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 .
DETAILED ACTION
This action is in response to papers filed December 5, 2025. Applicant’s reply to the restriction/election requirement of October 7, 2025 has been entered. Claims 1-12 have been amended; and claims 13 and 14 have been newly added. Claims 1-14 are currently pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/EP2021/081473, filed November 12, 2021 under 35 U.S.C. 365(c), is hereby acknowledged.
Acknowledgment is also made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of French Patent Application No. FR 2011592, filed in the French Republic on November 12, 2020, has been received as required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6 and 12-14, is hereby acknowledged. Applicant’s elections of i) “incorporated in the patch” as the species of disposition of the protein/polypeptide with respect to the patch, and ii) “hyaluronic acid” as the species of anionic polysaccharide are both also acknowledged. The Examiner has determined that claims 1-6 and 12-14 read on the elected subject matter.
The traversal is on the following grounds:
1. “The membranes disclosed in Caridade are intended for use in muscles and bones” and thus “not intended to be applied to the same part of the body as the patch of the present invention”;
2. “the membranes…in Caridade…do not contain a layer in contact with the buccal or sublingual environment…which consists of chitosan…i.e. the layer …as the part of the patch that is not stuck/attached to its application surface”;
3. “the patch…is asymmetrically charged with the protein/peptide of interest” and “the protein/peptide is incorporated in the one third of the total hydrated thickness of the patch” and thus the patch is an “asymmetric patch”; and
4. “the patch…is an electrostatic assembly in which the incorporated protein/peptide is released in a pH-dependent way”.
These arguments are not found persuasive because of the following reasons:
1. The special technical feature common to groups I-III is “a mucoadhesive patch comprising i) at least 100 bilayers, each bilayer comprising a layer of chitosan and a layer of an anionic polysaccharide of MW 500-1000 kDa; and ii) a protein/polypeptide”. As the claim is reasonably understood, neither buccal or sublingual mucosa, nor the compounds of the environment thereof, is necessarily a requisite constituent or structural element of the actual patch itself. Rather, the intended use of the patch is administration to the subject via the buccal or sublingual route. However, this is not a technical feature of the actual patch itself, as seen e.g. sitting on the desk.
2. Again, the special technical feature common to groups I-III is “a mucoadhesive patch comprising i) at least 100 bilayers, each bilayer comprising a layer of chitosan and a layer of an anionic polysaccharide of MW 500-1000 kDa; and ii) a protein/polypeptide”. As the claim is reasonably understood, neither buccal or sublingual mucosa, nor the compounds of the environment thereof, is necessarily a requisite constituent or structural element of the actual patch itself. Hence, there is no buccal or sublingual mucosa attached to the patch. Moreover, Group III, claims 8-11, requires the CH/anionic polysaccharide multilayer formation on a substrate, and loading the membrane with the protein. The substrate is not necessarily buccal or sublingual mucosa, and there is no requirement for any buccal or sublingual mucosa. Hence, this is not a technical feature common to all of Groups I-III.
3. The claims say nothing at all about an “asymmetric patch” or about “asymmetry”, and say nothing at all about the patch being asymmetrically charged with the protein/peptide generally, or about the protein/peptide being incorporated in one third of the total hydrated thickness of the patch in particular. This is not a technical feature common to Groups I-III.
4. The claims say nothing at all about the protein being released in a pH-dependent manner, or even about the protein being released in any particular manner. This is simply not a technical feature common to Groups I-III.
Accordingly, claims 7-11 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction/election requirement is still deemed proper, maintained, and is hereby made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on December 5, 2025. Claims 1-6 and 12-14 are currently under examination.
Claim Objections
Claim 1 is objected to because of the following:
1. The expression “wherein said protein or said polypeptide are” appears to be in improper English grammatical form. Applicant is advised to amend the expression to “wherein said protein or said polypeptide is”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-6 and 12-14 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 1 is indefinite for the following reasons:
1. Claim 1 is directed to mucoadhesive patch for buccal or sublingual administration comprising i) at least 100 bilayers of chitosan and anionic polysaccharide, and ii) a protein or polypeptide, but then claim 1 make a reference in a wherein cause to “the layer in contact with the mucosa and the layer in contact with the buccal or sublingual environment of the patch”. One of ordinary skill in the art cannot make heads or tails out of this limitation. One of ordinary skill in the art cannot definitively ascertain whether “mucosa” and one or more compounds or structures found in “the buccal or sublingual environment” are necessarily requisite constituent elements or structures of the claimed patch itself. Moreover, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of what constitutes “the buccal or sublingual environment”, and what chemical compounds and structures are necessarily included and excluded from “the buccal or sublingual environment”.
