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 .
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Applicant argues at Pages 8 of the Remarks against the rejection of claim 1 that Grasman and Niinobe fails to provide or suggest any of the sugar alcohols in currently amended claim 1.
Applicant further argues at Page 8 that the combination of cited references fails to provide or suggest the weight ratios recited in currently amended 1.
Applicant further argues on Page 9 that the Niinobe would guide one of ordinary skill in the art away from the claimed subject matter because Niinobe discloses that cellulose ether present in excess may not melt upon heating.
Regarding the first argument that Grasman and Niinobe fail to teach the currently claimed sugar alcohols, this argument is unpersuasive because the new grounds for rejection of claim 1 is based on Grasman, Niinobe, and Morken. Morken is cited as prior art disclosing a purging composition for cleaning polymer process equipment comprising the claimed sugar alcohols. Furthermore, Applicant’s arguments on Page 10, regarding Morken are that Morken fails to disclose the claimed weight ratios. These arguments are unpersuasive because, the Office maintains that the Niinobe suggests the claimed weight ratios as addressed below.
Regarding the second argument that the combination of references fails to provide or suggest the claimed range, the Office maintains that since Niinobe disclosing a range that is overlapping with the claimed range, the rejection over obviousness is proper. Here, a weight percentage of at least 10% cellulose ether in a composition comprising Applicant has absent evidence of new and unexpected results. An artisan would readily recognize the correlation between weight percentage of one component in a two-component system to a weight ratio between the two components. Here, Niinobe discloses a weight percentage of cellulose ether of at least 10% or a weight ratio of 10:90 or higher. Niinobe also teaches that it is desirable for the object of the invention that a high concentration of cellulose ether form a gel (see Col 4, Ln 35-37). Furthermore, there is no presented evidence of new and expected results to overcome the prima facie case of obvious based on the overlapping range taught by Niinobe.
Regarding the third argument, Applicant is reminded that preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (see MPEP 2123.II. Furthermore, Niinobe does not state that a ratio of 85:15 to 98:2 is an amount in excess. Niinobe merely describes the effect of cellulose ether in excess. The Office notes that Niinobe also teaches at Col 4, Ln 33-37 that
“The concentration of cellulose ether in the solvent is not particularly limited as long as the cellulose ether can melt in the solvent upon healing and form a gel upon cooling. It is desirable for the object of the invention that a high concentration of cellulose ether form a gel.”
Furthermore, one of ordinary skill in the art would recognize that an amount in excess would depend on the individual components of the purging composition including the cellulose ether and the sugar alcohol used.
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grasman et al (US 2015/140091) and in further view of Niinobe (US 9,222,063).
Regarding claim 1,
Grasman discloses a solid dispersion comprising at least one active ingredient in at least one hydroxyalkyl methylcellulose having a DS of from 1.0 to 2.7 and most preferably 1.6 to 2.1, an MS of from 0.50 to 1.20 and most preferably from 0.6 to 1.10 and a sum of DS and MS of at least 1.8 most preferably up to 3.2, wherein DS is a degree of substitution of methoxyl groups and MS is the molar substitution of hydroxyalkoxyl groups (see [0013] and [0025]). Grasman further discloses the hydroxyalkyl methylcellulose where the hydroxyalkoxyl group is preferably a single kind of hydroxyalkoxyl group with hydroxypropoxyl preferred (see [0021]). Grasman further discloses the solid dispersion prepared by extrusion and injection molding (see [0037]).
Grasman does not disclose the HPMC mixed with sugar alcohol in a weight ratio of HPMC to sugar alcohol from 98:2 to 85.15.
Niinobe discloses a composition comprising: (1) a cellulose ether; (2) and at least one solvent selected form water-soluble polyhydric alcohol (i.e., sugar alcohol), polyhydric alcohol ether, polyhydric alcohol ester, and ethanolamine and the cellulose either being present in the solvent in a concentration of at least 10% (see Col 2, Ln 43-49). Niinobe further discloses where the cellulose ether is a highly substituted hydroxypropyl methyl cellulose (HPMC) with a methoxyl content of 10 to 40 wt% and a hydroxyl propyl content of 3 to 30 wt% (see Col 4, Ln 5-8). Niinobe discloses purging compositions for cleaning extrusion and injection molding machines for removing residues like thermoplastic resins where the purging composition comprises thermoplastic resins (see Col 1, Ln 15 to Ln 64). Niinobe discloses that the purging composition when applied to extrusion and injection molding machines exerts a satisfactory purging or cleaning effect but with little abrasion (see Col 2, Ln 21-29). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to combine the solid dispersion prepared by extrusion as disclosed by Grasman where the cellulose ether is mixed with a polyhydric alcohol ether as disclosed by Niinobe to form a purging composition for the extrusion and injection molding machines that remove residue without abrasion as suggested by Niinobe.
