DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after May 11, 2022, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 05/11/2022 in the matter of Application N° 17/775,972. Said documents are entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after May 11, 2022, is being examined under the first inventor to file provisions of the AIA .
Thus, claims 1-7, 9-13, and 16-19 are pending. By this Amendment, claim 14-15 are canceled.
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.
Claims 1-7, 9-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Arzt et al., (WO2018019879).
Regarding claims 1 and 17, Arzt et al., teach a device having a structured coating to rough surfaces, especially biological ones. It consists of a carrier layer with multiple protrusions arranged on it. Each protrusion has at least one shaft with an end face pointing away from the surface, and there is another layer arranged at least on the end face. The layer’s modulus of elasticity differs from the protrusions. An internal structured coating can be created by the additional layer filling in the areas in between the protrusions. Device according to one of claims 1 to 5, characterized in that the further layer is part of a film which connects the projections (See abstract, Description paragraph 1, claim 1, and claim 6).
New claim 17 has been added and depends from claim 1. Claim 17 further recites that the backing layer has a thickness less than a maximum height of the protrusions.
Upon review, the applied prior art, including Arzt et al., teaches a backing (carrier) layer bearing a multiplicity of protrusions extending therefrom. As disclosed, the protrusions extend outwardly from the backing layer to engage a surface, which inherently requires that the height of the protrusions exceeds the thickness of the backing layer in order to provide the intended adhesive interaction. Accordingly, the limitation that the backing layer has a thickness less than a maximum height of the protrusions is either expressly disclosed or, at a minimum, inherently satisfied by the structure of Arzt et al. Alternatively, it would have been obvious to one of ordinary skill in the art to configure the relative dimensions of the backing layer and protrusions such that the protrusions extend beyond the backing layer thickness to achieve an effective target surface, as this represents a matter of routine design choice to ensure proper functionality of the adhesive structure. Therefore, claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arzt et al. for the same reasons set forth with respect to claim 1, and further in view of the inherent or obvious dimensional relationship between the backing layer and the protrusions.
Regarding claim 2, Arzt et al., teach the aspect ratio is greater than 1, preferably at least 3, in particular at least 7, preferably from 3 to 15, particularly preferably from 3 to 10. The average diameter is understood to mean the diameter of the circle which has the same area the same area as the corresponding cross section of the projection. The apparatus according to claim 1 or 2, characterized in that the projections have an aspect of greater than 1 (See Description paragraph 17, and claim 3).
Regarding claim 3, Arzt et al., teach in a further embodiment of the invention, the ratio of the height of a projection to the diameter at a certain height over the entire height of the projection is always 1 to 100, preferably 1 to 10, particularly preferably 2 to 5. In one embodiment this aspect ratio is at least 3, preferably 3 to 15, particularly preferably at 3 to 10 (See Description paragraph 18, and claim 4).
Regarding claim 4, Arzt et al., teach the moduli of elasticity of all regions of the projection and of the further layer are preferably 50kPa to 3GPa. Trans t is the modulus of elasticity of soft areas. In particular the further layer, at 50kPa to 20 MPa, and 100 kPa to 10 MPa. Preferably, regardless of the modulus of elasticity of the high modulus of elasticity, the support layer, at 1MPa to 3 GPa, preferably 2 MPa to 1 GPa. For all softer and harder areas, the elastic moduli are preferably in the ranges indicated above (See Description paragraph 30).
Regarding claim 5, Arzt et al., teach after being constructed, SSA 50:50 PDMS composite constructions were put to a dead mouse’s undamaged eardrum. The Kom positstruktur was adhered to the undamaged tympanic membrane using its adhesive side after being cut to the proper size. An eardrum rupture was not caused by repeated positional changes or loosening. An additional step was removing a section of the tympanic membrane to induce rupture. The composite structure might be fastened to the wound’s edges and pulled laterally. SSA 40:60 and SSA 50:50 complex modules were identified using rheometry at frequencies ranging from 0.1 to 100 Hz (Fig. 16). The measurement amplitude was 0.1%. The results SSA 50:50 has a lower modulus of elasticity than SSA 40:60. Comparing the two substrates to one another shows that the take-off stress of SSA is higher when using a rough substrate than with PDMS (Fig 17) (See Description paragraph 82).
Regarding claim 6, Arzt et al., teach a device according to one of claims 1 to 6, characterized in that the device is designed for adhesion to soft substrates (See claim 7).
Regarding claim 7, Arzt et al., teach the device according to one of claims 1 to 7, characterized in that the device for adhesion to biological tissues rule is formed (See claim 8).
