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.
Response to Amendment
Claims 1-96 were canceled in a preliminary amendment filed 11/23/2022.
Election/Restrictions
Claims 97-124 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/05/2026.
Claim Objections
Claim 125 recites the following objected subject matter:
"where the tapered distal end of the balloon is in contact with to the catheter shaft and is fixed thereto" (apparent typographical error); and
"whereby to trigger a coordinated defecation reflex in the rectum or colon of the patient" (apparent typographical error).
Appropriate correction is required.
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.
The following claims, 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 125 recites "a distalmost extension of the catheter shaft"; it is unclear what is meant by "extension" in this context.
Claim 125 also recites "the second radius", which lacks antecedent basis in the claim.
Claim 125 also recites "unpressurized state of the balloon". The meaning of "unpressurized" is unclear in this context. It is noted that any balloon must be pressurized to some degree in order to be inflated. For the purpose of examination, the limitation will be interpreted to mean pressurized to a pressure of less than 30 mbar (see claim 127, disclosing "the pressurized state of the inflatable balloon at 30 mbar").
The following dependent claims are also indefinite for the reasons set forth below:
Claim 128 recites the conditional statement "in case of an increased pressure in the balloon beyond 100 mbar", which renders the claim unclear as to whether it positively recites a method step.
Claim 128 recites "the distal terminal balloon section", which lacks antecedent basis in the claims.
Claim 133 recites the limitation "in case of a placement of the device in a patient" which appears to be a conditional statement. Therefore, it is unclear whether this phrase positively recites a method step. Further, claim 125 (upon which claim 133 depends) already recites that the device is placed in a patient (specifically, the catheter is placed inserting the catheter in the rectum or colon of a patient), and so it is not clear how claim 133 further limits claim 125.
Claim 144 recites the limitation "a diameter of an irrigation canal of the device is reduced in its dimension to a volume of equal or less than 1 ml "; however, no irrigation canal has been previously recited, and so it is unclear whether an irrigation canal is present in the device. Further, it is not clear what is meant by "a diameter…of the device is reduced in its dimension to a volume…" since it is not known what "its dimension" refers to and it is not clear how volume constitutes a dimension.
Claim 146 recites " a suitable marking" which is unclear because it is not known what is meant by "suitable".
Claim 149 recites a terms of degree and relative terminology for which no objective boundaries are provided, specifically: “gradual, user-controllable expansion,” The specification does not provide a standard for measuring this 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 149 with reasonable certainty.
Claim 149 recites "a compliance reserve"; it is unclear what structure is conveyed by this limitation.
Claim 149 recites "wherein the catheter balloon or the intrarectal balloon segment of the catheter balloon distends elastically from the pre-formed working dimension up to a final dimension" and " wherein further distention of the catheter balloon or the intrarectal balloon segment of the catheter balloon is not possible once the catheter balloon or intrarectal balloon segment has distended to its final dimension, and no further dimensional expansion is allowed, in order to avoid uncontrolled dilation and trauma"; it is unclear whether these limitations are intended to be a method steps of the claimed method, or merely functional/intended use.
Claims 149-152 recite "a working dimension associated with a filling state", but it is not clear what "working dimension" means. The limitation will be interpreted to mean "a dimension".
Claim 149 recites "unpressurized state of the balloon". The meaning of "unpressurized" is unclear in this context. It is noted that any balloon must be pressurized to some degree in order to be inflated. For the purpose of examination, the limitation will be interpreted to mean pressurized to a pressure of less than 30 mbar (see claim 127, disclosing "the pressurized state of the inflatable balloon at 30 mbar").
Claim 150 recites the term "pre-formed beyond a working dimension"; it is not clear what "working dimension" means in this context and what "beyond a working dimension" means.
Claims 125, 126, 128-132, 134, 135 and 139-145 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over view of Gobel (WO/2009/144028, hereinafter "Gobel '028"; the corresponding to U.S. Pub. 2011/0160657 has been referenced here for clarity), in view of Ivanovych (UA 68194 A, hereinafter "Ivanovych"; see English translation, attached).
