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 Amendment
The amendment filed 01/22/2026 has been entered. Claims 1 and 21 have been amended. Claims 11-12, 15-20, 25-36, and 40-50 are cancelled. Claims 1-10, 13-14, 21-24, and 37-39 remain pending in this application.
Response to Arguments
Applicant's arguments filed 01/22/2026 with respect to claim 1 have been fully considered but they are not persuasive. Claim 1 has been amended to recite “the plurality of sacrificial zones configured to not allow fluid communication between the first surface and the second surface”. Applicant argues that Kagan does not disclose apertures 22 having second material 224 that do not allow fluid communication between the first surface and the second surface of the manifold. However, as discussed in the rejection below, Kagan discloses that the second material 224 may be impervious to fluids (¶ 0033). Thus, Kagan discloses that the plurality of sacrificial zones are configured to not allow fluid communication between the first surface and the second surface. Accordingly, claim 1 remains obvious over Kagan in view of Watt.
Applicant’s arguments with respect to claim(s) 21 have been considered but are moot because the new ground of rejection does not rely on the same combination of references for any teaching or matter specifically challenged in the argument. Claim 21 has been amended to recite the bioresorbable manifold layer comprises “silver and dyestuff configured to absorb light between about 400 nm and about 700 nm”. A new grounds of rejection is made citing Delury, which teaches such limitation.
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) 1-7, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kagan et al. (Pub. No.: US 2009/0326515 A1) in view of Watt et al. (Pub. No.: US 2007/0225663 A1).
Regarding claim 1, Kagan discloses (fig. 1-3) a dressing for treating a tissue site (102) with negative pressure (¶ 0025), the dressing comprising:
A bioresorbable manifold layer (reduced-pressure manifold 210) formed from a first bioresorbable composition (first material 216, ¶ 0033), the bioresorbable manifold layer comprising:
A first surface (218),
A second surface (220) opposite the first surface (¶ 0030),
A thickness extending between the first surface and the second surface (fig. 3), and
A plurality of sacrificial zones (zones formed by apertures 222) disposed in the bioresorbable manifold layer (fig. 3, ¶ 0030), the plurality of sacrificial zones being formed from a second bioresorbable composition (second material 224, ¶ 0033), each sacrificial zone separated from adjacent sacrificial zones by the first bioresorbable composition (fig. 2), and
The plurality of sacrificial zones configured to not allow fluid communication between the first surface and the second surface (the second material 224 may be impervious to fluids, ¶ 0033) and to degrade upon placement of the bioresorbable manifold layer with respect to the tissue site and application of negative pressure to the bioresorbable manifold layer so as to allow communication of negative pressure between the first surface and the second surface (¶ 0032, ¶ 0035).
Kagan fails to disclose the first bioresorbable composition having a first solids-content and the second bioresorbable composition having a second solids-content, the solids-content being less than the first solids content.
However, Kagan discloses that the first bioresorbable composition is configured to degrade over a first duration (first bio-absorption term BA1) and the second bioresorbable composition is configured to degrade over a second duration (second bio-absorption term BA2), wherein the first duration is greater than the second duration (¶ 0036).
Further, Watt teaches (fig. 1) a system for treating a tissue site with negative pressure (abstract) and thus in the same field of endeavor, comprising: a dressing comprising a bioresorbable manifold layer (pad/screen 4, ¶ 0016), wherein the duration of which the bioresorbable manifold layer degrades can be increased by increasing the solids content (¶ 0025). Thus, Watt teaches that the solids content is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the first bioresorbable composition and the second bioresorbable composition of Kagan such that it has a first solids-content and a second solids-content, respectively, the second solids content being less than the first solids-content, in order to allow the first bioresorbable composition to degrade over a first duration that is greater than a second duration of the second bioresorbable composition degrading (Watt ¶ 0025, Kagan ¶ 0036).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 2, Kagan discloses wherein at least one of the first surface and the second surface is a continuous surface (fig. 3).
Regarding claim 3, Kagan discloses wherein the first surface and the second surface are continuous surfaces (fig. 3).
Regarding claim 4, Kagan discloses the bioresorbable manifold layer comprises: a plurality of apertures (222) extending between the first surface and the second surface (¶ 0030, fig. 3); and the second bioresorbable composition disposed within each of the plurality of apertures to form the sacrificial zones (¶ 0030, fig. 3).
Regarding claim 5, Kagan discloses wherein the first bioresorbable composition is configured to degrade over a first duration (first bio-absorption term BA1) and the second bioresorbable composition is configured to degrade over a second duration (second bio-absorption term BA2), wherein the first duration is at least 1000% of the second duration (the first bio-absorption term can be in the order of decades while the second bio-absorption term can be less than one week ¶ 0036, thus if the first bio-absorption term is 2 decades and the second bio-absorption term is 1 day, then the first duration will be 7300% of the second duration).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 6, Kagan discloses wherein the first duration is at least about 2500% of the second duration (see rejection of claim 5 above).
