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 .
Election/Restrictions
To summarize the current election, the applicant elected group I, with traverse.
Claims 6-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim employs different terminology to refer to vitamin B12. 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” that is later recited to be “at least one or more selected from the group consisting of cyanocobalamin, hydroxocobalamin, and methylcobalamin”. This latter recitation is a further limitation of the capability of the bifunctional macromolecule, as currently recited, 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. 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 1-4 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 recites
“at least one bifunctional macromolecule with a hydrophilic exterior and with a hydrophilic pocket capable of pocketing Vitamin B12 material…the at least one bifunctional macromolecule…consist of b-cyclodextrin…”[emphasis added]
“at least one permeation/penetration enhancer…the at least one permeation/penetration enhancer consists of isopropyl myristate”[emphasis added] and
“at least one mucoadhesive as well as penetration enhancer…the at least one mucoadhesive as well as penetration enhancer consists of chitosan…”[emphasis added]
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.
In addition, if the intent is to have a solid composition that requires the presence of a recited vitamin B12 material and three particular additional components without intrinsic factor, the claim language can be simplified and clarified to recite, for example, “A solid composition of Vitamin B-12 for transmucosal delivery without the need of intrinsic factor comprising Vitamin B-12 selected from the group consisting of cyanocobalamin, hydroxocobalamin, methylcobalamin, and combinations thereof; b-cyclodextrin at 2.5 to 15 % of the solid composition by weight; isopropyl myristate at 0.5 to 15 % of the solid composition by weight; and chitosan at 1 to 15 % of the solid composition by weight; wherein the solid composition is free of intrinsic factor.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites the same scope of the “Vitamin B12 material” that is recited in the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Examiner Remarks
In anticipation of clarifying amendments that address the remaining issues in the claims under examination as well as in consideration of the applicant’s attempt to recite the product limitations in the process claims, the examiner provides the following remarks/suggestions to facilitate efficiency and compact prosecution:
Claim 6 does not recite a recipient in its administration step. An example of clarifying language could be “A method of transmucosal delivery of Vitamin B-12 without the need of intrinsic factor comprising administering the solid composition of claim 1 to a subject.”
Claim 7 does not further limit claim 6.
Claim 8 could be changed to depend from claim 6 and adjusted to recite that “the solid composition of Vitamin B-12 is in the form of a lozenge, a candy,…”, similar to the language for claim 3.
Claim 11 recites “the steps of adding to the composition of Vitamin B-12 material: (a) at least one bifunctional macromolecule…(b) at least one permeation enhancer…(c) at least one agent…and (d) making the solid composition”. There is no prior mention of a “composition of Vitamin B-12 material”, so the identity of the component/components to which components (a)-(c) are added is not apparent. An alternative recitation could be, “A process of making a solid composition of Vitamin B-12 for transmucosal delivery without the need of intrinsic factor according to claim 1, comprising preparing a mixture of Vitamin B-12 selected from the group consisting of cyanocobalamin, hydroxocobalamin, methylcobalamin, and combinations thereof; b-cyclodextrin; isopropyl myristate; chitosan; and other excipients; forming the mixture into a solid composition, wherein b-cyclodextrin is present at 2.5 to 15 % of the solid composition by weight, isopropyl myristate is present at 0.5 to 15 % of the solid composition by weight, chitosan is present at 1 to 15 % of the solid composition by weight, and the solid composition is free of intrinsic factor.”
Claim 12 does not further limit its parent claim.
Claim 13 could be changed to depend from claim 11 and adjusted to recite that “the solid composition of Vitamin B-12 is in the form of a lozenge, a candy,…”, similar to the language for claim 3.
Claim 16 depends from a cancelled claim which could be corrected by depending from claim 14. The processes of making different forms of the solid composition could be clearer if recited in the alternative, since the claim can currently read as though all three method parts must occur. Each of process (a), (b), and (c) have a number of clarity issues several of which are detailed in a non-exhaustive listing below.
The processes (a), (b), and (c) appear to be missing the word “the” between “comprising” and “following steps”.
The claim recites preparing a solution of components that include isopropyl myristate in water in process (a) step (ii), yet isopropyl myristate is practically insoluble in water. Thus it is not clear if isopropyl myristate is truly required to be in solution and if so, whether a solution is possible given the recited components and proportions.
It is unclear if the combination of the step (i) and step (ii) preparations in process (a) actually yield a solution as recited.
The recitations “accurately weighing quantities”, “suitable size”, and “selected quantity” reduce the clarity of the claim in process (a).
In process (b) step (ii), it recites “the solution prepared in step i”, yet step (i) of process (b) does not recite making a solution. Instead it recites “isopropyl alcohol or another carrier” where the scope of the “carrier” is not limited in the step. Thus the required form of the preparation and the required components in process (b) step (i) are not clear.
Process (b) recites “the mixture”, “the powder blend”, “the dried granules”, “the sieve #18”, and “fines” , but none of these terms were previously recited in this section of the claim.
The recitation “weighted amounts” does not add to the clarity of process (b).
Process (b) recites “compressing to obtain orally disintegrating tablets”, but the claims do not mention the tablets being orally disintegrating at any point prior. Thus the impact of its recitation on the product that is made is unclear.
Process (c) recites “the mixture”, “the sieve #18”, and “fines”, but none of these terms were previously recited in this section of the claim.
Claim 16 has several clarity issues that warrant further attention from the applicant or could be canceled if expediency is preferred.
Claims 4, 9, and 14 would be improved if they recited either specific components in item (a) or categories in item (a). For example “(a) the film is a sub-lingual film further comprising a film forming polymer, a plasticizer, a high intensity sweetener, and an antisticking, anti-tacky agent, and (b) the tablet or the lozenge further comprises…” or “(a) the film is a sub-lingual film further comprising propylene glycol, sucralose, and magnesium aluminum silicate, and (b) the tablet or the lozenge further comprises…”. Claim 16 presents a similar styling of recitations in its component limitations that could also be improved.
Response to Arguments
Applicant's arguments filed December 12, 2024 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection are hereby withdrawn and new grounds of rejection are detailed to address the claim amendment.
Conclusion
No claim is allowed.
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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615