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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Rejections - 35 USC § 112
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.
Claims 1-9, 11, 16, 19, 20, 21, 26, 28, 33, 34, 36, 37, 39, 40 and all claims depending therefrom are 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 1 recites various inequalities (e.g., "VUDL > VREF"; "VIF,1 < VREF") and formulae (e.g., "PIF,1 = PTM,1 = PIR"; PIF,2 = PTM,2 > PIR) without clearly setting forth how these inequalities and/or formulae limit the claimed method steps.
Claim 1 also recites "the balloon filling volume (VBF) of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit (VUDL) at a pressure in a range of 10 mbar to 120 mbar applied to an interior of the balloon", and it is not clear what is meant by an "unvarying dimension limit" or what the units for this limit are intended to be.
Claim 1 also recites "reference dimension" followed by "(VREF)" which may imply to a reader that the "reference dimension" is a volume. However, whether the dimension is, in fact, a volume is not clearly set forth.
Claim 1 also recites multiple terms of degree and relative terminology for which no objective boundaries are provided, for instance: “freemoving manner,” “slightly stretchable,” “pressure-neutral manner,” “gradual, user-controllable expansion,” “best adapted to the individual anatomy,” “even distribution,” and “force level suited for triggering a coordinated physiological defecation reflex.” The specification does not provide a standard for measuring these limitations, and the claim fails to provide objective boundaries for determining the scope of these terms. Accordingly, a person of ordinary skill in the art would not be able to determine the scope of claim 1 with reasonable certainty.
Claim 1 also recites functional and result-oriented limitations tied to a user’s physiology, including “individual anatomy of the rectum or colon,” “current reflex status,” and “force level suited for triggering a coordinated physiological defecation reflex of the individual user.” These limitations depend on subjective or variable physiological conditions without providing objective criteria for determining when the limitations are met, and/or these limitations have not been clearly defined in the claims and/or the specification (e.g., it is unclear when the "current reflex status" occurs and/or what unit of measure is intended to quantify the status).
Claim 1 also recites a material properties in relative terms, i.e., “non-stretchable or only slightly stretchable”. The degree of stretchability is not clearly defined, and no objective standard is provided for determining when these limitations are satisfied.
Claim 1 also recites relationships between pressures (PIF,1, PTM,1, PIR, PIF,2, PTM,2) without specifying how such pressures are measured or whether the recited equalities are exact or approximate.
For the purpose of examination, the claims will be interpreted as described in the rejections, below.
The following dependent claims are also indefinite for the reasons set forth below:
Claim 2 recites the conditional statement "if placed in situ", which renders the claim unclear as to whether it positively recites a method step. Additionally, claim 2 recites "suited upstream the anal canal”, “suited in the anal canal”, and "suited beyond the anal canal”; the meaning of "suited" is unclear. It is interpreted to mean "situated". Further, the meaning of "upstream" is unclear because "upstream" depends on the direction of fluid or other material flowing through the area.
Claim 3 recites the limitation "wherein the reference dimension (VREF) of the balloon filling volume (VBF) is pre-shaped to a volume of 30 ml to 150 ml"; however, the so-called "reference dimension" is not a positively recited structure of the claims, and furthermore, claim 1 (upon which claim 3 depends) recites that the balloon is never inflated up to the reference dimension. For this reason, it is unclear whether claim 3 further limits claim 1. Further, it is not clear how a reference dimension can be "pre-shaped" because a volume dimension does not have an inherent shape.
Claim 4 recites the conditional statement "if the balloon filling volume (VBF) is below the preshaped reference-dimension (VREF)", which renders the claim unclear as to whether it positively recites a method step.
Claim 5 recites the limitation "in a reference state where the ballon filling volume (VBF) reaches the preshaped reference-dimension (VREF)" which appears to be a conditional statement. Therefore, it is unclear whether this phrase positively recites a method step. The limitation "the balloon adopts a geometrical shape that is unfolding/expanding in a radial direction more than in an axial direction of the catheter shaft" is also unclear because it is not known whether the claim is met when the balloon is actively unfolding or expanding or merely capable of doing so. Further, the limitation "unfolding" is unclear because claim 1, upon which claim 5 depends, does not recite a folded balloon.
Claim 6 recites the conditional statement "if the balloon is inflated up to this reference dimension (VREF) or beyond, it adopts a discoidal geometrical shape", which renders the claim unclear as to whether it positively recites a method step.
