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 .
Summary
Claims 1-4, 6-11, 15, 16 and 25-32 are pending in this office action. Claims 5, 12-14 and 17-24 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on November 12, 2024 is a 371 of PCT/JP2023/018619 filed May 18, 2023, which in turn claims priority to Japanese patent application JP2022-081879 filed on May 18, 2022. All copies of the certified copies of the priority documents have been received in this National Stage application from the International Bureau (PCT Rule 17.2(a)).
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on January 18, 2025 is acknowledged. A signed copy of the form PTO/SB/08 is attached to this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-11, 15, 16 and 25-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term "higher alcohol surfactant" is indefinite. The specification and claim 10 define them as just alcohols; Google search for definition of the term said no such concept exists. There are certainly surfactants that comprise higher alcohols in their structure but that is not what is claimed or disclosed. The claims have been interpreted as if they said “higher fatty alcohol.”
Claims 1 and 2 are substantial duplicates of each other; rearranging the words does not make a difference and the distinction between “membrane-forming” and “membrane-like” in unknown.
Claim 2 is indefinite because of the term “membrane-like.” What characteristics make something membrane-like?
Claims 10 and 31 contain a typographical error: hexydecanol should be hexadecanol.
Those claims not specifically discussed are included because they depend from claims that were discussed and do not correct the issue.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 6 - 10, 15, 16 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Slugg et al. (US 20040005358 A1, published 2004-01-08).
Slugg et al. teach coating formulations for pharmaceuticals comprising
(a) one or more modified-release hydrophilic polymers such as carboxymethylcellulose sodium, ethylcellulose, hydroxyethyl cellulose, hydroxypropylcellulose, and hydroxypropyl methylcellulose (instant water-soluble polymer);
(b) one or more plasticizing agents including lanolin alcohols (instant higher fatty alcohol);
(c) optionally one or more anti-adherents such as stearic acid (instant fatty acid);
(d) optionally one or more wetting agents which is polysorbate 80, polyoxyethylene sorbitan fatty acid esters and sorbitan esters (sorbitan fatty acid esters), and/or mixtures thereof (instant preferred nonionic surfactant). See claim 15 of Slugg et al.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to prepare a coating formulation such as that discussed by Slugg et al. involving selecting items from each list of functional material, with the expectation of creating a useful coating for pharmaceutical use.
With regard to claims 6 and 27, the specific proportions are not taught. However, Slugg et al. provide example compositions, one of ordinary skill in the art would use such conventional proportions with the expectation of beneficial results.
With regard to claims 7 and 28, the claimed fatty acid esters are taught under the broader category of sorbitan fatty acid esters. Polysorbate 80 is specifically named but Polysorbate 20 would be just as suitable a choice in view of their similar properties.
With regard to claims 9 and 30, stearic acid is specifically taught, which is one of the choices of fatty acid.
With regard to claims 10 and 31, lanolin alcohol is specifically taught, which is one of the choices of alcohol.
With regard to claims 15 and 16, Slugg et al. teach heating the components of the formulation to permit easier mixing; any solid material would necessarily have to be heated above its melting point to permit incorporation into the formulation. Therefore, the steps are deemed taught by the reference.
Claims 4, 11, 29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Slugg et al. (US 20040005358 A1, published 2004-01-08) as applied to claims 1, 2, 6 - 10, 15, 16 and 27-31 above, and further in view of Hayashi et al. (WO 2010074223 A1, published 2010-07-01).
The teachings of Hayashi et al. are taken from the English translation. Hayashi et al. teach film coating formulations comprising high hydrogen bonding resin such as carboxymethylcellulose, sugar alcohol-derived surfactant especially sorbitan fatty acid esters with high monoester ratio and they also teach the addition of swellable clay. See page 3, first and sixth full paragraphs.
With regard to instant claims 4 and 26, they teach that sorbitan fatty acid ester and sucrose fatty acid esters are preferable. Among the sorbitan fatty acid esters, those having a high monoester ratio are preferred; clearly, the same would be true of the sucrose fatty acid esters. See page 4, fourth and fifth full paragraphs.
With regard to claims 11 and 32, Hayashi et al. teach that the preferred clay is bentonite.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to add the bentonite of Hayashi et al. to the formulation of Slugg et al. in order to obtain the benefits taught by Hayashi et al. It would also have been obvious to use the high monoester esters since those are preferred by Hayashi et al.
Claims 3, 4, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Slugg et al. (US 20040005358 A1, published 2004-01-08) as applied to claims 1, 2, 6 - 10, 15, 16 and 27-31 above, and further in view of Hayashi et al. (WO 2010074223 A1, published 2010-07-01) and Pilgaonkar et al. (WO2016001937 A2, published 2016-01-07).
Slugg et al. do not teach specific sucrose fatty acid esters, nor the amounts of said esters but they do teach the sucrose esters as alternatives to sorbitan fatty acid esters.
Hayashi et al. teach a coating agent comprising a sugar alcohol derivative surfactant, sorbitan fatty acid ester and sucrose fatty acid ester are preferable, and sorbitan fatty acid ester is more preferable. Among the sorbitan fatty acid esters, those having a high monoester ratio are preferred (instant claim 26). Examples of sorbitan fatty acid esters include sorbitan monolaurate, sorbitan monopalmitate, and sorbitan monooleate; this emphasizes the desirability of monoesters. Since the sorbitan esters are taught to be equivalent to the sucrose esters, one of ordinary skill in the art would be motivate to use predominantly monoesters of either sorbitan or sucrose with the expectation of similar results.
Pilgaonkar et al. teach various sucrose fatty acid esters, including at least some of those explicitly claimed, in the context of delayed-release pharmaceuticals, see claim 9.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use any of the sucrose esters taught by Pilgaonkar et al. in place of the sorbitan esters with the expectation of beneficial results suggested by the teaching of Slugg et al. of the equivalence of sorbitan esters ant sucrose esters in the context of delayed-release pharmaceuticals.
Conclusion
No claim is allowed.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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