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 § 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.
Claim(s) 1-4, 6-15, 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al (US 8,075,536) in view of Wiley et al (US 9,079,004).
Regarding claim 1, Gray discloses a subcutaneous access port 30 (fig. 3), comprising: a base 32 defining a reservoir (fig. 3; col. 3, lines 21-25); a stem 18 in fluid communication with the reservoir and extending longitudinally (fig. 3; col. 2, line 42); a septum 22 positioned over the reservoir (col. 2, lines 46-47); a cap 34 configured to engage the base and secure the septum over the reservoir (fig. 3; col. 2, lines 44-47), the cap comprising a nose portion 42 defining a recess 44 (figs. 3, 4); and a radiopaque insert 36 including an aperture 46 (fig. 4; col. 3, lines 36-39), a perimeter of the aperture defining a symbol (fig. 4), the radiopaque insert configured to fit within the recess in a first orientation (fig. 4), the protrusion configured to maintain the radiopaque insert in the first orientation (fig. 4).
Claim 1 further calls for an alignment feature including a protrusion extending from a surface of the recess into the recess, the protrusion configured to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation. Wiley teaches a port having a cap and a radiopaque insert 40 wherein the cap has a protrusion 62 that engages a cutout 60 in the radiopaque insert such that the radiopaque insert can have only one orientation with respect to the port to ensure that the indicia on the insert is positioned in the correct orientation with respect to the port so that the user can accurately access the port (fig. 4, col. 6, lines 17-31). 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 cap and radiopaque insert of Gray such that the cap includes a protrusion to engage the insert located in the recess so that the insert can only engage the recess in a first orientation as taught by Wiley to ensure that the indicia on the insert is properly oriented relative to the port to provide the user the correct location for port access.
Regarding claim 2, Gray discloses that the base 38 engages the cap 42 to secure the radiopaque insert within the recess in the first orientation (fig. 4; col. 3, lines 39-43).
Regarding claim 3, Wiley teaches that the protrusion engages the radiopaque insert in only a single orientation as discussed above, particularly that the protrusion is received in a cutout of the insert. The result of this is that protrusion will abut against the radiopaque insert away from the cutout in the second orientation and prevents the cap from engaging the base.
Regarding claim 4, Wiley teaches that protrusion 62 is configured to engage a notch 60 disposed in a perimeter of the radiopaque insert in the first orientation (fig. 4; col. 6, lines 23-32) as discussed above. The result of this configuration is that the protrusion will abut against a portion of the perimeter of the radiopaque insert in the second orientation.
Regarding claim 6, Gray discloses that the symbol indicates a property of the port (col. 1, lines 17-22).
Regarding claim 7, Gray discloses that the symbol includes the letters "CT" (fig. 4).
Regarding claim 8, Gray discloses that the insert is disposed on an opposite side of the reservoir from the stem, along a longitudinal axis (fig. 3).
Regarding claim 9, Gray discloses that the reservoir is disposed between the stem and the insert along a longitudinal axis (fig. 3).
Regarding claim 10, Gray discloses the nose portion extends from the port along the longitudinal axis, opposite the stem (figs. 3, 4).
Regarding claim 11, Gray discloses the subcutaneous port arranged as claimed, and therefore implicitly discloses the steps of providing and arranging the elements of the port as such. Gray discloses a subcutaneous access port 30, comprising: a cap 34 including a nose portion 42 defining a recess 44 (fig. 4); a radiopaque insert 36 placed within the recess in a first orientation (fig. 4), the radiopaque insert including an aperture 46, a perimeter of the aperture defining a symbol (fig. 4); and a base 40 coupled with the cap, a portion of the base38 extending across the recess to secure the radiopaque insert within the recess in the first orientation (fig. 4; col. 3, lines 39-43).
Claim 11 differs from Gray in calling for the steps of engaging an alignment feature with the radiopaque insert, the alignment feature extending from a surface of the cap into the recess to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation. Wiley teaches a port having a cap and a radiopaque insert 40 wherein the cap has a protrusion 62 that engages a cutout 60 in the radiopaque insert such that the radiopaque insert can have only one orientation with respect to the port to ensure that the indicia on the insert is positioned in the correct orientation with respect to the port so that the user can accurately access the port (fig. 4, col. 6, lines 17-31). 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 cap and radiopaque insert of Gray such that the cap includes a protrusion to engage the insert located in the recess so that the insert can only engage the recess in a first orientation as taught by Wiley to ensure that the indicia on the insert is properly oriented relative to the port to provide the user the correct location for port access.
Regarding claim 12, Gray disclose that the base defines a reservoir and includes a stem 18 extending therefrom along a longitudinal axis, the stem in fluid communication with the reservoir (figs. 2-4; col. 2, lines 40-42).
Regarding claim 13, Gray discloses that a septum22 is secured over the reservoir when the base is coupled with the cap (col. 2, lines 40-48).
