DETAILED ACTION
Claims 18-20, 22-29, 32-36 and 41-44 are currently pending. Claims 18-20, 22-26, 29, 32-36 and 41-44 are currently under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/2025 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 06/30/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 06/30/2025, it is noted that claims 18 and 35 have been amended and claims 41-44 are newly added.
New Rejections:
The following rejections are new based on Applicant’s claim amendments and newly added claims.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-20, 22-26, 29, 32-36 and 41-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 18 and 35 contain the newly added limitation ‘formed into the iron absorption promoter through melt polymerization or enzyme-free ring-opening polymerization’ and ‘the antioxidant structural unit is contained in the molecular chain of the iron absorption promoter’. Support can be found for melt polymerization and ring-opening polymerization (page 10, lines 1-20). The instant specification does not recite enzyme-free polymerization. Enzyme polymerization is not recited positively or as a negative limitation and thus no support can be found for “enzyme-free ring opening polymerization”.
The instant specification recites “wherein the iron absorption promoter is a polymer containing an antioxidant structural unit on the molecular chain” which does not provide support for “antioxidant structural unit is contained in the molecular chain of the iron absorption promoter”. No support in the instant specification has been alleged by Applicant for the instantly claimed embodiment.
Alternatively, if Applicant believes that support for claims 18 and 35, drawn to ‘formed into the iron absorption promoter through melt polymerization or enzyme-free ring-opening polymerization’ and ‘antioxidant structural unit is contained in the molecular chain of the iron absorption promoter’, is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Claim Rejections - 35 USC § 112 (b)
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 18-20, 22-26, 29, 32-36 and 41-44 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.
Claims 18 and 35, the limitation of “an antioxidant is formed into the iron absorption promoter through melt polymerization or enzyme free ring opening polymerization, and the antioxidant structural unit is contained in the molecular chain of the iron absorption promoter” has unclear metes and bounds. The limitation of “in the molecular chain” is unclear if the antioxidant is required to be dispersed in the backbone of the polymer, is allowed to be the initiator only as an end group or is allowed to be a pendant group of the monomers and therefore “in the molecular chain” but not part of the structural backbone. The instant specification does not clarify the limitation of “in the molecular chain” see new matter ejection above. Therefore the instant claim has unclear metes and bounds by what is required by the “in the molecular chain” limitation. Any of the proceeding interpretation will be deemed to meet the instant claim limitation for compact prosecution.
Claims 23-24 and 42-43 are directed to “the iron absorption promoter further comprises at least one degradable polymer” or “further comprises at least one non-degradable polymer”. Instant claims 18 and 35 recite wherein the iron absorption promoter is a polymer, an antioxidant is formed into the iron absorption promoter”. The use of further comprising make it unclear if the degradable and non-degradable polymer are in addition to the previously recited polymer in claims 18 and 35, or if it is further defining the polymer to be degradable or non-degradable. Therefore, the instant claims have unclear metes and bounds as to whether the degradable/non-degradable polymer is in addition to the recited polymer in the independent claims or is further defining the polymer in the independent claim.
Claims 25, 29, 42 and 43 are rejected under antecedent basis. Claims 23-24 and 42-43 recites the limitation "at least one degradable polymer” and “at least one non-degradable polymer". Claims 25, 29, 42 and 43 recite “the degradable polymer” and “the non-degradable polymer”, wherein the limitations do not properly refer back to “at least one” degradable and “at least one” non-degradable polymer previously recited. It is unclear whether it refers to one or all degradable/non-degradable polymers. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 18-20, 22-23, 25-26, 32-36, 41-42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/034031 (previously applied) in view of US 2007/0010632 (Applicant provided), Farah (previously applied), CN 102871715 (previously applied) and US 2008/0183277 (previously applied).
Regarding claims 18 and 35-36, the limitation of an absorbable iron based implantable device comprising: an iron-based substrate and an iron absorption promoter attached to the iron-based substrate, wherein the iron-based promoter is a polymer, an antioxidant is formed into the iron absorption promoter and the structural unit is contained in the molecular chain of the iron absorption promoter is met by the ‘031 publication teaching bio erodible endoprostheses including a bio erodible material and an antioxidant carried by the member wherein the antioxidants include phenols (abstract). The endoprosthesis can include a carrier layer carrying the antioxidant on the surface of the member (page 2, lines 15-20) or applied directly to the endoprosthesis (page 5, lines 1-5), thus teaching attached. The bio erodible material can be iron (page 2, lines 29-31) wherein erodible endoprosthesis can be formed of bio erodible metallic materials such as magnesium and iron (page 2, lines 1-5, lines 20-25). Examples of the antioxidants include the elected procyandin (page 7, lines 9-16). The antioxidant can be covalently bonded to the carrier (page 7, lines 25-30) wherein suitable carrier include polylactic acid (PLA) (page 8, lines 15-20). The antioxidant can be covalently bonded to the carrier or the bioerodible material, e.g. by copolymerization with the carrier (page 7, line 30 to page 8, line 5).
The limitation of wherein the iron absorption promoter is dissolved in ethyl acetate, dichloromethane or trichloromethane to formulation a solution and then uniformly sprayed on the inner surface and the outer surface of the iron based substrate is met by the ‘031 publication teaching outer and inner surfaces coated with the antioxidant (page 17, lines 20-30) wherein the antioxidant can be applied to the endoprosthesis by being dissolved in a solvent and applied (page 16, lines 15-25) wherein spraying is taught (page 9, lines 20-25) where uniform or non-uniform antioxidant is taught (page 10, lines 20-30). Additionally, the application by dissolution in a specific solvent and uniformly sprayed on the inner surface and outer surface of the iron-based substrate is a product by process limitation. The ‘031 publication teaches the application of the polymer/antioxidant to the inner and outer surface of the implant and thus meet the structural limitations. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 19-20, 22 and 41, the limitation of wherein the iron absorption promoter is capable of being degraded to release an antioxidant, wherein the antioxidant is procyandin is met by the ‘031 publication teaching examples of the antioxidants include the elected procyandin (page 7, lines 9-16). The antioxidant can be covalently bonded to the carrier (page 7, lines 25-30) wherein suitable carrier include polylactic acid (PLA) (page 8, lines 15-20). The antioxidant can be released from the carrier by diffusion or erosion (page 7, lines 25-31).
Regarding claim 23, 25-26 and 42, the limitation of wherein the iron absorption promoter further comprises at least one degradable polymer structure unit, a polyester, the elected polylactic acid is met by the ‘031 publication teaching examples of the antioxidants include the elected procyandin (page 7, lines 9-16). The antioxidant can be covalently bonded to the carrier (page 7, lines 25-30) wherein suitable carrier include polylactic acid (PLA) (page 8, lines 15-20).
Regarding claim 32, the limitation of wherein the iron absorption promoter is attached to a surface of the iron-based substrate or is filled inside of the iron-based substrate is met by the ‘031 publication teaching the antioxidant can be coated on the inner surface of the endoprosthesis (page 17, lines 20-25) thus teaching filled inside the iron-based substrate.
Regarding claim 33, the limitation of wherein the absorbable iron based implantable device is a cardiovascular stent is met by the ‘031 publication teaching a coronary stent (page 17, lines 26-31).
Regarding claims 34 and 44, the limitation of further comprising an active drug attached to the iron-based substrate wherein the active drug is at least one of anti-inflammatory drug and antithrombotic drugs is met by the ‘031 publication teaching anti-inflammatory agents and anti-thrombogenic agents are applied to the stent as a coating (page 18, lines 25-30), thus teaching attached.
The ‘031 publication does not specifically teach wherein the iron absorption promoter is a polymer and an antioxidant structural unit contained in the molecular chain of the iron absorption promoter through melt polymerization or enzyme-free ring-opening polymerization, wherein the iron absorption promoter has a weight average molecular weight of 1,000 to 100,000 (claim 18 and 35).
The ‘031 publication does not specifically teach the iron absorption promoter to iron in the iron-based substrate is 0.05~0.15:1 (claim 18 and 35-36).
The ‘031 publication does not specifically teach that an iron absorption/metabolism percentage is more than 15% after implantation of the absorbable iron based implantable device for 36 months (claim 1 and 35).
The ‘632 publication teaches a polymer film functionalized with antioxidants. These antioxidant functionalized polymers can increase shelf life and quality of food products as well as increase effectiveness of pharmaceutical agents when used as coatings. The antioxidant coupled polymers may be used for a variety of applications including coatings on the inside of medical devices such as stents to substantially reduce free radical damage and/or oxygen depletion during medical produces (abstract). Non-limiting examples of antioxidants that may be coupled include procyanidins wherein one monomer may be coupled to each monomer ([0009], [0034], claim 129), reading on contain in the molecular chain of the iron absorption promoter. Examples of monomers are taught to include lactones and vinyl monomers [0011]. The coupling of the antioxidant to the biodegradable monomers is taught to control the delivery of the antioxidant [0017]. The biodegradable polymers are taught to include lactides [0017] specifically polymers of lactic acid ([0079], claim 135). The molecular weight of an exemplified polymer is 7,000 [0117]. The method of polymerization, e.g. melt of enzyme free ring opening, are product by process limitations. The ‘632 publication teaches the ring opening polymerization of lactide polymers containing antioxidant and meet the structural limitation, absent factual evidence to the contrary.
