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 amendment filed 02/17/2026 is accepted and entered. Applicant’s amendment to the claims has overcome the previous claim objection and the previous objection has been withdrawn.
Applicant’s arguments with respect to claim(s) 1 and 26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Hunt is now cited to disclose a tissue interface with a plurality of shapes/nodules, and a plurality of ribs/webs, each rib/web of the plurality of ribs/webs having a first end coupled to a respective shape/nodule of the plurality of shapes/nodules and a second end coupled to a second end of at least two other ribs/webs of the plurality of ribs/webs to form a rib/web node, as set forth below.
Applicant did not specifically argue the dependent claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 15, 18, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunt (US 2013/0218282).
Regarding Claim 1, Hunt discloses a tissue interface (implant 100, Fig. 1A) for treating a tissue site (¶ [0068]), the tissue interface (100, Fig. 1A) comprising:
a plurality of shapes (108, Fig. 1A); and
a plurality of ribs (107a, Fig. 1A), each rib (107a, Fig. 1A) of the plurality of ribs (107a, Fig. 1A) having a first end coupled to a respective shape (108, Fig. 1A) of the plurality of shapes (108, Fig. 1A) and a second end coupled to a second end of at least two other ribs (107a, Fig. 1A) to form a rib node (110, Fig. 1A).
Regarding Claim 15, Hunt discloses the first end of each rib (107a, Fig. 1A) of the plurality of ribs (107a, Fig. 1A) is tangentially coupled to a surface of the respective shape (108, Fig. 1A) of the plurality of shapes (108, Fig. 1A).
Regarding Claim 18, Hunt discloses a plurality of holes (gaps between 108 and 107a as seen in Fig. 1A) formed between the plurality of ribs (107a, Fig. 1A), each hole of the plurality of holes bounded by at least one respective tib (107a, Fig. 1A) of the plurality of ribs (107a, Fig. 1A).
Regarding Claim 66, Hunt discloses each rib (107a, Fig. 1A) of the rib node (110, Fig. 1A) is equidistantly spaced from the other two ribs (107a, Fig. 1A0 of the rib node (110, Fig. 1A).
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.
Claim(s) 9-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (US 2013/0218282) in view of Locke et al (US 2018/0353334).
Regarding Claims 9 and 10, Hunt is silent whether each shape of the plurality of shapes comprises a felted open-cell foam and a density of the felted foam is between 5 times and 7 times the density of an un-felted open-cell foam, and wherein each shape of the plurality of shapes has a firmness factor between about 5 and 7.
Locke teaches a wound dressing, thus being in the same field of endeavor, with a layer formed of a felted open cell foam with a firmness factor of 5, indicating that the felted foam is 5 times more dense than the un-felted foam (¶ [0045, 0100]). Felting a foam increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (¶ [0100]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue interface of Hunt to be made of a felted open-cell foam with a firmness factor between about 5 and 7 and a density between 5 times and 7 times the density of the un-felted foam, as taught by Locke (¶ [0045, 0100]). This increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (as motivated by Locke ¶ [0100]).
Regarding Claim 11, Hunt is silent whether each shape of the plurality of shapes comprises a felted open-cell foam and each shape of the plurality of shapes has a density of 1.522 g/cm3.
Locke teaches a wound dressing with a layer formed of a felted open cell foam (¶ [0045, 0100]). Felting a foam increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (¶ [0100]).
Therefore, it would have been obvious to modify the tissue interface of Hunt to be made of a felted open-cell foam, as taught by Locke (¶ [0045, 0100]). This increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (as motivated by Locke ¶ [0100]).
Hunt/Locke is silent whether each shape of the plurality of shapes has a density of 1.522 g/cm3.
However, it has been held that when the general conditions are disclosed in the art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP § 2144.05). One of ordinary skill would have found it obvious to optimize the density of the felted open-cell foam of Hunt/Locke to obtain the optimum stiffness for the dressing layer based on type and depth of wound, as well as other factors that a physician would take into account. Therefore, it would have been obvious to one of ordinary skill in the art to have each shape of the plurality of shapes have a density of 1.522 g/cm3.
Regarding Claim 17, Hunt is silent whether each rib of the plurality of ribs comprises a felted foam.
Locke teaches a wound dressing with a layer formed of a felted foam (¶ [0100]). Felting a foam increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (¶ [0100]).
