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 .
Response to Arguments
Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 7 of the Remarks that “The Office failed to articulate how Inhaber identifies the concentration of icodextrin, or dextrose, as result-effective variables.” The examiner respectfully notes that Inhaber was not relied upon for the teaching of the concentrations of icodextrin or dextrose to be result effective variables. Instead, Inhaber teaches an infusate composition which comprises both icodextrin and dextrose (claim 1) and further discloses ranges of the concentrations which encompasses both the claimed concentration value of icodextrin and the claimed concentration range of dextrose (paragraph 48). Inhaber differs from the claimed invention since Inhaber teaches a broader/overlapping range than the claimed concentration value and concentration range of icodextrin and dextrose, respectively. As such, the examiner maintains that PHOSITA would have been motivated to select the claimed icodextrin concentration since the claimed concentration is within the identified solutions provided by Inhaber. Additionally, the examiner maintains that it would have been obvious to have selected the claimed dextrose concentration since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant further argues on pgs. 7-10 of the Remarks that the specification provides for criticality in the claimed ranges in that the ranges show unexpected results over the prior art reference. The examiner respectfully disagrees and notes that while claim 1 is drawn to a narrow range of dextrose concentrations and a specific value of icodextrin concentrations, the specification makes it clear that, “in one exemplary embodiment” (paragraph 33), the infusate can comprise 0-15% wt dextrose and “up to 40% wt” icodextrin and that “such an exemplary DSR infusate composition is expected to remove both sodium and water” (paragraph 33). This paragraph of the specification further discloses that “more generally, formulations suitable for DSR therapy may contain” 0-50% wt dextrose and 0.5-50% wt icodextrin. Thus, Applicant discloses a wide range of concentrations for both dextrose and icodextrin as being within the scope of invention, which suggests that the claimed range is not critical since the claimed values are a much narrower subset than the disclosed values.
While the example provided in the specification (figs. 8-10) discloses a specific infusate containing 10%wt dextrose and 30% wt icodextrin which appears to produce satisfactory results, this seems to be the only specific example provided by Applicant. The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979). It is the examiner’s opinion that the one test provided by Applicant is insufficient to establish criticality over the entire claimed range, especially since the specific test was conducted with one volume of infusate whereas the claim is drawn to a range of infusate volumes. Additionally, per MPEP 716.02(d), to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). There does not appear to be any evidence which shows tests comparing the claimed range to concentration values outside of the claimed range. As such, it is still the examiner’s opinion that Applicant has not met the burden of establishing criticality for the claimed concentrations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber (US 20210187179).
Regarding claim 1, Inhaber discloses a method of conducting direct sodium removal (DSR) therapy for a patient, the method comprising:
providing an infusate comprising an aqueous solution (paragraph 155 discloses an infusate with water);
instilling 125 ml to 1 liter of the infusate into a peritoneal cavity of the patient (paragraph 155 discloses infusing 1liter of infusate);
retaining the infusate in the peritoneal cavity for a 4-24 hour dwell period to induce sodium and ultrafiltrate to accumulate within the peritoneal cavity (paragraph 155 discloses a dwell time of 6 hours); and
removing the infusate, sodium and ultrafiltrate from the peritoneal cavity (paragraph 155 discloses periodically taking fluid samples which comprises sodium-laden DSR infusate and osmotic ultrafiltrate).
However, Inhaber does not teach or disclose in this specific method that the infusate comprises 30 wt% icodextrin and 5-15 wt% dextrose.
However, Inhaber teaches than an example infusate can comprise between 0.5-50 wt% dextrose and 0.5-50 wt% icodextrin (claim 1 and paragraph 48 discloses an infusate comprising icodextrin, dextrose, and “any combination thereof”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the infusate of the method disclosed by Inhaber above to have both dextrose and icodextrin as Inhaber teaches that this is an example infusate which is used in the treatment of heart failure by removing excess sodium (claim 1).
As noted above, Inhaber teaches an infusate comprising a range of icodextrin concentrations which encompasses the claimed concentration (claim 1 and paragraph 48). As such, Inhaber teaches a finite number of identified, predictable potential solutions for providing an infusate for DSR therapy comprising icodextrin in that Inhaber teaches concentrations between 0.5-50% wt icodextrin which encompasses the claimed solution (30% wt). Therefore, PHOSITA would have been motivated to select the claimed icodextrin concentration with a reasonable expectation of success since the claimed icodextrin concentration is within the identified solutions provided by Inhaber. KSR, 550 U.S. at 421, 82 USPQ2d at 1397
Additionally, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the concentration of dextrose to be between 5-15% wt% since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, Inhaber discloses prior to instilling the infusate, reducing or suspending administration of loop diuretics to the patient (the examiner notes that the time period of the claim is not defined; PHOSITA would understand that at some point prior to instilling the infusate, loop diuretics would not be administered).
Regarding claim 4, Inhaber discloses the infusate is instilled into the peritoneal cavity using a peritoneal dialysis catheter (catheter 46 in fig. 1B).
Regarding claim 9, Inhaber discloses providing the infusate further comprises providing an infusate having a sodium concentration lower than 135 meq/l (claim 1).
