DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/22/2026 has been entered.
Status of the Claims
The claims filed 01/19/2026 are under consideration.
Claims 24-44 are pending.
Claims 24 and 37 are independent.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Terminal Disclaimer
The terminal disclaimer filed 01/19/2026 was not been accepted.
The remarks filed 05/22/2026 indicate that a power of attorney was filed on 05/11/2026 and a terminal disclaimer has been filed with the response.
The power of attorney filed 05/11/2026 is acknowledged and was accepted on 05/20/2026. However, a terminal disclaimer does not appear to have been filed with the response.
The double patenting rejections have been modified to address the claim amendment filed 05/22/2026.
Withdrawn
The rejection of claims 24-29, 31, 33, 37-40, and 42 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hulseman, US 20170014111 A1.
The rejection of claims 24-29, 30, 31, 33, 37-40, and 42 under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Burbank, US 20140171385.
The rejection of claims 24-29, 31, 32, 33, 37-40, 41, and 42 under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Spaans, US 6784273.
The rejection of claims 24-29, 31, 33, 34-36, 37-40, 42, and 43-44 under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Dubrow, US 20050221072.
Applicant's arguments filed 05/22/2026 regarding Hulseman have been fully considered and are persuasive because of Applicant’s amendment.
Specifically, Applicant’s argument that Hulseman does not teach the device surface further comprising a preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation is persuasive. Further, Applicant’s argument that the skilled artisan reading Hulseman would not have had motivation to make such a modification because of Hulseman’s design objectives is persuasive (Remarks, e.g., pp. 9-10).
Consequently, the claimed invention is novel and non-obvious based on the prior art of record.
Amendment
Independent claims 24 and 37 have been amended to recite wherein the outer surface comprises a preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation.
The specification indicates a preferential hydration zone is adapted to degrade at a different rate than the rest of the surgical implant (Spec, e.g., 0030). The specification indicates the preferential hydration zone comprises hierarchical surface microstructures that provides high surface area for surface-specific hydration (Spec, e.g., 0032). The specification indicates the preferential hydration zone comprises a self-similar zone of surface texture (Spec., e.g., 0033). The specification indicates the preferential zone comprises a microstructure that undergoes hydrolysis or enzymatic degradation preferentially during deployment of the surgical implant causing dissolution of at least a portion of the polymer of the surgical implant (Spec., e.g., 0034).
Consequently, when interpreted in light of the specification, the limitation of a preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation is interpreted to read on:
a) hierarchical surface microstructures that provides high surface area for surface-specific hydration, or
b) a self-similar zone of surface texture, or a microstructure that undergoes hydrolysis, or
c) a microstructure that undergoes hydrolysis or enzymatic degradation preferentially during deployment of the surgical implant causing dissolution of at least a portion of the polymer of the surgical implant.
Applicant’s amendment has been addressed in the rejections below.
Response to Arguments
Double patenting
As noted above the additional terminal disclaimer requested after acceptance of the power of attorney filed 05/11/2026 does not appear in the file. Therefore, the double patenting rejections have been reconsidered because of Applicant’s amendment and have been maintained.
With respect to the claims of US 12268255:
The device surface claimed by the ‘255 patent includes at least two hierarchical levels that are self-similar, including a first level and a second level, … and wherein the microstructured surface comprises a first plurality of the at least two hierarchical levels and a second plurality of the at least two hierarchical levels, wherein the first plurality is positioned at a first height about the microstructured surface, and the second plurality is positioned at a second height about the microstructured surface, wherein the first height and second height are different and create split contact levels capable of generating split contact Wenzel-Cassie wetting states (claim 1).
This feature is a preferential hydration zone (capable of generating split contact Wenzel-Cassie wetting states), and includes a self-similar zone of surface texture which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
Therefore, the double patenting rejection over US 12268255 is maintained.
With respect to the claims of US 11857700:
The device surface claimed by the ‘700 patent includes: the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and wherein the first plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, only a partial volume of the microstructure is hydrated.
