DETAILED ACTION
Claims 21-38 are currently pending. Claims 21-23, 25-32 and 34-38 are currently pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of 100-300 kDa and poly-racemic lactic acid in the reply filed on 05/16/2025 is acknowledged.
Newly added claims 24 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/16/2025.
Withdrawn Rejection
The double patenting rejection over 17/418,409 is withdrawn based on the abandonment of the ‘409 application.
Examiner’s Note
Applicant's amendments and arguments filed 02/09/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 02/09/2026, it is noted that claims 21-23, 25-32 and 34-38 are newly added.
New Rejections:
The following rejections are newly added based on Applicant’s newly added claims 21-23, 25-32 and 34-38.
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.
Claim(s) 21-23 and 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 106474545 (previously applied) in view of US 2004/0247644 (previously applied) and US 2006/0149365 (previously applied).
Regarding claims 21-23 and 25-29, the ‘545 publication teaches absorbable iron-based alloy implantation medical device which comprises an iron-based alloy substrate, a degradable polymer arranged on the surface of the iron-based alloy substrate and a zinc containing protection body arranged on the surface of the iron-based alloy substrate, wherein the zinc containing protection body is selected form zinc and/or zinc alloy (abstract). The zinc-containing protective body covers the area proportion is greater than 90% wherein at least part of the zinc protector covers the surface (page 2, last paragraph to page 3, first paragraph). The ‘545 publication teaches an iron-based alloy stent including a zinc containing protective body wherein the zinc area accounts for 60%. Poly(racemic) lactic acid-ethyl acetate solution with a molecular weight of 200,000 is sprayed to completely cover the surface of the zinc layer and the exposed surface of the iron stent with a coating thickness of 6 um (Example 6, page 10), 10 um Example 2, 12 um (Example 3), 8um (Example 5, Example 7), thus overlapping with the claimed thickness and thus must fall within the relational expression found in instant claim 21.
The limitation of wherein the material of the zinc-containing matrix is pure zinc or zinc alloy, the mass percentage of zinc in the zinc alloy is 50-99.99% is met by the ‘545 publication teaching when the zinc-containing protective body includes a degradable binder, the weight percentage of zinc and/or zinc alloy is greater than or equal to 20% and less than 100% and wherein the binder is not required to be present (page 3, second paragraph).
Regarding claims 22, the zinc containing layer covers all surfaces of the body is met by the ‘545 publication teaching the zinc containing protective layer may cover the entire surface of the iron-based alloy (page 2, last paragraph).
Regarding claims 23, the limitation of wherein the polylactic acid coating contains an active drug is met by the ‘545 publication teaching the degradable polymer may be mixed with active drugs (page 3, fifth paragraph).
Regarding claims 25-29, the limitation of wherein the polylactic acid is poly-racemic lactic acid with a weight-average molecular weight of 200 kDa; the average thickness of the polylactic acid is located on the outer surface of the polylactic acid coating is 9.1, the average thickness of the polylactic acid located on the inner surface of the polylactic acid coating is 5.0 um; and the average thickness of the polylactic acid located on the side surface of the polylactic acid coating is 9.1 um; outer 11um, side 11 um and inner is 6um; outer 7.1, side 4.5, inner 4.5 um; outer 7.1, side 7.1 and inner 5.1; outer 11.1, side 11.1 and inner 7.1 um is met by the ‘545 publication teaching poly(racemic) lactic acid-ethyl acetate solution with a molecular weight of 200,000 is sprayed to completely cover the surface of the zinc layer and the exposed surface of the iron stent with a coating thickness of 6 um (Example 6, page 10) wherein the coating thickness is taught to be 10 um spray coated on the stent at 2000,000 (Example 2).
The ‘545 publication does not specifically recite kDa.
The ‘545 publication does not specifically recite that xinner ≤ xouter, xinner <xside or wherein the average thickness x of the polylactic acid coating is the same for the outer surface and the side surface and different for the inner surface or the average thickness x of the polylactic acid coating is the same for the inner surface and the side surface and the different for the outer surface.
The ‘644 publication teaches a biodegradable material for use in making items usable in surgery and related fields of medicine. The material comprising a bioabsorbable thermoplastic polymer components (abstract). The device may be an implant [0002]. Poly L-lactide (PLLA) of molecular weight 200,000 Daltons ([0028]-[0029]).
