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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/17/2026 has been entered.
Claim Objections
The reply filed on 3/17/2026 is not fully responsive to the prior Office Action because of the following omission or matter :
The amendments to the claims do not comply with the Revised Amendment Practice of 37 CFR 1.121 (See OG Notice 23 September 2003). Specifically, a list of all claims should be submitted, the text of withdrawn claims must be included in the listing of the claims and the text of canceled claims must be omitted. Further the claims must have the proper identifiers in parenthetical expression.
New claim 29 appears to replace claim 29 as originally presented in the claim set filed 8/22/2025. Originally presented claim 29 should have been canceled and new claim 29 should have been labeled as claim 30. Applicant should cancel claims 29-32 and resubmit them as new claims 33-36. If Applicant desires to resubmit claim 29 as written in the claim set from 8/22/2025, Applicant must do this by adding it as a new claim. It is noted that 37 CFR 1.121 also states a claim which is previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Response to Amendments
In view of the amendment to the claims broadening their scope, the Notice of Allowability mailed 12/2/2025 is vacated and the Restriction requirement is reinstated. The claims as amended are no longer commensurate in scope with the previously presented data as such reinstated prior art rejections are presented below.
As previously noted by the Examiner, data is not commensurate in scope with the instant claims. All tested embodiments have a zinc matrix with a scaffold body wherein the zinc matrix is zinc or zinc alloy and the scaffold body is made of iron, Mg, stainless steel, iron alloy, zinc alloy or PLA. Also all examples comprise rapamycin or paclitaxel dispersed in a PLA carrier. The claims as amended embrace a multitude of polymers being the scaffold body (both degradable and non-degradable) or drug carrier (no limits at all), but only PLA was tested for both of these, the data does not present a trend showing that all polymers would results in the required effect when used as the scaffold body or drug carrier.
Election/Restrictions
Claims 17, 19 and 30 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/16/2024.
Upon further consideration of the art previously applied, the species requirement of matrix type, is withdrawn.
New 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 15, 18, 23 and 28 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 15 and 29 recite multiple wherein clauses, but there is no conjunction “and” or “or” thus its unclear if all the wherein clauses are required or if they are presented as alternatives. For purposes of examination the examiner will interpret the claim as reciting the conjunction “and” which makes the claimed equation, which has been stated multiple times by Applicant to be a crucial component, a required ingredient and not an optional one.
Claims 18, 23, 28 and 31-32 are rejected in view of their dependency on claim 15 or 29 as they do not cure the deficiencies of claim 15 and 29 and thus are deficient for the same reasons.
Reinstated 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.
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) 29 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 104857570, Zhao (US 2008/0200421) and Ma (2016). All references are previously cited.
Regarding claim 29: CN’570 discloses a biodegradable metal stent [0002]. The stent is made with a degradable zinc-based material matrix, a degradable polymer eluting coating containing therapeutic drugs arranged on the surface of the stent (reading on active drug layer attached to the zinc-containing matrix as recited by instant claim 15) and the stent matrix is a cylindrical mesh structure [0013]. CN’570 teaches that the degradable zinc-material is pure zinc or a zinc-based alloy, thus it would have been prima facia obvious to formulate the stent matrix (i.e. body) to comprise pure zinc (elected species). CN’570 also teaches that stent has uniform corrosion and the stent can maintain a supporting state in the blood vessel for a long time [0032].
Regarding claim 31: CN’570 teaches the degradable polymer elution coating to preferably comprise polylactic acid as the degradable polymer (elected species) and rapamycin as the therapeutic drug [0017].
Regarding claim 32: CN’570 teaches that the stent can be a vascular stent [0034] and teaches it to be a cylindrical mesh, reading on vascular scaffold.
CN’570 teaches that drug-eluting stents help reduce smooth muscle cell proliferation after surgery due to pharmacological effects of anti-proliferative drugs [0004]. CN’570 teaches that metallic zinc has excellent mechanical properties and developability and good biocompatibility and better degradation performance than magnesium-based alloys [0009]. CN’570 teaches that by carrying drugs that can inhibit the proliferation of smooth muscle cells on the surface of the stent, the pharmacological action of the drug can inhibit the proliferation and thickening of the intima, thereby reducing or even eliminating the occurrence of restenosis in the stent [0011].
However, CN’570 does not teach the active drug content and content of zinc eroded from the matrix to satisfy the claimed equation.
Zhao teaches medical devices and teaches that rapamycin is an active agent that prevents smooth cell proliferation and migration and should be used in amounts which are non-toxic but are sufficient to provide the desired local or systemic effect and performance at a reasonable benefit/risk ratio attending any medical treatment [0035-0036].
Ma teaches that bioabsorbable metal zinc (Zn) is a promising new generation of implantable scaffolds for cardiovascular and orthopedic applications. In cardiovascular stent applications, zinc ions (Zn2+) will be gradually released into the surrounding vascular tissues from such Zn-containing scaffolds after implantation. Lower concentrations (<80µM) of Zn2+ had no adverse effects on cell viability but promoted cell adhesion, cell spreading, cell proliferation, cell migration, and enhanced the expression of F-actin and vinculin. Cells treated with such lower concentrations of Zn2+ displayed an elongated shape compared to controls without any treatment. In contrast, cells treated with higher Zn2+ concentrations (80–120μM) had opposite cellular responses and behaviors. Gene expression profiles revealed that the most affected functional genes were related to angiogenesis, inflammation, cell adhesion, vessel tone, and platelet aggregation. Results indicated that Zn has interesting concentration-dependent biphasic effects on SMCs with low concentrations being beneficial to cellular functions (Abs). Ma teaches that Zn is an alternative to Mg and Fe (or perhaps a better choice) for cardiovascular stent application after all because of its better mechanical and corrosion properties (pg. 1). Studies demonstrates that that Zn might suppress the SMCs activities which is closely related to restenosis. In vitro study showed that pure Zn had lower corrosion rate, better hemocompatibility, and low cytotoxicity for cardiovascular stent application, compared to high purity Mg (pg. 2).
