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 .
Examiner’s Comments
It is noted that upon further search and consideration of the art, a new rejection has been made. A Notice of Withdrawal from Issue has been filed on 07/28/2026. Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lill (US Publication No. 2017/0035405 A1) and claims 1-2 and 4-6 are rejected under 35 USC 103 as unpatentable over Lill (US 20170035405) in view of Zaczek (US 20260020852).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lill (US 20170035405).
Regarding claim 18, Lill discloses a method for abdominal-wall repair ([0086]: “closure of the fascia…is possible with non-problematic wound healing after the period of the abdomen being open”), comprising: applying an upward tension (Fig. 3, tension vectors A and B, note upward/vertical components A1 and B1) to an abdominal wall flap (Fig. 3: edges 4.1 of opened fascia 4 of abdominal wall 2) via an upward tension linkage (tensile elements 12) extending between an upward tension rail (mounting bracket 14, see [0089]: “The mounting bracket 14 is preferably in the form of at least one rod”) and the abdominal wall flap (Fig. 3: edges 4.1 of opened fascia 4 of abdominal wall 2) along an upward retraction vector (Fig. 3, tension vectors A and B, note upward/vertical components A1 and B1) at an angle of at least 20° relative to a horizontal (Fig. 3, [0116]: “tensile force engages on the fascia 4 in a direction which encloses an angle which lies in the range from 5° to 90°, or in the range from 10° to 80°, or in the range from 15° to 70°, with a [horizontal] virtual connecting line between the edges 4.1 of the opened fascia 4”), in order to expose underlying fascia of the abdominal wall flap ([0087]: “by way of the apparatus 11 according to the invention, tensile forces A, B with a force component A1, B1 directed away from the body of the patient 1 are exerted on the edges 4.1 of the fascia 4 such that the apparatus holds the edges 4.1 under tension and spaced apart frost [sic] one another. The abdominal wall 2, and thus also the fascia 4, is held open. The abdominal wall opening 7 has an extent of greater than 1 cm, preferably of greater than 5 cm, such that unhindered access to the abdominal cavity 29 is possible.” That is, underlying fascia is exposed).
Regarding claims 19 and 20, Lill further discloses applying a lateral tension to the abdominal wall flap along a lateral retraction vector at an angle relative to horizontal less than 20°, and said upward retraction vector being at an angle of at least 30° relative to the horizontal (Fig. 3, [0116]: “tensile force engages on the fascia 4 in a direction which encloses an angle which lies in the range from 5° to 90°, or in the range from 10° to 80°, or in the range from 15° to 70°, with a [horizontal] virtual connecting line between the edges 4.1 of the opened fascia 4”).
It is noted that Lill was previously applied as a secondary reference in a 103 rejection. The rejection was apparently overcome by applicant’s remarks arguing that one would not be motivated to modify the primary reference with Lill. However, upon further consideration, it appears that the primary reference is not needed at all, and no argument against the factual teachings of Lill has been asserted. As shown above, Lill is sufficient on its own to reject claims 18-20, and the argument against Lill is not relevant to an anticipation rejection.
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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.
Claims 1-2 and 4-6 are rejected under 35 USC 103 as unpatentable over Lill (US 20170035405) in view of Zaczek (US 20260020852).
Regarding claim 1, Lill discloses an abdominal-wall retractor comprising: a mounting armature (at least struts 22, 23; see Fig. 15a and [0092] explaining how the mounting bracket 14 is fixed to the body of the patient); an upward tensioning rail (mounting bracket 14, see [0089]: “The mounting bracket 14 is preferably in the form of at least one rod”) affixed to the mounting armature (Fig. 15a, [0092]); and one or more upward tension linkages (tensile elements 12) configured to provide tension between the upward tensioning rail (14) and one or more respective upward retraction [connection] ([0088]: “tensile elements 12 are preferably connected to the fascia by way of an areal connecting means 13 in the form of a mesh”); wherein the mounting armature is configured to hold the upward tensioning rail in a fixed position above a surgical site (Figs. 5-6, 15a) in order to retract an abdominal wall upward ([0087]: “by way of the apparatus 11 according to the invention, tensile forces A, B with a force component A1, B1 directed away from the body of the patient 1 are exerted on the edges 4.1 of the fascia 4”), when grasped by the upward retraction [connection(s)] ([0088]: “areal connecting means 13 in the form of a mesh”), at an angle of at least 20° from a horizontal (Fig. 3, [0116]: “tensile force engages on the fascia 4 in a direction which encloses an angle which lies in the range from 5° to 90°, or in the range from 10° to 80°, or in the range from 15° to 70°, with a [horizontal] virtual connecting line between the edges 4.1 of the opened fascia 4”) via the provided tension in the one or more upward tension linkages (12) during a surgical procedure.
