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 26 November 2025 are acknowledged. Claims 1, 4-11, and 13-18 are currently pending. Claims 9-11 and 13-17 were previously withdrawn. Claim 18 is newly added. Claims 1 and 4 are amended. Claims 1, 4-8, and 18 are examined on the merits within.
Modified/New Rejections
Claim Rejections – 35 U.S.C. 103
2. 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.
3. Claim(s) 1 and 5-8 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).
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.
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 considerably swelled and formed an adhesive gel. See abstract. Modification occurred using a saturated solution of CaCl2. See Section 2.4.
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.
4. Claim(s) 4 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) as applied to claims 1 and 5-8 above and further in view of Ji et al. (EP3199025).
Chen et al. and Panwar et al. do not teach alginate.
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].
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, Ji et al. teach the functional equivalency of chitosan, alginate and hyaluronic acid and their compatibility in hemostatic formulations with carboxymethyl starch. Thus, substituting chitosan of Chen et al. with hyaluronic acid or alginate would yield predictable results.
Response to Arguments
Applicants’ arguments filed 26 November 2025 have been fully considered but they are not persuasive.
5. Applicants argued, “The combination of references would render the primary reference Chen unsuitable for its intended purpose. As provided in the Rule 132 Declaration, the calcium ions block the anionic carboxyl groups on the carboxymethyl starch which are necessary for the electrostatic PEC. Thus the formation of the stable insoluble structure responsible for hemostatic performance would be blocked and destroy the operability of the system.”
The Declaration under 37 CFR 1.132 filed 26 November 2025 is insufficient to overcome the rejection of claims 1-8 based upon 35 U.S.C. 103 as set forth in the last Office action because:
In view of the amendments, the rejection has been modified to state that it would have been obvious to add the calcium modified carboxymethyl starch to the formulation of Chen et al. to increase clotting efficiency as a third component of the composition that is not precluded. Thus the anionic carboxyl groups in the system taught by Chen et al. are not blocked.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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