Claim 7 recites "a peripheral-most extension of the balloon"; it is unclear what is meant by "extension" in this context.
Claim 8 recites the conditional statement "if the balloon is inflated up to this reference dimension (VREF) or beyond, it does not extend beyond a distal-most tip of the catheter shaft", which renders the claim unclear as to whether it positively recites a method step.
Claim 9 recites the conditional statement "if the balloon is inflated up to this unvarying dimension limit (VUDL), it does not extend beyond a distal-most tip of the catheter shaft," which renders the claim unclear as to whether it positively recites a method step.
Claim 11 recites the conditional statement "if the balloon filing volume (VBF) is further increased to a further increased balloon filling volume (VIF,3) above the reference dimension (VREF):VIF,3 > VREF, then the balloon filling pressure (PIF,3) is at a higher level than a regarding trans-mural pressure (PTM,3):PIF,3>PTM,3 > PIR," which renders the claim unclear as to whether it positively recites a method step. Further, it is not clear what is meant by "the balloon filling pressure … is at a higher level than a regarding trans-mural pressure".
Claim 16 recites "the reference dimension (VREF) of the balloon filling volume (VBF)"; it is not clear what is meant by "reference dimension".
Claim 19 recites "safety range"; it is not known whether this term recites a structure, a dimension or some other feature.
Claim 20 recites "a coordinated physiological defecation reflex is triggered, wherein an uncoordinated and only partially productive defecation reflex is avoided." The meaning of the terms "coordinated,", "uncoordinated" and "only partially productive" are unclear.
Claim 21 recites the limitation "especially by the user himself” which is unclear regarding whether the user must squeeze or inject air or fluid. Further, care should be taken to avoid reciting the gender of a user.
Claim 26 recites "up to 120 ml, or … 80 to 120 ml, or … even less than 80 ml” which contain overlapping alternatives that indefinitely recite the scope of each alternative.
Claim 27 recites "a volume (VLIIF) of a liquid irrigation inflow fluid introduced directly into the rectum of the user outside of the catheter balloon acts together with the balloon filling volume (VBF) as a pneumatic expansion stimulus that can be controlled by the user" is unclear regarding whether this volume is actually introduced into the rectum outside the balloon or whether this is intended to be a conditional or optional step. Further, it is not clear what is meant by "pneumatic expansion stimulus".
Claim 28 is similarly rejected for reciting additional limitations based on claim 27.
Claim 33 recites "the pressure-indicating manometer has a scale which displays one or more pressure ranges, recommended for various filling steps when applying the device", which is not clear regarding the specific structure of "recommended" (pressure ranges).
Claim 34 recites " a balloon filling volume (VBF)", but balloon filling volume has already been recited in claim 1, upon which claim 34 depends. Therefore, it is not clear whether "a balloon filling volume" refers to a new volume or the same volume recited in claim 1.
Claim 36 recites " a suitable marking that specifies a preferred balloon filling volume (VBF)" which is unclear because it is not known what is meant by "suitable" and "preferred".
Claim 37 recites "safe catheter insertion", but "safe" is not clearly defined.
Claim 39 recites " the balloon filling pressure (PBF)", which lacks antecedent basis in the claims.
Claim 40 recites " the balloon filling pressure (PBF)", which lacks antecedent basis in the claims. Further, claim 40 recites upon a further increase of the balloon filling pressure prevailing in the catheter balloon to approximately 60 to 120 mbar, the anal canal of the user is also caused to expand" which does not clearly set forth whether a method step is being carried out or whether the limitation is functional or intended use.
Claim Rejections - 35 USC § 103
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.
Claim 1, 2, 4-13, 15, 16, 18-23, 25, 27-30, 34, 35, 40 and 41 are rejected under 35 U.S.C. §103 as being unpatentable over Bristol-Myers (WO 2008/103788 A1) in view of Gobel (WO 2009/144028 A1, hereinafter “Gobel ‘028”), and further in view of Ivanovych (UA 68194 A).