Therefore, it would have been obvious to modify the tissue interface of Robinson to be made of a felted foam, as taught by Locke (¶ [0100]). This increases the stiffness of the foam in the direction parallel to the thickness, which can be beneficial in a wound dressing (as motivated by Locke ¶ [0100]).
Claim(s) 13, 14, 21, 22, 26, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (US 2013/0218282) in view of Robinson et al (US 2010/0160874).
Regarding Claim 13, Hunt is silent whether the tissue interface is configured to collapse laterally in response to an application of negative-pressure to the tissue interface.
Robinson teaches a wound dressing, thus being in the same field of endeavor, with a tissue interface (manifold 112/212, Figs. 2 and 4a), where the tissue interface collapses in response to application of negative pressure (¶ [0052]) to draw the wound together during reduced pressure therapy to assist in healing the wound (¶ [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the structure of the tissue interface of Hunt in place of the tissue interface of Robinson, to provide a structure that stabilizes the interior of a wound while assisting in drawing the wound together during negative pressure therapy (as motivated by Robinson ¶ [0052]).
Regarding Claim 14, Hunt further discloses the tissue interface (100, Fig. 1A) has a surface area.
Hunt is silent whether the tissue interface collapses in response to application of negative-pressure, and wherein the surface area decreases by about 30% in response to an application of negative-pressure to the tissue interface.
Robinson teaches a wound dressing, thus being in the same field of endeavor, with a tissue interface (manifold 112/212, Figs. 2 and 4a), where the tissue interface collapses in response to application of negative pressure (¶ [0052]) to draw the wound together during reduced pressure therapy to assist in healing the wound (¶ [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the structure of the tissue interface of Hunt in place of the tissue interface of Robinson, to provide a structure that stabilizes the interior of a wound while assisting in drawing the wound together during negative pressure therapy (as motivated by Robinson ¶ [0052]).
However, it has been held that when the general conditions are disclosed in the art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP § 2144.05). One of ordinary skill would have found it obvious to optimize the decrease in surface area of Hunt/Robinson to obtain the optimum collapse/contraction for the dressing layer based on type and depth of wound, as well as other factors that a physician would take into account. Therefore, it would have been obvious to one of ordinary skill in the art to have the surface area decrease by about 30% in response to an application of negative-pressure to the tissue interface.
Regarding Claim 21, Hunt is silent whether the plurality of shapes and the plurality of ribs are formed from a closed-cell foam.
Robinson teaches a wound dressing, thus being in the same field of endeavor, with a tissue interface (manifold 112/212, Figs. 2 and 4a) made of foam (¶ [0032]) to draw the wound together during reduced pressure therapy to assist in healing the wound (¶ [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the structure of the tissue interface of Hunt in place of the tissue interface of Robinson, to provide a structure that stabilizes the interior of a wound while assisting in drawing the wound together during negative pressure therapy (as motivated by Robinson ¶ [0052]).
The combination of Hunt/Robinson is silent whether the foam is a closed-cell foam.
However, one of ordinary skill in the art would have found it obvious to utilize a closed-cell foam for the tissue interface foam, as one of ordinary skill would recognize a closed-cell foam is one solution chosen from a finite number (two) of identified, predictable solutions (utilizing either an open-cell foam or a closed-cell foam) with a reasonable expectation of success (open-cell foams and closed-cell foams are known to be used for various wound dressing layers, and would be expected to function properly as a wound dressing layer).
Regarding Claim 22, the combination of Hunt/Robinson is teaches the claimed invention substantially as claimed as set forth above for Claim 21.
The combination of Hunt/Robinson further discloses the plurality of shapes (Robinson 226, Fig. 4a) are perforated (Robinson ¶ [0034, 0051]; the shaped projections can be cylindrical with a distal recess, which can be interpreted as a perforation).
Regarding Claim 26, Robinson discloses a system for treating a tissue site with negative pressure (Fig. 1), the system comprising:
a manifold (212, Figs. 1 and 4a; ¶ [0051]) configured to be disposed adjacent to the tissue site, the manifold (212, Figs. 1 and 4a) having:
a plurality of nodules (shaped projections 226, Fig. 4a); and
a plurality of webs (one half of each of members 236, Fig. 4a);
a sealing member (110, Fig. 1) configured to be disposed over the manifold (212, Figs. 1 and 4a) and to seal to tissue surrounding the tissue site (¶ [0028-0029]); and
a negative-pressure source (142, Fig. 1) configured to be fluidly coupled to the manifold (212, Figs. 1 and 4a) and operable to draw fluid through the manifold (212, Figs. 1 and 4a; ¶ [0045]).
Robinson is silent whether the plurality of webs, each web of the plurality of webs having a first end coupled to a respective nodule of the plurality of nodules and a second end coupled to a second end of at least two other webs of the plurality of webs to form a web node.
Hunt teaches a tissue implant, thus being in the same field of endeavor, comprising a plurality of nodules (108, Fig. 1A); and
a plurality of web (107a, Fig. 1A), each web (107a, Fig. 1A) of the plurality of web (107a, Fig. 1A) having a first end coupled to a respective nodule (108, Fig. 1A) of the plurality of nodule (108, Fig. 1A) and a second end coupled to a second end of at least two other webs (107a, Fig. 1A) to form a web node (110, Fig. 1A).
Therefore, it would have been obvious to modify the shape of the manifold of Robinson to have the shape and structure of the tissue implant of Hunt, to provide structural support to the healing wound during wound healing.
Regarding Claims 27 and 29, Robinson/Hunt teaches the claimed invention substantially as claimed as set forth above for Claim 26.
The combination of Robinson/Hunt further discloses each nodule (Hunt 108, Fig. 1A) of the plurality of nodules is spherical or polyhedral (Hunt ¶ [0081] indicates the building blocks can be spherical or polyhedral).
Claim(s) 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (US 2013/0218282).
Regarding Claim 16, Hunt is silent whether each rib of the plurality of ribs may have a width between about 1mm and about 4 mm, a thickness up to about 3 mm, and a length between about 1 mm and about 10 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hunt to have each of the plurality of ribs have a width between about 1 mm and about 4 mm, a thickness up to about 3 mm, and a length between about 1 mm and about 10 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hunt would not operate differently with ribs with the claimed width, thickness, and length and since changing these dimensions would merely adjust the stiffness of the device, the device would function appropriately as a wound manifold with the claimed width, thickness, and length. Further, applicant places no criticality on the range claimed, indicating simply that the width, thickness, and length “may” be within the claimed ranges (¶ [0010] of published specification).
Claim(s) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 2010/0160874) in view of Hunt (US 2013/0218282) further in view of Dagger et al (US 2015/0150729).
Regarding Claim 37, Robinson/Hunt is silent whether each nodule of the plurality of nodules has an average effective diameter between about 5 mm and about 20 mm.
Dagger teaches a wound dressing, thus being in the same field of endeavor, with a wound filler comprising rigid columns of felted foam to resist vertical collapse of the dressing (¶ [0064-0065]), where the columns have an average effective diameter between about 5 mm and about 20 mm (¶ [0065] indicates the diameters can be from 5 mm to 10 mm) to resist vertical collapse of the dressing while allowing horizontal collapse, thus assisting with wound closure (¶ [0064]).
Therefore, it would have been obvious to modify each nodule of the plurality of nodule to have an average effective diameter between about 5 mm and about 20 mm, as taught by Dagger (¶ [0064-0065]) to resist vertical collapse of the dressing while allowing horizontal collapse, thus assisting with wound closure (as motivated by Dagger ¶ [0064]).
Claim(s) 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 2010/0160874) in view of Hunt (US 2013/0218282) further in view of Robinson et al (US 2016/0158068).
Regarding Claims 44 and 45, Robinson ‘874/Hunt is silent whether the plurality of nodules are formed from a film, and the plurality of webs are formed from a polymeric film.
Robinson ‘068 teaches a foam wound dressing, thus being in the same field of endeavor, where the wound insert is made of a compressed foam that has been felted to have a porous polymeric film layer on one surface (¶ [0008-0009, 0039, 0042-0043]). The film layer has substantially smaller pores than the rest of the foam which may help prevent wound ingrowth (¶ [0043]).
Therefore, it would have been obvious to modify the manifold of Robinson ‘874/Hunt to be made of a felted foam that has a porous polymeric film layer on one surface, as taught by Robinson ‘068. The film layer has substantially smaller pores than the rest of the foam which may help prevent wound ingrowth (as motivated by Robinson ‘068 ¶ [0043]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781