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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 13, 2026 has been entered.
Election/Restrictions
The restriction requirement as set forth in the Office action mailed on November 19, 2018 is hereby withdrawn.
Claims 6, 8-9, 11, 13-14 and 16 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Specification
The disclosure is objected to because of the following informalities: The title “Summay of the Invention” at line 3 of the July 17, 2020 dated Specification misspells the word, “summary”.
Appropriate correction is required.
Claim Objections
Claims 1, 6, 9, 11, and 16 are objected to because of the following informalities:
Claim 1 employs different terminology to refer to vitamin B12 structures at different points in the claim in a manner that may not be intended. The product is initially recited as a “solid composition of Vitamin B-12…comprising: Vitamin B-12…”. Then a bifunctional macromolecule in the composition is recited to have capabilities of pocketing “Vitamin B12 material”. The claim later recites “Vitamin B-12 material that is at least one or more selected from the group consisting of cyanocobalamin, hydroxocobalamin, and methylcobalamin”. This latter recitation is a further limitation of the Vitamin B-12 material the bifunctional macromolecule is recited to be capable of pocketing, not the “Vitamin B-12” that is a recited component. The applicant should use consistent terminology throughout the claims to refer to components in the composition to avoid such confusion and deviation from the intended scope.
Claim 1 recites “a agent that is mucoadhesive as well as a permeation/penetration enhancer…the mucoadhesive as well as a penetration enhancer”. The two recitations for this component are inconsistent. One recitation calls the component an “agent”, while the other does not. One recitation states that it is “a permeation/penetration enhancer”, while the other states that it is “a penetration enhancer”. If “agent” is to be recited it should be recited “an agent” at its first appearance.
Claims 1, 6, and 11 recite “pocket Vitamin B-12 material consist of…”. The term “consist” should be plural.
Claim 6 recites “the solid composition” in line 3; however since it is the first occurrence of a recitation of a solid composition in the body of the claim, the article “a” instead of “the” would be better.
Claim 6 is inconsistent in its recitation of components. One component is recited as “permeation enhancer”, then later recited as “permeation/penetration enhancer”. Another component is recited as “agent that is mucoadhesive as well as penetration enhancer”, then later recited as “mucoadhesive as well as a penetration enhancer”.
Claim 6 recites “administering to a subject in need thereof, the solid composition comprising Vitamin B-12 material comprising, at least, one bifunctional”. “There is an extra comma or two in the portion, “Vitamin B-12 material comprising, at least, one bifunctional macromolecule”.
Claim 9 should replace “a antisticking” with “an antisticking”.
Claim 16 step (a)(ii) should replace “step i.” “with step i)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 6, 8-9, 11, 13-14 and 16 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 3-4 depend from or require the limitations of a cancelled claim. Specifically, claim 3 depends from claim 2 which is cancelled. Thus the scope of claim 3 and claims that depend from claim 3 is unclear.
Claim 6 recites “administering to a subject in need thereof, the solid composition comprising Vitamin B-12 material comprising, at least, one bifunctional macromolecule with hydrophilic exterior and with a hydrophobic pocket capable of pocketing Vitamin B- 12 material, at least one permeation enhancer and at least one agent that is mucoadhesive as well as penetration enhancer”[emphasis added]. The recitation states that Vitamin B-12 material comprises at least one bifunctional macromolecule, at least one permeation enhancer, and at least one agent. Vitamin B-12 itself is not recited as part of the “material” in this recitation and the bifunctional macromolecule is recited to pocket Vitamin B-12 material. Thus a component of the Vitamin B-12 material pockets the Vitamin B-12 material, which makes the recitation oddly circular. The claim later recites “the Vitamin B-12 material comprises at least one or more selected from the group consisting of cyanocobalamin, hydroxocobalamin and methylcobalamin”, then lists details of the bifunctional macromolecule, permeation/penetration enhancer, and agent separately as if the Vitamin B-12 material, bifunctional macromolecule, permeation/penetration enhancer, and agent are separate components. The recitation is quite unclear with its circular, yet seemingly incomplete language.
