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 Claims 1 and 3-12 are pending; claims 1, 3-7 and 11-12 are examined; claims 8-10 are withdrawn.
Applicant’s arguments, filed 17 April 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claim 6 is 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 6 recites wherein the formulation further comprises at least one excipient. The claim is indefinite because the scope of the claim is unclear. it is unclear how the at least one excipient of claim 6 differs from the excipient of claim 1. Clarification is requested.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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).
Response to Arguments
Applicant mainly asserts on p.5 of the Remarks dated 17 April 2026 that Chen teaches in Example 12, a formulation of vitamin C wherein a stabilizer such as BHA is included; thus Chen does not disclose or suggest the presently claimed vitamin C formulation that is free of any added stabilizer. Moreover, Applicant asserts it has been surprisingly discovered that the instantly claimed vitamin C formulation does not require an added stabilizer; Formulation 13 and 14 in Table 13 exhibit release of more than 90% of vitamin C over a period of 12 hours without dose dumping and are stable under standard (25° C and 60% relative humidity) and accelerated (40° C and 75% relative humidity) storage conditions over 3 months and were still capable of similar release profiles after storage as shown in Table 15.
The Examiner does not find the Applicant’s assertion to be persuasive. 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. In this instant case, the teachings of Chen are not limited to Example 12. As discussed in the rejection above and as demonstrated by Chen in claim 1, Chen does not disclose wherein the dosage form must comprise additional stabilizer, or wherein the dosage form must comprise BHA. As such, Applicant’s assertion is unpersuasive.
Regarding Applicant’s assertion that Chen fails to teach certain features of the invention, it is noted that the features being argued (i.e., release over a period of time, dose dumping, stability duration under particular temperatures and humidities) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the Specification are not read into the claims. See MPEP 2111.01. in addition, as the instant claims are directed to a composition, as long as the components are present in the composition made obvious (i.e., vitamin C, wax-like agent, sodium carboxymethylcellulose, and binder), there is a reasonable expectation that the functional recitations regarding such a composition are also met, given that the function of compositions is a product of the compositions’ structure. In other words, the components need not be included for the same purposes/benefits as Applicant’s reasoning.
Finally, regarding allegations of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). Applicant has explained that various statements referenced in the specification support their position, but these cannot take the place of evidence in the record. See MPEP § 716.01(c)(II).
Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on Applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. Applicant does not appear to have discussed same (at least in specific detail) with respect to the putative probative value of the objective data referenced in the working examples.
Finally, assuming purely arguendo that the unexpectedness of the results has been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Formulations 13 and 14 employ specific components in specific percentages, and even if Applicant were to show unexpected results, they would have been obtained, for example, not with the broad class of “hydrophobic non-polymeric excipient”, “hydrophilic release controlling excipient”, or “excipient acceptable in nutraceutical or pharmaceutical industry” generally, but instead with specific species. Note for example, Table 13 at page 21 of the instant Specification uses stearic acid, carnauba wax, and HPMC K4M. Applicant would need to explain how these specific species are “reasonably representative” of the more broadly claimed subject matter of the claims.
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
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights