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 1-20 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 1 recites the limitation “from horizontal” in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “from horizontal” will be interpreted as “from a horizontal”.
Claim 6 recites the limitation "a surgical procedure " in line 3 of claim 6. It is unclear whether “a surgical procedure” is referring the surgical procedure disclosed in the last line of claim 1, or if it is referring to a different surgical procedure. For the purpose of examining the claim, “a surgical procedure” in line 3 of claim 6 will be interpreted as “the surgical procedure”.
Claim 15 recites the limitation “relative to horizontal” in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “relative to horizontal” will be interpreted as “relative to a horizontal”.
Claim 18 recites the limitation “relative to horizontal” in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “relative to horizontal” will be interpreted as “relative to a horizontal”.
Appropriate corrections are required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 16 recites “means for adjusting the upward tension, and means for adjusting the lateral tension” and meets the three-prong test described above. Therefore, it will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (U.S. Publication No.2008/0234551 A1; hereinafter “Lin”).
Regarding claim 15, Lin discloses an abdominal-wall retractor system comprising: a mounting armature (feet 81 and pole 6); an upward tensioning rail (bridge 9) affixed to the mounting armature; an upward tension linkage (see pulling string 31 in Figure 4 and annotated Figure 1 below) configured to provide upward tension between the upward tensioning rail (9) and an upward retraction tool (hooks 2 connected to bridge 9) along an upward retraction vector (along string 31 that connects hooks 2 to bridge 9); a lateral tensioning rail (ring 4) affixed to the mounting armature (pole 6) at a location lower than the upward tensioning rail (Figure 1); a lateral tension linkage (pulling string 31 connected to ring 4) configured to provide lateral tension between the lateral tensioning rail (4) and a lateral retraction tool (hooks 2 connected to ring 4) along a lateral retraction vector (along string 31 that connects hooks 2 to ring 4); wherein the upward retraction vector is at a greater angle than the lateral retraction vector relative to horizontal (string 31 connected to bridge 9 is at a greater angle relative to the horizontal than string 31 connected to ring 4 since the bridge 9 is situated higher than ring 4, see Figure 1).
Regarding claim 16, Lin further discloses a means for adjusting the upward tension (via adjusting device 3 connected to bridge 9), and means for adjusting the lateral tension (via adjusting device 3 connected to ring 4)(para.0023 and 0026-0027).
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, 4-6, 10, 12-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lin as applied to claims 15 and 16 above, and further in view of Lill (U.S. Publication No.2017/0035405 A1).
Regarding claim 1, Lin discloses an abdominal-wall retractor comprising: a mounting armature (see feet 81 and stationary pole 6 in annotated Figure 1 below); an upward tensioning rail (bridge 9) affixed to the mounting armature; and one or more upward tension linkages (see pulling string 31 in Figure 4 and annotated Figure 1 below) configured to provide tension between the upward tensioning rail and one or more respective upward retraction tools (hooks 2 connected to bridge 9); wherein the mounting armature is configured to hold the upward tensioning rail in a fixed position above a surgical site (via guide slot 82 formed at each of the two feet 81 and a hanger provided at each of the two sides of the bridge 9) in order to retract an abdominal wall upward, when grasped by the upward retraction tools (para.0027).
Lin fails to disclose wherein the mounting armature is configured to hold the upward tensioning rail in a fixed position above a surgical site in order to retract an abdominal wall upward, when grasped by the upward retraction tools at an angle of at least 20 degrees from horizontal via the provided tension in the one or more upward tension linkages during a surgical procedure. However, Lill discloses a device for retracting the edges of an opened fascia of a patient such that the tensile force engages on the fascia in a direction which encloses an angle of at least 20 degrees from the horizontal (Lill discloses varied ranges of angles which encompass at least 20 degrees, see para.0018). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable Lin’s abdominal-wall retractor to retract the abdominal wall upward at an angle of at least 20 degrees from the horizontal via the provided tension in the upward tension linkages, as taught by Lill, in order to provide sufficient surgical access (see para.0014 of Lill), and 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.