Claim 6 recites “at least, one bifunctional macromolecule … at least one permeation enhancer…at least one agent mucoadhesive as well as a penetration enhancer …,wherein…(b) the at least one bifunctional macromolecule… consist of… (c) the at least one permeation/penetration enhancer consists of …(d) the at least one mucoadhesive as well as a penetration enhancer consists of”. In each instance, the category of component is first recited as “at least one” which has a scope that embraces one member of the category of component and a combination of more than one member of the category of component. The later recitation of each “at least one” grouping of component to “consist” of only one member of the category is confusing and inconsistent.
Claim 6 recites transmucosal delivery, but the active step does not administer the composition to a mucosal surface. Generic administration will not necessarily result in transmucosal delivery, particularly if a mucosal tissue is not required as the administration site.
Claim 6 recites “transmucosal delivery of a solid composition”, yet, the solid composition disclosed is not to be delivered across a mucosa as a solid. Instead, vitamin B-12 and perhaps some of the components in the solid composition, after dissolution, are delivered across the mucosa. Reversion to the previous wording that first recites a solid composition in the administration step would be clearer and better aligned with the invention as discussed in the specification.
Claims 6 and 11 are missing “by weight” after “0.5 to 15 % of the composition”.
Claim 9 recites “wherein the solid composition of Vitamin B-12 comprising: (a) the film is a sub-lingual film further comprising … (b) the tablet or a lozenge further comprises…” which is awkward and confusing because it reads as though the solid is a film and tablet or lozenge. A corrective as in claim 4, where “the solid composition of Vitamin B-12 comprising” is deleted and the word “and” precedes “(b)” would correct the issue.
Claim 11 recites “(a) at least one bifunctional macromolecule…consist of… (b) at least one permeation enhancer that consists …(c) at least one agent…consists of”. The category of component is first recited as “at least one” which has a scope that embraces one member of the category of component and a combination of more than one member of the category of component. However, the later recitation of each “at least one” grouping of component to “consist” of only one member of the category is confusing and inconsistent.
Claim 11 recites two steps, “adding” and “making the solid composition”. The step of “making” is vague and unclear. The sum of the recited components with proportions is at most 45 wt% of the composition; however the proportion of vitamin B-12 is not disclosed as being 55 wt% of the instant composition. The instantly contemplated actions undertaken to convert the recited components to a solid dosage form included a variety of excipient additions and specific procedures. Thus the claim is virtually circular where the active step of a method of making a composition with components inherently present does not recite any particular actions.
Claim 14 recites “wherein the solid composition of Vitamin B-12 comprising: (a) the film is a sub-lingual film further comprising … and (b) the tablet or a lozenge further comprises…” which is awkward and confusing because it reads as though the solid is a film and tablet or lozenge. A corrective as in claim 4, where “the solid composition of Vitamin B-12 comprising” is deleted would correct the issue.
Claim 16 –
The claim recites in the film, tablet and lozenge production processes, a step of adding b-cyclodextrin at 2.5 to 15 % of the composition,(b) isopropyl myristate at 0.5 to 15 % of the composition, and (c) chitosan at 1 to 15 %, where these component are added to a liquid that is later removed. It is not clear that “the composition” being referenced is the total composition or the intermediate component that is part of the production process. Also, none of the percentage recitations state a basis (e.g., weight).
Step (a)(i) of the claim recites film forming ingredient/polymer and it is unclear if a generic film forming component is sufficient since an “ingredient” and a “polymer” are not synonymous.
Step (a)(ii) of the claim recites “myristate at and b-cyclodextrin and chitosan”, however the “at and” appears to be an inadvertently incoherent recitation.
Step (a)(iii) of the claim recites “coating the resulting solution”; however the previous step did not state that a solution was made nor does it state that sufficient water or solvent is present to generate a solution.
Step (a)(iii) of the claim recites “to the desired thickness into a film” which is awkwardly worded and would be better as “to a desired film thickness”.
Step (a)(iv) of the claim recites “cutting the same into a size so that each film contained selected quantity of Vitamin B-12”. Most of the recitation is rather non-descript language and could be simplified and clarified to “cutting the dried film”.
Step (b)(v) recites “mixing the dried granules retained on sieve #18, along with 15% fines”; however there is no prior step employing such a sieve and no description of the source of the “fines”
Step (c)(i) recites “Vitamin B-12 material”, however the parent claims and previous text in this claim lineage do not use the “material” terminology Thus the terminology is inconsistent with parent claim that recites adding composition components to Vitamin B-12.
