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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/11/2026, 02/26/2025, and 10/19/2023 have been considered by the examiner.
Status of the Claims
The response and amendment filed 11/17/2025 is acknowledged.
Claims 1-4, 7-15, 18, 20, 25, 27, and 30-31 are pending.
Applicant’s election without traverse of Group I, claims 1-4, 7-11, and 30-31 in the reply filed on 11/17/2025 is acknowledged.
Claims 12-15, 18, 20, 25, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Claims 1-4, 7-11, and 30-31 are treated on the merits in this action.
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 Rejections not reiterated herein have been withdrawn.
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 1-4, 8, 10-11, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Migneco, Biomaterials, 30, 2009 (cited previously).
Applicable to claims 1 and 30: Migneco teaches a shape memory polymer material comprising at least one monomer unit of glycerol and at least one monomer unit of dodecanedioate (Migneco, entire document, e.g., Abstract). The polymer comprises glycerol and dodecanedioic acid monomers which have functional groups, e.g., hydroxyl groups of glycerol and carboxylic acid groups of dodecanedioic acid, which functional groups are capable of forming ester bonds, i.e., a polyester (Migneco, entire document, e.g., Title, Abstract, and pg. 6480, c1). Thus, the surface of Migneco’s shape memory polymer has hydroxyl functional groups and/or carboxylic acid and/or ester functional groups on the surface of the polymer material.
Claim 30 includes product by process steps of depositing a shape memory polymer resin into a mold, the shape polymer resin comprising at least one monomer unit of glycerol and at least one monomer unit of dodecanedioate; partially curing the shape memory polymer resin to form a shape memory elastomer; cutting the shape memory elastomer; and curing the shape memory elastomer to form an implant material. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. Here the recited process steps do not imply any specific additional structural features which could be used to distinguish the claimed implant material over the prior art. Migneco teaches the material is implantable (Migneco, e.g., 6480, e.g., ¶ 3: intrauterine device or coronary stent which is a tubular shape). Migneco teaches the material is cured (Migneco, e.g., pg. 6480, 2.1 polymer fabrication and characterization). Migneco teaches the material is cut (Migneco, e.g., pg. 6480, 2.2: cured samples were cut).
Applicable to claim 2: Migneco teaches below the Tg, the polymer has a glassy state where cold draw and plastic deformation are possible. However, the shape memory polymer material has a melt transition temperature above the Tg ~32°C ending about 37°C, at which point the polymer is “completely amorphous” and the polymer exhibits elastic deformation, i.e., the deformation is not maintained once external forces are removed unless cooled down below the Tg. See Migneco, e.g., pg. 6483, e.g., c1:¶ 3-c2:¶ 8. This appears to be a melt transition temperature in the claimed range.
Applicable to claims 3-4 and 31: Migneco teaches the shape memory polymer material takes a first rigid shape at a first temperature, e.g., room temperature subsequently becoming soft and compliant at body temperature to better match soft tissue elasticity (Migneco, e.g., pg. 6479, c1, ¶ 2 and pg. 6480, c1:¶ 3). Similarly, Migneco teaches the shape memory feature enables mini-invasive surgery wherein the device can be implanted at room temperature in a smaller configuration (first shape), and once placed in the appropriate position at body temperature deployed to a final functional configuration (second shape). See Migneco, e.g., pg. .6484, 5. Conclusions.
Applicable to claim 8: Migneco teaches the polymer material comprises glycerol and dodecanedioic acid monomers which have functional groups, e.g., hydroxyl groups of glycerol and carboxylic acid groups of dodecanedioic acid, which functional groups are capable of forming ester bonds, i.e., a polyester (Migneco, entire document, e.g., Title, Abstract, and pg. 6480, c1). Thus, the surface of Migneco’s shape memory polymer has hydroxyl functional groups and/or carboxylic acid and/or ester functional groups on the surface of the polymer material.
Applicable to claims 10 and 31: Migneco teaches the material has a glycerol to dodecanedioate molar ratio of 1:1 (Migneco, e.g., pg. 6480, 2.1).
Applicable to claim 11: the specification does not define what “biodegradation time” means. This term is broadly and reasonably interpreted to include complete degradation or less than complete degradation, e.g., loss of certain desired mechanical properties. Migneco teaches the polymer material has an estimated half life of 16 months (Migneco, e.g., pg. 6481, 3.4). This is a clearly disclosed value within the claimed range.
Migneco anticipates the subject matter of instant claims 1-4, 8, 10-11, and 30-31.
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 1-4, 7-11, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Migneco, Biomaterials, 30, 2009 (cited previously) and Hollister, US 20160051385.
Migneco teaches an implant material according to claims 1-4, 8, 10-11, and 30-31 as enumerated above which is useful to make implantable devices. The teachings of Migneco enumerated above are reiterated here.
Applicable to claim 7: Migneco does not expressly teach the implant material having holes useful for suturing (suture holes).
Hollister teaches implantable devices modified with apertures which are capable of receiving sutures to attach the device to the desired implant site (Hollister, e.g., claims 1 and 19, 0009, 0012, 0022-0023, 0028, 0030, 0031-0033, 0061, 0069, and 0073).
