DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election of Group II, and species of example 1, in the reply filed on December 31, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be obvious over the prior art. Furthermore, a nonelected species was found to be anticipated by the prior art. Pursuant MPEP 803.02 the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species and nonelected species shown below.
4. Claims 1-25 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on December 31, 2025.
Information Disclosure Statement
5. The information disclosure statements (dated February 22, 2024 and August 7, 2-2023) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
6. Claim(s) 26-29, 31-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170119674. The reference has a publication dated of 2017 which antedates the present claims having a filing date of 2023 and priority claim to application dated 2022.
The reference teaches method of making a tablet dosage form comprising mixing a drug having a log P of about -3 to about 10 (eg. Abiraterone acetate with log P > 5). Abstract, Example 7. The drug is mixed with a lipid component comprising at least one lipid to provide a pre-concentrate, wherein the lipid component includes mono and/or triglycerides and surfactants (eg. polyoxyl 35 castor oil – Table 9) and binder (eg. silicone dioxide, microcrystalline cellulose – paragraph [0151]). Paragraph [0113], [0127], Example 7. Adsorbing the pre-concentrate onto a plurality of carbohydrate sorbent particles (eg. maltodextrin – Examples 2 and 7) and granulating to provide a plurality of granules. Example 7, paragraph [0220]. The plurality of granules are mixed with tableting excipient to provide a tablet mixture, and compressed to provide a tablet dosage form, wherein the compressing includes a tableting press. Paragraph [0224]-[0235]. Claim 26-29 and 32. Claims 31 and 33 are inherently anticipated because the properties of the tablets are inseparable from the tablet. The reference teaches the preparation of the claimed tablet.
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.
7. Claim(s) 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170119674 as applied to claims 26-33 above, and further in view of Obitte et al. and Gong et al. and WO 0166087, as evidenced by Holland.
Determining the scope and contents of the prior art
US 20170119674 teaches method of making a tablet dosage form comprising mixing a drug having a log P of about -3 to about 10 (eg. Abiraterone acetate with log P > 5). Abstract, Example 7. The drug is mixed with a lipid component comprising at least one lipid to provide a pre-concentrate, wherein the lipid component includes mono and/or triglycerides and surfactants (eg. polyoxyl 35 castor oil – Table 9) and binder (eg. silicone dioxide, microcrystalline cellulose – paragraph [0151]). Paragraph [0113], [0127], Example 7. Adsorbing the pre-concentrate onto a plurality of carbohydrate sorbent particles (eg. maltodextrin – Examples 2 and 7) and granulating to provide a plurality of granules. Example 7, paragraph [0220]. The plurality of granules are mixed with tableting excipient to provide a tablet mixture, and compressed to provide a tablet dosage form, wherein the compressing includes a tableting press. Paragraph [0224]-[0235]. Claim 26-29 and 32. Claims 31 and 33 are inherently anticipated because the properties of the tablets are inseparable from the tablet. The reference teaches the preparation of the claimed tablet.
Obitte et al. teaches the formulation of ibuprofen SEDDS using a mixture of lipids and surfactants into oral tablets.
WO 0166087 teaches composition for oral administration in form of an emulsion pre-concentrate comprising an active compound, one or more surfactants, and oil. See abstract. The reference teaches diglycerides as oil. Page 7.
Gong et al. teaches SEDDS which comprises polymer such as polyvinypyrrolidone. Page 3 of machine translation.
Ascertaining the differences between the prior art and the claims at issue
The difference between US 20170119674 and Applicant’s elected species is that the reference does not teach ibuprofen as the drug, a mixture of mono-, di- and tri-glycerides as the oil, polyvinylpyrrolidone as binder. The reference does not teach the specific tableting parameters of dwell time.
Resolving the level of ordinary skill in the pertinent art and considering objective evidence present in the application indicating obviousness
MPEP 2143 B provides basic requirements of prima facie case of obviousness including examples of rationale of the simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale the following is considered below and applied to the present claims:
A finding that the prior art method differs from claimed method by the substitution of some component with another component
US 20170119674 does not teach ibuprofen as the drug, a mixture of mono-, di- and tri-glycerides as the oil, polyvinylpyrrolidone as binder. The prior art differs from the claims to the elected species by substitution of components of the tablet dosage form.
A finding that the substituted components and their functions were known in the art
Obitte et al. teaches the formulation of ibuprofen SEDDS using a mixture of lipids and surfactants into oral tablets.
WO 0166087 teaches composition for oral administration in form of an emulsion pre-concentrate comprising an active compound, one or more surfactants, and oil. See abstract. The reference teaches diglycerides as oil. Page 7.
Gong et al. teaches SEDDS which comprises polymer such as polyvinypyrrolidone. Page 3 of machine translation.
a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
One of ordinary skill has the knowledge that the tablet dosage form, including SEDDS that is used to prepare the tablet dosage form of ibuprofen, can have various ingredients as the oil, surfactant, binder and other excipients.
Moreover, the method parameters such as compressing dwell time (claim 30) is within routine experimentation. Dwell time is art recognized to be a parameter that impacts tablet manufacturing that is optimized. See Holland.
For the reasons provided above, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621