Step (c)(i) recites “adding…in a plasticizer and stirring for a period of time until a solution is obtained”. Neither added component is recited to be a liquid. All plasticizers are not liquids, thus the scope of the components required for the method step is unclear (see Wu et al. US PGPub No. 2006/0182796 paragraph 69).
Step (c)(iv) recites “granulating the blend using solution of a binder,”; however, no previous steps in part (c) result in a “blend”. Instead a blend is made in step (b)(iii). This recitation seems to conflate steps for making two different solid dosage forms.
Step(c)(vi) recites “mixing the dried granules retained on sieve #18, along with 15% fines”; however there is no prior step employing such a sieve and no description of the source of the “fines”.
Step(c)(vi) recites “compressing the tablets in machine to obtain tablet lozenges”; however “the tablets” were made in step (b)(v). This recitation seems to conflate steps for making two different solid dosage forms. Also “in machine to obtain tablet lozenge” appears to be missing some words so as to be a more coherent recitation.
The claims are inconsistent in their use of terminology concerning the vitamin B-12. Sometimes the component is referred to as vitamin B-12 and other times it is referred to as vitamin B-12 material. This variation more readily creates antecedent basis and clarity issues. The applicant is encouraged to choose one style of terminology to employ throughout the claims.
Allowable Subject Matter
Rasheed et al. (previously cited) discuss the nuanced behavior of cyclodextrin that facilitates drug delivery, where it can act as a solubilization aid and penetration aid. While known to enhance the transit of drugs across the oral mucosa, they also discuss that its presence can hinder or help transit across biological membranes, depending on concentration (see pages 569, 573, and 581 and table 2). The prior art teachings of a cyclodextrin concentration by Mura et al. (previously cited) to facilitate delivery to buccal tissue is not explicitly framed as also yielding transmucosal delivery and is not explicitly directed at vitamin B12 compounds. The prior art appears insufficient to predictably guide the selection of the claimed cyclodextrin concentrations for producing transmucosal delivery in the fashion attained by the applicant when also combined with isopropyl myristate and chitosan concentrations. Taken together, the vitamin B12 pairing with the claimed concentration range for b-cyclodextrin, chitosan, and isopropyl myristate acting to facilitate the transmucosal delivery of vitamin B12 compounds is non-obvious combination.
Response to Arguments
Applicant's arguments filed May 13, 2026 have been fully considered. The claims are not yet in condition for allowance. The amendment introduced new issues and did not address all the issues that were raised. In addition, the examiner remarks in the previous office action was not an exhaustive listing of issues in the process claims and a number still remain, as noted above. Some of the same issues noted in the product claims remain in the process claims. Due to the recognition of allowable subject matter and amendments as well as the remaining issues being those of clarity, the restriction has been withdrawn to hopefully expedite the process of moving the claims into allowable form.
The applicant argues that part (a) of claim 1 which recites “the Vitamin B-12 material comprises” is not a further limitation of the “Vitamin B-12 material” mentioned in the recitation, “a hydrophobic pocket capable of pocketing Vitamin B-12 material”. The discussion of the hydrophobic pocket is the only prior mentioning of “Vitamin B-12 material” in the claim. The composition is stated to comprise “Vitamin B-12”, not Vitamin B-12 material. As noted, the applicant is inconsistent in their use of terminology concerning vitamin B-12. The scope of Vitamin B-12 and Vitamin B-12 material is not the same, since the latter can include components that are not vitamin B-12 as part of the “material”. For the sake of clarity and reciting what is intended, the applicant is encouraged to choose and use one style of terminology in the claims.
The same issue noted in regard to the product claims reciting a category of component as “at least one”, then later reciting each “at least one” grouping of component to “consist” of only one member of the category is confusing and inconsistent in the process claims as well. Recitations of “at least one” have a scope that is a group of components that embraces one member of the category of component and a combination of more than one member of the category of component. To then constrain the group of multiple possible components to a single component within the same claim negates the recitation of a group. Such contradictory terminology is confusing. If the claims are to recite functional language in conjunction with a single compound that fulfills the function, instead of just reciting the compound, the recitations must be clear.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
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