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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lanfer et al. (EP 3181152) in view of Tsao (PG Pub. 2019/0053951).
Regarding claim 1-4, Lanfer et al. teach a method of manufacturing a utensil (such as a wound adj dressing) comprising a plurality of discrete, separately formed utensil elements (the plurality of utensil elements can be either the nanocellulose layer and the hydrogels layers or the multiple nanocellulose layers as multiple nanocellulose layers are taught) comprising the providing a first utensil element (can be construed as the nanocellulose layer or the hydrogel layer) made of hydrogel comprising bacterial nanocellulose, providing a discrete, separately formed second utensil element (can be construed as the other the nanocellulose layer or the hydrogel layer not taught in the first discrete, separately formed utensil element or an additional nanocellulose layer or an additional hydrogel layer) and several connecting elements (glue layers or intermediate layers) [0001, 0007, 0180, Examples]. Lanfer et al. teaches a connection element, but Lanfer et al. are silent regarding the claimed specifics of the connection element. However, in the analogous art of wound dressings, Tsao teaches using several connecting elements including yarns (threads) in stitching in order to tensile strength in the longitudinal and transversal directions [Abstract and 0003]. It would have been obvious to one of ordinary skill in the art to use the several yarn connection elements of Tsao in Lanfer et al. to mechanically connect the first utensil element to with the aid of the connecting element to the second utensil element and therefore form a positive and/or non-positive connection in additional to the glue/intermediate layer in order to improve the tensile strength in the longitudinal and transversal directions and thus provide different connecting elements (glue/intermediate layer and yarn stitching) to connect the first and second utensil elements and arrive at the claimed invention.
Regarding claim 5, Lanfer et al. teach the utensil elements (considered to be two layers of the nanocellulose) produced from a hydrogel are produced by a process comprising the steps of providing and inoculating the sugar containing solution (i.e. media containing sucrose) with a bacterial strain and cultivating the solution [0074, 0181].
Regarding claim 6, the hydrogel resulting from the cultivation is washed (several washing steps taught) [0076].
Regarding claim 7, Lanfer et al. teach the hydrogel resulting from the cultivation is washed in sodium hydroxide for the claimed time period at the claimed percentage of sodium hydroxide, but is silent regarding the claimed temperature. However, Lanfer et al. teach elevated temps for the washing and it would have been obvious to one of ordinary skill in the art to use the claimed temperature through routine experimentation in order to affect the cleaning and arrive at the claimed invention [0074-0077 and WO 01061026 which is incorporated in Lanfer et al.].
Regarding claim 8, Lanfer et al. teach gamma irradiation (sterilization) after the washing process.
Regarding claim 9, the utensil is a stimulation utensil as the utensil is taught as providing wound healing and tissue regeneration [0210].
Regarding claims 10 and 12-14, Lanfer et al. teach a nonwoven made from a hydrogel of bacterial nanocellulose with a cellulose content in the claimed range that is also loaded with a sliding agent (silicone or glycerine which are lubricants and oily, greasy and fat-free or silicone containing substances) [0074 and WO 01061026 which is incorporated in Lanfer et al.].
Regarding claim 11, Lanfer et al. teach the hydrogel has a water content in the clamed range [0074].
Regarding claim 15, Lanfer et al. teach the sliding agent is present, but are silent about it being an emulsion. However, given the limited number of options, it would have been obvious to one of ordinary skill in the art to have the sliding agent present as an emulsion in order to improve stability, adjust viscosity and control release and arrive at the claimed invention.
Regarding claim 16, Lanfer et al. the nonwoven is produced by the method of providing a first utensil element which is a hydrogel and providing a second utensil element, providing a connecting element with a positive and/or non-positive connection of the first utensil element to the second utensil element with the aid of connecting element [0001, 0007, 0180 and Examples].
Response to Arguments
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive.
Applicant argues the utensil elements are discrete and separately formed and argues the layers of Lanfer are within a single integrated wound dressing and are not separate components that are assembled. Lanfer plainly teaches the layers are connected and therefore are discrete and separately formed and moreover the layers being a part of the single wound dressing does not prevent the layers from meeting the limitations of the present claims.
Applicant argues Lanfer’s intermediate layer is an adhesive and therefore does not read on the mechanical connecting element. As set forth above, Tsao teaches using several connecting elements including yarns (threads) in stitching in order to tensile strength in the longitudinal and transversal directions [Abstract and 0003]. It would have been obvious to one of ordinary skill in the art to use the several yarn connection elements of Tsao in Lanfer et al. to mechanically connect the first utensil element to with the aid of the connecting element to the second utensil element and therefore form a positive and/or non-positive connection in additional to the glue/intermediate layer in order to improve the tensile strength in the longitudinal and transversal directions and thus provide different connecting elements (glue/intermediate layer and yarn stitching) to connect the first and second utensil elements and arrive at the claimed invention.
Applicant argues the sliding agent is loaded and the silicone of intermediate layer is not a lubricant. Silicone acts as a lubricant whether is it intended for that purpose or not. Further, glycerol is taught loaded in nonwoven, which would act as a sliding agent.
Applicant argues Tsao does not teach bacterial nanocellulose and has different properties. Paragraph 0022 of Tsao states “[0022] Preferably, the materials of the non-woven multiple natural polymeric threads comprise alginate, rayon, chitosan, gelatin, hyaluronic acid, collagen, bio-compatible natural polymeric fiber or any combination thereof.”. Bio-compatible natural polymeric fiber would include bacterial nanocellulose. Further, one would use bio-compatible nanocellulose as taught by Lanfer to provide improved compatibility and properties. Therefore, Tsao would not have different properties.
Applicant argues Tsao is seeking to solve a different problem than Applicant. Per MPEP 2144 IV, The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Applicant argues the combination of Tsao and Lanfer would not yield the present claims because it would yield a single integrated product. Again, it is reiterated, this does not prevent the cited art from reading on the present claims. The present claims do not require the method of making a utensil to not yield a single integrated product. Further, Figures 2b and 2c are likened unto a layer of Lanfer. Applicant is invited to amend the claims over the cited art.
Art Not Used by Relevant
WO 2008/135011 teaches a method of making a utensil including a first utensil, second utensil and connecting elements.
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.
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/Shawn Mckinnon/Examiner, Art Unit 1789