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 § 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 1-6, 9-12, 15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conseil (US 20190328918 A1).
Regarding claim 1, Conseil teaches a port connector for connecting a fluid port of a device to be sterilized to a sterilization apparatus (abstract), the fluid port having a distal end defining a fluid port outlet (Figure 22 article to be sterilized “302” has head body “310” and Figure 24 head body has second open end “314”, see paragraph [0155]), the fluid port defining a lumen extending proximally from the fluid port outlet (flexible tube and head body define as least one lumen, paragraph [0155]), the port connector comprising: a connector body having an insertion portion (article connector is arranged to be inserted inside the article lumen, paragraph [0165]), a connection portion (male portion configured to be connected to the sterilization apparatus, paragraph [0157]), and porous member brace (recessed portion to received annular member, paragraph [0159]), the insertion portion being sized and shaped to be inserted into the lumen via the fluid port outlet (Figure 24 body of connector “316” inserted into lumen “311”), the insertion portion having an inlet arranged to be disposed in and in fluid communication with the lumen (Figure 24 bore “318” of connector “300” and allows sterilant to flow through lumen via bore, paragraph [0162]), the connection portion being configured to connect to the sterilization apparatus (male portion configured to be connected to the sterilization apparatus, paragraph [0157]), the connection portion having an outlet in fluid communication with the inlet and configured to be fluidly couple to the sterilization apparatus (Figure 24 bore “318” of connector “300” and allows sterilant to flow through lumen via bore, paragraph [0162]); and a porous member supported by the insertion portion of the connector body (Figure 24 annular member “348” on inserted portion of body “316”), the porous member having a porous structure defining a plurality of minute passageways (annular member may have an interconnected porous structure, paragraph [0160]), the porous member being arranged to be inserted into the lumen via the fluid port outlet with the insertion portion (Figure 24 annular member “348” on inserted portion of body “316”), the porous member being biased outward by the porous member brace so that the porous member engages an interior of the fluid port (Figure 24 annular member “348” partially supported by recessed portion “346” to contact outer surface of article “350”).
Regarding claim 2, Conseil teaches wherein the porous member brace engages the porous member (Figure 24 annular member “348” supported by recessed portion “346”).
Regarding claim 3, Conseil teaches wherein the porous member brace extends outward from an exterior surface of the insertion portion (Figure 23 recessed portions “346” formed by rings extending out from connector “300”, and distal tip is flanged on the outer surface of the body, paragraph [0157]).
Regarding claim 4, Conseil teaches wherein the porous member brace comprises a ring extending circumferentially around the insertion portion (Figure 23 recessed portions “346” formed by rings extending out from connector “300”).
Regarding claim 5, Conseil teaches wherein the porous member comprises a porous sleeve encircling the ring (Figure 24 annular member “348” supported by recessed portion “346”).
Regarding claim 6, Conseil teaches wherein the porous member brace is arranged to bias only a portion of the porous member outward so that said portion of the porous member engages the interior of the fluid port (recessed portion is configured so that at least a portion of the annular member protrudes out of the recessed portion, paragraph [0161]).
Regarding claim 9, Conseil teaches wherein the porous member is arranged relative to the connector body such that at least a portion of the minute passageways of the porous member fluidly couple the inlet of the insertion portion of the connector body to an exterior environment of the port connector via the fluid port outlet when the port connector is connected to the fluid port (Figure 24 annular member “348” connects plurality of openings “344”, and provides a continuous flow path around the end of the article, paragraph [0161], Conseil).
Regarding claim 10, Conseil teaches wherein the porous member is configured to form an interface fit with the interior of the fluid port (Figure 24 annular members “348” mate with the surface of the lumen “311”).
Regarding claim 11, Conseil teaches a port connector for connecting a fluid port of a device to be sterilized to a sterilization apparatus (abstract), the fluid port having a distal end defining a fluid port outlet (Figure 22 article to be sterilized “302” has head body “310” and Figure 24 head body has second open end “314”, see paragraph [0155]), the fluid port defining a lumen extending proximally from the fluid port outlet (flexible tube and head body define as least one lumen, paragraph [0155]), the port connector comprising: a connector body having an insertion portion (article connector is arranged to be inserted inside the article lumen, paragraph [0165]), a connection portion (male portion configured to be connected to the sterilization apparatus, paragraph [0157]), and porous member brace (recessed portion to received annular member, paragraph [0159]), the insertion portion being sized and shaped to be inserted into the lumen via the fluid port outlet (Figure 24 body of connector “316” inserted into lumen “311”), the insertion portion having an inlet arranged to be disposed in and in fluid communication with the lumen (Figure 24 bore “318” of connector “300” and allows sterilant to flow through lumen via bore, paragraph [0162]), the connection portion being configured to connect to the sterilization apparatus (male portion configured to be connected to the sterilization apparatus, paragraph [0157]), the connection portion having an outlet in fluid communication with the inlet and configured to be fluidly couple to the sterilization apparatus (Figure 24 bore “318” of connector “300” and allows sterilant to flow through lumen via bore, paragraph [0162]), the connector body having a plurality of alignment projections arranged to be disposed in the lumen and engage an interior of the of the fluid port to resist withdrawal of the insertion portion from the lumen (distal tip is flanged on the outer surface and may assist in retention of the of the article connector in the lumen, paragraph [0157]); and a porous member supported by the insertion portion of the connector body (Figure 24 annular member “348” on inserted portion of body “316”), the porous member having a porous structure defining a plurality of minute passageways (annular member may have an interconnected porous structure, paragraph [0160]), the porous member being arranged to be inserted into the lumen via the fluid port outlet with the insertion portion (Figure 24 annular member “348” on inserted portion of body “316”).
