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. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 13 March 2026 are acknowledged.
Claims 58-77 are currently pending. Claims 1-57 have been cancelled. Claims 58 and 77 have been amended. Claims 66-75 were previously withdrawn. Claims 58-65 and 76-77 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 March 2026 has been entered.
Withdrawn Objections/Rejections
3. Applicants’ arguments, filed 13 March 2026, with respect to the 35 U.S.C. 103 Rejections have been fully considered and are persuasive. The 35 U.S.C. 103 Rejections in view of Looney et al. and Looney et al. in view of Clemens have been withdrawn in view of the amendments. However, upon further consideration, a new rejection is made in view of Fuzhou, Fuzhou in view of Looney et al. and Fuzhou in view of Clemens.
New Rejections
Claim Rejections – 35 U.S.C. 103
4. 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.
5. Claim(s) 58-59, 61-63, and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuzhou (CN104189945).
Regarding instant claims 58-59 and 62, Fuzhou teach double layer composite biological dressing and adhesive free composites. See page 1. Collagen sponge is a biological dressing made of collagen with a sponge-like porous structure prepared by a freeze-drying method. See page 2. The collagen sponge is compounded with a chitosan dressing to provide an improved composite dressing. See page 2. The composite is formed by spraying a sponge layer material solution on a non-woven fiber fabric of chitosan. See page 3. The process allows for controlling the thickness of a composite dressing embedding layer to ensure the dressing is firmly combined. The resultant product has two functional layers with different composition structures and functions and a double-layer junction (interface layer). See pages 3-4.
Regarding instant claim 61, the thickness of the sponge-like functional layer is 700-800 micrometers which is about 1 millimeter. See Example 2.
It would have been obvious to one of ordinary skill in the art to leave at least 50% of the fibers of the fabric support undissolved to control the thickness of the embedding layer to ensure the two layers are firmly combined while also allowing enough of each layer to perform it’s respective function. Since the prior art teaches the same combination of ingredients, it would have been expected to have the same properties, i.e., tensile strength of 0.1 MPa to 5MPa in wet conditions and 0.5 MPa to 10 MPa in dry conditions. 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). It would have been well within the purview of the skilled artisan to modify the thickness of each layer to control the function and ensure firm binding.
6. Claim(s) 60 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuzhou (CN104189945) as applied to claims 58-59, 61-63, and 77 above and further in view of Looney et al. (U.S. Patent Application Publication No. 2004/0005350).
Fuzhou does not teach an active ingredient.
Looney et al. teach methods of making wound dressings that include the steps of providing a solution of a water-soluble or water-swellable biocompatible polymer dissolved in a solvent for the polymer, providing a fabric substrate having a first surface and a second surface opposing the first surface, the fabric having properties effective for use as a hemostat and containing fibers prepared from a biocompatible polymer, contacting the fabric substrate with the polymer solution under conditions effective to distribute the polymer solution substantially homogenously on the first and second surfaces and through the fabric substrate, transferring the fabric substrate having the polymer solution substantially homogenously distributed there through to a lyophilization unit under conditions effective to maintain the homogeneous distribution on and throughout the substrate, and lyophilizing the fabric having the polymer solution distributed there through, thereby providing a porous, polymeric matrix substantially homogeneously distributed on the first and second surfaces and through the fabric, the matrix being made-up of the lyophilized water-soluble or water-swellable polymer. See abstract. The fabric substrate may be cellulose. See paragraphs [0047 & 0051-0052]. Polymers used to fabricate the matrices include cellulose, alginates, and chitosan. See paragraph [0064]. The tensile strength is 1.9/4.5 md/cd. See Table 1. The composite hemostat of the present invention remains very flexible, conforms to a bleeding site and retains good tensile and compressive strength to withstand handling during application. See paragraph [0064]. Oxidized cellulose can be used for the fabric. See paragraph [0052]. The hemostatic agent can be thrombin, fibrin, etc. See paragraph [0066]. The fabric may have a thickness of 0.645 mm. See Table 1. The fabric may be woven or nonwoven. See paragraph [0044]. Looney et al. teach an elongation % of 23/49 and absorption of 3.88 g/g and 0.2 g/cm2.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add thrombin to the biological dressing of Fuzhou to provide additional therapeutic benefit. One would have been motivated with a reasonable expectation of success because Looney et al. teach the effectiveness of thrombin in similar composite dressings comprising fabrics and matrix material.
7. Claim(s) 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuzhou (CN104189945) as applied to claims 58-59, 61-63, and 77 above and further in view of Clemens (DE112009002599).
Fuzhou does not teach alternating layers of porous matrix and fabric support comprising 3 layers.
Clemens teaches wound dressings comprising a first layer of polymer based fabric and a second layer of polymer based fabric with a foam matrix core in a sandwich like structure. See paragraph [0006]. The foam may include a hydrophilic agent that acts as a hemostat. See paragraph [0028].
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 matrix and fabric of Fuzhou into a sandwich like structure because this is a known design structure effective for wound healing. One would have been motivated, with a reasonable expectation of success, to form a composite dressing effectively applied to a wound to absorb exudate. See paragraphs [0004].
Response to Arguments
Applicants’ arguments filed 13 March 2026 have been fully considered but they are not persuasive.
8. Applicants argued, “Looney does not teach a multi-layered structure. Looney’s dressing is designed for dissolution/degradation inside the body. Clemens does not disclose a dressing with at least 50% of fibers remaining undissolved.”
In response to applicants’ arguments, the prior art of Fuzhou has been provided to make obvious the multi-layered structure including a fabric, porous matrix, and embedding layer. The prior art of Looney is now provided to make obvious the addition of thrombin and the prior art of Clemens is provided to make obvious a sandwich like structure.
Thus these rejections are maintained.
Correspondence
9. No claims are allowed at this time.
10. 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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