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.
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 Rejections not reiterated herein have been withdrawn.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 has not been accepted.
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
Please file a POA that gives power of attorney to the attorney who is signing the TD, along with another copy of the TD or file a TD that is signed by the applicant. No new fee is required.
Withdrawn
The rejection of claims 24-36 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claims 37-44 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claims 33 and 42 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
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 James, US 20160222203 has been withdrawn because of Applicant’s amendment. The combined teachings of Hulseman and James do not expressly teach chondroitin salts, chitin, or chitosan.
Amendment
Independent claims 24 and 37 have been amended for clarity regarding the dimensions of the second microstructure (claims 24 and 37) and third microstructure (claim 37).
Independent claims 24 and 37 have been further amended to include the recitation of limitations regarding the dimensions of the plurality of microstructures and the outer surface, e.g., are dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures; and wherein the outer surface is configured to induce non-inflammatory healing in adjacent tissue layers.
Applicant’s amendment has been addressed in the rejections below.
Response to Arguments
Applicant's arguments filed 01/19/2026 regarding Hulseman have been fully considered but they are not persuasive.
Regarding 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.
Applicant respectfully submits that Hulseman does not teach or suggest the newly added limitations of claim 24, as amended. Applicant argues Hulseman does not disclose microstructures that are "dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures," nor does Hulseman disclose an outer surface that is "configured to induce non-inflammatory healing in adjacent tissue layers."
This argument is unpersuasive.
Regarding inflammation, Hulseman teaches the importance of avoiding inflammation of underlying biological tissue in medical applications. Thus, Hulseman teaches the devices having an outer surface configured to induce non-inflammatory healing in adjacent tissue.
Regarding the dimensions, Hulseman teaches the device comprising a surface having first, second, and third dimensions which are within the claimed ranges as set forth previously and reiterated below. Hulseman’s surfaces, having the same dimensions as claimed, thus appear to be dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures as claimed.
Applicant argues the specification of the present application discloses that "[t]he microstructures 15 are dimensioned to permit the passage of fibroblasts thereinto" and that "[t]he arrangement of the microstructures is important because tissue ingrowth requires the migration of fibroblast cells into the pores to facilitate deposition of connective tissue between the microstructures." Specification, paragraph [0049]. Applicant argues the specification further discloses that "[i]t is believed that the irregular topography of the outer surface 14 of the implant induces non-inflammatory healing in the adjacent tissue layers comprising the surrounding body." Id. Applicant argues these features are entirely absent from Hulseman's disclosure.
Applicant argues Hulseman does not contemplate or suggest dimensioning microstructures to permit cellular passage or to facilitate tissue integration. Applicant argues Hulseman's microstructures are designed to "increase the surface area and affect at least one of adhesion, friction, hydrophilicity and hydrophobicity." Hulseman, paragraph [0013]. Applicant argues there is no teaching in Hulseman regarding fibroblast migration, connective tissue deposition, or inducing non-inflammatory healing responses in adjacent tissue. Accordingly, Applicant argues Hulseman cannot anticipate claim 24, as amended.
These arguments are unpersuasive.
Hulseman teaches the device comprising a surface having first, second, and third dimensions which are within the claimed ranges as set forth previously and reiterated below. Hulseman’s surfaces, having the same dimensions as claimed, thus appear to be dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures, and configured to induce non-inflammatory healing as claimed.
In response to applicant's argument that Hulseman does not teach their dimensions permit passage of fibroblasts thereinto, promotes connective tissue deposition, induces non-inflammatory healing in adjacent tissue layers, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In this case, Hulseman teaches the device having a surface with a plurality of first, second, and third microstructures which have the recited dimensions, and are arranged in the same manner required by the claimed invention. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01, I-II. Since the Hulseman’s structure is the same, the properties of permitting passage of fibroblasts thereinto, promoting connective tissue deposition, inducing non-inflammatory healing in adjacent tissue layers are presumed to be inherent to the Hulseman’s devices.
Regarding 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.
