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 .
Claim Objections
Claims 15-20 are objected to because of the following informalities: the parent claims for these claims recite “a device”, while these claims recite “a therapeutic device”. Consistent terminology should be used in the claims.
Appropriate correction is required (e.g., recite them all as “device” or recite them all as “therapeutic device”.
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 1-20 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 pre-AIA the applicant regards as the invention.
The claims recite or require a particle adhesion inhibitor that is to lower the attractive force between the polymeric matrix and the first particles comprising chitosan ‘coated’, first therapeutic agent. A single example of a non-ionic polymer in the form of hydroxypropyl methyl cellulose is discussed in this role. However, the scope of “particle adhesion inhibitor” is not clear because the functional requirements change depending on the composition of the particles and the polymeric matrix identity.
In addition, claim 18 implies that the particle adhesion inhibitor, hydration promoter, and particle aggregation inhibitor could be overlapping in scope. This adds to the lack of clarity in the scope of these components that are recited with functional language.
The claims also require that the first particles, and at times also the second particles, have a coating around the therapeutic agent. It is unclear what “coating” means in the context of the particles of the instant invention. The specification details a single process for generating particles of the invention that is an ionotropic gelation of chitosan with a stabilizer such as sodium tripolyphosphate that encapsulates the drug in the particles (see paragraphs 57-59). There is no discussion of any further processing that involves applying a coating to the particles that result from this gelation. Thus, it appears that the specification views the gelled particles as the particles of the invention. As a result, drug encapsulated in chitosan particles made via ionotropic gelation will also be interpreted as meeting the claim limitation for particles containing a therapeutic agent and coating comprising chitosan.
Claim 18 recites that the proportions of adhesion inhibitor, particle aggregation inhibitor, and hydration promoter are sufficient to achieve controlled release, but not to prevent formation of the freeze dried matrix. While ranges for these categories of components are detailed, none are linked with the function of controlled release. Only the aggregation inhibitor is discussed relative to the freeze drying process, but there is still no detail of what, if any impact, its proportion has on the ability of a composition to be freeze dried. As a result, the scope of proportions that are necessary to achieve the two claimed functions is unclear as is any additional limitation the claim recitation adds to its parent claim. For the sake of application of prior art, any proportion of these components will be deemed sufficient to meet the limitations of the claim. Clarification is still required.
Claims 19 and 20 both recite that a surface of the device is “configured to provide controlled release of the …particles”. The scope of additional structural features that are necessary to be “configured” in this way such that the recited outcome is able to occur is unclear. The specification provides no description of the necessary configuration or arrangement of features that correspond to the recited capabilities other than being porous. However, the parent claim already requires the claimed device to be porous. Thus the scope of matrices embraced by the claims are unknown. For the sake of application of prior art, the limitations will be deemed as met when the recited structural limitations are met. Clarification is still required.
Claims not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
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.
Claims 1-8, 10-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (US PGPub No. 2014/0234212) in view of Amasya et al. (Turkish Journal of Pharmaceutical Sciences 2012 9(1):1-12) and Barat et al. (Acta Pharmaceutica 2007 57:469-477).
Goldberg et al. teach a layered buccal delivery system that is to be placed on epithelial tissue of the mouth to deliver its drug actives to the tissue (see paragraphs 17-18). The structure has a mucoadhesive sponge (porous) layer loaded with nanoparticles encapsulating a drug and a backing layer on one side the sponge layer that is impermeable to the drug and promotes unidirectional delivery into tissue (see paragraphs 44 and 46 and figure 1; instant claims 1 and 10-11). The surfaces of the sponge are not otherwise treated to alter their innate water permeability (see paragraph 124; instant claims 10-11). The sponge layer may include a plasticizer as well as taste masking ingredients (see paragraphs 18 and 46). The drug active is envisioned as a chemotherapeutic that is preferably cisplatin as well as an anti-inflammatory agent that may be included in combination (see paragraphs 73-74). Goldberg et al. exemplify chitosan nanoparticles crosslinked with tripolyphosphate that encapsulate cisplatin and are embedded in a freeze-dried chitosan sponge as the sponge layer (see example 5; instant claims 1 and 14). The nanoparticles employing an optimized pure chitosan formulation are positively charged and sized between 70 and 144 nm (see example 2; instant claims 4, 12, and 15). Goldberg et al. further detail sucralose (particle aggregation inhibitor; chlorinated disaccharide) as an effective taste masking additive (see example 14; instant claims 1 and 8). The presence of an additional chitosan sponge layer with embedded chitosan ‘coated’ cisplatin particles that is located between the first sponge layer and the impermeable backing layer is not detailed. Hydroxypropyl methyl cellulose and propylene glycol also are not detailed as components of the sponge layers.