This feature is a preferential hydration zone (only a partial volume of the microstructure is hydrated), and includes a polymer that is degradable in vivo by hydrolysis or enzymatic degradation which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
Therefore, the double patenting rejection over US 11857700 is maintained.
With respect to the claims of US 10953138:
The device surface claimed by the ‘138 patent includes:
at least one preferential hydration zone associated with a first portion of the surface of said implant adapted to hydrate within the environment more quickly than a second portion of the implant (claim 18) and a polymer that is degradable in vivo by hydrolysis or enzymatic degradation (claim 1).
A preferential hydration zone is an expressly claimed feature, and includes a polymer that is degradable in vivo by hydrolysis or enzymatic degradation which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
Therefore, the double patenting rejection over US 10953138 is maintained.
Rejections Addressing Applicant’s Amendment
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 24-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-20 of US 12268255 in view of Hulseman, US 20170014111 A1, Burbank, US 20140171385, Spaans, US 6784273, and Dubrow, US 20050221072 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference patent claims teach a device comprising a microstructured surface having at least two hierarchical levels that are self-similar, including a first level and a second level, each of the first and second levels include microfeatures wherein the first level microfeatures have a width of 1 to 20 microns, a height of 1 to 20 microns, and a pitch between adjacent microfeatures of 1 to 20 microns, the second level microfeatures have a width of 10 to 500 microns, a height of 50 to 200 microns, and a pitch between adjacent microfeatures greater than 50 microns up to 200 microns, the first level being disposed about the second level, the height and the width of the first and second microfeatures being scaled by a constant factor, the at least two hierarchical levels produce Wenzel-Cassie fluid pinning states when placed in contact with a wet surface, wherein the microstructured surface comprises a first plurality of the at least two hierarchical levels and a second plurality of the at least two hierarchical levels, wherein the first plurality is positioned at a first height about the microstructured surface, and the second plurality is positioned at a second height about the microstructured surface, wherein the first height and second height are different and create split contact levels capable of generating split contact Wenzel-Cassie wetting states. 2. The device of claim 1, wherein the at least two hierarchical levels produce frustrated wetting states. 3. The device of claim 2, wherein the at least two hierarchical levels produce frustrated contact surfaces. 4. The device of claim 1, wherein the at least two hierarchical levels produce metastable wetting states on at least one hierarchical level. 5. The device of claim 1, wherein the at least two hierarchical levels possess a periodicity capable of accommodating a wrinkle eigenmode of a target deformable surface. 6. The device of claim 2, wherein the at least two hierarchical levels inhibit the evolution of a buckled state in a target deformable surface when a shear force is applied to said device. 7. The device of claim 3, wherein the at least two hierarchical levels inhibit translation of the device when in contact with a deformable surface when a shear force is applied to said device. 8. The device of claim 1, wherein the microstructured surface further comprises a smooth chemical surface with the same hydrophilicity, hydrophobicity, oleophobicity or oleophilicity of at least one of the at least two hierarchical levels. 9. The device of claim 1, wherein the microstructured surface further comprises a third level disposed hierarchically about the first level of the first plurality, or the second plurality, or both. 10. The device of claim 9, wherein the third level is 100-10,000 microns in width. 11. The device of claim 9, wherein the third level is 100-10,000 microns in height. 12. The device of claim 9, wherein the third level includes a pitch of 100-10,000 microns. 13. The device of claim 1, wherein the microstructured surface, when in contact with a wet contact surface, forms an interface, the interface comprising a solid contact surface, a hydrophobic liquid contact surface, and a hydrophilic liquid contact surface. 14. The device of claim 1, wherein the microstructured surface, when in contact with a wet surface forms an interface, the interface comprising a solid contact surface, a gas contact surface, and a hydrophilic liquid contact surface. 15. The device of claim 1, wherein the at least two hierarchical levels are multi-periodic, and wherein at least one period matches one or more wrinkle eigenmodes of a target deformable surface. 16. The device of claim 13, wherein at least two contact surfaces are frustrated. 17. The device of claim 13, wherein Shallamach motion in a target contact surface is inhibited. 18. The device of claim 1, wherein at least one Wenzel-Cassie wetting state transitions to a Wenzel wetting state when at least 1 mN of shear force is applied to said device. 19. The device of claim 1, wherein at least one Wenzel-Cassie wetting state transitions to a Cassie-Baxter wetting state when at least 1 mN of shear force is applied to said device. 20. The device of claim 1, wherein device comprises an implantable mesh that is biocompatible.