Regarding claim 2, Lin further discloses the upward tensioning rail having or approximating an open arcuate shape (see bridge 9 in annotated Figure 1 below).
Regarding claims 4 and 9, Lin further discloses the one or more upward tension linkages comprising a cord or wire (see pulling string 31 in Figure 4). Furthermore, Lin discloses one or more ratchet wheels (adjusting devices 3) removably positioned on the upward tensioning rail and operatively engaged with the respective one or more cords or wires (para.0023), 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 (para.0023).
Regarding claim 5, Lin further discloses wherein the tension supplied by the upward tension linkage is adjustable (via adjusting screw 33 shown in Figure 4, see para.0023).
Regarding claim 6, Lin further discloses wherein the one or more upward tension linkages comprises a plurality of said upward tension linkages (see multiple pulling strings 31 in annotated Figure 1 below) configured to provide upward tension for retraction at different locations, respectively, along an abdominal wall flap during a surgical procedure (adjusting device 3 is configured to move along bridge 9 as it is along fixation ring 4, see para.0023 and 0026-0027).
Regarding claim 10, Lin further discloses a lateral tensioning rail (fixation ring 4) affixed to the mounting armature (stationary pole 6) at a location lower than the upward tensioning rail (see Figure 1); and one or more lateral tension linkages (pulling strings 31 connected to ring 4) configured to provide tension between the lateral tensioning rail (4) and one or more second lateral retraction tools (hooks 2 connected to ring 4); wherein the position of the lateral tensioning rail (4) on the mounting armature (6) results in lateral retraction of the abdominal wall via the provided tension in the one or more lateral tension linkages (31) during the surgical procedure (once the stationary pole 6 is securely installed, the adjusting rod 5 is then secured onto the stationary pole 6, and then the fixation ring 4 is fixed in a desired position by the adjusting rod 5, see para.0026).
Regarding claim 12, Lin further discloses comprising a plurality of said lateral tension linkages (see multiple pulling strings 31 in annotated Figure 1 below) configured to provide lateral tension for retraction at different locations, respectively, along an abdominal wall flap during a surgical procedure (adjusting device 3 is configured to move along fixation ring 4, see para.0023 and 0026-0027).
Regarding claim 13, Lin further discloses wherein said upward tensioning rail (9) and said lateral tensioning rail (4) extending in respective, substantially parallel planes (see annotated Figure 1 below).
Regarding claim 14, Lin further discloses wherein the mounting armature (feet 81 and stationary pole 6) is configured to be affixed to an operating table or to a stationary stand near the operating table (Figure 1).
Regarding claim 17, Lin discloses the claimed invention, as disclosed in claim 15 above, except for wherein the upward retraction vector is at an angle of at least 20 degrees from the horizontal. However, Lill discloses a device for retracting the edges of an opened fascia of a patient such that the tensile force engages on the fascia in a direction which encloses an angle of at least 20 degrees from the horizontal (Lill discloses varied ranges of angles which encompass at least 20 degrees, see para.0018). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable Lin’s abdominal-wall retractor to retract the abdominal wall upward at an angle of at least 20 degrees from the horizontal, as taught by Lill, in order to provide sufficient surgical access (see para.0014 of Lill), and 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.
Regarding claim 18, Lin discloses a method for abdominal-wall repair, comprising: applying an upward tension to an abdominal wall flap via an upward tension linkage (pulling string 31 connected to bridge 9) extending between an upward tension rail (9) and the abdominal wall flap (via hook 2) along an upward retraction vector (along string 31 that connects to bridge 9, see annotated Figure 1 below).
Lin fails to disclose wherein the upward tension is applied along an upward retraction vector at an angle of at least 20 degrees relative to the horizontal. However, Lill discloses a device for retracting the edges of an opened fascia of a patient such that the tensile force engages on the fascia in a direction which encloses an angle of at least 20 degrees from the horizontal (Lill discloses varied ranges of angles which encompass at least 20 degrees, see para.0018). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable Lin’s abdominal-wall retractor to apply an upward tension to the abdominal flap along an upward retraction vector at an angle of at least 20 degrees from the horizontal, as taught by Lill, in order to provide sufficient surgical access (see para.0014 of Lill), and 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.