Regarding claim 125, Gobel '028 discloses a method for intermittently triggering a coordinated defecation reflex in the rectum or colon of a patient, said method comprising:
providing a catheter comprising an inflexible catheter shaft, e.g., 5 (see Fig. 1) (see Fig. 3) and an inflatable balloon, e.g., 28 (see Fig. 3), the inflatable balloon comprising a distal terminal balloon section having a larger radius and generally spherical or discoid shape and a maximal first radius, and which is adapted to be placed intrarectally (see Fig. 3),
wherein the inflatable balloon is fixed onto the catheter shaft only at fixation points located at the ends of the inflatable balloon (see Fig. 3 showing that the balloon is only attached at fixation points at either end of the inflatable balloon),
wherein both ends of the inflatable balloon taper approximately to a shaft dimension of the catheter shaft supporting the balloon (see Fig. 3 showing that the balloon tapers downward to approximately a shaft dimensions at the fixation points);
with the distal end of the balloon having a tapered second radius (approximately the same radius as the shaft);
and, wherein, in an inflated, but unpressurized state of the balloon (see para [0040] of the corresponding U.S. publication) that the balloon material is a noncompliant material, such that it can be inflated to its desired size without being pressurized to expand), the difference between the first radius of the intrarectal balloon segment (the maximal radius of the segment) and the second radius of the distal tapered balloon end (the minimal radius of the segment roughly equal to the radius of the shaft) is equal to a first difference, and further wherein the first difference is greater than a distance between a distal front side of the catheter and a distal fixation point (see annotated Fig. 3, below, "A" represents a distance between a distal front side of the catheter and a distal fixation point, and "B" represents the "first difference"),
where the tapered distal end of the balloon is in contact with to the catheter shaft and is fixed thereto (at preformation point 24; see Fig. 3), wherein the distal front side of the catheter is at a distalmost extension of the catheter shaft or of a distal tip piece of the catheter shaft (as shown in Fig. 3, the preformation point is at the distal tip piece of the shaft 25);
inserting the catheter into the rectum of a colon of a patient (left half of Fig. 4);
pressurizing the balloon, wherein at least a portion of the distal intrarectal balloon segment engages and expands a side wall of the rectum or colon of the patient (right half of Fig. 4).
It is noted that Gobel '028 does not appear to disclose the specific pressure exceeding 30 mbar, thereby resulting in the intrarectal balloon segment engaging and expanding a side wall of the rectum or colon of the patient, in order to to trigger a coordinated defecation reflex in the rectum or colon of the patient.
Ivanovych discloses an inflatable balloon catheter that triggers the coordinated defecation reflex (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.
A skilled artisan would have found it obvious to modify the method of Gobel '028 to inflate the balloon to a pressure of at least 30 mbar, in particular, 53-93 mbar, as taught in Ivanovych, in order to trigger the defecation reflex with a reasonable expectation of success. Gobel '028 further teaches that it is desirable to trigger the defecation reflex in order to mobilize stool in the colon in cases of constipation or bowel voiding dysfunction (see corresponding published U.S. application at paras [0009]-[0010]). Therefore, in treating constipation or bowel voiding dysfunction, a skilled artisan would have been motivated to choose a desirable balloon inflation pressure, and would have looked to the teachings of Ivanovych to choose such a pressure, with a reasonable expectation of success in arriving at the claimed invention.
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Gobel '028, Annotated Fig. 3 showing distances "A" and "B".
Regarding claim 126, Gobel '028 discloses that the catheter balloon comprises, additionally to the intrarectal balloon segment, a tapered transanal balloon section disposed proximally adjacent to the intrarectal balloon segment, the tapered transanal balloon section having a second radius, and wherein the first radius is larger than the second radius (see Fig. 4 showing the waisted shape and the two radially enlarged sections on either side; the waisted shape has a radius smaller than the radius of the intra-rectal balloon segment).