The microstructure arrangement of the reference claims is the same as that claimed. The dimensions of the microstructures are similar to those claimed at least because the ranges overlap.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Since the reference claims teach a device with a surface having a plurality of first, second, and third microstructures and since the reference patent claims teach the plurality of first, second, and third microstructures having dimensions which overlap with the claimed ranges, and since surfaces with substantially the same or similar dimensions are expected to have similar properties, it would appear the claims of the reference patent are dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures, and are configured to induce non-inflammatory healing in adjacent tissue layers to at least some degree as required by the claimed invention if tested in the same way.
The device surface claimed by the ‘255 patent includes at least two hierarchical levels that are self-similar, including a first level and a second level, … and wherein the microstructured surface comprises a first plurality of the at least two hierarchical levels and a second plurality of the at least two hierarchical levels, wherein the first plurality is positioned at a first height about the microstructured surface, and the second plurality is positioned at a second height about the microstructured surface, wherein the first height and second height are different and create split contact levels capable of generating split contact Wenzel-Cassie wetting states (claim 1).
This feature is a preferential hydration zone (capable of generating split contact Wenzel-Cassie wetting states), and includes a self-similar zone of surface texture which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
The reference claims teach the substrate comprising a microstructure surface but do not expressly teach a biodegradable polymer. Hulseman teaches similar devices comprising a biodegradable polymer (Hulseman, e.g., 0042, 0083, and examples teaching PLA).
It would have been obvious before the presently claimed invention was made to utilize a biodegradable polymer for the device of the reference claims with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification with a reasonable expectation of success because Hulseman teaches devices having microfeatures like those of the reference claims advantageously are made from bioabsorbable polymers and bioabsorbable polymers are able to form the same or similar microstructured surfaces to achieve similar properties.
The reference claims and Hulseman do not expressly teach the polymer comprising chondroitin salts, chitin, or chitosan. However, the teachings of Burbank enumerated above cure this defect.
Burbank teaches modifying compression molded implantable materials with chitosan (Burbank, e.g., 0026 and claim 2). Thus, chitosan was known and used in compression molded implants to help stop bleeding when in contact with tissue before the effective filing date of the presently claimed invention.
It would have been obvious before the effective filing date of the presently claimed invention to modify implantable devices known from Hulseman by incorporating chitosan in the degradable polymer with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar implantable devices in the same way. The skilled artisan would have been motivated to make this modification to improve the hemostatic properties of the device when implanted in the same way suggested by Burbank. The skilled artisan would have had a reasonable expectation of success since the references teach improvements for implantable devices.
It would have been obvious before the effective filing date of the presently claimed invention to modify implantable devices known from reference claims and Hulseman by incorporating chitosan in the degradable polymer with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar implantable devices in the same way. The skilled artisan would have been motivated to make this modification to improve the hemostatic properties of the device when implanted in the same way suggested by Burbank. The skilled artisan would have had a reasonable expectation of success since the references teach improvements for implantable devices.
The reference claims and Hulseman do not expressly teach wherein the biodegradable polymer is a polyurethane containing lactide diol blocks. However, the teachings of Spaans cure this defect.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices taught by the reference claims and Hulseman using polyurethane polymers known from Spaans with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known biodegradable polymer for another to achieve predictable results. The skilled artisan would have been motivated to use a polyurethane containing lactide and diol blocks for a combination of benefits including good mechanical properties, processability, biocompatibility, and less toxicity in the same way taught by Spaans. The skilled artisan would have had a reasonable expectation of success because Hulseman teaches the polymer may alternatively be a polyurethane.