Regarding claims 8, and 13, Arzt et al., teach a device according to claim 8 for use in treating tympanic membrane perforations (See claim 9). Gecko structures and other dry adhesive surfaces provide an alternative since they can demonstrate adhesion even on uneven surfaces without the need for adhesives. These, however, are frequently produced with very little customization. Tympanic membrane perforations are a common issue that can result in regularly recurring Infektio nen or hearing loss. Trauma, middle ear infections, and surgical complications are major causes of tympanic perforations. Acute perforations, which typically occlude spontaneously, can be distinguished from large or chronic perforations. Although surgical treatment of these massive perforations by Myringoplastie or Tympanoplastie has a high success rate, the risk of restperforation is nevertheless there (See Description paragraphs 2 and 3).
Regarding claim 9, Arzt et al., teach an implant comprising a device according to one of claims 1 to 8
Regarding claims 10, 11, and 12, Arzt et al., teach a structured coating device that consists of a carrier layer with multiple projections arranged on it, each consisting of at least one stem facing away from the surface end face. The device is distinguished by the presence of another layer, at least on the end face, that has a different module of elasticity than the corresponding projection (See claim 1). The apparatus according to claim 1, characterized in that the arranged on the end face further layer has a geringeren elastic modulus than the respective vor jump (See claim 2). The device characterized in that the further layer additionally fills the intermediate spaces between the projections (See claim 5). The device characterized in that the further layer is part of a film which connects the projections (See claim 6). The projection substance is added, ideally in the form of a liquid. If necessary, the material can also already be cured at least partially. The material for the upper surface, or carrier layer, on which the projections are organized, is then applied to the template and allowed to cure. This material is specifically the same as that used for the stresses of the projections because both the carrier layer and the Tra-strains can be created in a single process, for instance, by directly introducing a significantly volume of material. After that, the protrusions are fully covered by applying the material for the next layer in the appropriate amount to the surface. Spin coating or doctoring can be used for this (See Description paragraph 57). An additional step was removing a section of the tympanic membrane to induce rupture. The results SSA 50:50 has a lower modulus of elasticity than SSA 40:60. Comparing the two substrates to one another shows that the take-off stress of SSA is higher when using a rough substrate than with PDMS (Fig 17) (See Description paragraph 82). the moduli of elasticity of all regions of the projection and of the further layer are preferably 50kPa to 3GPa. Trans t is the modulus of elasticity of soft areas. In particular the further layer, at 50kPa to 20 MPa, and 100 kPa to 10 MPa. Preferably, regardless of the modulus of elasticity of the high modulus of elasticity, the support layer, at 1MPa to 3 GPa, preferably 2 MPa to 1 GPa. For all softer and harder areas, the elastic moduli are preferably in the ranges indicated above (See Description paragraph 30). Figure 1 shows a schematic representation of a cross section of an embodiment of the invention.
Therefore, considering all of the above, it would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to include the teachings learned by Artz et al., who describe a device that applies a structured coating to uneven surfaces. This device consists of a carrier layer with several protrusions arranged on it. At least one shaft with an end face pointing away from the surface is present in every protrusion. The protrusions and the layer’s modulus of elasticity are different. A device, as defined by claims 1 through 5, is distinguished by the fact that the additional layer is a component of a film that connects the projections (See 0064 and 0038).
Regarding claims 18, and 19, Arzt et al. disclose wherein the projections and the further layer can comprise the following materials: epoxy, and/or silicone-based elastomers, polyurethanes acrylate systems methacrylate systems as polyacrylates homopolymers and copolymers, polymethacrylates as homopolymers and copolymers, acrylates, silicones, silicone resins, and rubber such as R-Rubber (See Description, paragraph 29).
Response to Arguments
Applicant’s arguments filed March 18, 2026 have been fully considered but they are not persuasive.
The applicant argues that Arzt et al. fails to teach or suggest a device having multiple distinct layers as recited in the claim, particularly a backing layer with a multiplicity of protrusions, each including a stem with an end face bearing a further layer configured as a film, wherein the film comprises a bonding layer. A supporting layer, and an adhesion layer having a lower modulus of elasticity than the protrusions.
However, this argument is not persuasive. As acknowledged by the applicant, Arzt et al. discloses a device having a structured coating for adhesion to rough surfaces, including a carrier (backing) layer bearing a multiplicity of protrusions. Each protrusion includes a shaft (stem) with an end face pointing away from the surface, and a further layer is disposed at least on the end face. Arzt et al. further teaches that this additional layer has a modulus of elasticity different from that of the protrusions, thereby inherently suggesting functional differentiation consistent with the claimed layered structure.
