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 .
Claims 1-37 are presented for examination.
Claim 39 is withdrawn from examination.
Restriction/Election
Applicant’s election without traverse of Group I, claims 1-37 in the reply filed on 01/12/2026 is acknowledged.
Claim 39 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2024.
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 25, 28, and 32-35 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.
Claims 25, 28 and 32-35 are indefinite as to the phrase “preferably”. The term “preferably” in claims 25, 28 and 32-35 is a relative term which renders the claim indefinite. The term “preferably]” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. From the claimed language it is not clear whether the limitation following the phrase “preferably” is part of the claimed invention.
There are no claims dependent on the rejected claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Obeid et al. (US 20180360736 submitted by the applicant) in view of Monsuur et al. (US 20170246111) and further in view of Japakdee et al. (PREPARATION AND CHARACTERIZATION OF POLY (VINYL ALCOHOL)–POLY (VINYL PYRROLIDONE) MUCOADHESIVE BUCCAL PATCHES FOR DELIVERY OF LIDOCAINE HCL).
The claims are drawn to A mucoadhesive patch comprising a pharmaceutically acceptable soluble
film and mesoporous microparticles loaded with an analgesic agent.
Regarding claim 1, Obeid teaches controlled release oral dosage forms, especially those oral film dosage forms releasing an active agent over a sustained period of time. See Para [0002]. Obeid teaches that In some embodiments, the particles are mesoporous material covered in mucoadhesive polymers that slowly dissolve to release API at a controlled rate from the mesoporous material. A mesoporous material is a material containing pores with diameters between 2 and 50 nm. Silica is an example of a mesoporous material. See Para [0076]. The use of an analgesic, such as lidocaine and benzydamine is taught in Para [0045].
Obeid does not specifically teach a patch. Monsuur teaches compositions and methods of use thereof for the topical delivery of biological actives, e.g. cosmetic, cosmeceuticals and/or pharmaceutical actives, through the skin and/or mucus membranes in humans and animals. See Para [0001]. Monsuur teaches active-loaded porous silica particles have also been used for the prolonged release of actives in treating mucous membrane disease. See Para [0022]. Active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144]. Monsuur teaches that the drug delivery properties of the porous particles for topical administration may also be exploited for mucosal delivery, such as for example, oromucosal delivery in the oral cavity and pharynx. Apart from being used as suspension, a spray, or incorporated in mucosal films and patches. See Para [0150].
It would have been obvious to a person skilled in the art to use a patch the composition of Obeid, motivated by the teachings of Monsuur, which teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture.
Regarding claim 2, Obeid teaches the use of analgesics, such as lidocaine and benzydamine, which can be used in the mucoadhesive particles. See Para [0045]. Obeid does not teach the use of the salt of lidocaine or benzydamine. However, Japakdee et al. teach the use of mucoadhesive buccal patches for delivery of lidocaine hydrochloride. See the abstract. It would have been obvious to use lidocaine salt in a mucoadhesive patch, motivated by the teachings of Japakdee et al., which teach the use of mucoadhesive buccal patches for delivery of lidocaine hydrochloride.
Regarding claim 3, Obeid teaches the use of analgesics, such as lidocaine and benzydamine, which can be used in the mucoadhesive particles. See Para [0045]. Obeid does not teach the use of lidocaine or benzydamine hydrochloride. However, Japakdee et al. teach the use of mucoadhesive buccal patches for delivery of lidocaine hydrochloride. See the abstract. It would have been obvious to use lidocaine salt in a mucoadhesive patch, motivated by the teachings of Japakdee et al., which teach the use of mucoadhesive buccal patches for delivery of lidocaine hydrochloride.
Regarding claim 4, Obeid teaches suitable mucoadhesive materials may be chosen from the group consisting of alginate, pectin, chitosan, hyaluronic acid (and esters thereof), agar agarose, dextran, ovalbumin, collagen casein and copolymers of glycolide-based monomers. See Para [0042].
Regarding claims 5 and 6, Obeid teaches a mesoporous material is a material containing pores with diameters between 2 and 50 nm. Silica is an example of a mesoporous material. See Para [0076]. The determination of particle sizes is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claims 7 and 8, Obeid teaches a mesoporous material is a material containing pores with diameters between 2 and 50 nm. Silica is an example of a mesoporous material. See Para [0076].
