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 Office action is responsive to an amendment filed October 21, 2025. Claims 1-20 are pending. Claims 1, 7 & 17 have been amended.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2 & 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US 2013/0006176).
In regards to claim 1, Miller discloses an apparatus 10 capable of generating a continuous vacuum during a tissue biopsy procedure (see at least par 0013-0014, 0041, 0055-0056 & 0058), the apparatus comprising:
a pump housing 12 having a distal end 14 attachable to a medical device and a longitudinal axis (see at least fig. 1 and par 0038);
a piston 26 slidably receivable within the pump housing 12, the piston 26 being configured to create a seal between a distal portion of the pump housing 12 and a proximal portion of the pump housing 12 (see at least fig. 1 and par 0039-0042);
a piston rod 22 rotatably coupled to and extending proximally from a proximal side of the piston 26 and terminating in a proximal end with a piston rod pivot (i.e., having pin 73) (see at least fig. 1 and par 0038-0039 & 0045); and
PNG
media_image1.png
430
674
media_image1.png
Greyscale
a handle 38 including a grip 98 having a distal end and a proximal end and a handle arm 66 extending at a fixed angle from the proximal end of the grip 98 (see at least fig. 1 and par 0044-0045), the handle 38 rotatably attached to the pump housing 12 at a handle pivot (i.e., having pin 70) (see par 0020) disposed between the grip 98 and the handle arm 66 and a proximal end of the handle arm 66 rotatably pivotably attached to the piston rod 22 with a pivot pin 73 coupled to the piston rod pivot (i.e., having pin 73) (see at least fig. 1 and par 0044-0045),
wherein rotating the handle 38 towards the pump housing 12 about the handle pivot (i.e., having pin 70) causes the piston 26 to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing 12 (see at least fig. 1 and par 0013-0014, 0038, 0041, 0044 & 0055-0056), and
wherein the handle pivot (i.e., having pin 70) is in a fixed position relative to the pump housing 12 (see at least fig. 1).
In regards to claim 2, Miller discloses the apparatus of Claim 1, further comprising:
a fitting (i.e., having outlet port 32) disposed at a distal end of the pump housing 12, the fitting (i.e., having outlet port 32) attachable to a handle of a medical device (i.e., catheter such as a dilatation catheter) (see at least fig. 1 and par 0014, 0040 & 0057).
In regards to claim 7, Miller discloses a system capable of providing a vacuum force during a tissue biopsy procedure (see at least par 0041, 0055-0056 & 0058), the system comprising:
a medical device (i.e., catheter such as dilatation catheter) including:
a handle (not shown but inherent); and
an insertion portion (not shown but inherent); and
a vacuum generation apparatus 10 including:
a pump housing 12 having a distal end 14 attachable to the medical device (i.e., catheter) and a longitudinal axis (see at least fig. 1 and par 0038);
a piston rod 22 rotatably coupled to and extending proximally from a proximal side of a piston 26 to a proximal end (see at least fig. 1 and par 0038-0039 & 0045); and
a handle 38 including a grip 98 having a distal end and a proximal end and a handle arm 66 extending at a fixed angle from the proximal end of the grip 98 (see at least fig. 1 and par 0044-0045), the handle 38 rotatably attached to the pump housing 12 at a handle pivot (i.e., having pin 70) (see par 0020) disposed in a fixed position relative to the pump housing 12 between the grip 98 and the handle arm 66 and a proximal end of the handle arm 66 rotatably pivotably attached to the proximal end of the piston rod 22 via a pivot pin 73 (see at least fig. 1 and par 0044-0045),
PNG
media_image1.png
430
674
media_image1.png
Greyscale
wherein rotating the handle 38 towards the pump housing 12 about the handle pivot (i.e., having pin 70) causes the piston 26 to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing 12 (see at least fig. 1 and par 0013-0014, 0038, 0041, 0044 & 0055-0056).
In regards to claim 8, Miller discloses the system of Claim 7, wherein the apparatus further includes:
a fitting (i.e., having outlet port 32) disposed at a distal end of the pump housing 12, the fitting (i.e., having outlet port 32) attachable to the handle 38 of the medical device (i.e., catheter such as dilatation catheter) (see at least fig. 1 and par 0040 & 0057).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 7-9 & 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik (US 2007/0265573) in view of Miller (US 2013/0006176).