Farah teaches polylactic acid as a biodegradable polyester used in numerous applications (abstract). Molecular weight has a significant impact on the properties of polymers such as degradation, mechanical strength and solubility. High MW PLA has complete resorption time of 2 to 8 years. This prolonged existence may lead to inflammation and infection. Therefore, production of low MW PLA is desirable as it provides a shorter degradation rate. Low molecular weight PLA is taught to be 60,000 g/mol and found that implants were able to maintain mechanical properties for period usually required for healing and drug delivery (page 4, first column, second paragraph).
The ‘715 publication teaches an absorbable wire composite bone material comprising absorbable magnesium alloy and PLA polymer (page 1, first paragraph). The amount of PLA is 5 to 49.9% and the magnesium alloy is amount of 50.1 to 95% (page 1, first paragraph), which translates to ratios of magnesium allow to PLA as being between 19:1 to 1.004:1.
The ‘277 publication teaches bio erodible endoprostheses which include a member that is a bio erodible material and an antioxidant carried by the member (abstract). The antioxidant can be within the carrier material [0011]. The bio erodible material can be iron [0014]. The antioxidant can reduce (e.g. inhibit) erosion (e.g. corrosion) and can allow for control of biodegradation of metallic endoprosthesis [0015]. In embodiments the endoprosthesis exhibits a mass reduction of about 10% or more, e.g. about 50% or more after a period of implantation of one day or more e.g. about 60 days or more, about 600 days or more. [0017]. Spraying on the endoprosthesis is taught [0043].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to bond procyandin to polylactic acid polymer as the ‘632 publication teaches it is known to form polymer films with functionalized antioxidants bonded to the polymer for use on medical devices such as stent where the antioxidant may be procyanidin and the polymer may be polylactic acid. One of ordinary skill in the art would have a reasonable expectation of success as the ‘031 publication teaches coating on a stent wherein the coating includes antioxidants which may be covalently bonded to a polymer including polylactide and the ‘632 publication teaches methods of forming antioxidant/polymer films. One of ordinary skill in the art would be motivated to bond the antioxidant such as procyandin to polylactide polymer as the ‘632 publication teaches coupling of the polymer to the antioxidant can control the release of the antioxidant, thus motivating one of ordinary skill in the art to bond the antioxidant to the polymer coating on the medical device. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form the film by spraying as the ‘031 publication teaches the polymer/antioxidant may be dissolve din a solvent and spraying to form a uniform coating as methods of coating the device and the ‘277 publication teaches spraying to be a method of coating the medical device.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use low molecular weight PLA as Farah teaches low molecular weight PLA provides shorter degradation time that is useful for drug release and prevent inflammation and infection seen with high MW PLA, thus motivating one of ordinary skill in the art to use low molecular weight PLA on the stent taught by the ‘031 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Farah teaches the use of low molecular weight PLA is known and the ‘632 publication teaches examples wherein the polymer to which the antioxidant attached has a low molecular weight. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the molecular weight of the antioxidant containing polymer as Farah teaches the molecular weight of PLA impacts the properties such as the degradation rate and mechanical strength of the polymer, the ‘632 publication teaches the coupling of the antioxidant to a biodegradable monomer to control the delivery of the antioxidant and the ‘277 publication ties the antioxidant to controlled degradation of the endoprosthesis. Thus the skilled artisan would optimize the molecular weight of the polymer to control the degradation of the prosthesis. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known ratios of degradable metal to PLA polymers to be used in implantable devices for the degradable metal stent and PLA coating taught by the ‘031 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using known ratios of polymer to biodegradable metal known in the art for the biodegradable metal and polymeric device taught by the ‘031 publication and further optimizing as the ‘715 publication teaches a wide range of concentrations for both the polymer and degradable metal. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘031 publication teaches iron and magnesium are known bio erodible metals to be used in an implantable device in combination with a PLA polymer and the ‘715 publication teaches specific ratios known to be used in magnesium and PLA containing implants. It would have been obvious to one of ordinary skill in the art to use amounts of antioxidant to obtain the desired degradation of the bio erodible implant as the ‘277 publication teaches the antioxidant effects the biodegradation rate of the implant and teaches desired degradation times of a bioerodible implant. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claims 24, 29 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/034031, US 2007/0010632, Farah, CN 102871715 and US 2008/0183277 as applied to claims 18-20, 22-23, 25-26, 32-36, 41-42 and 44 above, and further in view of Voet (Voet, Vincent S. D. et al, Polym. Chem., 2014, 5, 2219, previously applied) and US 2010/00015200 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 18-20, 22-23, 25-26 and 32-36 are taught by the combination of the ‘031 publication, the ‘632 publication and Farah.
The combination of references does not specifically teach further comprising at least one non-degradable polymer structure unit (claim 24) selected from the group including polyvinylidene fluoride (claim 29, claim 43).
Voet teaches double crystalline PLA-b-PVDF-b-PLA triblock copolymers (abstract). Poly(vinylidene fluoride) demonstrates outstanding thermal, chemical and mechanical stability (page 2220, second column, last paragraph). The molecular weight was 25,100 g/mol (Table 2).