Lill discloses that the tensile elements are attached to the tissue by “an areal connecting means 13 in the form of a mesh” ([0088]) whereas claim 1 requires that the abdominal tissue is grasped by “upward retraction tool(s)”. Since a mesh may or may not reasonably qualify as a “tool”, a modification will be proposed for completeness.
Zaczek teaches a device for reducing retraction and/or stretching the edges of an opened tissue structure in which multiple retraction elements (104) are adapted for retraction and attachment to the edges 112 of the opened tissue structure 114 ([0091]). Similar to Lill, Zaczek discloses use of a mesh attachment to evenly distribute force exerted on the tissue/fascia ([0042]). Zaczek also explicitly teaches that, "[a]lternatively, another suture material or at least one mesh and/or at least one mesh strip and/or at least one clamp or at least one hook or at least one tube or at least one wire" or combinations thereof may be used ([0066], [0116]). In light of these teachings, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lill to use a tool (such as a hook, clamp, tube, etc.) in place of (or in addition to) the mesh to connect the tensile elements to the tissue. Zaczek's teachings suggest that these were known alternative means of attaching tensioning elements ([0066], [0116]) and evenly distributing force ([0042]) to tissue. Hence the claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
It is noted that Lill was previously applied as a secondary reference in a 103 rejection. The rejection was apparently overcome by applicant’s remarks arguing that one would not be motivated to modify the primary reference with Lill. However, this argument does not pertain to Lill when used as a primary reference and no argument against the factual teachings of Lill has been asserted.
Regarding claim 2, modified Lill discloses the retractor of claim 1, and Lill also discloses the upward tensioning rail (14) having or approximating an open arcuate shape ([0091]: “Alternatively, use may be made of a mounting bracket with a curved profile, such that the connecting points are arranged on a curved line, for example a circular line or the circumferential line of a closed curved line, for example of an ellipse.”) that is concave in a plane that is substantially horizontal and that is open toward the incision and operator (intended use, mounting bracket with a curved profile is capable of such an arrangement relative to the incision and operator).
Regarding claim 4, modified Lill discloses the retractor of claim 1, and Lill also discloses that the one or more upward tension linkages (12) comprising a cord or wire ([0088]: “The tensile elements 12 are preferably in the form of threads. Use may alternatively be made of wires, cables or meshes”).
Regarding claim 5, modified Lill discloses the retractor of claim 1, and Lill also discloses that the tension supplied by the upward tension linkage (12) is adjustable ([0119]: “The position of the connectors 32 relative to the attachment element 14.5 is adjustable, such that, by way of the adjustment of the position of the connectors 32, the tension of the tensile elements 12 can be adjusted independently of one another.”).
Regarding claim 6, modified Lill discloses the retractor of claim 1, and Lill also discloses a plurality of said upward tension linkages (12) configured to provide upward tension for retraction at different locations, respectively, along an abdominal wall flap during the surgical procedure (Fig. 6).
Allowable Subject Matter
Claims 15-17 are allowed.
Claims 3 and 7-14 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.
Claims 15-17 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 15. In particular, none of the cited references teach or suggest a lateral tensioning rail affixed to the mounting armature at a location lower than the upward tensioning rail; a lateral tension linkage configured to provide lateral tension between the lateral tensioning rail and a lateral retraction tool along a lateral retraction vector; wherein the upward retraction vector is at a greater angle than the lateral retraction vector relative to a horizontal, as required by claim 15.
Claim 3 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 3. In particular, none of the cited references teach or suggest wherein the upward tension linkage comprises a ball chain and the upward retraction tool comprises a clamp, as required by claim 3.
Claims 7-8 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 7. In particular, none of the cited references teach or suggest the upward tensioning rail comprising detents distributed along a length thereof, the detents being configured to adjustably engage and retain the upward tension linkage, as required by claim 7.
Claim 9 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 9. In particular, none of the cited references teach or suggest one or more ratchet wheels removably positioned on the upward tensioning rail and operatively engaged with the respective one or more cords or wires, the one or more ratchet wheels being configured to increase the tension between the upward tensioning rail and the upward retraction tools as the ratchet wheels are rotated, as required by claim 9.
Claims 10-13 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 10. In particular, none of the cited references teach or suggest a lateral tensioning rail affixed to the mounting armature at a location lower than the upward tensioning rail; and a one or more lateral tension linkages configured to provide tension between the lateral tensioning rail and one or more second lateral retraction tools; wherein the position of the lateral tensioning rail on the mounting armature results in lateral retraction of the abdominal wall via the provided tension in the one or more lateral tension linkages during the surgical procedure, as required by claim 10.
Claim 14 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and dependent claim 14. In particular, none of the cited references teach or suggest wherein the mounting armature is configured to be affixed to an operating table or to a stationary stand near the operating table, as required by claim 14.
Neither Lill, nor Lill in view of Zaczek disclose these features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