Regarding claim 10, the limitation “the dextrose rapidly crosses a peritoneal membrane of the patient and draws water into the peritoneal cavity to dilute the concentration of icodextrin, thereby reducing a rate at which the icodextrin is removed from the peritoneal cavity” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although modified Inhaber does not discuss that the dextrose rapidly crosses a peritoneal membrane of the patient and draws water into the peritoneal cavity to dilute the concentration of icodextrin, thereby reducing a rate at which the icodextrin is removed from the peritoneal cavity, this result is inherently met since the method steps are disclosed.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber, as applied to claim 1 above, and further in view of Soykan (US 20150250427).
Regarding claim 3, Inhaber teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose following removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity, reducing or suspending administration of loop diuretics to the patient during a follow-up period of at least three months as compared to the patient's loop diuretic regimen prior to the treatment.
Soykan teaches that diuretics are used to treat overload of fluid in patients but that diuretics can contribute to the downward spiral in patients with heart failure and that some patients do not respond to diuretic therapy due to diuretic resistance (paragraph 5). As such, ultrafiltration is used as an alternative to diuretics (paragraph 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to incorporate the method step of following removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity, suspending administration of loop diuretics to the patient during a follow-up period of at least three months as compared to the patient's loop diuretic regimen prior to the treatment in a patient which has resistance to diuretics, as taught by Soykan, for the purpose of eliminating the limitations associated with loop diuretics.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber, as applied to claims 1 and 4 above, and further in view of Becker (WO 0057833).
Regarding claim 5, Inhaber teaches all of the claimed limitations set forth in claims 1 and 4, as discussed above, but does not teach or disclose removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity following the 4-24 hour dwell periods uses the peritoneal dialysis catheter.
Becker teaches a similar method of instilling an infusate into the peritoneal cavity using a catheter (fig. 1 and pg. 5, lines 21-25 discloses infusing through a catheter connected to connector 4) and removal of the infusate from the peritoneal cavity using the catheter (fig. 1 shows drain bag connected to delivery tube 7 indicating that the catheter would also remove the infusate). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to include the step of removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity following the 4-24 hour dwell periods uses the peritoneal dialysis catheter, as Becker teaches that this would obviate the need for an implantable pump.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber, as applied to claim 1 above, and further in view of Levin (US 20140012180).
Regarding claim 7, Inhaber discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the infusate is instilled into the peritoneal cavity via a subcutaneous port.
Levin teaches that infusate is instilled into the peritoneal cavity via a subcutaneous port connected to a catheter (paragraph 59; port 603 in fig. 6). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to include the step of instilling the infusate into the peritoneal cavity via a subcutaneous port, as taught by Inhaber, to obviate the need to repeatedly insert a catheter into the peritoneum.
Claim(s) 11, 12, 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber in view of Wolfson (“A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Icodextrin in Peritoneal Dialysis”).
Regarding claim 11, Inhaber discloses a method of conducting direct sodium removal (DSR) therapy for a patient, the method comprising:
providing an infusate comprising an aqueous solution (paragraph 155 discloses an infusate with water);
on a first treatment day, instilling 125 ml to 1 liter of the infusate into a peritoneal cavity of the patient (paragraph 155 discloses infusing 1liter of infusate);
retaining the infusate in the peritoneal cavity for a 4-24 hour dwell period to induce sodium and ultrafiltrate to accumulate within the peritoneal cavity (paragraph 155 discloses a dwell time of 6 hours); and
removing the infusate, sodium and ultrafiltrate from the peritoneal cavity (paragraph 155 discloses periodically taking fluid samples which comprises sodium-laden DSR infusate and osmotic ultrafiltrate).
However, Inhaber does not teach or disclose in this specific method that the infusate comprises 30 wt% icodextrin and 5-15 wt% dextrose. Additionally, Inhaber does not teach a 14-28 day treatment period and repeating the instilling, retaining, and removing processes up to once daily following the first treatment day.
However, Inhaber teaches than an example infusate can comprise between 0.5-50 wt% dextrose and 0.5-50 wt% icodextrin (claim 1 and paragraph 48 discloses an infusate comprising icodextrin, dextrose, and “any combination thereof”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the infusate of the method disclosed by Inhaber above to have both dextrose and icodextrin as Inhaber teaches that this is an example infusate which is used in the treatment of heart failure by removing excess sodium (claim 1).
As noted above, Inhaber teaches an infusate comprising a range of icodextrin concentrations which encompasses the claimed concentration (claim 1 and paragraph 48). As such, Inhaber teaches a finite number of identified, predictable potential solutions for providing an infusate for DSR therapy comprising icodextrin in that Inhaber teaches concentrations between 0.5-50% wt icodextrin which encompasses the claimed solution (30% wt). Therefore, PHOSITA would have been motivated to select the claimed icodextrin concentration with a reasonable expectation of success since the claimed icodextrin concentration is within the identified solutions provided by Inhaber. KSR, 550 U.S. at 421, 82 USPQ2d at 1397
Additionally, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the concentration of dextrose to be between 5-15% wt% since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Wolfson is directed towards a 28 day treatment period comprising a once-day dwell (pg. 1 Abstract under “Methods”) comprising daily instilling, retaining, and removing steps (pg. 2 under “Methods” discloses instilling a volume of infusate, a dwell period, and draining the fluid). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to have the method be part of a 28 day treatment period which comprises instilling between 125-1.0 liter of the infusate into the peritoneal cavity once daily, retaining the infusate in the peritoneal cavity for a 4-24 hour dwell period, and removing the DSR infusate, sodium, and ultrafiltrate from the peritoneal cavity. Wolfson teaches that the 28 day treatment period with once daily dwells is sufficient to assess net ultrafiltration and peritoneal clearances (abstract) and that this treatment period shows an improved net ultrafiltration clearance (Discussion).