Applicant has argued Spaans does not cure the deficiencies of Hulseman argued above. Applicant argues Spaans’ teachings regarding polyurethane polymer compositions is unrelated to the claimed microstructure
These arguments are unpersuasive because the alleged deficiencies of Hulseman are not found persuasive for the reasons enumerated above.
Double patenting
Applicant submits that the amendments to claims 24 and 37 overcome these rejections for US 12268255 and 10953138. Applicant argues the reference patent claims do not teach or suggest microstructures that are "dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures," nor does Hulseman disclose an outer surface that is "configured to induce non-inflammatory healing in adjacent tissue layers." Applicant further argues the teachings of Hulseman, James, Spaans, and Dubrow do not cure this deficiency.
These arguments are unpersuasive.
With respect to the claims of US 12268255:
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.
Hulseman was cited for teaching the biodegradable polymer limitations.
With respect to the claims of US 10953138:
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 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.
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.
Rejections Addressing Applicant’s Amendment
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 24-29, 31, 33, 37-40, and 42 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hulseman, US 20170014111 A1.
Hulseman teaches a device having a substrate with a microstructured surface (Hulseman, e.g., all figures, 0107, claims).
Substrate comprises an outer surface comprising first, second, and third microstructures with dimensions in the claimed range, e.g., three stacked features having dimensions of 3 microns, 35 microns, and 300 microns, e.g., in diameter (Hulseman, e.g., Table 3). Additional embodiments are found in table 5. Each of these dimensions are within each of the claimed ranges.
Generally, dimensions may range from 3 to 750 microns (Hulseman, e.g., 0112-0144 and claims). Diameter/width of the third microfeatures ranges from about 450-750 microns and the height ranges from about 100-500 microns (Hulseman, e.g., 0149 and claims). Diameter/width of the second microfeatures ranges from about 10-50 microns and a height ranging from about 10-50 microns (Hulseman, e.g., 0150 and claims). Diameter of the first microfeatures ranges from about 0.4 to about 10 microns and height ranges from about 0.4-10 microns (Hulseman, e.g., 0151). See also Hulseman, e.g., 0051-0061.
The prior art ranges are described with sufficient specificity to anticipate the claimed ranges due to significant overlap with the claimed ranges and the presence of disclosed species within the claimed ranges.
Independent claims 24 and 37 have been further amended to include the recitation of limitations regarding the dimensions of the plurality of microstructures and the outer surface, e.g., are dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures; and wherein the outer surface is configured to induce non-inflammatory healing in adjacent tissue layers.
Regarding inflammation, Hulseman teaches the importance of avoiding inflammation of underlying biological tissue in medical applications (Hulseman, e.g., 0104). Thus, Hulseman teaches the devices having an outer surface configured to induce non-inflammatory healing in adjacent tissue.
Regarding the dimensions, Hulseman teaches the device comprising a surface having first, second, and third dimensions which are within the claimed ranges as set forth previously and reiterated below. Hulseman’s surfaces, having the same dimensions as claimed, thus appear to be dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures as claimed.
Hulseman teaches the device comprising a surface having first, second, and third dimensions which are within the claimed ranges as set forth previously and reiterated below. Hulseman’s surfaces, having the same dimensions as claimed, thus appear to be dimensioned to permit the passage of fibroblasts thereinto to facilitate deposition of connective tissue between the microstructures, and configured to induce non-inflammatory healing as claimed.
Hulseman teaches the device having a surface with a plurality of first, second, and third microstructures which have the recited dimensions, and are arranged in the same manner required by the claimed invention. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01, I-II. Since the Hulseman’s structure is the same, the properties of permitting passage of fibroblasts thereinto, promoting connective tissue deposition, inducing non-inflammatory healing in adjacent tissue layers are presumed to be inherent to the Hulseman’s devices.
The polymer may be biodegradable, e.g., polylactic acid, aka, PLA (Hulseman, e.g., 0083 and 0109 and 0107-0151). PLA is exemplified and meets the limitations of claims 29, 33, 39, and 42. PLA is a synthetic thermoplastic polymer. Alternative polymers include biodegradable polymers and polyurethanes (Hulseman, e.g., 0083).