The combined teachings of the reference claims and Hulseman do not expressly teach the microstructures further comprising adhesion peptides.
The combined teachings of the reference claims and Hulseman do not expressly teach the microstructures further comprising at least one bioactive substance.
The teachings of Dubrow enumerated above cures these defects.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices suggested by the reference claims and Hulseman using techniques known from Dubrow with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar devices in the same way. The skilled artisan would have been motivated to improve the prior art devices with adhesion peptides for enhanced utility in the same way suggested by Dubrow. The skilled artisan would have been motivated to improve the prior art devices with a drug to improve tissue healing in the same way suggested by Dubrow. The skilled artisan would have had a reasonable expectation of success because each reference teaches improvements for implantable devices.
Accordingly, the subject matter of claims 24-44 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 24-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-19 of US 10953138 in view of Hulseman, US 20170014111 A1, Burbank, US 20140171385, Spaans, US 6784273, and Dubrow, US 20050221072 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach absorbable polymer medical device comprising an implant, the implant including a microstructured surface having at least one morphological feature with a dimension ranging from 5 to 200 microns, wherein the implant comprises a polymer that is degradable in vivo by hydrolysis or enzymatic degradation, and wherein upon degradation, the implant develops a polymer skin, but said polymer skin is no greater than 100% of the at least one morphological feature dimension. 2. The device of claim 1, wherein the microstructured surface comprises at least two morphological features, wherein the first morphological feature comprises i) a height of 5 to 50 microns and ii) a width of 5 to 50 microns, the second morphological feature comprises i) a height of 50 to 200 microns and ii) a width of 50 to 200 microns, and further wherein the first morphological feature is disposed on the surface of said second morphological feature. 3. The device of claim 1, wherein the implant is a sheet having a flexural modulus, and the flexural modulus of the implant is less than a flexural modulus of a sheet of the polymer that does not comprise the microstructured surface, where the sheets have the same thickness. 4. The device of claim 3, wherein a force required to puncture the implant with a surgical suture is less than the force required to puncture the sheet that does not comprise the microstructured surface. 5. The device of claim 3, wherein the implant requires a shear force of translation greater than a sheet that does not comprise the microstructured surface when implanted in a mammalian body. 6. The device of claim 1, wherein the microstructured surface promotes cellular infiltration. 7. The device of claim 1, wherein the implant degrades into solid fragments having a size smaller than the largest morphological feature of the microstructured surface after implantation into a mammalian body. 8. The device of claim 1, wherein the implant does not degrade into solid fragments or particulates after implantation into a mammalian body. 9. The device of claim 1, the implant further comprising first and second sides, wherein the first side comprises the microstructured surface and the second side does not. 10. The device of claim 1, the implant further comprising first and second sides, wherein the first side comprises the microstructured surface and the second side comprises a second microstructured surface. 11. The device of claim 1, wherein the implant is adhered to a surgical mesh. 12. The device of claim 1, wherein the polymer is selected from the group consisting of polymers of lactide, glycolide, caprolactone, dioxanone, trimethylene carbonate, orthoesters, ethylene oxide, propylene oxide, urethane and combinations thereof. 13. The device of claim 1, wherein the polymer is a polyester polyurethane. 14. The device of claim 13, wherein the polyurethane is a copolymer comprising polylactide, a polyester selected from the group consisting of polyethylene oxide; polypropylene oxide; tetrathane; and mixtures thereof. 15. The device of claim 1, wherein the implant further comprises an elastomeric, bioabsorbable core portion having an outer surface comprising the microstructured surface, the microstructured surface comprising a plurality of discrete hierarchically arranged morphological features arranged periodically such that an exposed portion of the morphological features project outwardly from the outer surface, the exposed portion of said microstructures and said outer surface of said core portion in combination providing an outer surface of said implant, wherein the outer surface of said implant has a self-similar topography comprising at least two microstructured scales such that upon implantation the exposed portion of the plurality of morphological features project outwardly from said outer surface of said core portion; and after the morphological features are absorbed, the outer surface of the core portion has a soft partially dissolved skinless layer thereon. 