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 § 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.
Claim(s) 1-5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht et al. (US Publication No. 2011/0054260 A1) in view of Sedic (US Publication No. 2016/0038334 A1).
Regarding Claim 1, Albrecht discloses a wound retractor made from a flexible tubular sheath/sheet (150) (fig. 1A). Albrecht discloses that embodiments of the sheath can include rip-stop capabilities in order to resist tear propagation in the event of damage thereto [0060]. However, Albrecht is silent to the sheet comprising rib portions extending from at least one surface of the base portion, wherein the base portion comprises a plurality of cell regions that are each surrounded on an entire circumference by the rib portions and are continuously formed in plane through the rib portions, wherein the rib portions are continuously connected to each other, and wherein the rib portions and the base portion are a solid single sheet integrally molded from elastic material.
Sedic discloses a sheath material with rip-stop capabilities in the analogous art of elastic sheet molded medical devices. Sedic discloses the material comprises a sheet-like base portion (104); and rib portions (textured pattern 108) extending from at least one surface of the base portion (“the pattern can be ridges … formed on an inner or outer surface of the device 100. “ [0021]), wherein the base portion comprises a plurality of cell regions (shape 204 shown in Fig. 2) that are each surrounded on an entire circumference by the rib portions and are continuously formed in plane through the rib portions (ridges “formed on an inner/outer surface of the device” in [0021] is disclosure of the material (i.e. rest of device) otherwise being present for the ridges to be disposed on, therefore meeting this limitation), wherein the rib portions are continuously connected to each other (Fig. 4-5), and wherein the rib portions and the base portion are a solid single sheet integrally molded from elastic material [0022]. Sedic discloses that the cell regions provide a rip-stop capability ([0005], claim 24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Albrecht to be molded with rib portions in a textured pattern as taught by Sedic in order to provide rip-stop capabilities to contain a tear in the event of damage thereto.
Regarding Claim 2-3, Sedic discloses the cell region comprises a polygonal, shape [0026, Sedic] and a hexagonal shape (claim 2, Fig 4-5, [0033] Sedic) .
Regarding Claim 4, Sedic discloses the base portion and the rib portions are formed from a same resin material [0022, Sedic].
Regarding Claim 5, the base portion is formed in a tubular shape and the rib portions are formed on at least one of outer and inner surfaces of the tubular base portion (As modified in the rejection of claim 1, the material of the tubular sheath of Albrecht is modified to have molded textured pattern in the form of raised ridges formed on an inner or outer surface of the base portion as taught by Sedic in [0021]. Albrecht already has the base portion /sheath formed in a tubular shape.)
Regarding Claim 7, Albrecht in view of Sedic discloses the medical device (wound retractor) as described in claims 1-5 above. The wound retractor comprises annular outer and inner rings (110, 130, Albrecht Fig. 1A) arranged coaxially opposite each other, and the elastic sheet according to claim 5 with both end portions being fixed to the outer and inner rings (Fig. 1A Albrecht).
Claim(s) 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht et al. (US Publication No. 2011/0054260 A1) in view of Sedic (US Publication No. 2016/0038334 A1).
Albrecht in view of Sedic discloses the sheet as described in the rejection of claim 1 above. Sedic discloses that the lines forming the texture pattern which provides the rip stop function can have different thickness or widths, different lengths, different height (for ridges) [0024, Sedic]. However, the references are silent to:
the rib portions have a height of 0.3 mm to 1 mm;
the rib portions have a width of 0.7 mm to 2 mm; or
the cell regions have diameter of 2.5 mm to 10 mm.
However, it would have been obvious to make the rib portions in the dimensional range of 0.3-1mm (height) or 0.7-2mm (width) because material thickness has a direct and predictable correlation to pliability and strength (the thicker a material zone is, the stronger it is and the less pliable it is) and one of ordinary skill in the art would be able to, through routine experimentation, to discover the optimum or workable ranges of the rib portions to provide the strength for desired tear propagation resistance. It would have also been obvious to optimize the cell region diameter to be within 2.5 mm to 10 mm because this is a direct correlation to how far a tear is capable of propagating. One of ordinary skill would be able to, through routine experimentation, to discover the optimum or workable ranges of the cell diameter to provide the acceptable travel of a potential tear before intersecting a rib.
Claim(s) 6 and 8, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht et al. (US Publication No. 2011/0054260 A1) in view of Sedic (US Publication No. 2016/0038334 A1) in further view of Jaworek et al. (US Publication No. 2013/0085339 A1).
Regarding Claims 6 and 8, Albrecht in view of Sedic discloses the sheet as described in the rejection of claim 1 above. Albrecht discloses the membrane material for providing a wall of a wound retractor, however is silent to the base portion is formed in a flat shape and being a component of a medical device comprising: an annular ring, and the elastic sheet with a peripheral end portion being fixed to the ring.
Jaworek discloses a wound retractor in the same field of endeavor comprising an annular ring (102) fixed to a flexible membrane (104) in a flat configuration at the perimeter thereof (Fig. 1B) for providing a barrier to retain organs and tissues from a surgical site [0033]. It would have been obvious to one having ordinary skill in the art to use the membrane material of Albrecht in view of Sedic in a flat configuration attached to an annular ring as taught by Jaworek in order to retract/provide a material suitable as a barrier to retain organs and tissues for a surgical site.
Regarding Claims 11-12, Albrecht in view of Sedic discloses the sheet as described in the rejection of claim 1 above. Sedic discloses that the lines forming the texture pattern which provides the rip stop function can have different thickness or widths, different lengths, different height (for ridges) [0024, Sedic]. However, the references are silent to the base portion has a thickness of 0.3 mm to 1 mm.
Jaworek discloses a wound retractor in the same field of endeavor comprising a flexible membrane (104) for holding back tissue. Jaworek discloses that the thickness of the membrane is preferable about 1-5 mm thick but other dimensions can be used [0040]. It would have been obvious to make the membrane of Albrecht in view of Sedic to be 1mm thick as taught by Jaworek in order to provide a suitable dimension of a tissue retracting membrane. Further, it would have been obvious to make the membrane in the dimensional range of 0.3-1mm because membrane thickness has a direct and predictable correlation to pliability and strength (the thicker an elastic membrane is, the stronger it is and the less pliable it is) and one of ordinary skill in the art would be able to, through routine experimentation, to discover the optimum or workable ranges of 0.3-1mm of a membrane thickness.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 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.
Allowable Subject Matter
Claim 17 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
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