The ‘200 publication teaches coated implantable medical devices comprising a substrate and a coating on said substrate containing a biologically active agent (abstract). In some embodiments the polymer comprises copolymer of vinyl monomers including polylactides and polyvinylidene fluoride ([0083], [0239]-[0240]).
It would have been prima facie obvious to one of ordinary skill in the art before filing date of the claimed invention to use a combination of polyvinylidene fluoride and polylactic acid as the polymeric matrix as the ‘200 publication teaches that copolymers selected from a group of polylactide and polyvinylidene fluoride are known in the art to be used for coating stents and the ‘031 is directed to a coated stent. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a copolymer of polylactide and polyvinylidene fluoride because the ‘632 publication teaches non-limiting monomers include vinyl monomers and lactones [0011]. One of ordinary skill in the art would have a reasonable expectation of success as the ‘632 publication teaches the use of vinyl and lactone monomers to which an antioxidant may be attached and Voet teaches it is known to form copolymers of PLA and polyvinyldine fluoride.
Claims 34 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/034031, US 2007/0010632, Farah, CN 102871715 and US 2008/0183277 as applied to claims 18-20, 22-23, 25-26, 32-36, 41-42 and 44 above, and further in view of US 2004/0215312 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 18-20, 22-23, 25-26, 32-36, 41-42 and 44 are taught by the combination of the ‘031 publication, the ‘632 publication, Farah, the ‘715 publication and the ‘277 publication.
The combination of references does not teach the specifically elected rapamycin (claim 34 and 44).
The ‘312 publication teaches stents coated with a drug that inhibits restenosis such as rapamycin or paclitaxel [0055].
It would have been obvious to one of ordinary skill in the art to substitute an active agent, paclitaxel, as taught by the ‘031 publication with a second active agent, rapamycin, as taught by the ‘312 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using rapamycin in the coating taught by the ‘031 publication because the ‘031 publication teaches the use of paclitaxel and agents that inhibit restenosis and the ‘312 publication teaches the interchangeability of paclitaxel and rapamycin for the treatment of restenosis on a stent.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘031 publication (Atanasoska, the ‘632 publication (Kaplan), Farah, the ‘715 publication (Jing) and the ‘277 publication (Atanoska ‘277)
Applicant argues an antioxidant is formed into the iron absorption promoter through melt polymerization or enzyme-free ring-opening polymerization and wherein the iron absorption promoter is dissolved in ethyl acetate dichloromethane or trichloromethane to formulate a solution and then uniformly sprayed on the inner surface and the outer surface of the iron substrate is not taught.
In response, Applicant is referred to the modified rejections above addressing the newly added claim limitations. The ‘031 publication teaches the antioxidant can be covalently bonded to the carrier or the bioerodible material, e.g. by copolymerization with the carrier (page 7, line 30 to page 8, line 5). The ‘632 publication teaches the method of polymerization, e.g. melt of enzyme free ring opening, are product by process limitations. The ‘632 publication teaches the ring opening polymerization of lactide polymers containing antioxidant and meet the structural limitation, absent factual evidence to the contrary. The limitation of wherein the iron absorption promoter is dissolved in ethyl acetate, dichloromethane or trichloromethane to formulation a solution and then uniformly sprayed on the inner surface and the outer surface of the iron based substrate is met by the ‘031 publication teaching outer and inner surfaces coated with the antioxidant (page 17, lines 20-30) wherein the antioxidant can be applied to the endoprosthesis by being dissolved in a solvent and applied (page 16, lines 15-25) wherein spraying is taught (page 9, lines 20-25) where uniform or non-uniform antioxidant is taught (page 10, lines 20-30). Additionally, the application by dissolution in a specific solvent and uniformly sprayed on the inner surface and outer surface of the iron-based substrate is a product by process limitation. The ‘031 publication teaches the application of the polymer/antioxidant to the inner and outer surface of the implant and thus meet the structural limitations. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The ‘277 publication teaches spraying on the endoprosthesis is taught [0043].
Applicant argues supporting evidence as Proof Documents 1-3 are provided to overcome the rejection.
It is noted Applicant has not provided the Documents in an Information Disclosure Statement; however the documents have been reviewed for compact prosecution.
Applicant argues the Office action interprets the disclosure of the ‘715 publication (Jing) particularly the ratios of magnesium based degradable metals to PLLA polymers as applicable to the claimed mass ratio of iron base to polymer or the claimed iron absorption/metabolism percentage.
