3DETAILED 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-19 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Geiss et al. USPN 4834724 in view of Teague et al. US Patent Application Publication 2011/0066159.
As to claim 1, Geiss teaches a medical system for applying negative pressure within a gastrointestinal tract of a subject (col. 2, lines 33-36), the system comprising:
an elongate tube 10 defining:
at least one interior channel 14 along at least a longitudinal portion of the elongate tube 10 (Fig. 2-4; col. 3, lines 58-60);
a plurality of orifices 40 in fluid communication with the at least one interior channel 14 (col. 2, lines 38-41; col. 4, lines 24-27); and
at least one exterior channel 15 extending longitudinally along an exterior surface of the elongate tube (Fig 2-4; col. 3, lines 60-63),
at least one of the at least one exterior channel 15 being in fluid communication with the at least one interior channel 14 via at least one of the plurality of orifices,
the elongate tube having a delivery state, and a first operative state in which the elongate tube forms a coil 19 including a plurality of loops 20; and
a fluid-tight lumen 44 in fluid communication with an end 28 of the elongate tube 10, the fluid-tight lumen 44 adapted to couple to a source of negative pressure and to deliver negative pressure to the elongate tube (Fig. 3; col. 4, line 66-68).
Geiss teaches the present invention substantially as claimed. Geiss teaches that in the first operative state of the elongate tube 10, the coil 19 has a plurality of loops 20, which include at least 4 loops (Figures 2, 4, 7B and 8). Geiss is silent as to the length of the coil. Teague from the same field of endeavor, teaches a medical retrieval deice for removing material from a patient’s body. Teague teaches the device has a helical coil 108 (Fig. 9A; para. 0048). Teague further teaches the number of turns, the maximum diameter, and the length of the helical coil 108 depends on the intended use of the retrieval assembly. Teague teaches typically, the helical coil 108 has between about 5 and 15 turns, its maximum diameter, at the proximal end is in the range of about 0.2 cm to 3.0 cm, and the overall length of the helical coil 108 typically is in the range of about 0.5 cm to about 3.0 cm and for most applications is preferably about 1.5 cm (about 15mm) (Fig. 9A; para. 0049). It would have been obvious to one having ordinary skill in the art to provide the device of Geiss with the claimed coil length of 15 mm as taught in Teague since both references are from the same field of endeavor and solve the same problem of treating a body tract of a subject.
As to claim 2, the medical system of claim 1, wherein the at least one interior channel 14 comprises a first interior channel adapted for drainage of a fluid from the gastrointestinal tract, via the at least one exterior channel 15 and the plurality of orifices 40, when negative pressure is applied to the elongate tube (Geiss col. 5, lines 1-13).
As to claim 3, the elongate tube 10 comprises a shape memory material, an elastic material, or a super-elastic material adapted to form the coil 19 in the first operative state (Geiss col. 2, lines 62-66, col. 4, lines 1-5; col. 4, lines 17-25; col. 5, line 63 through col. 6, line 12).
As to claim 4, the elongate tube 10 has a textured exterior surface 19 adapted to frictionally engage an interior surface of the gastrointestinal tract (Geiss col. 4, line 64 through col. 5, line 13).
As to claim 5, The medical system of claims 1, wherein the at least one exterior channel 15 comprises a plurality of exterior channels forming troughs on the exterior surface of the elongate tube and extending longitudinally there along (Geiss Fig. 5).
As to claim 6, the medical system of 1, wherein the plurality of orifices 40 are disposed about a single circumference of the elongate tube (Geiss Fig. 2, 5).
As to claim 7, wherein the at least one exterior channel 15 extends longitudinally along the exterior surface of the elongate tube 10 between the orifices 40 and a distal end 32 of the elongate tube 10 (Geiss Figures 1A, 2A, and 2-4).
As to claim 8, The medical system of claim 1, wherein the plurality of orifices 40 are disposed longitudinally along a longitudinal length of the elongate tube 10 (Geiss Fig. 2 and 4).
