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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 01/02/26. As directed by the amendment: claims 1, 8, 11, 12 and 16 have been amended. Claims 2, 9, 10, 13, 14 and 17 have been cancelled. Claims 23 and 24 have been added.
Thus, claims 1, 3-8, 11, 12, 15, 16, 18-24 are pending in this application.
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, 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Grayzel (US 4921479 A) in view of McGurk et al (US 20060025815 A1) and further in view of Roschak et al (US 20060280773 A1).
Regarding claim 1, Grayzel discloses an implant device (see fig 3, 312), comprising: a tube (310) having a side wall (wall of tube 310), a lumen (lumen of tube 312), a proximal end portion (314), a distal end portion (316), and a central portion (portion between proximal end 314 and distal end (316) interposed between the proximal end portion and the distal end portion (see fig 3), the tube having a longitudinal extent (see fig 3), wherein, in an undeployed state, wherein the side wall has a longitudinal split (see fig 3) to define a first lateral edge surface (320) facing a second lateral edge surface (318) and defining a longitudinal gap therebetween (see fig 3, gap between edges 320 and 318), wherein each of the first lateral edge surface, the second lateral edge surface, and the longitudinal gap longitudinally extending through each of the proximal end portion, the central portion, and the distal end portion (see fig 3 and col 5, lines 12-16).
Grayzel fails to teach said implant device to facilitate access across pleura layers via an access opening through at least the pleura layers.
However, McGurk et al disclose an implant device (100) that facilitate access across pleura layers via an access opening (110) through at least the pleura layers (see figs 4A and 6, para 0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the implant device of Grayzel and incorporate the teachings of McGurk et al to have said implant device facilitate access across pleura layers via an access opening through at least the pleura layers. This would provide the benefit of using said device to access the thoracic cavity which enables diagnostic and therapeutic access to a thoracic cavity using large bore instruments (para 0003).
Grayzel fails to teach said implant device wherein each of the proximal end portion and the distal end portion extends outwardly from the central portion.
However, Roschak et al disclose an implant device (200) to facilitate access to the lung (para 0048) comprising a proximal end (228), a distal end (226) and a central portion (208) wherein each of the proximal end portion and the distal end portion extends outwardly from the central portion (see fig 3A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the implant device of Grayzel and incorporate the teachings of Roschak et al to have each of the proximal end portion and the distal end portion extends outwardly from the central portion. This would provide the benefit of assisting in retaining said implant to resist migration or movement of the device in a longitudinal direction to maintain the device in a fixed position on the tissue. This will limit movement of the implant within the tissue opening and securing the implant about the perimeter of the tissue opening (para 0055).
Grayzel in view of McGurk et al and Roschak et al fails to expressly disclose wherein, in a deployed state when the tube is arranged within the access opening, an external radial compressive force exerted by tissue surrounding the access opening causes the longitudinal gap to close so the first lateral edge surface contacts the second lateral edge surface. This limitation is a functional limitation, thus the longitudinal gap of the implant device of Grayzel is capable of closing so the first lateral edge surface contacts the second lateral edge surface when inserted in a access opening due an external radial compressive force exerted by tissue surrounding the access opening.
Regarding claim 3, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Grayzel further discloses wherein each of the first lateral edge surface and the second lateral edge surface is configured to form a circumferential termination end surface of the implant device (see fig 3).
Regarding claim 4, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Roschak et al further disclose wherein each of the proximal end portion (228) and the distal end portion (226) flares outwardly from the central portion (figs 3A-C and 5B).
Regarding claim 5, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Roschak et al further disclose wherein the proximal end portion (228) and the distal end portion (226) are symmetrical, on opposite sides of the central portion (figs 3A-C and 5B).
Regarding claim 6, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Roschak et al further disclose said implant device comprising a plurality of finger members (228, 226) that extend from at least one of the proximal end portion and the distal end portion (see figs 5D-F).
Regarding claim 7, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Roschak et al further disclose wherein each of the proximal end portion and the distal end portion includes a respective plurality of finger members (228, 226) that are spaced around a periphery of each of the proximal end portion and the distal end portion (see figs 5D-F).
Regarding claim 8, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 1,
Grayzel further discloses wherein the implant device is formed of at least one of a memory material, a bioabsorbable material, a metal, or a polymer (see abstract and claim 1).