Regarding claim 1, Bristol-Meyers discloses a method for intermittently triggering a coordinated defecation reflex in a rectum or a colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising the following steps:
providing a catheter, the catheter comprising:
a catheter shaft (stem 28a), and
a catheter balloon surrounding the catheter shaft and being fixed to it (see Fig. 1 and para [0021], showing a catheter shaft with an inflatable balloon mounted thereon);
wherein the catheter balloon comprises a balloon envelope (i.e., the surfaces of the balloon defining the balloon’s bounds) which has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein a distal fixation point of the catheter balloon is near a distal end of the catheter shaft, and which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft (see Fig. 1 showing the balloon mounted to the catheter shaft 28a at the shaft’s proximal and distal ends, without any attachment therebetween), and
in a first step, inserting the catheter in the rectum or colon of the user and providing an initial fill volume or an initial filling pressure of air or another fluid in the catheter balloon in order to inflate the catheter balloon (i.e., Bristol-Myers discloses that 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), producing a sealing and anchoring effect (see Fig. 3 and pg. 6, describing the large area seal against the inner wall of the rectum and the perianal skin 27 by the balloon) nor a reflex triggering expansion of portions of the lateral rectal wall exposed to the catheter balloon (Bristol-Myers is silent in disclosing the triggering of the defecation reflex, thus one of ordinary skill in the art would conclude that the defecation reflex is not triggered and the transmural pressure of the balloon does not exceed the intrarectally acting pressure),
and in a second step, increasing such initial fill volume or such initial filling pressure to an increased fill volume or an increased filling pressure by pumping, squeezing or injecting air or another fluid into the catheter balloon by the user (i.e., a further inflation of fluid into the catheter balloon, expanding the balloon as illustrated in Fig. 4, the further inflation being controlled in timing and intensity by the user with a syringe, electric or manual pump or oral inflation tube, all of which are interpreted to allow control in timing and intensity by a user of the device itself; see pg. 6, first paragraph).
It is noted that Bristol-Myers does not appear to disclose the specific material from which the balloon is made according to claim 1; or inflating the catheter balloon below the reference dimension of the balloon filling volume (VBF) thereof in a pressure-neutral manner, i.e. wherein the initial filling pressure inside the catheter balloon is equal to a physiologically acting intra-rectal acting pressure that is prevailing in the rectum of the user without any stretching of the balloon envelope of the catheter balloon and causing neither a trans-mural pressure beyond the physiologically intra- rectally acting pressure; as well as the second step occurring until there occurs a gradual, user- controllable expansion of portions of the lateral rectal wall exposed to the catheter balloon in such a way that a degree of filling of the balloon is best adapted to the individual anatomy, allowing for an even distribution of the trans-mural pressure (PTM,2) exerted by the balloon onto the exposed rectal structures, gradually increasing from the physiologically acting intra-rectal pressure (PIR) to a force level suited for triggering a coordinated physiological defecation reflex of the individual user,
and wherein the increased fill volume of the catheter balloon is still below the reference dimension of the balloon filling volume so that the balloon envelope of the balloon is not stretched.
Gobel '028 discloses a method for filling an inflatable, catheter balloon, e.g., 1, 28 (Figs. 1, 3) of a device for transanally introducing an infusion into the rectum or colon 29 (Fig. 3) of a patient by means of a filling device (i.e., a supply line 31 in Fig. 4). A catheter balloon 28 (Fig. 4) is used which consists of an only slightly volume expandable compliant material or of a non-volume-expandable material (para [0040]; the balloon material ideally has a low compliance). Gobel '028 discloses that that a catheter balloon 28 (Fig. 4) is used that consists of Pellethane 2363 with a Shore hardness of 80A to 60D (see English translation at pg. 12, second paragraph), which skilled artisan would recognize attains a stable dimension at a pressure in the range of 10 to 120 mbar (based on Applicant's specification at para [0096]).
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 have expectedly maintained a preferred shape, yielded superior functionality with respect to anchoring and sealing, and contributed to economical production and assembly of the drainage and/or irrigation device (see Gobel '028 at para [0029]).
Further, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Further, 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. 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"), one of ordinary skill in the art would have sought 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. Further, Bristol-Myers discloses that Fig. 4 shows an embodiment in which the balloon is inflated to form a closure in front of the distal end 48 of the catheter shaft to block waste from entering the catheter shaft; then, the balloon may be deflated slightly to open the closure and discharge the fecal matter (see pg. 7, second paragraph). Accordingly, a skilled artisan would have found it obvious to trigger the defecation reflex when the balloon is inflated to form a closure over the catheter shaft, corresponding to the inflation shown in Fig. 4 of Bristol-Myers, as doing so would expectedly prepare more fecal matter to be evacuated when it is desired to re-open the catheter shaft.