Regarding claim 7, Kagan discloses wherein the first duration is at least about 5000% of the second duration (see rejection of claim 5 above).
Regarding claim 14, Kagan in view of Watt fail to disclose wherein the bioresorbable manifold layer exhibits protease-modulating activity.
Watt teaches wherein the bioresorbable manifold layer exhibits protease-modulating activity (¶ 0013).
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 bioresorbable manifold layer of Kagan in view of Watt such that it exhibits protease-modulating activity, as taught by Watt, as elevated levels of protease enzymes in the wound interfere with the normal processes of tissue formation and destruction in the wound (Watt ¶ 0012).
Claims 8-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kagan in view of Watt, as applied to claims 4 and 38 above, and further in view of Waite et al. (WO 2019/094466 A1).
Regarding claim 8, Kagan discloses wherein the first bioresorbable composition exhibits a first density and the second bioresorbable composition exhibits a second density (¶ 0033-¶ 0034). Kagan in view of Watt fail to disclose wherein the first density is at least 1000% of the second density.
Waite teaches (fig. 1) a dressing (100) for treating a tissue site with negative pressure (¶ 0038) and thus in the same field of endeavor, the dressing comprising a bioresorbable manifold layer (bioresorbable sponge 102) comprising a first bioresorbable composition and a second bioresorbable composition (¶ 0003), wherein the time it takes for the bioresorbable composition to degrade is dependent on a collagen density of the bioresorbable composition (¶ 0004, ¶ 0007).
Accordingly, Waite teaches that the density of the first and second bioresorbable composition is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the density of the first and second bioresorbable composition of Kagan in view of Watt such that the first density is at least 1000% of the second density in order provide a first and second bioresorbable composition that is configured to degrade over a predetermined amount of time (Waite ¶ 0004).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 9, Kagan in view of Watt and further in view of Waite fail to teach wherein the first density is at least about 1500% of the second density.
However, as discussed above in claim 8, Waite teaches that the density of the first and second bioresorbable composition is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the density of the first and second bioresorbable composition of Kagan in view of Watt such that the first density is at least 1500% of the second density in order provide a first and second bioresorbable composition that is configured to degrade over a predetermined amount of time (Waite ¶ 0004).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 10, Kagan in view of Watt and further in view of Waite fail to teach wherein the first density is at least about 2000% of the second density.
However, as discussed above in claim 8, Waite teaches that the density of the first and second bioresorbable composition is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the density of the first and second bioresorbable composition of Kagan in view of Watt such that the first density is at least 2000% of the second density in order provide a first and second bioresorbable composition that is configured to degrade over a predetermined amount of time (Waite ¶ 0004).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 13, Kagan in view of Watt fail to disclose wherein each of the first bioresorbable composition and the second bioresorbable composition comprises from about 50% to about 60% collagen by weight and from about 40% to about 50% oxidized regenerated cellulose by weight.
Waite teaches (fig. 1) a dressing (100) for treating a tissue site with negative pressure (¶ 0038) and thus in the same field of endeavor, the dressing comprising a bioresorbable manifold layer (bioresorbable sponge 102) comprising a first bioresorbable composition and a second bioresorbable composition (¶ 0003), wherein each of the first bioresorbable composition and the second bioresorbable composition comprises 55% collagen by weight (¶ 0004) which falls within the claimed range of 50% to 60%, and 45% oxidized regenerated cellulose by weight (¶ 0004) which falls within the claimed range of 40% to about 50%.
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 first and second bioresorbable composition of Kagan in view of Watt such that they comprise from about 50% to about 60% collagen by weight and from about 40% to about 50% oxidized regenerated cellulose by weight, as taught by Waite, in order to provide a bioresorbable manifold layer that can be broken down by the patient’s enzymes rather than the enzymes breaking down the wound bed (Waite ¶ 0025).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Claim(s) 21-24 and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kagan in view of Delury et al. (Pub. No.: US 2019/0201574 A1) and further in view of Watt.
Regarding claim 21, Kagan discloses (fig. 1-3) a system (reduced-pressure delivery system 100) for treating a tissue site (102) with negative pressure (¶ 0025), the system comprising:
A dressing comprising a bioresorbable manifold layer (reduced-pressure manifold 210) formed from a first bioresorbable composition (first material 216, ¶ 0033), the bioresorbable manifold layer comprising:
A first surface (218),
A second surface (220) opposite the first surface, the second surface configured to be positioned adjacent the tissue site (¶ 0030),
A thickness extending between the first surface and the second surface (fig. 3), and
A plurality of sacrificial zones (zones formed by apertures 222) disposed in the bioresorbable manifold layer (fig. 3, ¶ 0030), the plurality of sacrificial zones being formed from a second bioresorbable composition (second material 224, ¶ 0033), the plurality of sacrificial zones configured so as to allow communication of negative pressure between the first surface and the second surface (¶ 0032, ¶ 0035); and
A negative-pressure source (reduced-pressure source 160) (¶ 0028).
