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 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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Riesinger (WO 2013/113906; citing English translation of record dated March 27th 2025).
Regarding claim 1, Riesinger discloses a wound cleaning device (Figure 11) having a carrier layer (31) and having arranged thereon a wound cleaning layer (29) designed to hold wound exudate and/or solid wound components and having cleaning threads (30).
Riesinger fails to disclose that the wound cleaning layer is characterized in that the wound cleaning layer is provided with at least one storage material that increases the holding capacity for wound exudate, and in that based on the dry weight of cleaning layer, the proportion of the at least one storage material is 0.2 % - 30 % by weight.
However, Riesinger discloses that a wound cleaning device can have a layer with an absorbent core having a storage material that increases the holding capacity for wound exudate, and in that based on the dry weight of layer, the proportion of the at least one storage material is 0.2 % - 30 % by weight ([0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cleaning layer of Riesinger with the above absorbant core in order to help increase the holding capacity for wound exudate.
Regarding claim 2, the cleaning threads include plastic fibers ([0382]).
Regarding claim 3, the cleaning threads are designed as monofilaments and/or multifilaments ([0382] the threads must be either monofilaments or multifilaments).
Regarding claim 4, the threads have a loop structure within the cleaning layer as seen in Figure 11.
Regarding claims 5 and 6, Riesinger discloses that the carrier layer is a thin film ([0384]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the film such that it does not contribute significantly to the overall mass of the device (within the generally accepted meaning of a film).
Regarding claims 7 and 11, the incorporation of the absorbent material into the cleaning layer can be regarded as an impregnation ([0129]). Use of an aqueous solution is not required by the claim.
Regarding claim 8, the concentration of the storage material is 0.1% or more ([0129]).
Regarding claim 9, the storage material has at least one substance that swells on contact with water or an aqueous solution ([0141], [0280]).
Regarding claim 10, the storage material contains at least one cellulose ether, in particular hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, ethyl cellulose and/or hydroxypropyl cellulose, additional polysaccharides, such as dextrans, starch, chitosan, carrageenan and alginates, milk protein, hyaluronic acid, sugar alcohols, glycols, salts and/or blends thereof ([0190]).
Regarding claims 12 and 13, Riesinger discloses that the device may be held in a pack ([0317]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the pack fluid impermeable with a dry device therein since the objective of the invention is to use the device for liquid absorption only after unpacking. Any completely enclosing pack can be regarded as a sheath. An aqueous solution is not required by the claim.
Regarding claim 14, Riesinger discloses a method of using a storage material for a wound cleaning device for wound bed preparation, wherein substances formed by the body itself are removed ([0089]-[0091] and elsewhere).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771