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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/30/26 has been entered.
Claim Objections
Claim 19 is objected to because of the following informalities: Claim 19, add a period at the end of the claim. Appropriate correction is required.
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, 4-5, 7, 18-21 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 elastomeric tubular sheath/sheet (150) (fig. 1A)[0065-0066]. 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]. Damage to the sheath of a flexible tissue retractor is fully capable of coming from contact by a medical instrument being inserted therethrough.
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 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).
Regarding Claim 18, Albrecht discloses the inner ring (130) has a smaller cross-sectional diameter than the outer ring (110) (shown in Figure 1A, see below), and the outer diameter of the inner ring (130) is smaller than the outer diameter of the outer ring (110) (“some embodiments of the inner ring have a smaller diameter than the outer ring” [0038]).
PNG
media_image1.png
605
649
media_image1.png
Greyscale
Regarding Claim 19, Albrecht shows in Fig. 1A-1B that the surgical instrument is a roll-up wound retractor [0039], and the outer ring (110) comprises a pair of outer rings (122a, 122b each house a ring or split hoop 124 as described in [0042]).
Regarding Claim 20, Albrecht discloses the medical elastic sheet (150) and outer and inner rings (110, 130) are configured to maintain the function holding an incision in an open state, or to maintaining holding an organ in a retracted state [0006, 0094-0095 Albrecht].
Regarding Claim 21, as modified to include have molded portions on the elastic sheath as taught by Sedic for providing rip-stop capability, the rib portions are configured to inhibit expansion of damage to the base portion (this concept is explained by Sedic who discloses that the texture pattern contains a tear [0005] which means that the rib portions do not allow the tear to propagate to other parts of the base portion) while the medical elastic sheet is in a tensioned state (the texture is fully capable of allowing for rip stop capability in any state because it exists on the surface of the material).
Claim(s) 9, 11, 13, 15 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 0.2 mm to 2 mm;
the rib portions have a width of 0.5 mm to 5 mm; or
the cell regions have diameter of 1.5 mm to 20 mm.
However, it would have been obvious to make the rib portions in the dimensional range of 0.2-2mm (height) or 0.5-5mm (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 1.5 mm to 20 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 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 Claim 11, 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 0.2 mm to 2 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 0.2-2mm 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 0.2-2mm of a membrane thickness.
Claim(s) 22 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 Milliman (US Publication No. 2007/0051375 A1).
Albrecht in view of Sedic discloses the sheet as described in the rejection of claim 1 and 7 above. Albrecht discloses in [0066] that the sheath comprises an elastomeric membrane film and describes a variety of materials from which the sheath could be made in [0059] but is silent to the hardness characteristic of the sheath material.
Milliman discloses an introducer sheath material in the analogous art of medical introducer devices made from materials which preferably have a durometer reading of about 20A to 70A (Shore A hardness) [0009, 0056] in order to allow the material to
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to be sufficiently extendible, expandible, pliable, malleable, ductile, compressible, elastic and/or rubbery to provide for controlled deflection and sufficient stiffness [0055].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a material for the sheath which has a 20A to 70A Shore A hardness as taught by Milliman since this hardness of material is shown in the art to provide a suitable pliable, malleable, ductile, compressible, elastic property to introducer sheaths.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are not persuasive.
Applicant argues that a person of ordinary skill in the art would not have been motivated to modify the wound retractor of Albrecht with rib portions applied to the very different sheet structure of Sedic because Albrecht and Sedic are directed to very different technical fields. This is not persuasive. Both Albrecht and Sedic are analogous art to the claimed invention. Albrecht is analogous because it is a reference in the same field of endeavor as the claimed invention- ring supported membrane wound retractors while Sedic is analogous because the reference is reasonably pertinent to the problem faced by the inventor even if it is not in the same field of endeavor as the claimed invention. The problem faced by the inventor is tear propagation mitigation or “rip-stop” capabilities of a membrane. The disclosure of Sedic is acutely pertinent to this problem as it discloses means to provide rip-stop or tear propagation mitigation characteristics to a membrane. In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention and a comparison of whether the references are themselves in the same technical fields is irrelevant.
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
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.
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, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
Prosecution Insights