DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to an implantable device, claims 1-12 in the reply filed on 01/27/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 are rejected 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 further limits claim 1 to further include Nitinol. But the claim does not provide guidance to how the Nitinol is applied to the device (a substrate, a coating, woven with the first polymer). Therefore, this claim in indefinite. The specification provides guidance for the implantable device to be a Nitinol article and the catechol group of the PGS is at the surface of the Nitinol (paragraph [0069] and [0071]). For examination purposes, the examiner interprets an implantable device formed from Nitinol and having the first polymer as a coating on top would meet this limitation. Claims 3 and 4 depend from claim 2 and are also rejected as being indefinite.
Allowable Subject Matter
Claims 6-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art, Wen et al. discloses a stent formed from Nitinol (paragraph [0025]) and a passivation layer comprising the first polymer of glycerol and sebacic acid (paragraph [0135], [0138], [0145]), wherein the passivation layer is bound to the Nitinol stent (paragraph [0025], [0138], [0145]). However, Wen does not expressly disclose nor render obvious a surface-modified polyester textile, and a tie layer, the tie layer binds the surface-modified polyester textile to the passivation layer such that the surface-modified polyester textile is suturelessly fixed to the Nitinol wire, and the surface-modified polyester textile comprises a textile of a polyester having a modified surface that provides surface crosslinkable groups. Claims 7-10 depend from claim 6.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. WO 2011/084811 A1 in view of Kim et al. Biodegradable and elastomeric poly (glycerol sebacate) as a coating material for Nitinol bare stent BioMed Research International, Volume 2014.
Regarding Claim 1, Wen et al. discloses an implantable device comprising a first polymer (paragraph [0009-0010] and [0138), the first polymer comprising a catechol group (paragraph [0052]). However, Wen et al. does not expressly disclose the first polymer is a polymer of glycerol and sebacic acid. Kim et al. teaches an implantable device in the same field of endeavor comprising a substrate formed of metal, Nitinol (page 1, abstract and introduction) and having a coating formed of PGS, poly(glycerol sebacate) (page 1, abstract and introduction) for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the Nitinol (page 1, abstract and introduction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wen’s first polymer to further include poly(glycerol sebacate) as taught by Kim et al. for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the Nitinol.
Regarding Claim 2, Wen et al. discloses the implantable device further comprising Nitinol (paragraphs [0036-0037] and [0145]).
Regarding Claim 3, Wen et al. discloses wherein the first polymer is coated on the Nitinol (paragraph [0025]). However, Wen et al. does not expressly disclose the first polymer is a polymer of glycerol and sebacic acid. Kim et al. teaches an implantable device in the same field of endeavor comprising a substrate formed of metal, Nitinol (page 1, abstract and introduction) and having a coating formed of PGS, poly(glycerol sebacate) (page 1, abstract and introduction) for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the Nitinol (page 1, abstract and introduction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wen’s first polymer to further include poly(glycerol sebacate) as taught by Kim et al. for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the Nitinol.
Regarding Claim 4, Wen et al. discloses wherein the catechol group is bound to the surface of the Nitinol, thereby passivating the Nitinol (paragraph [0025-0026] and [0028-0030], [0144-0145]).
Regarding Claim 5, Wen et al. discloses wherein the implantable device is a sutureless graft (paragraph [0136]).
Regarding Claim 11, Wen et al. does not expressly disclose wherein the first polymer of glycerol and sebacic acid is elastomeric, non-immunogenic, and resorbable, has a chemical structure selected to match a compliance of a tissue or other substrate, and acts as an adhesive bond-line or tie layer for the implantable device. Kim et al. teaches an implantable device in the same field of endeavor comprising a substrate formed of metal, Nitinol (page 1, abstract and introduction) and having a coating formed of PGS, poly(glycerol sebacate) (page 1, abstract and introduction), wherein the polymer is an elastomeric biomaterial that is biodegradable (see page 1, introduction, page 5, conclusion) for the purpose of having a polymer that is elastic and would enhance the mechanical strength and durability of the implantable device (page 1, abstract and introduction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wen’s first polymer to further include poly (glycerol sebacate) as taught by Kim et al. for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the implantable device.
Regarding Claim 12, Wen et al. discloses a composition comprising a polymer (paragraph [0009-0010] and [0138), the polymer comprising a catechol group so that it is capable of forming adhesion bond (paragraph [0052]). However, Wen et al. does not expressly disclose the polymer is glycerol and sebacic acid. Kim et al. teaches a composition in the same field of endeavor comprising a coating formed of PGS, poly (glycerol sebacate) (page 1, abstract and introduction) for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the composition (page 1, abstract and introduction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wen’s polymer to further include poly(glycerol sebacate) as taught by Kim et al. for the purpose of having a polymer that is elastic and biodegradable and would enhance the mechanical strength and durability of the composition.
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yip et al. U.S. Patent 6,896,697 in view of Hingston U.S. Publication 2014/0074219.
Regarding Claim 1, Yip discloses an implantable device (stent) comprising a first polymer of glycerol and sebacic acid (column 18, line 28 - column 19, line 10; polymers used to coat a stent includes glycerol sebacate). However, Yip does not expressly disclose the first polymer of glycerol and sebacic acid comprises a catechol group. Hingston teach an implantable device (stent 10) in the same field of endeavor comprising a first polymer (bioadhesive layer 14; see paragraphs [0036], [0046] - bioadhesives including adhesively modified biodegradable polymers), wherein the first polymer comprises a catechol group ([0049], [0051]) for the purpose of enhancing the adhesive properties of the first polymer (paragraph [0043-0045]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yip's first polymer to include a catechol group as taught by Hingston in order to enhance adhesive properties of the first polymer ([0045], [0049]).
Regarding Claim 12, Yip discloses a composition comprising a polymer of glycerol and sebacic acid (column 18, line 28 - column 19, line 10; polymers used to coat a stent includes glycerol sebacate). However, Yip does not expressly disclose the polymer of glycerol and sebacic acid comprises a catechol group. Hingston teach a composition in the same field of endeavor comprising a polymer (bioadhesive layer 14; see paragraphs [0036], [0046] - bioadhesives including adhesively modified biodegradable polymers), wherein the polymer comprises a catechol group ([0049], [0051]) for the purpose of enhancing the adhesive properties of the polymer (paragraph [0043-0045]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yip's polymer to include a catechol group as taught by Hingston in order to enhance adhesive properties of the polymer ([0045], [0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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