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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 28, the new matter is that the volume of the liquid irrigation inflow fluid fills the rectum.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites "suited upstream the anal canal”; the meaning of "upstream" is unclear because "upstream" depends on the direction of fluid or other material flowing through the area.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4-8, 29, 30, 35, 37 and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers (WO 2008/103788 A1) in view of Clayton (U.S Pat. 5,197,950, hereinafter “Clayton”), and further in view of Chi (U.S. Pat. 6,613,014, hereinafter “Chi”).
Regarding claim 1, Bristol-Myers discloses a method for intermittently triggering a coordinated defecation reflex, the method comprising the following steps:
positioning a catheter proximate to a portion of a gastrointestinal tract of a user, wherein the portion of the gastrointestinal tract comprises a rectum or colon of the user, the catheter comprising:
a catheter shaft (stem 28a), and
a balloon surrounding the catheter shaft and affixed to the catheter shaft (see Fig. 1 and para. [0021], showing a catheter shaft with an inflatable balloon mounted thereon), wherein a balloon envelope having two ends fixed to the catheter shaft at two fixation points in a fluid-tight manner (see Fig. 1 showing the balloon mounted to the catheter shaft 28a at the shaft's proximal and distal ends, without any attachment therebetween), wherein the balloon envelope surrounds the catheter shaft (see Fig. 1),
inserting the catheter in portion of the gastrointestinal tract of the user;
inflating the balloon with a filling medium while the catheter is inserted in the portion of the gastrointestinal tract of the user (i.e., the fill volume or fill pressure of the balloon may be increased, such as by inflation with gas or fluid to a second pressure, as illustrated in Figs. 3, in which the portion of the bowel wall 23 adjacent to portion 42 of the catheter balloon).
It is noted that Bristol-Myers does not appear to disclose that the balloon envelope is manufactured from a non-stretchable material.
Clayton discloses a catheter for use in the rectum having an inflatable balloon attached to a tube for retaining the tube in the rectum, and discloses that the balloon is made of a plastic, flexible and distensible but non-stretchable material (see col. 7, lines 27-30).
Clayton further explains that use of the non-stretchable material controls the fully expanded shape and size of the balloon. Clayton further discloses inflating the balloon after the tube has been inserted into the rectum.
A skilled artisan would have found it obvious at the time of the invention to modify the balloon of Bristol-Myers to be manufactured from the non-stretchable material taught by Clayton, since both Bristol-Myers and Clayton disclose rectal catheters having inflatable balloons used to provide an anchoring effect within the rectum, and the use of the non-stretchable material taught by Clayton would have provided a controlled balloon shape and size while maintaining the balloon's anchoring function. Accordingly, the modification would have amounted to selecting a known material based on its suitability for its intended purpose, which has been held to support a prima facie case of obviousness. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); see also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Further, Bristol-Myers, in view of Clayton, does not appear to disclose a catheter shaft comprising an oval-shaped gripping depression receiving surface configured to restrict movement of the catheter when a finger of the user is disposed on the oval-shaped gripping depression receiving surface.
Chi discloses a catheter having a detachable push device for facilitating advancement and manipulation of the catheter, the device comprising an oval-shaped gripping depression receiving structure (see structure 22 in Figs. 1, 2, 4, 6) which is configured to restrict movement of the catheter when a finger of the user is disposed on the oval-shaped gripping depression receiving surface (i.e., the structure is intended to help the user grip and move the catheter, and therefore also to restrict the movement as desired).
A skilled artisan would have found it obvious at the time of the invention to modify the catheter of Bristol-Myers to include the oval-shaped finger-receiving gripping structure of Chi, in order to facilitated manipulation and control of the catheter during insertion, adjustment and removal, with a reasonable expectation of success (i.e., the use of an oval-shaped finger-receiving depression or groove would have been a predictable modification of the catheter gripping structure to provide the known function of facilitating secure gripping and restricting relative movement of the catheter during manipulation, as taught in Chi at col. 3, line 63 to col. 4, line 15).
Regarding claim 2, Bristol-Myers discloses that after inserting the catheter in the portion of the gastrointestinal tract of the user, a proximal fixation point of the catheter shaft is suited upstream of an anal canal of the user (see Fig. 1, showing the proximal fixation point being within the rectal lumen 23 upstream of the anal canal 22).