16. The device of claim 15, wherein said elastomeric core portion comprises polylactic acid, polyglycolic acid, or a combination of polylactic acid and polyglycolic acid. 17. The device of claim 16, wherein said elastomeric core portion comprises a polyester polyurethane. 18. The device of claim 1, wherein the implant has at least one preferential hydration zone associated with a first portion of the surface of said implant adapted to hydrate within the environment more quickly than a second portion of the implant, the hydration zone comprising a microtextured surface that modifies the surface energy of the polymer. 19. The absorbable device of claim 1, wherein the implant comprises a sheet comprising the polymer, the sheet having at least one first portion of morphological features disposed on a second portion of morphological features, wherein said first portion has a spatial periodicity ranging from about 100 to about 500 microns between morphological feature centers, the second portion has a spatial periodicity ranging from about 100 to 10 microns between morphological feature centers, the sheet ranging in thickness from about 10 microns to about 2,000 microns, and, upon absorption of a fluid, the second morphological features expand geometrically and have a volume expansion ranging from about 10% to about 100%, and, in the expanded state, have a density ranging from about 0.1 g/cm3 to about 1.5 g/cm3.
The microstructure arrangement of the reference claims is the same as that claimed. The dimensions of the microstructures are similar to those claimed at least because the ranges overlap.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The device surface claimed by the ‘138 patent includes:
at least one preferential hydration zone associated with a first portion of the surface of said implant adapted to hydrate within the environment more quickly than a second portion of the implant (claim 18) and a polymer that is degradable in vivo by hydrolysis or enzymatic degradation (claim 1).
A preferential hydration zone is an expressly claimed feature, and includes a polymer that is degradable in vivo by hydrolysis or enzymatic degradation which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
The reference claims teach an implantable device having first and second microstructures which are dimensioned like those claimed but do not expressly teach third microstructures.
However, the teachings of Hulseman apply here. Hulseman teaches devices having third microstructures which dimensions overlap with the claimed ranges is effective to increase adherence to tissue. See Hulseman, e.g., examples.
It would have been obvious before the effective filing date of the presently claimed invention to modify a device of the reference claims by including a third plurality of microstructures dimensioned according to the teachings of Hulseman with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification with a reasonable expectation of improved adherence to tissue in the same way reported by Hulseman.
In combination, the combined teachings of reference patent claims and Hulseman teach a device having a surface having a plurality of first, second, and third microstructures, and the plurality of first, second, and third microstructures having dimensions which overlap with the claimed ranges. Since surfaces with substantially the same or similar dimensions are expected to have similar properties, it would appear the combined teachings of the claims of the reference patent and Hulseman are necessarily dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures, and are configured to induce non-inflammatory healing in adjacent tissue layers to at least some degree as required by the claimed invention if tested in the same way.
The reference claims and Hulseman do not expressly teach the polymer comprising chondroitin salts, chitin, or chitosan. However, the teachings of Burbank enumerated above cure this defect.
It would have been obvious before the effective filing date of the presently claimed invention to modify implantable devices known from reference claims alone or further in view of Hulseman by incorporating chitosan in the degradable polymer with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar implantable devices in the same way. The skilled artisan would have been motivated to make this modification to improve the hemostatic properties of the device when implanted in the same way suggested by Burbank. The skilled artisan would have had a reasonable expectation of success since the references teach improvements for implantable devices.