Substrate has a surface adhesion with a sliding friction force of greater than 50 gr/cm2 when applied against moist organ and muscle tissue (Hulseman, e.g., 0040). Substrate is a surgical material which is intended to contact organs and muscle tissue (Hulseman, e.g., 0081 and 0097 and 0104 and claim 28). This teaches the device is a medical implant.
Applicable to claim 28: claim 28 refers to a property of the medical device when tested with a liquid. With reference to Hulseman, e.g., Fig. 3, it shows a structure surface having a plurality of first microstructures (20) disposed on a second plurality of microstructures (14), wherein the first plurality of microstructures is dimensioned smaller than the second plurality of microstructures like that shown in the present application, e.g., Fig. 1. Since the structure of Hulseman’s device meets the structural limitations of claim 24, it is assumed the prior art device would show the recited property if tested in the same way. See MPEP 2112.01, I-II.
Hulseman anticipates the subject matter of instant claims 24-29, 31, 33, 37-40, and 42.
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 of this title, 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.
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.
Claims 24-29, 30, 31, 33, 37-40, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Burbank, US 20140171385.
The teachings of Hulseman enumerated above apply here.
In the event it can be determined that the claimed ranges are not described with sufficient specificity in Hulseman to conclude the claimed ranges are anticipated, the claimed ranges are alternatively rendered obvious by Hulseman since the claimed dimensions overlap with, or are within, the general dimensions taught by Hulseman. Generally, dimensions may range from 3 to 750 microns (Hulseman, e.g., 0112-0144 and claims). Diameter/width of the third microfeatures ranges from about 450-750 microns and the height ranges from about 100-500 microns (Hulseman, e.g., 0149 and claims). Diameter/width of the second microfeatures ranges from about 10-50 microns and a height ranging from about 10-50 microns (Hulseman, e.g., 0150 and claims). Diameter of the first microfeatures ranges from about 0.4 to about 10 microns and height ranges from about 0.4-10 microns (Hulseman, e.g., 0151). See also Hulseman, e.g., 0051-0061 and 0081.
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
Applicable to claim 30: Hulseman teaches the substrate comprises a polymer that is degradable in vivo by hydrolysis or enzymatic degradation (Hulseman, e.g., 0083 and examples, PLA), but Hulseman does not expressly teach the polymer comprising chondroitin salts, chitin, or chitosan.
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.
Accordingly, the subject matter of claims 24-29, 30, 31, 33, 37-40, and 42 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 24-29, 31, 32, 33, 37-40, 41, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Spaans, US 6784273.
The teachings of Hulseman enumerated above apply here.
In the event it can be determined that the claimed ranges are not described with sufficient specificity in Hulseman to conclude the claimed ranges are anticipated, the claimed ranges are alternatively rendered obvious by Hulseman since the claimed dimensions overlap with, or are within, the general dimensions taught by Hulseman. Generally, dimensions may range from 3 to 750 microns (Hulseman, e.g., 0081, 0112-0144 and claims). Diameter/width of the third microfeatures ranges from about 450-750 microns and the height ranges from about 100-500 microns (Hulseman, e.g., 0149 and claims). Diameter/width of the second microfeatures ranges from about 10-50 microns and a height ranging from about 10-50 microns (Hulseman, e.g., 0150 and claims). Diameter of the first microfeatures ranges from about 0.4 to about 10 microns and height ranges from about 0.4-10 microns (Hulseman, e.g., 0151). See also Hulseman, e.g., 0051-0061 and 0081.
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
Applicable to claims 32 and 41: Hulseman teaches the substrate comprises a polymer that is degradable in vivo by hydrolysis or enzymatic degradation (Hulseman, e.g., 0083 and examples, PLA), and Hulseman expressly teaches polyurethanes as an alternative polymer (Hulseman, e.g., 0083) but Hulseman does not expressly teach the polymer comprising absorbable polyurethane containing lactide diol blocks.