In regards to claim 1, Fojtik discloses an apparatus 10 capable of generating a continuous vacuum during a tissue biopsy procedure (see at least abstract), the apparatus comprising:
a pump housing 20 having a distal end 14 attachable to a medical device (i.e., needle, catheter) and a longitudinal axis (AB, AP) (see at least fig. 1 and par 0026-0027);
a piston 34 slidably receivable within the pump housing 20, the piston 34 being configured to create a seal between a distal portion of the pump housing 20 and a proximal portion of the pump housing 20 (see at least fig. 1 and par 0038-0040);
PNG
media_image2.png
360
706
media_image2.png
Greyscale
a piston rod 30 extending proximally from a proximal side of the piston 34 (see at least figs. 8A-B and par 0026); and
a handle 40 including a grip 60 having a distal end and a proximal end and a handle arm 50 extending at an angle from the proximal end of the grip 60 (see at least figs. 1 & 8A-B and par 0043-0047) (see at least fig. 1 and par 0044-0045).
Fojtik discloses an apparatus, as described above, that fails to explicitly teach an apparatus comprising a piston rod rotatably coupled to and extending proximally from a proximal side of the piston and terminating in a proximal end with a piston rod pivot; a handle including a grip having a distal end and a proximal end and a handle arm extending at a fixed angle from the proximal end of the grip, the handle rotatably attached to the pump housing at a handle pivot disposed between the grip and the handle arm and a proximal end of the handle arm rotatably pivotably attached to the piston rod with a pivot pin coupled to the piston rod pivot, wherein rotating the handle towards the pump housing about the handle pivot causes the piston to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing, and wherein the handle pivot is in a fixed position relative to the pump housing.
However, Miller teaches that it is known to provide an apparatus 10 comprising:
a pump housing 12 having a distal end 14 attachable to a medical device and a longitudinal axis (see at least fig. 1 and par 0038);
a piston 26 slidably receivable within the pump housing 12, the piston 26 being configured to create a seal between a distal portion of the pump housing 12 and a proximal portion of the pump housing 12 (see at least fig. 1 and par 0039-0042);
a piston rod 22 rotatably coupled to and extending proximally from a proximal side of the piston 26 and terminating in a proximal end with a piston rod pivot (i.e., having pin 73) (see at least fig. 1 and par 0038-0039 & 0045); and
a handle 38 including a grip 98 having a distal end and a proximal end and a handle arm 66 extending at a fixed angle from the proximal end of the grip 98 (see at least fig. 1 and par 0044-0045), the handle 38 rotatably attached to the pump housing 12 at a handle pivot (i.e., having pin 70) disposed between the grip 98 and the handle arm 66 and a proximal end of the handle arm 66 rotatably pivotably attached to the piston rod 22 with a pivot pin 73 coupled to the piston rod pivot (i.e., having pin 73) (see at least fig. 1 and par 0044-0045),
wherein rotating the handle 38 towards the pump housing 12 about the handle pivot (i.e., having pin 70) causes the piston 26 to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing 12 (see at least fig. 1 and par 0038, 0041, 0044 & 0055-0056), and
wherein the handle pivot (i.e., having pin 70) is in a fixed position relative to the pump housing 12 (see at least fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik comprising a piston rod rotatably coupled to and extending proximally from a proximal side of the piston and terminating in a proximal end with a piston rod pivot; a handle including a grip having a distal end and a proximal end and a handle arm extending at a fixed angle from the proximal end of the grip, the handle rotatably attached to the pump housing at a handle pivot disposed between the grip and the handle arm and a proximal end of the handle arm rotatably pivotably attached to the piston rod with a pivot pin coupled to the piston rod pivot, wherein rotating the handle towards the pump housing about the handle pivot causes the piston to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing, and wherein the handle pivot is in a fixed position relative to the pump housing as taught by Miller since such a modification would amount to applying a known technique (i.e., the actuator or lever mechanism of Miller) to a known device (i.e., as taught by Fojtik) ready for improvement to achieve a predictable result such as allowing the actuator or lever mechanism to pivot providing controlled movement of the plunger when either the first end of the actuator or the second end of the actuator is pushed toward the pump body (see at least par 0019 of Miller)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Fojtik discloses the apparatus 10 of Claim 1
further comprises: a fitting 25 disposed at a distal end of the pump housing 20, the fitting 25 attachable to a handle 62 of a medical device (i.e., needle, catheter) (see at least figs. 2-3 and par 0032-0033).