Regarding claim 9, Obeid teaches the drug concentration of 0.1-20%. See Para [0057]. Such concentrations overlaps with the claimed concentration of 20-45%. Obedi teaches analgesics as a group of drugs used for delivery to mucosal membrane. See Para [0045].
Regarding claim 10, the determination amount of analgesic per cm of patch is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 11, Obeid teaches the drug concentration of 0.1-20%. See Para [0057]. Such concentrations overlap with the concentration of 0.1-100 mg.
Regarding claim 12, the size of the patch that contacts with the mucosal membrane is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 13, Obeid teaches an active agent can be incorporated into the disintegrating film in an immediate release form (i.e., a form that is not incorporated into sustained release mucoadhesive particles), such as in a free particulate form or immediate release granular form. The agent incorporated into the disintegrating film in an immediate release form can be the same agent as in the mucoadhesive particles or a different agent. See para [0034]. The use of an analgesic as an active agent is taught in Para [0045].
Regarding claim 14, Obeid teaches the active agent can be located in the mucoadhesive layer or in a third, reservoir layer between the mucoadhesive layer and the diffusion barrier layer. Such multiple layer film dosage forms require preparation of multiple formulations, casting of multiple film layers, and combining the multiple layers into a composite, such as by casting one layer on another layer, or using a lamination process. See Para [0003].
Regarding claim 15, Obeid teaches Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier that prevents or restricts loss of the active agent from the dosage form to saliva in the oral cavity and ultimately to the gastrointestinal tract. See Para [0003]. The use of analgesics as active agents is taught in Para [0045]. Obeid does not teach the use of the active ingredients in a patch. However, Monsuur teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144]. It would have been obvious to use the analgesics agents taught by Obeid in a patch, motivated by the teachings of Monsuur, which teaches the use of active agents loaded in porous particles can be added to a patch with a film forming mixture.
Regarding claim 16, Obeid teaches Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier that prevents or restricts loss of the active agent from the dosage form to saliva in the oral cavity and ultimately to the gastrointestinal tract. See Para [0003]. Obeid makes clear of the presence of a mucoadhesive layer and non-mucoadhesive layer for delivering pharmaceutical formulations to the mucosal membrane. Obeid does not teach a patch. However, Monsuur teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144].
Regarding claim 17, Obeid teaches Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier that prevents or restricts loss of the active agent from the dosage form to saliva in the oral cavity and ultimately to the gastrointestinal tract. See Para [0003]. Obeid makes clear of the presence of a mucoadhesive layer and non-mucoadhesive layer for delivering pharmaceutical formulations to the mucosal membrane. Obeid does not teach a patch. However, Monsuur teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144].
Regarding claim 18, Monsuur teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144]. The use of a drug, such as an antibiotic is taught in Para [0162].
Regarding claim 19, Obeid teaches Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier that prevents or restricts loss of the active agent from the dosage form to saliva in the oral cavity and ultimately to the gastrointestinal tract. See Para [0003]. Obeid teaches the use of the composition for the treatment of disorders caused by vesicular stomatitis viruses. See Para [0036]. It would have been obvious to use a patch for the treatment of conditions caused by vesicular stomatitis viruses, motivated by the teachings of Monsuur, which teaches the claimed dosage form has been used in a patch. Furthermore, the intended use of a composition/patch claim does not create a patentably distinct patch.
Regarding claim 20, Monsuur teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144]. The use of a drug, such as an antibiotic is taught in Para [0162].
Regarding claim 21, Obeid teaches Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier. The use such bilayer in a patch would have been obvious to a person skilled in the art, motivated by the teaching of Monsuur, which teaches the use of active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144].
Regarding claim 22, Obeid teach Film dosage forms that provide extended release of an active agent have been known. Such film dosage forms are known to comprise at least two layers, which include at least one mucoadhesive layer to facilitate adhesion of the dosage form to mucosa for an extended period, and a layer that acts as a diffusion barrier that prevents or restricts loss of the active agent from the dosage form to saliva in the oral cavity and ultimately to the gastrointestinal tract. The active agent can be located in the mucoadhesive layer or in a third, reservoir layer between the mucoadhesive layer and the diffusion barrier layer. See Para [0003]. If the active agent is located in mucoadhesive layer, then the first and the second layer are adhered to each other directly.
