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 Status
Claim 10 is pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Restriction
Applicant’s election without traverse of Group II (claims 10-13 and 16-19) in the reply filed 7/15/2026 is acknowledged.
Further, Applicant’s amendment filed 7/15/2026 canceling claims 1-9 and 11-19 is acknowledged. Claim 10 remains under consideration.
Specification
The use of the term Tween, which is a trade name or a mark used in commerce, has been noted in this application (pars [0046],[0049], [0051], [0096]). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Attar et al. (US20200237957A1, published 7/30/2020) in view of Sambasivam (US20180338945A1, published 11/29/2018) and Larsen et al. (US Pat. No. 11,046,818 B2, published 6/29/2021).
Attar teaches a composition of a porous scaffold defined by pore size of 1 to 500 microns, wherein the composition comprises a cross-linkable protein, a cross-linker, and a liquid (abstract). Attar teaches that this biomaterial can be used as an adhesive “to bond tissue or seal gaseous or fluid leaks in a physiological environment” (par. [0003]), and more specifically to treat tissue defects wherein the defect is a would (par. [0035]). The composition comprises a protein of either collagen or gelatin (par. [0004]), and is taught to be gelatin in one embodiment (par. [0013]), wherein gelatin is present in the composition in the range of 0.5 to 25 wt. % (par. [0014]). In one embodiment, the cross-linker is transglutaminase, and is present in a range of 0.0001 to 2 wt. % (par. [0016]). The composition may further comprise a surfactant, including polysorbate 20 (par. [0179]). The composition may further comprise a stabilizer, which may further cross-link the gelatin and stabilize the composition, including glutaraldehyde (par. [0127] and [0192]). Attar continues to teach that mixing the gelatin and stabilizer forms a “stable… foam” (par. [0127]), and adds that in some embodiments, agents such as polysorbate can be added “to achieve a denser foam” (par. [0211]). Therefore, the composition of gelatin in 0.5 to 25 wt. %, polysorbate 20, and glutaraldehyde are mixed together to create a foam, and Attar teaches that this foam composition has pore sizes between 1 and 500 microns in diameter (par. [0208]). Attar teaches that the foam can be further “shaped and molded into any cavity” including ex-vivo cavities (par. 0114). Therefore, the composition of ingredients is molded after mixing and foaming. Attar also teaches freeze drying of the biomaterial to further deprive it of liquids, resulting in a stiff biomaterial that can be used for various applications (par. [0290]). Therefore, the composition of ingredients undergoes a freeze-drying step after mixing to foam and molding.
However, Attar does not teach a specific percentage of polysorbate 20 or glutaraldehyde in the composition.
This deficiency is made up for by the teachings of Sambasivam and Larsen.
Sambasivam teaches a composition related to skin adhesives, antimicrobial compositions, and articles thereof, wherein the antimicrobial compositions include adhesive compositions, gels, cleansers, wound dressings, and foams (abstract). Sambasivam teaches this composition comprises Nα-lauroyl-arginine ethyl ester or a salt thereof, and a thickener (claim 1). The composition may further comprise a hydrophilic additive to allow the composition to swell in aqueous medium and/or physiological fluid, and is selected from the group including gelatin (par. [0039]). The composition may further comprise a surfactant selected from the group including polysorbate, and is present in 0.1 to 40 wt. % (par. [0160]). Further, polysorbate 20 in particular is used in an exemplary formulation of the composition in an amount of 0.1 wt. % (par. [0247]).
Larsen teaches a composition that forms a paste for use in haemostatsis and wound healing upon addition of an aqueous medium (abstract). The composition comprises a biocompatible polymer, an aqueous medium, and either an alkaline or acidic compound (claim 1). This composition may be gelatin-based, as in one embodiment, this polymer “comprises or consists of cross-linked gelatine particles” cross-linked by exposure to glutaraldehyde in 0.01 to 0.05 wt. % (col 10 line 25).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to apply the teachings of Sambasivam and Larsen to the teachings of Attar, resulting in a composition comprising gelatin in 0.5 to 25 wt. %, polysorbate 20 in 0.1 wt. %, and glutaraldehyde in 0.01 to 0.05 wt. %, wherein this composition is mixed to foam with pore size of 1 to 500 microns, molded ex-vivo, and freeze-dried (cf. claim 10). In the case where the claimed ranges "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). Similarly, 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) (See MPEP 2144.05).
As all the previously described references teach composition for would healing, and comprise gelatin, there is an obvious reason to look from one to the other for specific weight percentages of polysorbate 20 and glutaraldehyde. Further, Attar already teaches the inclusion of polysorbate 20 and glutaraldehyde into the composition comprising gelatin that is foamed, molded, and freeze-dried. One would be motivated to modify Attar with Sambasivam and Larsen as Sambasivam and Larsen teach a specific weight percentage for ingredients that are common across the references that teach compositions with the same intended use. The specific percentages taught by Sambasivam and Larsen would be reasonably expected to inform the composition as taught by Attar with success, as the ingredients of the composition as well as the intended use align across the references. The resulting invention would be a composition comprising gelatin in 0.5 to 25 wt. %, polysorbate 20 in 0.1 wt. %, and glutaraldehyde in 0.01 to 0.05 wt. %, wherein this composition is mixed to foam with pore size of 1 to 500 microns, molded ex-vivo, and freeze-dried.
Therefore, the invention as a whole was prima facie obvious to one or ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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