The ‘365 publication teaches a stent with an eccentric coating having a different coating thickness on the stent outer diameter and the stent inner diameter, an eccentric coating. The eccentric coating can be primary carrier for a drug or other therapeutic agent. The eccentric coating can be thicker on the stent outer diameter to supply more drug to the vessel wall in which the coated stent is deployed and less drug to the vessel lumen. The eccentric coating can be applied by spraying a coating liquid on the stent outer diameter with a fixture mandrel interior or the stent to regulate the spray to the stent inner diameter (abstract). The stent coating is taught to have different coating thickness on the stent outer diameter and the stent inner dimer, e.g. an eccentric coating. The eccentric coating can be applied by spraying a coating liquid on the stent outer diameter with a fixture mandrels interior to the stent to regulate the spray to the stent inner diameter [0021]. The stent coating may be applied by as a liquid polymer/solvent matrix. Therapeutic agent can be incorporated in the cap coating [0023]. The whole stent is taught to be coated [0025].
It would have been prima facie obvious to one of ordinary skill in the art that the molecular weight of lactide polymer as taught by the ‘545 publication is in the form of Daltons as the ‘644 publication teaches lactide polymers used as biodegradable materials in the form of surgery is 200,000 Dalton and the ‘545 publication teaches a lactide polymer of 200,000 being used on an implant. It would be obvious to one of ordinary skill in the art that the molecular weight taught by the ‘545 publication be in the form of Daltons as the ‘644 publication teaches a known molecular weight of lactide polymers being used in medical field being 200,000 Daltons.
It would have been prima facie obvious to one of ordinary skill in the art before filing date of the claimed invention to optimize the thickness of the inner, outer and side polymer coating layers on the stent as the ‘545 publication teaches multiple known coating thickness of polylactide coatings on a zinc stent and the ‘365 publication teaches that it is known to different coating thickness on the inner and outer layer of a polymeric coating on stent. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the coating thickness as the ‘365 publication teaches great coating thickness on the exterior surface allows for more drug release to the vessel walls and the ‘545 publication teaches the polymeric coating to be used for drug release. Therefore, it would be obvious to optimize the coating thickness in order to obtain the desired drug release from the outer, inner and side portions of the stent as the ‘365 publication ties the coating thickness to the drug release rate with difference being desired on the interior and exterior. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘365 publication known method for obtained the desired coating thickness.
That being said and in lieu of objective evidence of unexpected results, the coating thickness can be viewed as a variable which achieves the recognized result of successfully desired drug release. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Claim(s) 30-32 and 34-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 106474545 (previously applied) in view of US 2004/0247644 (previously applied), US 2006/0149365 (previously applied) and US 2017/0028107.
Regarding claims 30-32 and 34-38, the ‘545 publication teaches absorbable iron-based alloy implantation medical device which comprises an iron-based alloy substrate, a degradable polymer arranged on the surface of the iron-based alloy substrate and a zinc containing protection body arranged on the surface of the iron-based alloy substrate, wherein the zinc containing protection body is selected form zinc and/or zinc alloy (abstract). The zinc-containing protective body covers the area proportion is greater than 90% wherein at least part of the zinc protector covers the surface (page 2, last paragraph to page 3, first paragraph). The ‘545 publication teaches an iron-based alloy stent including a zinc containing protective body wherein the zinc area accounts for 60%. Poly(racemic) lactic acid-ethyl acetate solution with a molecular weight of 200,000 is sprayed to completely cover the surface of the zinc layer and the exposed surface of the iron stent with a coating thickness of 6 um (Example 6, page 10), 10 um Example 2, 12 um (Example 3), 8um (Example 5, Example 7), thus overlapping with the claimed thickness and thus must fall within the relational expression found in instant claim 30.
The limitation of wherein the material of the zinc-containing matrix is pure zinc or zinc alloy, the mass percentage of zinc in the zinc alloy is 50-99.99% is met by the ‘545 publication teaching when the zinc-containing protective body includes a degradable binder, the weight percentage of zinc and/or zinc alloy is greater than or equal to 20% and less than 100% and wherein the binder is not required to be present (page 3, second paragraph).
Regarding claims 31, the zinc containing layer covers all surfaces of the body is met by the ‘545 publication teaching the zinc containing protective layer may cover the entire surface of the iron-based alloy (page 2, last paragraph).