Regarding claim 4, Bristol-Myers discloses that after inserting the catheter in the portion of the gastrointestinal tract of the user, the proximal fixation point of the catheter shaft is situated beyond an anal canal of the user (see Fig. 1, showing the proximal fixation point being within the rectal lumen 23 upstream of the anal canal 22).
Regarding claim 5, Bristol-Myers discloses that the balloon expands in a radial direction with respect to the catheter shaft (see Figs. 2-4).
Regarding claim 6, Bristol-Myers discloses that the balloon adopts a discoidal geometrical shape when inflated with the filling medium (see Figs. 2-4).
Regarding claim 7, Bristol-Myers discloses that when the balloon adopts the discoidal geometrical shape, a distance between a peripheral-most extension of the balloon and a lateral surface of the catheter shaft is a distance between the distal fixation point of the catheter shaft and the proximal fixation point of the catheter shaft (see Figs. 2-4).
Regarding claim 8, Bristol-Myers discloses that when the balloon is inflated with the filling medium, it does not extend beyond a distal-most tip of the catheter shaft (see Figs. 2-4).
Regarding claim 29, Bristol-Myers discloses that the catheter further comprises a filling conduit 50 (see Fig. 1) for charging the balloon with filling pressure.
Regarding claim 30, Bristol-Myers discloses that the balloon is inflated using a reusable filling device (see tube 56 of Bristol-Myers which is connected to an inflation source).
Regarding claim 35, Bristol-Myers discloses that the filling operation is conducted by use of a syringe element (see pg. 6, first paragraph).
Regarding claim 37, as noted above, Chi discloses a catheter having a detachable push device for facilitating advancement and manipulation of the catheter, the device comprising an oval-shaped gripping depression receiving structure (see structure 22 in Figs. 1, 2, 4, 6) which is configured to accommodate fingers gripping the catheter during insertion.
Regarding claim 38, it is noted that Bristol-Myers, in view of Clayton and Chi, does not appear to disclose that the plurality of gripping depressions are disposed on the catheter shaft in direct proximal adjacency to a rear fixation line of the balloon.
However, to place the plurality of gripping depressions in direct adjacency to the part of the catheter that the user is intending to control would have been a matter of obviousness, as doing so would have led to a reasonable expectation of success in improved control of the balloon relative to positioning the structure further away from the balloon.
Claims 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers, in view of Clayton, further in view of Chi, further in view of Gobel (WO 2007/118621 A1, hereinafter “Gobel ‘621”).
Regarding claim 3, it is noted that Bristol-Myers, in view of Clayton, further in view of Chi, does not appear to disclose that after inserting the catheter in the portion of the gastrointestinal tract of the user, the proximal fixation point of the catheter shaft is suited in an anal canal of the user.
Gobel ‘621 discloses the desirability of triggering the coordinated defecation reflex by pressurizing a balloon introduced into the rectum, where the balloon is fixed to a catheter at proximal and distal fixation points (23b and 23a in Fig. 2, respectively), and both points are located in the anal canal upon placement of the balloon (see Applicant’s description of Gobel ‘621 at pg. 7 of the instant specification).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the method of Bristol-Myers, by placing the balloon fully into an anal canal of a user such that both its proximal and distal fixation points are fully in the anal canal, in order to result in improved sealing performance of the balloon requiring only a low filling pressure (see Applicant’s description of ‘Gobel ‘621 at pg. 7 of the instant specification).
Claims 9-11 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers, in view of Clayton, further in view of Chi, further in view of Ivanovych (UA 68194 A).
Regarding claims 9-11, it is noted that Bristol-Myers, in view of Clayton, further in view of Chi, does not appear to disclose that the balloon is inflated to a filling pressure of 10 mbar (as per claim 9), or 25 mbar (as per claim 10), or 30 mbar (as per claim 11), or 60 mbar (as per claim 18).
Ivanovych discloses the desirability of triggering the coordinated defecation reflex by pressurizing a balloon introduced into the rectum (see Abstract). The balloon is introduced into the rectum and is then elevated to a pressure of under 10 mmHg, or under approx. 13 mbar (see lines 38-41). After a period of time, the balloon pressure is elevated to 40-70 mmHg, or approx. 53-93 mbar (see lines 47-51), causing stretching of the rectum to trigger the defecation reflex. During this procedure the balloon is gradually inflated to 25 mbar, and then 30 mbar, and then to the desired range of 53-93 mbar, which contemplates a pressure of 60 mbar.
