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 .
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 21 July 2026 are acknowledged. Claims 1, 4-5, 7-11, and 13-18 are currently pending. Claims 2-3, 6, and 12 have been cancelled. Claims 1, 4, and 18 have been amended. Claims 9-11 and 13-17 were previously withdrawn. Claims 1, 4-5, 7-8, and 18 are examined on the merits within.
Withdrawn Rejections
2. Applicants’ arguments, filed 21 July 2026, with respect to the rejection(s) of claim(s) 4 and 18 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. The 35 U.S.C. 103 Rejections of claims 1, 4-5, 7-8, and 18 over Chen et al. in view of Panwar et al. now include the prior art of Hedrich et al. The 35 U.S.C. 103 Rejection of Ji et al. in view of Panwar et al. now include the prior art of Hedrich et al.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1, 4-5, 7-8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Biomaterials Science, 2018) in view of Panwar et al. (Materials, 2019) and Hedrich et al. (U.S. Patent Application Publication No. 2013/0096062).
Chen et al. teach absorbable hemostatic agents with high hemostatic efficacy. Polyelectrolyte complexes using carboxymethyl starch and chitosan oligosaccharide formed absorbable hemostatic agents. See abstract. The carboxymethyl starch and chitosan oligosaccharide were combined in a mass ratio of 9:1, 4:1 and 7:3. See Section 2.2. Carboxymethyl starch and chitosan oligosaccharide were dissolved in water to form PEC gels, then lyophilized to form freeze dried granules. See Section 2.2. The mean particle size of carboxymethyl starch was 11.2 ± 1.5 µm. See Table 1. The mean particle size of the carboxymethyl starch and chitosan oligosaccharide polyelectrolyte complex are 12.4, 25.1, and 50.1. See Table 1.
Chen et al. do not teach modification of the anionized substituent or polyacrylic acid.
Panwar et al. teach topical hemostatic agents comprising carboxymethyl starch that is modified with calcium ions to obtain free flowing microparticles to improve clotting efficiency. See abstract. Addition of calcium ions resulted in free-flowing microparticles that swelled and formed an adhesive gel. See abstract. Modification occurred using a saturated solution of CaCl2. See Section 2.4.
Hedrich et al. teach the biocompatible polymer in particulate form suitable for use in hemostasis of the present invention may be formed from biologic and non-biologic polymers. Suitable biologic polymers may contain a protein, a polysaccharide, a biologic polymer, a non-biologic polymer, derivatives and combinations thereof. Suitable proteins include gelatin, collagen, albumin, hemoglobin, fibrinogen, fibrin, casein, fibronectin, elastin, keratin, and laminin, and derivatives and combinations thereof. Other suitable biologic, polymers include polysaccharides, such as glycosaminoglycans, starch, cellulose, dextran, hemicellulose, Xylan, agarose, alginate and chitosan, and derivatives and combinations thereof. Suitable non-biologic polymers will be selected to be degradable by either of two mechanisms, i.e. (1) break down of the polymeric backbone or (2) degradation of side chains which result in aqueous solubility. Exemplary non-biologic biocompatible polymers suitable) for use in hemostasis include synthetics, such as polyacrylates, polymethacrylates, polyacrylamides, polymethacrylamides polyethyleneimines, polyvinyl resins, polylactide-glycolides, polycaprolactones, and polyoxyethylenes, and derivatives and combinations thereof. Also combinations of different kinds of polymers are possible (e.g. proteins with polysaccharides, proteins with non-biologic hydrogel-forming polymers, etc.). See paragraph [0019]. The dry particle has a particle size of 10 to 1 µm. See paragraph [0033].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add the modified carboxymethyl starch of Panwar et al. to the formulation of Chen et al. to improve the hemostatic function of the formulation. One would have been motivated, with a reasonable expectation of success, because Panwar et al. teach the improved clotting efficiency and additional property of free flowing microparticles achieved by modifying carboxymethyl starch with a calcium chloride solution. Since the carboxymethyl starch and chitosan oligosaccharide complex is lyophilized into dried granules and the carboxymethyl starch that is modified with calcium ions forms free flowing microparticles, both components combined are in the form of powders. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one biocompatible agent for another to yield predictable results. In the instant case, Hedrich et al. teach the functional equivalency of chitosan and polyacrylate derivatives and their compatibility in hemostatic formulations with starch. Thus, substituting chitosan of Chen et al. with polyacrylic acid would yield predictable results. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use the teachings of Chen et al. and Hedrich et al. to modify the size of the particles to achieve the desired consistency and effect because Chen teaches the mean particle size of carboxymethyl starch was 11.2 ± 1.5 µm and Hedrich teaches particle sizes of 10 to 1 µm.
