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 .
Specification
The amendments to the Specification received 7/15/2026 are acceptable. They overcome the objection set forth in the last Office Action and do not introduce any new matter.
Drawings
The replacement drawing of Fig 1 received 7/15/2026 is acceptable. It corresponds to the amendment made to the Specification and does not introduce new matter.
Claim Objections
Claims 21, 22 and 24-26 are objected to because of the following informalities: The preamble of newly-presented independent claim 28 refers to the device of the invention as “An access device”, but claims 21, 22 and 24-26 still refer to the device of the invention as “The dual lumen access device of claim 28”. Accordingly, the preamble of each of claims 21, 22 and 24-26 should be amended to recite “The . 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.
Claims 28, 21, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Stubbs et al. (US Pat 7,285,112) in view of Judson et al. (PG PUB 2008/0294186) and Albrecht et al. (PG PUG 2009/0234293).
Re claim 28, Stubbs discloses an access device (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for use during laparoscopic surgical procedures (Col 1, Lines 12-32), comprising: an outer body 18+24 including a proximal housing 18 defining an interior chamber (as seen in Fig 2) and an elongated tubular outer cannula 24 extending distally from the proximal housing (as seen in Fig 2), the proximal housing including a first flow port 58 and a second flow port 42; an end cap 70 associated with the proximal housing (Col 8, Lines 65-67) and including a main access port 72 that defines a central longitudinal axis (extending vertically in Fig 2); an inner body 30+34 including a proximal support portion 34 (incorrectly labeled in Fig 2, but correctly labeled in Fig 5; described as “an annular radially outwardly extending flange” in Col 7, Lines 64-66) seated within the proximal housing (as seen in Fig 2; Col 7, Lines 62-64) and an elongated tubular inner cannula 30 extending distally within the elongated tubular outer cannula (as seen in Fig 2), wherein an inner tubular lumen is defined by an interior surface of the inner cannula (as seen in Fig 2) and an outer annular lumen 38 is defined between an exterior surface of the inner cannula and an interior surface of the outer cannula (Col 8, Lines 1-4), and wherein the first flow port communicates with the inner tubular lumen and the second flow port communicates with the outer annular lumen (Col 9, Line 54 – Col 10, Line 7); and a duckbill seal 74 above the proximal support portion of the inner body (as seen in Fig 2) and arranged in such a manner as to prevent gas flow between the inner tubular lumen and the main access port (Col 9, Lines 2-6) while permitting gas flow between the inner tubular lumen and the first flow port (due to its location in the end cap, as seen in Fig 2).
Stubbs does not disclose that the association between the end cap and the proximal housing is a threaded one, that the main access port extends into the interior chamber of the proximal housing, or that the duckbill seal resides within the proximal housing of the outer body. Stubbs also does not disclose a horizontal partition that is supported above the duckbill bill seal and that is arranged such that the main access port of the end cap communicates with the duckbill seal through an axially aligned aperture formed in the horizontal partition, wherein each of the duckbill seal and the horizontal partition have a radially outwardly extending upper support portion and the duckbill seal and the horizontal partition are arranged such that a top surface of the radially outwardly extending upper support portion of the duckbill seal is in abutting contact with a bottom surface of the radially outwardly extending support portion of the horizontal partition.
Judson, however, teaches a substantially similar access device 100 (Fig 1, exploded in Fig 3, seen in profile in Fig 4; it is noted that all reference characters cited below refer to Fig 1-4 unless otherwise noted) comprising an outer body 104+108 including a proximal housing 108 defining an interior chamber (as seen in Fig 4) and an elongated tubular outer cannula 104; an end cap 128+130 (since Para 27 disclose that cap portions 128 and 180 are adhered together, both of these portions form the “end cap”) associated with the proximal housing (as seen in Fig 4) and including a main access port 148 that extends into the interior chamber of the proximal housing (as seen in Fig 4) and defines a central longitudinal axis (extending horizontally in Fig 4); a duckbill seal 114 (Para 24) supported within the proximal housing of the outer body (as seen in Fig 4); and a horizontal 132 that is supported above the duckbill bill seal (as seen in Fig 4) and that is arranged such that the main access port of the end cap communicates with the duckbill seal through an axially aligned aperture formed in the horizontal partition (as seen in Fig 4), wherein each of the duckbill seal and the horizontal partition have a radially outwardly extending upper support portion (labeled in annotated Fig A below) and the duckbill seal and the horizontal partition are arranged such that a top surface of the radially outwardly extending upper support portion of the duckbill seal is in abutting contact with a bottom surface of the radially outwardly extending support portion of the horizontal partition (as seen in Fig 4). Judson teaches that the end cap 128+130, the horizontal partition 132 and the duckbill valve 114 form a cap assembly 110 that also includes an interface seal 152 and an armature mechanism 126 (as seen in Fig 4) and that this cap assembly facilitates alignment of an instrument inserted therethrough and, thereby, assists in the maintenance of the seal about the instrument and/or minimizes lateral movement of the instrument within the portal (Para 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Stubbs to replace the cap 70 + seal 74 assembly with the cap assembly 110 of Judson for the purpose of facilitating alignment of an instrument inserted therethrough and, thereby, assisting in the maintenance of the seal about the instrument and/or minimizing lateral movement of the instrument within the portal (Para 3).
