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 .
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.
Claims 18, 22, and 23 are 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.
Claim 18 recites “the wound dressing according to claim 1”, however, claim 1 is not drawn to a wound dressing; rather, claim 1 is drawn to a process for producing an adhesive and sterile silicone 2. Therefore, it is unclear what previous claim limitation claim 18 is actually intended to limit.
Claims 22 and 23 are drawn to the “use” of a silicone 1 in a would contact layer. However, the claims do not recite any positive method steps detailing how the silicone 1 is used in a wound contact layer, thereby rendering the claim indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22 and 23 rejected under 35 U.S.C. 101 because
the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite the use of a silicone 1 in a wound contact layer, but fail to recite actual physical steps or methods required to use it. This results an improper claim to a process, and therefore a non-statutory category under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (US 2020/0146900).
The instant claims are drawn to an adhesive and sterile silicon obtainable by the process of claim 1, to a silicone layer containing the same, and to a wound dressing.
Addison et al. teach a silicone wound dressing and method for making the same. According to the reference, silicone-coated substances may be bonded to a wound dressing layer, e.g., absorbent layers or backing sheets, by applying a silicone-coated layer wherein the silicone is incompletely cured to a further layer, followed by curing of the silicone with ionizing radiation. The wound dressing comprises a base layer and an apertured layer laminated to the base layer (0013-0014; 0016).
The base layer may be an adsorbent layer, e.g., a hydrophilic foam, a sponge, a film, or a textile layer. Suitable polymers for forming the base layer include polyurethanes, e.g., polyurethane foams (0021; 0024-0025). The fabric of the base layer may also comprise about 10 wt.% of hydrogel-forming fibers (0029-0030). In another embodiment, the base layer may comprise or consist of a second layer of the silicone coated apertured layer. Suitably the substrate is coated on both sides with the silicone coating, so that the face of the substrate opposite the base layer presents a silicone surface to the wound (0036-0041).
The difference between the instant claims and the silicone wound dressing taught by Addison et al. is that the sterile silicone taught by the reference is prepared by a different process than the process recited in claim 1 of the present invention. However, instant claim 10 recites that the adhesive and sterile silicone 2 is “obtainable” by the process of claim 1, suggesting that the adhesive and sterile silicone 2 may be produced by a different process, including the process taught by Addison et al. As such, the adhesive and sterile silicone 2, and the wound dressing taught by Addison et al., renders the instant claims obvious.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: claims 1-9, 24, and 25 are drawn to a process for producing an adhesive and sterile silicone 2, comprising irradiating a silicone 1; however, the prior art does not teach or suggest the inclusion of a process, wherein the silicone 1 is obtained by the steps recited in the present invention.
Claims 19-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
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