Ma discusses the effect of different concentration of zinc on smooth muscle cells and as taught by CN’570 and Zhao teaches that rapamycin can be effectively combined with zinc on a medical device and rapamycin is taught to inhibit proliferation of smooth muscle cells, therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts of rapamycin and corroded zinc to achieve the effect of effectively inhibiting smooth muscle cells without toxic side effects. While the prior art does not make obvious the claimed equation, the prior art is clear that the amounts of rapamycin and zinc can be optimized and it is well established that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
Claim(s) 15, 18, 20, 23 and 28-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cryer (AU 2015252144), Zhao (US 2008/0200421) and Ma (2016).
Regarding claims 15 and 29: Cryer teaches degradable implantable medical devices comprising a tubular body comprising a corrodible metal alloy including at least one corrosion-controlling element within the corrodible metal alloy and a passivation layer or a coating incorporated in or covering at least a portion of the body (Abs).
Cryer teaches an implantable body having a first layer having a 1st degradation rate comprising a metal, metal alloy or a combination thereof and a 2nd layer having a 2nd degradation rate comprising a metal, metal alloy or a combination thereof (pg. 5).
Cryer teaches that preferred metal and metal alloys include zinc, thus it would have been prima facie obvious to use pure zinc as the metal in 1st and/or 2ndlayer. Cryer teaches that the zinc containing layer (i.e. matrix) can cover at least a portion of the implant surface to initiate corrosion of the implant [0106], reading on the claimed body and zinc containing portions attached to the body as required by instant claims 15 and 18.
Cryer teaches that the implantable body comprises a metal, metal alloy or a combination thereof. A preferred metal is taught to be iron, thus it would have been prima facie obvious to use pure iron and not an iron alloy as this is specifically contemplated by Cryer (pg. 3).
Regarding claims 15, 23 and 31: Cryer teaches that an active agent can be released from the implant using non-degradable, partially degradable, fully degradable coating, or a combination. The active agent can be applied to the surface of the implant with a top coat [0125], a suitable active agent includes rapamycin [0129] and the coating can include a degradable polymer such as polylactic acid (Cryer – claims 2-6).
Regarding claim 20: Cryer makes obvious a coating layer comprising polylactic acid and rapamycin as a top coat, therefore, the top coat is expected to at least partially or completely cover the 1st and/or 2nd layers zinc layers already present on the implantable body.
Regarding claims 28 and 32: Cryer teaches the medical device to be a vascular stent and teaches that stents are small metal coil, slotted tube, mesh or scaffold, which reads on vascular scaffold (pg. 5 and [0005]).
However, CN’570 does not teach the active drug content and content of zinc eroded from the matrix to satisfy the claimed equation.
Zhao teaches medical devices and teaches that rapamycin is an active agent that prevents smooth cell proliferation and migration and should be used in amounts which are non-toxic but are sufficient to provide the desired local or systemic effect and performance at a reasonable benefit/risk ratio attending any medical treatment [0035-0036].
Ma teaches that bioabsorbable metal zinc (Zn) is a promising new generation of implantable scaffolds for cardiovascular and orthopedic applications. In cardiovascular stent applications, zinc ions (Zn2+) will be gradually released into the surrounding vascular tissues from such Zn-containing scaffolds after implantation. Lower concentrations (<80µM) of Zn2+ had no adverse effects on cell viability but promoted cell adhesion, cell spreading, cell proliferation, cell migration, and enhanced the expression of F-actin and vinculin. Cells treated with such lower concentrations of Zn2+ displayed an elongated shape compared to controls without any treatment. In contrast, cells treated with higher Zn2+ concentrations (80–120μM) had opposite cellular responses and behaviors. Gene expression profiles revealed that the most affected functional genes were related to angiogenesis, inflammation, cell adhesion, vessel tone, and platelet aggregation. Results indicated that Zn has interesting concentration-dependent biphasic effects on SMCs with low concentrations being beneficial to cellular functions (Abs). Ma teaches that Zn is an alternative to Mg and Fe (or perhaps a better choice) for cardiovascular stent application after all because of its better mechanical and corrosion properties (pg. 1). Studies demonstrates that that Zn might suppress the SMCs activities which is closely related to restenosis. In vitro study showed that pure Zn had lower corrosion rate, better hemocompatibility, and low cytotoxicity for cardiovascular stent application, compared to high purity Mg (pg. 2).
Ma discusses the effect of different concentration of zinc on smooth muscle cells and Zhao teaches that rapamycin can be effectively combined with zinc on a medical device and rapamycin is taught to inhibit proliferation of smooth muscle cells, therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts of rapamycin and corroded zinc in the device of Cryer to achieve the effect of effectively inhibiting smooth muscle cells without toxic side effects. While the prior art does not make obvious the claimed equation, the prior art is clear that the amounts of rapamycin and zinc can be optimized and it is well established that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
MPEP 2144.05 II: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)"
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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