DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 4, 6-7, and 10-12 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 01/30/2026 has been entered.
Claims 1-2, 4, and 6 were amended. Claim 5 was canceled. No new material was added.
Applicant’s amendments have overcome the previous rejections under 35 U.S.C. 112(b) of claims 4 and 6.
The rejections of claim 5 are moot, because the claim was canceled.
The rejection of claims 1-2, 4, 6-7 and 10-12 under 35 U.S.C. 103 has been modified to address the amendments and maintained.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
The Declaration under 37 CFR 1.132 filed 01/30/2026 is insufficient to overcome the rejection of claims 1-2, 4, 6-7, and 10-12 based upon Vooturi and Jun under 35 U.S.C. 103 as set forth in the last Office action.
Applicant argues that Vooturi teaches that it is not the barrier coating that provides reduced release, but instead the barrier coating prevents reduced release by separating the niacin from the enteric coating, preventing interactions between the two, and imparting moisture protection (Declaration, items 4 and 6; Remarks, pages 5-6). Applicant states that the skilled person would know that interactions between the niacin and the enteric coating would lead to reduced niacin release and a lower diffusion rate due to degradation and a lack of mobility (Declaration, item 5). This argument is not persuasive, because there is no evidence provided to support the Applicant’s assertions that the inner coating of the current invention provides reduced release or that it would provide an unexpected result over the barrier coating of Vooturi. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Arguments presented by the applicant cannot take the place of evidence in the record.
Applicant further states that the barrier coating does not delay release, but instead only protects against pH-related release inhibition (Declaration, items 5-7). As above, no evidence is provided to support this assertion. Further, Vooturi specifically states that the purpose of the invention is to provide modified release formulations to release niacin at a slower rate and/or with a release delayed for a time (Vooturi, pages 2-3, paragraph 0041). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Applicant states that Vooturi mentions a list of possible coating materials which do not include alginate or pectin and does not refer back to the definition of hydrophilic or hydrophobic materials in paragraphs [0093] and [0094]. Applicant states that Vooturi leads an ordinarily skilled person away from the use of alginate and/or pectin generally as a barrier coating material due to their modified release function, and therefore there would be no reason to combine Vooturi and Jun (Remarks, pages 6-7). This argument is not persuasive, because the use of alginate as the barrier coating material is further supported in paragraphs [0101]-[0102] of Vooturi which states that the barrier coating can include a bioadhesive polymer such as sodium alginate. Therefore, it would be prima facie obvious to one of ordinary skill in the art to modify the teachings of Vooturi with Jun as previously stated.
Modified/Maintained 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.
Claims 1-2, 4, 6-7 and 10-12 are rejected under 35 U.S.C. 103 as being obvious over Vooturi (US 20110123575 A1; IDS reference, 10/27/2021), further in view of Jun (Translation of KR 20080086176 A). The references were previously cited by the Examiner.
Regarding claim 1, Vooturi teaches a pharmaceutical formulation for the delivery of niacin (i.e., a delivery system; Vooturi, page 4, paragraph 0082) which can be in the form of multi-particulates (Vooturi, page 7, paragraph 0114) comprising a niacin-containing (i.e., vitamin B3, a water-soluble vitamin) solid core, a barrier coating (i.e., inner coating) over the core, and an enteric coating (i.e., outer coating) over the barrier coating (Vooturi, claim 1). Vooturi teaches the coatings can be applied using various known techniques (Vooturi, page 7, paragraph 0125), and further teaches the formulation can be prepared by spraying a coating to coat a bead (i.e., a spray-dried particle; Vooturi, page 7, paragraph 0107). Vooturi teaches the barrier (i.e., inner) coating can be a bioadhesive which is sodium alginate (Vooturi, page 5, paragraphs 0094, 0101-0102), and teaches the enteric (i.e., outer) coating can be shellac (Vooturi, page 5, paragraph 0097). Vooturi teaches the enteric coating prevents release of the active agent in the stomach and instead is predominately soluble in intestinal fluids (Vooturi, page 5, paragraph 0097), suggesting it would be reasonable to expect that the niacin would be released in the small intestine. Vooturi does not specifically teach cross-linking of the barrier coating, but does teach the barrier coating can be a bioadhesive which is sodium alginate (i.e., an alginate; Vooturi, page 5, paragraph 0094). Jun teaches a microcapsule (Jun, abstract) comprising a core active ingredient, an inner layer and an outer layer (Jun, claim 1), wherein the inner layer can be cross-linked sodium alginate (i.e., a cross-linked alginate) and calcium (Jun, page 3, paragraph 0001).
