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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-8 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Coulthard et al. (US 2015/0119833) in view of Locke et al. (US 2011/0257572) and further in view of Green (US 2013/0310811).
Regarding claims 1 and 8, Coulthard discloses a dressing configured to treat a tissue site (abstract) comprising:
a sealing member (140) configured to provide a sealed space at a tissue site [0045];
an inlet port (148) configured to be in fluid communication with the sealed space ([0029] and figure 1);
an odor filter 194 and the primary hydrophobic filter 195 are positioned in any exit location in the dressing 124 that is in fluid communication with the atmosphere (page 7, [0061]). Such exit location in the dressing can be considered as "a vent configured to be in fluid communication between the sealed space and an atmosphere exterior”, since position on the exit position provides communication from the dressing to the atmosphere.
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Coulthard does not expressly disclose a soluble material configured to preclude fluid communication through the vent until being exposed to moisture for a time period.
Locke teaches a dressing system (Abstract, line 1) comprising a vent valve 142 (page 4, [0036]; fig. 4) having a temporary, pressure-regulating valve/plug 144 (page 4, [0036]; fig. 4) configured to seal a vent as set forth in [0036].
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It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the vent of Coulthard with the temporary, pressure-regulating valve/plug as taught by Locke in order to regulate the pressure, as motivated by Locke (page 4, [0036]).
Coulthard in view of Locke do not expressly disclose the temporary, pressure-regulating plug as a soluble plug.
Locke recognizes that the pressure-regulating valve may take numerous forms as set forth in [0036].
Green teaches an analogous medical apparatus including a relief valve assembly having a dissolvable valve member configured to dissolve after being exposed to moisture for a time period (cl.8) as set forth in [0010].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the valve of Coulthard modified with a soluble material as taught by Green in order to allow for an infinite number of time ranges to be established to control air/fluid flow as taught by Green in [0035].
Additionally, it is also noted that the substitution of one type of temporary pressure-regulating valve for another is considered to be within the level of ordinary skill in the art since the general concept of providing such a valve has already been established by the prior art.
Regarding claim 2, Coulthard discloses a dressing wherein the sealing member (140) comprises a liquid impermeable drape [0047] configured to cover the tissue site (figure 1), and wherein the inlet port (148) is configured to communicate with reduced pressure from a reduced pressure source (128) to the sealed space as set forth in [0026] and in [0074] and as shown in figure 1.
With reference to claim 5, see the rejection of claim 1 with respect to the use of a soluble material.
Coulthard discloses that the temporary pressure-regulating valve is positioned in a fluid passageway defined by a vent as set forth in [0035-0036].
As to claim 6, Coulthard discloses that the vent is be positioned proximate to the inlet port as shown in claim 1 where the odor filter 194 and the primary hydrophobic filter 195 are positioned near the inlet and may be positioned in any exit location in the dressing 124 that is in fluid communication with the atmosphere (page 7, [0061]). Such exit location in the dressing can be considered as "a vent configured to be in fluid communication between the sealed space and an atmosphere exterior”, since position on the exit position provides communication from the dressing to the atmosphere.
With reference to claim 7, Coulthard in view of Locke teach the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Coulthard in view of Locke and claim 7 is the provision that the soluble material is configured to seal the vent before being exposed to moisture for the time period,
Green teaches an analogous medical apparatus including a relief valve assembly having a dissolvable valve member [0003] that is configured to seal (obstruct) the vent before being exposed to moisture for the time period as set forth in [0008-0010].
It is also noted that Green teaches adjusting the particular material used to provide the desired rate at which the valve member dissolves as set forth in [0031].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the valve of Coulthard modified with a soluble material as taught by Green in order to allow for an infinite number of time ranges to be established to control air/fluid flow as taught by Green in [0035].
As to claims 16-17, Coulthard discloses the dressing comprising two hydrophobic filters (page 7, [0061] and page 8, [0067]) capable of being positioned at any desired place.
With respect to claim 18, Coulthard acknowledges that the atmosphere is the area external to the conduit interface as set forth in [0058] and as shown in figure 1.
As to claim 19, Coulthard in view of Locke disclose the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Coulthard in view of Locke and claim 19 is the provision that the inlet port and the vent are carried by a conduit interface.
Since shifting the position of the vent plug would not have modified the operation of the device, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to position the vent plug at any desired place to convenience operation of the device, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 (VI-C)).
Claims 9-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Coulthard et al. (US 2015/0119833) in view of Locke et al. (US 2011/0257572) and Green (US 2013/0310811) and further in view of Hartwell et al. (US 2017/0007751).
With reference to claims 9-11 and 14-15, Coulthard in view of Locke and Green teach the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Coulthard modified and claims 9-11 and 14-15 is the provision that the soluble material includes specific materials.
It is noted that Green teaches adjusting the particular material used to provide the desired rate at which the valve member dissolves as set forth in [0031].
Additionally, Hartwell et al. (hereinafter “Hartwell”) teaches an analogous negative pressure treatment system and wound dressing system (abstract) that includes the use of a partially porous (cl. 15), coated (cl. 14), disclosed as laminated, sintered polymers (cl. 9), material associated with a casting (i.e., compressed), as required by cl. 10, a polymer film (i.e., PEEK) as required by cl. 11, as set forth in [0092].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the dressing of Coulthard modified with the specific materials of Hartwell because these materials aid in distributing negative pressure and may aid in removing fluid from the wound dressing as taught by Hartwell in [0092].
