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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2025 has been entered.
Response to Arguments
Applicant argues in the response filed 06/30/2025 that the claim amendments would overcome the 112 rejection. The rejection has been withdrawn.
The applicant argues the claim amendments overcome the 102 and 103 rejections with respect to Layne, Yoon, and Evans. The rejections have been withdrawn. New rejections with respect to Evans as modified by Gillespie/Azarbarzin have been made below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 63, 65-67, 70-72, 76, 77, 83, 84 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin.
As to claim 63, Evans discloses a trocar assembly (10, figure 1, paragraph 40), comprising a cannula (200) comprising a shaft (210) with a lumen (250) and a rib (220b, figure 5b, paragraph 43, 44) disposed on an interior wall of the lumen (figure 2c); an obturator (100), an obturator body (130), an obturator shaft (110) extending from the obturator body, the obturator shaft being at least partially positionable within the cannula (figure 3), the obturator shaft comprising a penetrating end (144/146) at a distal end of the obturator, and an internal structure accommodating portion comprising a recess (120b, paragraph 43-45, figure 5b) located in a surface of the obturator shaft and extending longitudinal between a first end and a second end, the second end located distally to the first end, the internal structure accommodating portion configured to locate around the rib of the cannula when the obturator shaft is located in the lumen of the cannula (figure 5). If however it would not be known that the mating structure 220b as seen in figure 5b would be able to read on a rib, Evans does disclose that multiple mating structures can be used, such as a protrusion, wing, or key that can mate with a notch, groove, or a slot as disclosed in paragraph 43, 44, and a rib in paragraph 45. At least one part of the mating structure 220b can be able to read on a rib and yield the predictable result of helping to lock the obturator in the cannula and. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the mating structure 220b of Evans be a rib in order to substitute a known mechanism that can help lock the obturator in the cannula
However, Evans is silent about the second end of the recess comprising a flared portion having a greater width than a width of the first end. Gillespie teaches a similar device (interengagable medical assembly, abstract) having a recess (260, figure 7) extending longitudinal between a first end and a second end distal to the first end, the second end comprising a flared portion having a greater width than width of the first end (col. 4 ll. 32-37) for the purpose of readily receiving the compliment protrusion with respect to the recess. Azarbarzin also teaches a similar device (trocar, abstract) having a recess (306, figure 7) extending longitudinal between a first end and a second end distal to the first end, the second end comprising a flared portion having a greater width than width of the first end (paragraph 55,56) for the purpose of facilitating alignment with a structure sliding therethrough. Both Gillespie and Azarbarzin teach that having a wider distal end of a recess/slot can help to receive and align that is introduced therein. The recess of Evans can have the wider slot will make it easier for the rib of the cannula to be received therein. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the second of the recess of Evans comprise a flared portion having a greater width than a width of the first end in order for readily receiving and aligning the rib within the recess.
As to claim 65, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the recess extends over a majority of a length of the distal end of the obturator shaft; the recess provides clearance for the obturator from the rib on the cannula; or the recess extends from the distal end of the obturator shaft at least partway towards the obturator body. Figure 5b, paragraph 43-45 of Evans will be able to read on at least one of the limitations, for instance: providing clearance since it is a recess.
As to claim 66, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the internal structure accommodating portion comprises a portion of the obturator shaft comprising a reduced diameter relative to the diameter of a remainder of the obturator shaft (figure 5b, paragraph 43, the slot will allow for a reduced diameter).
As to claim 67, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the portion of the obturator having the reduced diameter comprises a length of the obturator shaft between a proximal end of the obturator shaft and the distal end of the obturator shaft (figure 3b, paragraph 43-45).
As to claim 70, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the internal structure accommodating portion is located at or adjacent to one or more of the distal end of the obturator or a proximal end of the obturator shaft (figure 2, 3b).
As to claim 71, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the internal structure accommodation portion is located substantially along a length of the obturator (figure 2, 3b).