In response, the ‘031 publication teaches the bioerodible material can be iron or magnesium (page 2, lines 20-25). Thus the ‘031 publication provides the connection between the iron and magnesium in an implantable medical device, proving the reasonable expectation of success. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘031 publication teaches iron and magnesium are known bioerodible material to be used in an implantable device in combination with a PLA polymer and the ‘715 publication teaches specific ratios known to be used in magnesium and PLA containing implants. As MPEP 2144.05 recites “wherein general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. The ‘715 publication teaches an absorbable wire composite bone material comprising absorbable magnesium allow and PLA polymer (page 1, first paragraph). The amount of PLA is 5 to 49.9% and the magnesium allow is amount of 50.1 to 95% (page 1, first paragraph), which translates to ratios of magnesium allow to PLA as being between 19:1 to 1.004:1. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known ratios of degradable metal to PLA polymers to be used in implantable devices for the degradable metal stent and PLA coating taught by the ‘031 publication.
Applicant argues magnesium and iron material exhibit significant chemical differences as understood by those skilled in the art. Magnesium is highly reactive and easily reacts with water, whereas iron is much more stable, exhibiting a significantly slower corrosion reaction in water. Magnesium-based devices primary focuses on delaying corrosion while iron-based device research aims to accelerate corrosion. Applicant provides Proof Document 3 to demonstrate the electrode potential of magnesium alloy is lower than that of iron and easily corrosion. Proof 2 confirms magnesium has a higher reactivity than iron. The differences between magnesium and iron based medical devices. Magnesium medical devices do not face challenges with the absorption of corrosion products, and there are no publicly available research finding indicating difficulties in absorbing magnesium corrosion products. This application deals with Fe2+ and Fe3+ ions in the degradation products of iron, whose solubility varies with valence. This application employs an antioxidant modified polymer to maintain iron in its lower valent state, thus preventing the formation of Fe3+. Proof document 1 demonstrates magnesium devices degrade to fast while iron devices have slow degradation. Magnesium based medical devices do not face issues with absorbing corrosion products because magnesium hydroxide, formed in the body easily converts to highly soluble magnesium chloride in the presence of chloride ions. In contrast, iron-based devices struggle with the absorption of their corrosion products.
In response, the ‘031 publication teaches the bioerodible material can be iron or magnesium (page 2, lines 20-25). Thus the ‘031 publication provides the connection between the iron and magnesium in an implantable medical device, proving the reasonable expectation of success. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘031 publication teaches iron and magnesium are known bioerodible material to be used in an implantable device in combination with a PLA polymer and the ‘715 publication teaches specific ratios known to be used in magnesium and PLA containing implants. The ‘277 publication additionally teaches bio erodible endoprosthesis which include a member that is a bioerodible material an antioxidant where the bioerodible material can be iron and the antioxidant can reduce (e.g., inhibit) erosion (e.g., corrosion) and can allow for control of the biodegradation of metallic endoprosthesis [0015]. Thus the ‘277 publication provides further connection between the erodible device which may be Fe and an antioxidant to control the degradation. Applicant has provided information which addresses differences in degradation of Mg and Fe, the need for speeding up or slowing down the degradation, however it has not provided any unexpected results regarding the specific ratios claimed. It would have been obvious to one of ordinary skill in the art to use an antioxidant polymer with an iron medical devices based on the teachings of the ‘031 publication, and additionally would have been obvious to optimize the amounts of antioxidant to erodible metal based on the teachings of the ‘715 publication providing a range of metal to antioxidant amounts and the ‘277 publication teaching antioxidant to control degradation of the metallic endoprosthesis. The data provide by Applicant demonstrates the antioxidant have an effect on the degradation rate, and thus still would be an optimizable parameter, where no unexpected results are presented.
Applicant argues the fundamental differences between magnesium and iron indicate that those skilled in the art would not be motivated to apply magnesium based technical solution to address the unique challenges of iron-based materials. It would be unreasonable to expect a skilled artisan to directly apply or optimize the mass ratio of the iron absorption promoter to iron based on the PLA to absorbable magnesium alloy reaction disclosed in the ‘715 publication to the ‘031 publication design and thus would not have achieved the claimed mass ratio.
In response, the ‘031 publication teaches the bioerodible material can be iron or magnesium (page 2, lines 20-25). Thus the ‘031 publication provides the connection between the iron and magnesium in an implantable medical device, proving the reasonable expectation of success. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘031 publication teaches iron and magnesium are known bioerodible material to be used in an implantable device in combination with a PLA polymer and the ‘715 publication teaches specific ratios known to be used in magnesium and PLA containing implants. The ‘277 publication additionally teaches bio erodible endoprosthesis which include a member that is a bioerodible material an antioxidant where the bioerodible material can be iron and the antioxidant can reduce (e.g., inhibit) erosion (e.g., corrosion) and can allow for control of the biodegradation of metallic endoprosthesis [0015]. Thus the ‘277 publication provides further connection between the erodible device which may be Fe and an antioxidant to control the degradation.
