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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 8, 12-14, 16, 20, and 31-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 now recites “wherein the lipid matrix comprises a wax, a lecithin, an orange oil, and is characterized by a matrix melting point of at least 50⁰C”. The original disclosure discussed an individual component, namely a high flow excipient, having a melting point of at least 50⁰C, not the total lipid matrix having this melting profile (see specification paragraph 49). Given that the wax, which generally qualifies as a high flow point excipient, can compose no more than 50 wt% of the lipid matrix that is also required to include an oil, the lipid matrix having a melting point of at least 50⁰C is not implicit nor is it the outcome for a number of embodiments otherwise embraced by the claimed lipid matrix.
The applicant points to an example in the specification as being composed of a lipid matrix whose components have a melting point above 50⁰C as justification for the scope now claimed. A single embodiment that is able to be described by a generic category does not provide sufficient support for the recitation of the category as a claim limitation. It is not evident that the applicant contemplated this particular sub-category of lipid matrices amongst the genus of lipid matrices embraced by the original disclosure. As a result, the artisan of ordinary skill would not have deemed the applicant to be in possession of the claimed invention at the time of filing.
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 31 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.
The claim recites “lecithin/phospholipid” and the scope of this term is unclear. Specifically, it is not clear if the recitation 1) embraces phospholipids or lecithin or 2) is limited to lecithin and phospholipids found in lecithin.
Claim 31 recites “adding lecithin/phospholipid to an extended release composition according to claim 1 in an amount up to about 25% of the weight of the lipid multiparticulate particles”. The scope of this limitation is unclear. The extended release composition of claim 1 already requires lecithin within the lipid multiparticulate particles that it contains. Thus it is unclear if the “adding” step 1) intends to limit the proportion of lecithin during the process of making the product of claim 1, but inadvertently does not consider the fact that the parent claim already incudes lecithin or 2) is intended to add more lecithin to already formed multiparticulate particles that compose the extended release composition. For the sake of application of prior art and compact prosecution, interpretation 1 will be employed. Clarification is still required.
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, 5, 8, 12-14, 16, 20, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Diorio et al. (US PGPub No. 2016/0000714 – Diorio B) in view of Young et al. (KR 20090011339 – English translation referenced for citations), Villa et al. (US PGPub No. 2009/0011010), and Gin et al. (previously cited).
Diorio B teaches solid lipid particles (multiparticulates) comprising a lipid matrix that melts at 15 to 85⁰C, curcumin (second nutraceutical), and may also include at least one additional active compound (see abstract and paragraph 30; instant claim 20). The curcumin is envisioned for its properties that include its role as an antioxidant (see paragraph 14). The additional active compounds are envisioned to include vitamin E and vitamin C (see paragraph 30; instant claim 1). Diorio B teach that the particles are sized at 100 to 600 mm and are envisioned for oral administration (see paragraphs 6, 29, and 32-33). Further additives may include a flavoring as well as essential oils (see paragraphs 6, 29, and 32-33 29; instant claim 8). The curcumin is present in the particles at 0.2 to 75 wt%, where a narrower range of 5 to 30 wt% is claimed (see paragraph 29). The lipid matrix is composed of oils and/or waxes, where the waxes are envisioned to include glycerides as well as carnauba wax and candelilla wax and the oils are envisioned to include olive oil (see paragraphs 18-19; see instant claims 1, 12, and 35). Surfactants are also present in the particles (see paragraphs 16 and 18-19; instant claim 13). Additionally, fatty acids with 4 to 18 carbons as well as fatty alcohols are also envisioned as part of the lipid matrix (see paragraph 21; instant claim 33). Diorio B exemplify a lipid particle with 15 wt% curcumin, 15 wt% soy or sunflower lecithin, and 70 wt% of two forms of glycerides, where curcumin is dispersed within the lipid matrix that has been melted at about 60⁰C then formed into particles (see example 1; instant claims 1, 3, and 5). Diorio B teach their particles in various final forms such as tablets and capsules (see paragraph 33). The presence of orange oil is not detailed nor is vitamin C exemplified in the lipid particles.
Young et al. teach a synergistic combination of curcumin, vitamin C, and vitamin E for oral delivery as an antioxidant active blend (see page 1 second paragraph and page 2 first paragraph). Curcumin composes 10 to 50 wt%, vitamin C composes 40 to 80 wt%, and vitamin E (antioxidant) composes 1 to 40 wt% of the active combination (see page 2 second paragraph; instant claim 16). Young et al. also teach the active mixture in various final forms, such as tablets and capsules (see page 3 first partial paragraph).
Villa et al. teach lipid particles for encapsulating a pharmaceutical active for oral administration (see abstract). Here they combine lecithin, carnauba wax, and stearic acid (18 carbon fatty acid) in a 3:2:2 mass ratio to generate a lipid matrix in which the drug is dispersed and then milled into particles (see paragraph 29; instant claims 1 and 34).
