DETAILED ACTION
In Applicant’s Response filed 1/13/26, Applicant has amended claims 1-2, 7, 17, 20-22 and 26; and added new claims 29-30. Claims 5, 10-16, 25 and 28 have been cancelled. Currently, claims 1-4, 6-9, 17-24, 26-27 and 29-30 are pending.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-9, 17-22, 26-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Greener et al (US 8680360).
With respect to claim 1, Greener discloses an adhesive article (a lattice that is a wound dressing applied to a wound site using adhesive – col 5 lines 35-36; col 6 line 60- col 7 line 8), comprising: an adhesive layer comprising an adhesive (col 6 line 60 – col 7 line 8); and a substrate layer (lattice material) in contact with the adhesive layer (the adhesive forms a layer on (and thus is in contact with) the wound contacting surface of the open lattice/wound dressing – col 7 lines 5-8), wherein the substrate layer (lattice) defines a plurality of cuts (the lattice includes at least one slit – col 2 lines 11-15; fig 5 illustrates an embodiment which includes a plurality of slits) that allows the adhesive article to be pulled along a central axis thereof to transition between an unstressed state and a stressed state (col 2 lines 15-20), wherein each of the plurality of cuts (i.e. the cuts that are aligned horizontally in fig 5) extends along a corresponding cut axis (interpreted as being an axis that runs in the horizontal direction) that is transverse to the central axis (interpreted as being axis that runs vertically through the center of the article); wherein at least one of the cuts of the plurality of cuts extends to an edge of the substrate layer (as shown in fig 5); wherein, in the unstressed state (first conformation where slits are substantially closed), the length to the width of the cuts is a first ratio (inherent characteristic of a slit is that it is defined by length and width dimensions and thus a ratio of the length to the width), and wherein, in the stressed state (second confirmation where the lattice is stretched to expand the slits; shown in fig 5), the length to the width of the cuts is a second ratio less than the first ratio (when the lattice is stretched along the central axis, the width dimension of each slit is increased while the length dimension is increased to form open diamond shapes as shown in fig 5; thus, the length to width ratio in the open/expanded second confirmation inherently is less than the length to width ratio in the unstretched first conformation).
Greener does not, however, explicitly disclose that in the unstressed state, the length to the width of the cuts is a first ratio that is greater than 1000. Greener does, however, teach that the “cuts are not restricted to any particular geometry” (col 2 line 42). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to have modified the geometry of the slits by changing the length and/or width so that in the unstressed state, the length to the width of the cuts is a first ratio that is greater than 1000 since Greener explicitly teaches that changes to the geometry of the slits are customary and routine during manufacturing. Additionally, such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art. Furthermore, modification of the geometry so that the length to width ratio in the unstressed state is, specifically, greater than 1000, would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, since discovering an optimum value of a result effective variable involves only routine skill in the art.
With respect to claim 2, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that in the stressed state (shown in fig 5) at least some of the cuts of the plurality of cuts provide apertures configured so one can view through the adhesive article (extension of the lattice opens the slits forming a plurality of apertures – col 3 lines 4-11; the lattice is applied in this open configuration to a wound site as described in col 6 lines 41-42 and thus inherently permits viewing of the wound site through the apertures).
With respect to claim 3, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that the plurality of cuts is arrayed in a pattern along one axis or more than one axis (as shown in fig 5).
With respect to claim 4, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that wherein the adhesive comprises a pressure sensitive adhesive (col 7 lines 4-5).
With respect to claim 6, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that the stressed state comprises stretching (col 2 lines 18-20).
With respect to claim 7, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that when the adhesive article is in the stressed state (shown in fig 5) the adhesive article has optical properties different from optical properties of the adhesive article in the unstressed state (extension of the lattice opens the slits forming a plurality of apertures – col 3 lines 4-11; the lattice is applied in this open configuration to a wound site as described in col 6 lines 41-42 and thus inherently permits viewing of the wound site through the apertures; in the substantially closed configuration, substantially no visual inspection of the wound through the lattice with the naked eye is permitted – col 2 lines 25-28; thus, the optical properties in the two states differ because in the stressed state viewing is permitted and in the unstressed state it is not).
With respect to claim 8, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that the substrate layer has a lower effective modulus of elasticity in at least one axis than an identical substrate layer without the plurality of cuts (the cuts in the material render the material more flexible and extensible (as compared to a material with no cuts) – see col 2 lines 49-51; the increased flexibility is interpreted as being due to a lower modulus of elasticity in the material that includes a plurality of cuts).
With respect to claim 9, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses a device attached to the substrate layer (backing layer – col 3 lines 35-65).