Applicant argues the office action asserts that optimizing the molecular weight of the antioxidant containing polymer is obvious based on the regains of Farah, which state the molecular weight of PLA impacts the properties such as degradation rate of mechanical strength. This reasoning overlooks critical factors that distinguished the claimed invention from the cited references. The incorporation of an antioxidant into the PLA monomer fundamentally alters its chemical composition, spatial structure and functional groups leading to significant variation in the polymer’s degradation performance. The substantial differences in the molecular weight from the ‘657 publication to this application highlight the extensive modification that occur when an antioxidant is combined with the polymer. The molecular weight of a polymer affects its degradation rate, the result changes are not predictable. The inherent complexities of chemistry mean that simply increasing or decreasing molecular weight can lead to a range of corrosion degradation performance of the iron based varies singularity across components complicating any attempts to draw direct correlation with PLA molecular weight.
In response, it appears Applicant is arguing unexpected results however has not presented any factual data to support the unexpected results. Attorney’s argument may not take the place of factual data wherein factual date is required. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use low molecular weight PLA as Farah teaches low molecular weight PLA provides shorter degradation time that is useful for drug release and prevent inflammation and infection seen with high MW PLA, thus motivating one of ordinary skill in the art to use low molecular weight PLA on the stent taught by the ‘031 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Farah teaches the use of low molecular weight PLA is known and the ‘632 publication teaches examples wherein the polymer to which the antioxidant attached has a low molecular weight. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the molecular weight of the antioxidant containing polymer as Farah teaches the molecular weight of PLA impacts the properties such as the degradation rate and mechanical strength of the polymer, the ‘632 publication teaches the coupling of the antioxidant to a biodegradable monomer to control the delivery of the antioxidant and the ‘277 publication ties the antioxidant to controlled degradation of the endoprosthesis. Thus the skilled artisan would optimize the molecular of the polymer to control the degradation of the prosthesis. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Applicant argues the ‘715 publication solves problem of insufficient strength of internal bone fixation. The technical problem solved in the present invention is not the problem of insufficient mechanical properties of iron but metabolism of iron based corrosion products. The ‘715 publication is distinct inventive concept. It is directed to relative content of the binder polylactic acid and the matrix magnesium alloy wire and the thickness of the ceramic protective layer on the surface of the magnesium alloy wire, the degradation rate of the orthopedic device of the present invention can be effectively controlled and maintained. The mass ratio of the iron absorption promoter to iron in the iron based substrate and the weight average molecular weight of the iron absorption promoter containing the antioxidant structural unit, the is not motivate to refer to the ‘715 publication for improvement. The ‘715 publication is a different structure than the instant invention. The ‘715 publication teaches distinct method of forming than the instant application.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ‘715 publication teaches an absorbable wire composite bone material comprising absorbable magnesium alloy and PLA polymer (page 1, first paragraph). The amount of PLA is 5 to 49.9% and the magnesium alloy is amount of 50.1 to 95% (page 1, first paragraph), which translates to ratios of magnesium allow to PLA as being between 19:1 to 1.004:1. Thus the ‘715 publication teaches known ratios to be use between PLA and a degradable metal for use in the body as an implant.
Applicant argues it is unreasonable to expect a skilled artisan to directly apply or optimize the mass ratio of the iron absorption promoter to iron based on PLA to absorbable magnesium allow disclosed in the ‘715 publication for the ‘031 publication impalpable device designed for the iron base substrate.
In response, the ‘031 publication teaches the bioerodible material can be iron or magnesium (page 2, lines 20-25). Thus the ‘031 publication provides the connection between the iron and magnesium in an implantable medical device, proving the reasonable expectation of success. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘031 publication teaches iron and magnesium are known bioerodible material to be used in an implantable device in combination with a PLA polymer and the ‘715 publication teaches specific ratios known to be used in magnesium and PLA containing implants. As MPEP 2144.05 recites “wherein general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. The ‘715 publication teaches an absorbable wire composite bone material comprising absorbable magnesium allow and PLA polymer (page 1, first paragraph). The amount of PLA is 5 to 49.9% and the magnesium allow is amount of 50.1 to 95% (page 1, first paragraph), which translates to ratios of magnesium allow to PLA as being between 19:1 to 1.004:1. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known ratios of degradable metal to PLA polymers to be used in implantable devices for the degradable metal stent and PLA coating taught by the ‘031 publication.
Applicant argues that optimizing the molecular weight of the antioxidant-containing polymer is obvious based on teachings from Farah and the ’632 publication is not obvious. The technical problem solved by the ‘632 publication is different from the present application, which is to provide new preservative to replace the preservatives used in the art. The technical problem in this application is to promote long-acting iron absorption. The ‘632 publication neither discloses iron absorption promoter, an antioxidant is formed through melt or enzyme free ring opening polymerization or contained in the structural unit of the molecular chain. The ‘632 publication is an enzymatic method which improved over other known chemical methods in that it is easily scalable. Applicant argues choice of monomers id dependent upon the intended use of the resultant antioxidant coupled polymer with different monomers and different enzyme are different. Applicant argues the ‘632 publication polymer is different form the present application in that the polymer coupled with the antioxidant in the present appellation may not have sufficient degree of substation and therefore not sufficient carrying capacity either and slow release may not be achieved.
