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 .
Election/Restrictions
Applicant’s election without traverse of group I drawn to claims 59-60,62-63,65,67,70,73-74 and 80 in the reply filed on 05/27/2026 is acknowledged.
Claims 81 and 83-91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/27/2026.
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) 59-60, 62-63, 67 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph et al. U.S. Publication No. (2014/0276288 A1).
With respect to claim 59, Randolph et al. substantially discloses an apparatus for promoting circulation through a subcutaneous lymph vascular network (Abstract) and (figs.6A-6B), the apparatus comprising:
a manifold layer (610, fig.6A) the manifold layer configured to be positioned proximate a tissue site [0067]; and
a support layer (620, fig.6A) coupled to the manifold layer (as shown in fig.6B).
Randolph et al. substantially discloses the invention as claimed except the manifold layer having a first stiffness from about 800 gram-force to about 1000 gram- force and the support layer having a second stiffness from about 800 gram-force to about 3000 gram-force. Randolph et however, teaches in [0066, the dressing for applying vacuum to the intact skin extending or surrounding a tissue site] and [0067, the manifold layer 610 may be any breathable material that distributes vacuum uniformly over the intact skin of the tissue site 104 when subjected to a vacuum as described above] and [0069, comfort layer 620 may be formed from an occlusive material, and may include a plurality of perforations or holes 621 to allow for the transmittance of negative pressure to the underlying intact skin and to provide for further comfort]. Therefore, it would have been well within the skill of an ordinary artisan at the time the invention was made to optimize the manifold layer and the support layer of Randolph et al. such that the manifold layer having a first stiffness from about 800 gram-force to about 1000 gram- force and the support layer having a second stiffness from about 800 gram-force to about 3000 gram-force in order to withstand the transmittance of negative pressure while distributing vacuum uniformly over the intact skin of the tissue site when subjected to a vacuum, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 60, Randolph et al. discloses a fluid interface configured to fluidly couple at least one of the manifold layer and the support layer to a fluid conductor [0067, the dressing 602 further comprises a fluid coupling member such as, for example, the connector 114 for fluidly coupling the conduit 108 to the manifold layer 610 through an aperture 611 extending through the sleeve layer 612].
With respect to claim 62, Randolph et al. discloses the support layer (620) comprises one or more apertures [0069, layer 620 may be formed from an occlusive material, and may include a plurality of perforations or holes 621 to allow for the transmittance of negative pressure to the underlying intact skin and to provide for further comfort. The plurality of perforations or holes 621 also allow the sleeve layer 612 to be in partial contact with the epidermis 103 allowing the high tack adhesive to securely anchor the dressing 602 on the limb].
With respect to claim 63, Randolph et al. discloses a cover adjacent (612) to the support layer (620, fig.6B).
With respect to claim 67, Randolph et al. substantially discloses the invention as claimed except the manifold layer has a first thickness; and the support layer has a second thickness less than the first thickness. Randolph et al. however, suggests and teaches in [0037, the manifold may take many forms and may come in many sizes, shapes, or thicknesses depending on a variety of factors, such as the type of treatment being provided or the nature and size of the intact skin at the tissue site 104]. Therefore, based on the type of treatment being provided or the nature and size of the intact skin at the tissue site, it would have been an obvious matter of design choice to optimize the manifold layer having a first thickness; and the support layer having a second thickness less than the first thickness, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
With respect to claim 70, Randolph et al. substantially discloses the invention as claimed. Randolph et al. further discloses the manifold layer comprises open-cell foam [0038].
Claim(s) 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph et al. as applied to claim 59 above, and further in view of Coulthard U.S. Publication No. (2015/0057625 A1).
With respect to claim 73, Randolph et al. substantially discloses the invention as claimed except the support layer comprises a closed-cell foam.
Coulthard however, teaches systems, dressings, and related methods, for providing reduced pressure to a tissue site on a patient are presented that involve using a self-contained reduced-pressure dressing (Abstract) comprising a sealing member comprises a closed-cell foam [0048].
In view of the teachings of Coulthard, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the support layer by forming the support of a closed-cell foam to function to cushion to the wound.
With respect to claim 74, the combination of Randolph et al./Coulthard substantially discloses the invention as claimed. Coulthard further teaches the support layer comprises neoprene foam [0048].
Claim(s) 80 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph et al. as applied to claim 59 above, and further in view of Locke et al. U.S. Publication No. (2013/0317406 A1).
With respect to claim 80, Randolph et al. substantially discloses the invention as claimed except the support layer comprises rubber.
Locke et al. however, teaches in [0004, a dressing for treating a tissue site on a patient includes a wound interface member for placing proximate to the tissue site and a covering. At least a portion of the covering comprises an evaporative window having a liquid-impermeable, vapor-permeable membrane. The covering is operable to form a sealed space over the tissue site. The liquid-impermeable, vapor-permeable membrane allows evaporated liquids, e.g., water vapor or a priming fluid, in the sealed space to egress the sealed space. The egress of evaporated liquids may create a reduced pressure in the sealed space]; comprising a covering (108) having a first portion (124) comprising an elastomeric material [0025]; wherein the elastomeric material is rubber [0026].
In view of the teachings of Locke et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the support layer of Randolph et al. by forming the support layer of rubber as, rubber’s resilient material ability to recover from an elastic deformation [0026] of Locke et al.
Allowable Subject Matter
Claim 65 is 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior art(s) of record fail to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claim 65 which recite features not taught or suggested by the prior art of record. It is respectfully submitted that the cited references, considered either alone or in combination, fail to disclose, suggest, or otherwise render obvious the claimed combinations of features presently set forth in dependent claim 65.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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