With respect to claim 17, Greener discloses a method (col 7 lines 9-40 describes method of manufacturing a lattice that is a wound dressing applied to a wound site using adhesive – see also col 5 lines 35-36; col 6 line 60- col 7 line 8), comprising: preparing a substrate layer (preparing the lattice material; step “a” in col 7 line 12) that defines a plurality of cuts (the lattice includes at least one slit – col 2 lines 11-15; fig 5 illustrates an embodiment which includes a plurality of slits; i.e. the cuts that are aligned horizontally in fig 5) each cut of the plurality of cuts extending along a corresponding cut axis (interpreted as being an axis that runs horizontally across the article) that is transverse to a central axis of the substrate layer (the cut axis runs horizontally across the article while the central axis runs vertically through the center of the article – thus, the axes are perpendicular or transverse to each other), wherein at least one of the cuts of the plurality of cuts extends to an edge of the substrate layer (as shown in fig 5), and wherein the plurality of cuts allows the substrate layer to be repeatedly pulled (pulling is in steps “b” in col 7; the material can be pulled by hand – see col 5 lines 15-16 and is interpreted as being allowed to be repeatedly pulled due to the elastic behavior of the material – see col 5 line 62- col 6 line 10; the direction of the contractile force is influenced by the geometry of cut in the material to form the lattice, the geometry of extension of the lattice and the geometry of the attachment points between the lattice or wound dressing and the tissue – col 6 lines 55-59) along the central axis thereof (interpreted as being an axis that runs in the vertical direction through the center of the article) to transition back and forth (due to the elastic behavior of the material – see col 5 line 62- col 6 line 10) between the substrate layer from an unstressed state (first conformation where slits are substantially closed), in which the length to the width of the cuts of the plurality of cuts is a first ratio (inherent characteristic of a slit is that it is defined by length and width dimensions and thus a ratio of the length to the width), to a stressed state (second confirmation where the lattice is stretched to expand the slits; shown in fig 5), in which the length to the width of the cuts of the plurality of cuts is a second ratio less than the first ratio (when the lattice is stretched along the central axis, the width dimension of each slit is increased while the length dimension is increased to form open diamond shapes as shown in fig 5; thus, the length to width ratio in the open/expanded second confirmation inherently is less than the length to width ratio in the unstretched first conformation); and applying an adhesive to the substrate layer (col 6 line 60 – col 7 line 8; the adhesive forms a layer on the wound contacting surface of the open lattice/wound dressing – col 7 lines 5-8).
Greener does not, however, explicitly disclose that in the unstressed state, the length to the width of the cuts is a first ratio that is greater than 1000. Greener does, however, teach that the “cuts are not restricted to any particular geometry” (col 2 line 42). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to have modified the geometry of the slits by changing the length and/or width so that in the unstressed state, the length to the width of the cuts is a first ratio that is greater than 1000 since Greener explicitly teaches that changes to the geometry of the slits are customary and routine during manufacturing. Additionally, such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art. Furthermore, modification of the geometry so that the length to width ratio in the unstressed state is, specifically, greater than 1000, would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, since discovering an optimum value of a result effective variable involves only routine skill in the art.
With respect to claim 18, Greener discloses the method substantially as claimed (see rejection of claim 17) and Greener also discloses that preparing the substrate layer comprises modifying the substrate layer by cutting the plurality of cuts into the substrate layer with a knife, a blade, a water jet, or a laser beam (col 2 lines 33-34).
With respect to claim 19, Greener discloses the method substantially as claimed (see rejection of claim 17) and Greener also discloses that the adhesive is applied to the substrate layer prior to modifying the substrate layer (example 5 describes the method of manufacturing the article shown in fig 5 and includes discloses that an adhesive material is applied to a foam layer prior to cutting slits therethrough to form the lattice – see col 9 line 60 – col 10 line 23).
With respect to claim 20, Greener discloses the method substantially as claimed (see rejection of claim 19) and Greener also discloses that the adhesive further includes a plurality of cuts (as described in example 5, the adhesive material is provided on the foam layer prior to cutting slits therethrough – thus, the cuts are provided through both the foam and adhesive – see col 9 line 60 – col 10 line 23).
With respect to claim 21, Greener discloses an adhesive article (a lattice that is a wound dressing applied to a wound site using adhesive – col 5 lines 35-36; col 6 line 60- col 7 line 8), comprising: a substrate layer (lattice material) having a central axis (interpreted as being an axis that runs vertically through the center of the article in fig 5) and defining a plurality of cuts (the lattice includes at least one slit – col 2 lines 11-15; fig 5 illustrates an embodiment which includes a plurality of slits; i.e. the cuts that are aligned horizontally in fig 5) that are all angled relative to the central axis by a non-zero angle (as shown in fig 5, the cuts are diamond shaped and include sides that are angled more than zero degrees from the vertical direction) wherein at least one of the cuts of the plurality of cuts extends to an edge of the substrate layer (as shown in fig 5) and wherein the plurality of cuts allows the adhesive article to be pulled along the central axis thereof (pulling is in steps “b” in col 7; the material can be pulled by hand – see col 5 lines 15-16 and is interpreted as being allowed to be repeatedly pulled due to the elastic behavior of the material – see col 5 line 62- col 6 line 10; the direction of the contractile force is influenced by the geometry of cut in the material to form the lattice, the geometry of extension of the lattice and the geometry of the attachment points between the lattice or wound dressing and the tissue – col 6 lines 55-59) to transition the substrate layer from a first state (first conformation where slits are substantially closed) where the length to the width of the cuts is a first ratio (inherent characteristic of a slit is that it is defined by length and width dimensions and thus a ratio of the length to the width), to a second state (second confirmation where the lattice is stretched to expand the slits; shown in fig 5) where the length to the width of the cuts is a second ratio less than the first ratio (when the lattice is stretched along the central axis, the width dimension of each slit is increased while the length dimension is increased to form open diamond shapes as shown in fig 5; thus, the length to width ratio in the open/expanded second confirmation inherently is less than the length to width ratio in the unstretched first conformation); and an adhesive disposed on the substrate layer (col 6 line 60 – col 7 line 8; the adhesive forms a layer on the wound contacting surface of the open lattice/wound dressing – col 7 lines 5-8).