Regarding claim 128, the limitation "in case of an increased pressure in the balloon beyond 100 mbar" is interpreted to be conditional step of the method claim. In the case of method claims, it has been held that if the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016).
Even so, Gobel ‘028 discloses that it is known to inflate the balloon to a pressure of about 100 mbar to its working size (see above), and that the balloon is made of a low-compliance material such that the radius of the balloon approximates a constant limiting value (see Gobel ‘028 at para [0040]).
Regarding clam 129, it is noted that the combination of Gobel ‘028 and Ivanovych does not appear to disclose that the transanal balloon segment of the catheter balloon expands by less than 20%, preferably by less than 15%, at a pressure increase from 30 to 100 mbar.
Further, regarding claim 130, it is noted that the combination of Gobel ‘028 and Ivanovych does not appear to disclose that the transanal balloon segment of the catheter balloon expands by more than 15 %, preferably by more than 20%, at a pressure increase from 30 to 100 mbar.
However, based on the teaching in Gobel ‘028 that it is desirable for the balloon characteristics to reduce trauma on the transanal segment (see Gobel ‘028 at para [0016]]), a skilled artisan would have found it obvious at the time of the invention to experiment with the level of expansion of the balloon up to a maximum distention dimension, including choosing materials that fall within the claimed ranges, in order ensure against an overpressure on the rectum during inflation of the balloon that would result in traumatic effects on the rectal wall. Further, the specifically claimed value of less than 15% or more than 15% change in the segment due to a pressure increase from 30 mbar to 100 mbar does not appear to solve a stated problem or be critical to the invention.
Regarding claim 131, Gobel ‘028 discloses that the balloon is made from polyurethane material (paras [0029], [0159]).
Regarding claim 132, Gobel ‘028 discloses that the tapered balloon section is configured to terminate flush with the anus (see Fig. 4 of Gobel ‘028).
Regarding claim 134, the limitation of “the enlarged distal terminal balloon section being adapted to be placed intrarectally and the tapered balloon section being adapted to be placed transanally are manufactured separately, or from different materials and/or with different characteristics, or with different material characteristics like different durometers” is a product-by-process limitation. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 135, Gobel ‘028 discloses that the inflatable balloon has a waisted shape, comprising the distal terminal balloon section of larger radius and generally spherical or discoid shape, a proximal terminal balloon section of larger radius and generally spherical or discoid shape, and, disposed between them, the tapered balloon section having a reduced radius, wherein the tapered balloon section of the device being adapted to be placed transanally, such that the enlarged distal terminal balloon section is placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally (see Fig. 4 showing the waisted shape and the two radially enlarged sections on either side).
Regarding claim 139, Gobel ‘028 shows that the catheter shaft is provided with a waist portion in a region of the transanal placement inside the anal canal (i.e., the portion of the catheter shaft placed transanally; see Fig. 4).
Regarding claims 140 and 141, Gobel ‘028 discloses a non-return element 42 in the form of a thin-walled tube having a diameter of a duct, such that the distal end of the tube lies freely in the duct, and the tube proximal end is sealingly connected to an inner wall of the duct, thereby ensuring that the tube element opens in the presence of a flow of medium through the duct toward a tip thereof, and the tube element closes by collapsing in the presence of flow in an opposite direction (para [0178]).
Further, regarding claim 141, while Gobel ‘028 does not appear to disclose the wall thickness or the length of the non-return element, such values are considered to be optimized based on routine experimentation and/or the physical requirements of the patient and thus a skilled artisan would have found it obvious to use or find such values at the time of the invention. Further, these values do not appear to solve a stated problem or be critical to the invention.
Regarding claim 142, Gobel ‘028 discloses that catheter is an inflow catheter connected by a fixed tube connection 4 (Fig. 4 and para [0169]) to a container for irrigation fluid.