Claims 11, 12, 15, 16, 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Grayzel (US 4921479 A) in view of McGurk et al (US 20060025815 A1) and further in view of Roschak et al (US 20060280773 A1) and in view Green et al (US 5304187 A).
Regarding claim 11, Grayzel discloses a system (see fig 3, 312), comprising: an implantable tube (310) having a tubular side wall (wall of tube 310), a tubular lumen (lumen of tube 312), a proximal end portion (314), a distal end portion (316), and a central portion (portion between proximal end 314 and distal end 316) interposed between the proximal end portion and the distal end portion (see fig 3), the tube having a longitudinal extent (see fig 3), and wherein, in an undeployed state, the tubular side wall has a longitudinal split (see fig 3) to define a first lateral edge surface (320) facing a second lateral edge surface (318) and defining a longitudinal gap therebetween (see fig 3, gap between edge 320 and 318), each of the first lateral edge surface, the second lateral edge surface, and the longitudinal gap longitudinally extending through each of the proximal end portion, the central portion, and the distal end portion (see fig 3 and col 5, lines 12-16).
Grayzel fails to teach said system to facilitate access across pleura layers via an access opening through at least the pleura layers.
However, McGurk et al disclose a system (100) that facilitate access across pleura layers via an access opening (110) through at least the pleura layers (see figs 4A and 6, para 0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Grayzel and incorporate the teachings of McGurk et al to have said implant device facilitate access across pleura layers via an access opening through at least the pleura layers. This would provide the benefit of using said device to access the thoracic cavity which enables diagnostic and therapeutic access to a thoracic cavity using large bore instruments (para 0003).
Grayzel fails to teach said system wherein each of the proximal end portion and the distal end portion extends outwardly from the central portion.
However, Roschak et al disclose a system (200) to facilitate access to the lung (para 0048) comprising a proximal end (228), a distal end (226) and a central portion (208) wherein each of the proximal end portion and the distal end portion extends outwardly from the central portion (see fig 3A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Grayzel and incorporate the teachings of Roschak et al to have each of the proximal end portion and the distal end portion extends outwardly from the central portion. This would provide the benefit of assisting in retaining said implant to resist migration or movement of the device in a longitudinal direction to maintain the device in a fixed position on the tissue. This will limit movement of the implant within the tissue opening and securing the implant about the perimeter of the tissue opening (para 0055).
Grayzel fails to teach said system comprises a stylet assembly having a stylet and a stylet handle, the stylet having a distal tip, the stylet having an exterior surface and a longitudinal recess formed along the exterior surface of the stylet, the longitudinal recess having a longitudinal edge surface, the tubular lumen of the implantable tube configured to be received over the exterior surface of the stylet, with the first lateral edge surface of the tubular side wall of the implantable tube configured to be engaged by the longitudinal edge surface of the longitudinal recess of the stylet; and a cannula assembly having a cannula and a cannula handle, the cannula having a cannula side wall and a cannula lumen, the cannula side wall having a distal end and a longitudinal slotted opening proximal to the distal end, wherein the implantable tube and at least a portion of the stylet are configured to be received in the cannula lumen, with the second lateral edge surface of the tubular side wall of the implantable tube configured to be received through the longitudinal slotted opening of the cannula side wall.
However, Green et al disclose a system (10) to facilitate access across pleura layers (col 1, line 47-49 and col 2, lines 50-68) comprising a surgical implant (32), a stylet assembly (see fig 2, member 14 and retainer 18) having a stylet (18) and a stylet handle (38, see fig 1), the stylet (18) having a distal tip (20), the stylet (18) having an exterior surface (see fig 2) and a longitudinal recess (28 or see fig 3, slot 34) formed along the exterior surface of the stylet (see fig 2), the longitudinal recess having a longitudinal edge surface (members 28a-b/ edge of slot 34), the implant configured to be received over the exterior surface of the stylet (see fig 7, implant 32 is to be received through slot 34), and a cannula assembly (14) having a cannula (12) and a cannula handle (22), the cannula having a cannula side wall (see fig 2) and a cannula lumen (lumen of tube 12), the cannula side wall having a distal end (see fig 2) and a longitudinal slotted (36) opening proximal to the distal end (see fig 2), wherein the implant and at least a portion of the stylet are configured to be received in the cannula lumen (see figs 8-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Grayzel in view of McGurk et al and Roschak et al and incorporate the teachings of Green et al to have said system comprises a stylet assembly having a stylet and a stylet handle, the stylet having a distal tip, the stylet having an exterior surface and a longitudinal recess formed along the exterior surface of the stylet, the longitudinal recess having a longitudinal edge surface, and a cannula assembly having a cannula and a cannula handle, the cannula having a cannula side wall and a cannula lumen, the cannula side wall having a distal end and a longitudinal slotted opening proximal to the distal end. This modification would provide the benefit of having a stylet assembly and a cannula assembly that could be used to direct said implantable tube of Grayzel in view of McGurk et al and Roschak et al to access pleura layers. Implant of Green et al needs to be rolled within said cannula to be ejected to the body (col 2, lines 50-68), and since said implantable tube could be received over the exterior surface of the retainer 18, with its first lateral edge surface configured to be engaged by slot 34 of retainer 18 as seen in figure 7 and its second lateral edge surface configured to be received through the slotted opening 36 of said cannula side wall as seen fig 8. This configuration would be beneficial to the surgeon to retain said implantable tube within said cannula assembly and stylet assembly until pleura layers is crossed.
