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 .
This action is in response to the filing on 10/8/20252. Since the previous filing, claims 1, 3, 6, 11-13 and 15-19 have been amended, claims 2, 5 and 7-10 have been cancelled and no claims have been added. Thus, claims 1, 3, 4, 6 and 11-20 are pending in the application.
In regards to the previous Claim Objections, Applicant has amended to overcome these objections and they are therefore withdrawn with new objections entered as needed.
In regards to the previous 112 Rejections, Applicant has amended to overcome these rejections and they are therefore withdrawn with new rejections added as needed.
In regards to previous 102 and 103 Rejections, Applicant has amended to overcome these rejections and they are therefore withdrawn with new rejections entered below.
Claim Objections
Claims 6 are objected to because of the following informalities:
Claim 6 should depend from claim 1 and not cancelled claim 2
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 repeats the limitation of a “seal structure removably disposed within at least one of said supplementary ports” as seen in preceding claim 1 line 14-15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 3, 4, 6 and 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caruso (US 2018/0078723).
In regards to claim 1, Caruso discloses a valve assembly structured for regulating communication between medical tubing (device 700), said valve assembly comprising: a housing including a hollow interior (housing 705, Fig 7B), an airway port disposed on said housing and structured for attachment to an artificial airway (connector 710), an introduction port connected to said housing and including an open inner end disposed in communicating relation with said hollow interior (connector 720, Fig 7B); said introduction port disposed and structured to interconnect a catheter (catheter 108) to said hollow interior of said housing (paragraph 114), a guide structure disposed within said housing (diverter 600); said guide structure comprising an expanded open inner end of said airway port (second stage 608, Fig 7B), said expanded open inner end disposed and configured to direct the catheter from said open inner end of said introduction port, through said hollow interior into said airway port (paragraph 114, Fig 7B).
The embodiment of Fig 7 of Caruso does not explicitly disclose further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior; said guide structure further comprising a seal structure removably disposed within at least one of said supplementary ports, said seal structure including an inner closed end disposed adjacent to said open inner end of said introduction port and said expanded open inner end of said airway port, and said inner closed end of said seal structure further disposed and configured to deflect the catheter from said open inner end of said introduction port, through said hollow interior into said airway port.
However, the embodiment of Fig 18 teaches further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior (ventilation port 1830, paragraph 140); and the embodiment of Fig 3 teaches the guide structure further comprising a seal structure removably disposed within at least one of said supplementary ports (devices may have plugs to seal interior, paragraph 139 line 6-10), said seal structure includes an inner closed end disposed adjacent to said open inner end of said introduction port and said expanded open inner end of said airway port (plugs 320 and 322, Fig 3A and 3B), and said inner closed end of said seal structure further disposed and configured to deflect the catheter from said open inner end of said introduction port, through said hollow interior into said airway port (seal 320 includes a closed end within an inner portion and can be configured to deflect catheter from an introduction port, Fig 3A and 7B, paragraph 139).
Therefore, 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 embodiment of Fig 7 of Caruso to have a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior; said guide structure further comprising a seal structure removably disposed within at least one of said supplementary ports, said seal structure including an inner closed end disposed adjacent to said open inner end of said introduction port and said expanded open inner end of said airway port, and said inner closed end of said seal structure further disposed and configured to deflect the catheter from said open inner end of said introduction port, through said hollow interior into said airway port as taught by the embodiments of Fig 18 and 3 as this would provide alternate optional and adaptable access to the interior of the assembly and direct the insertion of a catheter as needed (all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 3, Caruso teaches the assembly of claim 1 and Caruso further discloses wherein said expanded open inner end comprises an outwardly flared configuration (Fig 7B).
In regards to claim 4, Caruso discloses the assembly of claim 3 and Caruso further discloses wherein said expanded open inner end comprises a substantially funnel-shaped configuration (paragraph 114, Fig 7B).
In regards to claim 6, Caruso teaches the assembly of claim 1 and Caruso further teaches said seal structure removably disposed within at least one of said supplementary ports (devices may have plugs to seal interior, paragraph 139 line 6-10).
However, the embodiment of Fig 18 teaches further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior (ventilation port 1830, paragraph 140); and the embodiment of Fig 3 teaches the guide structure further comprising a seal structure removably disposed within at least one of said supplementary ports (devices may have plugs to seal interior, paragraph 139 line 6-10).