5. Claim(s) 1, 4-5, 7-8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ji et al. (EP3199025) in view of Panwar et al. (Materials, 2019) and Hedrich et al. (U.S. Patent Application Publication No. 2013/0096062).
Ji et al. teach a modified starch for biocompatible hemostasis. See abstract. The hemostatic sponge and foam of the present invention can be a composite hemostatic sponge and a composite hemostatic foam made from one or more compositions of modified starch and other biocompatible hemostatic materials. See paragraph [0116]. The biocompatible hemostatic materials described above comprise gelatin, thrombin, collagen, carboxymethyl cellulose, oxidized cellulose, oxidized regenerated cellulose, chitosan, or sodium alginate. See paragraph [0117]. Modified starches can also comprise one or more components, such as modified starch + gelatin, modified starch + collagen, modified starch + thrombin, modified starch + chitosan, modified starch + carboxymethyl cellulose, and modified starch + hyaluronic acid. See paragraph [0118]. The modified starch includes carboxymethyl starch. See paragraph [0037]. The modified starch has a grain diameter of 1 to 1000 micrometers. See claim 1. The composition is formulated as a powder. See paragraph [0017]. The weight ratio between the modified starch and other biocompatible hemostatic materials can preferably be 95:5 or 90:10. See paragraph [0120]. The present invention accepts and adopts agglomeration processing technologies in the food and pharmaceutical industries to accumulate microscopic modified starch particles in the general 5~50µm diameter range, creating clinically applicable particles with a diameter range of 30∼500µm. Modified starch particles produced by the process disclosed above exhibit rapid water absorption, strong hydrophilic properties and rapid dispersion in blood to achieve improved hemostatic outcomes, while not readily forming a colloidal protecting layer which may disrupt the hemostatic effect. See paragraph [0110].
Ji et al. do not teach modification of the anionized substituent or polyacrylic acid.
Panwar et al. teach topical hemostatic agents comprising carboxymethyl starch that is modified with calcium ions to obtain free flowing microparticles to improve clotting efficiency. See abstract. Addition of calcium ions resulted in free-flowing microparticles that swelled and formed an adhesive gel. See abstract. Modification occurred using a saturated solution of CaCl2. See Section 2.4.
Hedrich et al. teach the biocompatible polymer in particulate form suitable for use in hemostasis of the present invention may be formed from biologic and non-biologic polymers. Suitable biologic polymers may contain a protein, a polysaccharide, a biologic polymer, a non-biologic polymer; derivatives and combinations thereof. Suitable proteins include gelatin, collagen, albumin, hemoglobin, fibrinogen, fibrin, casein, fibronectin, elastin, keratin, and laminin; and derivatives and combinations thereof. Other suitable biologic, polymers include polysaccharides, such as glycosaminoglycans, starch, cellulose, dextran, hemicellulose, xylan, agarose, alginate and chitosan; and derivatives and combinations thereof. Suitable non-biologic polymers will be selected to be degradable by either of two mechanisms, i.e. (1) break down of the polymeric backbone or (2) degradation of side chains which result in aqueous solubility. Exemplary non-biologic biocompatible polymers suitable) for use in hemostasis include synthetics, such as polyacrylates, polymethacrylates, polyacrylamides, polymethacrylamides polyethyleneimines, polyvinyl resins, polylactide-glycolides, polycaprolactones, and polyoxyethylenes, and derivatives and combinations thereof. Also combinations of different kinds of polymers are possible (e.g. proteins with polysaccharides, proteins with non-biologic hydrogel-forming polymers, etc.). See paragraph [0019]. The dry particle has a particle size of 10 to 1 µm. See paragraph [0033].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute the modified carboxymethyl starch of Panwar et al. for the carboxymethyl starch of Ji et al. to improve the hemostatic function of the formulation. One would have been motivated, with a reasonable expectation of success, because Panwar et al. teach the improved clotting efficiency and additional property of free flowing microparticles achieved by modifying carboxymethyl starch with a calcium chloride solution. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one biocompatible agent for another to yield predictable results. In the instant case, Hedrich et al. teach the functional equivalency of chitosan and polyacrylate derivatives and their compatibility in hemostatic formulations with starch. Thus, substituting chitosan with polyacrylic acid would yield predictable results. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the particle size of polyacrylic acid to similar sizes of the carboxymethyl starch because Ji et al. teach the importance of this particle size for clinical application and Hedrich et al. teach particle sizes of 10 to 1 µm.
Conclusion
6. Applicants’ 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.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