Grayzel in view of McGurk et al and Roschak et al and Green et al fails to expressly disclose wherein, when the implantable tube is moved to a deployed state via the cannula assembly within the access opening, an external radial compressive force exerted by tissue surrounding the access opening causes the longitudinal gap of the implantable tube to close so that the first lateral edge surface of the implantable tube contacts the second lateral edge surface of the implantable tube. This limitation is a functional limitation, thus the longitudinal gap of the implant device of Grayzel is capable of closing so the first lateral edge surface contacts the second lateral edge surface when inserted in a access opening due an external radial compressive force exerted by tissue surrounding the access opening.
Regarding claim 12, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Green et al further disclose wherein the stylet (18) and the cannula (12) are arranged along a longitudinal axis (see fig 7), and the stylet and the cannula are configured to rotate relative to each other to deploy the implantable tube through the longitudinal slotted opening of the cannula side wall (col 4, lines 49-58 and col 6, lines 36-49).
Regarding claim 15, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Green et al further disclose wherein the longitudinal slotted opening (36) includes a ramp (see fig 1, ramp of slot 36) that extends from the cannula lumen to an outer surface of the cannula, the ramp configured to guide the second lateral edge surface of the tubular side wall of the implantable tube into and through the longitudinal slotted opening (col 6, lines 17-35, see fig 8).
Regarding claim 16, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Green et al further disclose wherein a diameter of the implantable tube when the implantable tube is in the undeployed state is smaller than the diameter of the implantable tube when the implantable tube is in the deployed state (see figs 9 and 10, implant 32 is within cannula and fig 11, implant is unrolling to have wider diameter).
Regarding claim 18, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Roschak et al further disclose wherein each of the proximal end portion (228) and the distal end portion (226) flares outwardly from the central portion (figs 3A-C and 5B).
Regarding claim 19, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Roschak et al further disclose wherein the proximal end portion (228) and the distal end portion (226) are symmetrical, on opposite sides of the central portion (figs 3A-C and 5B).
Regarding claim 20, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Grayzel further discloses wherein the implant device is formed of at least one of a memory material, a bioabsorbable material, a metal, or a polymer (see abstract and claim 1).
Regarding claim 21, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Roschak et al further disclose said implant device comprising a plurality of finger members (228, 226) that extend from at least one of the proximal end portion and the distal end portion (see figs 5D-F).
Regarding claim 22, Grayzel in view of McGurk et al and Roschak et al and Green et al discloses the system according to claim 11,
Roschak et al further disclose wherein each of the proximal end portion and the distal end portion includes a respective plurality of finger members (228, 226) that are spaced around a periphery of each of the proximal end portion and the distal end portion (see figs 5D-F).
Regarding claim 23, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 4,
Grayzel further discloses wherein the proximal end portion, the distal end portion, and the central portion each have a planar exterior surface profile (see fig 3 of Grayzel).
Regarding claim 24, Grayzel in view of McGurk et al and Roschak et al discloses the implant device according to claim 4,
Grayzel further discloses wherein the side wall has a constant thickness in the proximal end portion, the distal end portion, and the central portion (see fig 3).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 01/02/2026, with respect to the rejection(s) of claim(s) 1, 3-8, 11, 12, 15, 16, 18-22 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Grayzel (US 4921479 A) in view of McGurk et al (US 20060025815 A1) and further in view of Roschak et al (US 20060280773 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783