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 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 125, 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 "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 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 125, 126, 131, 132, 133, 134, 135, 140-143, 145, 153 and 154 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 is referenced herein), in view of Ivanovych (UA 68194 A, hereinafter "Ivanovych"; see English translation, attached), further in view of Bharucha et al (American Journal of Physiology-Gastrointestinal and Liver Physiology, 2006, hereinafter " Bharucha").
Regarding claim 125, Gobel '028 discloses method for intermittently triggering a low-pressure coordinated defecation reflex in a rectum of a patient or a colon of the patient, the 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), comprising an intrarectal balloon segment configured to be inserted into the patient intrarectally (see Fig. 3),
wherein the inflatable balloon is fixed onto the inflexible catheter shaft at a distal fixation point located at a distal end of the inflatable balloon and a proximal fixation point located at a proximal end of the inflatable balloon (see Fig. 3 showing that the balloon is attached at fixation points at either end of the inflatable balloon),
wherein the inflatable balloon enables a low-pressure coordinated defecation reflex when the inflatable balloon transitions from an unpressurized state (see para [0040] of the corresponding U.S. publication and left half of Fig. 4) to a pressurized state (see right half of Fig. 4), wherein, in the pressurized state, the inflatable balloon is configured to trigger the low-pressure coordinated defecation reflex;
inserting the catheter in the rectum of the patient or the colon of the patient while the inflatable balloon is in the unpressurized state (see left half of Fig.4); and
after inserting the catheter, pressurizing the inflatable balloon to reach the pressurized state, thereby causing at least a distal portion of the intrarectal balloon segment to engage and expand a side wall of the rectum or colon (right half of Fig. 4) and trigger the low-pressure coordinated reflex,
wherein the inflatable ballon has a pressure between 30 mbar and 50 mbar in the pressurized state.
It is noted that Gobel '028 does not appear to disclose that in the pressurized state, the inflatable balloon is configured to trigger the low-pressure coordinated defecation reflex; and triggering this reflex occurs via the intrarectal balloon segment engaging and expanding a side wall of the rectum or colon, and the inflatable balloon has a pressure between 30 mbar and 50 mbar in the pressurized state.
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.
Further, though Ivanovych discloses that the balloon is elevated to a pressure of 40-70 mmHg, or approx. 53-93 mbar, which is outside of the claimed range of 30 mbar to 50 mbar, it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See, e.g., In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Ivanovych teaches that its balloon pressure is provided as a result-effective variable to produce "pneumostimulation", defined therein as changing the pressure in a balloon inserted into the rectum to trigger the defecation reflex (or "urge to defecate"; see Ivanovych at pg. 1). Accordingly, selecting a pressure of 30-50 mbar would have amounted to no more than optimization of a result-effective variable through routine experimentation, with a reasonable expectation of success.
Moreover, applying a pressure of 30-50 mbar was known at the time of the invention in view of Bharucha, which discloses rectal distension of up to 32 mmHg (approx. 42 mbar) to trigger a defecation urge.
It would have been obvious, based on the teaching in Bharucha and the knowledge generally available to those of ordinary skill in the art, to pressurize the balloon to less than the range taught in Ivanovych with a reasonable expectation of success in triggering defecation.
Further, Applicant has not demonstrated that the claimed range produces an unexpected result different in kind, rather than degree, from the results obtained using the pressures disclosed by Ivanovych. See In re Dreyfus, 73 F.2d 931 (C.C.P.A. 1934); In re Waite, 168 F.2d 104 (C.C.P.A. 1948). Applicant's own disclosure identifies 30-50 mbar as merely an exemplary pressure range and suggests that pressures of less than 100 mbar, including pressures below 70 mbar, are less likely to cause an uncoordinated defecation reflex (see instant specification at pg. 15). Thus, Applicant's disclosure does not establish that the claimed range is critical or that the relatively small reduction from Ivanovych's disclosed range would produce an unexpected result. Nor has Applicant provided evidence that the pressures disclosed by Ivanovych would cause the alleged "uncoordinated, traumatic, and painful spasms." On the contrary, Applicant's own disclosure teaches that pressures of up to 100mbar can be applied to trigger a coordinated defecation reflex without causing trauma (see, e.g., Applicant's original claims 124 and 152).
Regarding claim 126, Gobel '028 discloses that the inflatable balloon comprises a tapered transanal balloon section disposed proximally adjacent to the intrarectal balloon segment, wherein the tapered transanal balloon section has a radius smaller than a radius of the intrarectal balloon segment (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 131, Gobel ‘028 discloses that the inflatable 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 an anus of the patient (see Fig. 4 of Gobel ‘028).
Regarding claim 133, Gobel ‘028 shows, in Fig. 4, that the tapered balloon section projects over an anus of the patient to form a pre-anal segment of the balloon, which is pre-formed into a conical balloon section having a conical shape with a distal end and a proximal end.