Regarding claims 32, the limitation of wherein the polylactic acid coating contains an active drug is met by the ‘545 publication teaching the degradable polymer may be mixed with active drugs (page 3, fifth paragraph).
Regarding claims 34-38, the limitation of wherein the polylactic acid is poly-racemic lactic acid with a weight-average molecular weight of 200 kDa; the average thickness of the polylactic acid is located on the outer surface of the polylactic acid coating is 9.1, the average thickness of the polylactic acid located on the inner surface of the polylactic acid coating is 5.0 um; and the average thickness of the polylactic acid located on the side surface of the polylactic acid coating is 9.1 um; outer 11um, side 11 um and inner is 6um; outer 7.1, side 4.5, inner 4.5 um; outer 7.1, side 7.1 and inner 5.1; outer 11.1, side 11.1 and inner 7.1 um is met by the ‘545 publication teaching poly(racemic) lactic acid-ethyl acetate solution with a molecular weight of 200,000 is sprayed to completely cover the surface of the zinc layer and the exposed surface of the iron stent with a coating thickness of 6 um (Example 6, page 10) wherein the coating thickness is taught to be 10 um spray coated on the stent at 2000,000 (Example 2).
The ‘545 publication does not specifically recite kDa.
The ‘545 publication does not specifically recite that xinner ≤ xouter, xinner <xside or wherein the average thickness x of the polylactic acid coating is the same for the outer surface and the side surface and different for the inner surface or the average thickness x of the polylactic acid coating is the same for the inner surface and the side surface and the different for the outer surface.
The ‘644 publication teaches a biodegradable material for use in making items usable in surgery and related fields of medicine. The material comprising a bioabsorbable thermoplastic polymer components (abstract). The device may be an implant [0002]. Poly L-lactide (PLLA) of molecular weight 200,000 Daltons ([0028]-[0029]).
The ‘365 publication teaches a stent with an eccentric coating having a different coating thickness on the stent outer diameter and the stent inner diameter, an eccentric coating. The eccentric coating can be primary carrier for a drug or other therapeutic agent. The eccentric coating can be thicker on the stent outer diameter to supply more drug to the vessel wall in which the coated stent is deployed and less drug to the vessel lumen. The eccentric coating can be applied by spraying a coating liquid on the stent outer diameter with a fixture mandrel interior or the stent to regulate the spray to the stent inner diameter (abstract). The stent coating is taught to have different coating thickness on the stent outer diameter and the stent inner dimer, e.g. an eccentric coating. The eccentric coating can be applied by spraying a coating liquid on the stent outer diameter with a fixture mandrels interior to the stent to regulate the spray to the stent inner diameter [0021]. The stent coating may be applied by as a liquid polymer/solvent matrix. Therapeutic agent can be incorporated in the cap coating [0023]. The whole stent is taught to be coated [0025].
The ‘107 publication teaches an absorbable high strength and corrosion resistant zinc alloy implant material which can be absorbed by the body without side effects (abstract). The zinc alloy implant material contains zinc ([008]-[009]) with zinc present in greater than 50% (claim 8).
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 a zinc alloy as taught by the ‘107 publication for the implant taught by the ‘545 publication because the ‘545 publication teaches the use of a zinc alloy for an implantable device and the ‘107 publication teaches a specific zinc allow known to be used in implantable medical devices. One of ordinary skill in the art would have an expectation of success as the ‘545 publication and the ‘107 publication are both directed to zinc alloys used in implantable medical devices. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to do so as the ‘107 publication teaches the medical implant can be absorbed by the body without side effects.
It would have been prima facie obvious to one of ordinary skill in the art that the molecular weight of lactide polymer as taught by the ‘545 publication is in the form of Daltons as the ‘644 publication teaches lactide polymers used as biodegradable materials in the form of surgery is 200,000 Dalton and the ‘545 publication teaches a lactide polymer of 200,000 being used on an implant. It would be obvious to one of ordinary skill in the art that the molecular weight taught by the ‘545 publication be in the form of Daltons as the ‘644 publication teaches a known molecular weight of lactide polymers being used in medical field being 200,000 Daltons.