Regarding claim 23, Obeid teaches Controlled release of an active agent for local action in the buccal cavity in accordance with the disclosed dosage form is achieved by providing a dosage form in which mucoadhesive particles of a small size (e.g., from several nanometers to several micrometers), which contain the active agent, are dispersed in a disintegrating film. Upon administration in the oral cavity, the film disintegrates (e.g., within an acceptable period of time) and releases the mucoadhesive particles, some of which will contact the oral mucosa and immediately become tenaciously bound to the mucosa. The active agent can be released from the mucoadhesive particles over a prolonged period of time as the mucoadhesive material slowly dissolves or erodes. The dissolution of a patch in phosphate buffer is the inherent property of the patch taught by Monsuur.
Regarding claim 24, Obeid and Monsuur both teach the use of alginate as suitable mucoadhesive material. See Para {0042] of Obeid and claim 27 of Monsuur.
Regarding claim 25, the claimed specific polymers and the viscosity of alginate is the inherent property of alginate used by Obeid and Monsuur.
Regarding claim 26, the determination of optimum proportions or amounts of alginate is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 27, Obeid teaches the use of alginate and hyaluronic acid as suitable mucoadhesive material. The determination of optimum proportions or amounts of such ingredients is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 28, the determination of molecular weight of hyaluronic acid is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding Claim 29, Obeid teaches the use of polymers that can be employed in the disclosed films include water soluble cellulose derivatives, including hydroxypropylmethyl cellulose See Para [0030].
Regarding claim 30, Obeid teaches the use of polymers that can be employed in the disclosed films include water soluble cellulose derivatives, including hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose; polyvinyl pyrrolidone (PVP). See Para [0030].
Regarding claim 31, the proportions of methoxy group determination of optimum proportions of HPMC:PVP is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 32, the determination of optimum proportion or amounts of HPMC and PVP is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 33, the determination the concentration of methoxy group, hydroxypropyl groups and the viscosity of HPMC is considered to be within the skill of artisan in the absence of evidence to the contrary. Furthermore, the hydroxy propyl methyl cellulose taught by Obeid, would inherently have the same amounts of methoxy, hydroxypropyl and viscosity.
Regarding claims 34 and 35, the determination of molecular weight of PVP is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 36, Obeid teaches the active agent can be located in the mucoadhesive layer or in a third, reservoir layer between the mucoadhesive layer and the diffusion barrier layer. See Para [0003]. The use of analgesics as active agents is taught in Para [0045].
Regarding claim 37, Obeid teaches a controlled release oral dosage forms, especially those oral film dosage forms releasing an active agent over a sustained period of time. See Para [0002]. Obeid teaches that In some embodiments, the particles are mesoporous material covered in mucoadhesive polymers that slowly dissolve to release API at a controlled rate from the mesoporous material. A mesoporous material is a material containing pores with diameters between 2 and 50 nm. Silica is an example of a mesoporous material. See Para [0076]. The use of analgesics, such as lidocaine and benzydamine is taught in Para [0045].
Obeid does not specifically teach a patch. Monsuur teaches compositions and methods of use thereof for the topical delivery of biological actives, e.g. cosmetic, cosmeceuticals and/or pharmaceutical actives, through the skin and/or mucus membranes in humans and animals. See Para [0001]. Monsuur teaches active-loaded porous silica particles have also been used for the prolonged release of actives in treating mucous membrane disease. See Para [0022]. Active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture. See Para [0144]. Monsuur teaches that the drug delivery properties of the porous particles for topical administration may also be exploited for mucosal delivery, such as for example, oromucosal delivery in the oral cavity and pharynx. Apart from being used as suspension, a spray, or incorporated in mucosal films and patches. See Para [0150].
It would have been obvious to a person skilled in the art to incorporate the composition of Obeid in a patch, motivated by the teachings of Monsuur, which teaches active-loaded porous particles, preferentially inorganic porous particles such as silica, may be added to these in situ forming patches with a film forming mixture.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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