In response, the ‘632 publication teaches a polymer film functionalized with antioxidants. These antioxidant functionalized polymers can increase shelf life and quality of food products as well as increase effectiveness of pharmaceutical agents when used as coatings. The antioxidant coupled polymers may be used for a variety of applications including coatings on the inside of medical devices such as stents to substantially reduce free radical damage and/or oxygen depletion during medical produces (abstract). Non-limiting examples of antioxidants that may be coupled include procyanidins wherein one monomer may be coupled to each monomer ([0009], [0034], claim 129), reading on contain in the molecular chain of the iron absorption promoter. Examples of monomers are taught to include lactones and vinyl monomers [0011]. The coupling of the antioxidant to the biodegradable monomers is taught to control the delivery of the antioxidant [0017]. The biodegradable polymers are taught to include lactides [0017] specifically polymers of lactic acid ([0079], claim 135). The molecular weight of an exemplified polymer is 7,000 [0117]. The method of polymerization, e.g. melt of enzyme free ring opening, are product by process limitations. The ‘632 publication teaches the ring opening polymerization of lactide polymers containing antioxidant and meet the structural limitation, absent factual evidence to the contrary. Applicant presents arguments regarding the ease of polymerization and selection of monomers, however this does not provide distinct structural features through the use of enzymatic vs non-enzymatic ring opening polymerization.
Applicant argues there is no technical implication s for the iron absorption promoter. The ‘632 publication provides a safe preservative and reduction/prevention of the absorption of compounds is mentioned many times through the entire patent. Thus coupling of the antioxidant to a polymer and preventing absorption and/or exposure of these compounds by a person is an improvement over antioxidant mixtures or emulsions. Those of skill would only think the antioxidant coupled with the polymer is a safe preservative. The polymer in the ‘632 publication cannot be equivalent to the iron absorption promoter and it cannot be considered that the “iron absorption promoter” is disclosed it he ‘632 publication.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ‘031 publication teaches the antioxidant to be bound to the polymer. the ‘031 publication teaching bio erodible endoprostheses including a bio erodible material and an antioxidant carried by the member wherein the antioxidants include phenols (abstract). The endoprosthesis can include a carrier layer carrying the antioxidant on the surface of the member (page 2, lines 15-20) or applied directly to the endoprosthesis (page 5, lines 1-5), thus teaching attached. The bio erodible material can be iron (page 2, lines 29-31) wherein erodible endoprosthesis can be formed of bio erodible metallic materials such as magnesium and iron (page 2, lines 1-5, lines 20-25). Examples of the antioxidants include the elected procyandin (page 7, lines 9-16). The antioxidant can be covalently bonded to the carrier (page 7, lines 25-30) wherein suitable carrier include polylactic acid (PLA) (page 8, lines 15-20).
Applicant argues the ‘632 publication either discloses the substrate is iron based, the ratio of iron absorption promoter to iron based substrate nor the absorption/metabolism is more than 15 after implantation. Applicant argues the ‘632 publication prevent corrosion of oxygen sensitive material, achieve slow release and absorption of antioxidants and reduce/prevent the absorption of compounds.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ‘031 publication teaches the antioxidant to be bound to the polymer. the ‘031 publication teaching bio erodible endoprostheses including a bio erodible material and an antioxidant carried by the member wherein the antioxidants include phenols (abstract). The endoprosthesis can include a carrier layer carrying the antioxidant on the surface of the member (page 2, lines 15-20) or applied directly to the endoprosthesis (page 5, lines 1-5), thus teaching attached. The bio erodible material can be iron (page 2, lines 29-31) wherein erodible endoprosthesis can be formed of bio erodible metallic materials such as magnesium and iron (page 2, lines 1-5, lines 20-25). Examples of the antioxidants include the elected procyandin (page 7, lines 9-16). The antioxidant can be covalently bonded to the carrier (page 7, lines 25-30) wherein suitable carrier include polylactic acid (PLA) (page 8, lines 15-20). The ‘715 publication teaches an absorbable wire composite bone material comprising absorbable magnesium allow and PLA polymer (page 1, first paragraph). The amount of PLA is 5 to 49.9% and the magnesium allow is amount of 50.1 to 95% (page 1, first paragraph), which translates to ratios of magnesium allow to PLA as being between 19:1 to 1.004:1. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known ratios of degradable metal to PLA polymers to be used in implantable devices for the degradable metal stent and PLA coating taught by the ‘031 publication. The ‘632 publication teaches specific methods of coupling the antioxidant to the PLA polymer. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to bond procyandin to polylactic acid polymer as the ‘632 publication teaches it is known to form polymer films with functionalized antioxidants bonded to the polymer for use on medical devices such as stent where the antioxidant may be procyanidin and the polymer may be polylactic acid. One of ordinary skill in the art would have a reasonable expectation of success as the ‘031 publication teaches coating on a stent wherein the coating includes antioxidants which may be covalently bonded to a polymer including polylactide. One of ordinary skill in the art would be motivated to bond the antioxidant such as procyandin to polylactide polymer as the ‘632 publication teaches coupling of the polymer to the antioxidant can control the release of the antioxidant, thus motivating one of ordinary skill in the art to bond the antioxidant to the polymer coating on the medical device.