Regarding claim 19, Lin discloses the claimed invention except for applying a lateral tension to the abdominal wall flap along a lateral retraction vector at an angle relative to horizontal less than 20 degrees. However, Lill discloses exerting tensile forces on a fascia in a substantially lateral direction, thus parallel to the abdominal wall opening and therefore less than 20 degrees from the horizontal (see para.0103 of Lill). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable Lin’s abdominal-wall retractor to apply a lateral tension to the abdominal wall flap along a lateral retraction vector at an angle relative to horizontal less than 20 degrees, as taught by Lill, in order to provide sufficient surgical access (see para.0014 of Lill), and 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.
Regarding claim 20, Lin discloses the claimed invention except for wherein said upward retraction vector being at an angle of at least 30 degrees relative to horizontal. However, Lill discloses a device for retracting the edges of an opened fascia of a patient such that the tensile force engages on the fascia in a direction which encloses an angle of at least 30 degrees from the horizontal (Lill discloses varied ranges of angles which encompass at least 30 degrees, see para.0018). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable Lin’s abdominal-wall retractor to apply an upward tension to the abdominal flap along an upward retraction vector at an angle of at least 30 degrees from the horizontal, as taught by Lill, in order to provide sufficient surgical access (see para.0014 of Lill), and 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.
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Claims 3, 7, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Lill, as applied to claim 1 above, and further in view of LeVahn et al. (U.S. Publication No.2005/0215865 A1; hereinafter “LeVahn”).
Regarding claim 3, Lin in view of Lill discloses the claimed invention, as disclosed in claim 1 above, Lin further disclosing wherein the upward retractions tool comprises a clamp (see hook 2). Lin in view of Lill fails to disclose wherein the upward tension linkage comprising a ball chain.
Furthermore, regarding claims 7 and 8, Lin in view of Lill fails to disclose wherein the upward tensioning rail comprising detents distributed along a length thereof, the detents being configured to adjustably engage and retain the upward tension linkages, the upward tensioning rail comprising a vertical wall extending upward from a generally horizontal wall thereof, the detents being formed in the vertical wall.
However, LeVahn discloses a retractor comprising a beaded chain 230 having a plurality of beads 232 connected by narrow linkages 234 positioned and retained within one of a plurality of V-shaped notches 204 in the support arm 202 (see Figure 11 of LeVahn) to thereby retain the retractor blade 212 in a selected position (see para.0047-0048 of LeVahn). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the abdominal-wall retractor of Lin in view of Lill, such that the upward tension linkage comprises a ball chain (see beaded chain 230 of LeVahn), and the upward tensioning rail comprises detents distributed along a length thereof, the detents being configured to adjustably engage and retain the upward tension linkages, the upward tensioning rail comprising a vertical wall extending upward from a generally horizontal wall thereof, the detents being formed in the vertical wall, as taught by LeVahn (see Figures 11 and 13 of LeVahn), in order to retrain the retractor blade in various selected positions (see Figures 11 and 13, see also para.0047-0048 of LeVahn).
Regarding claim 11, Lin in view if Lill discloses the claimed invention, as disclosed in claims 1 and 10 above, except for the lateral tensioning rail having or approximating an open arcuate shape.
However, LeVahn discloses a retractor having a support arm 202 having an open arcuate shape (see Figure 11 of LeVahn). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the abdominal-wall retractor of Lin in view of Lill, such that the lateral tensioning rail has an open arcuate shape, as taught by LeVahn (see Figure 11 and para.0044 of LeVahn), in order to extend over the surgical table at a desired position (see para.0044 of LeVahn).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Rullo et al. U.S. Patent No.5,984,866
Nestor et al. U.S. Patent No.4,099,521
McCarthy U.S. Publication No.2016/0022254 A1
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