In regards to claim 3, Fojtik discloses the apparatus 10 of Claim 2, wherein the pump housing 20 includes an intake valve 83 disposed between the fitting 25 and a distal end of the pump housing 20, the intake valve 83 being configured to allow air to flow proximately between the distal end of the pump housing 20 and the pump housing 20 (see at least fig. 3 and par 0034).
In regards to claim 7, Fojtik discloses a system capable of providing a vacuum force during a tissue biopsy procedure (see at least abstract), the system comprising:
a medical device (i.e., needle, catheter) (i.e., catheter such as dilatation catheter) including:
a handle (not shown but inherent); and
an insertion portion (not shown but inherent); and
a vacuum generation apparatus 10 including:
a pump housing 20 having a distal end 14 attachable to the medical device (i.e., needle, catheter) (i.e., catheter) and a longitudinal axis (AB, AP) (see at least fig. 1 and par 0026-0027);
a piston rod 30 extending proximally from a proximal side of a piston 34 (see at least figs. 8A-B and par 0026); and
PNG
media_image2.png
360
706
media_image2.png
Greyscale
a handle 40 including a grip 60 having a distal end and a proximal end and a handle arm 50 extending at an angle from the proximal end of the grip 60 (see at least figs. 1 & 8A-B and par 0043-0047) (see at least fig. 1 and par 0044-0045).
Fojtik discloses a system, as described above, that fails to explicitly teach a system comprising a piston rod rotatably coupled to and extending proximally from a proximal side of a piston to a proximal end; a handle including a grip having a distal end and a proximal end and a handle arm extending at a fixed angle from the proximal end of the grip, the handle rotatably attached to the pump housing at a handle pivot disposed in a fixed position relative to the pump housing between the grip and the handle arm and a proximal end of the handle arm rotatably pivotably attached to the proximal end of the piston rod via a pivot pin, wherein rotating the handle towards the pump housing about the handle pivot causes the piston to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing.
However, Miller teaches that it is known to provide a system comprising:
a medical device (i.e., catheter such as dilatation catheter) including:
a handle (not shown but inherent); and
an insertion portion (not shown but inherent); and
a vacuum generation apparatus 10 including:
a pump housing 12 having a distal end 14 attachable to the medical device (i.e., catheter) and a longitudinal axis (see at least fig. 1 and par 0038);
a piston rod 22 rotatably coupled to and extending proximally from a proximal side of a piston 26 to a proximal end (see at least fig. 1 and par 0038-0039 & 0045); and
a handle 38 including a grip 98 having a distal end and a proximal end and a handle arm 66 extending at a fixed angle from the proximal end of the grip 98 (see at least fig. 1 and par 0044-0045), the handle 38 rotatably attached to the pump housing 12 at a handle pivot (i.e., having pin 70) (see par 0020) disposed in a fixed position relative to the pump housing 12 between the grip 98 and the handle arm 66 and a proximal end of the handle arm 66 rotatably pivotably attached to the proximal end of the piston rod 22 via a pivot pin 73 (see at least fig. 1 and par 0044-0045),
wherein rotating the handle 38 towards the pump housing 12 about the handle pivot (i.e., having pin 70) causes the piston 26 to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing 12 (see at least fig. 1 and par 0013-0014, 0038, 0041, 0044 & 0055-0056).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Fojtik comprising a piston rod rotatably coupled to and extending proximally from a proximal side of a piston to a proximal end; a handle including a grip having a distal end and a proximal end and a handle arm extending at a fixed angle from the proximal end of the grip, the handle rotatably attached to the pump housing at a handle pivot disposed in a fixed position relative to the pump housing between the grip and the handle arm and a proximal end of the handle arm rotatably pivotably attached to the proximal end of the piston rod via a pivot pin, wherein rotating the handle towards the pump housing about the handle pivot causes the piston to move from a first distal position proximally to a second proximal position to generate vacuum within the pump housing as taught by Miller since such a modification would amount to applying a known technique (i.e., the actuator or lever mechanism of Miller) to a known device (i.e., as taught by Fojtik) ready for improvement to achieve a predictable result such as allowing the actuator or lever mechanism to pivot providing controlled movement of the plunger when either the first end of the actuator or the second end of the actuator is pushed toward the pump body (see at least par 0019 of Miller)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 8, Fojtik discloses the system of Claim 7, further includes:
a fitting 25 disposed at a distal end of the pump housing 20, the fitting 25 attachable to the handle 62 of the medical device (i.e., needle, catheter) (see at least figs. 2-3 and par 0032-0033).
