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 .
Response to Arguments
Claims 6, 8, 11, 20-27, and 29-43 are cancelled. Claims 1-5, 7, 9, 10, 12-19, 28, and 44-46 are pending.
Applicant's arguments filed 05/21/2026 have been fully considered and they are partially persuasive. With respect to claim 1, Applicant states the Office equates the claimed interior channel to lumen 14 of Geiss, the claimed orifices to orifices 40 of Geiss, and the exterior channel to lumen 15 of Geiss, all shown in Figs. 2-4. Applicant argues in the prior art Geiss, external channel 15 is a separate tube from main elongate tube 14 as shown in Fig. 1A of Geiss, and functions as a sump, and only has fluid communication with main channel 14 at the distal end thereof to break the vacuum. Additionally, the disclosure of Geiss specifies that the sump 15 is connected to the main channel 14 via a single port at the distal end, not via orifices 40. Applicant argues that by contrast, in the present invention, the exterior channel is not a separate tube, but rather is formed within the wall (body) of the elongate tube. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the exterior channel is formed within the wall (body) of the elongate tube) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Amended claim 1 claims “at least one exterior channel being formed in, and extending longitudinally along an exterior surface of the tube wall”. Exterior channel 15 is formed in an ‘exterior’ surface’ of the tube wall and extends longitudinally along the exterior surface of the tube wall (Fig 2-4; col. 3, lines 60-63).
Applicant further argues the sump of the prior art has a completely different purpose, and is designed to solve the problem of mucosa being sucked into the ports, by breaking the vacuum. Consequently, the sump cannot be in communication with the main channel via the orifices, as that would negate the purpose for which the sump was intended. Applicant’s arguments are not persuasive as the exterior channel 15 also is in fact in fluid communication with the elongate tube 14 via at least one of the plurality of orifices where Geiss teaches the tube 10 includes a second elongated lumen 15 parallel with and affixed to the first lumen 14 (col. 3, lines 60-62) and fluidly connected with ports 40 as seen in Figs. 2 and 2A. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the exterior channel(s) is (are) formed in the wall of the elongate tube, and are not a separate tube from the elongate tube) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). What is recited in amended claim 1 is “at least one exterior channel being formed in, and extending longitudinally along, an exterior surface of the elongate-tube wall”. Figures 1,1A, 2A, 2, and 3 show the channel 15 formed in and extending longitudinally along an exterior surface of the elongate-tube wall 14.
With respect to claim 16, Applicant argues in Figs. 2 and 4 of Geiss, it appears that the entire coil forms the shape of a sine wave, or is ‘sinusoidal’. However, the claim requires that one or more specific loops be sinusoidal, not that the entire coil be sinusoidal when viewed from the side. Applicant argues sinusoidal loops, as claimed, are shown in Figure 4b of the present application. Applicant also argues the definition of a loop having a sinusoidal structure is provided in page 30, lines 25-31 of the specification. Applicant’s arguments are not persuasive as they are not commensurate with the scope of the claims. It is noted that the features upon which applicant relies (i.e., one or more specific loops be sinusoidal, not that the entire coil be sinusoidal when viewed from the side) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). What is required in amended claim 16 is “each loop of the at least some of the plurality of loops has multiple longitudinal direction changes along the length of the loop or multiple changes in a sign of the slope of the loop”. Giving the broadest reasonable interpretation, the loops of Geis represent multiple changes in a sign of the slope of the loop. In other words, at least one loop shows a positive slope, the line rises as it moves from left to right (Figs. 2, 4, and 6); and at least one loop (the same loop) shows a negative slope, the line falls as it moves from left to right slope (Figs. 2, 4, and 6) – thus along the length of the loop there are multiple changes in a sign of the slope.
Applicant’s arguments with respect to independent claims 1 and 16 are not persuasive and the rejection is maintained.
As to the rejection of claim 28, the remarks are discussed under Allowable Subject Matter below.