Gin et al. detail a particulate dosage form that pairs vitamin C with orange oil as a flavorant (see paragraph 41 and example 7; instant claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid matrix of Diorio B by substituting carnauba wax or candelilla wax for the wax component in the example. These modifications would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The addition of stearic acid and the selection of proportions as detailed by Villa et al. would have been obvious as known ratio of similar components in oral lipid matrix particles. Further, stearic acid is already envisioned by Diorio B in their compositions. The result is the wax at about 28.5 wt% of the lipid matrix. The selection of vitamin C and vitamin E to include with the curcumin in the lipid particles as additional active compounds, in light of Young et al., would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The range of proportions for these components as part of the active agent and the proportion for the curcumin as detailed by Diorio B yield an overlapping range of proportions for the active agent comprising vitamin C (ascorbic acid). For example the 5 to 30 wt% curcumin range of Diorio B could correspond the 50 wt% of the active where vitamin C and vitamin E composed 40 wt% and 10 wt%, respectively, of the active. That could result in the vitamin C composing 5 to 30 wt% of the composition and the vitamin E composing 0.5 to 3 wt% of the composition which totals a range of 10.5 to 63 wt% active agent comprising ascorbic acid (as calculated by the examiner). The lecithin would then compose about 42 wt% of the lipid matrix which would amount to about 15 to 38 wt% of the lipid particles (as calculated by the examiner). The overlapping ranges for the active agent, lipid matrix proportions, and lecithin proportions in the composition and method render the instantly claimed ranges obvious (see instant claims 1 and 31). “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The selection of orange oil as a flavoring in the lipid particles (multiparticulates) would have been obvious because 1) Diorio B teach flavoring in their lipid particles and 2) Gin et al. specifically pair orange oil flavorant with ascorbic acid in a particulate dosage form (see instant claim 1). This modification also would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and as the simple substitution of known element for another in order yield a predictable outcome. The result is lipid microparticulate/particles composed of carnauba wax or candelilla wax with soy or sunflower lecithin, orange oil, and active agent in the form of a combination ascorbic acid, curcumin (second nutraceutical) and vitamin E (see instant claims 34-35). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the instantly claimed functionality of release duration from the microparticulate particles would occur for an embraced composition, absent evidence to the contrary (see instant claims 1 and 20). The further addition of a fatty alcohol would follow from Diorio B. Therefore claims 1, 3, 5, 8, 12-13, 16, 20, and 31-35 are obvious over Diorio B in view of Young et al., Villa et al., and Gin et al.
Claims 1-3, 5, 8, 12-13, 16, 20, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Diorio B in view of Young et al., Villa et al., and Gin et al. as applied to claims 1, 3, 5, 8, 12-13, 16, 20, and 31-35 above, and further in view of Nasaka et al. (previously cited).
Diorio B in view of Young et al., Villa et al., and Gin et al. render obvious the limitations of instant claims 1, 3, 5, 8, 12-13, 16, 20, and 31-35, where an ascorbic acid encapsulating lipid microparticulate particles for oral delivery are detailed. The enantiomer for the ascorbic acid is not explicitly discussed.
Nasaka et al. teach lipid multiparticulate particles encapsulating L-ascorbic acid for oral administration and detail the importance of the compound nutritionally (see page 1 first-sixth paragraphs and example 4; instant claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select L-ascorbic acid as the ascorbic acid form in the modified multiparticulate particles of Kanaya et al. This modification would have been obvious in light of Nasaka et al. who teach its benefit and due to the finite number options that are available (e.g. L-, D-, and mixtures of L- and D-). Therefore claims 1-3, 5, 8, 12-13, 16, 20, and 31-35 are obvious over Diorio B in view of Young et al., Villa et al., Gin et al., and Nasaka et al.
Claims 1, 3, 5, 8, 12-14, 16, 20, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Diorio B in view of Young et al., Villa et al., and Gin et al. as applied to claims 1, 3, 5, 8, 12-13, 16, 20, and 31-35 above, and further in view of Appel et al. (previously cited).
Diorio B in view of Young et al., Villa et al., and Gin et al. render obvious the limitations of instant claims 1, 3, 5, 8, 12-13, 16, 20, and 31-35, where an ascorbic acid encapsulating lipid microparticulate particles for oral delivery are detailed. While a surfactant is generically envisioned, a polysorbate is not explicitly named in the lipid particles by Diorio B.
Appel et al. teach multiparticulates for oral delivery in which a drug is dispersed via mixture of the drug with a molten carrier and its formation into droplets and subsequent congealing (see paragraph 25). They teach various materials in the carrier that include lecithin and polysorbates as well as waxes such as carnauba wax (see paragraph 85). The polysorbate is envisioned generically as a carrier material and as a surfactant dissolution enhancer (see paragraph 64-66 and claims 9-10). Appel et al. additionally teach the presence of other excipients in the carrier such as flavorants and anti-static agents (flow aid) (see paragraph 70; instant claims 1 and 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add polysorbate or an anti-static agent (flow aid) to the lipid matrix in the particles of Diorio B in view of Young et al., Villa et al., and Gin et al. These modifications would have been obvious in light of Appel et al. who teach an overlapping set of components for matrix materials in sima melt formed particles. The polysorbate is a dissolution enhancing agent and surfactant, thus its inclusion is also obvious as the simple substitution of one known element for another in order to yield a predictable outcome and as the application of the same technique to a similar product in order to yield the same improvement. Further in the anti-static agent (flow aid) addition to the matrix is also obvious as matrix as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3, 5, 8, 12-14, 16, 20, and 31-35 are obvious over Diorio B in view of Young et al., Villa et al., Gin et al., and Appel et al.
Response to Arguments
Applicant's arguments filed May 7, 2026 have been fully considered. In light of the amendment to the claims, the previous objection and grounds of rejection are withdrawn. New grounds of rejection are detailed to address the claims limitations in light of the amendment.
Conclusion
No claim is allowed.
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.
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, 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.
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.
/CARALYNNE E HELM/ Examiner, Art Unit 1615
Prosecution Insights