Regarding claim 143, it is understood that virtually any volume (presuming it is limited by the volume of fluid of the container) may be squeezed out from the container into the rectum of a patient as necessary, including small volumes of fluid in the range of 5-15 mL, from the container as a micro-enema.
Regarding claim 144, it is noted that limitation “a diameter of an irrigation canal of the device is reduced in its dimension to a volume of equal or less than 1 ml or to a volume of less than 0.5 ml, to minimize the volume loss inside this volume” is interpreted to be an intended use limitation reciting reducing an irrigation canal. It is understood that the device in Gobel ‘028 is capable of performing this intended use.
Regarding claim 145, Gobel ‘028 discloses a disposable catheter, characterized in that the disposable catheter is connectable via a filling conduit to a filling device (see para [0146] and Fig. 10; it is understood that any feature could be disposable). The limitations “reusable” is interpreted to be functional. Further, the claim merely requires the catheter to be "connectable" to a reusable filling device, but does not positively recite any structure of the refilling device itself. The catheter of Gobel '028 is capable of connection to numerous other components, including filling devices.
Claims 127, 133, 146, 147, 150 and 152 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over view of Gobel '028, in view of Ivanovych, further in view of Gobel (U.S. Pub. 2007/0213661 A1, hereinafter “Gobel ‘661”).
Regarding claim 127, it is noted that Gobel’ 028 discloses that when in the inflated, but unpressurized state of the balloon at 30 mbar, the difference between the first radius of the intrarectal balloon segment and a third radius of the transanal balloon section is equal to a second difference (this is an inherent feature because the first radius has a value and a the transanal balloon also has a third radius on the opposite side of the balloon from the first radius), but does not appear to disclose (ii) in the pressurized state of the inflatable balloon at 100 mbar, the difference between the first radius of the intrarectal balloon segment and the third radius of the transanal balloon section is equal to a third difference, and further wherein the second difference is less than the third difference.
Gobel ‘661 discloses the aforementioned balloon having an unpressurized state in which the difference (i.e., “third difference”) between the larger radius (D; Fig. 6a) of the distal terminal balloon section and the reduced radius (DT; Fig. 6a) of the tapered balloon section is greater than the distance between the distal end of the catheter shaft on the one hand and the distal fixation point 10 (Fig. 6a) of the balloon to the catheter shaft on the other hand (i.e., the “distal end” of the catheter shaft may be considered to be at the distal fixation point of the balloon, such that the difference between D and DT may be as high as 4 cm which would be larger than the distance between the distal end and the fixation point).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the combination of Gobel ‘028 and Ivanovych, according to the teaching in Gobel ‘661, in order to prevent the distal end of the catheter shaft from extending too far into the rectal cavity.
Regarding claim 133, Gobel ‘028 shows, in Fig. 4, that the tapered balloon section projects over the anus to form a pre-anal segment which is pre-formed into a conical balloon section having a conical shape with a distal end and a proximal end, but does not disclose that a pre-formed diameter at the proximal end of the conical balloon section is 30 to 70% larger, or 40 to 60% larger than a pre-formed diameter at the distal end of the conical balloon section.
Gobel ‘661 discloses the balloon in which a tapered balloon section projects over the anus to form a pre-anal segment which is pre-formed into a conical shape with a distal end and a proximal end, and has a pre-formed diameter at its proximal end of 3-6 cm (D6) while the area at the distal end approximates DT which is 2-4 cm (para [0060]). Accordingly, D6 is 30 to 70% larger than the pre-formed diameter at the distal end of the conical balloon section (approximating DT).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Gobel ‘028 according to the teaching in Gobel ‘661, in order to adapt the balloon sections to the regions in which they are used (see Gobel ‘661 at para [0060]). Further, choosing from specific values within the claimed range does not appear to solve a stated problem or be critical to the invention.
Regarding claim 146, it is noted that Gobel ‘028 does not appear to disclose a manometer indicating the balloon filling pressure, characterized in that the manometer comprises a scale on which the filling pressure ranges required for the use of the catheter are specified by suitable markings.