Therefore, 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 embodiment of Fig 7 of Caruso to have a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior; said guide structure further comprising a seal structure removably disposed within at least one of said supplementary ports as taught by the embodiments of Fig 18 and Fig 3 of Caruso as this would provide optional alternate access to the interior of the assembly as needed (all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 7, Caruso teaches the assembly of claim 6 and Caruso further teaches wherein said seal structure includes an inner closed end disposed adjacent to said open inner end of said introduction port and said expanded open inner end of said airway port, and said inner closed end of said seal structure further disposed and configured to deflect the catheter from said open inner end of said introduction port, through said hollow interior into said airway port (seal 320 includes a closed end within an inner portion and can be configured to deflect catheter from an introduction port, Fig 3A and 7B, paragraph 139).
In regards to claim 8, Caruso discloses the assembly of claim 1.
The embodiment of Fig 7 of Caruso does not explicitly disclose further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior; said guide structure comprising a seal structure removably disposed within at least one of said supplementary ports.
However, the embodiment of Fig 18 teaches further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior (ventilation port 1830, paragraph 140); said the embodiment of Fig 3 teaches the guide structure comprising a seal structure removably disposed within at least one of said supplementary ports (devices may have plugs to seal interior, paragraph 139 line 6-10).
Therefore, 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 embodiment of Fig 7 of Caruso to have a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior; said guide structure comprising a seal structure removably disposed within at least one of said supplementary ports as taught by the embodiments of Fig 18 and Fig 3 of Caruso as this would provide optional alternate access to the interior of the assembly as needed (all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 9, Caruso discloses the assembly of claim 8 and Caruso further teaches wherein said seal structure includes an inner closed end disposed in adjacent relation to inner ends of said introduction port and said airway port (plugs 320 and 322, Fig 3A and 3B).
In regards to claim 10, Caruso teaches the assembly of claim 9 and Caruso further teaches wherein said closed end is disposed and configured to deflect the catheter from said introduction port through said hollow interior into said airway port (plugs prevent entry of catheter into interior, Fig 3A and 3B).
In regards to claim 11, Caruso teaches the assembly of claim 1.
The modified embodiment of Fig 7 does not teach further comprising a secretions discharge port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing.
However, the embodiment of Fig 21 teaches further comprising a secretions removal port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing (suction tube assembly 2154 serves as drain port, paragraph 143).
Therefore, 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 modified embodiment of Fig 7 of Caruso to have a secretions discharge port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing as taught by the embodiment of Fig 21 as this would allow the secretions to be removed from the device (paragraph 143 column 2 line 2-3, all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 12, Caruso teaches the assembly of claim 1 and Caruso further teaches wherein each of said supplementary ports includes a connecting sleeve rotationally connected to said housing (swivel connectors established for connections in multiple ports, paragraph 110 and 140-141)
In regards to claim 13, Caruso teaches the assembly of claim 1 and Caruso further teaches wherein said airway port includes a connecting sleeve movably connected to said housing (swivel connections, paragraph 110).
In regards to claim 14, Caruso discloses the assembly of claim 1 and Caruso further discloses further comprising a closure segment movably connected to said housing (bellows section 715), said introduction port connected to said closure segment and movable therewith between open and closed orientations; said open orientation comprising said introduction port disposed in substantially coaxial relation to said airway port (paragraph 112-113, Fig 7A-Fig 8B).
In regards to claim 15, Caruso teaches the assembly of claim 14 and Caruso further discloses further comprising an access opening formed in said housing in communicating relation with said hollow interior (space between end of guide segment 760 and housing 705), said closed orientation of said introduction port comprising said closure segment movable on said housing in overlying relation to said access opening, concurrent to said introduction port disposed in non-aligned relation to said access opening (bellows 715 overlay guide 760 and move over it, Fig 7B and Annotated Fig 8B).
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Annotated Fig 8B
In regards to claim 16, Caruso discloses the assembly of claim 1 and Caruso further discloses further comprising a coupler structure dimension to removably retain a catheter on the interior thereof (bellows section 715 encloses catheter, Fig 7B); said coupler structure includes one end cooperatively structured with said introduction port to secure said coupler structure and a catheter contained therein in communicating relation with said hollow interior of said housing (Fig 7A-8B).