The reference claims teach wherein the biodegradable polymer is a polyurethane but does not expressly teach a polyurethane having lactide diol blocks. However, the teachings of Spaans cure this defect.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices taught by the reference claims alone or further in view of Hulseman using polyurethane polymers known from Spaans with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known biodegradable polymer for another to achieve predictable results. The skilled artisan would have been motivated to use a polyurethane containing lactide and diol blocks for a combination of benefits including good mechanical properties, processability, biocompatibility, and less toxicity in the same way taught by Spaans. The skilled artisan would have had a reasonable expectation of success because Hulseman teaches the polymer may alternatively be a polyurethane.
The combined teachings of the reference claims and Hulseman do not expressly teach the microstructures further comprising adhesion peptides.
The combined teachings of the reference claims and Hulseman do not expressly teach the microstructures further comprising at least one bioactive substance.
The teachings of Dubrow enumerated above cures these defects.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices suggested by the reference claims alone or further in view of Hulseman using techniques known from Dubrow with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar devices in the same way. The skilled artisan would have been motivated to improve the prior art devices with adhesion peptides for enhanced utility in the same way suggested by Dubrow. The skilled artisan would have been motivated to improve the prior art devices with a drug to improve tissue healing in the same way suggested by Dubrow. The skilled artisan would have had a reasonable expectation of success because each reference teaches improvements for implantable devices.
Accordingly, the subject matter of claims 24-44 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 24-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-20 of US 11857700 in view of Burbank, US 20140171385, Spaans, US 6784273, and Dubrow, US 20050221072 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach an absorbable polymer medical implant for contacting tissue comprising: a substrate having an inner core and an outer surface, the outer surface comprising a first plurality of microfeatures disposed on top of a second plurality of microfeatures, at least one microfeature of the plurality of second microfeatures having a height of 50 to 200 microns and a width of 50 to 200 microns; the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and wherein the first plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, only a partial volume of the microstructure is hydrated. 2. The absorbable polymer medical implant of claim 1, wherein at least one microfeature of the plurality of first microfeatures includes a height of 10-25 microns and a width of 1-15 microns. 3. The absorbable polymer medical implant of claim 1, wherein the outer surface further comprises the second plurality of microfeatures disposed on top of a third plurality of microfeatures. 4. The absorbable polymer medical implant of claim 3, wherein at least one microfeature of the plurality of third microfeatures includes a height of 100-500 microns and a width of 100-500 microns. 5. The absorbable polymer medical implant of claim 1, wherein the outer surface and microfeatures are configured to facilitate deposition of connective tissue between at least a portion of the plurality of microfeatures when implanted. 6. The absorbable polymer medical implant of claim 1, wherein the substrate is configured to dissolve upon implantation without particulate formation. 7. The absorbable polymer medical implant of claim 1, wherein the substrate comprises a first discrete portion covered by the plurality of microfeatures and a second discrete portion that is not covered by the plurality of microfeatures. 8. The absorbable polymer medical implant of claim 1, wherein the substrate is covered by the plurality of microfeatures. 9. The absorbable polymer medical implant of claim 1, wherein the implant is absorbed in 2-3 months after implantation. 10. The absorbable polymer medical implant of claim 1, wherein the polymer comprises a bioabsorbable material selected from the group consisting of lactide, glycolide, caprolactone, polydioxaxone, trimethylene carbonate, polyorthoesters, polyethylene oxide, and polyester polyurethane. 11. The absorbable polymer medical implant of claim 1, wherein either of the first or second plurality of microfeatures are comprised of a polymer selected from the group consisting of ethylene vinyl acetate, polyanhydrides, polyorthoesters, lactic acid, glycoloic acid, and polyphosphazenes. 12. An absorbable polymer medical implant for contacting tissue comprising: a substrate having an inner core and an outer surface, the outer surface comprising a first plurality of microfeatures disposed on top of a second plurality of microfeatures, at least one microfeature of the plurality of second microfeatures having a height of 50 to 200 microns and a width of 50 to 200 microns; the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and wherein the first plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, a partial volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated. 13. The absorbable polymer medical implant of claim 12, wherein at least one microfeature of the plurality of first microfeatures includes a height of 10-25 microns and a width of 1-15 microns. 14. The absorbable polymer medical implant of claim 12, wherein the outer surface further comprises the second plurality of microfeatures disposed on top of a third plurality of microfeatures. 15. The absorbable polymer medical implant of claim 14, wherein at least one microfeature of the plurality of third microfeatures includes a height of 100-500 microns and a width of 100-500 microns. 16. The absorbable polymer medical implant of claim 12, wherein the outer surface and microfeatures are configured to facilitate deposition of connective tissue between at least a portion of the plurality of microfeatures when implanted. 17. The absorbable polymer medical implant of claim 12, wherein the substrate is configured to dissolve upon implantation without particulate formation. 18. The absorbable polymer medical implant of claim 12, wherein the substrate comprises a first discrete portion covered by the plurality of microfeatures and a second discrete portion that is not covered by the plurality of microfeatures. 19. The absorbable polymer medical implant of claim 12, wherein the substrate is covered by the plurality of microfeatures. 20. The absorbable polymer medical implant of claim 12, wherein the implant is absorbed in 2-3 months after implantation.