Moreover, Arzt et al. discloses that the further layer may be part of a film connecting the protrusions. Such a film structure reasonably encompasses multiple functional sub-layers, including layers providing bonding, structural support, and adhesion, as claimed. The variation in modulus of elasticity within the layers, as described by Arzt et al. would have suggested to one of ordinary skill in the art the use of layers with differing elastic properties to achieve the desired adhesion and mechanical performance.
Accordingly, Arzt et al. teaches or at least renders obvious the claimed configuration of a further layer comprising multiple functional layers, including a bonding layer, a supporting layer, and an adhesion layer having a lower modulus of elasticity than the protrusions.
The applicant further contends that Arzt et al. does not teach or suggest a layer having a modulus of elasticity for bonding to the end faces, as recited in the claim.
This argument is not persuasive. Arzt et al. expressly discloses that a further layer is arranged at least on the end faces of the protrusions. In order for such a layer to be disposed on and remain adhered to the end faces, the layer must necessarily possess material properties, such as an appropriate modulus of elasticity, suitable for bonding to those end faces. Thus, the claimed layer having a modulus of elasticity for bonding to the end faces is inherently met by the disclosed additional layer of Arzt et al.
Furthermore, Arzt et al. teaches That the modulus of elasticity of the additional layer differs from that of the protrusions, indicating that the material properties of the layer are deliberately selected to achieve desired mechanical interaction, including adhesion or bonding. It would have been obvious to one of ordinary skill in the art to select a modulus of elasticity for the layer that facilitates effective bonding to the protrusion end faces, as this represents a routine optimization of material properties to ensure structural integrity and functionality.
Accordingly, Arzt et al. teaches or at least renders obvious the claimed limitation of a layer having a modulus of elasticity for bonding to the end faces.
The applicant contends that, with respect to claim 5 and 16, Arzt et al. does not teach or suggest that the at least one further layer (or film) is detachable.
The argument is not persuasive. Arzt et al. discloses a composite structure (e.g., SSA/PDMS) that is applied to a biological surface, such as a tympanic membrane, using its adhesive properties. The reference further describes that the structure is positioned, repositioned, and ultimately removed, as evidenced by the described experimental procedures involving repeated positional changes and subsequent manipulation of the adhered structure. such use inherently requires that the applied layer or film be capable of detachment from the surface without causing damage under normal conditions.
Additionally, Arzt et al. teaches that the adhesive interaction between the structured surface and the substrate is governed by material properties, including modulus of elasticity and surface interactions, as demonstrated by rheological characterization and take-off stress measurements. These teachings indicate that the adhesion is reversible and controlled, rather than permanent, thereby suggesting detachability of the film from the substrate.
Furthermore, the ability to remove or reposition an adhesive structure is a well-understood and desirable property in the field of bio-inspired adhesive systems. It would have been obvious to one of ordinary skill in the art to configure the disclosed film or layer to be detachable in order to enable repositioning and reuse, particularly in applications involving delicate biological surfaces.
Accordingly, Arzt et al. teaches or at least renders obvious the claimed limitation that the at least one further layer (or film) is detachable.
Although claim 8 has been canceled, the limitations previously recited in claim 8 were considered in the examination of the remaining claims. In particular, former claim 8 has been reviewed to clarify the scope and meaning of the related subject matter as it pertains to claim 13. The use of the previously presented limitations is appropriate to the extent that they provide context for interpreting and evaluating the corresponding features recited in claim 13.
Accordingly, the rejection of claim 13 is based on the teachings of the applied prior art in view of the subject matter as reasonably understood from the specification and the previously presented claims, including former claim 8. The cancellation of claim 8 does not preclude reliance on its disclosed subject matter for purposes of understanding and applying the prior art to remaining claims.
In response to the applicant’s request for clarification regarding the citation to “Description, paragraph 15” on page 8 of the Office Action, the Examiner notes that this reference is directed to paragraph 15 of the present application’s specification, as originally filed. Paragraph 15 was cited to support the interpretation and evaluation of the subject matter recited in claims 14-15. The reference to “Description, paragraph 15” corresponds to the numbered paragraph in the specification and was not intended to refer to a separate document or prior art reference. Accordingly, the examiner clarifies that the citation is to the applicant’s own disclosure. (i.e. the specification), specifically paragraph 15, which provides support for the features discussed in the rejection of claims 14-15.
Conclusion
No claim is allowed.
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/KIMBERLY BARBER/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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