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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 22nd 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 10, the phrase "such as" (line 4) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lydon et al. (US 6,471,982).
Regarding claim 14, Lydon et al. disclose a method of using a storage material (gel forming fibres - col. 1, lines 40-46) for a wound cleaning device (woven swabs, pads or bandages - col. 2, lines 25-35), wherein substances formed by the body itself are removed (col. 1, lines 57-58; col. 3, lines 14-16). Placing the cleaning device on a wound can be regarded as wound bed preparation for (for example) healing.
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 1-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lydon et al. (US 6,471,982) in view of Cotton (US 2014/0309574).
Regarding claim 1, Lydon et al. disclose a wound cleaning device (Abstract) having a cleaning layer or sheet to hold wound exudate and/or solid wound components and having cleaning threads (textile fibers - col. 1, lines 40-46 or yarns including the textile fibers - col. 2, lines 29-35), characterized in that the wound cleaning layer is provided with at least one storage material (gel forming fibres - col. 1, lines 40-46) that increases the holding capacity for wound exudate (col. 3, lines 14-18), 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 (col. 1, lines 40-46), and wherein the storage material is located at least partially on the surface of the wound cleaning layer (col. 2, lines 29-35 - the gel forming fibers and the textile fibers are formed into yarns and then the yarns are woven together, therefore the surface would contain the gel forming fibers/storage material).
Lydon et al. fail to disclose a carrier layer on which the cleaning layer is arranged as claimed.
Cotton discloses a similar wound cleaning device having two layers, each formed by weaving yarns comprising gel forming fibers and textile fibers, which provides greater absorbance of wound exudate and prevents clogging (¶[0069]-[0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Cotton to have combined the sheets of Lydon et al. into two layers (either layer can be considered as a carrier or cleaning layer) in order to improve absorbance of wound exudate and prevent clogging.
Regarding claim 2, Lydon et al. disclose that the cleaning threads can include synthetic fibers (col. 1, lines 47-56) but fail to specifically state that the cleaning threads are or include plastic fibers.
Cotton teaches that the above textile fibers can be plastic fibers (¶[0042]).
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 cleaning threads as (or to include) the plastic fibers of Cotton since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 3, the cleaning threads are designed as multifilaments (col. 2, lines 29-35 of Lydon et al.).
Regarding claim 4, Lydon et al. disclose that the cleaning threads may be woven (col. 2, lines 29-35) but fails to disclose that they form loops and/or have freely cantilevered ends.
Cotton discloses the layers described above and further discloses that they can be woven such that loops or freely cantilevered ends are formed (see cantilevered loops at upper right and lower left edges of the sheet in Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the weaving design of Cotton to form each of the woven layers of Lydon et al. as a known prior art weaving design suitable for forming a similar wound cleaning layer.
Regarding claim 5, based on the dry weight of carrier layer and cleaning layer, the proportion of at least one storage material is 0.2 % - 25 % by weight (col. 1, lines 40-46 of Lydon et al., both layers would have a proportion within this range).
Regarding claim 6, based on the dry weight of cleaning layer, the proportion of at least one storage material is 0.25 % - 27 % by weight or 0.3 % - 25 % by weight (col. 1, lines 40-46 of Lydon et al.).
Regarding claims 7 and 8, the claimed phrases “impregnated using a preferably aqueous solution of the storage material” and “the concentration of the storage material in the solution is 0.1 % or more, and/or 5 % or less” are being treated as a product by process limitations; that is, as set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. The above cleaning device appears to be substantially the same or similar to the device claimed, although produced by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Regarding claim 9, the storage material has at least one surfactant and/or at least one substance that swells on contact with water or an aqueous solution (col. 1, line 57 to col. 2, line 20; col. 3, lines 14-18 of Lydon et al.)
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 (col. 1, line 57 to col. 2, line 20 of Lydon et al.).
Regarding claim 11, the uptake of wound exudate by the cleaning layer of Lydon et al. can be regarded as an impregnation. The claim does not require impregnation using an aqueous solution of the storage material.
Regarding claim 13, the woven swabs, pads or bandages of Lydon et al. (col. 2, lines 25-35) can be regarded as dry (col. 3, lines 32-33) cloths. The claimed kit does not require any additional items.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lydon et al. (US 6,471,982) in view of Cotton (US 2014/0309574), as applied to claims 1 or 2 above, and further in view of Milton (US 3,491,753).
Regarding claim 12, Lydon et al. disclose the wound cleaning device as described above and further disclose that it may take the form of a stocking (col. 2, line 32). Lydon et al. fail to disclose a fluid impermeable sheath as claimed.
Milton discloses that a wound stocking (20) may be sealed in a plastic sheath (22) for storage (col. 3, line 74 to col. 5, line 10; Figures 2 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have packaged the wound cleaning device of Lydon et al. within the sheath of Milton as a suitable prior art means for storing a wound cleaning stocking. It would have been further obvious to one of ordinary skill in the art to have made the sheath fluid impermeable since Milton teaches that the wound cleaning device should be “sealed” in the sheath. One skilled in the art would recognize that this fluid impermeability would prevent contamination of the stocking.
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
