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 .
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on May 23, 2023 and November 20, 2023 is acknowledged. Signed copies are attached to this office action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over
Koyanagi et al. (US 3,852,421) in view of JP200502740 (hereinafter referred to as JP740).
Koyanagi discloses an excipient comprising hydroxylalkylalkyl cellulose used in the preparation of compressed, hard, readily disintegrable tablets (abstract).
The cellulose ethers are prepared by the well-known conventional method which consists of:
(i) dipping pulp in a 10-30% aqueous solution of caustic soda and pressing it into alkali cellulose,
(ii) charging the alkali cellulose together with alkylene oxide (etherifying agent) into a reactor and reacting same therein at 20-50.degree.C and under pressure, for 2-5 hours,
(iii) thereafter neutralizing by washing the hydroxyalkyl cellulose or hydroxyalkyl alkylcellulose thus prepared with alkali,
(iv) then further washing the neutralized hydroxyalkyl cellulose or hydroxyalkyl alkylcellulose with water and pulverizing it, or cooling to 0.degree.-10.degree.C the neutralized hydroxyalkyl cellulose or hydroxyalkyl alkylcellulose containing from 30 to 70% of water, drying it, then pulverizing it. In order to make its particle size and apparent density as given above, the pulverized cellulose ether may be further ground by means of a device such as an atomizer.
Hydroxyalkyl cellulose or hydroxyalkylalkyl cellulose (first hydroxyalkylalkyl cellulose) powder is thus prepared (column 2, lines 50-68).
Regarding claim 3, as noted above, the neutralized pulverized cellulose ether (first hydroxyalkylalkyl cellulose) is washed, dried, and pulverized.
Regarding claim 7, the cellulose ether may be shaped into tablets via dry and direct compression (column 2, lines 45-46).
Lowey does not disclose subjecting the ground first hydroxyalkylalkyl cellulose to hydrolysis in the presence of an acid catalyst or oxidative degradation in the presence of an oxidant for depolymerization to obtain a second hydroxyalkylalkyl cellulose.
JP470 discloses a method of depolymerizing cellulose ether by acid/oxidative degradation. Ground and dried cellulose ether is first gassed with a gaseous acid or sprayed with an acid solution and contacted with an oxidizing agent or with an oxidizing agent solution (abstract).
Regarding claim 2, Example 1 discloses the depolymerized cellulose (second hydroxyalkylalkyl cellulose) is disclosed to be pulverized (grinding)
Regarding claims 4 and 6, JP740 discloses the degradation of the cellulose results in the production of low viscosity cellulose ethers from higher viscosity cellulose ethers. Based on the disclosure of Lowey the viscosities of the several grades of hydroxypropylmethylcellulose, as calculated based on the viscosity of a 2% aqueous solution at 20 ˚C, range from 5-100,000cps. Typically, the higher viscosity grade materials dissolve more slowly and can be used in lesser amounts than comparable materials having lesser viscosities (Lowey, column 2, lines 5-11). Therefore, the skilled artisan would be motivated to reduce the viscosity of the ether for use in pharmaceutical formulations.
Regarding claim 5, the acid catalyst is disclosed to include hydrochloric acid, sulfuric acid, nitric acid, and phosphoric acid (paragraph 0032).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have further processed the cellulose of Koyanagi according to the method of JP740 in order produce very low viscosity cellulose ether having a high whiteness (paragraph 0023).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615