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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Claim Status
Claims 10-12, 14 and 16-18 are previously withdrawn.
Claims 1, 4-5, 7, 9, 19, and 22-23 are rejected.
No claims are allowable.
Claim Rejections - 35 USC § 103 - New
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4-5, 7, 9, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al., (US 2018/0344650 A1, Dec. 06, 2018) (hereinafter Singh) in view of Huwyler et al., (US 2019/0022012 A1, Jan. 24, 2019) (cited by Examiner on Form 892 dated 03/20/2025) (hereinafter Huwyler).
Singh discloses a core-shell composite material comprising a core comprising an active ingredient compound; a shell structure comprising at least two alternating layers; the alternating layers being a protein layer and a polyphenol layer (Abstract). The core-shell composite material may be a micro-sized particle ([0028]) and the protein layer and polyphenol layer form a multi-layered shell structure encapsulating the active ingredient core (i.e., microcapsule) ([0046]). The compound or active ingredient to be transported may be a pharmaceutically active compound, such as lactoferrin ([0045]). The protein and polyphenol layers are formed using layer-by-layer deposition ([0047]). The active ingredient may be adsorbed or absorbed onto a solid support, e.g., CaCO3 ([0051]). The core-shell composite is used in therapy, e.g., as a pharmaceutically acceptable vehicle for drug delivery (i.e., pharmaceutical product). In the preparation method disclosed in Example 1-1 a calcium chloride (CaCl2) solution (720 mL, 1M) is added to aqueous lactoferrin (Lf) (i.e., active ingredient) solution (1.8 mL, 1-30 mg/mL). Then, sodium carbonate (Na2CO3) solution (480 mL, 1M) is injected in one shot under vigorous agitation, resulting in Lf being absorbed to CaCO3 microparticles (i.e., loaded) ([0081-0082]). Further, in Example 1-2, the CaCO3 microparticles with absorbed Lf from Example 1-1 are re-suspended in aqueous bovine serum albumin (BSA) (i.e., protein, i.e., first encapsulant) solution (2 mL, 2 mg/mL) (pH 5.8) and are shaken for at least 15 min. The resultant microparticles are collected by centrifugation and the residual BSA is removed by washing twice with deionized water (i.e., a first solvent). Subsequently, the microparticles are immersed into aqueous tannic acid (TA) (i.e., polyphenol, i.e., second encapsulant) solution (2 mL, 2 mg/mL) (pH 3) and are shaken for at least 15 min. The resultant microparticles are collected by centrifugation and the residual TA is removed by washing twice with deionized water (i.e., a second solvent). This procedure is repeated until a total of four BSA-TA bilayers are deposited on the microparticles ([0085]). Then in Example 1-3, the microparticles of Example 1-2 are collected by centrifugation and re-dispersed in deionized water (1 mL). Then, HCl solution (i.e., acidic compound) (1M) is added drop-wise to the dispersion until the about pH 3. FIG. 1-c shows the SEM image of the PLL-(BSA-TA)4 shells with the encapsulated Lf wherein the CaCO3 cores are completely dissolved (i.e., decomposed) ([0087]). FIG. 2-b shows the distribution of the amount of Lf encapsulated by the PLL-(BSA-TA)4 shells for a batch of Lf encapsulated shells ([0089]). The composition may be freeze dried ([0094]).
Singh differs from the instant claims insofar as not disclosing wherein the calcium
carbonate is a reaction product of natural ground calcium carbonate or precipitated calcium
carbonate with carbon dioxide and one or more H30+ ion donors, wherein the carbon dioxide is
formed in situ by the H30+ ion donors treatment.
However, Huwyler teaches the use of a surface-reacted calcium carbonate for improving
the friability of a pharmaceutical delivery system (Abstract). A method for producing a
pharmaceutical delivery system comprising the steps of: a) providing a surface-reacted calcium
carbonate, which is a reaction product of natural ground or precipitated calcium carbonate with
carbon dioxide and one or more acids in an aqueous medium, wherein the carbon dioxide is
formed in situ by the acid treatment (Claim 1). The acid is an H3O+ ion provider ([0045]). The
surface-reacted calcium carbonate has a BET specific surface area of from 20.0 g/m2 to 200.0
g/m2 ([0113]). The surface-reacted calcium carbonate comprises particles having a volume
median grain diameter d50 of from 2.0 to 50.0 μm ([0114]). The surface-reacted calcium
carbonate comprises particles having a volume top cut particle size (d98) in the range of from
5.0 to 40 μm ([0115]). The surface-reacted calcium carbonate has an intra-particle intruded
specific pore volume within the range of 0.15 to 1.35 cm3/g ([0116]). The pharmaceutical
delivery system may be a capsule ([0031]).
Generally, it is prima facie obvious to select a known material for incorporation into a
composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Singh
teaches the use of calcium carbonate in a pharmaceutical drug delivery vehicle. Accordingly, it
would have been obvious to one of ordinary skill in the art to have incorporated the surface-
reacted calcium carbonate of Huwyler into the drug delivery system of Singh since it is a known
and effective calcium carbonate particle for drug delivery and it also improves friability of a
pharmaceutical delivery system as taught by Huwyler.
Regarding claim 7 reciting the steps of incubating, as discussed above, Singh
discloses wherein the CaCO3 microparticles were suspended in aqueous bovine serum albumin and shaken for at least 15 min then immersed into aqueous tannic acid solution and shaken for at least 15 min. The act of having the CaCO3 microparticles in contact with the solutions for 15 mins may be interpreted as incubating. The claim does not limit how the incubation is conducted or for how long it occurs.
Regarding claims 22-23 reciting the active ingredient or inactive precursor thereof in an
amount of at least 10 wt.% and 25 wt.% based on the total weight of the capsule, as discussed above, Singh teaches that lactoferrin is an active pharmaceutical ingredient added in solution at 1.8 mL, 1-30 mg/ml. Further, FIG. 2-b shows the distribution of the amount of Lf encapsulated by the PLL-(BSA-TA)4 shells. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of active ingredient through routine experimentation depending on the level of lactoferrin necessary to be pharmaceutically active, as taught by Singh. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Response to Applicant’s Arguments
Applicant’s arguments have been fully considered but are moot because new rejections
have been made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614