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 1-5, , 9, 10, and 12-19 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 defined by a circumferential tube wall and including:
at least one interior channel 14 along at least a longitudinal portion 19 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 being formed in, and extending longitudinally along an exterior surface of the tube wall 14(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 longitudinal 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 tube wall 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 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 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 12, wherein, in the first operative state of the elongate tube, at least one of the plurality of loops has a sinusoidal structure, such that at least one of the plurality of loops has multiple longitudinal direction changes within the loop or multiple changes in a sign of the slope of the loop (Geiss Fig. 2, 4). Giving the broadest reasonable interpretation, the loops of Geis represent multiple changes in a sign of the slope of the loop. In other words, at least one loop shows a positive slope, the line rises as it moves from left to right (Figs. 2, 4, and 6); and at least one loop (the same loop) shows a negative slope, the line falls as it moves from left to right slope (Figs. 2, 4, and 6) – thus along the length of the loop there are multiple changes in a sign of the slope.
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);
and including 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 individually have a sinusoidal structure (Geiss Fig. 2 and 4). Giving the broadest reasonable interpretation, the loops of Geis represent multiple changes in a sign of the slope of the loop. In other words, at least one loop shows a positive slope, the line rises as it moves from left to right (Figs. 2, 4, and 6); and at least one loop (the same loop) shows a negative slope, the line falls as it moves from left to right slope (Figs. 2, 4, and 6) – thus along the length of the loop there are multiple changes in a sign of the slope.
The medical system further comprising 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 longitudinal 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).
Allowable Subject Matter
Claims 28 and 44-46 are allowed. The following is an examiner’s statement of reasons for allowance: With respect to claim 28, Applicant argues in Geiss, the tube 10, having a channel 14, is coiled around a support shaft 24. The support shaft 24, is not part of the same tube from which the coil is formed. Rather, it can be a mesh tube or another type of tube designed to provide suitable axial rigidity to the coil. By contrast, in the present inventions, the linear portion and coiled portion are a single continuous tube, as shown clearly in Fig. 9B. Thus, the prior art to Geiss does not show or suggest an elongate tube including a coiled portion and a linear portion extending through the coiled portion as claimed. The examiner respectfully disagrees. It is noted that the features upon which applicant relies (i.e., the linear portion from the same tube from which the coil is formed) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The elongate tube 10 of Geiss has a coil portion 19 and a linear portion as shown in Fig. 1. Geiss teaches a portion 19 of distal section 18 is formed in a helix having a plurality of turns 20 convolved about and affixed to an axially disposed support shaft 24 (col. 3, lines 64-68). Geiss further teaches the support shaft 24 has a proximal end 26 affixed to an axially disposed proximal end of tube 10 and a distal end 30 affixed to an axially disposed distal end 32 of tube 10 (col. 4, lines 8-11). The support shaft 24 is not a separate tube, but rather the support shaft 24 is a foraminous hollow cylinder integrated with tube 10 and forms a linear portion extending through a coiled portion as seen in Figs. 2 and 4.
Also with respect to claim 28, Applicant argues the claim reads “wherein the elongate tube is adapted to be delivered into the gastrointestinal tract of the subject with the coil portion disposed about the exterior of a delivery device and the linear portion extending through the interior of the delivery device”. Applicant argues the delivery arrangement recited in this claim limitation is clearly shown in Figure 9A. Applicant argues in the rejection of this limitation, the Office cites Figures 1 and 8 of Geiss, as well as col. 5, lines 53-62, and indicates that coil portion 19 is disposed about the exterior of a delivery device 80 and the linear portion 24 extends through the interior of the delivery device. Applicant argues Figure 8 and the description thereof do not show or suggest the subject matter as claimed, and specifically does not show the coil disposed about the exterior of sleeve 80,(which the Office considers as the delivery device). This argument is persuasive and the rejection of claim 28 is overcome by Applicant’s remarks.
Prior art Frassica USPN 7048717 teaches a medical system 121 having an elongate tube 132 and a delivery device 122 with a coil portion 123 disposed about the exterior of the delivery device (Frassica Fig. 7). However, the elongate tube 132 does not comprise a coil portion as claimed.
In view of the prior art reference, claim 28 is allowed. Claims 44-46 depend from claim 28 and are also allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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