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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
This action is in reply to the communication filed on August 14, 2025.
Claim 1 has been amended and are hereby entered.
Claims 7, 8, 10 – 13 and 23 have been cancelled previously.
Claims 14 – 22 and 24 – 28 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product and a method of making, there being no allowable generic or linking claim. Election was made without traverse in the reply filed January 23, 2023.
Claims 1 – 6, 9 and 29 – 33 are currently pending and have been examined.
This action is made FINAL.
Response to Arguments
Applicant's arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant argues that Pouchelon teaches a silicone elastomer, which is something other than just silicone as required by the claims. Applicant argues that silicone elastomers are compounded using reactive, straight chained molecules together with a crosslinking agent and reinforcement to give good mechanical properties and that the viscosity and type of the straight chain molecule combined with the processing temperature determine the type of elastomer produced. Applicant compares this to silicone which is a synthetic material made up of silicone, oxygen, carbon and hydrogen and its molecular structure consists of a backbone of silicon-oxygen chains. Therefore, concludes Applicant, Pouchelon fails to disclose or suggest the claimed silicone coating. Examiner respectfully disagrees. Applicant does not specifically argue what non silicone, oxygen, hydrogen or carbon atoms are present in a silicone elastomers that would distinguish the polymers. Examiner further submits that in the newly provided pamphlet “Characteristic Properties of Silicone Rubber compounds,” silicone rubbers are drawn as a backbone of silicone oxygen chains with hydrogen and carbon atoms. Therefore, this polymer appears to be the silicone polymer as claimed by Applicant.
Applicant argues that Pouchelon is not directed to medical fabrics/products but rather air bags, glass braids, conveyor belts, fire-barrier or thermal insulation fabrics, compensators, clothing, etc. and therefore teaches away from its use in the claimed medical barrier fabric. Examiner respectfully disagrees. Pouchelon does not teach away from its use in the claimed medical barrier fabric because does not criticize, discredit or otherwise discourage the use of the coating in a medical barrier fabric. Pouchelon teaches that the coatings are useful in clothing applications. The instant application teaches these fabrics are useful in apparel such as surgical gowns ([0003]). Furthermore, Bushman teaches that the coating may be any suitable liquid resistant material and Pouchelon teaches that silicone coatings are water resistant.
Applicant argues that there would be not motivation to use the same coating rate of Ikoma in the materials of the prior art combination as the Ikoma is discussing the coating rate for a different polymer. Examiner respectfully disagrees. Bushman does not limit or restrict the amount of liquid resistant coating. Ikoma teaches that basis weights for waterproof material is preferably between 15 to 250 g/m2 due to the balance between strength and comfort. As Pouchelon teaches water resistant coatings, it would have been reasonable to a person having ordinary skill in the art to expect the similar properties.
Applicant argues that Ikoma only teaches an arrangement in which two dissimilar coatings are opposing one another but not where the two opposing coatings are the same material, which is in stark contrast to the claimed orientation and arrangement. Examiner respectfully disagrees. Ikoma is not used to teach the composition of the coatings, merely the amount of coating used.
Information Disclosure Statement
The references provided in the Information Disclosure Statement filed on June 9, 2025 have been considered. A signed copy of the corresponding 1449 has been included with this office action.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 1 – 6, 9, and 29 – 33 are rejected under 35 U.S.C. 103 as being unpatentable over Bushman (US20060041988A1) in view of Pouchelon (US20100178517A1) and Ikoma (US20160318281A1).
As per claims 1, 9, and 29 – 32, Bushman teaches:
A barrier fabric comprising a first ply and a second ply each comprising a coated side and a non-coated side, wherein the coated side of the first ply and the coated side of the second ply face each other and define an interior of the barrier fabric, with each coated side able to come into direct contact with one another but remain movable thereagainst and able to form a gap therebetween and wherein the non-coated side of the first ply and the non-coated side of the second ply face opposing directions and define an exterior of the barrier fabric (Figure 2 shows a cross section of the sleeve. As described in [0018], the sleeve contains an inner piece 12 and an outer piece 14, which is interpreted as reading on the claimed first and second ply. The inner piece and the outer piece each contain a fabric layer, 28 and 29 and a membrane layer 30, 31 ([0018]). The membrane layers face each other as claimed and the non-coated sides face opposing directions defining an exterior of the barrier fabric as claimed. An annular space, indicated by 34 is interpreted as the claimed gap ([0018]).)
Wherein the first ply and the second ply are peripherally joined together to form the barrier fabric ([0016]: “The inner piece/outer piece combination 12, 14 has a first end 18 and a second end 20. The first end 18 includes conventional stitching 22 which connects the inner piece 12, outer piece 14, and cuff 16 together at that end 18.”)