Vooturi and Jun are considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical formulations which contain water soluble vitamins and coatings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Vooturi to have crosslinked the sodium alginate layer to arrive at the claimed invention, because Vooturi teaches the barrier coating reduces the release rate of niacin (Vooturi, page 4, paragraph 0083) and Jun teaches cross-linking of sodium alginate with calcium ions prevents disintegration of the tablet (Jun, page 3, 5th paragraph), which would further reduce the release rate.
Regarding claim 2, Vooturi and Jun together teach all the elements of the current invention as applied to claim 1. Vooturi further teaches ascorbic acid (i.e., vitamin C) can be included in the core (Vooturi, page 6, paragraph 0100).
Regarding claim 4, Vooturi and Jun together teach all the elements of the current invention as applied to claim 1. Vooturi teaches the barrier coating can be sodium alginate (Vooturi, page 5, paragraphs 0094, 0101-0102). Jun teaches the inner layer can be cross-linked sodium alginate and calcium (Jun, page 3, paragraph 0001). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Vooturi to have crosslinked the sodium alginate layer to arrive at the claimed invention, because Vooturi teaches the barrier coating reduces the release rate of niacin (Vooturi, page 4, paragraph 0083) and Jun teaches cross-linking of sodium alginate with calcium ions prevents disintegration of the tablet (Jun, page 3, 5th paragraph), which would further reduce the release rate.
Regarding claim 6, Vooturi and Jun together teach all the elements of the current invention as applied to claim 1. Vooturi teaches a barrier coating is layered onto the core (Vooturi, page 2, paragraph 0028), then the enteric coating is applied to the barrier coating (Vooturi, page 2, paragraph 0029). Vooturi teaches the barrier layer can be a bioadhesive which is sodium alginate (Vooturi, page 5, paragraph 0094), teaches the coatings can be applied using various known techniques (Vooturi, page 7, paragraph 0125), and further teaches spraying a solution as a method of applying a coating (i.e., outer coating can be sprayed to apply to inner coating; Vooturi, page 7, paragraph 0107). As above, Vooturi does not specifically teach cross-linking of the barrier coating. Jun, however, teaches the inner layer can be cross-linked sodium alginate and calcium (Jun, page 3, paragraph 0001). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Vooturi to have crosslinked the sodium alginate layer to arrive at the claimed invention, because Vooturi teaches the barrier coating reduces the release rate of niacin (Vooturi, page 4, paragraph 0083) and Jun teaches cross-linking of sodium alginate with calcium ions prevents disintegration of the tablet (Jun, page 3, 5th paragraph), which would further reduce the release rate.
Regarding claim 7, Vooturi and Jun together teach all the elements of the current invention as applied to claim 6. Vooturi further teaches a manufacturing process wherein a set amount of niacin tablets are prepared and then coatings are applied one after another (Vooturi, page 10, paragraph 0175-0186), which the instant specification defines as a continuous process (page 8, lines 13-15).
Regarding claim 10, Vooturi and Jun together teach all the elements of the current invention as applied to claim 6. Vooturi further teaches tablets can be coated by dissolving in a solvent, then spraying the solution on the substrate, then coating the beads to enhance binding, then adding a barrier material (Vooturi, page 7, paragraph 0107), and further teaches granulation (Vooturi, page 7, paragraph 0108), a step-wise process which the instant specification defines as a batchwise process (page 8, lines 5-10).
Regarding claim 11, Vooturi and Jun together teach all the elements of the current invention as applied to claim 1. As above, Vooturi teaches a process for preparing a pharmaceutical formulation (Vooturi, abstract) for the delivery of niacin (i.e., a delivery system; Vooturi, page 4, paragraph 0082), and further teaches the particles of the formulation can be filled into capsules or compressed into tablets (i.e., a process for the production of a pharmaceutical product; Vooturi, page 3, paragraph 0051).
Regarding claim 12, Vooturi and Jun together teach all the elements of the current invention as applied to claim 1. As above, Vooturi teaches a pharmaceutical formulation (Vooturi, claim 1) for the delivery of niacin (i.e., a delivery system; Vooturi, page 4, paragraph 0082), which can be in the form of a capsule or tablet (i.e., pharmaceutical products; Vooturi, page 3, paragraph 0051).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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