Based on the combined teachings of Bristol-Myers, Gobel ‘028 and Ivanovych, a person of ordinary skill in the art would have expected that inflating the modified balloon up to an elevated pressure of 53-93 mbar (as taught in Ivanovych) would both trigger the defecation reflex (as taught in Ivanovych) without stretching the balloon (i.e., Gobel ‘028 teaches that its balloon remains stable and non-stretched up to 120 mbar).
It is noted that the claim limitation “during manufacturing of the catheter balloon, is preshaped to a reference dimension (VREF) of a balloon filling volume (VBF) as a maximum filling volume of the fluid-tight fillable compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which the reference dimension (VREF) of the balloon filling volume (VBF) corresponds to a dimension of the rectum or colon of the user” constitutes a product-by-process limitation that has no apparent bearing on the final structure of the balloon
Claim 2 recites limitations conditionally (i.e., "if placed in situ") that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claim 4 recites limitations conditionally (e.g., "if the balloon filling volume (VBF) is below the preshaped reference-dimension (VREF)…", that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claim 5 recites limitations conditionally (i.e., "in a reference state where the ballon filling volume (VBF) reaches the preshaped reference-dimension (VREF)") that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claims 6 and 7 recite limitations conditionally (i.e., "if the balloon is inflated up to this reference dimension (VREF) or beyond, it adopts a discoidal geometrical shape"), that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claim 8 recites limitations conditionally (i.e., "if the balloon is inflated up to this reference dimension (VREF) or beyond, it does not extend beyond a distal-most tip of the catheter shaft"), that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claim 9 recites limitations conditionally (i.e., "if the balloon is inflated up to this unvarying dimension limit (VUDL), it does not extend beyond a distal-most tip of the catheter shaft,"), that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Regarding claim 10, the combination of Bristol-Myers, Gobel (WO 2009/144028 and Ivanovych suggests unvarying dimension limit (VUDL)of the balloon filing volume (VBF) is within a range of 100% to 150% of the reference dimension (VREF) of the balloon filling volume (VBF) (i.e., a value of 100%, since the volume at the unvarying condition is the same as the reference dimension corresponding to a dimension of the rectum or colon of the user).
Claim 11 recites limitations conditionally (i.e., " if the balloon filing volume (VBF) is further increased to a further increased"), that are not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
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 15, it is noted that Bristol-Myers does not appear to disclose that in the first step, the initial filling pressure (PIF,1) is between 10 mbar and 30 mbar, or between 10 mbar and 25 mbar.
As noted above, Ivanovych discloses a balloon introduced into the rectum and then elevated to a pressure of less than 13 mbar, which includes values between 10 mbar and 25 mbar (see lines 38-41).
Accordingly, a skilled artisan would have found it obvious to modify the method of Bristol-Myers so that, in the first step, the initial filling pressure is between 10 mbar and 30 mbar, or between 10 mbar and 25 mbar, with a reasonable expectation of success in inflating the balloon to a desired pressure.
Regarding claim 16, the combination of Bristol-Myers, Gobel '028 and Ivanovych teaches that in the second step, the increased fill volume is below the reference dimension of the balloon filling volume, so that the balloon envelope of the balloon is not wrinkle-free, since the second step occurs before the defecation reflex is triggered (as required in claim 1).
Regarding claim 18, it is noted that Bristol-Myers does not appear to disclose that in the second step, the increased filling pressure is between 30 mbar and 60 mbar.
As noted above, Ivanovych discloses a balloon introduced into the rectum and then elevated to a pressure of 40-70 mmHg, or approx. 53-93 mbar (see lines 47-51), causing stretching of the rectum to trigger the defecation reflex.
Accordingly, a skilled artisan would have found it obvious to modify the method of Bristol-Myers so that, in the second step, the increased filling pressure is between 30 mbar and 60 mbar, with a reasonable expectation of success of avoiding triggering the defecation reflex while still maintaining the seal of the balloon against the rectal wall.
