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 .
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 19, 21 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US 2012/0052125 A1) in view of Caimi (US 2015/0064748 A1).
Regarding claims 19 and 21, Wieland teaches a composition comprising a wound dressing device and cholesteryl sulfate, and especially a composition containing cholesteryl sulfate and at least one carrier material for use as a haemostatic agent (Abstract). The carrier material preferably is a hydrophilic material, i.e. a material that is wettable with water ([0031]). Preferably, it is a so-called hydrocolloid, that is a partly water-soluble or water-swellable natural or synthetic polymer ([0031]). Particularly preferred are hydrocolloids from the groups of proteins, polysaccharides, glucosaminoglycanes and/or synthetic polymers and foams ([0031]). Carrier materials from the group of polysaccharides include, for example, homoglycanes or heteroglycanes, such as, for instance, alginates, in particular sodium alginate, carrageen, pectins, gum tragacanth, guar gum, carob gum, agaragar, gum arabic, xanthan gum, natural and modified starches, dextrans, dextrin, maltodextrin, chitosan, glucans, such as β-1,3-glucan or β-1,4-glucan, cellulose etc. ([0033]). The group of synthetic polymers comprises (among others) polyurethanes (e.g., Kendal Hydrofoam ®) ([0035], [0038], [0144], and the Table on the left on page 10). Foams or plates are obtainable by providing the carrier material in thick formats ([0051]). Moulded articles are obtainable by moulding or by cutting thick format carrier materials e.g. plates or foams as to the preferred geometry ([0051]).
Wieland does not explicitly disclose wherein the polyurethane polymer comprises at least one polyisocyanate and optionally at least one polyol. However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have produced a polyurethane polymer with a polyol and a polyisocyanate because polyurethanes are usually produced by reacting polyols and polyisocyanates.
Wieland does not explicitly disclose wherein the polysaccharides such as glucan are poly alpha-1,3-glucan.
However, Caimi teaches a process for producing poly alpha-1,3-glucan with reduced molecular weight (Abstract). Caimi further teaches that driven by a desire to find new structural polysaccharides using enzymatic syntheses or genetic engineering of microorganisms or plant hosts, researchers have discovered polysaccharides that are biodegradable, and that can be made economically from renewable resource-based feedstocks ([0007]). One such polysaccharide is poly alpha-1,3-glucan, a glucan polymer characterized by having alpha-1,3-glycosidic linkages ([0007]). Films prepared from poly alpha-1,3-glucan tolerate temperatures up to 150° C. and provide an advantage over polymers obtained from beta-1,4-linked polysaccharides ([0007]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have included poly alpha-1,3-glucan as the glucan polymer in the composition of Wieland in order to provide a glucan polymer that is biodegradable, can be made economically from renewable resource-based feedstocks, and can provide an advantage over polymers obtained from beta-1,4-linked polysaccharides (Caimi: [0007]).
Regarding claim 25, Caimi teaches that the percentage of glycosidic linkages between the glucose monomer units of the poly alpha-1,3-glucan that are alpha-1,3 is at least about 50%, 60%, 70%, 80%, 90% ([0053]).
Regarding claim 26, Wieland teaches that a particularly preferred composition has one, several or all of the following features: it contains at least 50% by wt of one or more carrier materials, preferably from the group of natural hydrocolloids, particularly preferably collagen ([0052]-[0059]). The examiner notes that at least 50% by wt would overlap with the claimed range of an amount of about 0.1 weight percent to about 50 weight percent. In addition, or in the alternative, the dimensions are so close that prima facie one skilled in the art would have expected them to have the same properties. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Claim(s) 19-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieland et al. (US 2012/0052125 A1) in view of Caimi (US 2015/0064748 A1), as applied to claim 19 above, further in view of Schonberger et al. (US 2011/0160633 A1).
Regarding claims 19 and 21, Wieland in view of Caimi remains as applied above, teaching a polyurethane polymer comprising at least one polyisocyanate and at least one polyol.
However, Schonberger also teaches a foam layer that comprises in the first region and the second region a polyurethane foam which is obtained by foaming and drying a composition comprising an aqueous, anionically hydrophilicized polyurethane dispersion (Abstract). Schonberger teaches providing isocyanate-functional prepolymers which are obtainable from a reaction mixture including A1) organic polyisocyanates and A2) polymeric polyols ([0039]-[0046]). The foam layer is placed on a wound to be covered ([0012]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have produced the polyurethane with organic polyisocyanates and polymeric polyols in order to obtain shaped, thermoformable polyurethane foam articles for use in wound dressings (Schonberger: [0001], [0019] and the above-cited paragraphs).
Regarding claim 20, Schonberger teaches it is particularly preferred to employ in A1) 1,6-hexamethylene diisocyanate, isophorone diisocyanate, the isomeric bis(4,4'-isocyanatocyclohexyl)methanes, and mixtures thereof ([0055] and [0052]).
Regarding claim 22, Schonberger teaches that examples of such polymeric polyols are polyester polyols, polyacrylic polyols, polyurethane polyols, polycarbonate polyols, polyether polyols, polyester polyacrylate polyols, polyurethane polyacrylate polyols, polyurethane polyester polyols, polyurethane polyether polyols, polyurethane polycarbonate polyols and polyester polycarbonate polyols ([0057]).
Regarding claims 23-24, Schonberger teaches that examples of anionic or potentially anionic hydrophilicizing agents are dimethylolpropionic acid, dimethylolbutyric acid, hydroxypivalic acid, malic acid, citric acid, glycolic acid, lactic acid and the propoxylated adduct of 2-butenediol and NaHSO3, as described in DE-A 2 446 440, page 5-9, formula I-III ([0088] and [0086]-[0087]).
Regarding claims 25 and 28-30, Caimi remains as applied above to claim 20, further teaching that the percentage of glycosidic linkages between the glucose monomer units of the poly alpha-1,3-glucan that are alpha-1,3 is at least about 50%, 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, 99%, or 100% ([0053]).
Regarding claim 26, Wieland teaches that a particularly preferred composition has one, several or all of the following features: it contains at least 50% by wt of one or more carrier materials, preferably from the group of natural hydrocolloids, particularly preferably collagen ([0052]-[0059]). The examiner notes that at least 50% by wt would overlap with the claimed range of an amount of about 0.1 weight percent to about 50 weight percent. In addition, or in the alternative, the dimensions are so close that prima facie one skilled in the art would have expected them to have the same properties. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding claim 27, Schonberger teaches that suitable starter molecules in principle are inter alia water, polyethylene glycols, polypropylene glycols, glycerol, trimethylolpropane, pentaerythritol, ethylenediamine, tolylenediamine, sorbitol, sucrose and mixtures thereof ([0027]-[0029]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al. (US Patent No. 7,850,882 B2) teaches cured, integrated, layered, and water insoluble hydrophilic polyurethane foam shapes that can be molded (col. 1, lines 20-25). Especially for use in cosmetics applications, a wide range of working ingredients can be selected and incorporated into the uncured polyurethane foams by a dispensing zone (cols. 16-17, lines 66-5).
Hirano (JPH11349470A, see attachment) teaches an external preparation composition that contains mutan as an active ingredient ([0009]). Mutan in Hirano’s invention is a polymer in which glucose is α – 1,3 bonded, and can be obtained by treating glucan produced by oral streptococci typified by Streptococcus mutans and Streptococcus sobrinus with dextranase ([0010]). It is blended into various products in amounts of 0.1 to 10% by weight ([0013]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached Monday-Friday.
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/Kevin Worrell/Examiner, Art Unit 1789
/MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789