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 § 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 Rejections - 35 USC § 103
Claim(s) 12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al (WO 2017160412) in view of Kagan et al. (US 20120123323 hereinafter “Kagan”).
Regarding Claim 12, Locke teaches a method of treating a tissue site (103) with negative-pressure and therapeutic solution, the method comprising:
delivering the negative pressure to the tissue site for a first interval ([0027] "The negative pressure developed by a negative-pressure source may be delivered through a tube to a connector, such as the connector 121 and the connector 122. In one illustrative embodiment, a connector may be a T.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from KCI of San Antonio, Tex. A connector may allow the negative pressure to be delivered to a dressing. In other exemplary embodiments, a tube may be inserted through the cover 108 of the dressing 104.");
delivering a fill volume of the therapeutic solution to the tissue site for a second interval (see [0028] " And instillation solution may also be delivered to the therapeutic environment for treating the tissue site"); and
delivering a purge volume to the tissue site ([0070-0071]).
Locke does not specify the purge volume is the therapeutic solution.
Kagan teaches (fig 1) method including of treating a tissue site including a negative pressure source (112; [0039-0040]), and a purge volume of therapeutic solution (134; see [0042] teaching that 134 could be used to deliver purge fluid and therapeutic fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the purge volume of Locke such that it is the same therapeutic fluid as taught by Kagan. One of ordinary skill int eh art would have been motivated to do so as this is another fluid that is known to help inhibit/eliminate bocking during therapy (Kagan [0054]).
Regarding Claim 15, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the fill volume is at least 10 times the purge volume.
The instant disclosure describes the parameter of the fill volume is at least 10 times the purge volume as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the fill volume is at least 10 times the purge volume are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the fill volume is at least 10 times the purge volume would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 16, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1.
The instant disclosure describes the parameter of a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 13-14 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2017160412) in view of Kagan (US 20120123323) as applied to claim 12 above, and further in view of Cornet et al. (US Patent Pub. 20070219585 hereinafter “Cornet”).
Regarding Claim 13, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is delivered during the first interval.
Cornet teaches [0169] that delivery of purging fluid during the application of reduced pressure is sufficient to prevent blockages from forming.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Locke such that the purge volume is delivered during the first interval as taught by Cornet. One of ordinary skill in the art would have been motivated to do so in order to prevent or resolve blockages during a reduced or negative pressure delivery (Cornet [0168]).
Regarding Claim 14, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is delivered before the first interval.
Cornet teaches [0168] that purging the manifold and reduced pressure conduit with air for a selected amount of time at a selected interval assists in preventing or resolving blockages. The examiner takes the position that if a blockage occurs prior to the negative pressure interval (reduced pressure) then a purge volume could be delivered prior to the negative pressure interval to "resolve" the blockage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Locke such that the purge volume is delivered before the first interval as taught by Cornet. One of ordinary skill in the art would have been motivated to do so in order to resolve blockages that may have occurred prior to the delivery of negative pressure (Cornet [0168]).
Regarding Claim 17, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is in a range of about 0.1 milliliters to about 1 milliliter.
Cornet teaches [0169] that the quantity and frequency of the purging fluid may vary based on design and size of the system but should be high enough to sufficiently clear blockages.
The instant disclosure describes the parameter of the purge volume is in a range of about 0.1 milliliters to about 1 milliliter as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge volume is in a range of about 0.1 milliliters to about 1 milliliter are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. With the teachings of Cornet, it would have been obvious to one having ordinary skill in the art that the limitation of the purge volume is in a range of about 0.1 milliliters to about 1 milliliter would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 18, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is delivered at a frequency of no greater than 20 minutes.
Cornet taches [0169] that the quantity and frequency of the purging fluid may vary based on design and size of the system but should be high enough to sufficiently clear blockages. Cornet further provides an example including a frequency interval of 60 seconds (See [0169]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Locke such that the purge volume is delivered at a frequency of no greater than 20 minutes as taught by Cornet. One of ordinary skill in the art would have been motivated to do so in order to sufficiently clear blockages in the system (Cornet [0169]).
Claim(s) 31-35 and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2017160412) in view of Kagan (US 20120123323) and Cornet (US Patent Pub. 20070219585).
Regarding Claim 31, Locke teaches an apparatus for treating a tissue site (103), the apparatus comprising:
a supply of negative pressure (131,132; [0027]);
a solution source (142; [0026]); and
a controller (137, 138; [0052]) operatively coupled to the supply of negative pressure (131, 132) and to the solution source (142), the controller configured to:
deliver negative pressure to the tissue site for a negative-pressure interval ([0027] "The negative pressure developed by a negative-pressure source may be delivered through a tube to a connector, such as the connector 121 and the connector 122. In one illustrative embodiment, a connector may be a T.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from KCI of San Antonio, Tex. A connector may allow the negative pressure to be delivered to a dressing. In other exemplary embodiments, a tube may be inserted through the cover 108 of the dressing 104.");
deliver a fill volume of instillation fluid to the tissue site for an instillation interval (see [0028] " And instillation solution may also be delivered to the therapeutic environment for treating the tissue site"); and
delivering a purge volume to the tissue site ([0070-0071]).