Regarding claim 19, the combination of Bristol-Myers, Gobel '028 and Ivanovych teaches a safety range is provided at or above the reference dimension of the balloon filling volume, to ensure that the balloon envelope of the balloon will not substantially enlarge beyond such reference dimension of the balloon filling volume, based on the teaching in Gobel '028 of a balloon made from non-volume-expandable material (para [0040]; the balloon material ideally has a low compliance). Gobel '028 discloses that that a catheter balloon 28 (Fig. 4) is used that consists of Pellethane 2363 with a Shore hardness of 80A to 60D (see English translation at pg. 12, second paragraph), which skilled artisan would recognize attains a stable dimension at a pressure in the range of 10 to 120 mbar (based on Applicant's specification at para [0096]).
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). Further, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding claim 20, Bristol-Myers does not appear to disclose that during the second step, the catheter balloon remains in a pressurized state for about 1 minute to 5 minutes, until a coordinated physiological defecation reflex is triggered, wherein an uncoordinated and only partially productive defecation reflex is avoided.
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 balloon remaining in a pressurized state for about 1 minute to 5 minutes, 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 claim 21, Bristol-Myers discloses that in the first and or second step, the air or fluid is pumped, squeezed or injected manually, especially by the user himself (i.e., a further inflation of fluid into the catheter balloon, expanding the balloon as illustrated in Fig. 4, the further inflation being controlled in timing and intensity by the user with a syringe, electric or manual pump or oral inflation tube, all of which are interpreted to allow control in timing and intensity by a user of the device itself; see pg. 6, first paragraph).
Regarding claim 22, it is noted that Bristol-Myers does not appear to disclose that between the first and second step, a liquid irrigation inflow fluid is introduced directly into the rectum of the user.
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").
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 between the first and second steps, 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.
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.
Regarding claim 27, the limitation has been interpreted to be conditional, i.e., if a wherein a volume of a liquid irrigation inflow fluid were introduced directly into the rectum of the user outside of the catheter balloon, it would act together with the balloon filling volume as a pneumatic expansion stimulus that can be controlled by the user. This limitation is not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Claim 28 is similarly rejected for reciting the conditional limitation "a volume (VLIIF) of a liquid irrigation inflow fluid fills the rectum or colon of the user above the balloon filling volume (VBF) which is located nearby or adjacent to the anus of the user." This limitation is not required to be met by prior art. See MPEP 2111.04, instructing that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Regarding claim 29, Bristol-Myers discloses that the catheter further comprises a filling conduit 50 (see Fig. 1) for charging the catheter balloon with filling pressure.
Regarding claim 30, Bristol-Myers discloses a reusable filling device is provided for filling the balloon in the first and/or second step (see tube 56 of Bristol-Myers which is connected to an inflation source).
Regarding claim 34, Bristol-Myers discloses that the filling operation of the balloon with the initial or increased fill volume is conducted by controlling a balloon filling volume (VBF) (i.e., Bristol-Myers discloses that 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).
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 40, it is noted that Bristol-Myers does not appear to disclose that upon a further increase of the balloon filling pressure prevailing in the catheter balloon to approximately 60 to 120 mbar, the anal canal of the user is also caused to expand.
As noted above, Ivanovych discloses a balloon introduced into the rectum and then elevated to a pressure of 40-70 mmHg, or approx. 53-93 mbar (see lines 47-51), causing stretching of the rectum to trigger the defecation reflex.
Accordingly, a skilled artisan would have found it obvious to modify the method of Bristol-Myers so that, upon a further increase of the balloon filling pressure (PBF) prevailing in the catheter balloon to approximately 60 to 120 mbar, the anal canal of the user is also caused to expand, based on the teaching in Ivanovych that a pressure within this range would cause the anal canal to expand, in order to trigger the defecation reflex with a reasonable expectation of success.
Regarding claim 41, Bristol-Myers discloses that as soon as a coordinated physiological defecation reflex is triggered, the catheter balloon is deflated and the catheter is extracted from the rectum (see English translation: "If the peristaltic expulsion of intestinal contents begins, in the current system the inlet catheter is generally removed from the patient by the patient"; this peristaltic expulsion is caused by the triggering of the defecation reflex).
Claims 3, 14 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Shafik et al ("Effect of rectal distension on rectal electromechanical activity", J. Invest. Surg., 2001, hereinafter "Shafik").
Regarding claim 3, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that the reference dimension of the balloon filling volume is pre-shaped to a volume of 30 ml to 150 ml, interpreted to mean that the maximum fill volume of the balloon is 30-150 mL.