Amasya et al. teach a buccal drug delivery gel composed of chitosan as a primary constituent (see abstract). They detail the inclusion of hydroxypropyl methyl cellulose as an enhancer of the mucoadhesive properties of the chitosan and the inclusion of propylene glycol (see table 1 and table 4 samples X1 and X2; instant claims 5-7).
Barat et al. teach propylene glycol as a plasticizer in a chitosan film employed in the oral cavity for sustained release (see abstract and page 470 third full paragraph; instant claim 5). Here an increase in the concentration of the plasticizer increased the rate of drug release by altering its hydrophilicity in a concentration dependent fashion (see table 1, page 473, and figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include both hydroxypropyl methylcellulose and propylene glycol, as taught by Amasya et al. and Barat et al., in the chitosan of the cisplatin containing layers employed to generate the sponge of Goldberg et al. for the additional mucoadhesive and drug release control they provide. These modifications would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Sucralose was effective as an envisioned sweetener in the sponge of Goldberg et al. and its inclusion would follow from the teachings of Goldberg et al. In addition, MPEP 2144.04(IV)(B), states that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Thus the duplication of the chitosan sponge layer with its chitosan nanoparticle encapsulated cisplatin, hydroxypropyl methyl cellulose, propylene glycol, and sucralose, would have been obvious, given the absence of any indication of a new or unexpected result from the configuration of a single slab as a pair of layers (see instant claims 1, 13, and 18-20). Therefore claims 1-8, 10-15, and 18-20 are obvious over Goldberg et al. in view of Amasya et al. and Barat et al.
Claims 1-8, 10-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. in view of Amasya et al. and Barat et al. as applied to claims 1-8, 10-15, and 18-20 above, and further in view of Takayanagi et al. (US Patent No. 4,765,983),
Goldberg et al. in view of Amasya et al. and Barat et al. render obvious the limitations of instant claims 1-8, 10-15, and 18-20, but do not explicitly teach two layers of drug containing porous chitosan in the buccal delivery composition/device.
Takayanagi et al. teach adhesive patches for oral transmucosal drug delivery (see abstract). Here they teach the configuration of the patch as one or more drug containing matrix layers and a top support layer that promotes unidirectional delivery of the drug(s) into the tissue via its reduced permeability to the drug (see column 3 lines 18-62 and figure 3). Takayanagi et al. teach that two drug containing matrix layers are preferred, where the outer layer is formulated to be more adhesive to the mucosa and the intermediate layer/second drug containing layer is formulated to have slower release kinetics for the contained drug (see column 3 lines 18-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the cisplatin containing chitosan sponge region in the composition of Goldberg et al. in view of Amasya et al. and Barat et al., with two of the drug particle containing layers because it has explicitly been employed and found to beneficial for such transmucosal devices, as detailed by Takayanagi et al. The dual layered system would permit separate control of the release kinetics for the drug contained in each layer and flexibility for the end user to optimize the release rate and functionality of the structure as desired (e.g. differing levels of plasticizer to control mucoadhesivity or rates of degradation/solubilization. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-8, 10-15, and 18-20 are obvious over Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al.
Claims 1-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. in view of Amasya et al. and Barat et al. or Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. as applied to claims 1-8, 10-15, and 18-20 above, and each further in view of Jonassen et al. (Biomacromolecules 2012 13:3747-3756).
Goldberg et al. in view of Amasya et al. and Barat et al. as well as Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. both render the limitations of instant claims 1-8, 10-15, and 18-20 obvious. A particular salt form for the tripolyphosphate employed to crosslink the particles is not detailed.
