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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 11, 2026 has been entered.
Election/Restrictions
To summarize the current election, the applicant elected the species where the condition to be treated is inflammatory bowel disease which is an acidosis related inflammation disease. The administration route is oral and no additional biomedically active agent that treats the condition is present.
The amendment to the claims has changed their scope. Claim 1 no longer recites treating a subject afflict with an acidosis related disease or condition with a therapeutically effective amount of a solid composition comprising amorphous calcium carbonate particles. Instead, it now recites treating acidosis which was not previously recited as a condition being treated in the claims. While the patient population with acidosis may also be afflicted with a number of other diseases/conditions that include the elected inflammatory bowel disease, the election was not for treating both acidosis and inflammatory bowel disease. Therefore claim 1 and its dependent claims no longer read on the elected species.
Claims 1-2, 5, 30, 38-39, and 46-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim. The restriction requirement was made final.
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 23, 32, 36-37, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Sagi et al. (previously cited) in view of Meiron et al. (previously cited) and Haeberlin et al. (Patent No. 6,025,391).
Sagi et al. teach treating various conditions linked to inadequate calcium absorption by orally administering an effective amount of stabilized amorphous calcium carbonate (see abstract and paragraphs 15 and 76; instant claims 1 and 23). The stabilizer is envisioned as a number of materials including organic acids, phosphoric or sulfuric esters of hydroxy carboxylic acids, and hydroxyl bearing organic compounds that is present in combination with the amorphous calcium carbonate (see paragraphs 16 and 58; instant claim 37). The composition may be in the form of various solids such as tablets, capsules, powder, and capsules and may be included in food (see paragraphs 78-79 and 82). Sagi et al. teach treating specific envisioned conditions that include inflammatory bowel disease (see paragraphs 12 and 16; instant claim 40). As a treatment composition for a pathology, the composition meets the limitations of a pharmaceutical and a nutraceutical when in food (see instant claim 41). An enteric coating is not explicitly taught on the stabilized amorphous calcium carbonate tablets, capsules, or powder.
Meiron et al. teach a stabilized amorphous calcium carbonate for oral delivery of calcium (oral) (see abstract). They teach stabilized amorphous calcium carbonate to be composed of 40 to 100 nm particles of amorphous calcium carbonate (see page 367 first column second full paragraph). Meiron et al. teach that the stabilized amorphous calcium carbonate has better solubility than crystalline calcium carbonate (substantially soluble) and a portion is soluble at pH 6 to 7.5 (see page 368 second column first full paragraph and figure 4; instant claim 36). They additionally elaborate on the absorption of stabilized amorphous calcium carbonate in the gastrointestinal tract noting that its thermodynamic instability facilitates its absorption through the intestinal wall (see page 365 first column first -second full paragraphs).
Haeberlin et al. teach that the application of an enteric coating to a drug in a solid dosage form blocks the contained drug from being released in the stomach and instead the drug releases in the intestinal tract to allow absorption of the drug through the intestinal walls (see column 1 lines 35-39 and column 2 line 1-column 3 line 28; instant claim 32). They further elaborate that such an enteric coating disintegrates after incubation at pH 6.8 and releases the contained drug (see column 2 lines 31-41; instant claims 23 and 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat inflammatory bowel disease by orally administering an effective amount of stabilized amorphous calcium carbonate of Sagi et al. to a patient with inflammatory bowel disease. The identification of the subject with inflammatory bowel disease to whom the composition is administered implicitly requires the step of diagnosis because Sagi et al. apply their method to a subject in need of treatment due to this condition. The selection of the stabilized amorphous calcium carbonate of Meiron et al. for the stabilized amorphous calcium carbonate of Sagi et al. would also have been obvious as the simple substitution of one known element for another. Further, it would have been obvious to employ the coating of Haeberlin et al. on the stabilized amorphous calcium carbonate particles, tablets, or powders of Sagi et al. in view of Meiron et al. so as to provide the stabilized amorphous calcium carbonate in the intestine, where its absorption is desired to occur. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement because Meiron et al. teach that intestinal delivery of the stabilized compound is desirable and the enteric coating of Haeberlin et al. achieves this end goal. Therefore claims 23, 32, 36-37, and 40-41 are obvious over Sagi et al. in view of Meiron et al. and Haeberlin et al.
Claims 23, 32, 37, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Abo Riziq et al. (previously cited) in view of Sagi et al.