Regarding claim 12, Conseil teaches wherein each alignment projection comprises a rib (Figure 23 recessed portions “346” formed by rings extending out from connector “300”).
Regarding claim 15, Conseil teaches wherein each alignment projection is shaped to have only line contact or point contact with the fluid port (Figure 23 recessed portions “346” formed by rings extending out from connector “300”, and Figure 24 edged of recessed portions in contact with inner surface of the lumen “311”).
Regarding claim 17, Conseil teaches wherein the connector body includes a porous member stop arranged to inhibit the porous member from moving relative to the insertion portion of the connector body in a direction generally towards the outlet of the connector body (Figure 24 annular member “348” supported by recessed portion “346”).
Regarding claim 18, Conseil teaches wherein the porous member stop is formed by one of the plurality of alignment projections (Figure 24 annular member “348” supported by recessed portion “346”, and Figure 23 recessed portions “346” formed by rings extending out from connector “300”).
Regarding claim 19, Conseil teaches wherein the connector body includes one or more insertion stops arranged to engage the fluid port to stop further insertion of the insertion portion of the connector body into the lumen (Figure 24 connector body “316” has flanged edge to stop with contact at open end “314”).
Regarding claim 20, Conseil teaches wherein the one or more insertion stops are each shaped to have only line contact or point contact with the fluid port (Figure 24 connector body “316” has flanged edge to stop with contact at open end “314”).
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.
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Conseil in view of Malchesky (US 5552115 A).
Regarding claim 7, Conseil teaches all aspects of the current invention except wherein the porous member has a tapered portion arranged to facilitate insertion of the porous member into the fluid port outlet. However, Malchesky teaches wherein the porous member has a tapered portion arranged to facilitate insertion of the porous member into the fluid port outlet (porous portion is tapered, column 9 line 20).
Conseil and Malchesky are considered analogous to the current invention because all are in the field of fluid port connectors. Therefore, it would have been obvious to one of ordinary skill in the art to combine the port connector taught by Conseil with the tapered porous member taught by Malchesky because Malchesky teaches the tapered porous member advantageously facilitate receipt into the access port and provide passage for any air trapped in the access port to prevent air blocks (column 9 lines 21-25).
Regarding claim 8, the combination of Conseil and Malchesky teaches all aspects of the current invention including wherein the insertion portion of the connector body includes a tapered portion (see circled portion of Figure 24 of Conseil below), the tapered portion of the porous member overlying the tapered portion of the insertion portion of the connector body (sleeve of porous material is fused or otherwise connected with the tubing member, column 7 lines 45-46).
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Claims 14 are rejected under 35 U.S.C. 103 as being unpatentable over by Conseil in view of Gilbert (US 9173602 B2).
Regarding claim 14, Conseil teaches all aspects of the current invention except wherein each rib comprises a plurality of steps configured to engage fluid ports of different internal diameters. However, Gilbert teaches wherein each rib comprises a plurality of steps configured to engage fluid ports of different internal diameters (Figure 89 series of conical ribs “8918” with successively smaller diameters).
Conseil and Gilbert are considered analogous to the current invention because all are in the field of fluid port connectors. Therefore, it would have been obvious to one of ordinary skill in the art to combine the port connector taught by Conseil with the adaptive steps taught by Gilbert because Gilbert teaches the adaptor advantageously broadens the range of devices and tubing to which the end may be coupled to (column 60 lines 31-33).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Conseil in view of Mansour (US 20200297987 A1).
Regarding claim 13, Conseil teaches all aspects of the current invention except wherein each rib extends parallel to a longitudinal axis of the connector body, the longitudinal axis extending between the inlet and the outlet of the connector body. However, Mansour teaches each rib extends parallel to a longitudinal axis of the connector body, the longitudinal axis extending between the inlet and the outlet of the connector body (Figure 2 filter support “111” includes axial ribs “112”).
Conseil and Mansour are considered analogous to the current invention because all are in the field of fluid port connectors. Therefore, it would have been obvious to one of ordinary skill in the art to combine the port connector taught by Conseil with the axial support ribs taught by Mansour because Mansour teaches the axial ribs support the porous filter while facilitating the flow path (paragraph [0030]).
Regarding claim 16, Conseil teaches all aspects of the current invention except wherein each alignment projection is includes a curved surface or a beveled profile configured to having only line contact with the fluid port. However, Mansour teaches each alignment projection is includes a curved surface or a beveled profile configured to having only line contact with the fluid port (Figure 6 line contact from axial rib “112”).
Conseil and Mansour are considered analogous to the current invention because all are in the field of fluid port connectors. Therefore, it would have been obvious to one of ordinary skill in the art to combine the port connector taught by Conseil with the axial support ribs taught by Mansour because Mansour teaches the axial ribs support the porous filter while facilitating the flow path (paragraph [0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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