Jonassen et al. teach that the tripolyphosphate employed to crosslink chitosan nanoparticles can be sodium tripolyphosphate (see page 3747 second column and page 3748 first column fourth full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select sodium tripolyphosphate for the cisplatin containing nanoparticles in the modified multilayered construct of Goldberg et al. because it is a particular variety of the tripolyphosphates known to be employed to crosslink drug containing chitosan nanoparticles, as taught by Jonassen et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1-15 and 18-20 are obvious over Goldberg et al. in view of Amasya et al., Barat et al., and Johanssen et al. and over Goldberg et al. in view of Amasya et al., Barat et al., Takayanagi et al., and Johanssen et al.
Claims 1-8, 10-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. in view of Amasya et al. and Barat et al. or Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. as applied to claims 1-8, 10-15, and 18-20 above, and each further in view of Ream et al. (US PGPub No. 2003/0049280). and Beck et al. (US PGPub No. 2009/0280182).
Goldberg et al. in view of Amasya et al. and Barat et al. as well as Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. both render the limitations of instant claims 1-8, 10-15, and 18-20 obvious. The presence of unencapsulated cisplatin is not explicitly taught.
Ream et al. teach a chewing gum formulation for transmucosal delivery of its contained drug active (see abstract). The coating of the composition includes the drug active in unencapsulated form such that it is released into the saliva and forced through the mucosal wall by the chewing process (see paragraphs 62 and 93-96 and tables following paragraph 113). Cisplatin is a drug envisioned in the coating (see paragraph 75).
Beck et al. teach a solidified hydrogel that is envisioned to deliver drugs to an adjacent tissue, such as a wound site or internal (epithelial) implant location (see abstract and paragraphs 59-60). Here the inclusion of unencapsulated drug in combination with encapsulated drug is taught to be beneficial because the unencapsulated drug releases relatively quickly and the encapsulated drug releases in a delayed or prolonged fashion (see paragraph 114). The drug in both instances is envisioned to be the same compound (see paragraph 114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include cisplatin in unencapsulated form in the modified sponge of Goldberg et al., based on Ream et al. and Beck et al. who detail the known inclusion of unencapsulated cisplatin in a buccal delivery vehicle and the usefulness of having both immediate release and controlled release capabilities for a drug active in a single delivery vehicle. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-8, 10-16, and 18-20 are obvious over Goldberg et al. in view of Amasya et al., Barat et al., Ream et al., and Beck et al. and over Goldberg et al. in view of Amasya et al., Barat et al., Takayanagi et al., Ream et al., and Beck et al.
Claims 1-8, 10-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. in view of Amasya et al. and Barat et al. or Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. as applied to claims 1-8, 10-15, and 18-20 above, and each further in view of Ryoo et al. (US PGPub No. 2010/0112050).
Goldberg et al. in view of Amasya et al. and Barat et al. as well as Goldberg et al. in view of Amasya et al., Barat et al., and Takayanagi et al. both render the limitations of instant claims 1-8, 10-15, and 18-20 obvious. A particular concentration for the sucralose is not detailed.
Ryoo et al. teach transmucosal solid dosage forms for application to the oral mucosa (see abstract). Film embodiments are taught and exemplified (see paragraph 22 and examples). Further, Ryoo et al. teach sucralose as a component of several drug containing film embodiments at 1 to 1.45 wt% that were deemed to taste sweet (see table 10 and paragraph 171).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sucralose in the modified multilayered construct of Goldberg et al. at a concentration known to elicit sweetened in an oral transmucosal film. Thus the application of the proportion of sucralose taught by Ryoo et al. would have been obvious. Therefore claims 1-8, 10-15, and 17-20 are obvious over Goldberg et al. in view of Amasya et al., Barat et al., and Ryoo et al. and over Goldberg et al. in view of Amasya et al., Barat et al., Takayanagi et al., and Ryoo et al.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11 and 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-10 of U.S. Patent No. 11,938,288.