In regards to claim 9, Fojtik discloses the system of Claim 8, wherein the pump housing 20 includes an intake valve 83 disposed between the fitting 25 and a distal end of the pump housing 20, the intake valve 83 being configured to allow air to flow proximately between the distal end of the pump housing 20 and the pump housing 20 (see at least fig. 3 and par 0034).
In regards to claim 17, Fojtik discloses a method for continuously generating a vacuum during a tissue biopsy procedure, the method comprising:
placing a hand pump 10 in a pre-activated state, the hand pump 10 including:
a piston 34 coupled to a piston rod 30 extending proximally from a proximal side of the piston 34 (see at least fig. 1 and par 0038-0040);
a piston housing 20 configured to receive the piston 34 therein (see at least fig. 1 and par 0026-0027);
a fitting 25 disposed at a distal end of the piston housing 20 (see at least figs. 2-3 and par 0032-0033); and
PNG
media_image2.png
360
706
media_image2.png
Greyscale
a handle 40 including a grip 60 including a body 63 with an oval cavity (see at least figs. 8A-B and par 0044-0045), the body 63 having a distal end and a proximal end (see at least figs. 8A-B), the handle 40 configured to move the piston 34 within the piston housing 20 (see at least figs. 8A-B and par 0068-0073); and
placing the hand pump 10 in the activated state responsive to a distal end of a medical device (i.e., needle, catheter) being disposed adjacent to a target tissue and the fitting 25 being coupled to the medical device (i.e., needle, catheter) (see at least figs. 8A-B and par 0068-0073), wherein the placing the hand pump in the activated state includes pivoting the grip against the piston housing.
Fojtik discloses a method, as described above, that fails to explicitly teach a method comprising repeatedly placing the hand pump in a pre-activated state and subsequently placing the hand pump in the activated state to continuously generate vacuum during the tissue biopsy procedure.
However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Fojtik comprising repeatedly placing the hand pump in a pre-activated state and subsequently placing the hand pump in the activated state to continuously generate vacuum during the tissue biopsy procedure as claimed in order to more biopsy sample.
Fojtik, as modified above, discloses a method, as described above, that fails to explicitly teach a method with the body having a distal end and a proximal end and handle arm extending at a fixed angle from the proximal end of the grip, the handle configured to move the piston within the piston housing upon rotation of the group about a handle pivot disposed in a fixed position relative to the pump housing between the grip and the handle arm, wherein the placing the handle pump in the pre-activated state includes pivoting the grip away from the piston housing.
However, Miller teaches that it is known to provide a method with the body having a distal end and a proximal end 40 and handle arm 66 extending at a fixed angle from the proximal end 40 of the grip 98, the handle 38 configured to move the piston 26 within the piston housing 12 upon rotation of the grip 98 about a handle pivot (i.e., having pin 70) disposed in a fixed position relative to the pump housing 12 between the grip 98 and the handle arm 66, wherein the placing the hand pump 10 in the pre-activated state includes pivoting the grip 98 away from the piston housing 12 (see at least fig. 1 and par 0013-0014, 0038-0039, 0041, 0044-0045 & 0055-0056).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Fojtik, as modified above, with the body having a distal end and a proximal end and handle arm extending at a fixed angle from the proximal end of the grip, the handle configured to move the piston within the piston housing upon rotation of the group about a handle pivot disposed in a fixed position relative to the pump housing between the grip and the handle arm, wherein the placing the handle pump in the pre-activated state includes pivoting the grip away from the piston housing as taught by Miller since such a modification would amount to applying a known technique (i.e., the actuator or lever mechanism of Miller) to a known device (i.e., as taught by Fojtik) ready for improvement to achieve a predictable result such as allowing the actuator or lever mechanism to pivot providing controlled movement of the plunger when either the first end of the actuator or the second end of the actuator is pushed toward the pump body (see at least par 0019 of Miller)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 18, Fojtik discloses the method of Claim 17, wherein;
the piston 34 is in a distal position within the piston housing 20 as a result of the hand pump 10 being in the pre-activated state; and
the piston 34 moves in a proximal direction within the piston housing 20 as a result of the hand pump 10 being in the activated state (see at least figs. 8A-B and par 0069-0073).