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 the combination of Bristol-Myers, Gobel '028 and Ivanovych, in order to provide a fill volume of between 30 mL and 150 mL (for instance, up to 30-60 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, 20 mL, 30 mL, 40 mL, 50 mL and 60 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.
Regarding claim 14, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that, in the first step, the initial fill volume is between 10 ml and 20 ml; and as per claim 17, in the second step, the increased fill volume is between 30 ml and 150 ml.
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 the combination of Bristol-Myers, Gobel '028 and Ivanovych, in order to provide an initial fill volume is between 10 ml and 20 ml, in the second step an increased fill volume is between 30 ml and 150 ml (for instance, up to 30-60 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, 20 mL, 30 mL, 40 mL, 50 mL and 60 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.
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Gill et al (U.S. Pat. 7,918,836, hereinafter "Gill").
Regarding claim 24, is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych 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, Gobel '028 and Ivanovych, by squeezing the irrigation fluid out of a container, as doing so was a known way to provide fluid in a safe and effective manner with a reasonable expectation of success in irrigating a rectal cavity.
Claim 26 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Salim (WO 95002368 A1, hereinafter "Salim").
Regarding claim 26, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that, liquid irrigation inflow fluid is introduced into the rectum of the user in a volume of up to 120 ml, or in a volume of 80 to 120 ml, or in a volume of even less than 80 ml.
Salim discloses an irrigation system, comprising a step of providing liquid irrigation inflow fluid into the user at a volume of up to 5-100 mL (see pg. 5).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Bristol-Myers, Gobel '028 and Ivanovych, by providing irrigation fluid into the rectum of the user in a volume of up to 120 ml, or in a volume of 80 to 120 ml, or in a volume of even less than 80 ml, as taught in Salim, in order to prevent catheter blockage (see Salim at pg. 5) with a reasonable expectation of success.
Claims 31-33 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Gobel (U.S. Pub. 2007/0213661 A1, hereinafter "Gobel '661").
Regarding claims 31-33, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that a hand-operated pump balloon with a pressure-indicating manometer is provided as a unit for filling the balloon, wherein the pressure-indicating 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 in view of Ivanovych and Gobel '028 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]).
Regarding claim 39, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that the balloon filling pressure (PBF) is limited by a pressure limiting valve which is interposed between a filling element and the balloon of the catheter.
Gobel '661 discloses a valve element that limits the balloon pressure and is disposed in or on a reusable filling device such as inflation line (para [0047]).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Bristol-Myers, Gobel '028 and Ivanovych, according to the teaching in Gobel '661 in order to stop inflation fluid from flowing into the balloon as may be necessary.
Claims 36 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Clayton (U.S. Pat. 4,403,982, hereinafter "Clayton").
Regarding claim 36, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that the syringe body comprises a suitable marking that specifies the preferred fill volume.
Clayton discloses a method for filling an inflatable catheter balloon of a device for transanal use, comprising a unit for filling the balloon in the form of a reusable syringe 23 (Fig. 1) having markings 49 (Fig. 4) to indicate the preferred fill volume.
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bristol-Myers in view of Gobel '028 and Ivanovych, according to the teaching in Clayton, in order to accurately control the inflation of the balloon (see
Clayton at Abstract).
Claims 37 and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bristol-Myers in view of Gobel '028, further in view of Ivanovych, further in view of Nestenborg (U.S. Pat. 7,122,025 B1, hereinafter "Nestenborg").
Regarding claim 37, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych does not appear to disclose that catheter shaft is equipped in a proximal, preanal region with a plurality of gripping depressions, to accommodate fingers gripping the catheter during insertion and to ensure a safe catheter insertion.
Further, regarding claim 38, it is noted that the combination of Bristol-Myers, Gobel '028 and Ivanovych 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 catheter balloon.
Nestenborg discloses a device for insertion into the rectum, comprising an area with gripping depressions 15 (Fig. 3) located at the proximal end thereof.
It would have been obvious for one of ordinary skill in the art at the time of the invention to modify the combination Bristol-Myers, Gobel '028 and Ivanovych to incorporate gripping depressions in an area of the proximal shaft, in order that the preanal balloon extends over such portions adjacent to a fixation line, in order to aid gripping the device during insertion into the anal cavity (see also Nestenborg at col. 4, lines 58-60).
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/03/2026
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