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 .
Status of the Claims
The amendment filed 06/15/2026 has been entered. Claims 1-9 and 12-23 are pending and under consideration. Claims 18-22 remain withdrawn.
Response to Arguments
Applicant's amendments to the claims have overcome each and every 112(b) rejection and objection previously set forth in the Non-Final Office Action mailed 12/17/2025.
In response to the applicant’s argument with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation, in view of Wong (US 20050118246 A1), Hakimi et al (US 20050118246 A1), Nisbet (US 20120135062 A1) and Bonner (US 20180193621 A1).
Claim Objections
Claims 2, 6, 8 and 9 are objected to because of the following informalities:
Claim 2 line 2 recites “freeze-dried foam intermediate layers” which should read “solid freeze-dried foam layers”
Claim 6 recites “the two or more porous semi-solid or a solid freeze-dried foam intermediate layers” which should read “the two or more porous semi-solid or solid freeze-dried foam layers”
Claim 8 line 2 recites ties “a solid form intermediate layer” which should read “the solid freeze-dried foam layer”
Claim 8 lines 2 and 3 recite “the mucoadhesive layer is an adhesive fiber layer” which should read “the mucoadhesive layer being made of fibers produced by electrospinning”
Claim 9 lines 2, 6 and 10 recite “the adhesive fiber layer” which should read “the mucoadhesive layer”
Claim 9 lines 4, 8 and 13 recite “solid foam intermediate layer” which should read “”the solid freeze-dried foam layer”
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.
Claim 4 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 4 recites “mucoadhesive layer comprises fibers produced by spinning”. However, its independent Claim 1 recites “the mucoadhesive layer being made of fibers produced by electrospinning”. Claim 1 requiring fibers produced by electrospinning, and the additional recitation of fibers “produced by spinning” is a relatively broader limitation, which creates ambiguity as whether “spinning” is intended to encompass electrospinning as a type of spinning fiber production process, or to require a different fiber production process. In an effort to compact prosecution, the limitation is being interpreted as including the electrospinning.
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, 8, 9, 12-16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 20050118246 A1) in view of Hakimi et al (US 20050118246 A1) and Nisbet (US 20120135062 A1)
Regarding claim 1, 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 (figures 1a-2 and abstract, specifically an embodiment shown figure 1c, transdermal or transmucosal dosage form 2) for application on mucosae for release of at least one active pharmaceutical ingredient comprising:
a mucoadhesive 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, the mucoadhesive layer being made of fibers produced by electrospinning;
a water-repelling backing layer (figure 1c and [0032], aqueous impermeable backing layer 4); and
at least one intermediate layer (figure 1c, matrix layer 16 and drug layer 18 intermediate between the adhesive layer 6 and backing layer 4) positioned between the mucoadhesive layer and the water-repelling backing layer, the at least one intermediate layer being a porous semi-solid or a solid freeze-dried foam layer;
wherein the at least one active pharmaceutical ingredient is incorporated in the at least one intermediate layer and/or in the mucoadhesive layer ([0023-0028 and 0046] drug dispersed in the matrix 16 and drug layer 18)
Wong does not teach the mucoadhesive layer being made of fibers produced by electrospinning
In the same field of endeavor, namely a scaffold of tissue repair or wound dressing, Hakimi teaches a mucoadhesive layer being made of fibers produced by electrospinning ([0034-0040] adhesive component comprises fibre formed of electrospinning).
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 to incorporate the teachings of Hakimi and provides the mucoadhesive layer as claimed for the purpose of providing improved release profile of bioactive agents and control over the release, and allows the adhesive layer mimics the cellular environment ([0028]) thereby improving wound healing and tissue anchoring.
The combination is still silent as to the at least one intermediate layer being a porous semi-solid or a solid freeze-dried foam layer.
In the same field of endeavor, namely a wound dressing materials, Nisbet teaches the at least one intermediate layer being a porous semi-solid or a solid freeze-dried foam layer ([0040-0044] wound dressing is solid freeze-dried polymer sponge).
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 Hakimi, to incorporate the teachings of Nisbet and provides the intermediate layer as claimed for the purpose of providing suitable means to store and administer dose while providing desired flexibility for wound dressing as taught by Nisbet ([0040-0042]).
Regarding claim 2, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further teaches wherein the at least one intermediate layer comprises two or more freeze-dried foam intermediate layers (Nisbet; the modified the matrix 16 and drug layer 18 of Wong being freeze-dried foam)
Regarding claim 3, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further teaches wherein the porous semi-solid or the solid
Regarding claim 4, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further teaches wherein the mucoadhesive layer comprises fibers produced by spinning (Nisbet; [0040-0045])
Regarding claim 5, Wong, as modified by Hakimi and Nisbet, 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 Hakimi and Nisbet, 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 porous semi-solid or a solid freeze-dried foam intermediate layer (Wong; [0023]-[0028] the modified drug and matrix layers contains drug).