Kagan fails to disclose the bioresorbable manifold layer comprising: silver and dyestuff configured to absorb light between about 400 nm and about 700 nm wavelengths.
Delury teaches (fig. 1) a dressing (1) comprising a bioresorbable manifold layer (absorbent structure 2, ¶ 0017) and thus in the same field of endeavor, the bioresorbable manifold layer comprising silver and dyestuff configured to absorb light between about 400 nm and about 700 nm (¶ 0029, ¶ 0033) in order to configure the bioresorbable manifold layer to be operable to photochemically trap generated free radicals that could otherwise react with silver in the present compositions, acting as photochemical desensitizers (¶ 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify he bioresorbable manifold layer of Kagan such that it comprises silver and dyestuff configured to absorb light between about 400 nm and about 700 nm wavelengths, as taught by Delury, in order to configure the bioresorbable manifold layer to be operable to photochemically trap generated free radicals that could otherwise react with silver in the present compositions, acting as photochemical desensitizers (Delury ¶ 0033).
Kagan in view of Delury fail to disclose that the negative-pressure source is configured to be fluidly coupled to the first surface of the bioresorbable manifold layer.
Watt teaches (fig. 1) a system for treating a tissue site with negative pressure (abstract) and thus in the same field of endeavor, comprising: a dressing comprising a bioresorbable manifold layer (pad 4, ¶ 0016), the bioresorbable manifold layer comprising a first surface and a second surface opposite the first surface, the second surface configured to be positioned adjacent the tissue site (fig.1); and a negative-pressures source configured to be fluidly coupled to the first surface of the bioresorbable manifold layer (fig. 1, ¶ 0076).
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 system of Kagan in view of Delury such that the negative-pressure source is configured to be fluidly coupled to the first surface of the bioresorbable manifold layer, as taught by Watt, in order to configure the system to treat a tissue site of a wound surrounded by skin (Watt, ¶ 0076).
Regarding claim 22, Kagan discloses wherein at least one of the first surface and the second surface is a continuous surface (fig. 3).
Regarding claim 23, Kagan discloses wherein the first surface and the second surface are continuous surfaces (fig. 3).
Regarding claim 24, Kagan discloses the bioresorbable manifold layer comprises: a plurality of apertures (222) extending between the first surface and the second surface (¶ 0030, fig. 3); and the second bioresorbable composition disposed within each of the plurality of apertures to form the sacrificial zones (¶ 0030, fig. 3).
Regarding claim 37, Kagan in view of in view of Delury and further in view of Watt fail to disclose wherein the dressing further comprises a drape configured to form a sealed space including the bioresorbable manifold layer.
Watt teaches wherein the dressing further comprises a drape (cover sheet 1) configured to form a sealed space including the bioresorbable manifold layer (fig. 1, ¶ 0006).
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 dressing of Kagan in view of Watt such that it comprises a drape configured to form a sealed space including the bioresorbable manifold layer, as taught by Watt, in order to maintain a reduced pressure over the wound (Watt, ¶ 0006).
Regarding claim 38, the claim limitation, “wherein the bioresorbable manifold layer is formed from a process comprising: preparing a first solution; forming the bioresorbable manifolding structure by freeze-drying the first solution; preparing a second solution; and freeze-drying the second solution while disposed within the plurality of apertures” is being treated as product-by-process.
When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP § 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Kagan in view of Delury and further in view of Watt disclose the invention substantially as claimed by applicant but is silent to the process of forming. This claim is interpreted as a product-by-process claim, since it claims an apparatus and describes the process used to make or construct the apparatus. In spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established (MPEP 2113).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kagan in view of Delury and further in view of Watt, as applied to claim 38 above, and further in view of Waite.
Regarding claim 39, Kagan in view of Delury and further in view of Watt fail to disclose wherein the first solution comprises from about 1% to about 3% solids content by weight.
Waite teaches (fig. 1) a dressing (100) for treating a tissue site with negative pressure (¶ 0038) and thus in the same field of endeavor, the dressing comprising a bioresorbable manifold layer (bioresorbable sponge 102) comprising a first bioresorbable composition, wherein the first bioresorbable composition comprises about 1% solids content by weight (1% silver-ORC, ¶ 0004), which falls within the claimed range of about 1% to about 3%.
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 first solution of Kagan in view of Watt such that it comprises from about 1% to about 3% solids content by weight, as taught by Waite, in order to provide the first bioresorbable composition with antimicrobial properties (Waite ¶ 0024).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cullen et al. (Pub. No.: US 2006/0159732 A1) discloses a bioresorbable manifold layer comprising silver and a dyestuff. Delury et al. (Pub. No.: US 2022/0142820 A1) discloses a dressing comprising a bioresorbable manifold layer.
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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/MEAGAN NGO/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781