Bushman teaches that the membrane-laminated or coated-fabric inner and outer pieces provide enhanced liquid resistance ([0028]). Bushman teaches that the membrane layers may be made of any suitable material ([0027]) and may be made by any suitable method ([0025]). Bushman does not explicitly teach:
The coated side of the first ply and the coated side of the second ply is a non-fluorine containing polymer coating consisting of silicone to provide a silicone coating
Wherein the polymer coating is applied at a rate of from 9 – 50 g/m2
Pouchelon teaches a fibrous textile coated with a silicone elastomer (Abstract). Pouchelon teaches these composites are suitable for use in clothing ([0164]). Pouchelon teaches these silicone compositions are especially use for water repellent applications ([0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a liquid-resistant coating, such as the claimed non-fluorine containing polymer coating consisting of silicone because Pouchelon teaches that such silicone polymer coatings are predictably suitable for use as liquid resistant coatings for fabrics ([0007] & [0164]). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Ikoma teaches a waterproof material with a fiber layer and a porous film layered on top of each other ([0056]). Ikoma teaches that these materials are suitable for use in surgical gowns ([0002]). Ikoma teaches that the basis weight of the waterproof material is between 15 – 250 g/m2 because when the basis weight is less than 15 g/m2, the tensile strength, the abrasion strength or the water pressure resistance may be insufficient but when the basis weight is higher than 250 g/m2, the clothing may become uncomfortable to wear ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the coating of the barrier fabric of Bushman to be a polymer coating in an amount between 9 and 50 g/m2 as claimed, motivated by the desire to predictably produce a waterproof material with suitable abrasion strength and water pressure resistance for the desired application while remaining comfortable to wear as taught by Ikoma ([0004] & [0076]).
Regarding the limitation “wherein the barrier fabric is a reusable medical barrier fabric,” the instant application discloses that because the coatings are not exposed to outside or external elements, such as during the laundering and autoclave structure, the degradation of the coating can be avoided and the useful life can be extended ([0028]). Examiner notes that the prior art combination teaches the same composition and structure as claimed, including the interior coatings discussed in the instant specification as elongated the lifespan of the product. Therefore the property of reusability is assumed to naturally flow from the product of the prior art combination, absent evidence otherwise.
As per claims 31 and 32, Examiner notes that “less than 15 g/m2” and “13 g/m2” lie just outside of the teachings of Ikoma (a coating of 15g/m2). However, Examiner notes that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2144.05.
As per claim 2, Bushman teaches:
Wherein the first ply and the second ply are woven or knitted (In [0027], Bushman teaches a specific example where the layers are each a warp knit fabric layer.)
As per claims 3 and 4, since Bushman teaches fabrics and the two of the claimed options are that the yarns are monofilament or multifilament, i.e. the yarns either have one filament or more than one filament, which are the only options, it would naturally follow that Bushman would meet the claimed limitations.
As per claims 5 and 6, Bushman teaches:
Wherein the content of the first and second ply comprise approximately 100% polyester or 100% polyamide (In [0027], Bushman teaches a specific example where the layers are each a polyester warp knit fabric layer.)
As per claim 33, the prior art combination is silent with respect to the property of hydrostatic resistance. However, Since the prior art combination teaches substantially the same structure as disclosed by Applicant, the property of hydrostatic resistance is considered to naturally flow from the product of the prior art combination (and would be expected to fall within the range in the claim), absent evidence otherwise. Recitation of a newly disclosed property does not distinguish over a reference disclosure of the article or composition claims. When the structure recited in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed to be present. Applicant bears responsibility for proving that the reference composition does not possess the characteristics recited in the claims.
Claim 33 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Bushman (US20060041988A1) in view of Pouchelon (US20100178517A1) and Ikoma (US20160318281A1) as applied to claims 1 – 6, 9, and 29 – 32 above, and further in view of Haines (US20110107494A1).
In the case that it is determined that the barrier fabric of the prior art combination does not inherently meet the properties claimed in claim 33, Haines teaches surgical gowns with sleeves (Abstract). This is similar to the prior art combination. Haines teaches that the Association for the Advancement of Medical Instrumentation sets stands for liquid-barrier performance, including a level 2 protection defined as greater than or equal to 20 cm of hydrostatic resistance as tested by AATCC 127 ([0038 – 0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrier fabric of the prior art combination to achieve a hydrostatic resistance of 20 cm or more as claimed motivated by the desire to predictably produce a surgical gown with at least a level 2 protection as taught by Haines ([0038 – 0040]).
Conclusion
Applicant's amendment necessitated any 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA N CHANDHOK whose telephone number is (571)272-5780. The examiner can normally be reached on Monday through Friday from 6:30 - 3:30.
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, the examiner’s supervisor, Marla McConnell can be reached on (571) 270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNA N CHANDHOK/Primary Examiner, Art Unit 1789