Regarding claim 8, Wong, as modified by Hakimi and Nisbet, 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 (Nisbet; [0040-0044] solid sponge ) and wherein the mucoadhesive layer is an adhesive fiber layer (Hakimi; [0034-0040] adhesive component comprises fibre formed of electrospinning ).
Regarding claim 9, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further teaches the dosage form according to claim 8, comprising:
a) the adhesive fiber layer (Wong; figure 1c, adhesive layer 6);
the water-repelling backing layer (Wong; figure 1c, backing layer 4); and
The at least one intermediate layer (Wong; figure 1c, drug and matrix layers 18 and 16 comprising solid freeze-dried foam layer modified by Nisbet comprising drug) comprising 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 comprising 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 comprising at least one solid foam intermediate layer
Regarding claim 12, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination does not expressly teach wherein the mucoadhesive layer, intermediate layer(s), and backing layer comprise one or more hydrophilic polymers, hydrophobic polymers and/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 polysaccharides, polymethacrylate, mixtures thereof, salts thereof, and derivatives thereof.
In the same field of endeavor, namely a scaffold of tissue repair or wound dressing, Hakimi teaches wherein the mucoadhesive layer, intermediate layer(s), and backing layer comprise one or more hydrophilic polymers, hydrophobic polymers and/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 polysaccharides, polymethacrylate, mixtures thereof, salts thereof, and derivatives thereof ([0021-0022] polymer forming material layer comprises PLGA (poly(lactic-co-glycolic acid))).
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 Hakimi and Nisbet, to incorporate the teachings of Hakimi and provides the dosage foam as claimed for the purpose of providing a biocompatible material having sufficient mechanical strength for use in a wound dressing as taught by Hakimi ([0020-0022]) .
Regarding claim 13, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 21.
The combination further teaches wherein the one or more hydrophilic polymers, hydrophobic polymers, and/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 combination teaches the claimed material above, i.e., Hakimi [0020-0022], and the phrase “is in aqueous or organic dispersion, or as neat polymer with/before fabrication of layers by the process selected from the group consisting of …” 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 prior art teaches one or more hydrophilic polymers, hydrophobic polymers, and/or gums, and therefore the prior art is considered to be processed with the claimed step above).
Regarding claim 14, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further teaches Mucoadhesive 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 (Hakimi; [0022] polymer comprises chitosan).
Regarding claim 15, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination further 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), biological material (Wong; [0020] drug include any biologically active material), and particulate matter.
Regarding claim 16, Wong, as modified by Hakimi and Nisbet, 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] dug including anti-inflammatory agents or hormones)
Regarding claim 23, Wong, as modified by Hakimi and Nisbet, 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 and 0046] drug dispersed in the matrix 16 and drug layer 18) and not in the mucoadhesive layer (Wong does not expressly teach the drug is incorporated in the adhesive layer).
In the alternative, in the event that this interpretation is not envisaged by applicant, although the prior art above is silent as to whether the at least one active pharmaceutical ingredient is incorporated in the mucoadhesive layer or not,
However, Wong teaches the at least one intermediate layer as taught by Wong (Wong; [0023-0028 and 0056]) and Wong does not expressly teach the adhesive layer includes the at least one active pharmaceutical ingredient is incorporated in the mucoadhesive layer. One of skill in the art would have understood that the mucoadhesive layer is the layer intended to contact the tissue and is therefore exposed during application. Accordingly, placing the active pharmaceutical ingredient in the exposed mucoadhesive layer could result in premature exposure or degradation of the pharmaceutical ingredient and unintended administration to tissue other than the intended target site. Thus, 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 Hakimi and Nisbet, avoiding incorporation of the pharmaceutical ingredient in the mucoadhesive layer for the purpose of avoiding unnecessary exposure of pharmaceutical ingredient. Such an arrangement would have been a predictable design choice to protect the pharmaceutical ingredient from unintended release or degradation, with a reasonable expectation of success.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 20050118246 A1) in view of Hakimi et al (US 20050118246 A1) and Nisbet (US 20120135062 A1), and in further view of alternate embodiment of Wang (US 20050118246 A1; [0030])
Regarding claim 7, Wong, as modified by Hakimi and Nisbet, teaches the dosage form according to claim 1.
The combination does not teach wherein the at least one active pharmaceutical ingredient is incorporated in the mucoadhesive layer.
In the same field of endeavor, namely dosage forms, the alternate embodiment of Wang teaches wherein the at least one active pharmaceutical ingredient is incorporated in the adhesive layer ([0030])
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 Hakim and Nisbet, 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]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wong et al (US 20050118246 A1) in view of Hakimi et al (US 20050118246 A1) and Nisbet (US 20120135062 A1), and in further view of Bonner (US 20180193621 A1).
Regarding claim 17, Wong, as modified by Hakimi and Nisbet, 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 mucoadhesive 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).
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 Hakimi and Nisbet, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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