As to claim 9, the medical system of claim 1, wherein orifices in a first subset of the plurality of orifices 40 have a first diameter, and orifices in a second subset of the plurality of orifices – openings at spacers 60, have a second diameter, the second diameter being different from the first diameter (Fig. 5).
As to claim 10, in the first operative state, at least some of the plurality of orifices 40 are oriented outwardly, away from a center of the coil (Geiss col 4, line 66-68).
As to claim 11, wherein, in the first operative state, at least some of the plurality of orifices are oriented inwardly, toward a center of the coil (Geiss col. 3, lines 4-5).
As to claim 12, wherein, in the first operative state of the elongate tube, at least one of the plurality of loops has a sinusoidal structure (Geiss Fig. 2, 4).
As to claim 13, the medical system of claim 1, further comprising a linearizing element 76, wherein the elongate tube 10 has the delivery state, which is a linear state (Geiss Fig 7A 7B, 8), when associated with the linearizing element 76, and the first operative state, in which the elongate tube forms the coil (Geiss Fig. 2, 4), when dissociated from the linearizing element (Geiss Fig. 7B: col. 5, lines 41-52).
As to claim 14, wherein the fluid-tight lumen, and the elongate tube in the delivery state, are sized and configured to pass through a working channel of a delivery device 80 (Geiss Fig. 8; col. 5, lines 53-62). Geiss is silent as to the diameter of the working channel. Teague teaches typically, the helical coil 108 has between about 5 and 15 turns, its maximum diameter, at the proximal end is in the range of about 0.2 cm to 3.0 cm (2mm to 30 mm). In order for the tube of Geiss to pass through the delivery device 80, the delivery device channel must be at least larger than 2mm. Teague teaches the maximum diameter depends on the intended use of the retrieval assembly (para. 0049). It would have been obvious to one having ordinary skill in the art to provide the working channel with a diameter smaller than 5mm to accommodate the maximum diameter of the elongate tube in the delivery state.
As to claim 15, the medical system of 1, wherein the delivery state of the elongate tube is a coiled state (Fig. 8), and the elongate tube is adapted to be delivered into the gastrointestinal tract of the subject disposed about the exterior of a delivery device 80 (Geiss Fig. 1 and 8; col. 5, lines 53-62).
.
As to claim 16, Geiss teaches a medical system for applying negative pressure within a gastrointestinal tract of a subject (Geiss col. 2, lines 33-36), the system comprising:
an elongate tube 10 defining:
at least one channel 14 along at least a longitudinal portion thereof 10 (Geiss Fig. 2-4; col. 3, lines 58-60);
a plurality of orifices 40 in fluid communication with the at least one channel 14 (Geiss col. 2, lines 38-41; col. 4, lines 24-27); and
the elongate tube having a delivery state, and a first operative state in which the elongate tube forms a coil 19 including a plurality of loops 20;
at least some of the plurality of loops 20 have a sinusoidal structure (Geiss Fig. 2 and 4); and
a fluid-tight lumen 44 in fluid communication with an end 28 of the elongate tube 10, the fluid-tight lumen 44 adapted to couple to a source of negative pressure and to deliver negative pressure to the at least one channel 14 via the end of the elongate tube (Geiss Fig. 3; col. 4, line 66-68).
Geiss teaches the present invention substantially as claimed. Geiss teaches that in the first operative state of the elongate tube 10, the coil 19 has a plurality of loops 20, which include at least 4 loops (Geiss Figures 2, 4, 7B and 8). Geiss is silent as to the length of the coil. Teague from the same field of endeavor, teaches a medical retrieval deice for removing material from a patient’s body. Teague teaches the device has a helical coil 108 (Geiss Fig. 9A; para. 0048). Teague further teaches the number of turns, the maximum diameter, and the length of the helical coil 108 depends on the intended use of the retrieval assembly. Teague teaches typically, the helical coil 108 has between about 5 and 15 turns, its maximum diameter, at the proximal end is in the range of about 0.2 cm to 3.0 cm, and the overall length of the helical coil 108 typically is in the range of about 0.5 cm to about 3.0 cm and for most applications is preferably about 1.5 cm (about 15mm) (Geiss Fig. 9A; para. 0049). It would have been obvious to one having ordinary skill in the art to provide the device of Geiss with the claimed coil length of 15 mm as taught in Teague since both references are from the same field of endeavor and solve the same problem of treating a body tract of a subject.