In regards to claim 17, Caruso discloses a valve assembly structured for regulating communication between medical tubing (device 700), said valve assembly comprising: a housing including an access opening and a hollow interior (housing 705 and space provided by guide 760, Fig 7B), an airway port disposed on said housing and structured for attachment to an artificial airway (connector 710), an introduction port connected to said housing in communicating relation with said hollow interior (connector 720); said introduction port disposed and structured to interconnect a catheter (catheter 108) to said hollow interior of said housing (paragraph 114), a guide structure disposed within said housing (diverter 600); said guide structure disposed and configured to direct the catheter from said introduction port, through said hollow interior into said airway port (paragraph 114, Fig 7B), said guide structure comprising an open inner end of said airway port having a substantially funnel shaped configuration disposed in guiding relation to a catheter tip passing through said hollow interior, from said introduction port (second stage 608, paragraph 114, Fig 7B), a closure segment movably connected to said housing (bellows section 715), said introduction port connected to and movable with said closure segment between open and closed orientations (paragraph 112-113, Fig 7A-Fig 8B); said open orientation comprising said introduction port disposed in substantially coaxial relation to said airway port and said access opening, and said closing orientation of said introduction port comprising said closure segment movable on said housing in overlaying relation to said access opening, concurrent to said introduction port disposed in non-aligned relation to said airway port and said access opening (paragraph 112-113, Fig 7A-Fig 8B and Annotated Fig 8B).
The embodiment of Fig 7 of Caruso does not explicitly disclose further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior.
However, the embodiment of Fig 18 teaches further comprising a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior (ventilation port 1830, paragraph 140).
Therefore, 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 embodiment of Fig 7 of Caruso to have a plurality of supplementary ports each connected to said housing in communicating relation with said hollow interior as taught by the embodiments of Fig 18 of Caruso as this would provide optional alternate access to the interior of the assembly as needed (all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 18, Caruso teaches the assembly of claim 17.
The embodiment of Fig 7 of Caruso does not disclose wherein said guide structure further comprises a seal structure removably disposed within at least one of said supplementary ports; said seal structure including an inner closed end disposed and configured to deflect the catheter from said introduction port through said hollow interior and said open inner end into said airway port.
However, the embodiment of Fig 3 of Caruso teaches the guide structure comprising a seal structure removably disposed within at least one of said supplementary ports (devices may have plugs to seal interior, paragraph 139 line 6-10); said seal structure includes an inner closed end disposed in adjacent relation to inner ends of said introduction port and said airway port (plugs 320 and 322, Fig 3A and 3B).
Therefore, 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 modified embodiment of Fig 7 of Caruso wherein said guide structure further comprises a seal structure removably disposed within at least one of said supplementary ports; said seal structure including a closed end disposed and configured to deflect the catheter from said introduction port through said hollow interior and said open inner end into said airway port as taught by the embodiment of Fig 3 as this would allow the additional ports to be sealed off when not needed and all embodiments may have elements of other embodiments (paragraph 140 column 2 line 11-13).
In regards to claim 19, Caruso teaches the assembly of claim 18.
The modified embodiment of Fig 7 does not teach further comprising a secretions discharge port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing.
However, the embodiment of Fig 21 teaches further comprising a secretions discharge port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing (suction tube assembly 2154 serves as drain port, paragraph 143).
Therefore, 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 modified embodiment of Fig 7 of Caruso to have a secretions removal port disposed adjacent said seal structure and structured to remove secretions from said hollow interior to an exterior of said housing as taught by the embodiment of Fig 21 as this would allow the secretions to be removed from the device (paragraph 143 column 2 line 2-3, all embodiments may have elements of other embodiments, paragraph 140 column 2 line 11-13).
In regards to claim 20, Caruso teaches the assembly of claim 17 and Caruso further teaches wherein each of said plurality of supplementary ports and said airway port includes a connecting sleeve rotationally connected to said housing (swivel connections, paragraph 110).
Response to Arguments
In regards to the arguments concerning the independent claims, these arguments are in regards to the amendments made to the claims and are addressed in the new rejections entered above.
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 Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785