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 combination of Gobel ‘028 and Ivanovych, 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 147, Gobel ‘028 does not appear to disclose the claimed valve element.
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 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.
Regarding claim 149, it is noted that Gobel’ 028 discloses that when in the inflated, but unpressurized state of the balloon, the difference between the first radius of the intrarectal balloon segment and a third radius of the transanal balloon section is equal to a second difference (this is an inherent feature because the first radius has a value and a the transanal balloon also has a third radius on the opposite side of the balloon from the first radius), and
further wherein the second difference is greater than a distance between a distal front side of the catheter and a distal fixation point of the balloon to the catheter shaft (the balloon connects to the shaft at preformation point 24, which is at or adjacent to the front side of the catheter, such that the second difference would be greater than said distance; see Fig. 3),
wherein the catheter balloon or at least the intrarectal balloon segment is pre-formed into a working dimension associated with a filling state, characterized by an initial fill volume or an initial filling pressure, in which the filling pressure required for anchoring the catheter within the rectum or colon of the patient is approximately the same as the pressure prevailing in the rectum or abdomen (equalizing these pressure is how the device of Gobel '028 is able to counteract the rectal pressure and maintain rectal patency),
wherein the catheter balloon is configured such that an increase above an initial fill volume or filling pressure leads to a gradual, user-controllable expansion of portions of the bowel wall adjacent to the catheter balloon such that at least a portion of the catheter balloon engages and expands a side wall of a rectum or colon of a patient thus triggering a coordinated defecation reflex (i.e., inflating the pressure to 100 mbar as taught in Gobel '661), by generating a reflex-triggering stimulus of an intensity which can, determined by the user, substantially exceed the intensity achievable by an irrigation with fluid media (it is noted that this limitation recites a function of the balloon to trigger the defecation reflex; a pressure applied at 100 mbar would inherently exceed the intensity achievable by an irrigation with fluid media irrigated at a lower pressure);
wherein the catheter balloon or the intrarectal balloon segment has a compliance reserve (i.e., the balloon or its segment of Gobel '028 is made of a low-compliance material as described above),
where the catheter balloon or the intrarectal balloon segment distends elastically from the pre-formed working dimension up to a final dimension (e.g., inflated to a working size as disclosed in para [0012] of the corresponding U.S. application), wherein further distention of the catheter balloon or the intrarectal balloon segment of the catheter balloon is not possible once the catheter balloon or intrarectal balloon segment has distended to its final dimension, in order to avoid uncontrolled dilation and trauma (it is understood that any substantially non-compliant balloon has a dimension by which no additional expansion would be allowed unless the balloon was caused to rupture).
Regarding claim 150, Gobel '028 discloses that the catheter balloon or at least the intrarectal balloon segment is pre-formed beyond a working dimension associated with a filling state characterized by an initial fill volume or an initial filling pressure, in which the filling pressure in the catheter balloon required for anchoring the catheter within the rectum or colon of the patient is approximately the same as the pressure prevailing in the rectum or abdomen (equalizing these pressure is how the device of Gobel '028 is able to counteract the rectal pressure and maintain rectal patency),
wherein the catheter balloon is configured such that an increase above the initial fill volume or filling pressure causes a gradual, user-controllable expansion of the catheter balloon such that at least a portion of the catheter balloon engages and expands a side wall of the rectum or colon of the patient, whereby to trigger a coordinated defecation reflex by generating a reflex- triggering stimulus of an intensity which can, determined by the user, substantially exceed the intensity achievable by an irrigation with fluid media (see Gobel '661 disclosing increasing the inflation pressure to trigger the defecation reflex),
and wherein the catheter balloon or the intrarectal balloon segment is made of a non-volume- expandable, non-elastic material, such that no further dimensional expansion is allowed beyond a final dimension to which the catheter balloon or the intrarectal balloon segment is pre-formed, in order to avoid uncontrolled dilation and trauma (see Gobel '028 disclosing its substantially non-compliant balloon, which implicitly has a dimension by which no additional expansion would be allowed unless the balloon was caused to rupture).