2. Claim 1 stipulates that “the layer in contact with the mucosa and the layer in contact with the buccal or sublingual environment” consist of chitosan. One of ordinary skill in the art cannot definitively ascertain whether the layer in contact with the mucosa is one and the same layer in contact with the buccal or sublingual environment, or rather there are two distinct layers, with the one in contact with the mucosa necessarily not the one in contact with the buccal or sublingual environment. Moreover, one of ordinary skill in the art would reasonably understand that the layer in contact with the mucosa and/or the environment is an outer surface layer, which necessarily consists of chitosan. However, the claim goes on to provide that the protein or peptide can be incorporated in or adsorbed on the surface of the patch. Presumably, for mucosal delivery of the protein or peptide, the protein or peptide must be located in the layer in contact with the mucosa. Hence, one of ordinary skill in the art cannot definitively understand how the surface layer necessarily consists of chitosan (i.e. excludes protein or peptide) but presumably includes protein or peptide.
Claim 6 stipulates in a wherein clause that “the protein or polypeptide is an allergen”. The term “allergen” is not defined by the claim, and is arbitrary and subjective. For example, some people may be allergic to certain proteins or polypeptides, but others may not be. Humans may be allergic to certain proteins or peptides but other mammalian species may not be at all. Therefore, what protein or polypeptide constitutes an “allergen” is thus effectively arbitrary and subjective. One of ordinary skill in the art thus cannot definitively ascertain the metes and bound of the claimed subject matter.
Claims 2-6 and 12-14 are indefinite for depending from an indefinite claim.
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.
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 1-6 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Moreira et al. (Molecules. 2020; 25: 840), in view of Uddin et al. (J Pharm Pharm Sci. 2019: 22: 388-406), and Saint-Lu et al. (Allergy. 2009; 64(7): abstract).
Applicant Claims
Applicant’s elected subject matter is directed to a “patch” comprising 100-200 bilayers each comprising a chitosan layer and a hyaluronic acid layer (i.e. CHI/HA bilayers), and ovalbumin incorporated in the patch; wherein the patch is 10-20 µm thick.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Moreira et al. disclose a “patch” in the form of a multilayer and mucoadhesive film comprising 50-100 tetralayers (i.e. 100-200 bilayers) comprising a chitosan layer, a hyaluronic acid layer, a chitosan layer, and a hyaluronic acid layer (i.e. CHI/HA bilayers); wherein the patch can be loaded with active agents, and wherein the patch can be about 6-50 µm thick.
Uddin et al. disclose that multilayer films comprising e.g. biocompatible and biodegradable mucoadhesive polymers and e.g. an antigen, particularly a protein or peptide, are advantageously employed to deliver vaccines to the oral mucosa via the buccal or sublingual route; and further discloses that the multilayer film advantageously further contains an “outer layer” or “back layer” to protect the vaccine from dissolution by saliva.
Saint-Lu et al. disclose that ovalbumin is a specific protein allergen that can be advantageously delivered to sublingual mucosa by a mucoadhesive chitosan dosage form for efficacious immunotherapy.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Moreira et al. do not explicitly disclose that the “patch” contains ovalbumin for sublingual or buccal delivery. These deficiencies are cured by the teachings of Uddin et al. and Saint-Lu et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Moreira et al., Uddin et al., and Saint-Lu et al., outlined supra, to devise Applicant’s presently claimed “patch”.
Moreira et al. disclose a “patch” in the form of a multilayer and mucoadhesive film comprising 50-100 tetralayers (i.e. equiv. to 100-200 bilayers) comprising a chitosan layer, a hyaluronic acid layer, a chitosan layer, and a hyaluronic acid layer (i.e. CHI/HA bilayers); wherein the patch can be loaded with active agents, and wherein the patch can be about 6-50 µm thick. Since Uddin et al. disclose that multilayer films comprising e.g. biocompatible and biodegradable mucoadhesive polymers and e.g. an antigen, particularly a protein or peptide, are advantageously employed to deliver vaccines to the oral mucosa via the buccal or sublingual route; and since Saint-Lu et al. disclose that ovalbumin is a specific protein allergen that can be advantageously delivered to sublingual mucosa by a mucoadhesive chitosan dosage form for efficacious immunotherapy; one of ordinary skill in the art would thus be motivated to incorporate ovalbumin into the Moreira et al. “patch”, and to administer the patch to buccal or sublingual mucosa, with the reasonable expectation that the resuting “patch” will successfully deliver the ovalbumin to mucosal tissue for efficacious immunotherapy.
Moreover, Uddin et al. disclose that the multilayer film advantageously further contains an “outer layer” or “back layer” to protect the vaccine from dissolution by saliva. One of ordinary skill in the art would generally know that hyaluronic acid is readily dissolved by saliva, but that chitosan is not. Therefore, one of ordinary skill in the art would thus be motivated to modify the Moreira et al. “patch” by further including an ”outer layer” or “back layer” of chitosan, with the reasonable expectation that the resulting “patch” will successfully protect the vaccine from dissolution by saliva.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617