Abo Riziq et al. teach encapsulated (particulate) stabilized amorphous calcium carbonate (food supplement) that is envisioned for inclusion in functional food thereby making the preparation a nutraceutical (see abstract and page 4 lines 7-8; instant claim 41). They envisioned its utility in a food that may contain ingredients that would otherwise compromise a non-encapsulated stabilized amorphous calcium carbonate (see page 3 lines 12-17 and page 4 lines 10-18; instant claim 41). They teach that the stabilized amorphous calcium carbonate is distributed throughout the encapsulating material or is the core surrounded by a shell (coating) of the encapsulating material (see page 14 lines 7-10). Abo Riziq et al. also teach an encapsulated stabilized amorphous calcium carbonate that remains in amorphous form upon exposure to acidic pH, implying its maintenance in solid form under these conditions (e.g. controlled release/enteric coating) (see page 4 lines 26-page 5 line 3; instant claim 32). Abo Riziq et al. go on to teach ethyl cellulose as a preferred and exemplified coating material as well as the encapsulated particles releasing in a controlled fashion at a pH of 6.5 to 7.5 (see page 39 lines 20-29, page 41 lines 3-17, and example 6; instant claims 23 and 36). The instant specification recites ethyl cellulose as an enteric coating material (see paragraph 265). The stabilized amorphous calcium carbonate may be present as particle agglomerates that form the core of the encapsulated composite (see page 4 lines 19-25 page 14 lines 11-18). The stabilizer is envisioned as a number of materials including organic acids, sulfuric esters of hydroxy carboxylic acids, and hydroxyl bearing organic compounds that is present in combination with the amorphous calcium carbonate (see page 26 lines 4-11; instant claim 37). Abo Riziq et al. do not explicitly teach treating inflammatory bowel disease.
Sagi et al. teach treating various conditions linked to inadequate calcium absorption by orally administering an effective amount of stabilized amorphous calcium carbonate (see abstract and paragraphs 15 and 76; instant claim23). The composition may be in the form of various solids such as tablets, capsules, powder, and capsules and may be included in food (see paragraphs 78-79 and 82). They additionally teach treating specific envisioned conditions that include inflammatory bowel disease (see paragraphs 12 and 16; instant claims 23 and 40). The identification of the subject with inflammatory bowel disease to whom the composition is administered implicitly requires the step of diagnosis because Sagi et al. apply their method to a subject in need of treatment due to this condition (see instant claim 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat inflammatory bowel disease by orally administering an effective amount of the encapsulated stabilized amorphous calcium carbonate of Abo Riziq et al. via food to a patient with inflammatory bowel disease. This choice would have been obvious in light of the Sagi et al. who teach the treatment of inflammatory bowel disease as a known utility of stabilized amorphous calcium carbonate as well as its administration via food. It additionally would have been obvious to select a recited stabilizer for the stabilized amorphous calcium carbonate as taught by Abo Riziq et al. because they teach to do so. Therefore claims 23, 32, 37, and 40-41 are obvious over Abo Riziq et al. in view of Sagi et al.
Response to Arguments
Applicant's arguments filed February 11, 2026 have been fully considered. In light of the amendment, the rejections under 35 US 112(b) are hereby withdrawn. The applicant’s arguments are unpersuasive in regard to the rejections under 35 USC 103.
The applicant argues that Sagi et al. teach away from treating inflammatory bowel disease with their composition that comprises stabilized amorphous calcium carbonate. The applicant relies upon an example in the teachings of Sagi et al. to support their contention, but the example does not support the applicant’s characterization of the teachings of Sagi et al. While the highlighted example excludes patients with inflammatory bowel disease from its subjects, it also notes that the purpose of the study was to evaluate the gastrointestinal absorption of calcium from the amorphous calcium carbonate source in a population susceptible to the development of bone loss related disorders. To reach this end, the test subjects were “apparently healthy” and thus chosen to be devoid of major medical illness or metabolic bone disorder. The exclusion of patients with inflammatory bowel disease, along with other listed medical illnesses from this group of subjects, reduces the number of extraneous variables that could impact the outcome of the study and is not an indication that inflammatory bowel disease should not be treated with their stabilized amorphous calcium carbonate. As the rejection highlights, Sagi et al. explicitly state that inflammatory bowel disease is a disease they contemplate being treated with their stabilized amorphous calcium carbonate (see paragraphs 12, 16, and 67). While they characterize the treatment to occur via the treatment of the calcium malabsorption involved in the disease, the method treats the same inflammatory disease that is treated instantly with an effective amount of the same stabilized amorphous calcium carbonate instantly claimed.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615