administering liquid form drugs as taught by Bondi (col 3 lines 19-40).
Regarding claim 9, Wong as modified by Masek and Bondi, teaches the dosage form according to claim 9,
The combination further teaches comprising:
a) the adhesive fiber layer (Masek; adhesive fiber layer as set forth in claim 1);
the water-repelling backing layer (Wong; figure 1c and [0032], backing layer 4 impermeable to aqueous media); and
the at least one intermediate layer comprises one solid foam intermediate layer comprising the at least one active pharmaceutical ingredient (Bondi; the intermediate layer as set forth in Claim 8); or
b) the adhesive fiber layer
the water-repelling backing layer; and
the at least one intermediate layer comprises two or more solid foam intermediate layers each comprising the at least one active pharmaceutical ingredient; or
c) the adhesive fiber layer comprising the at least one active pharmaceutical ingredient;
the water-repelling backing layer; and
the at least one intermediate layer comprises least one solid foam intermediate layer.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 20050118246 A1) in view of Masek (WO 2018033744 A1), and in further view of Bonner (US 20180193621 A1).
Regarding claim 17, Wong as modified by Masek, teaches the dosage form according to claim 1.
The combination further teaches the dosage form according to claim 1 for use in administration of the at least one active pharmaceutical ingredient to a human or an animal wherein the adhesive layer adheres to the mucosa of the human or the animal (Wong; figure 1c [0023] and [0053], adhesive layer 6 configured to be adhered to mucosa of human), and wherein the at least one active pharmaceutical ingredient is released unidirectional in a controlled way to the mucosa of the human or the animal.
The combination does not teach wherein the at least one active pharmaceutical ingredient is released unidirectional in a controlled way to the mucosa of the human or the animal.
In the same field of endeavor, namely a device for oral delivery of active agents, Bonner teaches wherein the at least one active pharmaceutical ingredient is released unidirectional in a controlled way to the mucosa of the human or the animal ([0003] mucoadhesive device that administer an agent uni-directionally).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong, as modified by Masek, to incorporate the teachings of Bonner and provide the device as claimed for the purpose of protect the drug from contamination as taught by Bonner ([0003])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zaffaroni (US 3598122 A) is cited as teaching bandage for administrating active drug by absorption through the oral mucosa
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781