Spaans teaches medical grade polyurethanes with good mechanical properties (Spaans, entire document, e.g., all of column 1, e.g., c1:10-22).
Spaans teaches biomedical biocompatible polyurethanes based on (i) a diisocyanate linked polyester polymer block and (ii) a diol block, said polyurethane having the formula (A--B--C—B)n wherein A denotes said polyester component, B denotes said diisocyanate moiety, C denotes said diol component, n denotes the number of recurring units, and wherein at least 90% of the diol components, C, have the same block length, comprising from 40 up to 60% of units of lactide, based on the total number of monomeric units in the polymer (Spaans, e.g., claim 4). Similar lactide diol block polyurethane is found in claims 7, 10, and 17. The polyester is a diol (see structure in claim 14, e.g., -O-D-O-, where D is the polyester). The polyester may be lactide, e.g., lactic acid polyester is clearly named in Spaans, e.g., claims 7 and 17.
Thus, Spaans teaches a biocompatible, biodegradable polyurethane containing lactide diol blocks consistent with claims 32 and 41.
It would have been obvious before the effective filing date of the presently claimed invention to modify 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 to realize polyurethane embodiments suggested by Hulseman. The skilled artisan would have had a reasonable expectation of success because Hulseman teaches the polymer may alternatively be a polyurethane.
Accordingly, the subject matter of claims 24-29, 31, 32, 33, 37-40, 41, and 42 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 24-29, 31, 33, 34-36, 37-40, 42, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Hulseman, US 20170014111 A1 in view of Dubrow, US 20050221072.
The teachings of Hulseman enumerated above apply here.
In the event it can be determined that the claimed ranges are not described with sufficient specificity in Hulseman to conclude the claimed ranges are anticipated, the claimed ranges are alternatively rendered obvious by Hulseman since the claimed dimensions overlap with, or are within, the general dimensions taught by Hulseman. Generally, dimensions may range from 3 to 750 microns (Hulseman, e.g., 0112-0144 and claims). Diameter/width of the third microfeatures ranges from about 450-750 microns and the height ranges from about 100-500 microns (Hulseman, e.g., 0149 and claims). Diameter/width of the second microfeatures ranges from about 10-50 microns and a height ranging from about 10-50 microns (Hulseman, e.g., 0150 and claims). Diameter of the first microfeatures ranges from about 0.4 to about 10 microns and height ranges from about 0.4-10 microns (Hulseman, e.g., 0151). See also Hulseman, e.g., 0051-0061 and 0081.
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
Applicable to claims 34-36 and 43-44:
Hulseman does not expressly teach the microstructures further comprising adhesion peptides.
Hulseman does not expressly tech the implant comprising at least one bioactive substance.
Dubrow teaches modifying implants with bioactive substances and adhesion peptides.
Dubrow teaches medical devices with a nanostructured surface (Dubrow, entire document, e.g., title, abstract claims), wherein the nanostructured surface offers enhanced surface area like the microstructure surface of Hulseman (Dubrow, e.g., 0294).
Applicable to claims 34 and 43: Dubrow teaches the nanostructured surface further comprising RGD which is an adhesion peptide for enhanced utility, such as improved tissue integration and tissue formation (Dubrow, e.g., 0187-0189, claim 8, claim 15, and claim 32).
Applicable to claims 35-36 and 44: Dubrow teaches devices further comprising drugs, e.g., proteins, growth factors, and/or hormones to improve tissue healing at the target tissue site (Dubrow, e.g., 0199, claim 8, and claim 15).
It would have been obvious before the effective filing date of the presently claimed invention to modify Hulseman’s devices 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 Hulseman’s devices with adhesion peptides for enhanced utility in the same way suggested by Dubrow. The skilled artisan would have been motivated to improve Hulseman’s 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 both references teach improvements for implantable devices.
Accordingly, the subject matter of claims 24-29, 31, 33, 34-36, 37-40, 42, and 43-44 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 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 cures 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 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 cures 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 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 cures 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.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615