It would have been prima facie obvious to one of ordinary skill in the art before filing date of the claimed invention to optimize the thickness of the inner, outer and side polymer coating layers on the stent as the ‘545 publication teaches multiple known coating thickness of polylactide coatings on a zinc stent and the ‘365 publication teaches that it is known to different coating thickness on the inner and outer layer of a polymeric coating on stent. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the coating thickness as the ‘365 publication teaches great coating thickness on the exterior surface allows for more drug release to the vessel walls and the ‘545 publication teaches the polymeric coating to be used for drug release. Therefore, it would be obvious to optimize the coating thickness in order to obtain the desired drug release from the outer, inner and side poritions of the stent as the ‘365 publication ties the coating thickness to the drug release rate with difference being desired on the interior and exterior. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘365 publication known method for obtained the desired coating thickness.
That being said and in lieu of objective evidence of unexpected results, the coating thickness can be viewed as a variable which achieves the recognized result of successfully desired drug release. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘365 patent only discloses a stent having an eccentric coating that has different coating thickness. This does not disclose the specific relationships recited in claim 21 with the average thickness calculated under the claimed formula.
In response, the ‘365 publication teaches a stent with eccentric coating which can be a primary carrier for a drug, with the coating thickness on the outer diameter being thicker to supply more drug to the wall and less to the lumen. It would have been prima facie obvious to one of ordinary skill in the art before filing date of the claimed invention to optimize the thickness of the inner, outer and side polymer coating layers on the stent as the ‘545 publication teaches multiple known coating thickness of polylactide coatings on a zinc stent and the ‘365 publication teaches that it is known to different coating thickness on the inner and outer layer of a polymeric coating on stent. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the coating thickness as the ‘365 publication teaches great coating thickness on the exterior surface allows for more drug release to the vessel walls and the ‘545 publication teaches the polymeric coating to be used for drug release. Therefore, it would be obvious to optimize the coating thickness in order to obtain the desired drug release.
Applicant argues the ‘545 publication discloses that when the zinc containing ally is greater than or equal to 20% and less than 100%, the eight content disclose in the ‘545 and that recite in claim 21 have different meanings. The ‘545 publication teaches a mixture of the zinc and the degradable adhesive. When the zinc containing protect includes the degradable adhesive, the weigh percentage of zinc and/or zinc alloy is more than or equal to 20%.
In response, the ‘545 publication teaches the zinc containing protective body may be pure zinc and/or zinc alloy, wherein pure zinc meets the instant claim limitations. Additionally, the ‘107 publication teaches zinc alloys used in implantable medical devices wherein the zinc is over 50% and the device is absorbed without side effects (abstract, claim 8).
Applicant argues the ‘365 publication cannot be combined with the ‘545 publication. The ‘545 is a polylactic acid that is used to regulate corrosion while the ‘365 publication is a drug carrier. Applicant argues the ‘545 publication teaches absorbable iron-based alloy that corrodes slowly, in contrast the ‘365 publication teaches drug release. These are two very different functions.
In response, the ‘545 publication teaching the degradable polymer may be mixed with active drugs (page 3, fifth paragraph), thus teaching the polymeric coating is a drug carrier as is used in the ‘365 publication.
Applicant argues the ‘545 publication teaches away from the claimed invention stating that corrosion speed would be increased. A person of skill in the art when combining the content disclosed in [0004] would expect that local micro-acidic environment formed by polylactic acid degradation can accelerate iron corrosion and can similarity accelerate zinc corrosion. One of skill in the art would not believe that the corrosion rate of zinc could be reduced by regulating the molecular weight a thickness of polylactic acid. The invention achieves unexpected results when the molecular weight and thickness of polylactic acid falls within the formula range of the present invention the corrosion rate of the zinc layer is significantly lower than when they do not fall within the range.
In response, the presented results are not commensurate in scope with the instant claims. The tested examples include pure zinc stent comprising specific molecular weight polylactic acid at specific thickness of outer, side and inner thicknesses. The instant claims are broader than the presented examples, wherein independent claims contain xinner less than or equal to outer, xinner less than side, wherein the zinc containing matrix is pure zinc or zinc alloy attached to a body, and wherein the molecular weight is not resulted. Dependent claims further contain limitations to the zinc obtaining matrix to be the zinc alloy, and specific molecular weights and thickness of the outer, side and inner layers, however no claims are directed specifically to the tested pure zinc stent with the specific molecular weight and thickness on the outer, side and inner stent.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