Since Bristol-Myers discloses that it is desirable to permit discharge of stool from the rectum without having to remove the appliance (see Bristol-Myers at pg. 2, second paragraph under "Summary of Invention"), a skilled artisan would have found it obvious to modify the method of Bristol-Myers so that elevating the balloon pressure triggers the defecation reflex, according to the teaching in Ivanovych, with a reasonable expectation of success in encouraging the discharge of stool while keeping the appliance in place.
Claims 12, 13, 20, 22, 23, 27 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers, in view of Clayton, further in view of Chi, further in view of Gobel (WO 2009/144028 A1, hereinafter “Gobel ‘028”).
Regarding claim 12, it is noted that Bristol-Myers does not appear to disclose that the material of the catheter balloon is polyurethane (PUR).
Gobel '028 discloses that a catheter balloon is used which consists of polyethylene, PVC or mixtures of the aforesaid materials with polyurethane (para [0159]).
A skilled artisan would have found it obvious at the time of the invention to modify the material of the balloon in Bristol-Myers according to the teaching in Gobel '028, as such material would be suited to the purpose of easily sliding through and occluding a rectal cavity with an expandable balloon (see Gobel '028 at pg. 12, second paragraph).
Regarding claim 13, it is noted that Bristol-Myers does not appear to disclose that the material of the catheter balloon is selected from the group consisting of polyethylene, PVC and mixtures of polyethylene or PVC with polyurethane.
Gobel '028 discloses that a catheter balloon is used which consists of polyethylene, PVC or mixtures of the aforesaid materials with polyurethane (para [0159]).
A skilled artisan would have found it obvious at the time of the invention to modify the material of the balloon in Bristol-Myers according to the teaching in Gobel '028, as such material would be suited to the purpose of easily sliding through and occluding a rectal cavity with an expandable balloon (see Gobel '028 at pg. 12, second paragraph).
Regarding claim 20, it is noted that Bristol-Myers does not appear to disclose that after inflating the balloon, the balloon remains in a pressurized state until a coordinated physiological defecation reflex is triggered.
Gobel '028 discloses that after instillation of irrigation fluid, after several minutes peristaltic contractions begin to expel the intestinal contents (see Gobel '028, English translation, attached).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to carry out a step of the maintaining the balloon in in a pressurized state until a coordinated physiological defecation reflex is triggered, wherein an uncoordinated and only partially productive defecation reflex is avoided, in order to permit the peristaltic contractions necessary to expel intestinal contents to prepare for defecation.
Regarding claims 22, 27 and 28, it is noted that Bristol-Myers does not appear to disclose that a liquid irrigation inflow fluid is introduced directly into the rectum of the user, and as per claim 27, that introduced an inflow of such fluid directly into the rectum of the user outside of the balloon acts as a pneumatic expansion stimulus, and as per claim 28, the volume of the liquid irrigation inflow fluid fills the rectum.
Gobel '028 discloses that intermittent irrigation with irrigation fluid can occur among steps of inflation of the balloon, in particular, by introducing the fluid directly into the rectum of the user (see English translation: "The solution can, for example, pass directly into the patient via the emptying tube 5, or can also be administered via the inlet 32 (see FIG. 6) into the rectum"). The fluid would necessarily at least partially fill and rectum and, in the absence of any teaching to the contrary, performing the same method as described in the claimed invention would generate the same result, i.e., a pneumatic expansion stimulus.
Accordingly, a skilled artisan would have found it obvious at the time of the invention to carry out an irrigation of liquid inflow fluid directly into the rectum of the user, in order to achieve continence with a reasonable expectation of success.
Regarding claim 23, it is noted that Bristol-Myers does not appear to disclose that the liquid irrigation inflow fluid is introduced into the rectum of the user via a central lumen of the catheter shaft, which is open at a distal tip of the catheter shaft.
As noted above, Gobel '028 discloses that intermittent irrigation with irrigation fluid can occur among steps of inflation of the balloon, in particular, by introducing the fluid directly into the rectum of the user via a central shaft (see English translation: "The solution can, for example, pass directly into the patient via the emptying tube 5… into the rectum").
Accordingly, a skilled artisan would have found it obvious at the time of the invention to carry out an irrigation of liquid inflow fluid directly into the rectum of the user via a central lumen of the catheter shaft, which is open at a distal tip of the catheter shaft, in order to achieve continence with a reasonable expectation of success.