Claim(s) 4-6, 10-12 & 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik (US 2007/0265573) (“Fojtik ‘573” hereinafter) in view of Miller (US 2013/0006176) further in view of Fojtik (US 2011/0224642) (“Fojtik ‘642” hereinafter).
In regards to claim 4, Fojtik ‘573 as modified by Miller discloses the apparatus 10 of Claim 3, that fails to explicitly teach an apparatus wherein the pump housing includes an exhaust valve disposed at the distal end of the pump housing, the exhaust valve being configured to allow air to flow from within the pump housing to an exterior of the pump housing. However, Fojtik ‘642 teaches that is known to provide an apparatus wherein the pump housing 20 includes an exhaust valve 50 disposed at the distal end of the pump housing 20, the exhaust valve 50 being configured to allow air to flow from within the pump housing to an exterior of the pump housing 20 (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller wherein the pump housing includes an exhaust valve disposed at the distal end of the pump housing, the exhaust valve being configured to allow air to flow from within the pump housing to an exterior of the pump housing as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 5, Fojtik ‘573 as modified by Miller discloses the apparatus 10 of Claim 4, that fails to explicitly teach an apparatus further comprising a biasing member configured to apply a distal force to the piston; and wherein the piston is movable distally within the pump housing responsive to the distal force applied by the biasing member, the intake valve being configured to close and the exhaust valve being configured to open. However, Fojtik ‘642 teaches that is known to provide an apparatus further comprising a biasing member 60 configured to apply a distal force to the piston 30; and wherein the piston 30 is movable distally within the pump housing 20 responsive to the distal force applied by the biasing member 60, the intake valve (40, 40’) being configured to close and the exhaust valve (50, 50’, 150’) being configured to open (see at least figs. 1-3 & 7-10 and par 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller further comprising a biasing member configured to apply a distal force to the piston; and wherein the piston is movable distally within the pump housing responsive to the distal force applied by the biasing member, the intake valve being configured to close and the exhaust valve being configured to open as taught by Fojtik ‘642 since such a modification would amount to applying a known technique (i.e., the spring as taught by Fojtik ‘642) to a known device (i.e., as taught by Fojtik ‘573) ready for improvement to achieve a predictable result such as facilitating movement of the plunger through the interior of the barrel (see at least par 0046 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 6, Fojtik discloses the apparatus 10 of Claim 5, that fails to explicitly teach an apparatus wherein the piston is movable proximately within the pump housing responsive to motion of the handle toward the pump housing, the intake valve being configured to open and the exhaust valve being configured to close. However, Fojtik ‘642 teaches that is known to provide an apparatus wherein the piston 30 is movable proximately within the pump housing 20 responsive to motion of the handle 38 toward the pump housing 20, the intake valve 40 being configured to open and the exhaust valve 50 being configured to close (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller wherein the piston is movable proximately within the pump housing responsive to motion of the handle toward the pump housing, the intake valve being configured to open and the exhaust valve being configured to close as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 10, Fojtik ‘573 as modified by Miller discloses the system of Claim 9, that fails to explicitly teach a system wherein the pump housing includes an exhaust valve disposed at the distal end of the pump housing, the exhaust valve being configured to allow air to flow from within the pump housing to an exterior of the pump housing. However, Fojtik ‘642 teaches that it is known to provide a system wherein the pump housing 20 includes an exhaust valve 50 disposed at the distal end of the pump housing 20, the exhaust valve 50 being configured to allow air to flow from within the pump housing 20 to an exterior of the pump housing 20 (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller wherein the pump housing includes an exhaust valve disposed at the distal end of the pump housing, the exhaust valve being configured to allow air to flow from within the pump housing to an exterior of the pump housing as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 