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite a porous freeze dried chitosan matrix for mucosal delivery of a drug that is encapsulated in chitosan particles that are embedded in the porous chitosan and present as two layers. The chitosan particles in each layer include pure chitosan and sodium tripolyphosphate. The chitosan matrix has a first surface and opposing second surface where the first surface is configured to attach to the mucosal surface and both are permeable to water. The chitosan matrix includes an additional free drug, hydroxypropyl cellulose, a hydration promoter that can be propylene glycol, ethylene glycol, or beta propylene glycol, and sucralose as a particle aggregation inhibitor at 1 to 10 wt%. The chemotherapeutic compound, cisplatin, is in the particles. Therefore claims 1-11 and 13-20 are unpatentable over claims 1-7 of US Patent No. 11,938,228.
Claims 1-11 and 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,617,722 in view of Takayanagi et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite a porous freeze dried chitosan matrix for mucosal delivery of a drug that is encapsulated in chitosan particles that are embedded in the porous chitosan. The chitosan particles include pure chitosan and sodium tripolyphosphate. The chitosan matrix has a first surface and opposing second surface where the first surface is configured to attach to the mucosal surface and both are permeable to water. The chitosan matrix includes hydroxypropyl cellulose, a hydration promoter that can be propylene glycol, ethylene glycol, or beta propylene glycol, and a particle aggregation inhibitor at 0.1 to 50 wt%. The patented claims recite chlorinated disaccharides as the particle aggregation inhibitor. Chemotherapeutic compounds are named as the drug in the patented claims. The presence of an additional layer of porous freeze dried chitosan with embedded drug encapsulating particles is not detailed.
Takayanagi et al. teach adhesive patches for oral transmucosal drug delivery (see abstract). Here they teach the configuration of the patch as one or more drug containing matrix layers and a top support layer that promotes unidirectional delivery of the drug(s) into the tissue via its reduced permeability to the drug (see column 3 lines 18-62 and figure 3). Takayanagi et al teach that two drug containing matrix layers are preferred, where the outer layer is formulated to be more adhesive to the mucosa and the intermediate layer/second drug containing layer is formulated to have slower release kinetics for the contained drug (see column 3 lines 18-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the patented particle containing layer as two of the drug particle containing layers because it has explicitly been employed and found to beneficial for such transmucosal devices, as detailed by Takayanagi et al. The dual layered system would permit separate control of the release kinetics for the drug contained in each layer and flexibility for the end user to optimize the release rate and functionality of the structure as desired (e.g. differing levels of plasticizer to control mucoadhesivity or rates of degradation/solubilization). This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The second layer of chitosan matrix has third and fourth opposing surfaces where the third surface and second surface are attached. Therefore claims 1-20 are obvious over claims 1-10 of U.S. Patent No. 11,617,722 in view of Takayanagi et al.
Claims 1-11 and 13-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-10 of U.S. Patent No. 10,398,655 in view of Takayanagi et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite a porous freeze dried chitosan matrix for mucosal delivery of a drug that is encapsulated in chitosan particles that are embedded in the porous chitosan. The chitosan particles include pure chitosan and sodium tripolyphosphate. The chitosan matrix has a first surface and opposing second surface where the first surface is configured to attach to the mucosal surface and both are permeable to water. The chitosan matrix includes free drug, hydroxypropyl cellulose, a hydration promoter that can be propylene glycol, ethylene glycol, or beta propylene glycol, and a particle aggregation inhibitor at 0.1 to 50 wt%. The patented claims recite chlorinated disaccharides as the particle aggregation inhibitor. Chemotherapeutic compounds are named as the drug in the patented claims. The presence of an additional layer of porous freeze dried chitosan with embedded drug encapsulating particles is not detailed.