Regarding claim 134, the limitation of the intrarectal balloon segment and the tapered transanal balloon section being manufactured separately amounts to 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, the waisted shape being based on a spherical shape associated with a proximal terminal balloon section, and the tapered transanal balloon section disposed between the intrarectal balloon segment and the proximal terminal balloon section (see Fig. 4 showing the waisted shape and the two radially enlarged sections on either side).
Regarding claims 140 and 141, Gobel ‘028 discloses a non-return element 42 that is configured to prevent retrograde backflow of fluid is inserted in a duct of the inflexible catheter shaft or integrated into a tubing line that connects the inflexible catheter shaft with a fluid containing containment (see para [0178]).
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 irrigation fluid (presuming it is limited by the volume of fluid of the container) can be squeezed out from the container into the rectum of a patient as necessary.
Regarding claim 145, Gobel ‘028 discloses that the catheter is a disposable catheter connectable via a filling conduit to a filling device (see para [0146] and Fig. 10; it is understood that any feature could be disposable).
Regarding claim 153, Gobel '028 discloses that the inflatable ballon comprises a tapering of the distal end of the inflatable balloon to a shaft dimension of the inflexible catheter shaft and a tapering of the proximal end of the inflatable balloon to the shaft dimension of the inflexible catheter shaft (see Fig. 3 showing that the balloon tapers downward to approximately a shaft dimensions at the fixation points).
Regarding claim 154, Gobel '028 discloses that a difference between a radius of the intrarectal balloon segment and a radius of the distal end of the inflatable balloon is greater than a distance between a distal front side of the catheter and the 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").
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Gobel '028, Annotated Fig. 3 showing distances "A" and "B".
Claim 147 is 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 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.
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 distal of the inflatable balloon and the proximal end of the inflatable balloon or inwardly invaginated or inverted.
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, such that the intrarectal and the transanal balloon sections lie in a shaft region between the fixation points 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 inflexible catheter shaft adjacent 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.
Response to Arguments
Applicant's arguments filed 07/21/2026 have been fully considered.
Applicant argued that the objection to claim 125 is rendered moot because claim 125 has been amended. Applicant's amendment has been considered. The objection has been withdrawn.
Claims 125, 128, 133, 144, 146, and 149-152 were rejected under 35 U.S.C. § 112(b) as being indefinite. Applicant canceled claims 128, 144, 146, and 149-152 and amended claims 125 and 133. Applicant argued that, in view of the amendments to claims 125 and 133, the rejections under 35 U.S.C. 112(b) are rendered moot. The rejections have been withdrawn.
Regarding the rejections of claims 125 under 35 U.S.C. 103, Applicant argued that Gobel '028 and Ivanovych fail to disclose the claimed limitation, inter alia, "the inflatable balloon has a pressure between 30 mbar and 50 mbar in the pressurized state." (see Remarks, pg. 16).
In this case, values within Applicant's claimed range (30-50 mbar) are close to values within the prior art range (approx. 53-94 mbar). It has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See, e.g., In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Ivanovych teaches that its balloon pressure is provided as a result-effective variable to produce "pneumostimulation", defined therein as changing the pressure in a balloon inserted into the rectum to trigger the defecation reflex (or "urge to defecate"; see Ivanovych at pg. 1). Accordingly, selecting a pressure of 30-50 mbar would have amounted to no more than optimization of a result-effective variable through routine experimentation, with a reasonable expectation of success.
Moreover, applying a pressure of 30-50 mbar was known at the time of the invention in view of Bharucha, which discloses rectal distension of up to 32 mmHg (approx. 42 mbar) to trigger a defecation urge.
Further, Applicant has not demonstrated that the claimed range produces an unexpected result different in kind, rather than degree, from the results obtained using the pressures disclosed by Ivanovych. See In re Dreyfus, 73 F.2d 931 (C.C.P.A. 1934); In re Waite, 168 F.2d 104 (C.C.P.A. 1948).
Applicant's own disclosure identifies 30-50 mbar as merely an exemplary pressure range and suggests that pressures of less than 100 mbar, including pressures below 70 mbar, are less likely to cause an uncoordinated defecation reflex (see instant specification at pg. 15).
Thus, Applicant's disclosure does not establish that the claimed range is critical or that the relatively small reduction from Ivanovych's disclosed range would produce an unexpected result; nor has Applicant provided evidence that the pressures disclosed by Ivanovych would cause the alleged "uncoordinated, traumatic, and painful spasms." On the contrary, Applicant's own disclosure teaches that pressures of up to 100mbar can be applied to trigger a coordinated defecation reflex without causing trauma (see, e.g., Applicant's original claims 124 and 152).
Applicant argued that claims 133, 136, 137, 138, 147, 148 and 151 for substantially the same reason(s) as alleged above (see Remarks, pgs. 18-22). But these claims were not separately argued on their merits.
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 08/18/2026