11, Fojtik ‘573 as modified by Miller discloses the system of Claim 10, that fails to explicitly teach a system wherein the piston is movable distally within the pump housing responsive to motion of the handle away from the pump housing, the intake valve being configured to close and the exhaust valve being configured to open. However, Fojtik ‘642 teaches that it is known to provide a system wherein the piston 30 is movable distally within the pump housing 20 responsive to motion of the handle 38 away from the pump housing 20, the intake valve 40 being configured to close and the exhaust valve 50 being configured to open (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller wherein the piston is movable distally within the pump housing responsive to motion of the handle away from the pump housing, the intake valve being configured to close and the exhaust valve being configured to open as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 12, Fojtik ‘573 as modified by Miller discloses the system of Claim 10, that fails to explicitly teach a system wherein the piston is movable proximately within the pump housing responsive to motion of the handle toward the pump housing, the intake valve being configured to open and the exhaust valve being configured to close. However, Fojtik ‘642 teaches that it is known to provide a system wherein the piston 30 is movable proximately within the pump housing 20 responsive to motion of the handle 38 toward the pump housing 20, the intake valve 40 being configured to open and the exhaust valve 50 being configured to close (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller wherein the piston is movable proximately within the pump housing responsive to motion of the handle toward the pump housing, the intake valve being configured to open and the exhaust valve being configured to close as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Fojtik ‘573 as modified by Miller discloses the method of Claim 18, that fails to explicitly teach a method further comprising: responsive to the piston moving in a distal direction within the piston housing, expelling air from the piston housing through a first one-way valve and blocking air from entering the piston housing via a second one-way valve located between the fitting and the piston housing. However, Fojtik ‘642 teaches that it is known to provide a method comprising: responsive to the piston 30 moving in a distal direction within the piston housing 20, expelling air from the piston housing 20 through a first one-way valve 50 and blocking air from entering the piston housing 20 via a second one-way valve 40 located between the fitting and the piston housing 20 (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller further comprising: responsive to the piston moving in a distal direction within the piston housing, expelling air from the piston housing through a first one-way valve and blocking air from entering the piston housing via a second one-way valve located between the fitting and the piston housing as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 20, Fojtik ‘573 as modified by Miller discloses the method of Claim 19, that fails to explicitly teach a method further comprising: responsive to the piston moving in a proximal direction within the piston housing, receiving air into the piston housing via the second one-way valve located between the fitting and the piston housing and blocking air from exiting the first one-way valve. However, Fotjik ‘642 further comprising: responsive to the piston 34 moving in a proximal direction within the piston housing 20, receiving air into the piston housing 20 via the second one-way valve 40 located between the fitting and the piston housing 20 and blocking air from exiting the first one-way valve 50 (see at least abstract, figs. 1-3 & 7-9 and par 0029-0033 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fojtik ‘573 as modified by Miller further comprising: responsive to the piston moving in a proximal direction within the piston housing, receiving air into the piston housing via the second one-way valve located between the fitting and the piston housing and blocking air from exiting the first one-way valve as taught by Fojtik ‘642 since such a modification would amount to a simple substitution of one known element (i.e., the stopcock valve as taught by Fojtik ‘573) for another (i.e., the pair of one-way valves as taught by Fojtik ‘642) to obtain predictable results such as controlling the flow of fluid into or out of the distal opening of the syringe barrel (see at least par 0003-0005 of Fojtik ‘642)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik ‘573 in view Miller (‘176), Fojtik ‘642 further in view of Wang (US 4,532,935).