As to claim 72, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the obturator body comprising one or more locating elements (120) configured to mate with one or more corresponding receiving elements (222a) in the cannula.
As to claim 76, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the obturator is an optical obturator, comprising an obturator lumen configured to receive a scope (paragraph 52).
As to claim 77, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the obturator body has one or more seal elements (222, 300 paragraph 40, 45, 46) configured to prevent gas leaking from the lumen.
As to claim 83, with the device Evans and Gillespie/Azarbarzin above, Evans discloses the internal structure accommodating portion is configured to orient the obturator relative to the cannula before the one or more locating elements mate with the corresponding receiving elements in the cannula figure 2). The keyed structures shape(s) of the locating elements 222,122 can help allow the user to orient the obturator the cannula before the obturator is inserted into the cannula by visually seeing the orientation of the location elements.
As to claim 84, with the device of Evans and Gillespie/Azarbarzin above, Gillespie (figure 7) and Azarbarzin (figure 19) each further teach the flared portion of the internal structure accommodating portion is shaped to tolerate an incorrect rotational orientation of the obturator shaft on initial engagement with the rib and correct the incorrect rotational orientation on continued engagement with the rib as the obturator shaft is inserted in the lumen of the cannula. The recesses of each Gillespie and Azarbarzin each have the widened portion which will receive the rib if the rib is not properly aligned with the recess and then guide the rib into the rib.
Claims 68, 69 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin as applied to claims 63, 65-67, 70-72, 76, 77, 83, 84 above, and further in view of U.S. Patent 5,842,971 to Yoon and/or U.S. Patent 6,447,489 to Peterson.
As to claim 68, Evans as modified by Gillespie/Azarbarzin discloses the device above but is silent the internal structure accommodating portion comprises a deformable material disposed around a portion of the obturator shaft wherein the deformable material deforms or flexes around the rib of the cannula when the obturator shaft is inserted is inserted into the cannula.
Yoon teaches a similar device (endoscope, abstract) having an internal structure accommodating portion comprises a deformable material (col. 13 ll. 55-col. 14 ll. 23) disposed around a portion of the obturator shaft (figure 11, 12), wherein the deformable material deforms or flexes around the rib of the cannula when the obturator shaft is inserted is inserted into the cannula (figure 7, 11) in order to seal the lumen. Peterson also teaches a similar device (access device, abstract) having an internal structure accommodating portion comprises a deformable material (20, col. 3 ll. 64-29) disposed around a portion of the obturator shaft (figure 4, 11, 12), wherein the deformable material deforms or flexes around the rib of the cannula when the obturator shaft is inserted is inserted into the cannula in order to help ease introduction of the obturator as well as sealing the lumen. The sleeve 20 of Peterson is flexible and extends the length of the lumen so it will be in the internal structure accommodating portion as well as be able to flex around the rib. Both Peterson and Yoon teaches that using a deformable material can help seal the lumen as the obturation is inserted into the lumen of the cannula. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the internal structure accommodating portion of Evans comprises a deformable material disposed around a portion of the obturator shaft wherein the deformable material deforms or flexes around the rib of the cannula when the obturator shaft is inserted is inserted into the cannula in order to help seal the lumen of the trocar assembly.
As to claim 69, with the device of Evans, Gillespie/Azarbarzin, and Yoon/Peterson above, Yoon (col. 13 ll. 55-col. 14 ll. 23, figure 7, 8, 11) and Peterson (col. 3 ll. 64-col. 4 ll. 29, figure 4, 11, 12) both further teach the deformable material is configured as a sheath around the distal end of the obturator or the deformably material is provided as a ring around the distal end of the obturator shaft.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin as applied to claims 63, 65-67, 70-72, 76, 77, 83, 84 above, and further in view of U.S. Patent Publication 2008/00861167 to Mastri.
As to claim 73, Evans as modified by Gillespie/Azarbarzin discloses the device above but is silent about the one or more locating elements comprises one or more pins, tabs, or protrusions, extending from an underside of the obturator body.