Regarding claim 14, Wiley teaches that the protrusion engages the radiopaque insert in only a single orientation as discussed above, particularly that the protrusion is received in a cutout of the insert. The result of this is that protrusion will abut against the radiopaque insert away from the cutout in the second orientation and prevents the cap from engaging the base.
Regarding claim 15, Wiley teaches that protrusion 62 is configured to engage a notch 60 disposed in a perimeter of the radiopaque insert in the first orientation (fig. 4; col. 6, lines 23-32) as discussed above. The result of this configuration is that the protrusion will abut against a portion of the perimeter of the radiopaque insert in the second orientation.
Regarding claim 17, Gray discloses that the symbol indicates a property of the port (col. 1, lines 17-22).
Regarding claim 18, Gray discloses that the symbol includes the letters "CT" (fig. 4).
Regarding claim 19, Gray discloses that the insert is disposed on an opposite side of the reservoir from the stem, along a longitudinal axis (fig. 3).
Regarding claim 20, Gray discloses that the reservoir is disposed between the stem and the insert along a longitudinal axis (fig. 3).
Regarding claim 21, Gray discloses the nose portion extends from the port along the longitudinal axis, opposite the stem (figs. 3, 4).
Claim(s) 1, 5, 11, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of Evans et al (US 2009/0156928).
Regarding claim 1, Gray discloses a subcutaneous access port 30 (fig. 3), comprising: a base 32 defining a reservoir (fig. 3; col. 3, lines 21-25); a stem 18 in fluid communication with the reservoir and extending longitudinally (fig. 3; col. 2, line 42); a septum 22 positioned over the reservoir (col. 2, lines 46-47); a cap 34 configured to engage the base and secure the septum over the reservoir (fig. 3; col. 2, lines 44-47), the cap comprising a nose portion 42 defining a recess 44 (figs. 3, 4); and a radiopaque insert 36 including an aperture 46 (fig. 4; col. 3, lines 36-39), a perimeter of the aperture defining a symbol (fig. 4), the radiopaque insert configured to fit within the recess in a first orientation (fig. 4), the protrusion configured to maintain the radiopaque insert in the first orientation (fig. 4).
Claim 1 further calls for an alignment feature including a protrusion extending from a surface of the recess into the recess, the protrusion configured to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation. Evans teaches a port having a recess that receives a radiopaque insert 1100 wherein the recess has protrusions (fig. 12A: protrusions CT) that engages cutouts in the radiopaque insert (fig. 12A: cutouts CT) such that the radiopaque insert can have only one orientation with respect to the port (fig. 12A). This ensures that the indicia on the insert is positioned in the correct orientation with respect to the port so that the user can accurately access the port. 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 cap and radiopaque insert of Gray such that the cap includes a protrusion to engage the insert located in the recess so that the insert can only engage the recess in a first orientation as taught by Evans to ensure that the indicia on the insert is properly oriented relative to the port to provide the user the correct location for port access.
Regarding claim 5, Evans further discloses that the protrusion (fig. 12A: CT protruding from recess 1120) is configured to engage the aperture (fig. 12A: cutout CT) in the first orientation and abut against a portion of the radiopaque insert in the second orientation (fig. 12A).
Claim 11 differs from Gray in calling for the steps of engaging an alignment feature with the radiopaque insert, the alignment feature extending from a surface of the cap into the recess to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation. Wiley teaches a port having a cap and a radiopaque insert 40 wherein the cap has a protrusion 62 that engages a cutout 60 in the radiopaque insert such that the radiopaque insert can have only one orientation with respect to the port to ensure that the indicia on the insert is positioned in the correct orientation with respect to the port so that the user can accurately access the port (fig. 4, col. 6, lines 17-31). 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 cap and radiopaque insert of Gray such that the cap includes a protrusion to engage the insert located in the recess so that the insert can only engage the recess in a first orientation as taught by Wiley to ensure that the indicia on the insert is properly oriented relative to the port to provide the user the correct location for port access.
Claim 11 further calls for an alignment feature including a protrusion extending from a surface of the recess into the recess, the protrusion configured to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation. Evans teaches a port having a recess that receives a radiopaque insert 1100 wherein the recess has protrusions (fig. 12A: protrusions CT) that engages cutouts in the radiopaque insert (fig. 12A: cutouts CT) such that the radiopaque insert can have only one orientation with respect to the port (fig. 12A). This ensures that the indicia on the insert is positioned in the correct orientation with respect to the port so that the user can accurately access the port. 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 cap and radiopaque insert of Gray such that the cap includes a protrusion to engage the insert located in the recess so that the insert can only engage the recess in a first orientation as taught by Evans to ensure that the indicia on the insert is properly oriented relative to the port to provide the user the correct location for port access.
Regarding claim 16, Evans further discloses that the protrusion (fig. 12A: CT protruding from recess 1120) is configured to engage the aperture (fig. 12A: cutout CT) in the first orientation and abut against a portion of the radiopaque insert in the second orientation (fig. 12A).
Conclusion
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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