In regards to claim 13, although Fojtik ‘573 discloses a system wherein the medical device includes a needle (see at least par 0012 & 0032-0033 & 0073), Fojtik ‘573 as modified by Miller and Fojtik ‘642 discloses the system of Claim 7, that fails to explicitly teach a system, the handle of the medical device including a stylet inlet port couplable to the fitting. However, Wang teaches that it is known to provide a system the handle of the medical device including a stylet inlet port 32 couplable to the fitting 26 (see at least abstract and fig. 1 and col. 3, lines 16-41). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Fojtik ‘573 as modified by Miller and Fojtik ‘642, the handle of the medical device including a stylet inlet port couplable to the fitting as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Wang) to a known device (i.e., as taught by Fojtik ‘573) ready for improvement to achieve a predictable result such as providing a protection means which can be removed at the desired time to expose the sharp edge of the needle so as to permit taking of biopsy needles (see at least col. 1, lines 51-57 of Wang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, Fojtik ‘573 as modified by Miller and Fojtik ‘642 discloses the system of Claim 13, that fails to explicitly teach a system wherein the fitting and the stylet inlet port include Luer fittings. However, Wang teaches that it is known to provide a system wherein the fitting and the stylet inlet port include Luer fittings 24 (see at least abstract and fig. 1 and col. 3, lines 16-41). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Fojtik ‘573 as modified by Miller and Fojtik ‘642 wherein the fitting and the stylet inlet port include Luer fittings as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Wang) to a known device (i.e., as taught by Fojtik ‘573) ready for improvement to achieve a predictable result such as providing a protection means which can be removed at the desired time to expose the sharp edge of the needle so as to permit taking of biopsy needles (see at least col. 1, lines 51-57 of Wang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik ‘573 in view Miller (‘176), Fojtik ‘642 further in view of Laine et al. (US 5,261,889) (“Laine” hereinafter).
In regards to claim 15, Fojtik ‘573 as modified by Miller and Fojtik ‘642 discloses the system of Claim 7, that fails to explicitly teach a system further comprising:
a multi-lumen catheter device including: a flexible insertion tube comprising two or more lumen; a handle configured to be couplable to an endoscope, the handle including:
a base section; and an inlet port being configured to be slidably received longitudinally along the base section and configured to slidably receive the insertion portion of the medical device; and wherein: the medical device includes a needle slidably received within the insertion portion; and the handle of the medical device includes a stylet inlet port couplable to the distal end of the pump housing. However, Laine teaches that it is known to provide a system further comprising: a multi-lumen catheter device 10 including: a flexible insertion tube comprising two or more lumen (23, 24); a handle 30 configured to be couplable to an endoscope 14, the handle 30 including: a base section 36; and an inlet port being configured to be slidably received longitudinally along the base section and configured to slidably receive the insertion portion 20 of the medical device 25; and wherein: the medical device includes a needle 25 slidably received within the insertion portion 20; and the handle of the medical device includes a stylet inlet port (34, 38) couplable to the distal end of the pump housing 40 (see at least figs. 1-6 and col. 2, lines 46-68, col. 3, lines 1-66). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Fojtik ‘573 as modified by Miller and Fojtik ‘642 further comprising: a multi-lumen catheter device including: a flexible insertion tube comprising two or more lumen; a handle configured to be couplable to an endoscope, the handle including: a base section; and an inlet port being configured to be slidably received longitudinally along the base section and configured to slidably receive the insertion portion of the medical device; and wherein: the medical device includes a needle slidably received within the insertion portion; and the handle of the medical device includes a stylet inlet port couplable to the distal end of the pump housing as taught by Laine in order to provide a catheter for use with an endoscope that supports a retractable needle for introduction into the body and allows for simultaneous visualization of the needle via an adjacent port thereof.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik ‘573 in view Miller (‘176), Fojtik ‘642, Laine (‘889) further in view of Wang (US 4,532,935).
Fojtik ‘573 as modified by Miller, Fojtik ‘642 and Laine discloses the system of Claim 15, that fails to explicitly teach a system wherein the distal end of the pump housing and the stylet inlet port include Luer fittings. However, However, Wang teaches that it is known to provide a system wherein the distal end of the pump housing and the stylet inlet port include Luer fittings 24 (see at least abstract and fig. 1 and col. 3, lines 16-41). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Fojtik ‘573 as modified by Miller, Fojtik ‘642 and Laine wherein the distal end of the pump housing and the stylet inlet port include Luer fittings as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Wang) to a known device (i.e., as taught by Fojtik ‘573) ready for improvement to achieve a predictable result such as providing a protection means which can be removed at the desired time to expose the sharp edge of the needle so as to permit taking of biopsy needles (see at least col. 1, lines 51-57 of Wang)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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, Jason M. Sims can be reached on 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RENE T TOWA/Primary Examiner, Art Unit 3791