Locke does not specify the purge volume is the instillation fluid.
Kagan teaches (fig 1) method including of treating a tissue site including a negative pressure source (112; [0039-0040]), and a purge volume of therapeutic solution (134; see [0042] teaching that 134 could be used to deliver purge fluid and therapeutic fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the purge volume of Locke such that it is the same therapeutic fluid as taught by Kagan. One of ordinary skill int eh art would have been motivated to do so as this is another fluid that is known to help inhibit/eliminate bocking during therapy (Kagan [0054]).
The combination does not specify delivering a purge volume at a purge frequency in response to completion of the instillation interval.
Cornet teaches [0169] that the quantity and frequency of the purging fluid may vary based on design and size of the system but should be high enough to sufficiently clear blockages. Cornet also teaches [0168] that purging the manifold and reduced pressure conduit with air for a selected amount of time at a selected interval assists in preventing or resolving blockages. The examiner takes the position that if a blockage occurs after the instillation fluid is delivered then a purge volume could be delivered to "resolve" the blockage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Locke such that it delivers a purge volume at a purge frequency in response to completion of the instillation interval as taught by Cornet. One of ordinary skill in the art would have been motivated to do so in order to sufficiently clear blockages in the system (Cornet [0169]).
Regarding Claim 32, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke does not specify the apparatus wherein the controller is configured to deliver the purge volume of instillation fluid during the negative-pressure interval.
Cornet teaches [0169] that delivery of purging fluid during the application of reduced pressure is sufficient to prevent blockages from forming.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Locke such that the controller is configured to deliver the purge volume of instillation fluid during the negative-pressure interval as taught by Cornet. One of ordinary skill in the art would have been motivated to do so in order to prevent or resolve blockages during a reduced or negative pressure delivery (Cornet [0168]).
Regarding Claim 33, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke does not specify the apparatus wherein the fill volume is at least 10 times the purge volume of instillation fluid.
The instant disclosure describes the parameter of the fill volume is at least 10 times the purge volume as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the fill volume is at least 10 times the purge volume are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the fill volume is at least 10 times the purge volume would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 34, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke does not specify the apparatus wherein a ratio of the fill volume to the purge volume of instillation fluid is in a range of about 10:1 to about 5000:1.
The instant disclosure describes the parameter of a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of a ratio of the fill volume to the purge volume is in a range of about 10:1 to about 5000:1 would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 35, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke teaches the apparatus wherein the fill volume is in a range of about 10 milliliters to about 500 milliliters (See Locke [0052]). Locke does not specify the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter.
The instant disclosure describes the parameter of the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 38, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke further teaches the apparatus further comprising a fluid conductor (121, 122) fluidly coupled to the solution source, and wherein the controller (137, 138) is configured to deliver the purge volume of instillation fluid through the fluid conductor (See [0070]).
Regarding Claim 39, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke further teaches the apparatus further comprising a first fluid conductor (121) fluidly coupled to the supply of negative pressure (See Fig 1, a second fluid conductor (122) fluidly coupled to the solution source (see Fig 1), and wherein the controller is configured to deliver the purge volume of instillation fluid through the second fluid conductor and to remove the purge volume of instillation fluid through the first fluid conductor (See [0070]).
Regarding Claim 40, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke further teaches the apparatus further comprising a user interface coupled to the controller and operable to receive input to configure at least one of the purge volume of instillation fluid and the purge frequency (See [0031] and [0066] teaching a user interface connected with the controllers 137 and 138 that control the apparatus).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2017160412) in view of Kagan (US 20120123323) as applied to claim 12 above, and further in view of Robinson et al. (US Patent Pub. 20190046699 hereinafter “Robinson”).
Regarding Claim 19, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is delivered at a frequency of not less than 5 minutes.
Robinson teaches a therapy pressure unit that has a purge cycle implemented every 5 minutes (See [0070] “In one embodiment, the purge cycle may be implemented every five minutes”).
The instant disclosure describes the parameter of the purge volume is delivered at a frequency of not less than 5 minutes as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge volume is delivered at a frequency of not less than 5 minutes are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Based on the teachings of Robinson, it would have been obvious to one having ordinary skill in the art that the limitation of the purge volume is delivered at a frequency of not less than 5 minutes would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 20, the combination of Locke and Kagan teaches all elements of claim 12 as described above. Locke does not specify the method wherein the purge volume is delivered at a frequency between about 5 minutes and about 20 minutes.