As to claim 17, the medical system of claim 16, wherein the at least one channel 14 is adapted for drainage of a fluid from the gastrointestinal tract, via the plurality of orifices 40, when negative pressure is applied to the elongate tube (Geiss col. 5, lines 1-13).
As to claim 18, the elongate tube 10 comprises a shape memory material, an elastic material, or a super-elastic material adapted to form the coil 19 in the first operative state (Geiss col. 2, lines 62-66, col. 4, lines 1-5; col. 4, lines 17-25; col. 5, line 63 through col. 6, line 12).
As to claim 19, the elongate tube 10 has a textured exterior surface 19 adapted to frictionally engage an interior surface of the gastrointestinal tract (Geiss col. 4, line 64 through col. 5, line 13).
As to claim 28, Geiss teaches a medical system for applying negative pressure within a gastrointestinal tract of a subject (Geiss col. 2, lines 33-36), the system comprising:
an elongate tube 10 defining:
at least one channel 14 along at least a longitudinal portion of the elongate tube 10 (Geiss Fig. 2-4; col. 3, lines 58-60);
a plurality of orifices 40 in fluid communication with the at least one channel 14 (Geiss col. 2, lines 38-41; col. 4, lines 24-27); the elongate tube including:
a coil portion 19 forming a coil 19 having a plurality of loops 20; and
a linear portion 24 extending through a longitudinal center of the coil portion 19 (Geiss Fig. 2 and 4; col. 3, lines 64-68); and
a fluid-tight lumen 44 in fluid communication with the elongate tube 10, the fluid-tight lumen 44 adapted to couple to a source of negative pressure and to deliver negative pressure to the coil portion of the elongate tube (Fig. 3; col. 4, line 66-68).
wherein the elongate tube 10 is adapted to be delivered into the gastrointestinal tract of the subject with the coil portion 19 disposed about the exterior of a delivery device 80 and the linear portion 24 extending through the interior of the delivery device (Geiss Fig. 1 and 8; col. 5, lines 53-62).
Geiss teaches the present invention substantially as claimed. Geiss teaches that in the first operative state of the elongate tube 10, the coil 19 has a plurality of loops 20, which include at least 4 loops (Geiss Figures 2, 4, 7B and 8). Geiss is silent as to the length of the coil. Teague from the same field of endeavor, teaches a medical retrieval deice for removing material from a patient’s body. Teague teaches the device has a helical coil 108 (Geiss Fig. 9A; para. 0048). Teague further teaches the number of turns, the maximum diameter, and the length of the helical coil 108 depends on the intended use of the retrieval assembly. Teague teaches typically, the helical coil 108 has between about 5 and 15 turns, its maximum diameter, at the proximal end is in the range of about 0.2 cm to 3.0 cm, and the overall length of the helical coil 108 typically is in the range of about 0.5 cm to about 3.0 cm and for most applications is preferably about 1.5 cm (about 15mm) (Geiss Fig. 9A; para. 0049). It would have been obvious to one having ordinary skill in the art to provide the device of Geiss with the claimed coil length of 15 mm as taught in Teague since both references are from the same field of endeavor and solve the same problem of treating a body tract of a subject.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Frassica USPN 7048717, Kugler et al. US Patent Application Publication 2006/0240096, and Quinn US Patent Application Publication 2004/0158229 are cited to show systems and method of treating a gastrointestinal tract of a subject.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781