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 .
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.
Claims 1-17 and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bernett et al. WO 2010014661A1, in view of Atria et al. CN 107106498 A.
Bernett teaches an oral dosage form comprising a first active agent, calcium carbonate, at least one first binding agent, and at least one disintegrating agent as intragranular components in the form of a granulate, and as an extragranular component at least one hydrophilic colloid, an optionally a second binding agent, calcium carbonate, a super disintegrant, and a second active agent. See Abstract and Summary of The Invention. Oral dosage form such as tablet and coated tablet is found in page 5. The claimed binder in the amount that falls within the claimed range is found in pages 6-7. Intragranular component such as disintegrant is found in pages 8-9. Hydrophilic colloid in the extragranular component of the claimed invention is found in page 10. Second active agent in the extragranular component such as aspirin is found in page 11. The dosage form further comprising caffeine in the intra/extra/both intragranular and extragranular portions is found in page 11, second paragraph. Composition used for pain management is found in claims 24-25.
Bernett does not expressly teach calcium carbonate having a particle size of D50 greater than 11 µm.
Atria teaches a drug delivery system in the form of a tablet comprising an active agent and calcium carbonate. See Abstract and Claims. Atria further teaches calcium carbonate having D50 in the range of 2.0-50 µm. See Examples and Claim 3.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select calcium carbonate having particle size of D50 in view of the teaching in Atria with the expectation to obtain a tablet dosage form useful for the delivery of active agent similar to that of the claimed invention, namely, paracetamol and an NSAID. This is because Atria teaches the use of calcium carbonate having particle size that falls within the claimed range can provide improved friability and/or fluidity of the drug delivery system.
Claims 1-29 are rejected under 35 U.S.C. 103 as being unpatentable over Boulos et al. WO 2006049978 A1, in view of Bernett et al. WO 2010014661A1 and Atria et al. CN 107106498 A.
Boulos teaches an oral composition comprising aspirin and acetaminophen (paracetamol) formulated in a multi-layer tablet or caplet. The composition further comprises caffein and other materials such as starch, dextrose, sucrose or other saccharides, sorbitol, manitol, iso-malitol, or other compressible sugar alcohols, or mixtures thereof. In one embodiment, the composition of the present invention will also contain citric acid, sodium phosphate and starch. See Abstract, Claims, and pages 8-9.
Boulos does not expressly teach intra and extra granular.
Bernett teaches an oral dosage form comprising a first active agent, calcium carbonate, at least one first binding agent, and at least one disintegrating agent as intragranular components in the form of a granulate, and as an extragranular component at least one hydrophilic colloid, an optionally a second binding agent, calcium carbonate, a super disintegrant, and a second active agent. See Abstract and Summary of The Invention. Oral dosage form such as tablet and coated tablet is found in page 5. The claimed binder in the amount that falls within the claimed range is found in pages 6-7. Intragranular component such as disintegrant is found in pages 8-9. Hydrophilic colloid in the extragranular component of the claimed invention is found in page 10. Second active agent in the extragranular component such as aspirin is found in page 11. The dosage form further comprising caffeine in the intra/extra/both intragranular and extragranular portions is found in page 11, second paragraph. Composition used for pain management is found in claims 24-25.
Bernett does not expressly teach calcium carbonate having a particle size of D50 greater than 11 µm.
Atria teaches a drug delivery system in the form of a tablet comprising an active agent and calcium carbonate. See Abstract and Claims. Atria further teaches calcium carbonate having D50 in the range of 2.0-50 µm. See Examples and Claim 3.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the teaching of Boulos in view of the teaching of Bernett and Atria with the expectation to obtain a tablet dosage form useful for the delivery of active agent similar to that of the claimed invention, namely, paracetamol and an NSAID. This is because Atria teaches the use of calcium carbonate having particle size that falls within the claimed range can provide improved friability and/or fluidity of the drug delivery system.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant argues that None of Boulos, Bemett, and Atria disclose or suggest calcium carbonate provided in the form of particles having a d50 of from 11pm to 30pm. In fact, there is no evidence in any of the references that calcium carbonate particles having a d50 of from 11pm to 30pm was a relevant factor. The Office Action asserts that it would have been obvious to modify the teachings of Boulos, Bernett, and Atria to have the recited range "because Atria teaches the use of calcium carbonate having particle size that falls within the claimed range can provide improved friability and/or fluidity of the drug delivery system." (Office Action, page 5.) Atria merely discloses various particle size ranges for natural ground or precipitated calcium carbonate, none of which correspond to the presently recited range. There is no teaching or suggestion in Atria that calcium carbonate particle size affects friability and/or fluidity. In sum, the applied art has not established a connection between calcium carbonate particle size and friability and/or fluidity. In contrast, it is only the present application that discloses a particular particle size of calcium carbonate that enables the composition to achieve unexpected technical effects of improved dissolution and storage stability. These unexpected technical effects have been verified in the Examples of the present specification. One of ordinary skill in the art would not have had a reason to modify calcium carbonate particle size to impact friability and/or fluidity or improved dissolution and storage stability. As such, a prima facie case of obviousness has not been established. This rejection is respectfully traversed.
However, Applicant’s attention is called to the teaching in Atria, specifically in the Examples and in Claim 3. Atria teaches a drug delivery system in the form of a tablet comprising an active agent and calcium carbonate. See Abstract and Claims. Atria further teaches calcium carbonate having D50 in the range of 2.0-50 µm. See Examples and Claim 3.
Thus, for at least the above reason, the 103 rejections are maintained.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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