Even further, with respect to claim 10, Locke discloses the system wherein the plug is a ball (Locke, page 4, [0036]; fig. 4) that is a casting.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Coulthard et al. (US 2015/0119833) in view of Locke et al. (US 2011/0257572) and Green (US 2013/0310811) and further in view of Dagger et al. (US 2015/0351970).
With reference to claim 13, Coulthard in view of Locke and Green teach the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Coulthard modified and claim 13 is the provision that the soluble material further comprises a dye configured to be released when the soluble material is exposed to moisture.
It is noted that Green teaches adjusting the particular material used to provide the desired rate at which the valve member dissolves as set forth in [0031].
Additionally, Dagger et al. (hereinafter “Dagger”) teaches an analogous wound dressing (abstract) that includes a dye configured to be released when the soluble material is exposed to moisture as set forth in [0005].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the dressing of Coulthard modified with the dye of Dagger in order to provide a visual cue to the wearer as taught by Dagger in [0005].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Coulthard et al. (US 2015/0119833) in view of Locke et al. (US 2011/0257572) and Green (US 2013/0310811) and further in view of Robinson et al. (US 2012/0330253).
With reference to claim 12, Coulthard in view of Locke and Green teach the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Coulthard modified and claim 12 is the provision that the soluble material is a specific material.
It is noted that Green teaches adjusting the particular material used to provide the desired rate at which the valve member dissolves as set forth in [0031].
Additionally, Robinson et al. (hereinafter “Robinson”) teaches an analogous reduced pressure system for treating a tissue site (abstract) that includes the specific soluble material recited in claim 12 as set forth in [0036].
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the dressing of Coulthard modified with the specific material as taught by Robinson since it has been held that the substitution of one type of soluble material for another is considered to be within the level of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 11,883,261. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9 of the instant application are considered to be obvious over claims 1-48 of U.S. Patent No. 11,883,261.
The instant application requires all of the specifics of U.S. Patent No. 11,883,261. The instant application requires a soluble material as opposed to the transformable/temporary plug of U.S. Patent No. 11,883,261.
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize reasonably include and/or substitute a soluble material as required by the instant application as opposed to a transformable/temporary plug as recited in U.S. Patent No. 11,883,261 because the soluble material of the instant application is designed to become insoluble during use and may also therefore be considered as a transformable/temporary plug. The substitution of one transformable/temporary plug for another is within the level of ordinary skill in the art.
The limitations of claim 1 of the instant application can be found in claim 1 of U.S. Patent No. 11,883,261.
The limitations of claim 2 of the instant application can be found in claim 2 of U.S. Patent No. 11,883,261.
The limitations of claim 3-4 of the instant application can be found in claim 3 of U.S. Patent No. 11,883,261.
The limitations of claim 5-6 of the instant application can be found in claims 4-5 of U.S. Patent No. 11,883,261.
The limitations of claim 7 of the instant application can be found in claim 7 of U.S. Patent No. 11,883,261.
The limitations of claim 8 of the instant application can be found in claims 8-9 of U.S. Patent No. 11,883,261.
The limitations of claim 9 of the instant application can be found in claim 10 of U.S. Patent No. 11,883,261.
The limitations of claim 10 of the instant application can be found in claim 11 of U.S. Patent No. 11,883,261.
The limitations of claim 11 of the instant application can be found in claim 12 of U.S. Patent No. 11,883,261.
The limitations of claim 12 of the instant application can be found in claims 13-14 of U.S. Patent No. 11,883,261.
The limitations of claim 13 of the instant application can be found in claim 15 of U.S. Patent No. 11,883,261.
The limitations of claim 14 of the instant application can be found in claim 16 of U.S. Patent No. 11,883,261.
The limitations of claim 15 of the instant application can be found in claim 17 of U.S. Patent No. 11,883,261.
The limitations of claim 16 of the instant application can be found in claim 18 of U.S. Patent No. 11,883,261.
The limitations of claim 17 of the instant application can be found in claim 19 of U.S. Patent No. 11,883,261.
The limitations of claim 18 of the instant application can be found in claim 20 of U.S. Patent No. 11,883,261.
The limitations of claim 19 of the instant application can be found in claim 21 of U.S. Patent No. 11,883,261.
Response to Arguments
Applicant's arguments filed March 4, 2026 have been fully considered but they are not persuasive.
Applicant argues that the modification of Locke’s valve to include Green’s dissolvable valve would render the prior art valve unsatisfactory for its intended purpose. The examiner disagrees with the applicant’s interpretation of the rejection.
Locke is an analogous dressing system introduced for the teaching of a temporary, pressure regulating valve/plug where Locke also recognizes that the pressure-regulating valve may take numerous forms as set forth in [0036].
Locke provides the knowledge in the art that the dressing may have a temporary, pressure regulating valve/plug.
Green also teaches an analogous medical apparatus where the relief valve assembly has a dissolvable valve member configured to dissolve after being exposed to moisture for a time period.
Green is not meant to modify Locke. Locke has already set forth the knowledge that the valve may take numerous forms. Green is introduced as one of those numerous forms.
Green provides the benefit of allowing for an infinite number of time ranges to be established to control air/fluid flow.
The general concept of providing a pressure regulating valve/plug that can take numerous forms has already been established by Locke. The substitution of one type of temporary pressure-regulating valve for another in view of the teachings of Locke is considered to be within the level of ordinary skill in the art since the general concept of providing such a valve has already been established by the prior art.
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 MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781