Judson discloses that the end cap is associated with the proximal housing via locking detents (Para 27) and, therefore, does not disclose that the association is a threaded one.
Albrecht, however, teaches a substantially similar access device 100 (Fig 1A, wherein Fig 1C provides an internal view; it is noted that all reference characters cited below refer to Fig 1A,1C unless otherwise noted) having an outer body 110+130 comprising a proximal housing 130 and having an end cap assembly 120 comprising an end cap 140, a seal 190, and a partition 150, wherein the end cap and the proximal housing can be associated via multiple means including locking detents (as in Judson) or threads (Para 38) for the purpose of securing the end cap to the proximal housing (Para 38). Since Albrecht teaches that locking detents and threads can be used to perform the same function (securing the end cap to the proximal housing), these mechanisms were art recognized equivalents at the time the invention was made. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Stubb’s proximal housing and Judson’s end cap to include a threaded association, as taught by Albrecht, since it has been held that substituting art-recognized equivalent parts of an invention involves only routine skill in the art.
Re claim 21, Stubbs discloses that the proximal housing of the outer body is formed integral with the outer cannula of the outer body (as seen in Fig 2, note the same hashmarks indicating both the proximal housing and the outer cannula).
Re claim 22, Stubbs discloses that the proximal support portion of the inner body is formed integral with the inner cannula of the inner body (as seen in Fig 2, note the same hashmarks indicating both the proximal support portion and the inner cannula).
Re claim 25, Stubbs discloses that the first flow port is located proximal to the second flow port (as seen in Fig 2).
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Stubbs et al. (US Pat 7,285,112)/Judson et al. (PG PUB 2008/0294186)/Albrecht et al. (PG PUB 2009/0234293) in view of Stearns et al. (PG PUB 2010/0185139).
Re claim 24, although one of ordinary skill in the art would be led to believe that Stubbs discloses the first flow port being sealingly isolated from the second flow port (since the second port is used for pressure measurement and this measurement would be inaccurate if subject to the inflow from the first port, Stubbs as modified by Judson and Albrecht does not explicitly disclose this. Stearns, however, teaches an access device 2500 (Fig 25) comprising a proximal housing 2515 (Fig 25) and a proximal support portion 2520 (Fig 25) therein, wherein an o-ring 2552 is present at the proximal support (Para 149) for the purpose of providing a seal between the proximal support portion and the proximal housing (Para 149). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Stubbs to include the proximal support portion 34 with an o-ring, as taught by Stearns, for the purpose of providing a seal between the proximal support portion and the proximal housing (Para 149). Since the flow ports 58,42 of Stubbs are on opposite sides of the proximal support portion 34, the addition of the o-ring the proximal support portion would sealingly isolate the two ports from one another.
Re claim 26, Stubbs as modified by Judson and Albrecht discloses all the claimed features except an o-ring operatively associated with the proximal support portion of the inner body. Stearns, however, teaches an access device 2500 (Fig 25) comprising a proximal housing 2515 (Fig 25) and a proximal support portion 2520 (Fig 25) therein, wherein an o-ring 2552 is present at the proximal support portion (Para 149) for the purpose of providing a seal between the proximal support portion and the proximal housing (Para 149). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Stubbs to include the proximal support portion 34 with an o-ring, as taught by Stearns, for the purpose of providing a seal between the proximal support portion and the proximal housing (Para 149). Since the flow ports 58,42 of Stubbs are on opposite sides of the proximal support portion 34, the addition of the o-ring the proximal support portion would sealingly isolate the two ports from one another to ensure that the pressure measurement detected by the second port would not be influenced by the inflow from the first port.
Response to Arguments
Applicant’s arguments filed 7/15/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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