It would have been obvious before the effective filing date of the presently claimed invention to modify a shape memory polymer material implant suggested by Migneco with apertures or holes suitable for receiving sutures in the same way suggested by Hollister to improve the devices in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification so that the device may be secured to the desired tissue implantation site with sutures in the same way reported by Hollister, thereby securing the device at the desired tissue site to allow necessary time for tissue regeneration. The skilled artisan would have seen this modification as the use of a known technique to improve the utility of Migneco’s implantable devices in the same way. The skilled artisan would have had a reasonable expectation of success because both references teach improvements for implantable devices.
“Laser cut” is a product by process limitation which does not impart any structure beyond the recited structure of a hole capable of receiving sutures.
Applicable to claim 9: The surface of Migneco’s implant material, being made of the polymer comprising at least one monomer unit of glycerol and at least one monomer unit of dodecanedioate which are joined by ester bonds, includes hydroxyl, and/or carboxylic acid and/or ester functional groups. However, Migneco does not expressly teach the surface of the device comprising a bioactive agent.
Hollister teaches the technique of functionalizing the surface of implantable devices with a bioactive agent which provides local or systemic therapeutic benefit, e.g., healing and growth benefits (Hollister, e.g., 0050).
It would have been obvious before the effective filing date of the presently claimed invention to modify a shape memory polymer material implant suggested by Migneco by coating the surface with a bioactive agent as suggested by Hollister with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to improve the therapeutic benefits of the device in the same way reported by Hollister. The skilled artisan would have seen this as the use of a known technique to improve the healing and growth benefits of Migneco’s implants in the same way reported by Hollister. 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 1-4, 7-11, and 30-31 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) 1-4, 7-11, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-14, 16-20, and 22-25 of US 18288252.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a device comprising a bioresorbable scaffold comprising a shape memory polymer material comprising at least one monomer unit of glycerol and at least one monomer unit of dodecanedioate and a functionalized surface (claim 1); wherein the material takes a first shape at a first environmental temperature; the bioresorbable scaffold takes a second shape at a second environmental temperature; the second environmental temperature is greater than the first environmental temperature (claim 2); wherein the shape memory polymer has a melt transition temperature from approximately 25 °C to approximately 45 °C (claim 3); wherein the wherein the shape memory polymer is an elastomer above the melt transition temperature; and the shape memory polymer is a thermoplastic in the below the melt transition temperature (claim 5); the functionalized surface comprises a plurality of suture holes (claim 8); wherein the functionalized surface comprises at least one functional group (claim 9); wherein the functional group is a bioactive agent (claim 10); wherein the molar ratio of the at least one monomer unit of glycerol to the at least one monomer unit of dodecanedioate is from approximately 10:1 to approximately 1:10 (claim 11); wherein the bioresorbable scaffold has a biodegradation time when implanted in vivo from approximately 2 months to approximately 24 months (claim 12). The biodegradation time overlaps significantly with the claimed range, i.e., the claimed range is entirely within the range named in the reference claims. There is no period of time which would infringe the presently claimed invention without infringing the time period of the reference claims.
The subject matter of claims 1-4, 7-11, and 30-31 are anticipated by the reference claims. The difference between the presently claimed invention and the reference claims is that the reference claims are directed to an implantable device while the presently claimed invention is directed to an implantable material. While the reference claims are more specific in this aspect, the device of the reference claims is within the scope of the present claims because the reference devices are made of the presently claimed implantable material.
Thus, the applications are claiming obvious variants.
Claim(s) 1-4, 7-11, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-15, and 18-26 of US 18561058.
The reference claims teach a material comprising: a shape memory polymer having a first shape and a second shape, the shape memory polymer comprising: a polymer backbone having at least one monomer unit of glycerol and at least one monomer unit of dodecanedioate (claim 1), wherein the shape memory polymer has a melt transition temperature from approximately 25° C. to approximately 45° C (claim 6), wherein the shape memory polymer is an elastomer above the melt transition temperature and a thermoplastic below the melt transition temperature (claim 7), wherein the shape memory polymer comprises pores ranging from about 0.05 mm to about 10 mm, i.e., suture holes, surface functional group (claim 8), wherein the shape memory polymer further comprises a functionalized surface (claim 10), wherein the functionalized surface comprises at least one functional group (claim 12), wherein at least one functional group comprises a bioactive agent (claim 13), wherein the molar ratio of the at least one monomer unit of glycerol to the at least one monomer unit of dodecanedioate is from approximately 10:1 to approximately 1:10 (claim 14), wherein the implant material has a biodegradation time when implanted in vivo from approximately 4 months to approximately 24 months (claim 15), wherein the material is in a first shape and takes a second shape in response to the heating (claim 23), and wherein the implant material is an elastomer in the first shape and a thermoplastic in the second shape (claim 24).
The claim sets differ in that the reference claims teach the feature of photocurable side chains. However, the present claims encompass this additional feature.
Thus, the applications are claiming obvious variants.
Conclusion
No claim is allowed.
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615