Mastri teaches a similar device (surgical access device, abstract) having one or more locating elements comprise one or more pins, tabs or protrusions (2223a,b, paragraph 99, 100) extending from an underside of the obturator body (figure 22) to engage with one or more corresponding elements in the cannula (2012) for the purpose of using an alternative mechanism that removably secure parts of the trocar assembly together. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the locking mechanism of Mastri with the locating elements extending along an underside of the obturator in the cannula as the locating element of Evans in order for using an alternative mechanism that removably secure parts of the trocar assembly together.
Claims 74, 75 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin as applied to claims 63, 65-67, 70-72, 76, 77, 83, 84 above, and further in view of U.S. Patent Publication 2018/0140286 to Householder.
As to claim 74, Evans as modified by Gillespie/Azarbarzin discloses the device above but is silent about locating elements comprises at least one locking finger extending distally from a lower surface of the obturator body receivable by a corresponding aperture in the cannula.
Householder teaches a similar device (cannula assembly, abstract) having an obturator body (1110, figure 2-5) having locating elements include at least one locking finger (1130) extending distally from a lower surface of the obturator body (figure 2), configured to be received in a corresponding aperture (figure 9, the aperture defined by attachment feature 1016, figure 9, paragraph 73) in the cannula for the purpose of using an alternative mechanism to secure the obturator to the cannula. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the locking fingers and aperture of Householder as the locking mechanism of Evans in order for using an alternative mechanism to secure the obturator to the cannula.
As to claim 75, with the device of Evans, Gillespie/Azarbarzin, and Householder above, Householder further teaches the at least one locking finger comprises a locking tab (1132) configured to engage with a corresponding engagement tab (1016) in the cannula.
Claims 78-80 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin as applied to claims 63, 65-67, 70-72, 76, 77, 83, 84 above, and further in view of U.S. Patent Publication 2009/0192444 to Albrecht.
As to claim 78, Evans as modified by Gillespie/Azarbarzin discloses the device above but is silent about the upper or lower seal.
Albrecht teaches a similar device (cannula device, abstract) having a seal (122/124, paragraph 29, figure 1b) that is one or both of: an upper seal configured to seal around a medical instrument when inserted into the obturator lumen; or a lower seal configured to create a gas seal when there is no medical instrument in the obturator lumen for the purpose of forming a fluid seal between the parts of the assembly. It would have been obvious to one of ordinary skill in the art before the effective filing date in order to use the seal of elements of Albrecht as the seal of Evans in order to use an alternative mechanism that can form a fluid seal between the parts of the assembly.
As to claim 79, with the device of Evans, Gillespie/Azarbarzin, and Albrecht above, Albrecht teaches wherein the one or more seal elements are located about a proximal open end of the obturator body, the one or more seal elements configured to prevent gas leaking out of the obturator body (figure 1b).
As to claim 80, with the device of Evans, Gillespie/Azarbarzin, and Albrecht above, Albrecht teaches the one or more seal elements comprise a flexible or deformable material configured to form a seal against a medical instrument when inserted into the obturator (paragraph 29, 42,49).
Claims 81 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0323808 to Evans in view of U.S. Patent 6,336,914 to Gillespie and/or U.S. Patent Publication 2014/0088491 to Azarbarzin as applied to claims 63, 65-67, 70-72, 76, 77, 83, 84 above, and further in view of U.S. Patent Publication 2005/0090852 to Layne.
As to claim 81, with the device of Evans and Gillespie/Azarbarzin above, Evans discloses the penetrating end has a blunt top or a dilating tip (figure 2) the tapered shape of 144 allows the penetrating end to be a dilating tip. If it however, would not be known that the penetrating end of Evans, Layne teaches a similar device (inserting structures, abstract), having an obturator with a penetrating end having a blunt tip or a dilating tip (paragraph 102,103) in order to permit placement of the device in the desired tissue location. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the penetrating end of Evans have a blunt tip or a dilating tip in order permit placement of the device in the desired tissue location.
Conclusion
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771