Regarding claim 152, Gobel '028 discloses that the catheter balloon or at least the intrarectal balloon segment is pre-formed into a working dimension associated with a filling state, characterized by an initial fill volume or an initial filling pressure, in which the filling pressure required for anchoring the catheter within the rectum or colon of the patient is approximately the same as the pressure prevailing in the rectum or abdomen (equalizing these pressure is how the device of Gobel '028 is able to counteract the rectal pressure and maintain rectal patency),
wherein the catheter balloon is configured such that an increase above the initial fill volume or filling pressure causes a gradual, user-controllable expansion of the catheter balloon such that at least a portion of the catheter balloon engages and expands a side wall of the rectum or colon of the patient, whereby to trigger a coordinated defecation reflex (see Gobel '661 disclosing increasing the inflation pressure to trigger the defecation reflex),
wherein the catheter balloon or the intrarectal balloon segment has a compliance reserve (i.e., the balloon or its segment is made of a low-compliance material as described above),
wherein the catheter balloon or the intrarectal balloon segment of the catheter balloon distends elastically (e.g., inflated to a working size as illustrated in para [0012]),
but does not disclose:
wherein the transanal balloon segment expands by more than 15%, at a pressure increase from 30 to 100 mbar.
However, based on the teaching in Gobel ‘028 that it is desirable for the balloon characteristics to reduce trauma on the transanal segment (see Gobel ‘028 at para [0016] and Gobel ‘661 at para [0062]), a skilled artisan would have found it obvious at the time of the invention to experiment with the level of expansion of the balloon up to a maximum distention dimension, including choosing materials that fall within the claimed ranges, in order ensure against an overpressure on the rectum during inflation of the balloon that would result in traumatic effects on the rectal wall. Further, the specifically claimed value of more than 15% in the segment due to a pressure increase from 30 mbar to 100 mbar does not appear to solve a stated problem or be critical to the invention.
Claim 136 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gobel '028, in view of Ivanovych, further in view of Hirszowicz et al (U.S. Pub. 2009/0171278 A1, hereinafter “Hirszowicz”).
Regarding claim 136, it is noted that the combination of Gobel ‘028 and Ivanovych does not appear to disclose that the ends of the inflatable balloon, beginning at an inflection point of their longitudinal section, are inwardly invaginated, or inverted, and in the inverted or invaginated state are fixed on an outer jacket surface of the catheter shaft.
Hirszowicz discloses a catheter having a balloon which is fixed to an outer surface of the shaft at two points where the balloon is inwardly invaginated or inverted (see Fig. 5B).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the combination of Gobel ‘028 and Ivanovych according to the teaching in Hirszowicz, as this type of fixation was well-known to enable the balloon to take on a rounded atraumatic shape, and would have therefore been useful for atraumatic use with a reasonable expectation of success.
Claim 137 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gobel '028, in view of Ivanovych, further in view of Nestenborg (U.S. Pat. 7,122,025 B1, hereinafter “Nestenborg”).
Regarding claim 137, it is noted Gobel '028 shows that an envelope of the evacuated, ready-to-use catheter balloon is placed on the shaft, or clings closely thereto, in such fashion that the intrarectal and the transanal balloon sections lie in a shaft region between the fixations of the upper and lower balloon ends, and a preanal balloon portion extends in the proximal direction in a pocket-like manner, but does not appear to disclose that such portion extends over gripping depressions.
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 of 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).
Claim 138 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gobel '028, in view of Ivanovych, further in view of Miller (U.S. Pat. 3,459,175, hereinafter “Miller”).
Regarding claim 138, it is noted that Gobel ‘028 in view of Ivanovych does not appear to disclose gripping depressions disposed on the catheter shaft in direct proximal adjacency to a rear balloon fixation line.