Greener does not, however, explicitly disclose that in the first state, the length to the width of the cuts is a first ratio that is greater than 1000. Greener does, however, teach that the “cuts are not restricted to any particular geometry” (col 2 line 42). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to have modified the geometry of the slits by changing the length and/or width so that in the first state, the length to the width of the cuts is a first ratio that is greater than 1000 since Greener explicitly teaches that changes to the geometry of the slits are customary and routine during manufacturing. Additionally, such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art. Furthermore, modification of the geometry so that the length to width ratio in the first state is, specifically, greater than 1000, would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, since discovering an optimum value of a result effective variable involves only routine skill in the art.
With respect to claim 22, Greener discloses the article substantially as claimed (see rejection of claim 21) and Greener also discloses that the cuts of the plurality of cuts are defined in a pattern along one or more axes of the substrate layer (as shown in fig 5).
With respect to claim 26, Greener discloses the article substantially as claimed (see rejection of claim 21) and Greener also discloses that the cuts are in the form of two-dimensional shapes wherein the two- dimensional shapes include crosses, asterisks, chevrons, letters, or numbers, or combinations thereof (“I” shape in figs 6-8 and “S” shape in fig 9).
With respect to claim 27, Greener discloses the article substantially as claimed (see rejection of claim 1) and Greener also discloses that the cut axis is perpendicular to the central axis (cut axis runs horizontally across the article while the central axis runs vertically through the center – therefore, the axes are perpendicular to each other).
With respect to claim 29, Greener discloses the article substantially as claimed (see rejection of claim 17) and Greener also discloses that the cut axes are perpendicular to the central axis (cut axis runs horizontally across the article while the central axis runs vertically through the center – therefore, the axes are perpendicular to each other).
With respect to claim 30, Greener discloses the article substantially as claimed (see rejection of claim 21) but does not disclose in the embodiment of figure 5 that the non-zero angle is 90 degrees. Greener does, however, teach an embodiment in figure 7 wherein the cutter is designed such that the resulting article will include cuts extending horizontally across the article that include a portion that is angled 90 degrees with respect to the vertical direction (see fig 7; longest/center portion of sideways “I” shaped cut shapes are aligned 90 degrees with respect to the vertical direction). Greener further teaches that the direction of the contractile force is influenced by the geometry of cut in the material to form the lattice, the geometry of extension of the lattice and the geometry of the attachment points between the lattice or wound dressing and the tissue (col 6 lines 55-59). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article such that the cuts are angled relative to the central axis by a non-zero angle that is 90 degrees, such as the cut design shown in figure 7, in order to influence the direction of the contractile force in the article.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Greener et al (US 8680360) in view of Stebbings et al (US 20020193724).
With respect to claim 23, Greener discloses the article substantially as claimed (see rejection of claim 21) but does not disclose that the article further comprises a sensor attached to the substrate layer.
Stebbings teaches an adhesive article (adhesive construction 10; fig 1-3) which further comprises a sensor attached to the substrate layer (see Claim 28 and para [0034-0036]; wherein the medical article is in the form of a sensor that is interpreted as being attached to the second major layer of the substrate layer in which the medical article comprises a backing and a stretch removable pressure sensitive adhesive layer disposed thereon). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the article of Greener to further include a sensor attached to the substrate layer, like the article of Stebbings, in order to provide healthcare providers with information related to the condition of a wound for targeted treatment and improved wound monitoring and management.
With respect to claim 24, Greener discloses the article substantially as claimed (see rejection of claim 21) but does not disclose that the article further comprises a monitor attached to the substrate layer.
Stebbings teaches an adhesive article (adhesive construction 10; fig 1-3) which further comprises a monitor attached to the substrate layer (para [0034-0036]; wherein the examiner is interpreting the monitor as a device for observing a biological condition or function, wherein the medical article is in the form of a device such as electrodes and sensors used to monitor biological function, that is interpreted as being attached to the second major layer of the substrate layer in which the medical article comprises a backing and a stretch removable pressure sensitive adhesive layer disposed thereon). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the article of Greener to further include a monitor attached to the substrate layer, like the article of Stebbings, in order to provide healthcare providers with information related to the condition of a wound for targeted treatment and improved wound monitoring and management.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 1/13/26 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 101, Applicant has cancelled claim 10, thereby obviating the basis for the rejection. Accordingly, the rejection has been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on page 7 of the Response have been fully considered but are rendered moot in view of the modified grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786