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 .
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 in a manner that changes which claims read on the election and are under examination. It appears that the elected oral administration is implicitly embraced by the “further administration of enteric coated stable ACC composition” in dependent claims 32 and 46, since the purpose of an enteric coating is to protect an orally administered dosage form from the gastric environment (see instant specification paragraphs 132 and 264-270). Since the recitation of the enteric coated form occurs in addition to a sublingual administration step and claim 1 which recites sublingual administration has also been amended such that its treated condition embraces the elected inflammatory bowel disease, the sublingual administration species are rejoined. Claim 54 recites local acidosis as the acidosis-related disease or condition it treatments. Inflammatory bowel disease is not instantly identified as being a local acidosis, therefore claim 54 is withdrawn from consideration.
Claims 5, 30, 38-39, 46, 49-52, and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim.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 § 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.
Claim 41 is 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.
When the language of the parent claim is considered, claim 41 embraces a scope of sublingually administering a solid composition ..wherein said composition is a nutraceutical composition...wherein said nutraceutical composition comprises a food supplement or a medical food”. It is not clear that the applicant contemplated food sublingually administered in combination with the instantly claimed stabilized amorphous calcium carbonate. While a food supplement and medical food are discussed, their administration is in the context of swallowing (see paragraphs 258-259. Thus it would not have been clear to the artisan of ordinary skill that the applicant was in possession of the invention as currently claimed at the time of filing.
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 1-2, 23, 36-37, 40-41, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Sagi et al. (previously cited) in view of Basu et al. (US PGPub No. 2002/0025348), Ben et al. (WO 2016/193983), Rai et al. (World Journal of Pharmaceutical Sciences 2019 7(1):38-45), Meiron et al. (previously cited), and Bentov et al. (Journal of Structural Biology 2010 171:207–215).
Sagi et al. teach treating various conditions linked to inadequate calcium absorption by orally administering an effective amount of stabilized amorphous calcium carbonate (ACC) (pharmaceutical composition) (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 (pharmaceutical composition) such as tablets, capsules, powder, and capsules (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). Adult human populations are envisioned patients (see paragraph 13). Sagi et al. teach daily dosing amounts of their stabilized ACC containing composition to range from 0.5 to 5 g, where the elemental calcium dose provided by the composition ranges from 0.15 to 1.5 g (see paragraph 80). Sublingual administration is not explicitly detailed nor is an enteric coating explicitly taught on the stabilized amorphous calcium carbonate tablets, capsules, or powder.
Basu et al. teach the administration of a composition to treat inflammatory bowel disease (see abstract). Here they contemplate dose quantities based on a 70 kg adult (see paragraph 23).
Ben et al. teach the administration of stabilized ACC via routes in addition to oral because the oral route may not be sufficient for the desired treatment dose (paragraph 5). They detail buccal and/or sublingual administration in combination with oral administration (see paragraph 172; instant claims 1 and 23). Solid powder forms as well as tablets that may be chewed are envisioned (see paragraph 9 and example 11). An example administers a tablet form that comprises stabilized ACC where a subject chews the tablet for five minutes to conduct buccal administration/delivery then swallows the remainder for oral administration (see paragraphs 269-270 and example 11). They teach a combination buccal and oral administration that totals 600 to 2000 mg stabilized ACC (see paragraph 210).
Rai et al. teach that saliva, the physiological liquid found in the sublingual region, has a pH of 5.5 to 7 and is the major factor in promoting absorption in this region (see page 39 first column second paragraph and page 40 both half of page, first column first paragraph, and page 41 first column first partial paragraph). They also note similarities between buccal and sublingual administration, given that both occur in the oral mucosa (see page 39 first column-second column first partial paragraph).
Meiron et al. teach a stabilized ACC for oral delivery of calcium (oral) (see abstract). They detail their source of the stabilized ACC as being from the work of Bentov et al. who teach ACC stabilized by phosphorylated organic compounds (see page 365 second column third full paragraph and Bentov et al. abstract and page 208 first column second full paragraph-second column first partial paragraph; instant claims 1, 23, and 37). Bentov et al. elaborate that the stabilized ACC is aggregates (agglomerates) of 20 to 300 nm nanospheres (see page 210 first column last partial paragraph; instant claim 2). Meiron et al. teach that the stabilized ACC 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 ACC 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).
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 administering an effective amount of stabilized ACC via a solid dosage form to a patient with inflammatory bowel disease, as taught by Sagi et al., where the administration is both oral and sublingual. The identification of the subject with inflammatory bowel disease to whom the composition is administered implicitly requires the step of selecting the subjects because Sagi et al. apply their method to a subject in need of treatment due to this condition (see instant claims 23). The administration via two routes would have been obvious in light of Ben et al. as the application of the same technique to a similar process in order to yield the same improvement. This modification is additionally obvious in light of the similarity between buccal and sublingual administration and the example of Ben et al. of a similar combined administration of a solid via oral and buccal routes. The dosing of Sagi et al. considered for a typical 70 kg person, as detailed by Basu et al., would follow and converts the 0.5 to 5 g daily dose to about 7 to about 71 mg/kg/day. The possible distributions of this dosing between the oral and sublingual administration routes yields a range of sublingual doses that overlap with those instantly claimed, thereby rendering the instantly claimed range obvious (see instant claims 1 and 23. “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). In light of the teachings by Rai et al. that sublingual administration is reliant upon absorption from saliva, it would have between obvious to formulate the sublingual composition to release in the 5.5 to 7 pH environment of the saliva. This meets the range limitations instantly claimed or provides a range of pH values that overlap with those instantly claimed thereby rendering the instantly claimed range obvious (see MPEP 2144.05). The selection of the stabilized ACC of Bentov et al. and Meiron et al. for the stabilized ACC of Sagi et al. would also have been obvious as the simple substitution of one known element for another. Therefore claims 1-2, 23, 36-37, 40-41, and 48 are obvious over Sagi et al. in view of Basu et al., Ben et al., Rai et al., Meiron et al., and Bentov et al.
Claims 1-2, 23, 32, 36-37, 40-41, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Sagi et al. in view of Basu et al., Ben et al., Rai et al., Meiron et al., and Bentov et al. as applied to claims 1-2, 23, 36-37, 40-41, and 48 above, and further in view of Haeblein et al. (previously cited).
Sagi et al. in view of Basu et al., Ben et al., Rai et al., Meiron et al., and Bentov et al. render obvious the limitations of instant claims 1-2, 23, 36-37, 40-41, and 48. Meiron et al. note that the thermodynamic properties of the stabilized ACC can make it particularly suited for intestinal absorption. The presence of an enteric coating on the orally delivered solid is not explicitly detailed.
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 employ the coating of Haeberlin et al. on the stabilized ACC particles, tablets, or powders that are to be orally administered to deliver the stabilized ACC to 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 the enteric coating of Haeberlin et al. achieves delivery to the intestinal locale noted to be desirable for orally delivered stabilized ACC. Therefore claims 1-2, 23, 32, 36-37, 40-41, 46, and 48 are obvious over Sagi et al. in view of Basu et al., Ben et al., Rai et al., Meiron et al., and Bentov et al., and Haeberlin et al.
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered. In light of the amendment, the rejections under 35 USC 103 over Sagi et al in view of others is modified to address the new claim limitations. Other new grounds of rejection in light of the amendment are also detailed. The rejection over Abo Riziq et al. in view of Sagi et al. is hereby withdrawn in light of the amendment.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