Miller discloses a balloon for insertion into an anal cavity, comprising gripping depressions 39 (Figs. 1-2) situated on a catheter shaft 15 including at an area adjacent a balloon fixation point of a balloon 28 to the catheter shaft 15 (see Figs. 1-2).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Gobel ‘028 and Ivanovych, by providing gripping depressions, as taught in Miller, in order to facilitate placement of the catheter in the body and retain the catheter in the anal cavity.
Claim 148 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gobel '028, in view of Ivanovych, further in view of Nielsen et al (U.S. Pub. 2010/0087792 A1, hereinafter “Nielsen”).
Regarding claim 148, it is noted that the combination of Gobel ‘028 and Ivanovych does not appear to disclose the claimed user-adjustable decompression mechanism.
Nielsen discloses an irrigation system that has a user-adjustable decompression mechanism in the form of a vent that opens the balloon to ambient space and deflates the balloon (para [0015] and [0053]).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Gobel ‘028 and Ivanovych according to the teaching in Nielsen, if one desired to deflate the balloon when the irrigation procedure is ended (see Nielsen at para [0015]). It is understood that this vent could be activated at any time including when pressure increase inside the balloon is caused by peristaltic contraction of the colo-rectal bowel segment due to the released coordinated defecation reflex.
Claim 151 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gobel '028, in view of Ivanovych, further in view of Gobel '661, further in view of Miller.
Regarding claim 151, Gobel '028 discloses that the catheter balloon or at least the intrarectal balloon segment is pre-formed into a working dimension associated with a filling state, characterized by an initial fill volume or an initial filling pressure, in which the filling pressure required for anchoring the catheter within the rectum or colon of the patient is approximately the same as the pressure prevailing in the rectum or abdomen (equalizing these pressure is how the device of Gobel '028 is able to counteract the rectal pressure and maintain rectal patency),
wherein the catheter balloon is configured such that an increase above the initial fill volume or filling pressure causes a gradual, user-controllable expansion of the catheter balloon such that at least a portion of the catheter balloon engages and expands a side wall of the rectum or colon of the patient, whereby to trigger a coordinated defecation reflex (see Gobel '661 disclosing increasing the inflation pressure to trigger the defecation reflex),
wherein the catheter balloon or the intrarectal balloon segment has a compliance reserve (i.e., the balloon or its segment is made of a low-compliance material as described above),
wherein the catheter balloon or the intrarectal balloon segment of the catheter balloon distends elastically (e.g., inflated to a working size as illustrated in para [0012]),
but does not disclose:
wherein the transanal balloon segment expands by less than 20%, at a pressure increase from 30 to 100 mbar, and wherein gripping depressions are disposed on the catheter shaft in direct proximal adjacency to a rear balloon fixation line.
However, based on the teaching in Gobel ‘028 that it is desirable for the balloon characteristics to reduce trauma on the transanal segment (see Gobel ‘028 at para [0016] and Gobel ‘661 at para [0062]), a skilled artisan would have found it obvious at the time of the invention to experiment with the level of expansion of the balloon up to a maximum distention dimension, including choosing materials that fall within the claimed ranges, in order ensure against an overpressure on the rectum during inflation of the balloon that would result in traumatic effects on the rectal wall. Further, the specifically claimed value of less than 20% in the segment due to a pressure increase from 30 mbar to 100 mbar does not appear to solve a stated problem or be critical to the invention.
Further, Miller discloses a balloon for insertion into an anal cavity, comprising gripping depressions 39 (Figs. 1-2) situated on a catheter shaft 15 including at an area adjacent a balloon fixation point of a balloon 28 to the catheter shaft 15 (see Figs. 1-2).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Gobel ‘028, Ivanovych and Gobel '661, by providing gripping depressions, as taught in Miller, in order to facilitate placement of the catheter in the body and retain the catheter in the anal cavity.
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/08/2026
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