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 . Claims 1 and 3-12 are pending; claims 1, 3-7 and 11-12 are examined; claims 8-10 are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 in the reply filed on 11/23/2025 is acknowledged. The traversal is on the ground(s) that: (1) claims 8-10 have been amended to depend from claim 1, thus the search and examination of the claims of Group II (claims 8-10) would not be a serious burden on the examiner; and (2) example 12 of Chen is prepared by dry blending therefore Chen does not disclose or suggest the benefits of including a melted blend of vitamin C and hydrophobic non-polymeric excipient.
This is not found persuasive because: (1) claim 8 is directed to a process of preparing the product of claim 1, specifically involving steps such as sieving and aqueous granulation, which are not required by claim 1; and (2) a prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments and working examples. See MPEP 2123. Therefore, the teachings of Chen are not limited to Example 12 and Applicant’s traversal ground is unpersuasive.
Accordingly, claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
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 4-6 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “lipids,” and the claim also recites “fats,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites "the hydrophilic release controlling agent" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which it depends, recites hydrophilic release controlling excipient. To obviate this issue, it is suggested for claim 5 to recite --- the hydrophilic release controlling excipient --- in lines 1-2.
Claim 6 recites “at least one excipient”. The claim is indefinite because the scope of the claim is unclear. it is unclear whether the excipient of claim 6 refers to the hydrophobic non-polymeric excipient, hydrophilic release controlling excipient, the excipient of claim 1, or an additional excipient. For sake of compact prosecution, the examiner has interpreted claim 6 to recite an excipient of claim 1(c).
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, 3-7, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2008/0220079 A1, 09/11/2008) (hereinafter Chen).
Chen discloses oral dosage forms comprising sustained release pellets (abs) comprising (a) about 5-90% of an active ingredient, (b) about 5-40% of a wax-like agent, and (c) about 5-40% of a spheronizing agent ([0027]). The active ingredient includes vitamins ([0031]) such as vitamin C and vitamin D ([0315]). The wax-like agent includes carnauba wax ([0138]). The spheronizing agent includes sodium carboxymethylcellulose ([0147]). The wax-like agent has a melting point in a range formed by any two values between 40 and 120 °C ([0140]). The pellets are extruded and heated at a temperature of about 15 to 20 °C higher than the melting point of the wax-like agent to impart the desired sustained release property to the pellets ([0238]). The composition has an in vitro dissolution rate of about 40% to about 90% of the active ingredient released after 8 hours ([0024]). The pellets may further comprise about 0.01-5% wt. of one or more pharmaceutically acceptable inactive ingredients, including binders ([0028]).
Accordingly, Chen discloses sustained release dosage form comprising: about 5-90% of active including vitamin C and D (i.e. claimed one or more bioactives of claim 7); about 5-40% of wax-like agent including carnauba wax (i.e. claimed hydrophobic non-polymeric excipient of claim 4); and about 5-40% of a spheronizing agent including sodium carboxymethylcellulose (i.e. claimed hydrophilic release controlling excipient of claim 5); and about 0.001-5% of binders (i.e. excipient of claim 6) (abs, [0027]-[0028], [0138], [0147], [0315]). Chen does not disclose wherein the dosage form must comprise additional stabilizer. Together these would provide a formulation as instantly claimed.
Regarding the various amounts of actives, the claimed amounts (i.e. 40-75% wt. Vitamin C, 10-20% wt. hydrophobic non-polymeric excipient, 10-40% wt. hydrophilic release controlling excipient; and 0.5-10% excipient) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 5-90% wt. active including vitamin C, about 5-40% wt. wax-like agent, about 5-40% wt. of spheronizing agent including sodium carboxymethylcellulose, and about 0.001-5% binder, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding the claim reciting a melt granulated, melt extruded, or melt solidified blend, such recitation appears to be product-by-process limitations. Accordingly, as the instant claims are drawn to a product (i.e. a stable prolonged release vitamin C formulation), the claims are interpreted as not requiring the steps set forth in the claims, but only the structure implied by the steps. See MPEP § 2113. In this instant case, Chen discloses both extruding the pellet and melting the wax-like agent with the active to provide the sustained-release properties. Thus one of ordinary skill in the art would reasonably conclude the pellets of Chen to reasonably possess substantially the same resulting structure as the claimed invention, such as comprising a melted and extruded blend of vitamin C and hydrophobic non-polymeric excipient.
Regarding claim 3, as discussed above, Chen discloses an in vitro dissolution rate of about 40% to about 90% of the active ingredient released after 8 hours. Accordingly, the claimed release rate range (i.e. about 85% vitamin C over a period of more than 8 hours) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 40% to about 90% released after 8 hours). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 11 and 12 reciting specific temperature ranges of heating, such recitation appears to be product-by-process limitations. As the instant claims are drawn to a product (i.e. a stable prolonged release vitamin C formulation), the claims are interpreted as not requiring the steps set forth in the claims, but only the structure implied by the steps. See MPEP § 2113. In this instant case, Chen discloses a stable prolonged release composition comprising vitamin C, comprising substantially the same ingredients as the claimed invention, therefore the composition of Chen meets the limitations of claims 11 and 12 as instantly claimed. Moreover, in any case, as discussed above, Chen discloses wherein the wax-like agent has a melting point in a range formed by any two values between 40 and 120 °C, and wherein pellets are extruded and heated at a temperature of about 15 to 20 °C higher than the melting point of the wax-like agent to impart the desired sustained release property to the pellets, and so alternatively the claimed temperature ranges (i.e. 40 to 120 °C, or 60 to 90 °C, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 15 to 20 °C higher than a range of between 40 and 120 °C). See MPEP § 2144.05(I).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
JP 6647902 B2 (01/17/2020, IDS reference), directed to sustained release vitamin C granules.
US 2008/0248107 A1 (10/09/2008), directed to controlled release formulation with reduced initial burst release.
CN 110917144 A (03/27/2020, IDS reference), directed to sustained release vitamin C pellets.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612