Claims 14-17 and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Clayton, further in view of Chi, further in view of Shafik et al ("Effect of rectal distension on rectal electromechanical activity", J. Invest. Surg., 2001, hereinafter "Shafik").
Regarding claims 14-17, it is noted that Bristol-Myers, in view of Clayton, further in view of Chi, does not appear to disclose that the balloon is inflated to a filling volume of 10 ml (as per claim 14), at least 20 ml (as per claim 15), at least 30 ml (as per claim 16), at least 150 ml (as per claim 17), or at least 120 ml (as per claim 26).
Shafik discloses a rectal balloon which is distended in a rectal cavity in 10 mL increments (such that one step had an initial fill volume of 10 or 20 mL and a subsequent step had a fill volume of 30 mL to 60 mL; see Abstract). Shafik teaches that the more the rectal wall balloon was distended, the greater the increase in rectal pressure and electrical wave activity associated with rectal motile activity (see Abstract).
A skilled artisan would have found it obvious at the time of the invention to modify Bristol-Myers, in order to provide a fill volume of 10 ml, at least 20 ml, at least 30, at least 150 ml, at least 120 ml, as a matter of routine experimentation and/or optimization. In this case, Shafik teaches that the fill volume is a result-effective variable (the more the rectal wall balloon was distended, the greater the increase in rectal pressure and electrical wave activity associated with rectal motile activity). In the presence of a known result-effective variable, a person of ordinary skill in the art would have found it obvious to try various fill volumes such as 10 mL, at least 20 mL, at least 30 mL, at least 150 ml, or at least 120 ml, in various steps, with a reasonable expectation of success. Further, Applicant has not disclosed that the claimed ranges solve a stated problem or are critical to the invention.
Claims 24 and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers, in view of Clayton, further in view of Chi, further in view of Gobel ‘028, further in view of Gill et al (U.S. Pat. 7,918,836, hereinafter "Gill").
Regarding claim 24, it is noted that Bristol-Myers, in view of Clayton, Chi and Gobel ‘028, does not appear to disclose that the liquid irrigation inflow fluid is introduced into the rectum of the user by squeezing it out of a container.
Gill discloses introducing irrigation fluid into a rectal cavity by squeezing the fluid out of a container (see col. 2, lines 33-35).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Bristol-Myers, in view of Clayton, Chi and Gobel ‘028, by squeezing the irrigation fluid out of a container, as taught in Gill, as a well-known way to provide fluid in a safe and effective manner with a reasonable expectation of success in irrigating a rectal cavity.
Regarding claim 25, it is noted that Bristol-Myers does not appear to disclose that the liquid irrigation inflow fluid is delivered as a ready-to-use solution through a fixed feed conduit to the catheter, as a disposable product.
As noted above, Gobel '028 discloses that intermittent irrigation with irrigation fluid can occur among steps of inflation of the balloon, in particular, the liquid irrigation inflow fluid is delivered as a ready-to-use solution through a fixed feed conduit to the catheter, as a disposable product (see a solution container 35 with ready-to-use solution).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to carry out an irrigation of liquid inflow fluid directly into the rectum of the user, such that the liquid irrigation inflow fluid is delivered as a ready-to-use solution through a fixed feed conduit to the catheter, as a disposable product in order to achieve continence with a reasonable expectation of success.
Claims 31-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers, in view of Clayton, further in view of Chi, further in view of Gobel (U.S. Pub. 2007/0213661 A1, hereinafter "Gobel '661").
Regarding claims 31-33, it is noted that Bristol-Myers does not appear to disclose that the reusable filling device is a pump balloon connectable to the balloon via a coupling, and as per claim 32, the balloon is with a pressure-indicating manometer, and as per claim 33, the manometer has a scale which displays one or more pressure ranges, recommended for the various filling steps when applying the device.
Gobel '661 discloses a pump balloon 40 (Fig. 5) interpreted to be reusable (i.e., the pump balloon can be used multiple times), and that can be configured with a pressure-indicating manometer (paras [0063], [0064]); such devices are known to have a scale to display one or more pressure ranges).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bristol-Myers according to the teaching in Gobel '661, in order to control and measure sphincter function to assist in training the sphincter muscle to regain rectal continence (see Gobel '661 at para [0064]).
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered, but are moot in view of the new grounds of rejection necessitated by the claim amendments.
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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/29/2026