Further regarding sugar alcohol, given that Niinobe discloses solvent compositions that overlaps the presently claimed composition, including highly substituted HPMC and sugar alcohol, it therefore would be obvious to one of ordinary skill in the art, to use the sugar alcohol as a solvent, which is both disclosed by Niinobe and encompassed within the scope of the present claims and thereby arrive at the claimed invention.
Further regarding the weight ratio of the HPMC to sugar alcohol, as set forth in MPEP 2144.05, in the case where the claimed range “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). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol in any range overlapping with at least 10% cellulose ether as disclosed by Niinobe including the claimed range and thereby arrive at the claimed invention.
Morken discloses a purging composition for cleaning polymer process equipment comprising starch and a polyol plasticizer where the polyol plasticizer is selected from sorbitol, glycerol, maltitol, xylitol, mannitol, erythritol and others (see [0065]). Morken further discloses that the most preferable are glycerol, sorbitol, erythritol and/or xylitol (see [0065]) and that low molecular weight plasticizer such as glycerol are very volatile and may be lost during drying or processing of the composition (see [0066]). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purging composition comprising highly substituted HPMC and sugar alcohol, as disclosed by Grasman and Niinobe where the sugar alcohol comprises sorbitol or xylitol as disclosed by Morken since it is a preferred polyol plasticizer for plasticizing the resin to be purged in purging compositions compared to glycerol which may be lost during drying or processing of the purging composition.
Regarding claim 2, as applied above Grasman discloses where the DS is from 1.4 to 2.7. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol where the DS in any range overlapping with 1.4 to 2.7 as disclosed by Grasman including the claimed range and thereby arrive at the claimed invention.
Regarding claim 3, as applied above Grasman discloses where the MS is from 0.6 to 1.10. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol where the MS in any range overlapping with 0.6 to 1.10 as disclosed by Grasman including the claimed range and thereby arrive at the claimed invention.
Regarding claim 4, as applied above Grasman discloses where the DS is from 1.4 to 2.7 and where the MS is from 0.6 to 1.10. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol where the DS and MS are any range overlapping with 1.4 to 2.7 and 0.6 to 1.10 respectively as disclosed by Grasman including the claimed range and thereby arrive at the claimed invention.
Regarding claim 5, It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol in any range overlapping with at least 10% cellulose ether as disclosed by Niinobe including the claimed range and thereby arrive at the claimed invention.
Regarding claim 6, Niinobe discloses glycerol (see Col 3, Ln 39).
Regarding claim 8, Niinobe discloses a cellulose ether with a viscosity of 3 mPa·s to 300,000 mPa·s as a 2 wt% aqueous solution measured at 20°C (see Col 4, Ln 25-33). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol where the viscosity is any range overlapping with the prior art range of 3 to 300,000 mPa·s as disclosed by Niinobe including the claimed range and thereby arrive at the claimed invention.
Regarding claim 9 Niinobe discloses a cellulose ether with a viscosity of 3 mPa·s to 300,000 mPa·s as a 2 wt% aqueous solution measured at 20°C (see Col 4, Ln 25-33). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the purge composition comprising highly substituted HPMC and sugar alcohol where the viscosity is any range overlapping with the prior art range of 3 to 300,000 mPa·s as disclosed by Niinobe including the claimed range and thereby arrive at the claimed invention.
Regarding claim 10, Grasman discloses a solid dispersion of active ingredient in hydroxypropyl methylcellulose (see [0031]).
Conclusion
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 MICHAEL FORREST whose telephone number is (571)270-5833. The examiner can normally be reached Monday-Friday (10AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sally A Merkling can be reached at (571)272-6297. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL FORREST/Primary Examiner, Art Unit 1738