The microfeatures have substantially the same dimensions and the same arrangement as claimed.
Since the reference claims teach a device with a surface having a plurality of first, second, and third microstructures and since the reference patent claims teach the plurality of first, second, and third microstructures having dimensions which overlap with the claimed ranges, and since surfaces with substantially the same or similar dimensions are expected to have similar properties, it would appear the claims of the reference patent are dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures, and are configured to induce non-inflammatory healing in adjacent tissue layers to at least some degree as required by the claimed invention if tested in the same way.
The device surface claimed by the ‘700 patent includes: the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and wherein the first plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, only a partial volume of the microstructure is hydrated.
This feature is a preferential hydration zone (only a partial volume of the microstructure is hydrated), and includes a polymer that is degradable in vivo by hydrolysis or enzymatic degradation which corresponds to the claimed preferential hydration zone adapted to hydrate at a faster rate than the inner core to promote surface dissolution rather than bulk degradation when interpreted in light of the specification.
The reference claims and Hulseman do not expressly teach the polymer comprising chondroitin salts, chitin, or chitosan. However, the teachings of Burbank enumerated above cure this defect.
It would have been obvious before the effective filing date of the presently claimed invention to modify implantable devices known from reference claims by incorporating chitosan in the degradable polymer with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar implantable devices in the same way. The skilled artisan would have been motivated to make this modification to improve the hemostatic properties of the device when implanted in the same way suggested by Burbank. The skilled artisan would have had a reasonable expectation of success since the references teach improvements for implantable devices.
The reference claims do not expressly teach wherein the biodegradable polymer is a polyurethane containing lactide diol blocks. However, the teachings of Spaans cure this defect.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices taught by the reference claims using polyurethane polymers known from Spaans with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known biodegradable polymer for another to achieve predictable results. The skilled artisan would have been motivated to use a polyurethane containing lactide and diol blocks for a combination of benefits including good mechanical properties, processability, biocompatibility, and less toxicity in the same way taught by Spaans. The skilled artisan would have had a reasonable expectation of success because the reference claims teach the polymer may alternatively be a polyurethane.
The combined teachings of the reference claims do not expressly teach the microstructures further comprising adhesion peptides.
The combined teachings of the reference claims do not expressly teach the microstructures further comprising at least one bioactive substance.
The teachings of Dubrow enumerated above cures these defects.
It would have been obvious before the effective filing date of the presently claimed invention to modify devices suggested by the reference claims using techniques known from Dubrow with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar devices in the same way. The skilled artisan would have been motivated to improve the prior art devices with adhesion peptides for enhanced utility in the same way suggested by Dubrow. The skilled artisan would have been motivated to improve the prior art devices with a drug to improve tissue healing in the same way suggested by Dubrow. The skilled artisan would have had a reasonable expectation of success because each reference teaches improvements for implantable devices.
Accordingly, the subject matter of claims 24-44 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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