Takayanagi et al. teach adhesive patches for oral transmucosal drug delivery (see abstract). Here they teach the configuration of the patch as one or more drug containing matrix layers and a top support layer that promotes unidirectional delivery of the drug(s) into the tissue via its reduced permeability to the drug (see column 3 lines 18-62 and figure 3). Takayanagi et al teach that two drug containing matrix layers are preferred, where the outer layer is formulated to be more adhesive to the mucosa and the intermediate layer/second drug containing layer is formulated to have slower release kinetics for the contained drug (see column 3 lines 18-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the patented particle containing layer as two of the drug particle containing layers because it has explicitly been employed and found to beneficial for such transmucosal devices, as detailed by Takayanagi et al. The dual layered system would permit separate control of the release kinetics for the drug contained in each layer and flexibility for the end user to optimize the release rate and functionality of the structure as desired (e.g. differing levels of plasticizer to control mucoadhesivity or rates of degradation/solubilization). This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The second layer of chitosan matrix has third and fourth opposing surfaces where the third surface and second surface are attached. Therefore claims 1-11 and 13-20 are obvious over claims 1-6 and 8-10 of U.S. Patent No. 10, 398,655 in view of Takayanagi et al.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-11, 13-16, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/782685 (reference application) in view of Takayanagi et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the copending claims recite or prepare a porous freeze dried chitosan matrix for mucosal delivery of a drug that is encapsulated in chitosan particles that are embedded in the porous chitosan in the delivery system of the patented claims. The chitosan particles include pure chitosan and sodium tripolyphosphate. The chitosan matrix has a first surface and opposing second surface where the first surface is configured to attach to the mucosal surface and the second surface is permeable to water. The chitosan matrix includes free drug, hydroxypropyl cellulose, a hydration promoter that can be propylene glycol, ethylene glycol, or beta propylene glycol, and a particle aggregation inhibitor. The copending claims recite chlorinated disaccharides as the particle aggregation inhibitor and a chemotherapeutic compound as the drug in the particles of the copending claims. The presence of an additional layer of porous freeze dried chitosan with embedded drug encapsulating particles is not detailed.
Takayanagi et al. teach adhesive patches for oral transmucosal drug delivery (see abstract). Here they teach the configuration of the patch as one or more drug containing matrix layers and a top support layer that promotes unidirectional delivery of the drug(s) into the tissue via its reduced permeability to the drug (see column 3 lines 18-62 and figure 3). Takayanagi et al teach that two drug containing matrix layers are preferred, where the outer layer is formulated to be more adhesive to the mucosa and the intermediate layer/second drug containing layer is formulated to have slower release kinetics for the contained drug (see column 3 lines 18-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the copending particle containing layer as two of the drug particle containing layers because it has explicitly been employed and found to beneficial for such transmucosal devices, as detailed by Takayanagi et al. The dual layered system would permit separate control of the release kinetics for the drug contained in each layer and flexibility for the end user to optimize the release rate and functionality of the structure as desired (e.g. differing levels of plasticizer to control mucoadhesivity or rates of degradation/solubilization). This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The second layer of chitosan matrix has third and fourth opposing surfaces where the third surface and second surface are attached. Therefore claims 1-11, 13-16, and 18-20 are obvious over claims 1-11 of copending Application No. 18/782685 in view of Takayanagi et al.
Claims 1-11 and 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/782685in view of Takayanagi et al. as applied to claims 1-11, 13-16, and 18-20 above, and further in view of Ryoo et al. and Crowley et al. (US PGPub No. 20120071567).
Claims 1-11 of copending Application No. 18/782685 render obvious the limitations of instant claims 1-11, 13-16, and 18-20. A proportion for the chlorinated disaccharide is not detailed.
Ryoo et al. teach transmucosal solid dosage forms for application to the oral mucosa (see abstract). Film embodiments are taught and exemplified (see paragraph 22 and examples). Further, Ryoo et al. teach sucralose as a component of several drug containing film embodiments at 1 to 1.45 wt% that were deemed to taste sweet (see table 10 and paragraph 171).
Crowley et al. teach that sucralose is a chlorinated disaccharide (see paragraph 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select sucralose at a known chlorinated concentration as the chlorinated disaccharide to include in the delivery system because it was a known compound of this class employed in transmucosal delivery devices as taught by Ryoo et al. Therefore claims 1-11 and 13-20 ae obvious over claims 1-11 of copending Application No. 18/782685 in view of Takayanagi et al., Ryo et al., and Crowley et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615