Robinson teaches a therapy pressure unit that has a purge cycle implemented every 5 minutes (See [0070] “In one embodiment, the purge cycle may be implemented every five minutes”).
The instant disclosure describes the parameter of the purge volume is delivered at a frequency between about 5 minutes and about 20 minutes as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge volume is delivered at a frequency between about 5 minutes and about 20 minutes are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Based on the teachings of Robinson, it would have been obvious to one having ordinary skill in the art that the limitation of the purge volume is delivered at a frequency between about 5 minutes and about 20 minutes would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2017160412) in view of Kagan (US 20120123323) and Cornet (US Patent Pub. 20070219585) as applied to claim 31 above, and further in view of Robinson (US Patent Pub. 20190046699).
Regarding Claim 36, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke does not specify the apparatus wherein the purge frequency is in a range of about 5 minutes to about 20 minutes.
Robinson teaches a therapy pressure unit that has a purge cycle implemented every 5 minutes (See [0070] “In one embodiment, the purge cycle may be implemented every five minutes”).
The instant disclosure describes the parameter of the purge frequency is in a range of about 5 minutes to about 20 minutes as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge frequency is in a range of about 5 minutes to about 20 minutes are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Based on the teachings of Robinson, it would have been obvious to one having ordinary skill in the art that the limitation of the purge frequency is in a range of about 5 minutes to about 20 minutes would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 37, the combination of Locke, Kagan and Cornet teaches all elements of claim 31 as described above. Locke further teaches the apparatus wherein:
the fill volume is in a range of about 10 milliliters to about 500 milliliters (See [0052]). Locke does not specify the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter.
The instant disclosure describes the parameter of the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the purge volume of instillation fluid is in a range of about 0.1 milliliters to about 1 milliliter would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Locke also does not specify the purge frequency is in a range of about 5 minutes to about 20 minutes.
Robinson teaches a therapy pressure unit that has a purge cycle implemented every 5 minutes (See [0070] “In one embodiment, the purge cycle may be implemented every five minutes”).
The instant disclosure describes the parameter of the purge frequency is in a range of about 5 minutes to about 20 minutes as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the purge frequency is in a range of about 5 minutes to about 20 minutes are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Based on the teachings of Robinson, it would have been obvious to one having ordinary skill in the art that the limitation of the purge frequency is in a range of about 5 minutes to about 20 minutes would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
As to the remarks on Pgs. 5- 6, the applicant argues that Kagan does not teach a purge volume of therapeutic fluid. The applicant states that Kagan [0042] teaches either a liquid purge or a therapeutic volume, not that they are both the same. The applicant further cites [0041] teaching a purge gas that is used in the device of Kagan. The examiner does not find this persuasive. The examiner takes the position that the liquid source 134 of Kagan could be used as a purge fluid. Since Kagan teaches in [0042] that the liquid source could be a therapeutic liquid as well, it is interpreted that the therapeutic liquid could also be used as a purge liquid. The examiner takes the position that the system of Kagan is capable of using the fluid source of 134 as a purging fluid with the fluid connection between 134 and 130 and 122 as stated in [0043] and [0048], as such even if the fluid of 134 is a therapeutic fluid it would still be able to function as the purging fluid. For these reasons the rejection is maintained.
As to the arguments on Pg. 6-8, the applicant argues that there is no motivation to combine Locke/Robinson and Kagan as both references use a purging gas to remove obstructions rather than a liquid purge. The examiner does not find this persuasive. The While Kagan may teach a gas purge in [0041], the examiner is using Kagan [0042] teaching that there may also be a liquid purge in the fluid source 134. Since both devices teach a purge volume, it would have been obvious to one of ordinary skill in the art to use a liquid purge in place of a gas purge. This is an alternative fluid that would provide the same results of the purge as described in Kagan [0054]. For these reasons the rejection is maintained.
As to the arguments on PG. 8-10, the applicant argues that the combination of Locke/Robinson, Kagan and Cornet does not teach the limitation of “deliver a purge volume of instillation fluid to the tissue site at a purge frequency in response to completion of the instillation interval”. The applicant argues that Cornet does not specify this limitation. The examiner does not find this persuasive. Cornet broadly states that the purge volume is released to help remove any blockages that occur. As such, if there was a blockage that occurred after the instillation fluid was delivered, then a purge volume could be delivered in order to resolve the blockage issue. For these reasons, the examiner believes that the teachings of Cornet would make it obvious to deliver a purge volume after the completion of the instillation interval, and the rejection is maintained.
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783