Applicant argues the office action asserts that optimizing the molecular weight of the antioxidant containing polymer is obvious based on the regains of Farah, which state the molecular weight of PLA impacts the properties such as degradation rate of mechanical strength. This reasoning overlooks critical factors that distinguished the claimed invention from the cited references. The incorporation of an antioxidant into the PLA monomer fundamentally alters its chemical composition, spatial structure and functional groups leading to significant variation in the polymer’s degradation performance. The substantial differences in the molecular weight from the ‘657 publication to this application highlight the extensive modification that occur when an antioxidant is combined with the polymer. The molecular weight of a polymer affects its degradation rate, the result changes are not predictable. The inherent complexities of chemistry mean that simply increasing or decreasing molecular weight can lead to a range of corrosion degradation performance of the iron based varies singularity across components complicating any attempts to draw direct correlation with PLA molecular weight.
In response, it appears Applicant is arguing unexpected results however has not presented any factual data to support the unexpected results. Attorney’s argument may not take the place of factual data wherein factual date is required. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use low molecular weight PLA as Farah teaches low molecular weight PLA provides shorter degradation time that is useful for drug release and prevent inflammation and infection seen with high MW PLA, thus motivating one of ordinary skill in the art to use low molecular weight PLA on the stent taught by the ‘031 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Farah teaches the use of low molecular weight PLA is known and the ‘632 publication teaches examples wherein the polymer to which the antioxidant attached has a low molecular weight. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the molecular weight of the antioxidant containing polymer as Farah teaches the molecular weight of PLA impacts the properties such as the degradation rate and mechanical strength of the polymer, the ‘632 publication teaches the coupling of the antioxidant to a biodegradable monomer to control the delivery of the antioxidant and the ‘277 publication ties the antioxidant to controlled degradation of the endoprosthesis. Thus the skilled artisan would optimize the molecular of the polymer to control the degradation of the prosthesis. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Applicant argues Farah is directed to injection molding and the present invention is formed by spraying.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The limitation of wherein the iron absorption promoter is dissolved in ethyl acetate, dichloromethane or trichloromethane to formulation a solution and then uniformly sprayed on the inner surface and the outer surface of the iron based substrate is met by the ‘031 publication teaching outer and inner surfaces coated with the antioxidant (page 17, lines 20-30) wherein the antioxidant can be applied to the endoprosthesis by being dissolved in a solvent and applied (page 16, lines 15-25) wherein spraying is taught (page 9, lines 20-25) where uniform or non-uniform antioxidant is taught (page 10, lines 20-30). Additionally, the application by dissolution in a specific solvent and uniformly sprayed on the inner surface and outer surface of the iron-based substrate is a product by process limitation. The ‘031 publication teaches the application of the polymer/antioxidant to the inner and outer surface of the implant and thus meet the structural limitations. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Applicant argues that while the ‘277 publication mentions the role of antioxidant in slowing corrosion and controlling the corrosion of the endoprosthesis, it does not suggest that they promote the absorption of corrosion products. As defined in the instant specification the iron absorption/metabolism percentage is calculated using the formula discussed in [0062]. The absorption/metabolism percentage defined in this application reflects the actual bioavailability of iron, which can exceed, but is not equivalent to, the degradation rate or percentage of mass reduction of the device. Additional magnesium does not product insoluble corrosion products and this not associated with absorption challenges in the physical effect. Thus skilled in the art would not be included to refence magnesium related methodologies when addressing the specific technical problems related to enhancing the absorption of iron based corrosion product. Applicant argues the 277 publication teaches antioxidant can inhibit restenosis or provide anti-inflammatory effects or act as a barrier or inhibit corrosive degradation particularly of metals. However the antioxidant of the iron based implantable device the present application promote long acting iron absorption.
In response, the ‘277 publication teaches in embodiments the endoprosthesis exhibits a mass reduction of about 10% or more, e.g., about 50% or more after a period of implantation of one day or more e.g., about 60 days or more, about 600 days or more. [0017]. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The combination of references teach the use of the antioxidant bonded to the polymer applied over the medical device, thus teaching the structure of the device and further overlapping degradation of the device overlapping with the claimed amount.
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613