Regarding claim 12, in modified Inhaber, Inhaber discloses prior to the first treatment day, reducing or suspending administration of loop diuretics to the patient (the examiner notes that the time period of the claim is not defined; PHOSITA would understand that at some point prior to instilling the infusate, loop diuretics would not be administered).
Regarding claim 14, in modified Inhaber, Inhaber discloses the infusate is instilled into the peritoneal cavity using a peritoneal dialysis catheter (catheter 46 in fig. 1B).
Regarding claim 19, in modified Inhaber, Inhaber discloses providing the infusate further comprises providing an infusate having a sodium concentration lower than 135 meq/l (paragraph 47).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber in view of Wolfson, as applied to claim 11 above, and further in view of Soykan.
Regarding claim 13, modified Inhaber teaches all of the claimed limitations set forth in claim 11, as discussed above, but does not teach or disclose following the 14-28 day treatment period removal, reducing or suspending administration of loop diuretics to the patient during a follow-up period of at least three months as compared to the patient's loop diuretic regimen prior to the treatment.
Soykan teaches that diuretics are used to treat overload of fluid in patients but that diuretics can contribute to the downward spiral in patients with heart failure and that some patients do not respond to diuretic therapy due to diuretic resistance (paragraph 5). As such, ultrafiltration is used as an alternative to diuretics (paragraph 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to incorporate the method step of following the 14-28 day treatment period removal, suspending administration of loop diuretics to the patient during a follow-up period of at least three months as compared to the patient's loop diuretic regimen prior to the treatment, as taught by Soykan, for the purpose of eliminating the limitations associated with loop diuretics.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber in view of Wolfson, as applied to claims 11 and 14 above, and further in view of Becker (WO 0057833).
Regarding claim 15, Inhaber teaches all of the claimed limitations set forth in claims 11 and 14, as discussed above, but does not teach or disclose removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity following the first and subsequent 4-24 hour dwell period uses the peritoneal dialysis catheter.
Becker teaches a similar method of instilling an infusate into the peritoneal cavity using a catheter (fig. 1 and pg. 5, lines 21-25 discloses infusing through a catheter connected to connector 4) and removal of the infusate from the peritoneal cavity using the catheter (fig. 1 shows drain bag connected to delivery tube 7 indicating that the catheter would also remove the infusate). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to include the step of removal of the infusate, sodium and ultrafiltrate from the peritoneal cavity following the first and subsequent 4-24 hour dwell periods uses the peritoneal dialysis catheter, as Becker teaches that this would obviate the need for an implantable pump.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber in view of Wolfson, as applied to claim 11 above, and further in view of Levin (US 20140012180).
Regarding claim 17, Inhaber discloses all of the claimed limitations set forth in claim 11, as discussed above, but does not teach or disclose the infusate is instilled into the peritoneal cavity via a subcutaneous port.
Levin teaches that infusate is instilled into the peritoneal cavity via a subcutaneous port connected to a catheter (paragraph 59; port 603 in fig. 6). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Inhaber to include the step of instilling the infusate into the peritoneal cavity via a subcutaneous port, as taught by Inhaber, to obviate the need to repeatedly insert a catheter into the peritoneum.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inhaber in view of Wolfson, as applied to claim 11 above, and further in view of Garcia (US 20210134431).
Regarding claim 20, Inhaber discloses all of the claimed limitations set forth in claim 11, as discussed above, but does not teach or disclose the dextrose rapidly crosses a peritoneal membrane of the patient and draws water into the peritoneal cavity to dilute the concentration of icodextrin, thereby reducing a rate at which the icodextrin is removed from the peritoneal cavity.
Garcia teaches a method of using an infusate comprising both icodextrin and up to 15 wt% dextrose (paragraph 112). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the infusate of Inhaber to also comprise dextrose at a level of up to 15 wt%, as taught by Garcia, for the purpose of helping remove the ultrafiltrate more quickly (paragraph 206).
The limitation “the dextrose rapidly crosses a peritoneal membrane of the patient and draws water into the peritoneal cavity to dilute the concentration of icodextrin, thereby reducing a rate at which the icodextrin is removed from the peritoneal cavity” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although modified Inhaber does not discuss that the dextrose rapidly crosses a peritoneal membrane of the patient and draws water into the peritoneal cavity to dilute the concentration of icodextrin, thereby reducing a rate at which the icodextrin is removed from the peritoneal cavity, this result is inherently met since the method steps are disclosed.
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.
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783