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
Applicant’s arguments/remarks filed 3 June 2026 are acknowledged. Claims 1-10 and 21-30 are currently pending. Claims 11-20 have been cancelled. Claims 1, 4, 8, 21, 25, 27, and 30 are amended. Claims 1-10 and 21-30 are examined on the merits within.
Modified Rejections
Claim Rejections – 35 U.S.C. 102
2. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
3. Claim(s) 1-10 and 21-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leshchiner et al. (U.S. Patent No. 4,795,741) as evidenced by Cambridge Dictionary.
Regarding instant claims 1-4, 21-25, and 30, Leshchiner et al. disclose crosslinked gels of hyaluronic acid, hylan or hyaluronic acid or hylan mixed with other materials, thrombin, and cationic substances. See abstract. Example 6 mixes the gel with cellulose and a thrombin solution and tested in vivo using arterial injection. Since Leshchiner et al. teach both a biocompatible viscous gel and delivery mechanism, it should function in the same manner, i.e., adhere to tissues and the cut blood vessels, retard flow of blood, remain in position, and enable clotting.Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Wherein the gel is configured to be removed from the wound and a wound caused by trauma are future intended uses of the composition. Since Leshchiner et al. teach the same combination of ingredients, it should be capable of being applied to a wound caused by trauma and capable of being removed.
Regarding instant claim 5, Example 6 injects the composition for testing wherein inject is defined as using a needle and syringe to put liquid such as a drug into the body. See Cambridge Dictionary.
Regarding instant claims 6, 8-10, and 27-29, the claims are directed to a system, i.e., a product. The wound, configuration of the gel, wound in a human, and wound in an animal are future intended uses of the system.
Regarding instant claims 7 and 26, thrombin is a blood clotting agent. See Example 6.
Thus the instant claims are anticipated by Leshchiner et al.
Response to Arguments
Applicant's arguments filed 3 June 2026 have been fully considered but they are not persuasive.
4. Applicants argued, “Leshchiner fails to disclose embodiments in which the disclosed gel compositions are configured to be removed after forming an embolism and teaches away from removing the gel.”
In response to applicant’s arguments, wherein the gel is configured to be removed from the wound is a future intended use of the composition. Since Leshchiner et al. teach the same combination of ingredients it should function in the same manner, i.e., capable of being removed. However, if it is not capable of being removed, then what structural component is different and required for this property. This poses the question as to whether the claims lack sufficient written description to achieve the claimed function. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Since the same combination of ingredients should function in the same manner, the prior art does not teach away.
Thus this rejection is maintained.
Conclusion
5. THIS ACTION IS MADE FINAL. 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
6. No claims are allowed at this time.
7. 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
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